IMPROVING ACCESS TO ESSENTIAL FOR CIRCULATORY DISEASES A CALL TO ACTION IMPROVING ACCESS TO ESSENTIAL MEDICINES FOR CIRCULATORY DISEASES

2 A CALL TO ACTION WORLD HEART FEDERATION

ACKNOWLEDGEMENTS

The World Heart Federation would like to thank Professors Salim Yusuf and Martin McKee for their outstanding co-chairing of the 3rd Global Summit on Circulatory , as well as the speakers at and contributors to the event for the fruitful discussions and insightful presentations that have 3 shaped this paper, and for their work to improve access to essential medicines for cardiovascular diseases. We would also like to thank our partners Access Accelerated, Amgen, Novartis, Pfizer, CONTENTS Boehringer Ingelheim and Sanofi for making the 3rd Global Summit possible. Writer and project coordinator: Oana Scarlatescu EXECUTIVE SUMMARY 4 Reviewers: Pablo Perel, Sharon Mitchell, Andrea Vassalotti, Jean-Luc Eiselé.

PART 1: TAKING STOCK OF Design: MINT© designbymint.com ACCESS TO ESSENTIAL MEDICINES 6 ©World Heart Federation Why access to essential cardiovascular medicines matters 8 Suggested citation: Improving Access to Essential Medicines for Circulatory Diseases: The real-world impact of lack of access to medicines 10 A Call to Action. Geneva, Switzerland. World Heart Federation. 2019.

You may copy, redistribute and adapt the work for non-commercial purposes, provided the work PART 2: CHALLENGES AND is appropriately cited, as indicated above. In any use of this work, there should be no suggestion OPPORTUNITIES IN ENSURING ACCESS that the World Heart Federation as a whole endorse any specific organization, product or service. The use of the logo of the World Heart Federation is not permitted. If you create a translation of TO CARDIOVASCULAR MEDICINES 11 this work, you should add the following disclaimer along with the suggested citation: Financing 12 “This translation was not created by the World Heart Federation.” Governance 12 The World Heart Federation is not responsible for the content or accuracy of this translation. The Monitoring and Evaluation 14 original English edition shall be the binding and authentic edition”. The World Heart Federation Education and Awareness 14 has taken all reasonable precautions to verify the information in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. Health Workforce 15 The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Heart Federation be liable for damages arising from its use. PART 3: TAKING ACTION 16 Streamlining access to essential medicines 18 We thank our sponsors for making the 3rd Global Summit on Investing in health care professionals 19 Circulatory Health possible. Rethinking health financing 20 Harnessing innovation 21

CONTENTS EXECUTIVE SUMMARY BACKGROUND CHALLENGES AND OPPORTUNITIES TAKING ACTION IMPROVING ACCESS TO ESSENTIAL MEDICINES FOR CIRCULATORY DISEASES EXECUTIVE SUMMARY Only 9% reduction in the burden of CVD 2 2 billion mortality lack access to in low- and middle- essential medicines income countries

Up to Together, heart disease, stroke and diabetes 60% caused more than in low- and middle-income countries cannot afford 20 million cardiovascular medicines7 annual deaths 4

e are at a crossroads What is more, on average, only Access to essential medicines in the prevention 38 percent of essential medicines for CVD is not high on the global and control of are available in the health agenda, despite circulatory systems in low- and middle-income diseases* being the number cardiovascular countries.4 Medicines account one killer and cause of disability diseases (CVDs) and for up to a quarter of the global worldwide, as well as the cause of Wother circulatory diseases. health expenditure, with LMICs debilitating health costs. Together, In almost three decades, allocating between 20-60 percent of heart disease, stroke and diabetes 5 between 1990 and 2017, health expenditure on medicines. caused more than 20 million annual To put these figures further into deaths and accounted for almost high-income countries context, 70 percent of the global half a billion disability-adjusted have reduced the burden population resides in 105 low- and life years (DALYs) in 2016.8 Of those, of CVD-induced mortality, middle-income countries; the latter cardiovascular diseases alone claim as expressed in Disability shoulder most of the global burden 17.9 million lives every year, cost the Adjusted Life Years, by 30 of disease.6 world USD$ 957 billion in 2015 in percent1. Part of this success productivity losses and treatments, and are set to cost approximately As staggering as these statistics lies in ensuring access to USD$ 1,044 billion to manage are, they can obscure gaps in affordable and quality globally by 2030.9 essential medicines for CVD. access to essential medicines for cardiovascular and other circulatory diseases. One of the largest * defined here as diseases that By contrast, low- and middle- epidemiological studies globally, affect the circulatory system income countries (LMICs) have the Prospective Urban Rural achieved only a 9 percent Epidemiology (PURE) study, reduction.2 Not surprisingly, an showed that 25 percent of estimated two billion people, households in upper middle- almost one third of the world’s income countries (MICs), 33 percent population, lack access to essential in lower-MICs, and up to 60 percent medicines. Of those, approximately of households in low-middle 50 percent are in and Asia.3 income countries (LICs) cannot afford cardiovascular medicines.7

