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Newsletter N° 159 – June 2018

In this issue:

HOPE activities

Launch of the HOPE Exchange Programme 2019 HOPE Agora 2018 ICT4Life Consortium meeting in Budapest

News from Members: United-Kingdom

NHS European Office - Protecting the public's health across Europe after Brexit

Bulgarian Presidency of the Council of the

Employment, Social Policy, Health and Consumer Affairs Council

• Coordination of social security systems • Draft directive on work-life balance • Transparent and predictable working conditions • Posting of workers • Future of Health in the EU • Health technology assessment • Conclusions on "healthy nutrition for children: the healthy future of Europe"

Avenue Marnix 30 - BE-1000 l www.hope.be HOPE is an international non-profit association under Belgian law

EU institutions and policies

Public Health

Falsified Medicines – Expert Group meeting Preparedness self-assessment tool launched by ECDC Antimicrobial Resistance – European Antibiotic Awareness Day Antimicrobial Resistance “One Health” Report adopted by ENVI Committee

Communicable diseases: Commission updates surveillance list Commission and WHO discuss how to strengthen their collaboration

Internal Market, Industry, Entrepreneurship and Small and Medium Entreprises

Pharmaceuticals: Commission refines intellectual property rules Study on the economic impact of pharmaceutical incentives and rewards in Europe Communications Networks, Content and Technology

Artificial Intelligence: Expert group appointed by the Commission and launch of the European AI Alliance

Artificial Intelligence: Commission discusses ethical and social impact with philosophical and non-confessional organisations

Cybersecurity common certification framework – Council agrees on position

European programmes and projects

EU Healthy Gateways: Joint Action launched Health Equity in Europe: Joint Action launched e-Health: Joint Action launched Horizon Europe: Proposal for 9th EU Framework Programme for Research and Innovation

EU-funded actions for better preparedness and coordination in health crisis: New booklet

Active and Assisted Living Market and Investment Report

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Reports and publications

Reports

➢ World Health Organization (WHO)

WHO European Centre for Primary Health Care: annual report of activities 2017

Mental Health Atlas 2017

Mental health, human rights and standards of care

Improving health literacy at national, regional and organisational levels in the WHO European Region

Tuberculosis among refugees and migrants in the WHO European Region

Healthy settings for older people are healthy settings for all: the experience of Friuli-Venezia Giulia, Italy

➢ Organisation for Economic Cooperation and Development (OECD)

Care Needed: Improving the Lives of People with Dementia

Articles

Paying hospital specialists: Experiences and lessons from eight high - income countries

Strategic Purchasing in Practice: Comparing Ten European Countries

Should interventions to reduce variation in care quality target doctors or hospitals?

Health care service provision in Europe and regional diversity: a stochastic metafrontier approach

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Other news – Europe

Private practices in public hospitals

European Civic Prize on Chronic Pain Collecting Good Practices: Application open

Sale of patients’ data in hospitals –

Sepsis – Improving prevention, diagnosis and clinical management

European Society of Radiology

ECCO 2018 European Cancer Summit

European Health Forum Gastein in European Parliament talks

Financing integrated care and population health management

What future for EU cooperation on Health Technology Assessment (HTA)? - MEP Interest Group on Access

The digital transformation of healthcare - challenges and opportunities - MEP Interest Group on Access

Infection prevention: a sustainable solution against Antimicrobial Resistance (AMR)

Interprofessional education: a way to transform tomorrow´s healthcare

User Forum on Frailty Prevention

Health inequalities – “Oral health for all” – Council of European Dentists

How to maximize the value of innovative health technology

Skin cancer registries in Europe: from knowledge to action - MEPs Against Cancer

Early diagnosis & cancer of unknown primary - MEPs Against Cancer

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Upcoming HOPE (and co-organised) conferences and events

European Association of Hospital Managers Cascais, 26-28/09/2018 Congress

Study Tour: The Management of Innovation in Marseille, 3-5/10/2018 Cancer Care

7th International Congress of Hospitals – Lisbon, 21-23/11/2018 Citizen involvement and accountability in the National Health Service

Conducting change in Psychiatry and Mental Marseille, 21-23/11/2018 Health

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Launch of the HOPE Exchange Programme 2019

The HOPE Exchange Programme 2019 will start on 6 May and end on 4 June 2019.

Every year HOPE runs an exchange programme to promote the sharing of knowledge and expertise within the European Union and to provide training and experience for hospital and healthcare professionals.

This Exchange Programme covers a four-week training period and is open to anyone with a minimum of three years experience working in hospitals and/or healthcare facilities.

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HOPE Agora 2018

From 3 to 5 June 2018, the Swedish Association of Local Authorities and Regions (SALAR) welcomed the HOPE Agora 2018 in Stockholm, a two-day conference closing the 2018 HOPE Exchange Programme organised under the authority of Erik Svanfeldt (HOPE Governor for Sweden).

Around 300 persons attended the event including the 135 HOPE Exchange participants from 24 different countries. The focus of the HOPE Exchange programme and conference was on “Improving the quality of healthcare using the experiences and competencies of patients: Are we ready?”. The participants of the HOPE exchange programme showed how the quality and efficiency of healthcare can be improved by using the experiences and competencies of

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patients and their relatives. But the participants also pointed at factors that stimulate or constrain patient involvement in healthcare in the countries they visited.

On 4 May 2018, HOPE President Eva Weinreich-Jensen opened HOPE Agora 2018, final stage of the HOPE Exchange Programme 2018. Since 1981, HOPE has been organising this Exchange Programme for hospital professionals, which is pivotal in achieving HOPE objective of promoting the exchange of knowledge and expertise within the European Union. It offers a chance for participants to receive invaluable experience from hospital and healthcare professionals across Europe. The HOPE Exchange Programme lasts four weeks during which participants investigated how this topic is developed in their host country and present together their findings at the event.

In addition to these presentations made by the HOPE exchange programme participants, several Swedish speakers also gave their perspectives. Cristin Lind, Neha Sharma and Hans Lindqvist, Patient Partnership Facilitators at QRC Stockholm (a regional registry centre for National Quality Registries) presented “From for to with: improving health care together with patients”. Cristin Lind pointed out the role of patients’ participation in healthcare and the virtues of a shared knowledge for a better health. Hans Lindqvist explained why partnership has to be built together with quality improvement and showed the importance of challenging existing roles and reducing power differential in care. Neha Sharma described different methods to involve patients in healthcare: shadowing, conducting interviews or even giving responsibilities in the hospital units. Thanks to the use of Mentimeter, an interactive presentation software, the three were able to display their favourite tool for patient involvement and the expected learning with the participation of the audience. Finally, Ida Björkman, Postdoctoral Fellow at University of Gothenburg, Centre for Person-centred Care (GPCC) presented how Person-centred Care can answer the current and future challenges of Healthcare.

Hans Karlsson, Director of SALAR Health and Social Care Division introduced the second part: the work of SALAR on user-driven development and patient participation. He presented the “Innovationsguiden” and how the use of design thinking can improve public services. Sofie Zetterström, Deputy CEO of Inera presented digital solutions that support patient participation. The developed the examples of UMO, a youth clinic online, and its translated version Youmo, which are used by a large amount of young people in Sweden and abroad. She underlined that online health support allows the provision of secure information.

In the afternoon, two patient perspectives were presented. Patrik Blomqvist, Patient Supporter at the unit for self-dialysis at Ryhov Hospital, Jönköping explained in a short movie “Dialysis on the patient’s own terms”, how he started to work at the hospital to support patients in care processes after his kidney transplantation. Åsa Steinsaphir, User Involvement Coordinator at North Stockholm Psychiatry developed the concept of patient experience as a competence. She showed how keeping tracks of patients’ opinions thanks to a patient forum allowed implementing meaningful changes and improvements.

On 5 June 2018, following the final round of presentations of HOPE Exchange participants a World Café took place during which the participants were able to exchange, in small groups and with the help of facilitators, ideas and experiences about various topics. They could express what was according to them the best example developed during the Agora and during their Exchange Programme experience in a different country. The participants also discussed

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the differences of culture and attitudes among countries regarding patients’ involvement, the impact of legislation and the differences in resources mobilised (financial, staff, education, etc.) as well as factors that could stimulate and encourage patients’ involvement.

Finally, Pascal Garel, chief executive of HOPE, chaired the Prize Giving Ceremony and gave the final words of the HOPE Agora 2018.

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ICT4Life Consortium meeting in Budapest

On 20 and 21 June 2018, HOPE took part to the ICT4Life Consortium Meeting in Budapest, Hungary. The event was hosted by the consortium partner Netis Informatics Ltd. and was the opportunity for two days of intense exchange about the project’s achievements and next steps.

The meeting was opened by ICT4Life Coordinator, Alejandro Sánchez-Rico de las Heras from Artica Telemedicina who provided an overview of the project and the activities to perform until the end of 2018. He highlighted the importance of the results’ analysis the Key Performance Indicators (KPIs) achievements in this last phase of the project.

Various topics were discussed during the two-day meeting. First, it was the opportunity for ICT4Life partners to share the first pilots’ results. Indeed, pilots have been running for about three months in Spain, France and Hungary.

