COUNTRYISSN 2256-0580 World Medical Journal Official Journal of The World Medical Association, Inc. Nr. 2, July 2015 vol. 61

Contents

The General Assembly in Moscow ...... 41

200th WMA Council Session, Oslo, April 2015 ...... 42

WMA Council Resolution on Trade Agreements and Public Health ...... 52

World Health Assembly Week ...... 53

Global Epidemics . Industrialised Nations Must Develop Global Strategies to Counter Epidemics ...... 57

WMA Roles for Climate Action ...... 58

The Art and Heart of Medicine ...... 60

One Health: A Concept for the 21st Century ...... 62

Pros and Cons of the Over-the-counter Sales of Antimicrobials ...... 64

Medicines Shortages: Global Problems Need Global Solutions ...... 69

Do Ethics Need to Be Adapted to mHealth? A Plea for Developing a Consistent Framework ...... 72

Health Apps – Sound and Trustworthy? ...... 75

Interview with Vytenis Andriukaitis, EU Commissioner for Health and Food Safety . . . . 78

Position of Israeli Medical Association in Forced Feeding Issue ...... 82 WMA News

World Medical Association Officers, Chairpersons and Officials

Dr . Xavier DEAU Dr . Margaret MUNGHERERA Sir Michael MARMOT Dr . Ardis D . HOVEN WMA President WMA Immediate Past-President WMA President-Elect WMA Chairperson of Council Conseil National de l’Ordre des Uganda Medical Association British Medical Association American Medical Association Médecins (CNOM) Plot 8, 41-43 circular rd., P.O. BMA House, Tavistock Square AMA Plaza, 330 N. Wabash, 180, Blvd. Haussmann Box 29874 London WC1H 9JP Suite 39300 75389 Paris Cedex 08 Kampala United Kingdom 60611-5885 Chikago, Illinois France Uganda United States Dr . Heikki PÄLVE Dr . Donchun SHIN Dr . Joseph HEYMAN WMA Chairperson of the Medical Dr . Otmar KLOIBER WMA Chairperson of the Finance WMA Chairperson Ethics Committee Secretary General The General Assembly in Moscow and Planning Committee of the Associate Members 163 Finnish Medical Association World Medical Association Korean Medical Association Middle Street P.O. Box 49 13 chemin du Levant October 14–17, 2015 46-gil Ichon-ro West Newbury, Massachusetts 01985 00501 Helsinki 01212 Ferney-Voltaire Yongsan-gu, Seoul 140-721 United States Finland France Korea Amnesty International and Physicians for Human Rights, to name Dr . Masami ISHII Dr . Miguel Roberto JORGE An Invitation Prof . Dr . Frank Ulrich WMA Treasurer WMA Chairperson of the Socio- just a few. MONTGOMERY Japan Medical Assn Medical Affairs Committee The World Medical Association was founded in the wake of World WMA Vice-Chairperson of Council 2-28-16 Honkomagome Brazilian Medical Association War II. After a two-year preparation period, 27 medical associations We support member associations in making their case for the ethi- Bundesärztekammer Bunkyo-ku Rua-Sao Carlos do Pinhal 324, met in Paris in September 1947 to found a new association. Since cal practice of our profession, we call upon governments to allow Herbert-Lewin-Platz 1 (Wegelystrasse) Tokyo 113-8621 CEP-01333-903 Sao Paulo-SP then, medical ethics and socio-medical affairs have been at the core physicians to perform properly and we advise on how to stay within 10623 Berlin Japan Brazil Germany or our work and we are proud to have shaped major international the rules. We are searching deeper for the causes behind the causes medical guidelines and regulations over the past seven decades. of diseases, and we often find very simple mechanisms that deter- mine our health and our chances of dealing with disease. Of course, physicians have had many other interest groups both before and since, but the WMA became, and still is, an advocacy The WMA has become a strong voice for physicians and their pa- www .wma net. group striving to make the best health care possible for all, including tients worldwide and we need to stay that way: able to raise ques- through health education, prevention, rehabilitation and palliative tions, willing to find answers, and able to speak out. We invite our therapy, aside from curative care and public health. members – Constituent and Associate Members – to join us in Moscow from 14–17 October for the Council Session and the 2015 Over past years, aspects of human rights and social determinants General Assembly. Please register on our website now. We need ev- have become more prominent and important for the work of the ery single one of you! association. The spectrum we deal with stretches from equitable ac- http://www.wma.net/en/50events/10statutorymeetings/13ga_2015/ cess to treatment through to issues of human rights violations in index.html Official Journal of The World Medical Association medicine right up to the challenge of preserving medical neutrality. We are now working more closely than ever on human rights issues Dr. Otmar Kloiber with partners like the International Committee of the Red Cross, WMA Secretary General

Editor in Chief Dr. Pēteris Apinis, Latvian Medical Association, Skolas street 3, Riga, Latvia Phone +371 67 220 661 [email protected], [email protected]

Co-Editor Prof. Dr. med. Elmar Doppelfeld, Deutscher Ärzte-Verlag, Dieselstr. 2, D-50859 Köln, Germany

Assistant Editor Inese Sviestiņa, [email protected]

Journal design and cover design by Pēteris Gricenko

Layout and Artwork Latvian Medical Publisher “Medicīnas apgāds”, President Dr. Maija Šetlere, Katrīnas street 2, Riga, Latvia

Publisher Latvian Medical Association “Latvijas Ārstu biedrība”, Skolas street 3, Riga, Latvia.

ISSN: 2256-0580

Opinions expressed in this journal – especially those in authored contributions – do not necessarily reflect WMA policy or positions

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Emergency Resolution about 40 years’ experience of the alcohol ban in Norway. She said th 200 WMA Council Session, Oslo, April 2015 A proposal was put forward by the British Medical Association that the ban, which was introduced in 1975, was very strict and probably the meeting should consider an urgent Resolution about the several the most comprehensive in Europe. It covered all the media and trade agreements being negotiated throughout the world and their all expressions associated with alcoholic beverages. Phrases such as impact on the provision of health. The Council accepted this as an ‘happy hour’ and ‘a cold one’ were even covered, as well as the mere The 200th WMA Council meeting, was held at the Hotel Bristol in Oslo, Melbourne, where it was concluded that health was a wise investment urgent matter which should be discussed in committee. The Council use of a neutral picture of a beverage and alcohol sponsorships such Norway. The meeting was opened by the Secretary General Dr. Otmar and an economic driver in society for the creation of employment. then adjourned for the committee meetings. as beer brands on football shirts and on boards at sport venues. Kloiber, who began by reminding delegates that this was a confidential He also spoke about WMA’s role on the issue of climate change, the The aim of the ban was twofold – to reduce directly the demand and meeting and that tweeting should not take place. There were no apolo- importance of the issue of the Social Determinants of Health and the thereby the consumption and harm of alcohol, and secondly to re- gies for absence. He welcomed three new members of Council, Dr. Heidi successful revision of the Declaration of Helsinki. Finance and Planning Committee inforce the effect of other alcohol policy measures and to contribute Stensmyren from Sweden, Prof. Rutger Jan Van Der Gaag from the to the support for the alcohol policy as a whole. Netherlands and Dr. Carlos Jorge Janez from Argentina. He also wel- Secretary General’s Report Dr. Dongchun Shin (Korean Medical Association) was elected un- Addressing the question of whether the ban was working, Ms Ottesen­ comed delegates from more than 35 national medical associations, Past Dr. Kloiber had presented a lengthy written report to Council about opposed as Chair of the Committee. The Committee received a re- replied that it was. Alcohol consumption in Norway was low com- Presidents, observers and guests and in particular the return of one of the the secretariat’s activities. In his oral report he highlighted two port on membership dues payments and on the Financial Statement pared to the rest of Europe and there was evidence to back up the WMA’s founding members, the Italian Medical Association. ­issues to illustrate the WMA’s influence and impact. for 2014.The Committee approved the document as an interim fi- assumption that the ban reinforced other alcohol measures. Public The Association had received an invitation from the United States nancial statement. A debate took place on a new dues structure. support for the ban had grown in recent years. There had been chal- Defence Health Board to advise the US Defence Secretary and the lenges to the ban from the alcohol industry, but there was now a broad Council US military on issues relating to health and the military. The WMA political consensus that Norway should keep the ban. was invited to take part in a session on medical ethics. Past Presi- Alcohol Session She concluded: ‘We believe that it is important to maintain a strict Elections and Appointments dent Dr. Cecil Wilson represented the WMA at this meeting and the and media neutral advertising ban. We do not see any threats to The Council began with an election for Chair of Council. Two nomi- Board came out with 16 recommendations. Dr. Kloiber then quoted The Committee meeting then adjourned to hear two invited speak- the ban as such, but as there will always be changes in society, com- nations were received – from the sitting Chair Dr. Mukesh Haik- from a letter from the Vice Chair of the US Senate Committee on ers talking about the alcohol policy in Norway. Mr Øystein Bakke, munications and industry, and we must make sure that the ban and erwal (Australian Medical Association) and from Dr. Ardis Hoven Intelligence, Senator Dianne Feinstein, to the US Defence Secretary Senior Adviser, FORUT, Campaign for Development and Solidar- its exceptions adapts to these changes. This, along with an efficient (American Medical Association). Both candidates briefly addressed referring to the WMA’s Declaration of Malta on the issue of ending ity and Secretary of the Global Alcohol Policy Alliance, spoke about control and sanction system, is important to safeguard the support the meeting. Dr. Haikerwal, a former President of the Australian the forced feeding of detainees at Guantanamo Bay. Norway’s 40 years of experience with a ban on alcohol advertising. for the ban also in the years to come.’ Medical Association, spoke about his achievements as a leader of the The second development illustrating the WMA’s impact related to He said that increasing amounts of evidence showed that alcohol ad- medical profession throughout his career and talked about his vision the issue of scheduling the drug Ketamine some weeks ago by the vertising and other marketing efforts had an impact on consumption. for the future of the WMA to build on his work of the past four years. United Nations Commission on Narcotic Drugs. The WMA had Marketing was a dominant feature of the global alcohol trade, and Finance and Planning Committee (resumed) Dr. Hoven, Immediate Past President of the American Medical As- asked its members to argue against this scheduling as many people drinks companies spent massively towards “investments in the brands”. sociation, spoke of the great opportunity the WMA had to influence would have suffered from the absence of the drug. Eventually it was Advertising and marketing had the strongest impact on young people, WMA Strategic Plan medical practice and global health, and the complex and far reaching decided to postpone the decision for a year and Dr. Kloiber thanked speeding up onset of drinking and increasing the amount consumed by The Secretary General spoke about the WMA’s strategic alliances challenges facing the Association – shrinking resources, complicated those NMAs who had lobbied on this issue. those who already drank. The alcohol industry looked for new markets and highlighted a number of activities implemented according to its and difficult practice environments, shifting government regulations Dr. Margaret Mungherera, the Immediate Past President, said that as the traditional markets of the West were becoming less profitable. In strategic plan. These included organising another Regulation Con- and dangerous working conditions. The WMA’s current work spoke the largest threat to global health were the African health systems, these emerging markets in Africa and Asia, marketing was effective in ference with the World Health Professions Alliance in May 2016. to its impact and credibility. She said she valued consensus and the but there was not enough attention being paid to this. She said the recruiting new consumers from the non-drinking population. There would be a Global One Health Conference with the World WMA’s diversity and she would work to increase the Association’s WMA needed to keep this issue on the agenda. The WMA had The alcohol industry’s response to calls for marketing regulations Veterinarian Association on 21–22 May in Madrid with an agenda visibility and strengthen its voice. In the vote, Dr. Hoven was elected done a lot of work to reduce the deafening silence of NMAs in was “self-regulation”. This approach to alcohol marketing had gen- concerning issues relating to both professions. There would be a and immediately took the Chair, thanking the Council for its support ­Africa on this issue, but it had a moral authority to do more and erally been deemed ineffective by several studies, but the alcohol UNESCO Bioethics Conference from October 20–22 in Naples at and in particular thanking Dr. Haikerwal for his work as Chair. could not afford to sit back. producers and their so called “social aspects organizations” still re- which the WMA would be organising two sessions and the WMA Prof. Dr. Frank Ulrich Montgomery (German Medical Associa- ferred to this as the best way forward. was now participating in the World Federation of Medical Educa- tion) was elected unopposed as Vice-Chair to succeed Dr. Masami Chair’s Report He said that, marketing restrictions existed in many countries tion as a voting member. Ishii and Dr. Ishii ( Japan Medical Association) was elected unop- In his report, Dr. Haikerwal reported on the WMA’s increased foot- around the world and not only in Norway. Almost 50 countries had posed as Treasurer to succeed Dr. Montgomery. print on the global health map. He referred to the first “H20+” Health a total ban on alcohol advertising on national television in 2012, Business Development The Council approved the membership of the Council committees Summit in Melbourne, adjacent to the G20 World Leader’s Summit. while another 50 had some sort of partial restriction on TV adver- A report was given on the Business Development Group’s work and approved the names of their advisers. He said ethical guidance and ensuring access to health and healthcare tising. That added up to about half the world’s countries. Advertis- and the issue of finding external sources of funding. The Group had remained core and key. He and the WMA’s leaders continued to re- ing bans were effective measures, particularly in reducing the impact worked on the first principle that the core work of the WMA had to President’s Report mind people that health was a core component of a successful fair and on underage and young consumers. be funded by membership subscriptions. The question was whether The President Dr. Xavier Deau gave an interim report on his activities just society, that health was a wise investment and that health brought The second speaker, Lilly Sofie Ottesen, Deputy Director General of other activities, such as educational activities, should be funded in since his inauguration in Durban last year. He referred to the work on human, political and economic dividends. Physicians were part of the the Unit for Alcohol and Illicit Drugs Policy at Norway’s ­Ministry some way by external sources. The meeting agreed that the Group the Health Care in Danger project and the H20 Health Summit in solution in health and healthcare research planning implementation. of Health and Care Services Department of Public Health, spoke should prepare a paper on the issue and come back to the Committee.

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Future Meetings sented for the WMA. He said there was a need for some guidelines medical issues. He again highlighted the key importance of address- document, which would be an online publication only, be submitted The Committee considered the planning and arrangements for fu- and rules for a more efficient and productive use of social media. ing violence against health care personnel and facilities that occurred to the Committee for consideration ture WMA statutory meetings. The Taiwan Medical Association not only in situations of armed conflict, but also in civil situations. suggested that at the Assembly meeting in Taipei in October 2016 IFMSA Memorandum of Understanding There were some instances, such as in Mexico, where violence was Violence Against Women and Girls the scientific session should be on ‘Healthcare System Sustainabil- Dr. Kloiber reported on a new Memorandum of Understanding reaching armed conflict in a war on drug gangs between the state Sir Michael Marmot reminded the Committee of the very success- ity’ with two sessions, the first on ‘Health System Performance’ and with the International Federation of Medical Students Associa- and the people, and doctors were being taken hostage and killed. ful WMA luncheon held in Geneva in May 2014 alongside the the second session on ‘eHealth’. This was agreed. tions. Dr. Agostinho de Sousa, President of IFMSA, explained that He mentioned the WMA’s commitments in this area, in particular World Health Assembly that was dedicated to violence against The Secretary General reported that as in previous years, a WMA IFMSA had been cooperating with the WMA since the 1960s, within the Health Care in Danger Project, initiated by the ICRC. women. He said that one in three women globally would experience luncheon in Geneva would again be held during the WHO World and that the official MoU would facilitate future collaboration. The He called on national medical associations to cooperate with the physical or sexual violence. This was a huge public health issue. It Health Assembly period. The main theme this year would be public Committee agreed to recommend to the Council to accept the new Secretariat in sharing information on situations in their countries was now proposed that the British Medical Association would host health issues, including health and investments. Dr. Haikerwal re- Memorandum of Understanding. and to become further engaged in addressing this issue. a discussion meeting of interested NMAs in London about how the ported that a second H20+ Health Summit was also being planned WMA could continue working on this subject. following the success of the Melbourne meeting. Internship and Secondment Health and the Environment The Committee received an oral report from the Secretary General Dr. Shin, Chair of the Environmental Caucus, reported on the ac- Social Determinants of Health Associate Members on internships and secondment to the WMA. He reported that two tivities of the Caucus that had met the previous day. The meeting A report on the successful BMA symposium that was held in March The Committee received an oral report from the Chair of the As- bioethics students from the University of Pennsylvania and medical had focused on the forthcoming United Nations Climate Change organised jointly by the British Medical Association, the Canadian sociate Members, Dr. Joe Heyman. He informed the Committee students from the IFMSA had been interning at the WMA Secre- Conference in Paris in early December 2015. The expected outcome Medical Association and the Institute of Health Equity was given of his plans to draw more commitment from individual associate tariat in Ferney Voltaire annually. He asked NMAs to consider sec- of the event was to reach a new universal agreement on climate by Sir Michael Marmot. He updated the Committee on his plans members by promoting membership through introducing life mem- ondment for intensive contact with the WMA for mutual benefit. aiming at keeping global warming under 2°C. So far the draft ne- for following up the conference. The first aim would be to continue bership. An international conference call was planned for May and gotiating text included a plan to completely phase out fossil fuel strengthening global networks and building a social movement. The he also spoke about holding regional, on-site meetings when statu- Violence Against Doctors emissions. The text also for the first time included language on the next would be to increase the visibility of the WMA Statement on tory meetings were held and linking up with the Junior Doctors The meeting heard a report from the Indian Medical Association health benefits of climate action. Social Determinants of Health and build on the best evidence to pro- Network and the Past Presidents and Chairs of Council Network. about increasing incidents of assaults on doctors by patients in India. Participants in the Caucus had discussed ways of influencing the duce a report. The third aim would be to develop educational tools for Dr. Kloiber ­agreed that this was a very pressing issue that had arisen in process and have doctors’ voices heard at the national and interna- physicians to learn what they could do to tackle the Social Determi- Junior Doctors Network countries around the globe. He had received reports in recent months tional level. Dr. Deau had presented a plan for the WMA in col- nants of Health through online courses and training workshops. The Chair of the Junior Doctors Network, Dr. Ahmet Murt, gave an from every continent, from Asia, Eastern Europe and from Latin Amer- laboration with the Société Française de Santé Publique (French oral report on the JDN’s activities. Among the current topics it was ica. The WMA had recently issued a press release about the case of a sur- Society of Public Health) and the European Public Health Asso- Role of Physicians in Preventing the Trafficking with Minors and Illegal working on were physicians’ wellbeing, medical work force, medical geon murdered in a Boston hospital in the USA. There had also been a ciation to target the French negotiating team, which would have a Adoptions education, Ebola and social media. recent case in Germany. He added that this was a second line of violence major role in the negotiations as it was the host country of the event. It was reported that experts on the topic had been consulted over in addition to the violence taking place in areas of armed conflict, about recent months. However, having not received enough material or Past Presidents and Chairs of Council Network which the WMA was working with the International Committee of the Health Care in Danger responses, it had so far not been possible to submit a paper to the Delegates received a written report on the activities of the Past Presi- Red Cross. He told the meeting that the WMA would need to step up Prof. Vivienne Nathanson, Chair of the Work Group on Health Work Group. It was hoped that the Work Group would be in a dents and Chairs of Council Network. Dr. Cecil Wilson had repre- its work on violence against doctors not connected with armed conflict. Care in Danger, reported on the activities of the Group, which had position to submit a draft policy in October 2015. sented the WMA at the U.S. Defence Health Board Subcommittee met the previous day. She said Dr. B. Eshaya-Chauvin (ICRC) had It was decided to postpone further discussion until the next com- Meeting in February, Prof. Dr. José Luiz Gomes do Amaral had given updated the Group on the latest developments on the ICRC proj- mittee meeting in Moscow. expert advice on the possible scheduling of Ketamine as a narcotic drug Socio-Medical Affairs Committee ect. He said the project had been extended by two years. The Group and Dr. Dana Hanson was presenting a paper entitled, “Global Physi- discussed ways of translating into action the recommendations Proposed Statement on Physicians’ Well-Being cian Resilience: The Role of Social Context to the European Associa- Elections emerging from the project. Two actions were identified: that NMAs A new draft Statement on Physicians’ Well-Being was presented tion for Physician Health” in Barcelona in April. Dr. Jon Snaedal gave The proceedings began with a contested election for Chair of the make contact with Red Crescent societies at the national level and to the Committee by the Work Group. There was a brief debate an oral report and said the activities of the Network were increasing. Committee, following the decision of President Elect Sir Michael that the WMA website include a defined area featuring activities about the need for doctors with disabilities to be enabled to return Marmot to stand down. Two candidates were nominated, Prof. developed by NMAs in this area. to work by making the necessary adaptions to the workplace. It was World Medical Journal Miguel Roberto Jorge (Brazilian Medical Association) and Dr. An- The Group had examined a proposed revision of current WMA policy also argued that the paper should contain a more expanded section The WMJ Editor, Dr. Peteris Apinis, in his oral report, said the dré Bernard (Canadian Medical Association). After both candidates on Ethical Issues Concerning Patients with Mental Illness adopted in on physicians at risk from alcohol abuse. It was agreed to recom- transition producing a digital edition of the Journal had been com- addressed the meeting, the Committee elected Prof. Jorge, Associate 2006. This revision would reflect doctors’ concerns about recent policy mend to Council that the paper should be recirculated to NMAs plicated. Four issues had been scheduled for this year and the first Professor of Psychiatry and Chair of the Research Ethics Commit- developments in this area and reaffirm medical ethics principles in for comments. digital edition would be published within days. tee, at the Federal University of São Paulo. relation to patients in psychiatric centres. It was proposed that the revised version be submitted to the Committee for consideration. Revision of the WFME Standards for Post-Graduate Education and Public Relations Oral Report Finally Prof. Nathanson referred to the draft toolkit the British Continuing Professional Development The WMA’s Public Relations Consultant, Mr. Nigel Duncan, spoke Dr. Kloiber noted the increasing number of items on the SMAC Medical Association had developed for doctors going into situa- A report was received on the activities of the Work Group on about the importance of social media and the advantages this pre- agenda, reflecting the increased involvement of the WMA in socio- tions of armed conflict for the first time. It was proposed that the Medical Education. The Group had made comments on revising