CONTENTS EXECUTIVE SUMMARY BACKGROUND CHALLENGES AND OPPORTUNITIES TAKING ACTION A CALL TO ACTION EXECUTIVE SUMMARY

Beyond the costs, ensuring access medicines to those who need it to improve health outcomes and to essential, safe and quality the most. Political commitments quality of life. Target 3.4 medicines is a cornerstone of underpinned by investments in strong health systems and of national health systems are key However, for all the reasons SDG 3 progress towards achieving to ensuring access to essential highlighted so far, we have chosen universal health coverage (UHC). medicines. Governments are to make access to essential still the primary coordinators of medicines for cardiovascular and resources and systems in countries Achieving it globally has been circulatory diseases the focus of and exert significant influence at enshrined in the Sustainable this position paper. 1/3 regional and global levels. Development Goals (SDG) framework, in particular in target to reduce by one Therefore, the four pillars are 3.8 to “achieve universal health Therefore, this position paper puts grounded in evidence and are third premature coverage, including financial forward a four-pronged approach globally relevant but take into risk protection, access to quality aimed at national governments mortality account regional or national essential health-care services to improve and expand access differences, align with WHF’s and access to safe, effective, to essential medicines for CVDs. from non- mission and areas of expertise, quality and affordable essential Together, the recommendations and provide value for money. communicable medicines and for under the 4 pillars aim to drive Moreover, the recommendations all.”10 Given the impact of access action and make progress towards diseases build on the World Health to medicines on the health of achieving access to safe, effective, Organization’s (WHO) draft populations and individuals, quality and affordable essential “Roadmap for Access 2019-2030. achieving it has an impact on medicines for heart health by: Comprehensive Support for other SDGs, including SDG 3, Access to Medicines and Vaccines,” target 3.4 to “reduce by one 1. Streamlining access to WHO’s General Programme of third premature mortality from essential medicines in health, Work 2019-2023 and the Lancet non-communicable diseases,” regulatory and surveillance Commission Report on Access to SDG 1 to “end poverty in all systems; Medicines 2017. its forms,” SDG 4 to “ensure inclusive and equitable quality of 2. Investing in and building education and promote lifelong the capacity of health care Leading up to the learning,” SDG 5 to “achieve professionals; recommendations, Section gender equality and empower 3. Rethinking health financing 1 of the paper takes stock of Target 3.8 all women and girls,” SDG 8 to through win-win-win taxation; access to medicines in general 5 “promote sustained, inclusive and 4. Harness innovations for access and to essential medicines SDG 3 sustainable economic growth, to essential medicines. for cardiovascular diseases in full and productive,” and SDG 10 particular, and Section 2 highlights to “reduce inequality within and challenges and opportunities in achieve universal among countries”. 11 While we look at Ministers of ensuring access and brings the health coverage (...) Health, Finance, Education stories of patients, programmes and Labour to take forward and initiatives alongside the The World Heart Federation including access the recommendations, we scientific and policy literature. (WHF) and its members believe acknowledge the role of national to safe, effective, in a world where heart health and international civil society, is a fundamental human right academia, and the private sector quality and for everyone and a crucial in supporting and initiating access affordable essential element of global health justice. programmes and initiatives. In 12 Global health justice cannot addition, while we acknowledge medicines be achieved without access that ensuring access to medicines to essential medicines for relies on transparent supply chains circulatory diseases. and procurement practices, on We acknowledge that ensuring sound research and development, access to safe, effective and on the enforcement of anti-graft quality essential medicines is a legislation, and on calibrating complex and multidimensional pricing policies, these aspects undertaking. It depends on the are beyond both the scope of strength and financing of health this paper. systems, the running of supply chains, the appropriateness of the selection, prescribing Moreover, we recognize that and use of drugs, and on the ensuring access to essential quality of medicines, to name medicines must be complemented just a few key factors. Common by access to health technologies. denominators, however, are Without technologies, health the overall policymaking and systems cannot provide the right policy strategies that underpin screening, diagnosis, rehabilitation the process of getting the right and palliative care that are needed IMPROVING ACCESS TO ESSENTIAL MEDICINES FOR CIRCULATORY DISEASES