In Spain, 18 patients and 18 control groups took part in the pilots in rehabilitation rooms and Day Care Centres (DCC) under the supervision of Asociación Párkinson Madrid and with the support of Universidad Politécnica de Madrid. Pilots have now been moved to home sets for the second step of the monitoring process.

In France, 4 patients, 1 doctor and 2 health professionals took part in the pilots under the supervision of E-Seniors and the assistance of partners from the Maastricht University. A video was released to show the technical deployment, the implementation of the ethical procedures

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and the participation of social workers and health professionals. The training session organised to teach the patients how to use the system was very useful and was the opportunity to ask patients their opinion and get their feedback.

In Hungary, 5 patients and 2 health professionals with a control group took part in the pilots in the Day Care Centre with a Smart TV under the supervision of the University of Pécs.

Information collected during the pilots were used to describe the first results obtained in the pilots’ phase by CERTH, one of the partners of the consortium. The pilots have allowed to take actions and improve the ICT4Life platform in relation with these findings, especially regarding the censors’ detection carried out during rehabilitation exercises and sedentary phases.

The meeting was also the opportunity for the partners to meet new collaborators from IMIBIC - Instituto Maimónides de Investigación Biomédica de Córdoba, who will strengthen with their contribution the medical aspects of the project.

Finally, the meeting was also the opportunity to detail some technical aspects and to discuss about quality, dissemination and exploitation issues as well as the ICT4Life Final Conference that will take place in Brussels in October 2018.

Read more

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United-Kingdom

NHS European Office - Protecting the public's health across Europe after Brexit

This briefing from the Brexit Health Alliance (BHA) and the Faculty of Public Health, a member of the Alliance, sets out how people across Europe currently benefit from the close collaboration between the UK and EU on public health, and proposes solutions to maintain and improve a high level of public health protection after the UK leaves the European Union.

The Alliance is calling for:

• Both the EU Commission and UK government to prioritise the public’s health in negotiations on the future relationship between the UK and the EU. • A security partnership based on strong coordination between the UK and EU in dealing with serious cross-border health threats, such as pandemics, infectious diseases, safety of medicines (pharmacovigilance) and contamination of the food chain. Ideally, this would be by continuing access to the European Centre for Disease Prevention and Control and other relevant EU agencies, systems and databases. • Alignment with current and future EU regulatory and health and safety standards relating to (for example) food, medicines, transplant organs and the environment, to avoid the need for replication of inspections and non-tariff barriers at the UK/EU border. • The UK government to commit to a high level of human health protection when negotiating future free trade and investment agreements.

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Employment, Social Policy, Health and Consumer Affairs Council

Coordination of social security systems

On 21 June 2018, the Council agreed its negotiating position (general approach) on the coordination of social security systems (revision of regulations 883/2004 and 987/2009). On the basis of this mandate, the Council Presidency will start negotiations with the European Parliament once the latter has adopted its position.

The revision of the regulations on coordination of social security systems aims at modernising the rules by bringing them in line with the development of national social security systems, as well as making them clearer, fairer and simpler to enforce. This will make people movement within the EU easier.

The draft amending regulation focuses on five areas: unemployment benefits, long-term care benefits, access to benefits for economically inactive persons, family benefits and applicable legislation for posted workers and persons working in two or more member states. It also includes a number of other smaller amendments.

Draft directive on work-life balance

On 21 June 2018, the Council agreed its negotiating position (general approach) on the directive on work-life balance for parents and carers. On the basis of this mandate, the Council Presidency will start negotiations with the European Parliament once the latter has adopted its position.

The aim of this proposal is to improve access to work-life balance arrangements, such as leave and flexible working arrangements for parents and carers. It should boost the take-up of family- related leave by men, which will help increase female labour market participation.

The directive would:

• introduce new minimum standards on paternity leave, with fathers or second parents being able to take at least 10 working days of leave around the time of the birth of the child, paid at a level defined by the member state concerned. • update the minimum standard on parental leave, keeping the existing individual right of 4 months but with 2 non-transferable months, with at least 1.5 months to be paid at a level set by the member state concerned. • introduce an individual right to carers' leave, previously not recognised at EU level. • extend the right to request flexible working arrangements for parents, until the child is at least 8 years old, as well as for carers. Parents and carers could ask, for example, for flexible working hours or working patterns and for the right to work remotely.

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Transparent and predictable working conditions

The Council agreed its negotiating position (general approach) on the directive on transparent and predictable working conditions. This draft directive addresses challenges brought by developments in the world of work, including growing flexibilisation of the labour market. On the basis of this mandate, the Council Presidency will start negotiations with the European Parliament once the latter has adopted its position.

Posting of workers

The Council adopted the revision of the posting of workers directive. The directive aims at ensuring fair wages and a level playing field between posting and local companies in the host country whilst maintaining the principle of free movement of services.

Future of Health in the EU

Ministers discussed the future of health in the EU. Member states highlighted that EU action aiming at promoting health is particularly useful when there is a cross-border dimension or when it facilitates improving national measures based on exchange of best practices. They outlined various areas where EU cooperation can be beneficial for Member States such as exchange of best practices in the areas of prevention and non-communicable diseases, cross- border health threats, patients’ safety, AMR, eHealth, research, and cooperation between specialised centres or voluntary cooperation between groups of member states on issues which are important to them.

Health technology assessment

Ministers held a debate on the proposed regulation on health technology assessment, providing guidance on possible ways to improve the current cooperation. The discussion focused on the choice between a mandatory approach and a more voluntary approach with greater flexibility for Member states. The Presidency concluded that the debate indicated prevailing preference for a voluntary approach, which would require discussions on alternative solutions, and indicated that discussions in the Council will take time.

Conclusions on "healthy nutrition for children: the healthy future of Europe"

The Council adopted conclusions on 'Healthy nutrition for children: The healthy future of Europe'.

Bearing in mind that an unhealthy diet is one (avoidable) risk factor behind serious chronic diseases, the conclusions focus on promotion of healthier diets for children, as one of the best investments for a young European generation in good health.

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Falsified Medicine – Expert Group Meeting

HOPE was invited with other European stakeholders to the afternoon sessions of the 21st meeting of the expert group (member states representatives) on the delegated act on safety features for medicinal products for human use taking place in Brussels on 26 June 2018.

To start this dialogue between the expert group and the European Medicines Verification Organisation (EMVO) and other European Associations, Directorate General SANTE provided a short update on the outcomes of the morning discussions with Member States: progress on questions and answers documents, presentation of European Regional Funds as a way to find funding, article 23 concerning wholesalers (as some members states are in the process of launching consultation or even legislation the Commission will collect information). Then several issues were listed: the lack of progress of one of the two IT providers, still relatively low on-boarding, the fees, access to data and hospital preparedness.

EMVO provided an update of the progress in setting up the national repositories. The latest update from EMVO was circulated to the Member States (see power point).

Updates were then provided from the member states working groups.

Working group 2 on “National Competent Authorities (NCA) access to data in the repository system” (Lead: ES. Participants: BE, CY, CZ, EE, ES, FR, GR, HU, IE, LT, LU, LV, MT, NL, PL, PT, SE, SI, UK.) presented the four papers on access to data adopted by the expert group and the prioritisation document. WG2 asked EMVO for more clarity on the timelines for the development of the reports and access by NCAs through the API and GUI.

Working group 3 on “Data traceability that includes IT/EL pack authentication, parallel trade” (Lead: IT. Participants: IT, EL, ES, FR, CZ, UK, NL, PL, PT, BE) presented the information to be shared between IT/(EL) and the EU hub in case of exports/imports between IT/(EL) and the remaining EU Member States.

Working group 4 on “Exchange of best practices” (Lead: BE. Participants: ES, BE, FR, EE, FI, UK, IE, HR, EL, DK, PT, SI, PL, SK) presented its work to identify solutions to facilitate decommissioning by hospitals. In particular, the WG, together with the Expert Group, has identified four options for the aggregation of unique identifiers in secure data files as a potential way forward. The Working group expressed its wish to have a final document published and distributed after having received the comments of stakeholders, to be made before end of July.

EMVO director general presented a first answer agreed the morning by all stakeholders to set up series of technical meeting to work on the four options. But then a comment of a

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representative of Medicine of Europe arguing against the discussion on the argument that create unpredictability and is risking disrupting led to general discussion on aggregation. France explained that this was a way to find solutions for February 2019. Germany followed the same line.

At the end the Commission concluded that the suggestion of WG IV would be followed and that the proposal of a meeting would be considered once the contributions have been received by the end of July. The Commission will assess if there is enough material to hold a meeting.

EMVO in consultation with its members has requested to raise the following issues under this agenda point: • Onboarding of manufacturers: EMVO would like support from NCAs to reach out to manufacturers and remind them of their obligations under the Falsified Medicines Directive and Delegated Regulation. Currently, only 900 manufacturers are in the process of on-boarding to the hub/EMVS whereas EMVO had expected more than 2 000 manufacturers to on-board at this stage. The Commission, with the support of EMA, has provided a list of the 4000 Market Access Holders (MAH) for centrally authorised products.