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the World Federation of Medical Education Standards for Post- Mobile Health Statement on Destruction of Smallpox Virus Stockpiles important global health issue with an estimated one third of the Graduate Education. The revision was considered thorough and A proposed new Statement on Mobile Health was presented to the The Junior Doctors Network re-presented a revised proposed State- population having insufficient vitamin D concentrations. It was ar- comprehensive. Committee by the German Medical Association. Delegates were ment on Destruction of Smallpox Virus Stockpiles. The JDN sug- gued that Vitamin D should now be considered essential for overall Dr. Kloiber reported that he has been consulted by the WFME in a told that National Medical Associations had commented on the pa- gested setting up a Work Group to work on bringing forward a fur- health and well-being and that attention should be focused on ad- personal capacity on the revision of standards for Continuing Pro- per and many of their suggestions had been included. ther paper at the next Committee meeting. This prompted a debate equate action in populations at risk, such as young children, older fessional Development. He thanked those members that had sent Speakers welcomed the document on what they said was a very on the complexity of the issue. Several speakers said that although people and pregnant women. The Committee recommended that comments on the proposed revision and he expected there would important issue. There was one suggestion that the Statement they supported the Statement they would prefer to wait for a pending the Statement be circulated among NMAs for comments. also be an open consultation with the opportunity for NMAs to should include more about secrecy and confidentiality. This led to report on the issue from the World Health Organisation scientists. submit further comments. a debate during which many speakers argued that the guidelines At the end of the debate the Committee decided that the Statement Ageing should remain as broad and as general as possible. The meeting should be postponed to the next Council meeting, so that members The Brazilian Medical Association proposed that a new policy on Statement on Providing Health Support to Street Children decided to reorder the wording of the document and the Commit- could review the WHO report when it was published. ageing should be drafted. In the last hundred years life expectancy New guidelines for National Medical Associations on providing tee agreed that the proposed Statement, as amended, be approved had increased by more than 30 years worldwide. By 2050 the pro- health support to street children were set out in a revised Statement by the Council and be forwarded to the General Assembly for Corporal Punishment of Children portion of those over 60years old was likely to increase from 11.9 on Providing Health Support to Street Children. approval and adoption. A proposal was made to endorse a statement by international health per cent to more than 21 per cent, a total of over two billion people The reworded Statement was introduced by the Conseil de l’Ordre organizations in support of Prohibition and Elimination of all of whom 83 per cent were living in developing countries. There National des Medecins. Delegates were told that the issue effect- World Day for Eliminating Violence Against Health Professionals Corporal Punishment of Children. The Committee considered the would be a consequential increase in diseases such as NCDs, car- ed a large number of countries in all continents. It was difficult to The Turkish Medical Association introduced a revised Statement Statement and recommended Council that the Statement should be diovascular disease, cancer, diabetes and chronic respiratory diseases. quantify this phenomenon but it was a reality in large cities w­hich on a World Day for Eliminating Violence against Health Profes- endorsed by the General Assembly. These diseases could be controlled but doctors were not sufficiently ­children sought out after leaving their villages and towns. Many sionals. This would be in memory of all those health professionals prepared for these challenges. It was time to begin considering children were dumped in ships and sent across the sea to find a bet- who had died in the course of duty, including the young Turkish Guidelines on Mass Media Appearances by Physicians guidelines on this issue. Committee members heard about the expe- ter future. They often travelled in groups and many died on the way. surgeon Dr. Ersin Arslan who was stabbed by a relative of his pa- The Korean Medical Association introduced a draft Statement con- rience of several countries and supported the proposal for a policy. So how could doctors help them? A specific response was required. tient while on duty in his hospital three years ago. taining guidelines for physicians appearing in the media. Delegates The Committee recommended that a Work Group be set up with It was argued that the WMA had a duty to support local organisa- Several speakers questioned whether there was a need to adopt new were told that some physicians misused appearances on the mass media the mandate to produce a draft policy on ageing. tions working with these children and a duty to sensitise govern- policy and it was suggested that this proposal should be referred to for marketing purposes misleading patients’ trust in physicians. Speak- ments. It was urgent to work together with people working in the the WMA Advocacy Group. Other speakers supported the idea for ers generally supported the document but said there needed to be some Classification of 2005 Policies field and on the streets. a special day. It was reported that the Conseil de l’Ordre National clarification about whether it related to all media appearances or only The Committee considered the potential revision of SMAC policies The Committee agreed that the proposed Statement should go to des Medecins had set up an observatory to monitor physician safety appearances related to marketing products. The Committee recom- for which it had been 10 years since adoption or revision. Council to be approved and forwarded to the General Assembly for and a form had been devised for physicians to report physical and mended that the guidelines be circulated among NMAs for comment. It recommended that the following policies be rescinded and ar- approval and adoption. verbal attacks. In 2014 they had noted a major increase in incidents chived: of violence. In France it was not as usual for physicians to report Statement on Transgender People • the Council Resolution on Chronic Non-Communicable Disease Proposed revision of WMA Statement on Child Abuse and Neglect such attacks and therefore the known figures should be multiplied The German Medical Association brought forward a proposed • the Council Resolution on the Healthcare Skills It was decided that this proposed document should be withdrawn. to get a correct picture of what was going on. Statement on Transgender People as a new item of business. This • the Council Resolution on the Genocide in Darfur Speakers also said that one of the reasons for violence was the lack referred to the crucial role played by physicians in advising and con- Statement on Chemical Weapons of resources for hospitals and doctors when it came to working sulting with transgender people and their families about desired It recommended that the following policies undergo a major revi- The Committee considered the proposed revision of the WMA conditions, and the public sometimes reacted violently as a con- treatments. It was meant to serve as a guideline for patient-phy- sion: Statement on Chemical Weapons which deals with the appropriate sequence. Doctors felt helpless when confronted with this type of sician relations and to foster better training to enable physicians to • the Council Resolution on Implementation of the WHO Frame- use of riot control agents. It was proposed that the title of the paper problem and often resorted to defensive medicine. It was said that increase their knowledge and sensitivity toward transgender people work Convention for Tobacco Control be changed to Statement on Riot Control Agents. in Mexico over four years more than 60 physicians had died at the and the unique health issues they faced. • the Statement on Boxing This was approved and it was decided to send the document to hands of the drug trafficking industry. The Committee agreed that Speakers welcomed the paper, although one delegate expressed some • the Statement on Body Searches of Prisoners Council for forwarding to the General Assembly for approval and the proposed Statement be forwarded to the Advocacy Group for concern that WMA policy might enter into conflict with national • the Statement on Female Genital Mutilation adoption. considering possible action. legislation. However another speaker referred to the saying ‘Ethics trumps national law’. The issue of medical ethics and intersexual- It recommended that following policies be reaffirmed: Proposed Declaration on Alcohol Nuclear Weapons ity was also raised and it was agreed that this was a separate topic • the Declaration of Hong Kong on the Abuse of the Elderly The Australian Medical Association introduced a draft Declaration The Committee considered the proposed Statement on Nuclear and that a specific paper should be drafted on this. The Committee • the Statement on Drug Substitution on Alcohol which recommends priority legal and regulatory mea- Weapons requesting all National Medical Associations to join the recommended that the Statement be circulated among constituent • the Statement on Medical Liability Reform sures as well as social policy interventions to address alcohol-related WMA in urging their respective governments to work to ban and members for comments. harm. The document was welcomed by a succession of speakers and eliminate nuclear weapons. Advocacy after a brief debate it was agreed that with two minor amendments Members of the Committee welcomed the Statement and recom- Statement on Vitamin D Insufficiency Dr. André Bernard, Chair of the Advocacy Advisory Committee, it should be sent to Council for forwarding to the General Assem- mended that it be sent to Council for forwarding to the General A proposed Statement on Vitamin D Insufficiency was introduced reported on the activities of the Committee, including the use of bly for approval and adoption. Assembly for approval and adoption. by the Czech Medical Association. Delegates were told this was an social media and the need to develop guidelines on how social

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­media and particularly twitter might fit into WMA’s proceedings. The Secretary General highlighted four current international topics would incorporate the comments received at a drafting meeting in Classification of 2005 Policies He said a task group would be set up to draft some guidelines of discussion within the committee’s remit: Berlin later this year. The Work Group then proposed to hold an The Committee considered the status of several policies which were and bring them back to the next meeting of the Advocacy Com- • The potential of health databases and biobanks for improving open meeting with additional experts at the beginning of Septem- adopted or last revised 10 years ago. It was proposed that the State- mittee. He also referred to the need to follow up the advocacy treatment, while at the same time facing the risk of undue com- ber 2015. The Danish Medical Association had offered to host this ment on Physician-Assisted Suicide, rather than being automati- training session held at the Assembly in Durban and said that the mercial exploitation meeting in Copenhagen and the Work Group would report back at cally reaffirmed, should undergo a major revision. The Canadian Committee would explore how to advance the various initiatives • Reproductive health (surrogacy, and social freezing) the next Council meeting in October. Medical Association volunteered to do this. This prompted a brief discussed. • End of life (physician assisted suicide and euthanasia) Speakers emphasised that this was an ever changing topic and debate when it was pointed out that in responses from NMAs, the Finally he said the Committee was considering how advocacy fit- • Medical confidentiality and reporting of medical findings follow- even when a paper was produced it would only be a work in prog- majority opinion was that this policy should not be revised. On a ted with the Association’s policy making process. There was a need ing the recent German air crash ress. The topic was a core issue for the profession of patient con- vote, the Committee recommended that the Statement on Physi- to have clear messaging and to consider what levers for advocacy • Conscientious objection fidentiality. cian-Assisted Suicide and three other policies be reaffirmed: communication were available for each piece of work produced by • The Declaration of Lisbon on the Rights of the Patient the WMA. On the issue of medical confidentiality, Dr. Kloiber said this had Inclusion of Medical Ethics and Human Rights in the Curriculum of • The Declaration on Euthanasia become an issue following the recent German air crash when the Medical Schools • The Resolution on Academic Sanctions or Boycotts Resolution on Trade Agreements and Public Health question arose about the pilot’s medical fitness. This raised the issue A report was given to the Committee on a major revision of the The British Medical Association submitted a proposed urgent of the obligation on physicians for mandatory reporting of medical WMA Resolution on the Inclusion of Medical Ethics and Hu- It recommended that the Statement on Non-discrimination in Pro- Resolution on Trade Agreements and Public Health. It was re- fitness. So far the medical associations had reacted very appropri- man Rights in the Curriculum of Medical Schools World-Wide. fessional Membership and Activities of Physicians be reaffirmed ported that there were a large number of trade agreements moving ately, pointing out the value of medical confidentiality and the po- The aim was that the teaching of medical ethics and human rights with a minor revision by the Secretariat and be submitted to the towards finality. It was very difficult for individual NMAs to have tential damage that could be done by lifting medical confidentiality at every medical school should be obligatory. It was also recom- Committee and Council at the next meeting. a significant impact on these agreements because of the secrecy and secrecy. Delegates were told that in South Africa and Holland mended that medical schools should ensure they had sufficient fac- surrounding the negotiations. But it was possible to get concerns physicians were either legally obliged to or allowed to release infor- ulty skilled at teaching ethical enquiry and human rights to make Human Rights heard if it was handled collectively. The key issue was that the mation about a patient if it was in the public interest. However in courses sustainable. The revised draft argued that there was a clear Clarisse Delorme, the WMA’s Advocacy Advisor, reported on the WMA wanted to protect the ability of governments to make deci- Australia, on the issue of the mandatory reporting for physicians need for physicians in training to understand the social and envi- WMA’s work on human rights in Turkey, Saudi Arabia and else- sions about promoting health and well-being and health equity in who were unwell, it was unclear whether this was for all physicians ronmental context within which they would practice. Failures of where. She highlighted that the WHO and PAHO were developing each country. It did not want to have those policies damaged or when they were unwell or only when they were a danger. Although individual physicians to recognize the ethical obligations they owed a training curriculum for health professionals about care for women stopped because it was felt by some companies that their trading this was supposed to be a national law, certain states had not ad- their patients and communities damaged the reputation of doctors subjected to intimate partner violence and sexual violence. As a first rights had been infringed and to use the new trade agreements to opted that policy and doctors were going to these states to get their throughout a country, and could have a global impact. The Com- step, a survey had been prepared with the aim of identifying the needs either stop the policy changes or even worse to make governments treatment. mittee recommended that the proposed revision be circulated to of health professionals in providing adequate care for women sub- pay for damage to their trade. This could be policies as simple as NMAs for comment. jected to violence and she asked members to respond to the survey. plain packaging of cigarettes or something more complicated such Person Centred Medicine as bringing in a new form of competition within the provision of The Committee received an oral report about the activities of the Declaration of Geneva health care. Work Group on Person Centred Medicine which had begun its The German Medical Association put forward a proposal that it Council What was needed was a process within the negotiations which said work in 2012. It was reported that a white paper would be de- should form an informal workgroup to explore the potential revi- that these services introduced by governments for the public would veloped for the next meeting in October explaining the different sion of the Declaration of Geneva. The Declaration was due to be On the final day of the conference, the Council meeting reconvened be protected. existing concepts and their challenges. The language had evolved revised in 2016 and the German Medical Association said it would to hear reports back from the three Committee meetings. Speakers agreed that this was a particularly hot topic in Europe over the different definitions of person centred medicine. The white like to express its support for re-exploring this crucial document and in Asia. Health care was being endangered by these nego- paper would address the difficulty in balancing the patient focus from a 21st century perspective. This would be to ensure an appropri- tiations. It was also said that the Trans-Atlantic Trade and In- of medicine and public health and the physicians’ perspective. A ate level of careful preparedness for when the official revision pro- Medical Ethics vestment Partnership might lead to the commercialization of WMA policy would be developed out of this white paper. cess began. The informal work group would create an initial draft to education, particularly medical education. It was argued that This led to a brief debate in which speakers elaborated on the defi- serve as a basis for the final revision next year. Health Databases and Biobanks Government medical services should not be hindered by a trade nition of person centred medicine and the reason why the name Some speakers agreed with this approach and said the Declara- The Council approved the Committee’s recommendation to hold an agreement. Following agreement on an amendment to the Reso- patient centred medicine was an incomplete term. tion needed a thorough revision. This led to a lengthy debate dur- open meeting as part of the public consultation on the Health Data- lution on securing services in the public interest, the Committee ing which many other speakers questioned whether such a working bases and Biobanks draft document. The meeting, at the beginning agreed to recommend that the proposed Resolution, as amended, Health Databases and Biobanks group would be set up to revise the Declaration or simply to review of September 2015, would include outside experts. be ­adopted by the Council. The activities of the Work Group on Health Databases and Bio- whether the Declaration should be revised. Several speakers were banks were outlined to the Committee in an oral report. It had pro- doubtful whether the Declaration needed revising at all, although Physician-Assisted Suicide duced a draft policy paper and an open public consultation had been there was general agreement that any work group set up should be a A lengthy debate took place on the recommendation from the Com- Medical Ethics Committee started, which would run until 5 June 2015. The Work Group in- formal and not an informal group. mittee to reaffirm the Statement on Physician-Assisted Suicide. vited all constituent members to contact experts in their country to The Committee concluded by recommending to the Council that a Some speakers spoke strongly in favour of reviewing this policy in Dr. Heikki Pälve (Finnish Medical Association) was re-elected comment on the draft paper or to send the WMA Secretariat sug- formal WMA Work Group be set up to review the Declaration of view of changing public opinion. It was argued that very few of the Chair of the Committee. gestions of who to contact for this process. A small drafting group Geneva and come back to the Committee with recommendations. 111 national medical associations consulted on the issue had argued

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for reaffirmation and that the WMA should not attempt to hush up Business Development Group Mobile Health eral private practitioner, said she wanted to share two very impor- debate. Delegates were reminded that there was already legislation The report of the Group was approved. The Council approved the proposed Statement on Mobile Health tant messages with the WMA. The first was the common ground on physician-assisted suicide in several countries. Other speakers, and agreed that it be forwarded to the General Assembly for on which the two organisations could collaborate. These included however, said it was not the WMA’s role to follow public opinion IFMSA Memorandum of Understanding ­approval and adoption. zoonotic diseases, such as rabies. Rabies still killed around 60,000 and argued that discussion on this policy should not be re-opened. The Council approved a new Memorandum of Understanding be- humans every year primarily through exposure to unvaccinated and After further debate the Council voted to accept the recommenda- tween the WMA and the International Federation of Medical Stu- World Day for Eliminating Violence Against Health Professionals infected dogs. It killed more people every year than Ebola had killed tion of the Committee that the Statement on Physician-Assisted dents Associations. The Council agreed that the proposed Statement on a World Day over several decades. Yet rabies was almost one hundred per cent Suicide be reaffirmed and invited any NMA who wished a review for Eliminating Violence Against Health Professionals be forward- preventable. If the WMA and WVA worked together to strengthen to produce a paper. ed to the Advocacy Group for considering possible action. health care systems, and advocate to the appropriate government Socio medical affairs committee agencies to establish policies that would protect their own citizens’ Classification of 2005 Policies Nuclear Weapons lives, they could have a large impact on improving human and ani- The Council also approved the reaffirmation of the Declaration of Social Determinants of Health The proposed Statement on Nuclear Weapons was accepted and the mal health just by eliminating dog-mediated human rabies. Lisbon on the Rights of the Patient, the Declaration on Eutha- Sir Michael Marmot welcomed the offer from the Zambian Medi- Council agreed that it should be sent to the General Assembly for A second area of collaboration was animal welfare, which directly nasia and the Resolution on Academic Sanctions or Boycotts. It cal for Zambia to become part of the global movement in support approval and adoption. affected human well-being in many cases. Healthy and well-cared agreed that the Statement on Non-discrimination in Professional of the Social Determinants of Health. He said that to become an for animals produced a safer, more nutritious, more abundant, and Membership and Activities of Physicians should undergo a minor active partner needed the support of the NMA, a university and the Ageing more economically profitable and affordable food supply. revision by the Secretariat and be submitted to the Committee and government. The Council agreed that a Work Group be set up with the mandate A third area was good quality education which improved the Council at the next meeting. to produce a draft policy on ageing. ­knowledge and core competencies of veterinarians around the world Proposed Declaration on Alcohol as it did for physicians, and which benefited the global public good. Declaration of Geneva The Council considered the proposed Declaration on Alcohol which Reclassification of Policies Finally was pharmaceutical stewardship. According to the World The Council approved the Committee’s recommendation to set up a had been brought forward by the Australian Medical Association. It The Council agreed that several 10-year-old SMAC policies should Health Organization, antimicrobial resistance was the next major Work Group to review the Declaration of Geneva. was proposed that there should be an amendment to the document’s be reclassified as recommended by the Committee. global public health threat. Physicians and veterinarians must be wording on reducing the impact of harmful alcohol consumption in part of the solution and must work together to move toward keeping Person Centered Medicine at risk populations, such as children and young people, alcohol depen- Resolution on Trade Agreements and Public Health people and animals healthy in the first place, rather than depending The proposal for a white paper on person-centred medicine to be de- dents, pregnant and breast-feeding women, ‘and minority groups’. It The Council approved the emergency Resolution on Trade Agree- on medicines to treat the consequences of poor management and veloped for the next meeting in October was agreed by the Council. was proposed that the words ‘and minority groups’ be deleted because ments and Public Health without debate. illness, especially with excessive use of antimicrobials. in some countries minority groups did not see themselves at risk. This Her second message was that the WMA and the WVA were hosting Inclusion of Medical Ethics and Human Rights in the Curriculum of led to a lengthy debate and opposition from the Australian Medi- World Health Assembly the Global Conference on One Health in Madrid shortly, along with Medical Schools cal Association on the grounds that it was imperative to highlight Delegates heard a report on likely items to be discussed at the World the Spanish Medical and Veterinary Associations. This meeting could The Council approved the Committee’s recommendation that the Australia’s indigenous population. Two further amendments were Health Assembly agenda in May. This included the Millennium be a real turning point and was receiving a lot of attention world- WMA Resolution on the Inclusion of Medical Ethics and Human proposed, one to reword the statement to read ‘and some minority Development Goals, air pollution, anti-microbial resistance and the wide. This was their opportunity to move past the usual rhetoric and Rights in the Curriculum of Medical Schools World-Wide be cir- groups’ and the other to ‘vulnerable groups’. Other speakers argued ­Social Determinants of Health. Side events included a WHPA Lead- continuing justification that One Health issues were important from culated to NMAs for comment. that the document should not list particular groups, which led to a ership Forum, the WHPA luncheon celebrating collaborative practice both their perspectives. But they must define how they could truly lively debate. The meeting eventually decided to amend the document and the WMA luncheon on the topic of investments and their effects bridge the gap between the two professions to strengthen collabora- to read ‘Reduce the impact of harmful alcohol consumption in at risk in health and healthcare. The Junior Doctors Network would also be tion as these diseases became more prominent in the future. Finance and planning committee populations’ and the Council approved the Declaration as amended having a side event with the International Committee of the Red Dr. Carlson concluded: ‘The continuing good collaboration between for forwarding to the General Assembly for approval and adoption. Cross on the roles of education and training for preparing students our two organizations is both important and beneficial in many ways. Dues Structure and junior doctors for their possible roles for health care in danger. People are intricately interconnected to animals as fellow members of The Council agreed that a recommendation should be sent to the Proposed Statement on Physicians’ Well-Being the animal kingdom. We know why we should work together, so now General Assembly for setting a budget based on a new dues struc- The Council agreed that the proposed Statement on Physicians’ Social Determinants of Health how do we work together to more effectively protect and improve ture. Well-Being be recirculated to NMAs for comments. The Council decided to upgrade the WMA Statement on the Social the health of humans, animals, and our planet? That is the question Determinants of Health. It was decided that the Statement should we want to answer next month in Madrid. For that to happen, it is Future Meetings Statement on Providing Health Support to Street Children be named the Declaration of Oslo. The Council agreed to recom- important that both physicians and veterinarians attend that meeting. It was agreed to recommend to the Assembly that Zambia be the The Council agreed that the proposed Statement on Providing mend this change to the General Assembly for adoption. ’If we continue to work jointly on many of these common issues, we venue for the April 2017 Council meeting. Following the success- Health Support to Street Children should be forwarded to the will become a working model for national and regional collabora- ful H20 meeting in Melbourne last year, the Council agreed that a General Assembly for approval and adoption. tion between our two professions leading to a much greater impact further meeting, H20+ Health Summit, be held in Istanbul, Turkey. World Veterinary Association on improving human, animal, and environmental health’. Statement on Riot Control Agents. Financial Statement The Council agreed to send the renamed Statement on Riot Con- The meeting concluded with an address from Dr. René Carlson, Mr. Nigel Duncan, The Financial Statement for 2014 was approved. trol Agents to the General Assembly for approval and adoption. President of the World Veterinary Association. Dr. Carlson, a gen- Public Relations Consultant, WMA