TAKING STOCK OF ACCESS TO ESSENTIAL MEDICINES

6

CONTENTS EXECUTIVE SUMMARY BACKGROUND CHALLENGES AND OPPORTUNITIES TAKING ACTION A CALL TO ACTION BACKGROUND

TAKING STOCK OF ACCESS TO ESSENTIAL MEDICINES

rom the diseases,” SDG 1 to “end that up to 90 percent of health 1958 Nairobi poverty in all its forms,” facilities in some countries Conference on the SDG 4 to “ensure inclusive cannot provide a “complete 1. and equitable quality of ‘basket’ of essential medicines Rational Use of education and promote for treating non-communicable Drugs to the 2017 lifelong learning,” SDG 5 to diseases (NCDs).”16 FLancet Commission “achieve gender equality on Essential and empower all women and girls,” SDG 8 to “promote Medicines Policies DEFINING ACCESS and the Sustainable sustained, inclusive and sustainable economic Development Goal 3.8 growth, full and productive,” (access to safe, effective, and SDG 10 to “reduce Essential medicines are “those quality and affordable inequality within and medicines that respond to the essential medicines among countries”.13 priority health needs of a specific and vaccines for all), the population.”* Ensuring access to policy and academic Nevertheless, staggering medicines means “the reliable consensus is clear: statistics highlight the gap and consistent availability of access to essential between policy ideals and appropriate essential, quality the reality on the ground. An medicines at health facilities, medicines is crucial for estimated two billion people, a healthy population almost one third of the the rational prescribing and and is a cornerstone population globally, lack access dispensing of such medicines, of achieving universal to essential medicines. Of those, and ensuring that they are 7 health coverage (UHC). approximately 50 percent are affordable.”** 14 in Africa and Asia. Moreover, on average, only 38 percent of Given the impact of access to essential medicines are available medicines on the health of in the public health systems populations and individuals, in low- and middle-income achieving it has an impact countries (LMICs).15 Even against on other SDGs, including this background of SDG 3.4 to “reduce by one scarcity, the World Health third premature mortality Organization (WHO) suggests from non-communicable

BACKGROUND*Maryam Bigdeli, David Peters and Anita Wagner eds, “Medicines in Health Systems. Advancing Access, Affordability and Appropriate Use,” Alliance for Health Policy and Systems Research and World Health Organization, 2014, 11. **World Health Organization, Report by the Director General, “Addressing the Global Shortage of, and Access to Medicines and Vaccines,” Executive Board 142nd session, EB142/13,12 January 2018, 2. IMPROVING ACCESS TO ESSENTIAL MEDICINES FOR CIRCULATORY DISEASES

Even considering this low availability, medicines ‘WHO’S WHO’ OF ESSENTIAL account for up to a quarter of Global cost MEDICINES the global health expenditure, with LMICs allocating between of CVD is 20-60 percent of health The minimum list of CVD expenditure on medicines.17 estimated medicines and technologies, as to reach defined in WHO’s Global Action More worrying still, for the Plan on Non-communicable majority of the population Diseases (NCDs), includes in low- and middle-income at least aspirin, statin, an countries, purchasing drugs USD$ is the second largest type angiotensin-converting enzyme of expenditure after food.18 inhibitor, a thiazide diuretic, Even when medicines are a long-acting calcium channel accessible, available and 1.4 billion blocker, metformin, insulin, affordable, questions about in 2030 a bronchodilator and a their safety and quality may steroid inhalant.* arise, with an estimated 10 percent of medicines in LMICs believed to be substandard 19 WHO’s Global Action Plan for or falsified. NCDs targets for access to medicines are: WHY ACCESS TO • “At least 50 percent of eligible people receive drug therapy CARDIOVASCULAR DISEASES and counselling to prevent heart attacks and strokes; MEDICINES MATTERS 8 • An 80 percent availability ith non- Disease (GBD) 2015 found Approximately 75 percent of the affordable basic communicable a 12.5 percent increase of CVD is attributable to technologies and essential diseases in the global burden of modifiable risk factors such medicines, including as high blood pressure, on the rise mortality attributable to generics, required to treat diabetes, high cholesterol nationally and CVD in the past decade.22 major non-communicable and obesity, tobacco use, Wglobally, there is an even alcohol consumption, physical diseases in both public and stronger case to make activity and unhealthy diet.25 private facilities; Diseases that affect the for providing access to circulatory system, such Moreover, an estimated 20 percent of deaths occur in essential medicines. In as CVDs and related co- morbidities, are not only individuals who had been • A 25 percent relative reduction 2016, NCDs claimed diagnosed with cardiovascular in the prevalence of raised 41 million lives, the the world’s number one cause of death, but also of diseases, which highlights the blood pressure or contain equivalent of 71 percent disability. Indeed, the global need for access to safe and the prevalence of raised of the 57 million deaths burden of CVD, diabetes and effective essential medicines 26 blood pressure, according to registered worldwide that kidney diseases, expressed for CVD. national circumstances.” ** year. Of the four main in disability-adjusted years NCDs — cardiovascular (DALYs), amounted to almost Indeed, the management of half a billion years in 2016.23 diseases, , chronic CVD relies on medicines. Circulatory diseases carry For example, respiratory diseases, and a hefty price tag as well. to control hypertension is diabetes — heart diseases The global cost of CVD is key, especially considering accounted for 17.9 estimated to reach USD$ that an estimated 62 million deaths and were 1.4 billion in 2030 in both percent of deaths caused by particularly devastating in direct healthcare expenditure cerebrovascular conditions and losses to productivity and 49 percent of those cause low- and middle-income because of disability or 20 by ischemic heart disease may countries, where premature death.24 have been preventable with approximately 80 percent an appropriate control 27 of all CVD deaths are However, circulatory diseases of blood pressure. 21 occurring. Moreover, need not be synonymous the Global Burden of with global death, disability and financial losses.