• Financing of the system: EMVO informed the expert group and Commission of the procedures they plan to put in place to disconnect on-boarding partners and NMVSs that do not pay their fees. They have also indicated that they will request national authorities to implement measures that ensure payment by relevant end-users.

• Supporting tools for NMVOs (establishing list of MAHs, end-users…): The NMVOs have difficulties identifying all end-users that must connect to the national hubs, in particular, wholesalers, hospitals and persons entitled to supply medicines outside of retail pharmacies. According to EMVO, the lack of information on the total number of end-users makes it difficult to ensure compliance and budget the costs of running the repository system.

• Scope, voluntary use and coding requirements: Stakeholders requested further information from Member States on the possible extension of the scope of the unique identifier, the voluntary use of the safety features and the coding requirements.

More about EMVO

Preparedness self-assessment tool launched by ECDC

On 20 June 2018, ECDC launched the HEPSA (Health Emergency Preparedness Self- Assessment) tool, in order to support countries in improving their level of public health emergency preparedness.

This tool facilitates the evaluation of the levels of preparedness and contributes to identification of potential gaps. It also facilitates interactions among stakeholders to discuss themes related to public health emergency preparedness. Based on the outcomes of the self-assessment,

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areas for improvement can be identified and actions can be taken by the countries in order to strengthen capacities.

The HEPSA tool is worksheet-based and is targeted at professionals in public health organisations responsible for emergency planning and event management. It consists of seven domains that define the process of public health emergency preparedness and response: 1) Pre-event preparations and governance; 2) Resources: Trained workforce; 3) Support capacity: Surveillance; 4) Support capacity: Risk assessment; 5) Event response management; 6) Post-event review; 7) Implementation of lessons learned. The tool is complemented by a user guide and an evaluation form.

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Antimicrobial Resistance – European Antibiotic Awareness Day

HOPE was invited as a member to the Technical Advisory Committee of the European Centre for Diseases Control (ECDC) in Stockholm on 18 and 19 June 2018.

The main aim of the meeting is to discuss the plans for European Antibiotic Awareness Day (EAAD)2018 as well as the strategy and direction from 2019 onwards.

In the past months, ECDC has been performing an analysis of the yearly EAAD evaluations completed since the first EAAD in 2008, with a focus on the national needs and the barriers for the implementation of the campaigns at country level. ECDC is currently also consulting with professional, patient and consumer organisations that support EAAD, and plan to integrate their feedback as part of a 2 to 5-year working framework for the campaign.

Based on this work, ECDC is developing a set of actions and priorities that were discussed on 18 and 19 June. Guiding principles for future work were agreed as well.

The meeting was also an opportunity to review 2017 activities at EU and at national level, coordinate activities with the and with WHO/Europe (in the framework of the World Antibiotic Awareness Week) and share best practices (Poland, Croatia and Spain presentations) and discuss preliminary plans for 2018.

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Antimicrobial Resistance “One Health” Report adopted by ENVI Committee

The own initiative report on “A European One Health Action Plan against Antimicrobial Resistance” was adopted by the Environment, Public Health and Food Safety (ENVI) Committee of the European Parliament on 20 June 2018.

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The Committee is now calling on the Commission and the Member States to support the development and uptake of new economic models, pilot projects and push and pull incentives to boost the development of new antimicrobials, vaccines and rapid diagnostics.

The report stresses that the correct and prudent use of antimicrobials is essential to limiting the emergence of AMR and that national strategies to address AMR are crucial in this respect.

The ENVI Committee also calls on the Commission and the Member States to align surveillance, monitoring and reporting of AMR patterns. Member States should share best practices and optimise data collection measuring antibiotics usage and resistance.

Draft Report

Communicable diseases: Commission updates surveillance list

On 22 June 2018, the Commission adopted an Implementing Decision on the list of communicable diseases and related special health issues as well as relevant case definitions to be monitored through the EU’s epidemiological surveillance network.

The new list includes communicable diseases that have recently emerged or re-emerged, such as Chikungunya, Dengue, Lyme neuroborreliosis and Zika infections and corresponding case definitions. The Decision also includes revised case definitions for several other communicable diseases and related health issues such as antimicrobial resistance (AMR) and healthcare associated infections (HAI). Moreover, the list of diseases and the list of case definitions are brought into line with the World Health Organisation nomenclature according to the International Statistical Classification of Diseases.

The regular updates are triggered by new scientific information, by evolving laboratory diagnostics and practices, and are based on the scientific advice by the European Centre for Disease Prevention and Control (ECDC).

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Commission and WHO discuss how to strengthen their collaboration

On 29 June 2018, senior European Commission and World Health Organization (WHO) officials met in Geneva to discuss how to strengthen health systems, Universal Health Coverage, health emergencies, and improving the health of populations (including Commission priorities such as vaccination and antimicrobial resistance).

Director-General Dr Tedros Adhanom Ghebreyesus, Deputy Director-General Soumya Swaminathan and several other senior officials represented the WHO, while Xavier Prats Monné, Director-General for Health and Food Safety, lead the Commission delegation. Senior representatives of the Directorates-General for International Cooperation and Development, Environment, Research and Innovation, European Civil Protection, Humanitarian Aid

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Operations also attended the meeting, as well as staff of the European Centre for Disease Prevention and Control.

The discussions also focused on joint activities, shared priorities, the advancement of health goals of the UN's Sustainable Development Goals, and the implementation of the 2015 Vilnius Declaration, which sets the collaboration between EU and WHO Europe.

More on International Cooperation

Pharmaceuticals: Commission refines intellectual property rules

On 25 May 2018, the Commission proposed a targeted adjustment to intellectual property rules to help Europe's pharmaceutical companies tap into fast-growing global markets and foster jobs, growth and investments in the EU.

The EU has a strong intellectual property rights framework in place which protects Europe's know-how and sustains the pharmaceutical industry's world-class innovation capacity. To improve the current system further and remove a major competitive disadvantage of EU manufacturers, the Commission proposes a targeted amendment: the 'export manufacturing waiver' to Supplementary Protection Certificates.

Supplementary Protection Certificates (SPCs) extend patent protection for medicinal products which must undergo lengthy testing and clinical trials prior to obtaining regulatory marketing approval. Thanks to the waiver, in the future EU-based companies will be entitled to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the certificate, if done exclusively for the purpose of exporting to a non-EU market where protection has expired or never existed. The waiver will support Europe's pioneering role in pharmaceutical research and development.

The proposal is accompanied by a series of safeguards which will create transparency and prevent IP-infringing products from entering Member State markets. The proposal amends Regulation 469/2009 on the supplementary protection certificate for medicinal products. Once adopted by the European Parliament and Council, it will be directly applicable in all EU countries.

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Study on the economic impact of pharmaceutical incentives and rewards in Europe

On 20 May 2018, a study on the economic impact of pharmaceutical incentives and rewards in Europe, requested and funded by the European Commission, and carried out by Copenhagen Economics was published. This study was conducted in response to the invitation of Member States in the Council Conclusions of June 2016 to conduct an analysis on the functioning and actual use of the various pharmaceutical incentives.

The study provides an overview of pharmaceutical incentives and economic evidence on how Supplementary Protection Certificates and regulatory data protection are used in practice and their overall effects on innovation, availability and accessibility of medicinal products.

More specifically, the factual and evidence-based report presented by Copenhagen Economics gives insights into the following 5 types of pharmaceutical incentives:

• The supplementary protection certificate (SPC) which extends the standard duration of patent protection to a medicinal product; • Data protection which prevents marketing authorisation applications for generics to refer to the results of pre-clinical tests and clinical trials of authorised medicinal products; • Market protection which ensures that generic copies of authorised medicinal products are not marketed; • Market exclusivity for orphan medicinal products; and • Rewards for paediatric medicinal products (i.e. used for treating children aged 0 to 18), which can benefit from a 6-month extension of the SPC or additional 2 years of market exclusivity in the case of orphan medicinal products.

Access the study

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Artificial Intelligence: Expert group appointed by the Commission and launch of the European AI Alliance

On 14 June 2018, the Commission appointed 52 experts to the new High-Level Group on Artificial Intelligence. The Group, consisting of representatives of academia, business, and civil society, will support the implementation of the EU Communication on Artificial Intelligence published in April 2018.

The High-Level Expert Group will make recommendations on how to address mid-and long- term challenges and opportunities related to artificial intelligence. The recommendations will

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feed into the policy development process, the legislative evaluation process and the development of a next-generation digital strategy. The Group will also prepare draft ethics guidelines that will build on the work of the European Group on Ethics in Science and New Technologies and of the European Union Agency for Fundamental Rights in this area. The guidelines will cover issues such as fairness, safety, transparency, the future of work, and more broadly the impact on upholding fundamental rights, including privacy and personal data protection, dignity, consumer protection and non-discrimination. The draft guidelines will be finalised by the end of the year and presented to the Commission at the beginning of 2019.