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care services or medicines including but not Oppose any trade agreement provision References WMA Council Resolution on Trade Agreements and Public Health limited to: which would reduce public support for or 1. TPP negotiations currently include twelve par- • Patenting (or patent enforcement) of diag- facilitate commercialization of medical ed- ties: the United States, Canada, Mexico, Peru, Adopted by the 200th WMA Council Session, Oslo, April 2015 nostic, therapeutic and surgical techniques; ucation. Chile, Australia, New Zealand, Brunei, Singa- • “Evergreening”, or patent protection for pore, Malaysia, Japan and Vietnam. minor modifications of existing drugs; Ensure trade agreements promote environ- 2. TTIP negotiations currently include the Euro- Preamble Investor-state dispute settlement (ISDS) limiting the availability of new procedures • Patent linkage or other patent term ad- mental protection and support efforts to pean Union and the United States. provides a mechanism for investors to bring to patients.” justments that serve as a barrier to generic reduce activities that cause climate change. 3. CETA negotiations currently include the Euro- Trade agreements are sequelae of globaliza- claims against governments and seek com- entry into the market; pean Union and Canada. tion and seek to promote trade liberaliza- pensation, operating outside existing sys- The WMA Statement on Medical Work- • Data exclusivity for biologics; Call for transparency and openness in 4. See World Trade Organization, Declaration on tion. They can have a significant impact on tems of accountability and transparency. force states that the WMA has recognized • Any effort to undermine TRIPS safe- all trade agreement negotiations includ- TRIPS and Public Health (“Doha Declaration”) the social determinants of health and thus ISDS in smaller scale trade agreements has the need for investment in medical educa- guards or restrict TRIPS flexibilities in- ing public access to negotiating texts and (2001). on public health and the delivery of health been used to challenge evidence-based pub- tion and has called on governments to “… cluding compulsory licensing; meaningful opportunities for stakeholder care. lic health laws including tobacco plain pack- allocate sufficient financial resources for the • Limits on clinical trial data transparency. engagement. aging. Inclusion of a broad ISDS mecha- education, training, development, recruit- Trade agreements are designed to produce nism could threaten public health actions ment and retention of physicians to meet economic benefits. Negotiations should designed to effect tobacco control, alcohol the medical needs of the entire popula- take account of their potential broad impact control, regulation of obesogenic foods and tion…” World Health Assembly Week as was the case when targets were set for especially on health and ensure that health beverages, access to medicines, health care both the Millennium Development Goals is not damaged by the pursuit of potential services, environmental protection/climate The WMA Declaration of Delhi on Health Geneva, May 18–26, 2015 and the Sustainable Development Goals. economic gain. change and occupational/environmental and Climate Change states that global cli- On the issue of ageing populations, the Fo- health improvements. This especially in na- mate change has had and will continue to The Sixty-eighth session of the World wide range of issues such as adolescent rum considered the challenges that would Trade agreements may have the ability to tions with limited access to resources. have serious consequences for health and Health Assembly, the supreme decision- health, immunization, noncommunica- be faced as the number of citizens over 65 promote the health and wellbeing of all demands comprehensive action. making body of the World Health Organ- ble diseases, women and health, and the increased to almost 30 per cent by 2060, people, including by improving economic Access to affordable medicines is critical to isation, was held in Geneva May 18–26. WHO’s response to severe, large-scale while those over 80 would nearly triple. structures, if they are well constructed and controlling the global burdens of communi- As usual it attracted to the city an array emergencies. This year, for the first time, During this time, health and health care protect the ability of governments to legis- cable and non-communicable diseases. The Recommendations of world leaders, health ministers, chief the WHO provided a live feed from the services would need to adapt to a growing late, regulate and plan for health promotion, World Trade Organization’s Agreement medical officers, global leaders from the Assembly to allow people to follow its demand. health care delivery and health equity, with- on Trade-Related Aspects of Intellectual Therefore the WMA calls on national gov- health professions and countless lobby- proceedings remotely. Although the offi- out interference. Property Rights (TRIPS) established a set ernments and national member associations ists. More than 3000 delegates from the cial Assembly dominated the week, it was At the same time as the WHPA Forum of common international rules governing to: Advocate for trade agreements that pro- WHO’s 194 Member States, including the many side events and unofficial meet- was meeting, the WMA’s Junior Doc- the protection of intellectual property in- tect, promote and prioritize public health a large proportion of the world’s health ings held simultaneously that proved just tors Network was gathering to prepare Background cluding the patenting of pharmaceuticals. over commercial interests and ensure wide minis­ters, ­attended the Assembly. This as beneficial. its activities for the week. It organized a TRIPS safeguards and flexibilities includ- exclusions to secure services in the pub- year, the WMA leaders who were present two-day workshop at the WMA office in There have been many trade agreements ing compulsory licensing seek to ensure that lic interest, especially those impacting on were ably assisted by a particularly active During the weekend before the Assembly Ferney-Voltaire which was attended by negotiated in the past. New agreements patent protection does not supersede public individual and public health. This should group from the Junior Doctors Network opened, the World Health Professions more than twenty JDN members from under negotiation include the Trans Pa- health. [4]. include new modalities of health care pro- ( JDN), as well as by representatives from Alliance held a successful Leadership four continents. The focus of the work- cific Partnership (TPP), [1] Trans At- vision including eHealth, Tele-Health, the International Federation of Medi- Forum, bringing together representatives shop was on preparing JDN delegates for lantic Trade and Investment Partner- TiSA may impact on eHealth provision by mHealth and uHealth. cal Students Associations (IFMSA), with from the nursing, pharmaceutical, physi- the Assembly. ship (TTIP)[2], the Trade in Services changing rules in licensing and telecoms. Its whom the WMA has recently signed a cal therapy, dental and medical associa- Agreement (TiSA) and the Compre- impact on the delivery of eHealth could be Ensure trade agreements do not interfere Memorandum of Understanding. tions. The Forum held two sessions, one JDN members met with Dr. Xavier Deau, hensive Economic and Trade Agreement substantial and damage the delivery of com- with governments’ ability to regulate health devoted to discussing human resources as WMA President, and Dr. Otmar Kloiber, (CETA [3]. prehensive, effective, cost-effective efficient and health care, or to guarantee a right to During the Assembly delegates discussed a health component in all WHO policies WMA Secretary General. Highlights in- health care. health for all. Government action to protect a host of topics, including antimicrobial and the other concerning issues around cluded discussions on the International These negotiations seek to establish a global and promote health should not be subject to resistance, Ebola, epilepsy, the Interna- ageing populations and the ageing health Recruitment of Healthcare Personnel, in- governance framework for trade and are un- The WMA Statement on Patenting Medi- challenge through an investor-state dispute tional Health Regulations, malaria, nu- workforce. fluenza preparedness with Dr. Julia Seyer precedented in their size, scope and secrecy. cal Procedures states that patenting of diag- settlement (ISDS) or similar mechanism. trition, polio, public health, innovation, from the WMA, Emergency and Disaster A lack of transparency and the selective nostic, therapeutic and surgical techniques intellectual property, counterfeit medical Participants discussed the fact that health Risk Reduction, Air Pollution and Climate sharing of information with a limited set of is unethical and “poses serious risks to the Oppose any trade agreement provisions products, surgical care and anaesthesia. workforce implications were often largely Change, advocacy at the WMA and trade stakeholders are anti-democratic. effective practice of medicine by potentially which would compromise access to health They also reviewed progress reports on a ignored when public health goals were set, and health.

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Dr. Caline Mattar, Chair of the JDN’s Meanwhile, at the UN Palais des Nations ­delegates to adopt the draft global action communities to deliver the highest quality tobacco hazards to all levels of education, children and should use their trusted posi- Pre-WHA Organizing Committee, pro- the World Health Assembly was getting plan on antimicrobial resistance on this of care across settings. creating a national network of 321 smok- tions and skills to reintegrate these children vided attendees with an introduction to under way with an opening address from year’s Assembly agenda. ing cessation clinics in the network hos- back into society. He also said that national the WHA and what to expect for the Angela Merkel, Chancellor of the Federal Dr. Peña said that the Thai Health Profes- pitals in over 77 provinces throughout the medical associations had an important role week to come. In addition, JDN mem- Republic of Germany. She said that the She also noted the need to ensure that sional Alliance Against Tobacco brought nation and conducting research in 85 proj- to play in educating their members about bers joined the International Federation WHO was the only international organiza- the International Health Regulations, the together more than 21 different associa- ects. what they could do to help. of Medical Students’ Associations’ Pre- tion that had universal political legitimacy world’s legal instruments for outbreak pre- tions, most being healthcare professionals WHA workshop at the Graduate Institute on global health issues, but said she would paredness and response, were effective. She bodies. It had initiated many projects cov- Dr. Somsri Pausawasdi continued stating: Dr. Deau quoted WMA policy deriving in Geneva for a successful panel discussion like to see a new plan to deal with “catas- urged the delegates to ready themselves for ering different areas such as public promo- “The ultimate goal of our campaign is to from the Declaration of Ottawa on Child and collaborative issue-based small group trophes” like the recent Ebola outbreak. The the post-2015 development agenda and to tion of smoking-free environment, educa- create a tobacco-free environment for the Health adopted in 1998. This stated that sessions on human resources for health, outbreak had highlighted the critical need ensure that health received the attention, tion, and national health policy. It was also nation. We now have smoking-free envi- children needed to grow up in a place where climate change and antimicrobial resis- for urgent, collaborative action in emergen- and the resources it needed the pioneer in starting educational centres ronment in 47 universities, all hospitals they could thrive, spiritually, emotionally, tance. These sessions prepared participants cies, and the importance of having efficient on tobacco hazard in 12 provinces of Thai- and most of the pharmacy in the nation. physically and intellectually. This required for the Assembly and provided the oppor- structures in place. At lunchtime on the Monday the WHPA land. We have implemented a larger graphic a safe and secure environment, the oppor- tunity to learn more about WHA agenda held its annual reception at the InterCon- health warning on cigarette packages from tunity for growth and development, health items. She said that under Germany’s presidency, tinental Hotel when it presented the first The WHPA award was received by Prof. 55% to 85% of the cover and actively in- services when needed and monitoring and the G7 would focus on fighting antimi- of what will become an annual award for Dr. Somsri Pausawasdi, President of the volved in the national policy on tobacco research for evidence-based continual im- Representatives from both the JDN and crobial resistance and neglected tropical collaborative practice. This is a new award THPAAT and CEO of the Medical Asso- control. provement. IFMSA helped to prepare the various in- diseases. She emphasized the need for all which aims to recognise an outstanding in- ciation of Thailand. She said that THPAAT terventions to be made by the WMA and countries to have strong health systems and terprofessional team which has improved was established in 2005 under the vision of Finally, we have joined together with other He said that assisting street children re- the WHPA to the Assembly during the highlighted the key role of health in sus- patients’ health and promoted a collabora- the Medical Association of Thailand and a organizations and many foundations to quired a method, such as a multi profes- week. tainable development. tive approach to healthcare. time when the King of Thailand, Bhumibol initiate “the National Alliance for To- sional team including health professionals, Adulyadej, had expressed his wish to reduce bacco Free Thailand-NATFT” in 2013 to social workers, drivers, teachers and police. On the Monday morning, while thousands In the afternoon, WHO Director-­ The winner of the award was the Thai the growing problems of cigarettes addic- push forward the act of legislation on to- There had to be a medical and psycho-social of delegations gathered for the opening General Dr. Margaret Chan spoke about Health Professional Alliance Against To- tion in Thailand. The Medical Association bacco control for our nation. Currently, the approach and co-operation with local and of the Assembly, leaders of the World the WHO’s response to the Ebola out- bacco (THPAAT). The award was present- of Thailand had responded to the King’s NATFT has more than 1,400 members governmental authorities. Health Professions Alliance were meet- break and criticism that it should have re- ed by Dr. Carmen Peña, President of the wish and to the WHO campaign by initiat- and 729 organizations. We are working to- ing a group of African journalists to brief acted earlier. She admitted that the world World Dental Federation. She reminded ing the THPAAT with the goal of recruit- wards the United Nations policy on non- He said that although there was no official them on the events of the coming week. was ill prepared to respond to the out- the audience that the WHPA spoke for ing a mixture of health professionals for an communicable diseases (NCD) to decrease definition of street children, all such child­ Organised by the World Health Editors break, but promised that the WHO would more than 26 million healthcare profession- antismoking campaign. the tobacco consumption rate to 15% by ren faced common issues – they suffered Network and its founder Franklin Apfel, learn from what happened and would not als through more than 600 national associa- the year 2025. from a lack of cultural identity, they lived the gathering allowed the Presidents and be overwhelmed again. She outlined new tions of healthcare professionals. She went on: “It was clear that the best in the streets, they were no longer part of CEOs of the five WHPA professions to plans to create a single new WHO pro- way to accomplish our goals was to create We do hope that our experience can inspire any social or family environment, they were talk to the African media about their pri- gramme for health emergencies, uniting She went on: “WHPA works to improve a collaborative interprofessionals team and some tobacco control initiatives in many organised in small societies and they hardly orities at the ­Assembly and their respective outbreak and emergency resources across global health and the quality of patient thus the Medical Association collaborated countries, and together we create a healthier survived. roles. Among the priorities mentioned by the three levels of the Organization. She care and facilitates collaboration among the with the Thai Health Foundation and re- world for us and for our next generations the WHPA leaders were childhood obe- said she had heard what the world expect- health professions and major stakehold- cruited four more organizations including to come.” Finally, Dr. Deau said that at the WMA’s sity, antimicrobial resistance, the social ed from the WHO and she promised it ers. For several years, our motto has been the Pharmacy Council, the Nurses’ Associa- General Assembly in Moscow delegates determinants of health and the problem of would deliver. “Teaming up for better health” and clearly, tion, the Dental Association, and the Public The following day it was the turn of the would consider a new Statement for adop- counterfeit medicines. this is the vision that guided our activities: Health association to join the team. Over WMA to host its annual luncheon semi- tion, calling for all street children to be The new programme would set up a new we believe that healthcare professionals’ im- the years, our network has expanded and nar at the Pavillon Gallatin, Chateau de provided with care and where necessary This was followed by a meeting between global health emergency workforce, as well pact is bigger when we are working in syn- we currently comprise 21 different health ­Penthes. This year the theme was “Health returned to a living environment. He said the WHPA leaders and representatives as strengthening its own core and surge ca- ergy.” professional bodies under the support of the Support to Street Children” and the speak- that remaining indifferent towards street from the World Health Students Alli- pacity of trained emergency response staff. Thai government. The goals of our team are er was WMA President Dr. Xavier Deau. children was not an option. ance and the International Federation of Dr. Chan reiterated Chancellor Merkel’s In 2013 the WHPA adopted its joint state- to promote a reduction in tobacco use and He began by saying that the United Na- Medical Students Associations. This was points about the importance of building ment on Interprofessional Collaborative enforce the smoking free society as national tions had estimated there could be around During the Assembly, the JDN and ­IFMSA a useful opportunity for student bodies to resilient health systems and defeating an- Practice, defining collaborative practice as health policy.” 150 million street children throughout the delivered a number of interventions they explain to the leaders of the global health timicrobial resistance, citing the “spectre when multiple health workers from dif- world. This was “a worldwide and grow- had drafted on behalf of the WMA and/ professions the role and workings of their of a post-antibiotic era in which common ferent professional backgrounds worked She said the Alliance’s activities included ing phenomenon”. He said physicians were or World Health Professions Alliance. organizations. infections will once again kill,” and urging together with patients, families, carers and the aim of improving the awareness of often the first point of contact for these These were based on the WMA policy and

54 55 WMA News GERMANY Epidemiology

in collaboration with the WMA staff and bidity and mortality related to cardiovas- was one which the JDN co-hosted with the leadership and included interventions on cular diseases, cancers, chronic respiratory International Committee of the Red Cross Global Epidemics . Industrialised Nations Must Develop Global antimicrobial drug resistance, polio, non- diseases and diabetes, as well as reduce the on the Healthcare in Danger. This focused communicable diseases, climate change and four shared risk factors. It strongly recom- on the role of education and training in ad- Strategies to Counter Epidemics Ebola. mended that interventions aimed at re- dressing healthcare in danger and featured ducing the burden of NCDs must include a panel discussion including Dr. Ahmed sociation and the Standing Committee of there are promising trials in progress, there On the Global Action Plan on Antimicro- addressing risk factors during childhood Berzig (Head of Health Unit, ICRC), European Physicians (CPME) called for is still no approved vaccine available. The bial Drug Resistance the WMA said that and adolescence. Prof. David Gordon (President, WFME), concrete measures to contain the virus. The World Medical Association and the CPME antimicrobial resistance was a threat to all Dr. Bruce Eshaya-Chauvin (Medical Ad- necessary structures must be developed on have demanded that adequate funding fi- countries without regard for geographical The IFMSA also spoke on the issue of viser, Healthcare in Danger) and Dr. ­Ahmet a national and international level in order nally be made available for immunization boundaries. A commitment was needed health in the post-2015 development agen- Murt (Chair, JDN). to combat epidemics more efficiently in the programmes and for vaccine research and from both member states and the WHO da asking the WHO to focus its attention future. Providing protection for physicians development. The Declaration of Helsinki to ensure financial sustainability to imple- on supporting the development of realistic At the end of the Assembly, IFMSA Presi- before, during and after they engage in relief can and must serve as the basis for these de- ment interventions in LMICs. The WMA’s targets and clear indicators, which would dent Agostinho Sousa said: “The voices of efforts is a key component of this. This pro- velopments. But this call from the Europe- intervention emphasized that the Global remain a main topic of discussions in the medical students, and of youth more gener- tection must include, for example, guaran- an and global medical communities should Action Plan could not be separated from following months. However, it referred to ally, have been recognized several times dur- teed repatriation for physicians in the case not be limited to research focused on Ebola strengthening healthcare systems, building the absence of several important health ing this World Health Assembly. Addresses of infection, access to comprehensive medi- vaccines. As a matter of principle, if there is on lessons learned from the Ebola epidemic. ­areas, such as recognizing primary health by Dr. Margaret Chan, Director General cal and psychological care upon their return, a lack of incentives for conducting research A focus on access to primary care, availabil- coverage and the importance of health lite­ of the World Health Organisation, and as well as sufficient life insurance. and if the development of diagnostic tests, ity of diagnostic labs including rapid diag- racy, patient centered care and patient em- references made by numerous Ministers of therapies and vaccines is not being pursued nostic methods and surveillance systems powerment. Health or their representatives, have shown In hindsight, we must concede that govern- rigorously, governments are called upon to was needed to fight the spread of resistant the crucial role that future health profes- ments, the scientific community and relief take effective measures in this regard, start- pathogens. The Assembly went on to agree On the issue of the International Recruit- sionals play in shaping the global health Frank Ulrich Montgomery organisations underestimated the severity ing with providing access to adequate finan- on resolutions to improve access to afford- ment of Health Personnel, the IFMSA agenda.” of the Ebola crisis in West Africa for far cial resources. able vaccines. raised a concern that the current Code was In March 2014, the Ebola virus was iden- too long. Although the situation appears mainly focused on regulating the migra- The Assembly ended with thousands of tified as the force behind a wave of illness to be largely under control and the Ebola Above and beyond research into vaccines, On polio eradication, the WMA said, it tion of health personnel. It was important delegates returning to their countries, feel- in Guinea. According to the latest figures epidemic is now only a passing reference in the international community and, in partic- had condemned in the strongest terms the that member states tackled fundamental ing they had spent a worthwhile 10 days in from the WHO, there have been nearly the media, we cannot fall back into the old ular, the industrialised world are called upon recent killing of five health care workers in factors that caused the migration, such as Geneva. 27,000 cases of Ebola reported in West habit of ignoring and avoiding the problem. to provide the resources needed to develop Pakistan while providing polio immuniza- poor or unsafe practice environments, poor Africa and 11,120 deaths. The approach The Ebola outbreak continues to demand the appropriate infrastructure to ensure tion to the citizens of Pakistan. This trag- education and excessive workload. Medical Among the JDN representatives who spoke taken in response to previous outbreaks of the full attention of the international com- the early containment of epidemics. The edy had underscored the urgent need to students were facing mental and physical at the Assembly were: the Ebola virus (i.e. quarantining patients munity. ­German government recently announced ensure the protection of health care work- strain, harming their practice, decreasing Dr. Ahmet Murt ( JDN Chair) speaking at and monitoring their immediate social cir- that it will earmark 200 million euros in ers in conflict areas. It urged the WHO patient safety and exponentially increas- the Assembly cles) proved to be inadequate in this case At the same time, it demonstrates by exam- funding to support the development of and member states to ensure adequate se- ing the costs of healthcare systems, and Dr. Thorsten Hornung ( JDN) due to the mobility of the population and ple that in a globalised world, epidemics not healthcare systems in the countries affected curity for the healthcare workers to enable sometimes even leading to suicide. Health Dr. Kostas Roditis ( JDN) the prolonged duration of the disease. As only have the potential to wipe out entire by this crisis. The administration also plans effective implementation of immunization workers and students must be protected Dr. Mike Kalmusz-Elias ( JDN) a result, major cities in West Africa had to populations, but also that they do not stop to organise a team of physicians and other protocols, to develop systems sensitive sur- from violence, discrimination and exploi- contend with large numbers of victims for at national borders, nor are they confined medical personnel that could be deployed veillance and immediate notification to the tation in the workplace, and be allowed to the first time. to certain continents. We must work to de- anywhere in the world within three to WHO of any detected poliovirus transmis- operate within a positive practice environ- Mr. Nigel Duncan, velop effective global strategies to ensure five days, and to provide additional medi- sion and to implement adequate immuni- ment that guaranteed occupational safety Public Relations Consultant, One particular problem facing the affect- that viruses can be contained early going cal supplies, like field hospitals and mobile zation training for health professionals. The and health. WMA ed countries was the lack of appropriately forward. These strategies must incorporate laboratories. However, a breakthrough will WMA also wanted to see an increase in trained professionals needed to contain the elements of prevention, as well as rapid re- only be possible if the G7 countries agree to effective public awareness and education to The Assembly passed several landmark virus. In Germany, the German Medical sponse facilities. coordinate their activities effectively on an prevent and dispel myths. resolutions on air pollution, on epilepsy and Association teamed up with the Federal international level and to commit sufficient the next steps in finalizing the framework of Ministry of Health and the German Red The Ebola outbreak made it clear that vac- financial resources. It is therefore a welcome The IFMSA spoke about the need to engagement with non state actors. Cross, as well as the national professional cines, a sensible tool for combating epidem- sign that neglected diseases and diseases tackle, prevent and control the global associations of physicians, to promote vol- ics, were initially not developed by the phar- associated with poverty, as well as Ebola, burden of noncommunicable diseases Among the many side events attended by unteer efforts in the affected regions. On an maceutical industry because the market was were addressed at this year’s G7 summit in (NCDs), and reduce the worldwide mor- WMA representatives and JDN delegates international level, the World Medical As- not deemed profitable enough. Although Germany.­