CONTENTS EXECUTIVE SUMMARY BACKGROUND CHALLENGES AND OPPORTUNITIES TAKING ACTION A CALL TO ACTION BACKGROUND

Despite the global burden of The PURE study also explored medicine cost on average 2.0 death and disability linked to The four CVD medicines the associations between days wages and one originator cardiovascular diseases, access were available in socioeconomic status and brand CVD costs on average 8.3 to essential medicines for the risk of CVD in 20 countries at days wages for the lowest paid 95% of urban communities prevention and treatment of different levels of development, government worker.”33 90% of rural CVD remains challenging. One and found that lower levels in high-income countries, of the largest epidemiological of education correlated with Indeed, across different regions undertakings globally provides 80% of urban reduced access to medication of the world, the discrepancy compelling evidence in that 73% of rural for raised blood pressure, between who has access to respect. in middle-income countries, diabetes or secondary medication and who does not 62% of urban prevention.31 is significant. Data gathered at 42% of rural The Prospective Urban Rural household level in Cambodia, in lower-middle-income Epidemiology (PURE) surveyed The evidence on inequities Colombia, Iran, , South countries.29 pharmacies from 18 countries and inequalities in access to Korea and USA indicated that in 2013 to assess the availability The four medicines were essential medicines for CVD is close to 66 percent of people and cost of four cardiovascular unaffordable to0.14 % of mounting beyond the PURE in high-income countries had medicines (aspirin, Beta blockers, households in high-income study. A study conducted by access to treatment for high angiotensin-converting enzyme countries, 25% of upper middle- Health Action International and blood pressure, compared to inhibitors, and statins). What it income countries, 33% of lower WHO found that, in the majority less than 50 percent in LMICs.34 found was significant gaps in middle-income countries, 60% of the 70 countries surveyed, availability and affordability of of low-income countries and cardiovascular medicines were 30 Not surprisingly, several medicines between rural and 59% of households in . outside the financial reach of literature reviews conducted urban communities and between many households,32 particularly in the past five years have low- and high-income in low-income settings. For found that oncology and settings. 28 example, “in the public CVD patients face the highest sector, a 1-month burden of catastrophic health supply of one expenditure because of out- generic of-pocket expenses.35 This CVD further emphasizes the need for access to medicines in the prevention, treatment and management of CVDs, to avoid or diminish the impact of out- 9 of-pocket health expenses. This will be particularly important considering the epidemiological transition that we are experiencing from communicable to non-communicable diseases,36 which has implications for CVD.

Indeed, cardiovascular diseases are becoming more prevalent as populations age, lifestyles become more sedentary, diets unhealthier and higher in sugar and salt, and risk factors such as raised blood pressure, alcohol and tobacco consumption and obesity become more widespread.37

*World Health Organization, “Essential Medicines And Basic Technologies for Noncommunicable Diseases: Towards a Set of Actions ti Improve Equitable Access in Member States,” WHO Discussion Paper, 2 July 2015, 7. **World Health Organization, “Global Action Plan for the Prevention and Control of Noncommunicable Diseases 2013-2020, 2013, 40.” IMPROVING ACCESS TO ESSENTIAL MEDICINES FOR CIRCULATORY DISEASES

A GLIMPSE INTO THE REAL WORLD: IMPACT OF LACK OF ACCESS TO ESSENTIAL MEDICINES BREAKING THE GENERATIONAL HOLD OF CHAGAS DISEASE THROUGH TREATMENT

Francisca is 40 and lives in the newborn son and the test came have health insurance. Eventually United States (US) but she is back positive, so he successively she found a doctor who worked originally from . received the treatment and is now with many Chagas patients a healthy young boy. Francisca and who helped her access the did not know at the time but the treatment called benznidazole. Her second son was born treatment for Chagas Disease has This was very important for prematurely and was very sick few side effects for babies and Francisca because she may want but the doctors in the US did worked very well at curing the to have another child one day not know why. Francisca’s uncle, disease for life. She also wanted and getting treatment would who is a doctor in Brazil, told her to take the treatment for Chagas greatly reduce the risk of she should ask about Chagas but she couldn’t find a doctor having another baby born with Disease. They tested her tiny, to treat her because she did not the disease.38 GIVING A CHILD WITH RHEUMATIC HEART DISEASE A SECOND CHANCE