The High-Level Expert Group will additionally support the Commission in building a broad community of stakeholders through the European AI Alliance that was launch on the same day. Everyone interested in AI can become a member to address all aspects of AI in discussions, blogs, documents and events. The Alliance input will be included in the Group’s recommendations. The Group proposed ethics guidelines will also be submitted for consultation with the members of the Alliance through the dedicated platform and a series of workshops.

The High-Level Expert Group met for the first time on 27 June 2018. Other planned events include other meetings, such as joint meetings with representatives of the Member States, specialised workshops, and consultation with the European AI Alliance.

More on the high-level group on AI

Artificial Intelligence: Commission discusses ethical and social impact with philosophical and non-confessional organisations

On 18 June, the European Commission hosted a high-level meeting with 12 representatives from philosophical and non-confessional organisations from across Europe, as part of the regular dialogue with churches, religions, philosophical and non-confessional organisations foreseen by Article 17 of the Lisbon Treaty. This ninth annual high-level meeting discussed the topic "Artificial Intelligence: addressing ethical and social challenges". It was chaired by the Commission Vice-President Andrus Ansip.

The meeting provided an occasion to address two important issues related to artificial intelligence (AI). First, the meeting looked at the potential impact of AI on fundamental rights, in particular when it comes to privacy, dignity, consumer protection and non-discrimination. Second, the social dimension of AI was addressed looking in particular at the impact of AI on social inclusion and on the future of work.

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Cybersecurity common certification framework – Council agrees on position

The EU is to enhance its cyber resilience by setting up an EU-wide certification framework for information and communication technology (ICT) products, services and processes. The industry could use the new mechanism to certify products such as connected cars and smart medical devices. The Council agreed on 8 June 2018 its general approach on the proposal, known as the Cybersecurity Act. The proposal will also upgrade the current European Union Agency for Network and Information Security (ENISA) into a permanent EU agency for cybersecurity.

The draft regulation creates a mechanism for setting up European cybersecurity certification schemes for specific ICT processes, products, and services. Certificates issued under the schemes will be valid in all EU countries, making it easier for users to gain confidence in the security of these technologies, and for companies to carry out their business across borders.

• Certification will be voluntary unless otherwise specified in EU law or member states' law. • Features covered would include for instance resilience to accidental or malicious data loss or alteration. • There will be three different assurance levels: basic, substantial or high. For the basic level, it will be possible for manufacturers or service providers to carry out the conformity assessment themselves.

The new rules will grant ENISA a permanent mandate and clarify its role as the EU agency for cybersecurity. ENISA will be given new tasks in supporting member states, EU institutions and other stakeholders on cyber issues. It will organise regular EU-level cybersecurity exercises, and support and promote EU policy on cybersecurity certification.

A national liaison officers network will be part of the mandate facilitating information sharing between ENISA and the member states.

The text agreed is the Council's position for negotiations with the European Parliament. Both the Council and the Parliament have to agree on the final text before it can enter into force.

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EU Healthy Gateways: Joint Action launched

On 12-13 June 2018, the new Joint Action EU Healthy Gateways was launched in Varna (Bulgaria). The meeting welcomed 60 participants representing 22 partners and collaborating stakeholders as well as representatives from Directorate General SANTE, CHAFEA (Consumer, Health, Agriculture and Food Executive Agency), ECDC (European Centre for Disease Prevention and Control), EASA (European Aviation Safety Agency), FRONTEX (European Border and Coast Gard Agency), and transport industry representatives.

The Healthy Gateways Joint Action will produce guidelines, catalogues of best practices and action plans to be implemented by Member State health authorities at operational level in the field of transport, covering all types of health threats, risk communication, advice for public health event management and contingency planning. The action will also support rapid exchange of information in the event of cross-border health risks, using electronic means via established communication networks for points of entry. Online and face-to-face training on contingency planning and management of events at points of entry will be provided at the European, national and local level, while the Joint Action will also support the execution of hygiene inspections on ships and airplanes. In the event of future public health emergencies of international concern (PHEIC), the Joint Action will move from the interepidemic mode to an emergency mode, to support the coherent response according to Decision No 1082/2013/EU, International Health Regulations (205) and WHO temporary recommendations.

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Health Equity in Europe: Joint Action launched

On 21 and 22 June 2018, the new Joint Action Health Equity in Europe was launched in Luxembourg in the presence of the EU Commissioner for Health and Food Safety .

The new Joint Action Health Equity in Europe is funded under the 3rd EU Health Programme with an EU contribution of €2,5 M. It brings 49 participants from 25 EU Member States working together to address health inequalities and underlying social determinants of health across Europe. Under the coordination of the Italian Institute of Public Health, the Joint Action aims to achieve greater equity in health in Europe across all social groups while reducing the inter- country heterogeneity in tackling health inequalities.

Joint efforts will be specifically directed toward:

• delivering a policy framework with suggested actions and recommendations for national, regional and local uptake and implementation; • implementing actions that provide the best opportunity to tackle health inequalities in each participating country;

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• strengthening a cooperative approach in tackling health inequalities and facilitating exchange and learning among Member States; • facilitating transferability of good practices.

Particular attention will be given to migrants since poor health and lack of access to health care services can be an obstacle to their social integration.

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e-Health: Joint Action launched

On 21 June 2018, the first meeting of a new Joint Action on e-health took place in Lisbon, in the context of the 2nd Lisbon eHealth summer week. The Joint Action will contribute to integrate eHealth into health policy and align eHealth investments with health requirements, thus improving healthcare with the use of ICT.

The JA will also support the eHealth network which aims to facilitate the management of chronic diseases and multimorbidity, to increase the sustainability and efficiency of the health systems, to facilitate personalised care and finally to empower citizens.

Coordinated by the Serviços Partilhados do Ministerio da Saude E.P.E. in Portugal, the Joint Action is a 3-year action with an estimated budget of EUR 4.5 million (including the EU contribution of EUR 2.7 million) and the participation of 20 EU Member States plus Norway and Serbia.

Horizon Europe: Proposal for 9th EU Framework Programme for Research and Innovation

The Commission has published its proposal for Horizon Europe programme for 2021-2027, €100 billion research and innovation programme, higher than the €78 billion under the existing Horizon 2020 initiative. The proposal was made as part of the EU's proposal for the next EU long-term budget, the multiannual financial framework (MFF).

Horizon Europe will incorporate policy missions to ensure the effectiveness of research and innovation funding by pursuing clearly defined targets. The Commission has engaged policy experts to develop studies, case studies and reports on how a mission-oriented policy approach will work.

The Commission is proposing to allocate €7.7 billion to health research, a €300 million increase on the funding in Horizon 2020. The Commission appears to have downgraded the importance of research programmes aiming to develop vaccines for these diseases, raises some criticism in the NGO sector.

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EU-funded actions for better preparedness and coordination in health crisis: New booklet

The Health threats 2009-2018 booklet on the EU-funded actions for better preparedness and coordination in health crisis presents several actions funded under health programmes that have helped to improve health security in the EU. It was produced by the Chafea (Consumers, Health, Agriculture and Food Executive Agency) Health unit, in collaboration with health security experts and the Directorate General for Health and Food Safety and launched during the Conference on Best practices in implementing the International Health Regulations (IHR), which took place on 7and 8 June 2018, in Athens (Greece).

These activities implement the Decision on Serious Cross border Health Threats to Health (1082/2013/EU) and complement, support and provide added value to the policies of the EU Member States to improve the health of EU citizens, increase their safety and protect them from serious cross-border health threats of chemical, biological, environmental or unknown origin.

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Active and Assisted Living Market and Investment Report

In May 2018, Technopolis Group released, together with the Active and Assisted Living (AAL) Programme, the AAL Market and Investment Report. It aims to provide a consolidated view of the existing market and investment information in Europe for the Active and Assisted Living domain. It covers data relevant to AAL and related technologies including current status, trends and future opportunities in the European Union (EU) and in which areas links could be created between those opportunities and innovation in the delivery of services.

The scope of this report is largely limited to market developments that exclusively or predominantly focused on ageing and the older people. The report also introduces the new and emerging business models that will shape the AAL market in the near future and provides an overview of the technologies that enabled the development of AAL solutions. While the primary goal of the report is to monitor the European market, relevant information on global markets is also included to provide context and indicate the potential for growth. This report serves as a guide to investors, start-ups and small and medium enterprises (SMEs), mature companies, and policy-makers that are interested in becoming more familiar with the market to support the independent living of older people.

Link

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➢ World Health Organization (WHO)

WHO European Centre for Primary Health Care: annual report of activities 2017

The WHO European Centre for Primary Health Care published in June 2018 a report summarizing its activities in 2017 in working with the Region Member States and contributing to priorities for strengthening health systems in accordance with guiding regional and global commitments. Based in Almaty, Kazakhstan, the WHO European Centre for Primary Health Care is the technical hub on health services delivery for the WHO European Region.

Key achievements in 2017 include conducting research for policy action on the integration of services across levels and sectors of care, developing frameworks for rethinking quality of care and primary health care performance, providing technical assistance to countries, including assessing services delivery and mapping quality of care governance, providing support for planning and implementing services delivery policies through pilot projects and launching new collaborations and partnerships, training and learning resources.