56 57 Climate changes Climate changes

West Africa’s Ebola epidemic demon- gional, national and European crisis inter- cal Assembly. This fund should be financed ills. Floods are frequently followed by dis- 200th Council Session of WMA, partici- strated the consequences of uncontrolled vention, as well as the limits of each. He by the United Nations, the World Bank, ease clusters. Major coastal storms can also pants all agreed on the importance of form- outbreaks of infectious disease. For this also presented early warning and response the International Monetary Fund and the trigger harmful algal blooms (“red tides”), ing a coordinated voice representing the reason, this year’s 118th German Medi- systems for monitoring and controlling ­European Union, among others. The Medi- which can be toxic, help to create hypoxic entire medical community in anticipation cal Assembly in Frankfurt deliberated the spread of communicable diseases and cal Assembly also demanded essential pro- “dead zones” in gulfs and bays, and harbor of COP 21 and shared ideas about what we the most pressing issues relating to civil options for improving risk and crisis com- tection for medical and non-medical per- pathogens. can do. protection under the heading “Medicine munication. sonnel during their deployment abroad, as in times of global epidemics”. The discus- well as approved leaves of absence and job These are only a few examples of what is in The discussion can be summarized into the sion was initiated by presentations meant The level of engagement with which the security for physicians who volunteer to store. The impact of climate change comes following approaches: to shed light on the domestic and inter- parliament of the German medical profes- participate in aid missions. in many shapes and sizes from not only 1. Recognition of co-benefits of dealing national aspects of battling global epidem- sion dealt with this issue and formulated damage from increase in harmful substances with health issues in climate action ics. Dr. Tankred Stöbe, chairman of the political demands through a very lively The Medical Assembly also called upon the or chemicals in the air but also the increase 2. Getting involved in liaising with each board of the German chapter of Médecins discussion is noteworthy. In the battle German federal government to establish a in prevalence of various contagious diseases, government’s negotiation representa- Sans Frontières (Doctors Without Bor- against global epidemics like Ebola, the state-funded and organised medical relief which are all major public health challenges. tives ders), drew attention to the preconditions 118th German Medical Assembly called organisation to provide emergency medical In particular, the detrimental effects of cli- 3. Active media coverages and journal ex- and challenges of establishing a preventive for Germany, Europe and the international relief with specially trained health profes- mate change on health are far more serious poses medical infrastructure in regions affected community to promote the research of in- sionals in crisis areas. This would make it among the more vulnerable population such 4. Collaboration with other professional by epidemics. He reported on practical fectious disease and the development and possible for doctors and other health profes- Dong Chun Shin as children, the elderly and people in less organizations and NGOs on joint ini- measures taken to stem the disease, which implementation of diagnostic tests, thera- sionals to be deployed faster by simplifying developed countries. tiatives on the issue included educating the population and in- pies and vaccines. One resolution of the the process of obtaining approved leaves of ture, wind, and precipitation with profound 5. Promoting awareness of members on creasing public awareness about infectious Medical Assembly expressed that “govern- absence from their employers and provid- effects on all natural systems. These, in turn, WMA has continuously expressed its con- green policies for daily operation of disease and safe burials, as well as efforts to ment funding must be made available for ing social protection. The Ebola epidemic in have effects on the health, safety, and liveli- cern over the health impact by climate health facilities. strengthen countries affected by epidem- the development and provision of pharma- West Africa demonstrated that the systems hoods of people-especially the poor. change, and has worked to raise awareness ics. From the perspective of an interna- ceuticals and vaccines to curb epidemics in place for gathering the appropriate medi- regarding the benefits of putting health in As described by LANCET, climate change tional non-governmental organisation, it and to finance comprehensive vaccination cal personnel to engage in crisis situations We have already seen previews of the the center of the climate change agenda. is “the greatest global health challenge of is also essential to address what is needed programmes”. The parliament of physi- were inadequate. According to the Medical health impact that lies ahead if extreme As a way to tackle the issue in the WMA, the 21st century.” This is a battle cry for all to protect and safeguard medical and non- cians also called upon drug manufacturers Assembly, a state-organised medical relief weather events continue to increase. Heat the Environment Caucus was organized. physicians to take on a more active role in medical personnel and their employment to conduct targeted research, even at low organisation must be created to work with waves like the one that hit Chicago in It aims to exchange opinions among WMA tacking climate change, and for us to feel a rights during their deployment abroad. profit margins, in order to develop the per- non-governmental organisations to facilitate 1995, killing some 750 people and hospi- members and related bodies regarding greater sense of responsibility starting from tinent drugs and vaccines. prompt delivery of healthcare in crisis areas. talized thousands, and the 2003 European WMA future activities related with health our everyday lives and also at a national level Following this talk, Prof. Dr. René heat wave, killing 21,000 to 35,000 people and environment. through each NMA, and at an international ­Gottschalk, Director of the Public Health Financial resources to combat epidemics Prof. Dr. Frank Ulrich Montgomery, in five countries, are becoming more com- level through the WMA. Office of the city of Frankfurt/Main, dis- and to rebuild healthcare systems and pub- President of the German mon. The main activity of the Environmental cussed the domestic and European aspects lic life in the wake of an epidemic should Medical Association, Caucus is sharing global trends and con- Much is at stake as COP21 approaches, and of the fight against global epidemics. Prof. be allocated to the affected countries in Vice-Chairperson of the WMA Council But even more subtle, gradual climatic ference information regarding environ- hopes are high that we will be able to de- Dr. Gottschalk addressed options for re- the form of a fund, according to the Medi- E-mail: [email protected] change can still harm human health. El- ment and identifying common topics of liver our voices effectively so that COP21 evated carbon dioxide levels promote the interest and to discuss follow-up measures. will find a meaningful framework to pre- growth and sporulation of some soil fungi, It encourages free exchange of opinions vent and resolve health problems caused by and diesel particles help deliver these aero- by adopting an informal setting. Major climate change. WMA Roles for Climate Action extremely difficult to reverse. Even if all allergens deeper into our alveoli and present themes discussed at the Environmental emission of greenhouse gas is stopped now, them to immune cells along the way. Caucus with regards to the direction of it would still be difficult to completely pre- future WMA activities include the role of Dong Chun Shin, MD, PhD, The 21st Conference of the Parties reduction in greenhouse gas emissions to vent global warming. The goal of limiting Mosquitoes, which can carry many diseases, physicians and of constituent members in Chair, Environment Caucus, WMA (COP21) to the UN Framework Conven- limit global warming within 2 °C. That is global warming to 2 °C is the minimum are very sensitive to temperature changes. greenhouse gas reduction, promoting re- Chair, Finance and Planning tion on Climate Change (UNFCC) will why some are even calling it the “historic measure necessary to prevent the worst Warming of their environment – even search on the health co-benefits of coun- Committee, WMA be held in Paris for two weeks from No- two weeks.” case scenario. within its viable range – boosts their rates tering climate change and expansion of Prof., Dept. of Preventive Medicine vember 30 to December 11, 2015. COP21 of reproduction and prolongs their breeding green hospitals and clinics. Yonsei Univ. College of Medicine is practically the last opportunity to reach Due to the earth’s feed-back mechanism, Health needs to be given the greatest pri- season, and shortens the maturation period E-mail: [email protected]; [email protected] an agreement on a plan where all nations any change, once gaining enough mo- ority in efforts to minimize climate change. for the microbes they disperse. Extremely At the last meeting of the Environmental would participate to achieve substantive mentum in a certain direction, becomes Climate change causes change in tempera- wet weather may bring its own share of Caucus held in Oslo, Norway, during the

58 59 Medical Ethics UNITED KINGDOM UNITED KINGDOM Medical Ethics

control over the uncertainties of the illness. The erosion of tion into a meaningful format. As rapport “What concerns do you have?,” then asking The Art and Heart of Medicine As the physician listens to the patient, he or humanistic medicine is established elements of the patient’s tem- “Anything else?” repeatedly until a complete she follows the narrative thread of the story in perament and personality become more agenda has been identified appears to take all its existential, cultural, familial, biological, Where this professional space is taken over apparent and the patient’s reaction to each 6 seconds longer than interviews in which avoid ‘harms’ where possible, be truthful and social, psychological and spiritual dimensions. by an authoritarian organization not only is question can be noted. the patient’s agenda is interrupted. Agenda be treated equally with others according to this patient/physician relationship seriously setting is a teachable and learnable skill that their needs. The act of listening, so essential to the damaged but also the independent spirit of Very often the physician will have a very deserves emphasis and reinforcement. process, enlists the physician’s interior re- enquiry that drives advances in medicine is good idea of the likely diagnosis of the pa- The physician also has a duty of care to their sources – memories, association, curiosities, distorted [7]. As the cost of health care has tient’s problem within the first two minutes A few verbal affective remarks can be ef- patients and should keep their medical re- creativity, interpretive powers and allusions escalated, additional pressures on this ‘pro- through his or her experienced pattern rec- fective and this is not necessarily time con- cords secret within applicable national laws. to other stories by the person and others to fessional’ space by Healthcare providers, In- ognition of the common disease processes. suming [12]: In one study it took only 38 These ethical principles need to become identify meaning. Only then the physician surance Companies and Governments are The physician will search for additional seconds to make a difference! The affective ‘internalized’ as the individual physician’s can hear and confront the person’s narrative occurring which are distorting the patient/ clues – information that will aid in the solu- statements that caused this reduction were ‘professional’ conscience and act as a com- questions wWhat is wrong with me? Why physician discourse [8]. tion of the person’s problem. There is then related to emphasizing being there for the pass through the complex scientific, medical, is this happening to me? And what will be a tendency to move to gather more specific person – the sense of a physician’s duty of psychological, social, cultural and spiritual the result?” [3] During the professional consultation, elicit- information to exclude other possibilities care – providing reassurance of continuing scene. These principles relate both to the in- ing a ‘history’ from a patient is one of the and confirm the presumptive diagnosis. The medical support. These points have been dividual health care professional as a basis for Listening to stories of illness and recognizing least perfected and most neglected clinical danger is that at this stage other pertinent defined as fundamental for effective patient- the ‘trust’ given by the patient as a person to that there are often no clear answers to pa- skills despite a wealth of research and time information may not be given by the patient physician communication. Whilst one of the them and to society in general where they tients’ narrative questions demand the cour- spent in undergraduate training [9]. Yet for or sought by the physician. Some physicians most difficult tasks for physicians is to convey form part of the essential ‘contract’ between age and generosity to tolerate and to bear the great majority of ’patient’ the narrative may avoid eliciting multiple concerns due to bad news, physicians who are emotionally James Appleyard the health care professions and society allow- witness to unfair losses and random tragedies history is the most important and most the fear of extending the encounter when supportive can influence patients’ emotional ing the physician to work as an independent [4]. Accomplishing such acts of witnessing revealing part of any personal health data time is limited. functioning with little effort and time [13]. The Art of the conversation between a clinician whose primary duty is to their pa- allows the physician to proceed to his or her base. Too often a computer generated form physician and their‘patien; is at the heart tient. Only in this ‘trusting’ culture will a ‘pa- more recognizably clinical narrative tasks: to is completed with the minimum of narra- However, unexpressed patient concerns Affective communication may have the of medical practice [1]. It is a dialogue be- tient’s inner worries and secrets be gradually establish a therapeutic alliance, to generate tive followed by a cursory clinical examina- may lead to a prolonged investigation of a power to elicit beneficial effects in clinical tween a person seeking help and a physi- shared with their physician”. and proceed through a differential diagnosis, tion and a huge array of expensive investiga- concern hypothesized to be the “chief com- encounters as it enables patients to adjust cian who possesses the relevant medical to interpret physical findings and laboratory tions from which a diagnosis is expected to plaint” but which in reality was the second better to the emotional and cognitive im- knowledge­ and skills This patient/physician reports correctly, to experience and convey emerge. It is important to realize that not most important problem. Repeated invita- pact of medical information [14]. Indirect relationship is founded both on service and A person’s narrative empathy for the patient’s experience [5], and, only is the patient presenting with symp- tions to express additional concerns early in effects might also be present. When pa- on trust within which two way communi- as a result of all these, to engage the patient toms of a possible illness but experiencing the consultation may enhance the efficiency tients remember more about treatment cation is key. The physician’s professional A patient’s own story is the key to the phy- for effective care. the effect of all of their life’s events in their of the interview by decreasing late-arising procedures and their consequences, this service to their patient must be conducted sician finding out what may be right and biological, social, mental, psychological, cul- concerns, allowing the physician and patient may affect adherence to treatment or medi- within a professional code of ethics which what may be wrong during a professional If the physician cannot perform these narra- tural and spiritual dimensions. to prioritize problems at the outset, to make cation regimen. A few affective statements has become enshrined within the World consultation. A narrative approach encom- tive tasks, the patient might not tell the whole the best use of their time and minimize im- can have a large impact on patients’ anxiety, Medical Associations International Code passes an open awareness of health and dis- story, might not ask the most frightening plicit assumptions of what the patient wants uncertainty and recall. Affective communi- of Medical Ethics 1949 et seq. ease within a storied structure from which questions, and might not feel heard [6]. A person centered approach to discuss. Patients may defer emotionally cation allows physicians to temper patients’ the meaning and purpose in both an illness laden topics until the trustworthiness of the emotional responses and improve their abil- This statement includes the requirement and the experience of recovery emerge. Di- The resultant diagnostic workup might be Those starting out on a medical career may physician is better known or until the physi- ity to remember medical information. that “a physician shall be dedicated to pro- agnostic ‘labels’ become secondary to the unfocused and therefore more expensive need a format to act as guidance. The per- cian brings up the topic [11]. viding competent medical service in full life of the individual person. A story is re- than need be, the correct diagnosis might be son centered Integrated Diagnostic model professional and moral independence with counted in a complicated narrative of illness missed, the clinical care might be marked by is being developed and refined to meet this The tendency of even experienced family Conclusion compassion and respect for human dignity’. told in words, silences, gestures, physical ob- noncompliance and the search for another need. It proposes the whole person in con- physicians not to seek the patient’s com- servations, overlain not only by the objective opinion, and the therapeutic relationship text as the Centre and goal of clinical care plete agenda is similar to the finding of A person-centered approach involves a re- findings but also with the fears, hopes and might be shallow and ineffective. The nar- and public health [10]. This encourages a Beckman and Frankel 15 years ago. Despite newal of our ethical commitment both to Trust implications associated with it [2]. rative is absorbing. It engages the listening more flexible and conversational style. concern that a patient-centered approach each person as a patient and to society as physician and invites an interpretation. It will take more time, the study further re- a whole within a wide biomedical, psycho- Trust can only be assured if the patient be- The narration is a therapeutic central act be- gives him or her the experience of “living It is only through this open style interactive inforces that exploring all of the patient’s logical, social, cultural and spiritual frame- lieves that the physician respects them as in- cause to find the words to contain the disorder through”, not simply “knowledge abou” the conversation and questioning the physician concerns does not decrease efficiency. Using work. It attends to both ill health and posi- dividuals, will act only in their best interests, and its attendant worries gives shape to and characters and events in the story. sorts, extracts, subtracts and adds informa- a simple opening empathic enquiry, such as tive health and focusds on the diagnostic

60 61 One Health concept UNITED STATES OF AMERICA UNITED STATES OF AMERICA One Health concept