Lilian is the mother of a young and did not eat much. In the end, Lilian’s daughter deteriorated receive the first 2 months supply of girl and lives in a village in Lilian had no choice but to make further and stayed in bed all the the medication. However, Lilian’s Western . the trip to the clinic. Once there, time. Lilian went back to see the daughter will need to take the she waited in the queue all day nurse in the community health medication for at least 5 years. This until the nurse listened her child clinic but was told there was will mean many long trips back to One day, she saw a poster at the with a stethoscope and said there nothing they could do for her the city, which will take up much of community health clinic in the 10 was something wrong with her daughter because there was Lilian’s time and the household’s next village which said she should heart. The nurse told Lilian that something wrong with her heart, income and leave the family come to the clinic if her child had her child needed the penicillin and that she needed to take the struggling to meet their basic fever, as it could be . She medication but that she did not penicillin to stop it from getting needs at the end of each month. also saw a sign which said that a have it at the clinic; it was only worse. Eventually Lilian took a sore throat can damage the heart. available in a city 100 km away. bumpy, 5-hour long bus ride to the In only a matter of days, Lilian’s But at least her daughter has city, where she waited all day at little girl developed a sore throat. been given a chance to reach the clinic with all the other people But Lilian could not make the trip Lilian realized that it would cost adulthood. The long course of needing to see the one doctor. to the village because she had to too much for her and her little girl medication, the cost involved, and work in the field. to travel to the city by bus and that the damage already done to the she would have to wait for several The doctor prescribed penicillin heart could have been avoided days for a doctor to see them at a once a month for 5 years to stop if she had received the correct Over the next months the child public hospital. In any case, Lilian the progression of the rheumatic diagnosis and treatment for her suffered on and off from a fever would not be able to travel for long heart disease Lilian’s daughter had sore throat. and also aches and pain in the because her other child needed developed from her sore throat joints. Then she started to have care and her husband works all many months before. Luckily, difficulty breathing and she could day every day. the hospital had it in stock and only watch the other children play Lilian’s daughter was able to LIVING WITH HYPERTENSION IN A REMOTE VILLAGE Maria worked hard all her short drive her to the nearest village thought it was safe to stop taking preventable had she been life. She had been living off the with a community health center. the . near a health center and could land, as generations before afford medication to keep her her, and had not given much hypertension in check. There she was told that she had Even if she wanted to continue thought to doctors and hospitals. high blood pressure and that the treatment, she did not have She did not have one near her she was at risk of stroke or heart the money and could not afford anyways, nor did she have the disease if she did not start taking to travel to the community money for regular check-ups. medication. Maria was given a health center. Not even a year After six months of suffering with prescription but only had the later, Maria had a stroke caused unbearable headaches, frequent money for a couple of weeks of by her uncontrolled high dizzy spells, fatigue and chest treatment. After the first week, blood pressure, an outcome pain, she begged a neighbor to she started feeling better and that could have been entirely

CONTENTS EXECUTIVE SUMMARY BACKGROUND CHALLENGES AND OPPORTUNITIES TAKING ACTION A CALL TO ACTION CHALLENGES AND OPPORTUNITIES

CHALLENGES AND OPPORTUNITIES IN ENSURING ACCESS TO MEDICINES FOR CIRCULATORY DISEASES

11 IMPROVING ACCESS TO ESSENTIAL MEDICINES FOR CIRCULATORY DISEASES

CHALLENGES AND OPPORTUNITIES IN ENSURING ACCESS TO MEDICINES FOR CIRCULATORY DISEASES

hallenges abound Insufficient or inappropriate at high risk of CVD plus measures in ensuring access public financing for health, to prevent ” to essential especially for CVDs and other — is estimated to cost only 2. NCDs, stands out as the main USD$ 2.5 dollars per person a medicines in barrier to ensuring a basket of year in upper-middle income general and essential medicines. Households countries,40 less than USD$ Cto CVD and other in low- and middle-income 1.5 dollars in middle-income circulatory diseases countries are forced to make countries and USD$ 1 dollar per drugs in particular. difficult choices about whom person in low-income countries. gets treatment for which disease These figures put in context As mentioned in the and for how long, and often why health investments are introduction, this face catastrophic expenditure smart investments. position paper focuses when confronted with health on those challenges that emergencies or long-term are within the purview of treatment for chronic diseases. governments to address Indeed, WHO estimates that WHO estimated that USD$ 1 low-income households in put towards the Best Buys will but acknowledges developing countries spend generate a return of at least the importance of up to 10 percent of their USD$ 7, reduce premature multi-sectoral and total income on medicines,39 mortality by 15%, prevent 17 multi-partnership compared to the 3.5 percent million case of ischemic heart approaches. that poorer households in high- disease and stroke, save 8.2 income countries spend million lives in LMICS and bring 12 on medicines. USD$ 350 billion in economic Therefore, this section 41 growth — all by 2030. highlights health governance and financing, surveillance These statistics are striking, systems, workforce capacity, but they could also become a gaps in innovation uptake, footnote of history, especially and low health awareness for cardiovascular diseases, and education as key pain provided that the right points and showcases investments are made in case studies of initiatives healthcare. Indeed, providing trying to address some of WHO’s “best buys” — namely “a these challenges. multi-drug regime for individuals

CHALLENGES

CONTENTS EXECUTIVE SUMMARY BACKGROUND CHALLENGES AND OPPORTUNITIES TAKING ACTION A CALL TO ACTION CHALLENGES AND OPPORTUNITIES

NOVEL ORAL ANTICOAGULANTS (NOACs)