This report details these achievements by the Centre’s four core pillars of work while highlighting activities locally in Kazakhstan and plans looking forward to the landmark 40th anniversary of the Declaration of Alma-Ata in 2018.

Report

Mental Health Atlas 2017

WHO's Mental Health Atlas 2017 published on 6 June 2018 reveals that although some countries have made progress in mental health policy-making and planning, there is a global shortage of health workers trained in mental health and a lack of investment in community- based mental health facilities.

The Atlas provides information on the existence of policies, plans and laws for mental health, and their alignment with established human rights instruments; the human and financial resources available; the type of facilities providing care; and mental health programmes for prevention and promotion.

It is based on data provided by 177 WHO Member States, representing 97% of the world’s population, and measures the extent to which countries are strengthening leadership and governance for mental health; providing comprehensive mental health and social care;

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implementing strategies to promote mental health and prevent problems, and strengthen evidence and research – as outlined in WHO’s Comprehensive Mental Health Action Plan 2013-2020.

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Mental health, human rights and standards of care

In June 2018, the WHO Regional Office for Europe, with support from Picker Institute Europe in data analysis and reporting, published the report “Mental health, human rights and standards of care”, based on the WHO project on adults with psychosocial and intellectual disabilities living in institutions in the WHO European Region. It targets a highly marginalised, vulnerable group whose quality of life, human rights and reinclusion in society are seriously compromised by outdated, often inhumane institutional practices. Its goal is to promote and facilitate deinstitutionalisation. The specific objectives of the project were to address gaps in knowledge about the number and characteristics of such long-term institutions and to identify deficiencies in current care standards through the lens of the United Nations Convention on the Rights of Persons with Disabilities. This publication examines and rates the quality of care and protection of human rights in selected institutions in over 20 countries in the Region using the WHO QualityRights toolkit. It identifies steps to take toward deinstitutionalisation and to ensure respect for the rights of people with psychosocial and intellectual disabilities.

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Improving health literacy at national, regional and organisational levels in the WHO European Region

Health literacy is gaining increasing attention as a means of promoting health. This synthesis, published on 20 June 2018 by Health Evidence Network and the WHO European Office, describes health literacy policies in the WHO European Region: their distribution, organisational levels, antecedents, actors, activities and outcomes, along with the factors influencing their effectiveness. Evidence was obtained by a scoping review of academic literature in English, Dutch and German and of grey literature in English, Dutch, German and Italian, supported by a Region-wide expert enquiry. Emerging findings were presented to representatives from 19 Member States of the Region to check for accuracy and omissions. The report highlights much good health literacy policy-related activity, mostly in the health and education sectors, and proposes areas for future development. Policy considerations are presented to facilitate the sharing of good practices; the development of activities across all societal areas; the development of robust health literacy metrics.

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Tuberculosis among refugees and migrants in the WHO European Region

The WHO European Region has faced high rates of external and internal migration in recent years, with concerns that this is contributing to the burden of tuberculosis (TB), multidrug- resistant TB (MDR-TB) and TB/HIV coinfection in some countries.

On 18 June 2018, the report “What constitutes an effective and efficient package of services for the prevention, diagnosis, treatment and care of tuberculosis among refugees and migrants in the WHO European Region?“ was published in ‘Themed issues on migration and health, VIII’ by Health Evidence Network together with WHO European Office. This report examines evidence of effective and efficient service packages for the prevention, diagnosis and treatment of TB to inform strategies to address the TB burden in refugee and migrant populations. Significant regional variations were identified in both migration levels and TB burden in refugees and migrants, as well as in approaches to TB control, with low quality of evidence in many cases. While it is unlikely that a single strategy/package will be effective for all situations, the evidence highlights some common approaches that could guide policy- making and service development. TB elimination targets for the Region will not be met unless inequalities in access to screening and treatment for migrants are addressed, alongside efforts to tackle TB globally.

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Healthy settings for older people are healthy settings for all: the experience of Friuli-Venezia Giulia, Italy

In June 2018, WHO Europe Office published a report on “Healthy settings for older people are healthy settings for all: the experience of Friuli-Venezia Giulia, Italy”. This report shows how age-friendly environments have been created at the subnational level, using examples primarily from the Autonomous Region of Friuli-Venezia Giulia but also from other regions belonging to the WHO Regions for Health Network. Over the past 20 years, Friuli-Venezia Giulia has utilised WHO frameworks on healthy ageing and scaled up the pioneering experience of the city of Udine to develop a whole-of-the-region policy response to an ageing population, involving many sectors and all levels of governance. With the older segment of its population reaching 25% and still increasing, Friuli-Venezia Giulia put in place an integrated system to promote healthy ageing. The system incorporates new models of social protection and fosters new social relations and networks in local areas in order to promote sustainability, solidarity in relationships, behaviours and actions, and social responsibility. The report shows that healthy settings for older people are healthy settings for all.

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➢ Organisation for Economic Cooperation and Development (OECD)

Care Needed: Improving the Lives of People with Dementia

On 12 June 2018, the OECD published a report untitled “Care Needed: Improving the Lives of People with Dementia” as part of the series OECD Health Policy Studies. Across the OECD, nearly 19 million people are living with dementia. Millions of family members and friends provide care and support to loved ones with dementia throughout their lives. Globally, dementia costs over USD 1 trillion per year and represents one of the leading causes of disability for elderly adults. These numbers will continue to rise as populations age. Until a cure or disease- modifying treatment for dementia is developed, the progress of the disease cannot be stopped. This report presents the most up-to-date and comprehensive cross-country assessment of the state of dementia care in OECD countries. In recent years, OECD countries have enhanced their efforts to provide high-quality dementia care during diagnosis, early and advanced dementia, but improving measurement is necessary for enhancements in care quality and outcomes for people with dementia. The report advises a set of policies that can help countries to improve diagnosis, strengthen access to care services, improve the quality of care, and support the families and carers of people living with dementia. Measuring and comparing the services that are delivered to people with dementia and the outcomes they achieve is a crucial part of improving dementia care. Most health systems have very poor data on dementia care and countries should work to strengthen the measurement of quality and outcomes of dementia care.

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Paying hospital specialists: Experiences and lessons from eight high-income countries

Payment systems for specialists in hospitals can have far reaching consequences for the efficiency and quality of care. This article presents a comparative analysis of payment systems for specialists in hospitals of eight high-income countries (Canada, England, France, Germany, Sweden, Switzerland, the Netherlands, and the USA/Medicare system). A theoretical framework highlighting the incentives of different payment systems is used to identify potentially interesting reform approaches. In five countries, most specialists work as employees − but in Canada, the Netherlands and the USA, a majority of specialists are self- employed. The main findings of this review include: many countries are increasingly shifting towards blended payment systems; bundled payments introduced in the Netherlands and Switzerland as well as systematic bonus schemes for salaried employees (most countries) contribute to broadening the scope of payment; payment adequacy is being improved through regular revisions of fee levels on the basis of more objective data sources (e.g. in the USA) and through individual payment negotiations (e.g. in Sweden and the USA); and specialist

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payment has so far been adjusted for quality of care only in hospital specific bonus programmes. Policy-makers across countries struggle with similar challenges, when aiming to reform payment systems for specialists in hospitals. Examples from the reviewed countries may provide lessons and inspiration for the improvement of payment systems internationally.

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Strategic Purchasing in Practice: Comparing Ten European Countries

Strategic purchasing of health care services is widely recommended as a policy instrument. Authors conducted a review of literature of material drawn from the European Observatory on Health Systems and Policies and selected country-specific literature to augment the comparative analysis by providing the most recent healthcare trends in ten selected countries. There is little evidence of purchasing being strategic according to any of the established definitions. There is little or no literature suggesting that existing purchasing mechanisms in Europe deliver improved population health, citizen empowerment, stronger governance and stewardship, or develop purchaser organisation and capacity. Strategic purchasing has not generally been implemented. Policy-makers considering adopting strategic purchasing policies should be aware of this systemic implementation problem. Policy-makers in systems with strategic purchasing built into policy should not assume that a purchasing system is strategic or that it is delivering any expected objectives. However, there are individual components of strategic purchasing that are worth pursuing and can provide benefits to health systems.

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Should interventions to reduce variation in care quality target doctors or hospitals?

Interventions to reduce variation in care quality are increasingly targeted at both individual doctors and the organisations in which they work. Concerns remain about the scope and consequences for such performance management, the relative contribution of individuals and organisations to observed variation, and whether performance can be measured reliably.

This study explores these issues in the context of the English National Health Service. Except for length of stay after hip replacement, no more than 11% of variation in case-mix adjusted performance indicators can be attributed to doctors and organisations with the rest reflecting random chance and unobserved patient factors. Doctor variation exceeds hospital variation by a factor of 1.2 or more. However, identifying poor performance amongst doctors is hampered by insufficient numbers of cases per doctor to reliably estimate their individual performances. Policy-makers and regulators should therefore be cautious when targeting individual doctors in performance improvement initiatives.