­communication between the patient and of Healing: How Telling Our Stories Transforms communication about HIV risk. Ann Intern twenty-first century demand that these two Animals have served as sentinels for toxic 7. Morse SS. “Factors in the Emergence of Infec- physician. There is shared understanding Our Lives. San Francisco, Calif: Harpe Med.12:,435-442 disciplines re-establish ties and begin work- environmental contamination. In the mid- tious Diseases.” Emerging Infectious Diseases. 4. Laine C., Davidoff F. (1996) Patient-centered 11. Marvel M.K, Epstein R. M., Flowers K.. Beck- 1995; 1: 7-15. http://wwwnc.cdc.gov/eid/arti- and decision making with prevention and ing collaboratively again. Increasing global 1950’s, dancing cats of Minamata Bay, medicine: a professional evolution. JAMA; man H. B, (1999) Soliciting the Patient’s Agen- cle/1/1/95-0102_article health promotion as shared commitments 27:,152-156 da Have We Improved? JAMA 281:283-287 populations, widespread deforestation and ­Japan were exhibiting mercury poisoning 8. Grant S, Olsen CW. “Preventing Zoonotic Dis- and the promotion of partnerships at all 5. Charon R. (2001) Narrative medicine: form, 12. van Osc, M., Sep M., van Vliet,L. M., van environmental destruction, intensive agri- from industrial pollution [12]. Humans eases in Immunocompromised Persons: The Role of levels. function, and ethics. Ann Intern Med;134,:83-87. Dulme, S., Bensin, J. M. (2014) culture, global trade and travel, and likely began suffering from mercury poisoning Physicians and Veterinarians.” Emerging Infec- 6. Acare G., Pulmarski B., Acare (2015). Lost in 13. Reducing patients’ anxiety and uncertainty, and climate change will adversely impact life as well [13]. Pets and other small animals tious Diseases. 1999; 5: 159-163. http://wwwnc. cdc.gov/eid/article/5/1/99-0121_article translation WMJ 61, 28-30 improving recall in bad news consultations. The im- on the planet [7]. Zoonotic diseases such as can develop symptoms of lead poisoning pact of affective communication. In press 9. Rabinowitz PM, Gordon Z, Odofin L. “Pet- 7. Lown B. (1996) The Lost Art of Healing. References 14. Street R. L. J., Makoul G., Neeraj K. A., Epstein HIV/AIDS, West Nile virus, SARS, MERS, from very small doses and should serve as Related Infections.” 2007; 76: 1314-1322. http:// 1. Mezzich J.E. (2011) Building Peron Centered Houghton rd R.M. (2009). How does communication heal? and Ebola that cross species barriers require sentinels for potential human cases if they www.aafp.org/afp/2007/1101/p1314.html medicine through dialogue and partnerships. 8. Cutler P. (1998) From data to diagnosis. 3 En. Pathways linking clinician-patient communica- increased communication and collaboration become sick [14, 15]. 10. Hoenig M. “Comparative Aspects of Human, Lippincott Williams and Wilkins International Journal of Person Centered medi- tion to health outcomes. Patient education and between the health professions. Occasional- Canine, and Feline Obesity and Factors Pre- cine,(), 10–13 9. Salloum I,M, Mezzich J.E. (2011) Conceptual counseling, 74, 295-301 ly, animals become infected before humans Physicians and veterinarians have much to dicting Progression to Diabetes.” Vet Sci. 2014; 2. Genette G. (1980) Narrative Discourse: An Essay appraisal of the person centered Integrative Di- 1: 121-135. http://www.mdpi.com/2306- in Method. Lewin J., trans. Ithaca, NY: Cornell agnostic Model. International Journal of Person James Appleyard MD FRCP, and should serve as important sentinels for learn and benefit from each other. Recently, 7381/1/2/121 University Pres Centered medicine 11, 39-42 President, International College of Person looming epidemics in human populations. the World Medical Association and the 11. Heflin M. “Canine Melanoma Vaccine Gets Con- 3. Greenhalgh T. Hurwitz. B. (1999)”Narrative 10. Epstein R.M., Morse D.S., Frankel R.M., Fra- centered medicine Thimble Hall, Blean World Veterinary Association held a joint ditional OK.” Veterinary Practice News. May based medicine: Why study narrative” BMJ rey L., Anderson K., Beckman H.B. (1998) Common Kent CT2 9JJ UK For people who live with chronic immuno- global conference on One Health. Informa- 2007. http://www.veterinarypracticenews.com/ 318,:48–50)DeSalvo L. (1999) Writing as a Way Awkward moments in patient-physician E-mail: [email protected] suppression such as organ transplant recipi- tion was shared, and collegial relationships April-2009/Canine-Melanoma-Vaccine-Gets- Conditional-OK/ ents or people taking immunosuppressive formed. These two professions are comple- 12. Aronson S. “The Dancing Cats of Minamata medications, the risk of zoonotic disease mentary and synergistic, and ideally, if they Bay.” Medicine and Health Rhode Island. transmission becomes much greater than re-forge old ties, they will make great new 2005; 88.7: 209. http://search.proquest.com/ st One Health: A Concept for the 21 Century for the general population. Grant and Olsen discoveries that will benefit the health of all docview/195779436/fulltext/2FCF9AF281834 found that assessing zoonotic disease risks in species as the twenty-first century progresses. 074PQ/1?accountid=13314 13. Eto K, Marumoto M, Takeya M. “The pathol- this vulnerable population often gets ignored ogy of methylmercury poisoning (Minamata dis- One Health is a new term, but an ancient mal health. For example, Dr. Edward Jenner, because physicians are not familiar with the ease).” Neuropathology 2010; 30: 471-479. concept that recognizes the inherent links an apprentice surgeon, learned from dairy- diseases while veterinarians defer to physi- References http://onlinelibrary.wiley.com/store/10.1111/ between human, animal, and environmen- maids that they were immune from smallpox cians for human health care [8]. Physicians 1. Taylor LH, Latham SM, Woolhouse ME. “Risk j.1440-1789.2010.01119.x/asset/j.1440- tal health. Humans and animals cannot be because they had had cowpox. He applied rarely ask their patients about pet ownership Factors for Human Disease Emergence.” Philos 1789.2010.01119.x.pdf?v=1&t=iao5jp4n&s=b Trans R Soc Lond B Biol Sci July 29, 2001. healthy if the environment in which they this concept to the practice of variolation or animal exposures, yet pet-associated infec- f561531ab8e6609a20ea4d31ebeb4a45513790a http://rstb.royalsocietypublishing.org/con- 14. Newman AA. “For Small Animals, a Fleck live is sick. The One Health concept seeks to and developed the word “vaccination” from tions are common and can be deadly [9]. tent/356/1411/983 is a Lot.” New York Times. December 22, increase communication and collaboration the Latin word “vacca” meaning cow [2]. Ap- 2. Riedel S. “Edward Jenner and the history of small- 2007. http://www.nytimes.com/2007/12/22/ between human, animal, and environmental proximately two centuries later, Dr. Jenner’s Beyond zoonoses, comparative medicine is pox and vaccination.” BUMC Proceedings. 2005; business/22petside.html 18: 21–25. http://www.ncbi.nlm.nih.gov/pmc/ 15. Morgan RV. “Lead poisoning in small companion health professionals. vaccine was used to eradicate smallpox from the study of disease processes such as asth- articles/PMC1200696/ global human populations [3]. ma, diabetes, and cancer across species. Dis- animals: an update (1987–1992).” Vet Hum Toxi- 3. Deria A, Jezek Z, Markvart K, et al. “The world’s cology 1994; 36: 18-22. The One Health concept is important for coveries in veterinary medicine can benefit last endemic case of smallpox: surveillance and con- many reasons. Zoonotic disease risks from Drs. Louis Pasteur and Robert Koch, a human medicine and vice versa. As with hu- tainment measures.” Bull World Health Organi- wildlife, livestock, and pets cannot be ad- French chemist who studied chicken cholera mans, an increase in canine and feline obe- zation. 1980; 58: 279-283. http://www.ncbi.nlm. Laura H. Kahn, MD, MPH, MPP, nih.gov/pmc/articles/PMC2395794/ equately addressed without meaningful and a German physician who studied anthrax, sity has led to an increase in diabetes [10]. 4. Smith K.A. “Louis Pasteur, the Father of Immu- Research Scholar, collaboration and cooperation between vet- respectively, independently developed the Laura H. Kahn Studying disease similarities and differences nology?” Frontiers in Immunology. 2012; 3: 68. Program on Science and Global Security, erinarians and physicians. Microbes do not germ theory of disease. Dr. Pasteur discov- between species could shed important new http://www.ncbi.nlm.nih.gov/pmc/articles/ Woodrow Wilson School of Public necessarily recognize the differences between ered the theory of immunity and developed mental discovery stage for the widespread information on disease progression, treat- PMC3342039/ and International Affairs, species and could infect across them if given the world’s first rabies vaccine, and Dr. Koch recognition that other arthropods could ment, and control. In another example, a ca- 5. Committee to Update Science, Medicine, and Princeton University Animals, National Research Council. “Science, the right conditions. Indeed, approximately developed “Koch’s Postulates” for establish- serve as vectors for zoonotic diseases, such as nine vaccine for oral melanoma was the first Medicine, and Animals.” 2004. National Acad- E-mail: [email protected] 75 percent of emerging infectious diseases ing the infectious causations of disease [4, 5]. mosquitoes transmitting yellow fever. therapeutic vaccine approved for the use in emies Press. Washington DC. Page 7. http:// and approximately 60 percent of all human either animals or humans [11]. An impor- www.ncbi.nlm.nih.gov/books/NBK24656/pdf/ The author would like to acknowledge pathogens are zoonotic in origin [1]. Drs. Theobald Smith and Frederick As the twentieth century progressed, sci- tant benefit to studying diseases in animals Bookshelf_NBK24656.pdf her One Health Initiative colleagues: 6. Assadian O, Stanek G. “Theobald Smith— L. ­Kilbourne, a physician and veterinarian entific knowledge exploded, and medicine is that they do not experience the placebo the discoverer of ticks as vectors of disease.” Bruce Kaplan, DVM Some of the greatest discoveries in the histo- team, respectively, discovered that an arthro- became increasingly specialized. Collabo- effect, so improvements resulting from nov- Wien Klin Wochenschr. 2002 114 (13-14): Tom Monath, MD ry of medicine and public health were made pod, in this case a tick, could transmit cattle ration between medicine and veterinary el treatments demonstrate actual benefits 479-81. http://www.ncbi.nlm.nih.gov/pub- Jack Woodall, PhD at the intersection between human and ani- fever from animal to animal [6]. This monu- medicine waned, but the challenges of the that warrant further study in humans. med/12422586 Lisa Conti, DVM, MPH

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Table 1 . Frequency of the sale of antimicrobials based on simulated client method surveys otics during the time covered by the survey had got them from a healthcare provider, but Sore LRTI Specific anti- Vari- Pros and Cons of the Over-the-counter Author, year Country Type URTI OM Sin . Dia . UTI STI a 3% of users reported to have obtained them throat or flu microbials ous Sales of Antimicrobials without prescription and 2% more stated EUROPE that they used the leftovers from a previous Contopoulos-Ioannidis DG, Greece D 78% course. However, when more reliable meth- 2000 ods are used the results are much higher. Plachouras D, 2008 Greece D 53–100%b One of the most reliable ways to estimate Marković-Peković V, 2010 Bosnia&Herzegovina D 58% how frequent the sale of antibiotics is in- Simó S, 2006c Spain I 12% cludes simulated-client-method pharmacy Llor C, 2007 Spain D 35% 16% 80% studies in which actors simulating certain Gastelorrutia, 2009 Spain D 17% infectious diseases manage to obtain anti- Simó S, 2012c Spain I 6% biotics at community pharmacies. Table 1 Guinovart M, 2014 Spain D 48% 33% 81% describes the 30 studies published so far and AMERICA applying this methodology. Gellert GA, 1994 Mexico I 100% Bartoloni A, 1992 Bolivia D, Id 24% 91% 24% 40–92%e 58% 67%f In 2007 in Spain, making use of a mystery Volpato DE, 2002 Brazil I 74% shopper who presented at community phar- Vacca CP, 2007 Colombia D 80% macies requesting an antibiotic for one of AFRICA three different clinical scenarios, our group g observed that these drugs were sold in Nyazema N, 2004 Zimbabwe D 9% 8–65% 45.6% of the pharmacies without a medi- MIDDLE EAST Carl Llor Ana Moragas cal prescription [7]. This percentage was Amidi S, 1975 Iran D 60% 40% slightly higher at 54.1% when the study was Tomson G, 1985 Yemen I 9% Most antimicrobial use is probably pharmacists to promote the appropriate use repeated in 2014 using the same methodol- Al-Faham Z, 2009 Syria I 97% ­inappropriate. It has been estimated that of antimicrobials. However, implementation ogy [8]. However, according to the Euroba- Dameh H, 2005 United Arab Emirates D 69% up to 50% of human antibiotic use and up has generally been weak in many countries, rometer, the percentage of Spanish people Al-Ghamdi MS, 1999 Saudi Arabia D 82% to 80% of veterinary antibiotic use could be and the prevalence of bacterial resistance who admitted having bought an antimicro- Bin Abdulhak AA, 2010 Saudi Arabia I 51% 40% 90% 73% 90% 75% eliminated without serious consequences continues to increase since antimicrobial bial at the pharmacy was only 4% [6]. ASIA [1]. The inappropriate use of these drugs in- resistant bacteria are common in commu- Wolffers I, 1983 Sri Lanka D 100% creases the risk of selection of resistant bacte- nities where over-the-counter policy is still By contrast with Northern Europe and Tomson G, 1985 Sri Lanka I 41% ria and may contribute to antibiotic resistance available. North America, non-prescription access Tomson G, 1985 Bangladesh I 68% [2]. Antibiotic resistance has become a global to antimicrobials is common in the rest of Hadi U, 2006 Indonesia D 74% health problem and is responsible for signifi- the world [5], as shown in Table 1. In a nice Puspitasari HP, 2010 Indonesia D 91% cant morbidity and mortality and, therefore, Prevalence study carried out in a Finnish community Quagliarello AB, 1999 Vietnam D 99% 75% restriction of antibiotic use and marketing living in Spain, Väänänen et al. found that Chalker J, 1999 Vietnam D 98% regulations are among many important strate- The prevalence of over-the-counter sale antibiotics, which are considered as pre- h Wachter DA, 1996 Nepal D, I 97% 38% gies to control this problem [3,4]. of antibiotics varies across countries, be- scription-only medicines in Finland, were 50– Thajlikitkul V, 1986 Thailand D ing common outside Northern Europe purchased by 41% of the immigrants who 100% The sale of antibiotics and other antimicro- and North America [5]. The percentage of admitted having taken an antibiotic in the Chalker J, 1999 Thailand I 76% bial medicines without prescription remains non-prescription access to antimicrobials previous 6 months [9]. Apisarnthanarak A, 2006 Thailand I 80% 74% 65% 76% 100% widespread, with many countries lacking is often underestimated, and also depends standard treatment guidelines; thereby in- on the methodology used to estimate it. In Type=type of simulated patient (D, direct: the patient him-/herself; I, indirect: simulating having a relative or friend with an infectious disease); URTI=upper respira- creasing the potential for overuse of antimi- 2013, the European Commission published Drawbacks of the over-the- tory tract infection (including rinorrhoea, sneezing, with or without fever); OM=otitis media; Sin.=sinusitis; LRTI=lower respiratory tract infection; Dia.=diarrhoea; crobial medicines by the public and medical a questionnaire-based study (Eurobarom- counter sale of antimicrobials UTI=urinary tract infection; STI=sexually transmitted infection professionals [5]. In general, governments eter), carried out in 28 European countries, support policies on the prudent use of including 27,680 respondents, in which 35% The link between the over-the-counter sale aVarious infectious diseases considered; bMistery shoppers requested ciprofloxacin (53% of success) and amoxicillin/clavulanate (100% of success);c Related to a ­antimicrobials in order to control resistance admitted having taken at least one dose of of antibiotics and antibiotic overconsump- 9-month old baby with an upper respiratory tract infection and fever; dThe indirect simulated patients corresponded to children; e40% in case of a 6-month old child and recommend control measures to sup- antibiotic in the previous 12 months [6]. The tion is clearly established. Southern Euro- and 92% when an adult with this infection was simulated; fCase of male urethral discharge; g8% in the case of a male urethritis and 65% when a vaginal discharge was port careful use by encouraging doctors and large majority of those who had used antibi- pean countries usually rank at the top in simulated; hThe direct simulated patient corresponded to the case of UTI; the indirect case corresponded to his 5-year son with diarrhoea

64 65 Antimicrobials use SPAIN SPAIN Antimicrobials use

terms of the consumption of antibiotics, colds and influenza. A north-south gradient rifampicin and isoniazid being sold for indi- scription of the drug sold by the pharmacist Table 2 . Drawbacks of the over-the-counter sale of antimicrobials as described in the last report issued by the was also observed, with better knowledge of cations other than tuberculosis as over-the- to thereby be partially or totally reimbursed • Self-medication with antimicrobials European Surveillance of Antimicrobial how antibiotics work in northern countries counter antimicrobials [20,21]. This easy for the cost of the antimicrobial. • Storage of antimicrobials in households Consumption Network (ESAC-Net) [10]. and, conversely, citizens living in southern access and inappropriate use of these drugs • Inappropriate use of antimicrobials Indeed, over-the-counter sale of antibiot- countries were less knowledgeable about this clearly constitute risk factors for further de- • Potential side effects ics is reportedly common in countries such subject [6]. Since 2008, the European Union, velopment of multidrug resistant tuberculo- Advantages of over-the- • Masking of underlying clinical syndrome as Italy, Greece, and Spain [5]. In a study through the European Centre for Disease sis, which is nowadays challenging due to counter sale of antimicrobials • No questioning by pharmacists regarding allergies, pregnancy and side effects on pharmaceutical surveillance in Spain, Prevention and Control, has encouraged the associated high morbidity and mortality • Contraindicated antimicrobials Campos et al. observed that about 30% of public information campaigns on prudent [22]. Over-the-counter sale without a pre- Accessibility to over-the-counter antimi- • Inadequate dose regimens the outpatient antimicrobials purchased antibiotic use in its member countries, by scription may also lead to the use of insuf- crobials has also some advantages. Some of • Low-quality medication was not identified by reimbursement data, promoting the European ­Antibiotic Aware- ficient dosages, with lower doses dispensed these are for the patient, others for the physi- • Pressure of having an antimicrobial prescribed largely because over-the-counter sales were ness Day on the 18 November [16]. Never- being more common when the antibiotic is cian, the pharmacist, the pharmaceutical in- not tracked [11]. theless, concerns have been raised that such sold at the pharmacies compared to other dustry itself and others for the government. campaigns are not having their anticipated healthcare facilities [23]. The individuals would have a greater choice Self-medication with antimicrobials is also effect [17]. In addition, the recent Euroba- of access to healthcare both in the way it is widespread, occurring among the population rometer stated that 60% of respondents had Safety issues associated with non-prescrip- delivered and at a time and place convenient in the same countries where over-the-coun- taken at least one course of antibiotics in the tion use also include adverse drug reactions to them. For instance, patients with recur- ter sale is available [12]. Antibiotics available previous year for flu, acute bronchitis, colds, and masking of underlying infectious pro- rent urinary tract infections, who clearly at home have been found to be an important or sore throat [6]. cesses (Table 2). Antimicrobials frequently know their symptoms, can be benefitted risk factor for this practice [13], and leftover cause side effects, despite most being mild; from an over-the-counter policy. Physicians medication may later be considered for self- Another factor is patients’ non-adherence however, side effects accounted for nearly may gain from having fewer consultations medication, leading to inappropriate usage of to antibiotic therapy. Our group observed one fifth of all visits to the emergency room for minor ailments; pharmacists would have these drugs. In a study carried out in 2006, an intentional non-adherence to antibiotic for adverse drug events in a US study [24]. a further opportunity to use their profes- the prevalence of antibiotic­ storage in Span- regimens of 35% for respiratory tract in- Linked to this, low-quality and counterfeit sional knowledge and develop their range of ish households was 37% [14]. This in-home fections with the use of Medication Event antimicrobials have been more frequently services to the public. In our study, however, antibiotic storage might also increase the risk Monitoring System or MEMS contain- reported among antimicrobials sold without the pharmacists who refused to sell antibi- of self-prescription of antibiotics to families ers [18], resulting in the presence of some a medical prescription, mainly in develop- otics without a prescription gave responses and friends. In a population survey con- leftover drugs that might be used on future ing countries, resulting in a possible direct related to health or resistance issues in only Figure 1 . Relationship between over-the-counter sale of antimicrobials, storage and self- ducted in 19 ­European countries, covering occasions by the members of the house- harm and treatment failure [25]. Another 30% of the cases and pharmacists only asked medication 15,548 respondents, Grigoryan et al. found hold. Although a relationship between in- concern of the non-prescription status is about possible allergies, or potential preg- that the main reason for self-medication tentional non-compliance and the storage the possibility of drug interactions, particu- nancy and side effects in less than half of the more, in these low-income settings, a high strategies to accomplish this objective. The was a previous medical prescription of the of antibiotics has not been proven, the fact larly in children, elderly patients and preg- subjects to whom antibiotics were sold [7]. demand for antibiotics without a prescrip- over-the-counter sale of antimicrobials has same medication [15]. Thus, the over-the- that approximately one third of individuals nant women. In another study carried out in Education is therefore particularly impor- tion might be expected from customers who pros and cons but, in any case, this policy counter sale of antibiotics both encourages store antibiotics in their households and a Taiwan, patients with detectable ­antibiotic tant in the over-the-counter sale of anti- cannot afford to consult a doctor. requires that pharmacists have a key role as self-medication and the storage of leftover similar percentage intentionally do not take concentrations in urine were nearly twice as microbials; when patients choose self-care, healthcare agents and it must be forbidden antimicrobials, creating a vicious circle that them as requested makes this association likely to have a missed diagnosis of a true there is often no possibility to obtain advice to pharmacists who are not familiar with increases the consumption of antimicrobials very likely. bacterial infection compared to the patients from a physician, and thus the responsibil- Conclusions the management of some mild infectious (Figure 1). without any antimicrobial detected [26]. ity of providing appropriate information diseases, mainly in non-low-income coun- Over-the-counter sale of antimicrobials of- Proper diagnosis of an infectious disease falls on pharmacists. It should not be for- Antimicrobial resistance is a global issue tries. Notwithstanding, critically important Public awareness of the issue is low, with ten leads to a wrong choice of these drugs. can also be challenging in a pharmacy. Di- gotten that one of the greatest beneficiaries [27]. According to the current UK Health antimicrobials should never be purchased many people still believing that antibiot- For instance, in our study carried out in agnosis is even often difficult in the primary of the non-prescription use of antimicrobi- Chief Officer, we are losing the battle without a medical prescription anywhere. ics are effective against viral infections. Ac- 2007, fluoroquinolones, which are consid- care clinic and to distinguish between bac- als is the pharmaceutical industry, which against infectious diseases since bacteria are cording to the last Eurobarometer available, ered as critically important antimicrobials terial and viral aetiology is even more so, sees a new marketing opportunity with this fighting back and are becoming resistant to carried out in November 2013, 84% of re- by the World Health Organization as also mainly in respiratory tract infections. policy. Furthermore, the government could modern medicine so that, in short, antibiot- References spondents were aware that the overuse of are third- and fourth-generation cephalo- be relieved of some costs of antimicrobials ics will no longer work [28]. This reinforces 1. Wise R., Hart T., Cars O., Streulens M.; Hel- antibiotics makes them ineffective. When sporins and macrolides) [19], accounted for Another inconvenience is the pressure of obtained on National Health Service pre- the need to prescribe antimicrobial agents muth R., Huovinen P., et al. (1998) Antimicro- bial resistance. Is a major threat to public health? asked questions about antibiotics and how 40% of the antibiotics sold for urinary tract the population on both the pharmacist and scriptions. In addition, non-prescription only when there is good evidence that the BMJ, 317,609–10. they work, 49% of Europeans replied that infections [7]. Similarly, essential antitu- the physician. In the first case this pressure status of antimicrobials might be an impor- benefits outweigh the risks. Barring the dis- 2. Goossens H., Ferech M., Vander Stichele R,. El- antibiotics kill viruses and 52% correctly re- berculosis drugs are available without pre- is related to the selling of the antimicrobial tant mechanism of access to antimicrobials pensing of antibiotics without a prescrip- seviers M.; ESAC Project Group. (2005) Out- plied that antibiotics are not effective against scription in many areas, with streptomycin, and in the second, to obtaining the pre- in countries with low resources. Further- tion constitutes one of the most valuable patient antibiotic use in Europe and association