Novel oral anticoagulants example is warfarin. The confer a lower risk of bleeding, The MPP is a public health (NOACs) are blood number of people with NVAF have fewer interactions with organization that negotiates thinners used to reduce are on the rise in low- and other medications and fewer licensing middle-income countries and dietary restrictions. agreements with the risk of stroke in is estimated to reach 17.8 holders to allow generic people with non-valvular million by 2020, and at least Nevertheless, the use manufacture and supply of atrial fibrillation (NVAF) – 6 million cases of venous of NOACs in LMICS has patented medicines in LMICs. a common heart rhythm thromboembolism annually. generally remained very MPP licensing for the NOACs disturbance. They are limited. Low availability could potentially contribute and unaffordable prices are to increasing their availability also used by people One of the most important reported as being major and improving affordability advantages of NOACs over who have previously barriers to their wider in LMICs. Given the lower warfarin is that they do not suffered venous use. With the inclusion of monitoring requirements require regular monitoring, thromboembolism NOACs in the World Health of NOACs over alternatives, due to significantly more Organization’s Model List of this could enable more to reduce the risk of stable and predictable Essential Medicines (WHO people in need to access recurrence. pharmacokinetics and EML) in 2019, there is a real anticoagulation therapy, pharmacodynamics. This opportunity to scale up their therefore reducing the risk of In both cases, NOACs are may be particularly important use. Licensing the NOACs strokes and other sometimes now preferred in the United in resource limited settings, to the Medicines Patent fatal complications in LMICs. States and Europe over an where access to regular Pool (MPP) could contribute older class of anticoagulants monitoring (which is required to making such medicines — vitamin K antagonists — of with warfarin) can be limited. available sooner at which the most widely used In addition, NOACs likely affordable prices in LMICs. A TALE OF TWO PUBLIC-PRIVATE PARTNERSHIP PROGRAMMES FOR 13 ACCESS TO NCD MEDICINES IN KENYA In Kenya, 27 percent of Kenya, looking specifically at diabetes care for individuals deaths among adults aged the “availability and price of living on low-incomes in LMICs between 30 and 70 years portfolio medicines at health, in 28 of Kenya’s 47 counties, irrespective of brand, and and capped the price of a old are caused by non- availability of medicines at insulin viable at USD$ 5. An communicable diseases, patient households.”42 The 2019 evaluation showed that making access to essential evaluation indicated that the project was successful medicines for NCDs a Novartis Access had little in ensuring a “stable and In Kenya critical issue. This is also impact on the availability and affordable insulin supply,” cost of medicines for chronic especially compared with considering that many diseases in health facilities and the unpredictable supply in of the patients end up at household level. This may counties in which the BOP paying for the medicines suggest that lowering prices project was not implemented. out-of-pocket. is not enough and that other However, as with the Novartis 27% factors, including awareness Access program, Novo of deaths around access programmes, Nordisk’s BOP project revelead Against this background, extension to private sector Novartis launched its Access that reduced cost is not the among adults facilities and navigating the only factor in ensuring access programme in the country complexities of the health aged between to provide a basket of NCD to medicines. Many benefiting system — may equally from BOP still fell short of 30-70 are medicines — including for CVD, influence access to medicines. type 2 diabetes, respiratory access to the comprehensive caused by non- illnesses and breast cancer care they needed, including — at the price of USD$ 1 per Similarly, Novo Nordisk medicines, because of the high communicable treatment per month. 15 implemented its Base of the costs of medical follow-up and 43 months after the launch of the Pyramid (BOP) project, travel to health facilities. diseases programme, its impact was a public-private partnership evaluated in eight counties in designed to increase access to

*Access to Medicines, Lancet Global Health, 385. IMPROVING ACCESS TO ESSENTIAL MEDICINES FOR CIRCULATORY DISEASES

aking the right investments for access to medicines depends on good leadership, strong regulation and appropriate governance for health. The reality in many countries, however, is contrary to these aspirations. Fragmentation in decision-making, work in silos, regulations lacking monitoring and enforcement, lack of transparency, corruption and inappropriate alignment between health needs and policies are just a few of the issues plaguing health systems and hampering concrete actions to ensure a consistent basket of essential medicines. Particularly concerning is the issue Mof substandard and falsified medicines, whose global prevalence is estimated at 13.6 percent and regional prevalence at 18.7 in Africa and 13.7 in Asia respectively.44