Link

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Health care service provision in Europe and regional diversity: a stochastic metafrontier approach

In the last decades, demographic change coupled with new and expensive medical innovations have put most health care systems in developed countries under financial pressure. Therefore, ensuring efficient service provision is essential for a sustainable health care system. This paper investigates the performance of regional health care services in six West European countries between 2005 and 2014. The results indicate that regional deprivation plays a key role for the efficiency of health care provision. Furthermore, a pooled model which assumes a similar technology for all countries cannot sufficiently account for differences between countries. Surprisingly, the Scandinavian regions lag behind other regions with respect to the metafrontier.

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Private practices in public hospitals

HOPE CEO was invited to speak in Dublin on 19 June 2018 during an Evidence briefing organized by WHO European Observatory on Health Systems and Policies for the benefit of the Irish Department of Health on reducing private practice in public hospitals.

A cross-party consensus for reform of the Irish health system has been achieved. One aim of the reform package known as Sláintecare is to try and eliminate the ‘two-tier’ health system where people with private health insurance are able to jump the queue and access better quality care in the same hospitals as those patients who are using the public system. The financial incentives in place prioritise patients with private insurance and there are real capacity issues with reducing waiting lists for elective care for state-funded patients. The issue is politically very important as it is seen as a key challenge to equity in the system.

In the Sláintecare Report, the cross-party Committee on the Future of Healthcare recommended the “expansion of public hospital activity, including through removal of private care from public hospitals”. The overall aim is to reduce inequalities in the hospital sector. More specifically, the aim of phasing out private practice in public hospitals is sought to ensure: timely access to (elective) hospital care; treatment according to need and not capacity to pay; clear lines of accountability and sound hospital governance.

Currently, most hospital consultants have split contracts that allow them to conduct 20% (in some case 30%) private practice. They may charge different tariffs for private patients. Private and public patients are not separated and may be placed on the same ward and in the same room.

The overall aim of this evidence briefing is to support efforts to reduce inequalities in access to hospital care. One way to achieve this is by informing policy-making with experience from other countries. To this end, the evidence briefing shall support the work of the Review Group developing a report on the impact of different strategies for removing or phasing out private practice from public hospitals.

To this end the Evidence briefing pursued the following objectives:

• Clarifying the international experience of private practice in public hospitals as although it is widespread, it is a ‘non-issue’ in many countries; • Discussing regulatory frameworks to control private practice in public hospitals; • Discussing health workforce policies that may ameliorate problems with private practice in public hospitals.

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European Civic Prize on Chronic Pain Collecting Good Practices

The application period for the second edition of the bi-annual research-project at the European level “EU Civic Prize on Chronic Pain - Collection of good practices” is open. The award is open to any healthcare stakeholder: patients’ associations, health professionals, private and public hospitals, universities, etc.

The contest seeks to give evidence on good practices in their struggle to combat pain. Additionally, it seeks to encourage the exchange of experience among health professionals, providers, institutions, civic associations, and patient advocacy groups as well as to foster the multi-stakeholder platform of operators of good practices on pain. All with the end goal of fighting chronic pain and protecting patient’s rights in Europe.

This is the second of a series of prizes –awarded every two years – celebrating progress in the treatment and manage of chronic pain. Closing date for receiving submissions is 31 December 2018.

Good practices are actions whose very nature have a positive impact on the quality of services, the protection of citizens' rights, the promotion of civic participation, and the enhancement of human resources. In particular, they are very successful initiatives aimed at improving the efficiency (cost) and the effectiveness (as a way to meet, in an appropriate manner, the needs and expectations of citizens) of the management and provision of services.

The types of good practice to be identified will be classified as follows:

• Patients’ empowerment • Innovation • Clinical practices • Professional education

There will be 4 prizes, the winner will be offered the opportunity to share its project in a public meeting pain related Publication in English in a suitable journal.

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Sale of patients’ data in hospitals – European Parliament

A question for written answer was asked to the European Commission on 31 October 2017 by Member of the European Parliament (MEP) Claude Rolin (EPP) concerning the sale of patients’ data in hospitals in Belgium.

The MEP wrote that in Belgium recently, around 15 of the country’s 100 or so hospitals have sold their patients’ confidential data to the American medical data processing multinational, Quintiles IMS. The data in question concern the patients’ treatment (course of treatment, pathology, medical examinations, consultants) and the sums invoiced by the hospitals to mutual benefit insurance companies. For Quintiles IMS, this is a deal that offers plenty of

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potential advantages as it could sell this data on to the highest bidder, and in particular pharmaceutical companies seeking to fine-tune their marketing strategy.

The MEP declared that he is opposed to all commercialisation of health: “Patients do not know that their data has been recorded and may be passed on for mercenary purposes. Patients’ data should only be used for their benefit and within an ethical framework. Health data are of inestimable value for those who wish to profit from them. Transactions of this kind must be strictly regulated, with the data involved rendered strictly anonymous.”

Commissioner Jourová answered by quoting article 8 of the directive 95/46/CE that defines a strict protection of personal data relative to health of individuals. Using those data can only be justified if needed for prevention, diagnostic, treatment or management of health services. She added that article 9 of Regulation (EU) 2016/679(, replacing directive 95/46/CE from 25 May 2018, confirms those strict rules.

She added that hospitals cannot share medical data with private companies, only in a limited number of cases defined by the legislation. This can only be done on the basis of a law that precisely allows it and with patients consent.

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Sepsis – Improving prevention, diagnosis and clinical management

A new industry-oriented lobbying group has been created in Brussels called the European Network for Safer Healthcare (ENSH) entitled “Improving prevention, diagnosis and clinical management of Sepsis”.

The European Network for Safer Healthcare pretends to be an informal group of health stakeholders to ensure that the issue of patient and healthcare worker safety is in the limelight of the European institutional discussions. We can currently count on the expertise and help of the following associations representing a well-balanced range of health stakeholders:

• Health First Europe (Coordinator), • European Network to Promote Infection Protection for Patient Safety, • European Health Management Association, • International Alliance of Patients' Organizations, • Global Sepsis Alliance, • European Society for Emergency Medicine, • European Biosafety Network.

Its first meeting took place on 27 June 2018 in Brussels.

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European Society of Radiology

The European Society of Radiology (ESR) event at the European Parliament, Brussels invited HOPE to speak on 6 June 2018 in the European Parliament during a seminar called: From health policy to practice.

The host, Dr Biljana Borzan Croation MEP (SD), member of the ENVI Committee presented the European Parliament’s vision on innovation in healthcare (value-based healthcare, HTA, eHealth, …) and interinstitutional cooperation.

Dr Andrzej Rys, director at Directorate General SANTE Health Systems and Medicinal Products Director, focused on translating policies and innovation in healthcare into practical benefits for patients. He mentioned the Communication on Transformation of Health and Care, the Health Technology Assessment Initiative and the European Reference Networks.

HOPE CEO spoke on the involvement of stakeholders to link policy and practice: Stakeholder involvement should be guaranteed “by design”, Professional societies and representative associations provide concentrated expertise, Stakeholder organisations are vital network to disseminate information and facilitate compliance and best practices.

ECCO 2018 European Cancer Summit

The European CanCer Organisation (ECCO) organises the ECCO 2018 European Cancer Summit on 7-9 September 2018 in Vienna, providing a focal point for resolutions on the burning matters affecting access to high quality cancer care for patients across Europe.

This unique event will bring together worldwide leaders from across the diverse cancer stakeholder community in order to give attention to pressing policy challenges, and make consensus resolutions for action upon them.

Speakers include Dr. Vytenis Andriukaitis, EU Commissioner for Health & Food safety, Her Excellency Marie-Louise Coleiro Preca, President of Malta, Professor Richard Sullivan, Professor Françoise Meunier and many more.

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European Health Forum Gastein in European Parliament talks

On 25 June 2018, HOPE attended an event organised by the European Health Forum Gastein (EHFG) in the European Parliament in Brussels and hosted by MEP Karin Kadenbach (S&D, Austria). The speakers reflected on the theme “Health and Sustainable Development – Bold Political Choices for Agenda 2030”.

MEP Karin Kadenbach introduced the event stressing out that decisive political action and strong commitments are necessary to ensure health remains a key concern for European

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actors and institutions. She emphasizes that health must be brought at all different political levels to ensure it tackles the evolving health needs of all.

Clemens Martin Auer, President, European Health Forum Gastein (EHFG) reminded that the European countries are facing significant challenges in terms of social, political and technological change, with resulting implications for health systems and policies. According to him, due to the economic global competitiveness, the internal market cannot work without health policies and the social determinants of health are too important for issues to be tackled at national level, though a need of a strong EU agenda for action in the next period. He underlined the vulnerability of patients in relation to business interests. As about 6 to 7% of the public expenditures goes to healthcare, the focus should be put, according to him, on research and innovation, assessment of innovations, medical technologies and public health.