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with resistance: a cross-national database study. 13. McNulty C.A., Boyle P., Nichols T., Clappison pharmacies. (2004) The International Journal of statement “medicines shortages in my hos- Lancet,;365, 579–87. D.P., Davey P. Antimicrobial drugs in the home, Tuberculosis and Lung Diseases,8, 1325–29. Medicines Shortages: Global Problems pital are having a negative impact on patient 3. Butler C.C., Rollnick S., Pill R., Maggs-Rap- United Kingdom. (2006) Emerging Infectious 22. Gandhi N.R., Nunn P., Dheda K., Schaaf H.S., care”. Many respondents then went on to port F., Stott N. (1998) Understanding the cul- Diseases12, 1523–26. Zignol M., van Soolingen D., et al. Multidrug- ture of prescribing: qualitative study of general 14. González J., Orero A., Prieto J. Almacenamiento resistant and extensively drug-resistant tubercu- Need Global Solutions provide examples including: practitioners’ and patients’ perceptions of antibi- de antibióticos en los hogares españoles. (2006) losis: a threat to global control of tuberculosis. • The aggravation caused to patients, main- otics for sore throats. BMJ, 317, 637–42. Revista Espanola de Quimioter, 19, 275–85. (2010) The Lancet, 375, 1830–43. surveyed responded with less than 60% ly elderly, when explaining the required 4. Carbon C., Bax R.P. (1998) Regulating the 15. Grigoryan L., Burgerhof J.G., Haaijer-Ruskamp 23. Mukonzo J.K., Namuwenge P.M., Okure G., agreement that medicines shortages are a changes or delays to their treatment; use of antibiotics in the community. BMJ, 317, F.M., Degener J.E., Deschepper R., Monnet Mwesige B., Namusisi O.K., Mukanga D. Over- current problem. 88% of the respondents • The distress caused by delays or interrup- 663–65. D.L., et al., on behalf of the SAR group. Is self- the-counter suboptimal dispensing of antibiot- 5. Morgan D.J., Okeke I.N., Laxminarayan R., medication with antibiotics in Europe driven by ics in Uganda. (2013) Journal of Multidisciplinary experience medicines shortages at least tions to chemotherapy treatments; Perencevich E.N., Weisenberg S. (2011) Non- prescribed use? (2007) Journal of Antimicrobial Healthcare;6, 303–10. monthly, with 66% expressing it as a daily • The confusion experienced by prescrib- prescription antimicrobial use worldwide: a sys- Chemotherapy 59,152–56. 24. Shehab N., Patel P.R., Srinivasan A., Budnitz or weekly problem. ers and nurses when out-of-stock but tematic review. The Lancet Infectious Diseases.,11, 16. Earnshaw S., Mancarella G., Mendez A., To- D.S. Emergency department visits for antibi- familiar medicines must be replaced by 692–701. dorova B., Magiorakos A.P., Possenti E., et al., otic-associated adverse events. (2008) Clinical But what kinds of problem are being cre- available alternatives, and the potential 6. European Commission. Special Eurobarometer on behalf of the European Antibiotic Awareness Infectious Diseases, 47, 735–43. 407 ‘Antimicrobial resistance’. (2013) Available Day Technical Advisory Committee; on behalf 25. Taylor R.B., Shakoor O., Behrens R.H. Drug ated? The report sheds some further light on increase in medication error risk; from: http://ec.europa.eu/public_opinion/ar- of the European Antibiotic Awareness Day Col- quality, a contributor to drug resistance? (1995) the nature of the negative impacts entailed • Heightened risk of hospital acquired in- chives/ebs/ebs_407_en.pdf laborative Group. European Antibiotic Aware- The Lancet, 346, 122. for pharmacists, but above all, patients, fection as a result of antibiotic shortage; 7. Llor C., Cots J.M. (2009) The sale of antibiotics ness Day: a five-year perspective of Europe-wide 26. Liu Y.C., Huang W.K., Huang T.S., Kunin C.M. when a medicine prescribed for the patient • Deterioration in patients’ condition due without prescription in pharmacies in Catalonia, actions to promote prudent use of antibiotics. Inappropriate use of antibiotics and the risk for simply becomes unavailable. to shortage of the most efficacious medi- Spain. Clinical Infectious Diseases.,48, 1345–49. (2014) Eurosurveillance,19, 20928. delayed admission and masked diagnosis of in- cines; 8. Guinovart M.C., FIgueras A., Llop J.C., Llor 17. Stockley J.M. European Antibiotic Awareness fectious diseases: a lesson from Taiwan. (2001) C. Obtaining antibiotics without prescription in Day 2010: why doesn’t promoting antibiotic Archives of Internal Medicine, 161, 2366–70. For pharmacists, enormous amounts of time • Raised risk levels from the required use Spain in 2014: even easier now than 6 years ago. awareness always work? (2010) Journal of Infec- 27. Okeke I.N., Edelman R. Dissemination of can suddenly be absorbed into the pressing of unlicensed alternatives to a medicine in (2015) Journal of Antimicrobial Chemotherapy,70, tion,61, 361–63. antibiotic-resistant bacteria across geographic task of finding a new source of supply for shortage; and, 1270–71. 18. Llor C., Hernández S., Bayona C., Moragas A., borders. (2001) Clinical Infectious Diseases, 33, Richard Price the medicine. In the European context, this • Additional hospital admissions as a result 9. Väänänen M.H., Pietilä K., Airaksinen M. Self- Sierra N., Hernández M., et al. A study of ad- 364–69. might often be from other countries, with of some shortages (e.g. cardiology medi- medication with antibiotics--does it really hap- herence to antibiotic treatment in ambulatory 28. Davies S.C., Grant J., Catchpole M. (2013) The pen in Europe? (2006) Health Policy, 77,166–71. respiratory infections. (2013) International Jour- Drugs Don’t Work. A Global Threat. London: Pen- Is there a health system in the world at this all the delay, and potential knock-on im- cines). 10. European Centre for Disease and Prevention nal of Infectious Diseases,17, e168–72. guin Specials moment not suffering from the impacts of pacts for supply in the source country that Control. Summary of the latest data on antibi- 19. World Health Organization Advisory Group medicines shortages? With strong docu- can be involved [5]. EAHP’s 2014 report As suggested by the title, however, simply otic consumption in the European Union, No- on Integrated Surveillance of Antimicro- mentation of the problem in such coun- finds that 55% of hospital pharmacists in drawing attention to the problems caused vember 2014. Available at: http://ecdc.europa. bial Resistance (AGISAR). Critical impor- tries as the USA [1], Australia [2], South Europe say that up to 5 hours of staff time by medicines shortages is not enough. Ef- eu/en/eaad/Documents/antibiotic-consumptio- tant antimicrobials for human medicine. ESAC-Net-2014-EAAD.pdf (2012) World Health Organization. Avail- Carl Llor, Primary care physician, Africa [3], Canada [4] and elsewhere, to a week is being diverted from other tasks in fort, energy and awareness must be drawn 11. Campos J., Ferech M., Lázaro E., de Abajo F., able at: http://apps.who.int/iris/20.bitstre Primary Healthcare Centre, the understanding of the pan-European order to deal with shortage problems, with to potential solutions. With the causes of Oteo J., Stephens P., Goossens H. Surveillance am/10665/77376/1/9789241504485_eng.pdf Via Roma, Barcelona dimensions of the problem was recently a further 32% indicating that more than 5 shortages acknowledged to be so multi-fac- of outpatient antibiotic consumption in Spain 20. Kobaidze K., Salakaia A., Blumberg H.M. Ana Moragas, Primary care physicians, added the publication of the report by the hours a week is consumed with managing eted, as well as situation and region-specific, according to sales data and reimbursement data. Over-the-counter availability of antituberculosis Primary Healthcare Centre, European Association of Hospital Phar- the situations caused by shortages. Indeed, it need barely to be mentioned that it is a (2007) Journal of Antimicrobial Chemotherapy, 60, drugs in Tbilisi, Georgia in the setting of a high Jaume I, Tarragona, Spain macists “Medicines Shortages in European some respondents reported the need to em- list of mitigating policy actions that are re- 698–701. prevalence of MDR-TB. (2009) Interdisciplinary 12. Grigoryan L., Haaijer-Ruskamp F.M., Burger- Perspective of Infectious Diseases, 513609. E-mail: [email protected] Hospitals” (November 2014) [5]. ploy full time equivalents dedicated solely quired, rather than any single answer. hof J.G.M., et al. Self-medication with antimi- 21. Lambert M.L., Delgado R., Michaux G., Volz to locating new sources for out-of-stock crobial drugs in Europe. (2006) Emerging Infec- A., Van der Stuyft P. Tuberculosis control and Distributed across Europe by the net- medicines. The reflections of the International Phar- tious Diseases,12, 452–59. the private health sector in Bolivia: a survey of work of 34 EAHP national country asso- maceutical Federation (FIP) and, indeed, ciations [6], over 600 hospital pharmacists However, if the medicines shortages prob- the regulatory action advocated for by from 36 countries responded to a call for lem was simply a question of inefficiency it our colleagues at the American Society information about the problems being would not excite the attention and momen- of Health System Pharmacists (ASHP) faced in practice as a result of medicines tum that the matter has been gaining at the have certainly informed the outlook of the shortages. A definitive answer was re- international level [8]. The most telling and ­European Association of Hospital Pharma- turned: 86% responded in the affirmative pressing impact is for patients. Here again, cists on the matter of potential solutions to that, yes, medicines shortages are a current EAHP’s 2014 report provides some addi- the medicines shortages problem. problem in the hospital the responding tional insight. pharmacist works in, in terms of delivering In 2013 FIP brought together pharmacy the best care to patients and/or operating Over 75% of the respondents to the survey professionals from across the globe in an in- the hospital pharmacy. Indeed, no country either agreed or strongly agreed with the ternational summit on medicines shortages

68 69 Medicines shortages Medicines shortages

Approximately how often does your hospital pharmacy experience shortages? held in Toronto, Canada [8]. At the end of EAHP is now working with counterpart In which area of medicine does your hospital experience shortage most commonly? Most hospital pharmacists responded that they are affected by shortages on a weekly basis. two days of deliberations they made a series healthcare professional and patient organ- The areas in which shortages of medicines are most commonly reported are: of principal recommendations for tackling isations at the European level to promote Hospital pharmacists are affected by shortages on a daily basis, with 21.1% (n=111) replying that they • antimicrobial agents experience a shortage of a medicine every day. the problem, including: this much needed policy agenda [11] and • oncology medicines • Improved publicly available information hope that in time a positive European ex- • emergency medicines The situation for the majority of those who replied was that they experience shortages at least weekly, • cardiovascular medicines 45.2% (n=238) selecting this response. on shortages; ample of response to the shortages prob- • anaesthetic agents • A globally agreed list of critical/vulner- lem may yet be provided to our colleagues 21.2% (n=112) replied that they are affected by shortages on a monthly basis with 12.4% (n=65) stating It is interesting to note that at least 19 (4.5%) reports were received for the lowest affected category: that they are affected occasionally. able products; elsewhere in the world. That work, how- transplant medicines. This indicates the many categories of medicine are affected by shortage. • Improved procurement processes to as- ever, remains ongoing. A new European This resulted in a combined 87.6% (n=112) of the respondents replying by saying that they are affected sure continuity of supply; and, Commission settling into its 5 year term 57% by medicines shortages at least monthlyy. 60.0% • Improved regulatory cooperation be- of office could provide the opportunity re- 55% tween countries on the matter. quired [12]. 50.0% Daily Occasionally 21.2% Meanwhile, in the United States, some 40.0% 12.4% 30% 30% case study examples of what can be References 30.0% 26% achieved, at least as interim steps, have 1. McLaughlin M., et al. Empty Shelves, Full of Monthly Frustration: Consequences of Drug Shortages 20.0% Weekly been provided via the FDA Innovation 21.2% Act (FDASIA) of 2012 [9]. This legisla- and the Need for Action. (2013) Hospital Phar- 45.2% macy, 48(8). 617-618 10.0% tion not only clarified the statutory remit 2. Quilty S. Medicines shortages in Australia – the 0.0% t s of the USA’s medicines agency to be in- y

reality. (2014). The Australasian Medical Journal, cy

volved in resolving medicine shortages 7(6), 240-242 ther Renal O Orphan problem, but also addressed problems in 3. Bateman C. Drug stock-outs: Inept supply- Urology ansplan Oncology . vaccines) Tr Emergen Figure 1 . relation to the legal responsibilities of chain management and corruption. (2013) Respirator Antibiotics/ . g

manufacturers to report likely disrup- SAMJ: South African Medical Journal, 103, 600- (e Gastrointestinal

602. opical treatments

tions to supply at an early stage in order ediatric medicines T Anaesthetic agents Which type of medicine do you most commonly experience to be in short supply? eventive medicines

4. Barthelemy I., Lebel D., Bussieres J-F. Drug Pa Endocrine medicines to enable better contingency planning. Pr shortages in health care institutions: perspec- Antivirals/Antifungals) According to the respondents they most commonly experience originator (patented) products to be in Some early monitoring results from the Haematology medicines short supply. 51.8% (n=221) reported them as the most common category of shortage. tives in early 2013. (2013) Canadian Journal of Cardiovascular medicine University of Utah has suggested such ac- Hospital Pharmacy, 66(1), 39–40 Generic products (including branded generics) were affected to a lesser degree, with 36.5% (n=156) of tion, whilst by no means eliminating the 5. European Association of Hospital Pharmacists.

hospital pharmacists starting that they are the most affected category in theri experience. Antimicrobilal agents ( problem, it has proven effective in so far Medicines shortages in European hospitals. (2014) 11.7% (n=50) of respondents considered that unlicensed medicines are the most common type of as reducing the difficulties [10]. Available: http://www.eahp.eu/press-room/ medicines in short supply. patients-suffering-medicines-shortages-all-eu- Figure 3 . Category of shorages reported overall. The categories with the highest responds ropean-countries. Accessed 17 June 2015. Unlicensed Drawing inspiration, EAHP’s 2014 report include antimirobials (56.7%), oncology (54.5%), emergency medicines (30.4%) 6. European Association of Hospital Pharmacists. medicines on medicines shortages in European hospi- and cardiovascular medicines (30.4%). n=418 tals ends with a set of policy calls to political EAHP Members. (2015) Available at: http:// 11.7% www.eahp.eu/about-us/members. Accessed 17 decision makers: FDASIA/ucm313121.htm. Accessed 17 June s3.amazonaws.com/documents/pdf/common- June 2015. 2015. position-supply-shortages-final-10-2013.pdf. Originator • Improved collection and sharing of in- 7. Gray A., & Manasse H. R. (2012). Shortages formation about medicines shortages 10. Are Shortages Going Down Or Not? Interpreting 12. European Commission (2014, Sep 10) The 51.8% of medicines: a complex global challenge. Bul- Data From The FDA And The University Of Utah Juncker Commission: A strong and experienced in Europe, by both national medicines Generic letin of the World Health Organization, 90(3), Drug Information Service. [ONLINE] Available team standing for change, http://europa.eu/rapid/ 36.5% agencies and the European Medicines 158–158A. at: http://healthaffairs.org/blog/2015/04/08/ press-release_IP-14-984_en.htm Accessed 17 Agency; 8. Besancon L., Chaar B. Report of the interna- are-shortages-going-down-or-not-interpreting- June 2015. • Clarification and enforcement of legal re- tional summit on medicines shortage. (2013) data-from-the-fda-and-the-university-of-utah- sponsibilities on manufacturers of medi- International Pharmaceutical Federation (FIP), drug-information-service/Accessed 17 June Richard Price, cines to report disruptions to supply; Toronto. Available at: http://www.fip.org/files/ 2015. Policy and Advocacy fip/publications/FIP_Summit_On_Medicines_ 11. Houÿez F., et al. Common position between The countries with highest recordes prevalence of originator (patented) shortages are Belgium • An inquiry at the European level into the Shortage.pdf. Accessed 17 June 2015. Officer at the European Association of (78.3%, n=69), Spain (64.5%, n=62), Austria (73.3%, n=15) and Slovakia (78.6%, n=14). The pharmaceu- primary factors causing medicines short- patients’, consumers, and healthcare profession- Hospital Pharmacists (EAHP) tical markets of Bulgaria, Ireland, Switzerland, Italy, Norway, France, and Poland also expressed that 9. Fact Sheet: Drug Products in Shortage in the Unit- ages; als’ organisations involved in the activities of the E-mail: [email protected] patented products were the most common category of shortages. ed States. (2015) [ONLINE] Available at: http:// European Medicines Agency on Supply Short- • Criteria for a fair distribution of supply in www.fda.gov/RegulatoryInformation/Legisla- ages of Medicines. (2013) [cited 21.03.2014.]; cases of shortage, based on primary con- tion/FederalFoodDrugandCosmeticActFD- Available from: http://download.eurordis.org. Figure 2 . Nature of the shortages reported from all of the respnseces. N=427 sideration of patient need. CAct/SignificantAmendmentstotheFDCAct/

70 71 Mobile Health GERMANY GERMANY Mobile Health

What Constitutes mHealth? mote monitoring of various data as well as called “Georgetown mantra” [10] as well as Do Ethics Need to Be Adapted to mHealth? large scale collection of health related data similar aspects mentioned in other docu- As specified by the WHO’s Global Obser- for biomedical research (the so called “big ments and normative analyses have to be an A Plea for Developing a Consistent Framework vatory for eHealth (GOe), mHealth, also data” approaches [8, 9]), many different lev- essential part of all further work. known as mobile health, can be seen as the els of medical ethics are affected and must be “medical and public health practice support- considered. Codes of ethics that are already available The rapid advancement of technology does bile technologies can offer in healthcare, the technologies when it comes to monitoring ed by mobile devices, such as mobile phones, and deal with issues related to the conse- not stop at mobile devices: For most people, highly sensitive nature of this field of appli- their health because they have been told this patient monitoring devices, personal digital For example, as soon as data originally re- quences of using technologies, public health these sophisticated gadgets have become cation raises a number of ethical questions may help to reduce their risk for disease. assistants (PDAs), and other wireless devic- corded in a care context is (additionally) [11], research [10, 12], or telemedicine [13] an integral part of their daily life. Smart that need to be answered [3]. Also, they believe that being well informed es.” [6]. However, considering the rapid tech- evaluated in a research project, research eth- as well as the general use of internet based phones and tablets as well as various wear- may also serve to mitigate potential risks. nological evolution that of course does not ics need to be included in the equation. On services [14] or other subject areas such as able devices, e.g. smart watches, perform People who use health related apps for re­ At the same time apps have already proven stop at mobile devices, this definition (dating the other hand, if mobile devices are em- medical informatics [15] also need to be their duties in an unobtrusive way but still creational purposes, training or other health to be effective tools for boosting adherence back to 2011) falls short of what is possible ployed to record physiological parameters scrutinized with respect to their applicabil- provide users with impressive functional- related tasks are usually confident that those to therapies (for example, via text messag- nowadays. Even sensors commonly found in (independent of whether this patient care or ity to the mHealth sector. ities that would have been unthinkable of who provide the apps (vendors as well as ing reminders) or for disease management mobile devices but developed with entirely research in mind), patient autonomy as well only a few years ago: the sensor technology developers) follow the unwritten rules with [5]. However, these developments go hand different fields of application in mind are of- as the patient’s right “not to know” must be However, such an analysis reveals that there included in most of these devices can record respect to how personal data should be han- in hand with technical challenges and ethi- ten used for medical and health related pur- respected. Also, sometimes, the target ori- are certain dimensions that might be in con- data relating to many different aspects of dled or not. They are not necessarily ignorant cal concerns: Above all, the medicalisation poses. Apart from applications making use of ented approach commonly used in medicine, flict with each other. For example, while a the user’s life and these data can easily be or careless, but often, they like to think that of apps results in limited consumer choices. sensor based data, there are also those that namely, research vs. treating patients, stands user may simply want to have his or her data stored and evaluated either on the devices datasets recorded by the mHealth applica- This refers as much to using the apps them- aim at providing users with health related in the way of applying the value-rational monitored to stay healthy and continue to be themselves or be sent to some remote loca- tions they use are deleted as soon as they are selves as to targeted advertising users may information, while even others target bio- principles of medical ethics as would be able to participate in public, mHealth pro- tion for further processing and storage. no longer needed or that only they them- receive which is specifically adapted to their medical research or can be used for (preven- ­appropriate. And lastly, the use of mHealth viders may rather have the collection of data selves can gain access to their data because “health”-related data or their health pro- tive) healthcare. Often, it is impossible (and may also influence the relationship between for research or marketing purposes in mind At first gaining great popularity with busi- they do not suspect anything else. However, file. Consumers may be led to think that not even desirable) to clearly distinguish patients and their physicians. A striking ex- and may also want to influence the behavior nesspeople as well as private users who feel there are divergent interests involved that they need certain apps or commercialized between these areas, since they all make use ample is the reference to the traditional issue of consumer in one or the other direction. they can rarely do without their constant may lead some providers of mHealth apps to products for their well-being. Having these of monitoring, recording as well as surveil- of confidentiality: mHealth app users might Here, specifically the above mentioned tra- mobile companions, the devices have also collect data and use them for purposes that radical examples in mind, we believe that it lance functionalities and there are many use them to communicate their disease spe- ditional concepts like autonomy, confiden- become accepted in other sectors, including the users are not aware of (and would never is essential to transparently describe what overlaps. A “definition” guideline has been cific parameters with their physician, either tiality, beneficence and maleficience are at the medical field. Part of this stems from or only hesitatingly acquiesce to if they were people using mobile devices for mHealth provided, for example, by the FDA in their actively, for example, via text messaging or stake. At the same time and on another level, the fact that economists as well as politi- told), e.g. marketing. The consequences of can expect from mHealth providers. Thus, “Guidance for Industry and Food and Drug passively by having their data monitored. This a consumer using mHealth may have the im- cians have come to realize that mobile de- this “misinterpretation” of the other party’s mHealth ethics is not so much about find- Administration Staff – Priority Review of communication can only be frank, trustful, pression that the promise of confidentiality vices along with the (public) health related goals are not trivial. This is not about wheth- ing out which rules people want mHealth Premarket Submissions for Devices” [7] re- true and free of manipulation if confidential- commonly applied in medical contexts also apps running on them offer great potential er people should clap hand in the British providers to follow, but about which rules vised on February 9, 2015. Also, the manner ity, as a crucial element of patient-physician extends toward mHealth settings in gen- for the medical field, not only by improv- House of Parliament or not – it is about seri- mHealth providers promise to follow in the in which mHealth is being used means that relationships, is guaranteed. For both sides, eral and, thus, his or her health related data ing the quality of care for patients, but also ous issues regarding autonomy, participation, future. the access­ to health related services is no lon- confidentiality is of utmost importance and are also protected similarly. However, many from an economic point of view. Their uses personal health, economy and public inter- ger restricted to time or location, i.e. getting this also holds true for third parties because mHealth providers have a more or less legiti- in the medical context are manifold. For ests. Different interests and different notions Our objective in this article is to provide to a doctor’s office or a hospital at a specific this is essential for guaranteeing mutual re- mate interest to simply make use of the data example, they are regarded as invaluable about “what should be done” cause tensions some starting points for the clearly need- time. Instead, by using mHealth technolo- spect, full disclosure of symptoms to the phy- they obtain. Additionally, the interest in data for prevention, e.g. for monitoring chronic and conflicts of goals and norms. Conflicts ed discussion about ethics in mHealth. gies, ­users can gain access to an impressive sician and privacy, including protection from does not stop with researchers. Public health conditions such as high blood pressure or like these are well known to medicine at Therefore, after an introductory definition number of health related services whenever stigmatization. officials, a “medical police”, insurances or diabetes [1, 2] and improving adherence to large, but mHealth in its ubiquity, availabil- of what constitutes “mHealth”, we outline they need them [5]. employers might also have interest in these therapies. For patients, the main aspect is ity and accessibility may provoke a new and how the fundamental principles of medical Considering the different spheres of pa- data to increase their chances on the market the added comfort of such mobile solutions enhanced debate about some ethical aspects ethics as they are described in several stan- tient’s life which apps can monitor and by choosing the clients or employers with the compared to conventional methods, while that are already being discussed in medicine dard codices can be transformed in order to Evaluating Existing Biomedical record, it becomes clear that at least in the best risk profile. Transparency usually has a from a professional point of view, better ad- in general. make them applicable to mHealth. In a nut- Principles and Codes medical field, the health related use of apps good reputation, but from a patient perspec- herence to a prescribed regimen as well as shell, we propose mHealth specific ethical needs some ethical guidance. Referring to tive, mHealth transparency interpreted in meticulous monitoring may serve to prevent The power of mHealth apps to medicalise principles to be developed that – while they Due to the vast number of imaginable areas classical elements of medical ethics this this manner may go too far. long-term damages that might be caused as [4] the behaviour of individuals causes us are still based on established principles and of application for mHealth solutions, start- means that, for example, the four principles a result of a more careless approach. Never- to start a debate about ethics in mHealth. guidelines – also take the specific require- ing with their use in private settings in the of “autonomy”, “nonmaleficence”, “benefi- As a first approach, we would therefore sug- theless, despite the perceived benefits mo- ­Users often make excessive use of mobile ments of mHealth under consideration. patient’s home and further extending to re- cence”, and “justice” mentioned in the so- gest to follow the classical codes of medical