Even when efforts are made Another systemic challenge in HARNESSING DIGITAL to improve governance, MAKING HYPERTENSION ensuring access to essential policies and regulations at medicines for circulatory SOLUTIONS AGAINST national levels, gaps persist in AND DIABETES DRUGS diseases is the level of monitoring and evaluating education and health FALSIFIED MEDICINES how those are implemented on AVAILABLE AND awareness. For example, when Across the world, entrepreneurs the ground and how access to examining the association working at the nexus of health essential medicines and health AFFORDABLE IN BRAZIL between education, wealth and and technology are creating outcomes is, thus, impacted. With non-communicable risk of cardiovascular diseases in innovative products to fight fake In the cardiovascular field, for diseases on the rise in Brazil, 20 low-income, middle-income or substandard medicines. In example, what is also lacking is the government established the and high-income countries, Nigeria, for example, a company a clear understanding of the real Farmacia Popular programme in the PURE study found that called RxAll is using artificial burden of access to medicines 2004 to address the insufficient individuals with low levels of intelligence and a portable and of surveillance systems stock of medicines in the public educations had higher rates nanoscanner to test the quality around the continuum of care. sector and the high prices in of cardiovascular events and of drugs and protect patients This is because, in many LMICs the private sector. One of the encountered more barriers to from life-harming substandard for example, primary healthcare milestones of the programme accessing healthcare, especially medicines. Once the drug is facilities “do not have room for came in 2014, when it started in low-income countries.49 scanned, the information is cardiovascular diseases and providing for free diabetes and cross-referenced with data in only have few blood pressure- hypertension medicines to Beyond the PURE study, there the company’s cloud database, measuring devices. If monitoring patients who went to public or is mounting evidence that low and its quality and authenticity access to diagnosis is not private pharmacies affiliated to 47 levels of education and health is verified. The founder of RxAll possible, it becomes difficult to the programme. Going beyond literacy correlate with adverse 14 was inspired in his fight against monitor access to medicines.”46 public sector pharmacies to falsified medicines by his own include private retail pharmacies, health outcomes, increased near-death experience; in 2004, Farmacia Popular had built an mortality rates, and challenges RxAll’s founder spent 21 days in a impressive network of 25,200 in navigating health systems coma caused by a fake drug.45 private-sector pharmacies and and interacting with health 50 558 public sector ones by 2013, professionals at all levels. albeit the majority of them in more prosperous regions of the country, and had reached more than six million people with medication for diabetes and more than 14 million people with medicines for hypertension for 80 percent of the period of the treatment.48

CONTENTS EXECUTIVE SUMMARY BACKGROUND CHALLENGES AND OPPORTUNITIES TAKING ACTION A CALL TO ACTION CHALLENGES AND OPPORTUNITIES

Under-staffed, under-funded and in many settings under-trained COMMUNITY-LED and under-valued, the health workforce is key to ensuring good PROJECT AGAINST health, but it is in crisis. Indeed, a shortage of 18 million health HYPERTENSION IN workers, the majority in low- and middle-income countries, is NIGERIA (CLUB-MEDS) estimated until 2030. 51 Nigeria is facing one of the highest prevalence rates of hypertension in the world, with much of it Addressing this will require not uncontrolled because of “low only considerable investments in motivation and social support 52 recruiting new health workers to medication adherence, long but also a shift in the way distance to healthcare facilities, health professionals at all levels long waiting time and under- are trained and in how their dispensing of drugs.”* competencies are mapped, evaluated and thought The CLUB MEDS pilot project through for the best health is tackling hypertension with outcomes and optimal access community groups such as to essential medicines. adherence clubs, supported by community health workers and Among the challenges linking facility nurses. The adherence 15 the health workforce with access clubs are centered around to medicines is the appropriate role-model patients who receive dispensing of and advice for the training to: use of essential medicines, which remains difficult in many low- 1) support and educate the group income settings. Moreover, some about adherence; low-income countries face rates of absenteeism of between 35 to 2) collect and deliver BP 68 percent among public sector medication refills, conduct BP health workers.53 With challenges measurements; and come opportunities, however. For 3) screen for alert signs during the example, WHO is developing a monthly club sessions. Global Competency Framework for Universal Health Coverage that will map the key competencies 104 people with hypertension required for health workers have been recruited from urban to make UHC possible in their and rural sites and nine role- countries and to meet both the model patients trained to lead changing educational needs and the nine adherence clubs. Seven the epidemiological shifts.53 of the clubs are run in urban sites and two in rural areas and each club brings together a maximum of 13 patients. Their meetings are currently ongoing; data on adherence and control of blood pressure will be collected at six months.

*World Heart Federation Emerging Leaders Program. CLUB MEDS World Congress of Cardiology Poster, December 2018. IMPROVING ACCESS TO ESSENTIAL MEDICINES FOR CIRCULATORY DISEASES