This introduction was followed by a panel discussion involving Sylvain Giraud, Head of Unit, DG Health and Food Safety, European Commission (DG SANTE), Clemens Martin Auer, President, European Health Forum Gastein (EHFG), Ilaria Passarani, Secretary General, Pharmaceutical Group of the European Union (PGEU) and Birgit Beger, CEO, European CanCer Organisation (ECCO) and co-moderated by Dorli Kahr Gottlieb, Secretary General, European Health Forum Gastein (EHFG) and Josep Figueras, Director, European Observatory on Health Systems and Policies (OBS)

Several issues were discussed like the need to take action in health policy and in particular to develop legislation in the areas of prevention and cross-border issues and to strengthen a non- communicable diseases framework. The top-down approach should be completed by citizens’ inputs and a coherent message built on collaboration of different actors is essential to promote change.

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Financing integrated care and population health management

HOPE was invited to a Pre-conference event of ICIC18 (18th International Conference on Integrated Care) untitled “Financing integrated care and population health management” that took place on 22 May 2018 in The Hague (NL).

This was organised as a follow-up to the seminar "Strategic investments for the future of healthcare", which the European Commission DG SANTE held in February 2017.

Moving away from the traditional hospital-centred model requires "softer" investments too, not just in physical infrastructure. But strategies for such investments are lacking. In addition, while investments in physical infrastructure can be "tangible and attractive" to investors, investments in services are seen as "intangible and less attractive".

The discussions emphasised on:

• the range of investments needed for integrated care: infrastructure/facilities (such as primary care & community care centres to host multi-disciplinary care teams),

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technologies (such as diagnostics, eHealth/mHealth tools, decision support systems), and services (such as prevention programmes, workforce skills, organising partnerships and patient pathways etc.) • the difficulties/practical problems in investing in any (and all) of these elements • the possibilities related to EIB financing, EFSI (European Fund for Strategic Investments), ESIF (Structural Funds), social impact investments, venture/private capital, philanthropy funds etc.

The need for capacity building and technical assistance to health authorities to invest in health – including awareness and ability to manage various financing sources and instruments was mentioned as a key challenge. The need for better data on the impact of innovative health solutions, to help build stronger investment propositions was also expressed as well as the need to share lessons from good investment examples and the need for connecting investment plans to contracting and payment models.

Ernst van Koesveld, Deputy Director-General for Long-Term Care and Director of the Health Insurance Department, Ministry of Health, Welfare and Sports of the Netherlands spoke on the health reforms in the Netherlands and the plans to finance these. He said that the five Dutch (care and cure) systems are not integrated enough. He regretted the medicalisation syndrome considering that social issues are more important the medical ones and the hospitalisation syndrome considering that care should be done more at home.

Martin Seychell, Deputy Director-General for Health, DG Health and Food Safety, European Commission was asked to deliver a keynote speech on the requirements (the know-how and the financing) for the successful transitioning to the healthcare models of the future but in reality he presented the different tools of the Commission.

Gregg Meyer, Chief Clinical Officer, Partners Healthcare System in Boston, Massachusetts, (USA) made a presentation about the variety of investments required for the implementation of integrated care/population health management. He showed that using all kind of tools his healthcare group was able to reach a 7% cost reduction and 4% lower mortality with 20% less hospitalisation and 25% lower emergency department visits

Lieve Fransen, from the think tank European Policy Centre, presented the main messages and recommendations regarding investments in the health and long-term care sector from the report of the High-Level Task Force on Investing in Social Infrastructure in Europe. She mentioned an investment gap of at least 50 billion euros in health.

Volker Amelung, German Managed Care Association, presented the German Innovation Fund, how it finances and incentivises new care models, and its opportunities and pitfalls. He explained that the German healthcare system has far too much money and that there is then no need, nor motivation for process changes.

Dana Burduja (European Investment Bank / European Investment Advisory Hub) presented how to use European Investment Bank and European Fund for Strategic Investment, the concept of investment platforms, and the advisory/technical assistance services of the European Investment Advisory Hub.

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Madeleine Clarke (European Venture Philanthropy Association, Belgium and Ireland) presented examples of philanthropy investments in health and social care, explaining how such investments can be attractive in these domains, with whom philanthropy investors collaborate and where they see the return on their investment.

Finally, Thomas Kergall, Council of Europe Development Bank showed examples of infrastructure and services that received financial help.

Report

What future for EU cooperation on Health Technology Assessment (HTA)? - MEP Interest Group on Access

On 5 June 2018, HOPE took part in “What future for EU cooperation on HTA” conference in the European Parliament.

Hosted by MEP Andrey Kovatchev (PPE, Bulgaria) and organised by the Patient Access Partnership, this meeting gathered key institutional players and stakeholders to deepen the ongoing debates on health technologies assessment (HTA) and the European Commission Proposal for a Regulation released on 31 January 2018. MEPs Biljana Borzan (S&D Croatia), Cristian Silviu Bușoi (EPP, Romania), Lieve Wierinck (ALDE, Belgium), Kateřina Konečná (GUE/NGL, Czech Republic) and Karin Kadenbach (S&D, Austria) welcomed this proposal and pointed out the pressing need to decrease fragmentation between healthcare systems and inequalities between citizens, and urged for closer cooperation between national and regional HTA bodies.

Anna-Eva Ampelas from DG SANTE (Head of Unit, Health Technology Assessment) presented the rationale behind the proposal and its content. Then, Pr Ilko Getov, Chair of the HTA Committee to the Ministry of Health of Bulgaria, developed the point of view of Member States, warning that a consensus was still far to be reached in the Council of the European Union. While welcoming European Commission’s initiative, Philipp Tillich (Health Attaché, permanent Representation of Austria to the EU) stressed out that the proposal has some downsides and should be considered as a basis for further discussions.

MEP Soledad Cabezon Ruiz (S&D, Spain) then introduced the ENVI Committee draft report on the Commission proposal. As rapporteur, she recognised the benefits of past voluntary cooperation but urged the assembly to move beyond this situation. Explaining the philosophy of the amendments made, she further identified the needs for transparency, flexibility, trust and scientific evidence and shed light on the potential conflicts of interest that could happen in the current proposal’s framework.

François Hoüyez (EURORDIS) and Kaisa Immonen (European Patients Forums) focused on the patients’ position. Mrs Immonen stressed out that patients face confusion and ignorance when it comes to health technology assessment. According to him, patients’ involvement from an early stage enables the accuracy and acceptability of the report, and thus patients should be represented in the main governing body of HTA. Mr Hoüyez detailed the benefits of joint cooperation, and underlined that more flexibility in the proposed mandatory uptake could help

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Member States to consider their national particularities, for instance with addendums to the initial report.

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The digital transformation of healthcare - challenges and opportunities - MEP Interest Group on Access

On 18 June 2018, HOPE took part in “The digital transformation of healthcare – challenges and opportunities” conference hosted in the European Parliament by MEP Andrey Kovatchev (EPP, Bulgaria).

EU Commissioner for and Society delivered a keynote speech on eHealth and about new European Commission Communication on eHealth released on 25 April 2018. Tapani Piha (DG SANTE) and Miguel Gonzalez-Sancho (DG CONNECT) further elaborated on this communication and on the data package. They highlighted the objective to set up a mechanism for cooperation in order to assemble data and procedure and discussed the new possibilities for integrated care provided by eHealth.

Tairi Täht (Councillor for Health Affairs, Permanent Representation of to the EU) provided the audience with statistics on eHealth perception by Estonian and EU citizens. She stressed out that, according to the 2017 Eurobarometer “Attitudes towards the impact of digitisation and automation on daily life”, the digital divide is decreasing, and presented improvement perspectives such as the eHealth network Multiannual Work Plan 2018-2021, the new Joint Action eHAction and the Digital Health Society collaboration platform.

Alexander Ognyanov (Director of Information Technologies at the Bulgarian National Health Insurance Fund) gave an example of an integrated information system at national level launched in 2009, while Ivailo Dachov (CEO, Checkpoint Cardio) demonstrated a surveillance device and expressed the industry ambition to replace current offline devices by 21st century eHealth systems.

Kaisa Immonen (European Patients Forum) pointed out the need for empowering patients and in which ways eHealth can fulfil this need, if technology is made accessible in an understandable language and digital health literacy is guaranteed. She said patients are expecting better coordination, a more effective data sharing, patients’ access, and a person- centred model. She further noted that patients are more and more in favour of sharing their health data as long as safeguards are in place.

European Commission’s communication on enabling the digital transformation of health and care in the Digital Single Market; empowering citizens and building a healthier society

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Infection prevention: a sustainable solution to the rise of Antimicrobial Resistance (AMR)

On 6 June 2018, HOPE took part in an event hosted by MEP (ALDE, Sweden), organised by the company 3M and titled “Infection prevention: a sustainable solution to the rise of AMR”.

As healthcare-associated infections (HAI) is the main cause of anti-microbial resistance (AMR), HAI’s prevention at the very core of the experts’ discussions. The European Commission “One Health Action Plan on Antimicrobial Resistance” being currently discussed in the European Parliament, ENVI Committee rapporteur Karin Kadenbach (S&D, Austria), Charles Price (Head of AMR, DG SANTE) and Jean Eric Paquet (Director General DG Research and Innovation) brought some institutional insights to the debate.