72 73 Mobile Health GERMANY GERMANY Health Apps

ethics and codes for e-health and telemedi- -- mHealth interventions should aim at nomic interests. Maintaining the overview (2013) International Journal of Environmental 13. Iserson K.V. Telemedicine: a proposal for an eth- Dr. med. Urs-Vito Albrecht, MPH, cine in order to examine the dimensions of eliminating existing inequalities. For of all aspects that need to be respected by Research and Public Health, Nov.10(11),6131-53. ical code. (2000) Cambridge Quarterly of Health- Hannover Medical School, 10. Beauchamp T.L., Childress J.F. (2009) Principles normative conflicts involved. From this ba- this, the fair distribution of potential stakeholders involved in mHealth is not an care Ethics.9, 404–406 Peter L. Reichertz of Biomedical Ethics. Oxford University Press. 14. Rippen H., Risk A. e-Health Code of Eth- sis, we propose to develop a specific WHO benefits and potential harm within the easy task as the aforementioned consider- Institute for Medical Informatics, Germany 11. Public Health Leadership Society. (2002) Prin- ics. (2000) Journal of Medical Internet Research. mHealth code of ethics along the following target group is a prerequisite. ations reveal. Although several codes re- ciples of the Ethical Practice of Public Health. E-mail: [email protected] 2(2):e9 URL: http://www.jmir.org/2000/2/e9 http://phls.org/CMSuploads/Principles-of-the- lines: 4. It is often forgotten that mHealth apps garding eHealth exist, we think that, due to DOI: 10.2196/jmir.2.2.e9 PMID: 11720928 Prof. Dr. med. Heiner Fangerau, 1. Above all, patient interests need to be differ from other apps in the very aspect its ubiquity, the requirements to be met for Ethical-Practice-of-PH-Version-2.2-68496.pdf Institute of the History, 12. World Medical Association. (2014) World Med- PMCID: PMC1761853 addressed and questions of autonomy that they address the fundamental issue mHealth are even more challenging. Hav- ical Association Declaration of Helsinki. Ethical 15. International Medical Informatics Association. Philosophy and Ethics have to be integrated in such a mHealth of health. Therefore, mHealth providers ing a unified “code of ethics” specifically Principles for Medical Research Involving Hu- IMIA Code of Ethics for Health Information Pro- of Medicine at Cologne code as well. This would involve should – in line with the medical tra- targeting mHealth would simplify the ten- man Subjects. JAMA. 2013; 310(20):2191-2194. fessionals. http://www.imia-medinfo.org/new2/ University of Cologne, Germany -- respecting the right to self-determina- dition – promise not to cause harm to sion caused by the mismatch between users’ doi:10.1001/jama.2013.281053 node/39 E-mail: [email protected] tion with respect to active or passive their users. For example, expectations and the morals of providers participation where use or application -- the mHealth intervention shall not in and it might improve compliance with the of mHealth are concerned, any way have a negative impact on its required principles. -- voluntary participation and the right to user or on the receiving party. Specifi- Health Apps – Sound and Trustworthy? apps per month [7]. An exact number for withdraw at any time, cally, this applies to the physical and mHealth apps cannot be determined since -- providing comprehensive and target- mental wellbeing of each individual, a References the app stores only offer very basic rules for group as well as situation specific in- group of individuals or the individual’s 1. Eng D.S., Lee J.M. The promise and peril of mo- mobile offers, the situation is often confus- assigning apps to one category or another. formation to allow for an informed environment. bile health applications for diabetes and endo- ing. The most difficult part in determining Rather, this is left to the manufacturers, who crinology. (2013) Pediatric Diabetes,2013,14(4,) decision, -- The risks of an intervention must be whether an offer is acceptable or not is rat- will often choose a category that promises 231–238. -- promotion of health awareness for commensurate with its expected ben- 2. Fangerau H., Martin M. (2014) Blutdruck ing the quality of health apps. Most users – better sales. To clarify the classification and (self-) confident decision making in efits. This requires carefully weighing messen: Die ‚Technikalisierung‘ der Kreislauf- patients and healthcare professionals alike – to give users a better understanding, we rec- health contexts. up the risks and benefits based on valid diagnostik. Technomuseum (Hrsg): “Herzblut. are simply not familiar with the strategies ommend the following to clearly differenti- 2. Furthermore, the mHealth code of eth- and reliable information. Geschichte und Zukunft der Medizintechnik”, needed for carrying out such an assessment ate between health apps and medical apps ics needs to address possible settings -- The right to privacy, which aside from Theiss/WBG, Darmstadt, S. 74-93 on their own. Although various tools exist [8]. While, following the WHO’s definition where mHealth apps can be beneficial, confidentiality also includes protecting 3. Albrecht U.V., Pramann O. (2014) Ethical and that could help them in this process (e.g. [1, of health as “a state of complete physical, Legal Implications on Apps in Clinical Trials. their inclusive or exclusive character and personal integrity, must be protected in (2014) Biomed Tech 59 (s1,) pp. 674-675 DOI 2]), many of these are still under develop- mental and social well-being and not merely their accessibility for people potentially order to prevent any harm. 10.1515/bmt-2014-4290 ment or users are simply not aware of their the absence of disease or infirmity” [9] – benefitting from their use. This would 5. Finally, when using mHealth tools for 4. Conrad P. (2007) The Medicalization of Society. existence. What are the dangers users may the term “health apps” encompasses a wide for example mean that research purposes, one should be care- On the Transformation of Human Conditions into be confronted with in this context? This ar- range of health related apps, “medical apps” -- the primary benefits for the affected ful to respect the existing principles for Treatable Disorders. Baltimore ticle is meant to shed some light on the cur- are primarily intended for diagnosing, treat- persons must be obvious or deducible, good scientific practice, specifically 5. Boulos M.N., Brewer A.C., Karimkhani C., rent situation and to provide some remedies. ing or preventing illnesses or injuries. -- objectives of the mHealth app must be -- that research using mHealth appli- Buller D.B., Dellavalle R.P. Mobile medical and health apps: state of the art, concerns, regulatory achieved based on valid data, cations needs to generate valid and control and certification. (2014) Online Journal of -- decision processes must be transparent reliable data and that the commonly Public Health Informatics.5(3),229. doi:10.5210/ Urs-Vito Albrecht The App Market, Health Risks and Limitations and need to include all stakeholders known principles of good scientific ojphi.v5i3.4814. Apps and Medical Apps concerned (affected persons) in order practice as well as the biomedical prin- 6. World Health Organization. (2011) mHealth – A gold rush mood is prevailing among all The relevance of this categorization becomes to justify an intervention in a compre- ciples of research must be observed. New horizons for health through mobile technolo- stakeholders who are active in healthcare The smartphone and app hype really started apparent when one considers the potential hensible manner. gies. Global Observatory for eHealth series. V.3, 6 and everybody is clamoring for “their” app: in 2008 when 500 apps were made available risks and ramifications that may arise in the 7. FDA. Mobile Medical Applications. Guidance 3. Additionally, for Industry and Food and Drug Administration Healthy users want to track their fitness and on one app store [3]. In May 2015, the num- intended field of application. For medical -- mHealth interventions must be avail- Conclusion Staff. http://www.fda.gov/downloads/Medi- to obtain health related information and pa- ber of offered apps had already grown to the apps, the inherent risks of causing harm are able to everyone, regardless of social calDevices/.../UCM263366.pdf. (Last access: tients hope to get a comfortable means to formidable number of 3,730,000 [4] for four considerably greater, since their focus is pri- status, income, education, political ori- The presented catalogue of principles is 18.06.2015) manage their condition or to get into con- mobile platforms in five app stores. The con- marily on diagnosing or treating patients – entation, religious faith, inclinations supposed to offer a first glimpse of a pos- 8. Sungmee Park, Jayaraman S. A transdiscipli- tact with their doctors. For manufacturers, tinuing growth of the app market in general supported by the app and the mobile devices and ideals, gender, age, ethnic group but sible code promising certain behaviors (on nary approach to wearables, big data and qual- apps and mobile technology in general stand also applies to apps for health and fitness they run on – whose health is already com- also when it comes to technical affinity, the part of mHealth providers) to users of ity of life. (2014) Conference Proceedings of the for an additional chance for selling “health”, and, in fact, some analysts predict that this promised in some way. However, the desired IEEE Engineering in Medicine and Biology Soci- health competence, mental or physical mHealth apps. Users seek health, provid- ety.4,155-58. either under a new guise, or ideally based on part of the app market will have the largest success may either fail to materialize or, in a impairments. Neither discrimination ers may seek data as well as novel revenue 9. Hsieh J.C., Li AH, Yang C.C. Mobile, cloud, entirely new and exciting ideas. The market percentage change [5]. Recent estimates are worst-case scenario, it may come to an exac- nor stigmatization may be caused by generating areas of application and, thus, and big data computing: contributions, chal- is diverse and it is hard to maintain an over- that there are about 100 000 mHealth apps erbation or additional health problems. Of the intervention. they may follow public, individual or eco- lenges, and new directions in telecardiology. view – for those interested in health related [6] with an estimated growth of about 1 000 course, this outcome is highly undesirable,

74 75 Health Apps GERMANY GERMANY Health Apps

3. Engadget. Jobs: App Store launching with 500 not only for the patients themselves but of- products, manufacturers often avoid or ignore [12]. Users of health apps are in a difficult ity and trustworthiness can rarely be found. Transparency as an Added Value iPhone applications, 25% free. (2008) http:// ten also for the medical staff, their employ- this due to the considerable hurdles raised by situation: they have to decide for themselves Alternative sources of information need to be www.engadget.com/2008/07/10/jobs-app- ers, as well as the manufacturers. There exist the necessary regulatory processes. Currently, whether they place their trust in an app. This identified and are often only available some The situation in the market can be improved store-launching-with-500-iphone-applications- many possible sources of risks and the fol- compared to the number of available apps, is a difficult and error prone decision mak- time after an app has been published. Certifi- as soon as manufacturers acknowledge that 25-free/(accessed June 17, 2015). 4. Statista. Number of apps available in leading app lowing paragraphs will mention the most only a relatively small number of apps have so ing process. The probability for errors can be cations are also rare and they often suffer from providing transparent information about their stores as of May 2015. (2015) http://www.statista. obvious ones – the list is by no means ex- far gained approval by a federal authority (e.g. reduced if users can base their decision on questionable credibility. There are even fewer product can significantly contribute towards com/statistics/276623/number-of-apps-available- haustive. Roughly speaking, two areas where by the Food and Drug Administration in the readily available and valid information, but apps conforming to regulatory standards. an app’s perceived quality. Users will appreci- in-leading-app-stores/(accessed June 17, 2015). 5. Research2Guidance. Mobile Health Market Re- problems can arise can be discerned: USA) or passed an assessment following the such information is often hard to come by. What can be done to make things work? ate the added value they receive via this trans- port 2013-2017. Available from http://www.re- 1. “The app does not do what is supposed federal laws of other states (e.g. conformity parent reporting. For manufacturers, it is an search2guidance.com/shop/index.php/mhealth- to do!” This sentence and other simi- assessment for European countries). The im- easy task to compile the information point by report-2 (accessed June 17, 2015). lar utterances, often voiced by discon- possibility of closer scrutiny of all apps by the point and to publish it, for example on the app 6. Research2Guidance. mHealth App Devel- Available Information Is not Always Sensitizing Users as well as oper Economics 2014. Available from http:// tented users, for example in user com- authorities, which would be appropriate, can Reliable and Reliable Information Manufacturers Combined with stores, since they already possess the necessary mhealtheconomics.com/mhealth-developer- ments that they leave on the stores, is also easily be explained by the sheer number knowledge. Thus, users have a fair chance to economics-report/(accessed June 17, 2015). often caused not only by shortfalls in of apps and additionally contributes to the Is Only Rarely Available Standardized Information inform themselves about an app even before 7. Becker S., Miron-Shatz T., Schumacher N., Krocza J., Diamantidis C., Albrecht UV. performance that may for example be uncertainties in this area, although the intent they download it. For users, this is only fair mHealth 2.0: Experiences, Possibilities, and caused by technical limitations of the of regulation is to protect patients as well as Users often rely on comments made by other Users need reliable applications, especially since they are also affected by the potential Perspectives. (2014) Journal of Medical Internet devices used to run the app, but also by users of these products. An exhaustive over- users on the distribution platforms. Such com- where either their own health or that of consequences of using the app. This can serve Research, 2:e24. 8. Albrecht U.V., Pramann O., von Jan U. Synopsis programming errors, deficiencies of the view of the subject of “apps and regulations” ments can be easily created and publicized. the patients they treat is concerned. This both as an important confidence building for Health Apps – Transparency for Trust and content or simply bad usability. can be found in [10]. The more “stars” and positive comments an is not only an ethical imperative, but also a measure as well as towards improving sales. Decision Making. (2014) In: Househ M, Bory- 2. “The app does more than it should!” app has received, the greater its attractiveness strict requirement from a legal point of view Still, just providing this information does cki E, Kushniruk A (Hrsg): Social Media and This is often caused by non-obvious for users as well as for the search algorithms (buzzword: “medical device”). Imprudent not suffice as in addition users must be made Mobile Technologies for Healthcare. (pp. 94- 108) Medical Information Science Reference (an “features” of an app, for example when Private Certification of the stores. However, these comments and use of apps can cause serious harm. There aware of the inherent risks of apps that are to imprint of IGI Global), Hershey PA, USA. data protection and data security or ratings are not subject to any review and do is no alternative to requiring manufacturers be used in a health context and they must also 9. WHO. Preamble to the constitution of the the user’s right to self-determination For many apps, regulations simply do not not follow any standards. They can be freely to actively provide reliable and trustworthy learn to ask the right questions. Educating World Health Organization as adopted by the International Health Conference, New York, are compromised. This may be caused apply, while for others, manufacturers ig- assigned and given pseudonymously. Their apps and corresponding information. Ex- ­users towards this goal is imperative. 19-22 June, 1946; signed on 22 July 1946 by the either with or without intent, e.g. by nore the regulatory processes either due to quality is often questionable, but still they erting pressure will work best if sales are af- representatives of 61 states (official records of failing to observe due security measures a lack of knowledge about the requirements are generally the main source of information fected. In order to enable users to use their the World Health Organization, No. 2, p. 100) when dealing with this highly sensitive or intentionally. Unfortunately, this means for those interested. Other information can power in this context, they need tools that and entered into force on 7 April 1948 Conclusion 10. Pramann O., Albrecht UV.: Medical Apps – Alles type of data, lack of providing users with that in order to obtain some sort of qual- usually only be found via time-consuming can support them in their decision whether was recht ist: Ein rechtlicher Überblick über den adequate information regarding data ity seal for their product, the manufacturers searches: blogs, evaluations done by (private) to purchase an app or not. Information to be One objective of the article was to present Einsatz von Apps und Mobilgeräten im Kinikbe- handling or even worse, secret and illicit have to resort to using the services offered initiatives or databases containing specific in- used towards this end may be gained from aspects relevant for assessing the trustwor- trieb. (2013) E-HEALTH-COM, 1, 22-27. 11. Dolan P.L. Health app certification program data transmission and evaluation. by a number of private contractors. These formation provided by the manufacturers that a number of different sources. For example, thiness of a health related app, while also halted. (2013) Irving, TX: MultiView, Inc;. seals can also be used for advertising pur- are often not widely known. If available, peer it may be based on standardized reporting sensitizing readers to what needs to be in- URL: http://exclusive.multibriefs.com/content/ poses. Of course, this comes with a price reviews of apps or corresponding scientific mechanisms, such as an app synopsis [4, cluded even during the development phase health-app-certification-program-halted [ac- cessed 2014-02-15] The App as a Medical Device and such services are offered both nationally studies provide more reliable information, but 10] which covers all important aspects and of a trustworthy app. Only based on trust- 12. Pramann O., Albrecht UV.: Medical-Apps im as well as on an international level. Still, the finding this information often requires con- provides the crucial information in a single worthy apps will it be possible to fully re- Krankenhaus – Sicherheit, Verantwortung, Haf- Although many aspects of the app business reliability of these offers is highly variable, siderable effort on the users’ part. location. Information covered by the synop- alize the potential apps offer for healthcare tung. (2013) Krankenhausjustitiar 04, 16-17. give the impression of a “wild west” scenario, as was recently underlined by the deficien- sis contains not only the background of the without risking to lose the trust users place 13. Albrecht UV.: Transparency of Health-Apps for Trust and Decision Making (2013) Journal of at least some apps, namely, those where the cies found in the recently halted certifica- manufacturer or distributor of an app and in them – only an app that can be used Medical Internet Research 15(12): e277. manufacturers have specified that they are a tion processes offered by Happtique [11]. Which Information Is Important his associates as well as the experts involved without any problems will be a success. 14. Albrecht UV., Pramann O., U von J. Medical “medical device”, have to conform to the of- in the development, but also the rationale Apps – The Road To Trust. (2015) European for Making a Decision? Journal for Biomedical Informatics,11:en7–12. ficial regulatory requirements that apply to behind the app, i.e. its intended purpose(s) such products. However, whether these re- Appraising the For users, the situation is quite chaotic due to and target audience. It also makes provi- References quirements apply also depends on whether the vast number of available apps. Identify- sions for aspects such as functionality and 1. Bonacina S., Marceglia S., Pinciroli F. A pictorial Dr. med. Urs-Vito Albrecht, Trustworthiness of Apps schema for a comprehensive user-oriented iden- the manufacturer has assigned a medical pur- ing apps that match the desired use and are reliability of the app as well as data acquisi- tification of medical Apps. (2014) Methods of In- MPH, Deputy Director, pose to his product, in this case the app. Go- Ultimately, the decision on whether to use an trustworthy is like a mixture between finding tion, data transmission and storage and, of formation in Medicine;53, 208–24. doi:10.3414/ Peter L. Reichertz Institute for Medical ing through the processes is often time-con- app or to refrain from using it remains with a needle in the haystack and playing Wheel of course, also calls for information on how ME13-01-0093. Informatics, Hannover Medical School, suming and costly. Thus, although some apps the users. They carry the prime responsibility Fortune. The emphasis of available informa- data protection and privacy are handled. A 2. Lewis T.L. A systematic self-certification mod- Germany el for mobile medical apps. (2013) Journal of can be medical products and would therefore and can also be held accountable – at least tion is often on marketing aspects and infor- more exhaustive description of the app syn- Medical Internet Research;15:e89. doi:10.2196/ E-mail: [email protected] have to comply with regulations for such in a professional context – when using apps mation that can support the claimed credibil- opsis can be found in [8, 13, 14]. jmir.2446. http://www.plrimedapplab.de

76 77 NMA News LATVIA LATVIA NMA News

workplaces campaigns and European Anti- Vaccination is one of the most effective contain chemically active substances: vi- Q . More often than not, the pharmaceuti- Interview with Vytenis Andriukaitis, EU biotic Awareness Day, to name a few. With means of preventing diseases. I am keen tamins, ferments and minerals, and their cal business in Europe would not supply Member States facing common challenges to support Member States in securing ef- abuse may cause health problems . Is the all countries with drugs on equal terms, Commissioner for Health and Food Safety such as a rise in chronic diseases, and in- ficient vaccination programmes, and to Commission for Health going to intro- and the prices vary significantly across the creasing antimicrobial resistance, I find foster co-operation at European level in duce somewhat more stringent restric- countries . If there were a common phar- By Dr.Peteris Apinis. June, 2015 these types of pan-EU initiatives extremely this area, while bearing in mind that in the tions to the distribution and advertising maceutical policy for Europe, what would valuable. EU vaccination is a responsibility of the of dietary supplements? the effect be like? will be guiding action to address this im- One of my priorities is to increase the avail- individual Member States. As such, the EU rules are in place to ensure that food At EU level, prices of medicines are un- portant – and often neglected – disease in ability of scientifically sound, comparable way national immunisation programmes supplements placed on the EU market are der the responsibility of Member States. the European Union. The Presidency has and high quality health information to are organised differs considerably between safe. The list of vitamins and minerals that The only field of EU regulatory interven- further explored how eHealth could benefit identify the key challenges in health. Policy countries. National immunisation strate- may be used in food supplements is har- tion is the so-called “transparency directive” both citizens and health systems, and con- makers need this type of reliable health in- gies range from voluntary vaccinations to monised at EU level; however, maximum (Directive 89/105/EEC) which lays down tributed to the discussions on how to create formation, based on good indicators, sound almost complete mandatory vaccination levels of such substances are not harmon- procedural rules for regulating prices of efficient, equitable health systems. data and regular analysis. The overall aim of programmes. ised and may be set by Member States in medicines and their inclusion in the scope EU health information policy is to support The Commission provides support to accordance with the rules of the Treaty. Bo- of health insurance systems. I am keen to Q . Currently there is a tendency all across evidence-based development, implementa- Member States on vaccination, e.g. in the tanicals are covered by the general frame- foster discussions and support co-operation Europe that patients obtain information tion and evaluation of actions for health at field of seasonal influenza and childhood work on food safety together with appli- between Member States in this area so as about diseases and health from the Inter- EU-level and in Member States. vaccination. The Commission is working cable national rules. The Commission does to make medicines more affordable and net or magazines . Over 80% of Internet with Member States within the Health Se- not envisage at this stage any measures to accessible to patients. I am encouraged by portals and social sites which are dedicated Q . Right now, there is quite an opposi- curity Committee to be better prepared to restrict the marketing of such foods. recent developments including the Coun- to health topics are financed by businesses: tion to vaccination in Latvia .The situa- address vaccine shortages as well as scepti- cil conclusions whereby Member States drugs, dietary supplements or a special tion is pretty similar in other European cism about vaccines; to prevent cases like Q .Today, health of and polypragmasia have agreed to exchange information about method . More often than not, it is difficult countries .There are excellent lecturers, the recent tragic death of an unvaccinated in senior citizens is becoming an ever in- the prices of innovative medicines; about for patients to discriminate between the nice-looking books and You Tube files child in Spain. Last year’s Council conclu- creasing problem all across Europe . On on-going discussions on this issue, as well Vytenis Andriukaitis truth about health and surreptitious adver- discouraging people from vaccination and sions on vaccination provide an opportunity average, each senior citizen in Europe as emerging pilot project amongst some tising . As to Latvia, there is even a publi- explaining about the dangers of vaccina- to co-operate further in this area, and en- consumes 6 .4 various drugs daily . Doesn’t Member States. Q .The half-year of the Latvian Presidency cation, the magazine Ko Ārsti Tev Nestāsta tion . What could the European Commis- courage Member States to share best prac- the pharmaceutical business have a too Other challenges of pharmaceutical policy of the Council of the European Union has (What Doctors Don’t Tell You), advertis- sion do in order to present information on tices on their vaccination policies. heavy influence on the healthcare system? in Member States that also gained atten- come to an end . As to healthcare, we have or- ing dietary supplements, Ayurveda, unjus- the need of immunization in an equally When it comes to vaccination of immi- Demographic and epidemiologic trends, to- tion lately at EU level relate to the optimal ganised a number of European-level confer- tified diets, and at the same time discour- attractive manner from the visual and in- grants from third countries, this is also the gether with a range of other factors as phar- use of current regulatory framework, the ences on the topics of healthy lifestyles and aging patients from seeing an oncologist formative aspect? Maybe it is the time to responsibility of individual Member States. maceutical markets’ own dynamics, changes early dialogue with all relevant stakehold- nutrition for children, tuberculosis, eHealth, or gynaecologist . How to deliver correct have a common immunization calendar in The Commission, together with ECDC, is in medical practice and pharmaceutical ers and the bilateral agreements between popular sports, healthcare financing as well information to the patient? Is the Euro- Europe? This issue is more and more topi- developing screening guidance that includes policies influence pharmaceutical spend- member states. Such issues also relate to as addressed a number of other important pean Commission going to set up a health cal due to the increasing labour mobil- the issue of vaccination of migrants to sup- ing, which is an important component of the efficiency of pharmaceutical spending, issues . How do you evaluate Latvia’s per- information site for Europe containing ev- ity in Europe . Children are moving along port EU countries. We have also financed healthcare expenditure in Member States. i.e. the capacity to get the most value from formance in its half a year of presidency? idence-based information, similar to Med- with their parents . Each single country in the project “Promote Vaccinations among In addition, changes in the therapeutic today’s expenditure while keeping appro- I would like to congratulate Latvia for linePlus in the USA? What is your opinion Europe has its own vaccination calendar, Migrant Populations in Europe” under our mix of medicines used that occur with new priate incentives for future innovation, succeeding in delivering results on a set on pan-European level information cam- which is the reason why many children do health programme, which has resulted in treatments can also influence the share of ­associated with challenges for affordabil- of priority issues during its Presidency of paigns on healthcare topics? not get adequate vaccination and immu- recommendations for policy-makers on the the overall pharmaceutical bill accounted ity in some countries. It is agreed in the the Council of the EU. Latvia took up the The European Commission has a dedicated nization . Shouldn’t such vaccinations as immunisation of migrants and educational for by hospitals. The use of multiple medi- Council that further cooperation between Presidency at a very important moment and website on health and healthcare topics [1] against diphtheria, poliomyelitis, tetanus material for health professionals and mi- cations in elderly increases the possibility of Member States is needed in such areas and contributed to the discussions on the future and several specialised EU agencies offer and some more be declared as mandatory, grants. adverse reactions to drugs, increases the risk the Commission is ready to further coop- directions for health policy at EU level. In health-specific information to the citizens to be administered according to strictly of hospitalisation, of medical errors caused erate based on an integrated approach and addition, the European conferences organ- [2]. The Commission has also supported a defined time schedule, whereas the rest Q . In Europe, the manufacturing and by these medicines and may question the a long term agenda. ised under Latvian leadership helped make number of recent and ongoing health cam- (rotavirus, German measles, pneumo- distribution of dietary supplements is quality of healthcare in general. This is an progress in reducing the risks associated paigns, carried out by the EU in collabora- cocci) could be left on the national level? becoming increasingly widespread . Con- area of Member States competence; how- Q .Today the biggest issue concerning with poor nutrition and lack of exercise. The tion with Member States and neighbouring Isn’t it high time that we have a mandatory trary to drugs, the supervision of manu- ever, the Commission supports Member children all over Europe is sedentary Latvian Presidency has put the spotlight on countries, for example, awareness raising requirement to vaccinate all immigrants facturing, distribution and advertising States to exchange experience and in par- lifestyle and obesity . Every fifth child in tuberculosis – and led discussions towards campaigns about tobacco, the initiative from third countries because their earlier of dietary supplements is much more ticular on developing of tools and method- ­Europe is overweight . Unfortunately, in the adoption of the Riga Declaration which European Action Against Cancer, healthy vaccination is unreliable? lenient . As a rule, dietary supplements ologies to assess the quality of care. Latvia the national Ministry for Educa-

78 79 NMA News LATVIA ISRAEL NMA News

tion resists to introduce the third sports and exchange best practices in this area. The Q . In terms of percentage of GDP, ­Latvia Q . Shouldn’t public health issues override On alcohol, whereas the main responsibility them increase availability of services. The class per week . Could the European Com- promotion of healthier environments, espe- has the lowest healthcare financing in the national level? For example, isn’t it the for public health interventions lies with Mem- cross-border healthcare Directive makes mission be more active in making the cially at schools and pre-schools, is one of Europe, it is less than 3% . Could the time for the European Union to declare ber States, the Commission will continue­ it easier for patients to access services in national governments to introduce daily the key areas of the 2014 Action Plan on European Union make a pressure on na- that it has a common policy as to pesticides to support them in reducing alcohol related other Member States. We are in the pro- sports classes for children? Childhood Obesity. tional governments that the accessibility and other substances which inhibit the de- harm. This will be done based on the objec- cess of setting up European Reference I regret to report that the figures are even to healthcare services for population is velopment of hormonal system? Isn’t it the tives of the 2006 Strategy and by making use Networks which will bring together cen- worse. One out of three children in Europe Q . In the past two years, the Latvian a priority and thus healthcare financing time to have a common European strategy of existing structures like the Committee on tres of expertise for conditions or treat- in 2010 was overweight or obese. This is Medical Association managed to intro- throughout Europe should be at least in place for reducing the consumption of National Alcohol Policy and Action. In line ments where expertise is rare: these will act a major increase compared to 2008 when duce two important regulations in legal 4 .5% of GDP? alcoholic beverages and tobacco products, with the Commission’s “health in all policies” as a resource for all Member States. We are one out of four children was overweight or acts .The first is that smoking in the pres- The Commission acknowledges that and for prohibiting trans fatty acids? approach, we will further consider how to en- working together to deliver the consider- obese. ence of minors should be treated as child healthcare systems need to be reformed The overriding principle of EU health pol- shrine alcohol harm into a holistic approach able potential benefits of Health Technol- Member States play the key role in provid- abuse .This means that in Latvia an adult to provide accessible and quality health- icy is that human health is well protected to reduce the burden of chronic diseases. ogy Assessments and eHealth. And we are ing education for school children in relation must not smoke in the presence of a child, care through efficient structures. Sustain- and accounted for in the development of all increasingly looking at the question of how to nutrition, physical activity, overweight be it at home, in the street or at a bus stop . ability challenges of healthcare systems EU policies and activities. All EU policies Q . Would you agree that the vast dif- collaboration in border areas can improve and obesity – and this is something most The other amendment to the law stipu- in the EU are addressed and monitored are required by the EU treaty to follow this ference as to the availability of medical the delivery of health services. are addressing. lates that a person has the statutory right within the process of the European “Health in all Policies” (HIAP) approach. services is actually a shame for Europe? I am ready to use all the tools at my dis- to clean smoke-free air, and this right ­Semester. Taking some of your specific examples: Maybe it is the time we start considering posal to support them in their efforts to has a priority over other persons’ right to Under the 2014 European Semester Latvia Endocrine disruptors are already regulated a common European health strategy, uni- References promote healthy lifestyles. The Commission smoke .Thereby, smoking in the presence received for the first time a country-specific in some sectors. Currently, the European fied health tax, unified standards for emer- 1. See link: http://ec.europa.eu/health/index_ is working with Member States in this re- of another person is impermissible, un- recommendation (CSR) calling for the Commission is carrying out an impact as- gency medical care and first aid? en.htm gard within the High Level Group on Nu- less the latter has given permission . Apart reform of its health system with concrete, sessment to analyse different options for At present there is no unified health sys- 2. e.g. the European Centre for Disease Prevention and Control (ECDC) (http://ecdc.europa.eu/ trition and Physical Activity. In 2014 this from that, in Latvia it is absolutely pro- targeted areas including the quality and ac- defining the criteria for the identification tems policy in the EU: it is for Member en/Pages/home.aspx), the European Medicines group ­adopted an Action Plan on Child- hibited to smoke at sports and cultural fa- cessibility. Since then, the Latvian govern- of endocrine disruptors in the context of States to decide which services to provide Agency (http://www.ema.europa.eu/ema/), the hood Obesity with the aim to prevent the cilities, in the premises of central and local ment increased the health budget by € 31.2 the plant protection products and biocidal to their citizens and how this should be European Agency for Health and Safety at increase in obesity in children by 2020. government institutions, in cafes, restau- million in 2015 compared with 2014 and products regulations. The decision at EU funded. However, the EU does have a role Work (https://osha.europa.eu/), and the Euro- A Joint Action on Nutrition and Physical rants, work places, on loggias, balconies, approved a € 30.6 million increase each year level concerning the criteria will be made in supporting Member States and we are pean Monitoring Centre for Drugs and Drug Activity will start after the summer period common staircases and elsewhere where until 2017. But even with this additional once the impact assessment is concluded. actively working on ways to try to help Addiction (http://www.emcdda.europa.eu/). to further support Member States in the it can harm other people’s health . How funding, still below 3% of GDP, the finan- implementation of this Action Plan. would you evaluate our achievement and cial burden on patients in Latvia remains how could we attain this in entire Europe? very high and accessibility is still a prob- Q . In Latvia, the attitude of the Minis- I am very pleased to hear about Latvia’s lem. Therefore, in 2015 the Commission­ Position of Israeli Medical Association in of legislation being prepared in Israel that try of Education to children’s health is efforts towards achieving a smoke-free once again proposed the same health CSR would allow the forced feeding of prisoners. quite an issue . Since 2002, health educa- environment and, in particular, to protect to Latvia, and we will closely monitor its Forced Feeding Issue The IMA immediately requested a meeting tion is no longer in the school curricula . children. Furthermore, strengthening the implementation. with the Ministry of Health and the Min- The situation (i .e ., no health education right of the individual person wishing to The Commission provides help and sup- istry of Justice, in which we expressed, in no for children) is similar in many countries be protected against tobacco smoke is an port, which is what countries that are fac- Hunger strikes have been used as a means of and, when the prisoners’ medical condition uncertain terms, our complete opposition to in Eastern Europe . Could the Commis- important step in that direction. While the ing difficulties need. For example, Member non-violent resistance by political prisoners deteriorated, this stage was followed by hos- such a bill and the fact that we would in- sioner make some pressure on national legislative competence in this area lies pri- States can make use of the European Stra- throughout history in an effort to achieve pitalization in public hospitals. The hunger struct our physicians not to comply with it. governments with regard to educating marily with the Member States, the Euro- tegic and Investment Funds (ESIF) for specific objectives. strikes lasted everywhere from several days We followed this with a letter to then Jus- children in the basics of health? pean Commission is indeed committed to health investments. I welcome the com- to weeks and months, during which most, tice Minister, Tzippi Livni, explaining our Again, the competence in the field of edu- continue working with Member States in mitment made by the Latvian authorities Famous examples include Mahatma though not all, prisoners drank and agreed strong ethical positon. cation lies with the 28 EU Member States. their implementation and enforcement of to use ESIF for better access to healthcare, ­Gandhi, British and American suffragettes, periodically to undergo tests, and take vita- However, under the EU Strategy on Nu- the Council recommendation on smoke- especially for those socially and territori- and the Irish Republican hunger strike of mins and carbohydrates intravenously. Each Our objections notwithstanding, the Min- trition, Overweight, and Obesity-related free environments (2009/C 296/02). We ally excluded. For the years 2014–2020 the 1981. In Israel, Palestinian detainees and time, the duration and extent of cooperation istry of Justice continued work on the bill Health Issues for example, the Commis- regularly discuss the state-of-play and health infrastructure allocation for Latvia prisoners have used the hunger strike as a with IPS and/or hospital physicians varied. and brought it before our Parliament (the sion closely cooperates with the national progress in this area with representatives of exceeds €152 million and further alloca- tool for soliciting acquiescence to their de- No detainee or prisoner in Israel has ever Knesset). We sent a letter to the Knesset governments to promote healthy lifestyles the Member States’ competent authorities. tions have been programmed for measures mands. Over one thousand hunger strikes died during a hunger strike. members before the bill was considered in in children. The High Level Group on We know from past experience that good such as health promotion and prevention, have occurred in Israel to this point. In the Ministerial Committee for Legislation, Nutrition and Physical Activity brings to- examples from one country often motivate enhancing qualifications of the medical general, these hunger strikes began in the In the early months of 2014, the Israeli but unfortunately it passed this commit- gether governmental experts that promote others to follow. staff and health. facilities of the Israeli Prison Services (IPS), Medical Association (IMA) became aware tee. Although we urged those Ministers

80 III it does not materialize. The IMA took out paid announcements in major Israeli news- papers (in addition to regular press coverage on the matter) explaining our opposition to the proposed law.

The World Medical Association (WMA) has also been a steadfast partner in our struggle against this unethical bill. On June 22, Drs. Deau and Hoven sent a let- ter to Prime Minister Benjamin Netanyahu explaining the WMA’s position and its sup- port of the IMA, and the inevitable interna- tional condemnation that would follow the passage of such a law.

In its letter, the WMA stated the following: Leonid Eidelman Malke Borow “Over the past four decades there have been who opposed the bill in the Committee to In our view, the proposed law is both unethi- clear directives developed on what physi- ­appeal the decision, the bill continued to a cal and unrealistic and does not help solve cians can do, and from what they must first review in the Knesset plenum, where the problem. It creates an illusion that forced refrain. Clearly torture, inhuman and de- it passed. feeding will prevent medical harm to the grading treatments are nothing with which patient, whereas the opposite may in fact be a doctor should be involved in any way. Seeing that the bill was progressing, and true. We cannot approve a law that puts phy- Force-feeding is violent, very painful and against the backdrop of a mass hunger strike sicians at the forefront of a policy – both as absolutely in opposition to the principle of in the Israeli prisons in June 2014, the IMA a group and as individuals – which is against individual autonomy. It is a degrading, in- and its Ethics Bureau convened an emer- their professional and ethical obligations. humane treatment, amounting to torture. gency consensus conference, under the title But worse: It can be dangerous and is the “Treatment of prisoners/detainees on hunger The fundamental change underlying this most unsuitable approach to save lives. strikes – the medical challenge.” Participat- proposal is in contradiction with and con- ing in the conference were representatives of trary to the accepted medical ethics in Israel The evidence from many cases around the the IMA scientific associations, members of and throughout the world, including the world that our colleagues have been work- the IMA ethics bureau, representatives of the IMA’s ethical Code and the WMA’s Dec- ing on over the past four decades shows that Ministry of Health, the National Council for laration of Tokyo and Declaration of Malta, the best results are obtained when the pa- Bioethics, IPS physicians, representatives which recognize it as a form of inhuman tient/physician relationship is maintained, of the International Committee of the Red and degrading treatment. even under the difficult circumstance of a Cross and others. hunger strike. This includes patient confi- The IMA is strongly opposed to the in- dentiality, proper medical care and advice At this conference, IMA officials made it tended force feeding law. Our opposition by the physician, but also respecting the free clear that the law does not change a doctor’s was expressed to the government offices will of the patient. Force-feeding is com- ethical obligations not to coerce feeding on and representatives of the attorney general pletely incompatible with this and destroys a competent individual. At the end of the at every possible opportunity. We are pre- any patient/physician trust.” conference, all parties agreed on a list of pared to continue to protect the doctors at principles which can be viewed on the IMA all levels, including in the public sphere and We are determined to prevent force feeding website [1]. parliamentary level, in order to thwart the in Israel and we will continue to support our legislative process. physicians and remind them of their ethical Recently, Gilad Erdan, the new Israeli Min- obligations. ister for Interior Security, announced plans We know our hospital doctors will be pre- to renew the proposed legislation regard- sented with ethical dilemmas and be placed ing forced feeding of hunger strikers. The in an impossible position professionally. References proposal will be put for discussion in the Therefore, we have established a hotline for 1. http://www.ima.org.il/ENG/ViewCategory. ­Knesset Committee for Internal Affairs and these physicians to call with any questions aspx?CategoryId=4497 2. http://www.ima.org.il/Ima/FormStorage/ then for final voting. they may have, as well as professional and Type8/IMAHungerEN.pdf ethical guidelines that we released in a hand- The proposal enables obtaining legal per- book following last year’s mass hunger strikes. mission for the provision of medical care Dr. Leonid Eidelman, President, IMA and/or nutrients (including force-feeding Our concern is that the proposed law will Malke Borow, Director, Division through a tube) despite the active opposi- move quickly through the legislative process of Law and Policy, IMA tion of the prisoner. and we are taking measures to ensure that E-mail: [email protected]