The Joint Action on Antimicrobial Resistance and Healthcare-Associated Infection (EU- JAMRAI) as well as successful hand-hygiene prevention campaigns in Belgium hospitals are among the solutions presented during the event.

Interprofessional education: a way to transform tomorrow’s healthcare

On 7 June 2018, HOPE attended an event organised by MEP Lieve Wierinck (ALDE, Belgium) and European Healthcare Students´ Association Summit (EHSAS) on “Interprofessional Education:

A way to transform tomorrow’s healthcare”. Considering that a substantial majority of students surveyed by EHSAS declared to want interprofessional education (IPE) to be integrated in their curricula, this meeting has been a good opportunity for participants to share knowledge and experience and to open the debate on such an integration. Various and complementary points of view emphasised the importance of interprofessional education, and its fruitful consequences on healthcare providers wellbeing, healthcare system sustainability, and answers provided to chronic conditions. Topics such as competencies-based curricula, patient- centred care, innovation in medicine, peer learning, or sanitary service for healthcare students have also been addressed by the panellists.

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User Forum on Frailty Prevention

On 8 June 2018, HOPE took part to AGE Platform Europe “User Forum on Frailty prevention” during which the EU-funded project FrailSafe has been introduced to the participants.

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As a loss of physiological reserve, frailty can lead to a loss of independence. Thus, society could benefit from prevention and early detection of frailty. Physiological reserve is influenced by psychological, locomotion, sensory, vitality and cognition factors.

Therefore, FrailSafe project promotes a global approach and offers a variety of devices aimed to monitor several biological data. It aims to prevent falls, make the patient more aware of his own health, and collect health data in an anonymized way. Personalised monitoring has also been said to become easier for clinicians. The overall objective is to empower and monitor people that are likely to be affected by frailty, so that they adopt healthy behaviours. During the event, smart garments as well as serious games were showcased.

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Health Inequalities – “Oral health for all” - Council of European Dentists

On 19 June 2018, HOPE attended the “Focus on oral Health inequalities – oral health for all” event in Brussels.

Hosted by MEP Nessa Childers (S&D, Ireland) and organised by the Council of European Dentists, this meeting gathered experts to address dental diseases related issues and inequalities in access to care.

Dental diseases have a huge societal impact, generating economic expenses from direct costs such as treatment reimbursement, and indirect costs (communication of emotions, dental pain…). Inequalities are visible between countries but also within them. It affects many aspects of EU citizens lives.

The topics of life course and social determinants of oral health, connections between homelessness and oral health, universal access to health, dental treatment for the most vulnerable parts of the population have been covered by the panelists. The adequate research frame to monitor and find solutions to such inequalities have also been mentioned, with the hope that Horizon Europe (2021-2027) will help to bridge the gap and improve access to health and care.

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How to maximize the value of innovative health technology

On 19 June 2018, HOPE attended “How to maximize the value of innovative health technology” conference organized by the company Intuitive Surgical.

Paige Bischoff (Intuitive Surgical ‘s Vice president on Global Public Affairs) welcomed the participants. The panel included MEP Cristian-Silviu BUŞOI (chair of the EP Interest Group on Innovation in Health and Social Care), Olivier Babeau (President of the Institut Sapiens Think-

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tank), Flora Giorgio (DG SANTE, European Commission), Miguel Gonzalez Sancho (DG CONNECT, European Commission) and Ortwin Schulte (German Federal Ministry of Health).

Debates on subsidiarity, on the good and sustainable use of data or on the paradox between the eagerness of citizens to adopt technologies and the institutional inertia in some Member States were among the highlights of the debate, while the current institutional work on health technologies assessment (HTA) was a recurrent theme of discussion. Demonstration models of robot-assisted surgical systems were made available for the participants.

Skin cancer registries in Europe: from knowledge to action - MEPs Against Cancer

On 20 June 2018, HOPE attended MEP’s against cancer (MAC) meeting on “Skin cancer registries in Europe: from knowledge to action”.

The event was hosted at the European Parliament by MEP Dr Charles Tannock, MAC Vice- President. The importance of registration for skin cancer control has been emphasised by Dr Ana-Maria Forsea (Euromelanoma) as skin cancers are a major health problem causing around 22200 deaths per year, but data is insufficiently collected throughout Europe. Yet, cancer registries-derived information can have many uses: epidemiologic research, discovery of etiological factors of cancer, planning of cancer control measures, etc. Inequalities between EU countries are of primary concern as late detection and high mortality countries have been identified as the countries where the use of cancer registries-derived data is rare.

Maria Stella de Sabata (Fondo Anglesio Moroni per l’Oncologia) presented the trends in melanoma studies, identifying non-melanoma skin cancer as being registered only partly while Pr. Dr. Swen Malte John (EADV) stated that it is one of the costliest cancers because this disease occurs frequently in the population. He also said population-based cancer registries tend to be more frequent in northern than southern Europe, which increases inequalities.

Dr Elizabeth van Eycken presented the European network of cancer registries, founded in 1990. Malvika Vyas (European Society for Medical Oncology) detailed the General Data Protection Regulation (GDPR) implications for cancer registries.

Event page

Report

Early diagnosis and cancer of unknown primary - MEPs Against Cancer

On 26 June 2018, HOPE attended an event organised by the MEP’s against cancer and hosted by MEPs Theresa Griffin (S&D, UK) and Christel Schaldemose (S&D, Denmark) on “early diagnosis and cancer of unknown primary” (CUP), a type of cancer in which anatomical

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primaries are not identified after clinical evaluation, which makes its detection harder to realise and adapted treatment prescription more complex for practitioners.

An insufficient amount of data is undermining policy-making in this field. Even though through years incidence and mortality have decreased, it has also been clearly stated that awareness needs to be raised, including among politicians.

Awareness-raising and prevention can be promoted from early detection of cancer to cancer treatment. The benefits of early diagnosis over cancer screening (which is less cost-effective) have been recognised by several panellists, but a spill-over effect of screening to raise awareness about early diagnosis is not to be neglected. During this meeting, the Innovative Partnership for Action Against Cancer (iPAAC) Joint Action has also been presented.

Guide to cancer early diagnosis - WHO

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European Association of Hospital Managers Congress

Cascais (Portugal), 26 - 28 September 2018

In September 2018, the Portuguese Association of Hospital Managers (APAH) and the European Association of Hospital Managers (EAHM) will organize the 27th edition of the EAHM Congress in Cascais, Portugal.

The congress theme “Redefining the Role of Hospitals – Innovating in Population Health“ will explore the possibility of integrating innovation and technology to positively change how we can deliver our services and define the role of hospitals into the future. Aligned with the theme of the event, the following key topics will be discussed: People centeredness; Integration of care; Innovative provision models; Financial sustainability; and Population Health Management.

For European hospital managers and indeed hospital managers worldwide, the EAHM congress is an excellent forum to discuss issues that impact hospitals and public health and also an opportunity share good practices and expertise with colleagues.

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Study Tour: The Management of Innovation in Cancer Care

Marseille (France), 3 - 5 October 2018

HOPE organises a study tour in Institut Paoli-Calmettes, Unicancer-Marseille, France: “The management of innovation in cancer care”. Organizational, technical and therapeutic innovations in cancerology can be transferable to other pathologies and especially chronical diseases. In addition to the presentation and visits, a part of the programme will be dedicated to exchange between participants.

You can register online before August 20. The fee is €410 and includes two lunches, one diner, transportation in Marseille, as well as two hotel nights at Hôtel Maison Montgrand for the 3 and 4 October.

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7th International Congress of Hospitals – Citizen involvement and accountability in the National Health Service

Lisbon (Portugal), 21-23 November 2018

APDH is organizing the 7th International Congress of Hospitals – Citizen Involvement and accountability in the National Health Service”, for 21 to 23 November in Lisbon, Portugal.

The Portuguese Association for Hospital Development - APDH is a non-profit association, and it has collective (hospitals) and individual members from all over the country. Being the representative of HOPE - European Hospital and Healthcare Federation and IHF - International Hospital Federation in Portugal, its basic goals are to encourage cooperation between the Portuguese hospital institutions and the foreign ones, in order to promote and develop innovation in the hospital management sector.

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Conducting change in Psychiatry and Mental Health

The ADESM (French Association of Mental Health Institutions) organises with the support of HOPE from 21 to 23 November 2018 in Marseille (France) a conference “Conducting Change in Psychiatry and Mental Health”.

Considering the health systems of European countries are confronted in different ways and rhythms to converging evolutionary and transformation factors, the congress will look at the trends bringing European societies closer and at the main external influences to consider the grounds and the nature of this phenomenon. Change and progression of science and medical knowledge concerning psychiatry or disrupting the larger field of neuroscience will also be covered.

The main goal of the conference will be to enable the members of congress to gain tools of thought, conception and action in order to help them in defining, driving, and implementing their own local project of change in their own care projects by medical teams, nurses and managers. The main theoretical and academical models concerning transformation of care organisation and the implementation of change in mental health will be presented.

It will be followed by a confrontation of actual down to earth experiences, regional, territorial or carried out by health establishments, adapting or transforming health supply offered to the citizens.

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