16

TAKING ACTION

CONTENTS EXECUTIVE SUMMARY BACKGROUND CHALLENGES AND OPPORTUNITIES TAKING ACTION A CALL TO ACTION TAKING ACTION

TAKING ACTION

he‌ World Heart effective, quality and affordable Therefore, the four pillars Federation (WHF) essential medicines for heart are grounded in evidence and its members health by: and are globally relevant but 3. take into account regional believe in a world or national differences, align T where heart health 1. Streamlining access to with WHF’s mission and areas is a fundamental human essential medicines in health, of expertise, and provide right for everyone and a regulatory and surveillance value for money. Moreover, crucial element of global systems; the recommendations health justice. Global 2. Investing in and building build on the World Health Organization’s (WHO) draft health justice cannot be the capacity of health care professionals; “Roadmap for Access 2019- achieved without access 2030. Comprehensive Support to essential medicines 3. Rethinking health financing for Access to Medicines and for circulatory diseases. through win-win-win taxation; Vaccines,” WHO’s General Programme of Work 2019-2023 4. Harnessing health and the Lancet Commission technologies. We acknowledge that ensuring Report on Access to access to safe, effective and Medicines 2017. quality essential medicines is a While we look at Ministers of complex and multidimensional Health, Finance, Education undertaking. It depends on the and Labour to take forward strength and financing of health the recommendations, we systems, the running of supply acknowledge the role of 17 chains, the appropriateness national and international civil of the selection, prescribing society, academia, and the and use of drugs, and on the private sector in supporting and quality of medicines to name initiating access programmes just a few key factors. Common and initiatives. In addition, while denominators, however, are we acknowledge that ensuring the overall policymaking and access to medicines relies on policy strategies that underpin transparent supply chains and the process of getting the right procurement practices, on sound medicines to those who need it research and development, on the most. Political commitments the enforcement of anti-graft underpinned by investments in legislation, and on calibrating national health systems are key pricing policies, these aspects to ensuring access to essential are beyond both the scope of medicines. Governments are this paper. still the primary coordinators of resources and systems in countries and exert significant Moreover, we recognize influence at regional and that ensuring access to global levels. essential medicines must be complemented by access to health technologies. Therefore, this position paper Without technologies, health puts forward a four-pronged systems cannot provide the approach aimed at national right screening, diagnosis, governments to improve and rehabilitation and palliative expand access to essential care that are needed to improve medicines for circulatory health outcomes and quality diseases. Together, the of life. However, for all the recommendations under the reasons highlighted so far, we four pillars aim to drive action have chosen to make access and make progress towards to essential medicines for achieving access to safe, cardiovascular diseases the focus of this position paper. IMPROVING ACCESS TO ESSENTIAL MEDICINES FOR CIRCULATORY DISEASES RECOMMENDATION 1 STREAMLINE ACCESS TO ESSENTIAL MEDICINES IN HEALTH, REGULATORY AND SURVEILLANCE SYSTEMS

he World Health Organization highlights six components of a well-functioning health system: leadership & governance, health information systems, health financing, human resources for health, essential medical products and technologies, and service delivery. 54 Turning these around, we argue that four of these components — leadership & governance, health information systems, health financing, human resources for health — are central to ensuring equitable access to essential medicines in general and essential medicines for CVD in particular. While financing and human resources will be explored Tin subsequent recommendations, we start by urging governments to strengthen their national health, regulatory and information systems as a pathway to ensuring or to improving access to essential medicines.

Improved health governance is and efforts towards universal • Increase uptake and utilization within the frameworks of the not a lofty ideal but a pragmatic health coverage.” 57 of WHO’s technical guidelines Health Data Collaborative, the approach to address pressing and standards to regulate WHO-Health Action International health issues impacting access Regarding regulation, we for safe and quality essential (HAI) Regional Collaboration for to essential medicines. This is understand that National medicines.59 Action on Essential Medicines in because medicines account Medicines Regulatory Authorities Africa, the Service Availability for up to 60 percent of health are the first line of defense and Readiness Assessment The road to strong health expenditure in some countries,55 against substandard, fake (SARA), the Global Surveillance governance and regulatory meaning that a transparent, or falsified health products, and Monitoring System for systems for access to essential well-governed and well-regulated including essential medicines for Substandard and Falsified 18 medicines is long but having health system is more likely cardiovascular diseases. Similar Medical Products, and the a good surveillance and to prevent waste and ensure to national health systems, shortages notification systems.60 information system in place can access to essential medicines. in-country regulatory agencies act as a map to track and assess Each national health system and systems have strengths progress. This is particularly deals with its own unique and weaknesses unique to their important for CVD, as we are set of challenges. As a global context and history. Across many lacking a comprehensive picture actor connected to its 200 plus contexts, however, they are under- of access to essential medicines to national and regional members, staffed and under-resourced. prevent and treat heart diseases. WHF cannot be prescriptive Not surprisingly, an estimated We acknowledge that making in its recommendations 70 percent of national regulatory any recommendations about and understands that what agencies globally cannot meet surveillance and information works in a country may not their core mandate. systems means factoring in the be relevant in another or contradictory realities of either across different geographies Therefore, WHF calls on limited in place of the same state. What we national governments to: or a proliferation of competing, are recommending, however, fragmented and inefficient is a health system approach • Submit health products, surveillance systems nationally, that calls for governments to including essential medicines regionally and globally. examine bottlenecks to access for CVD, to WHO’s pre- to medicines throughout their qualification program, and countries’ health infrastructure harness the potential of the Therefore, we recommend and across “the interconnections national Essential Medicines governments to assess the between system components.”56 List for CVD; extent to which their current information and surveillance • Work with WHO to assess the systems give them an accurate Building on the evidence base strength of their regulatory picture of access to essential from WHO and the Alliance systems through the Global medicines, especially for CVD for Health Policy and Systems Benchmarking Tool; and NCDs, and to build, improve Research, we advocate for or revamp their information “access to medicines and • Report progress in their infrastructure accordingly. their appropriate use as an countries against the We also strongly encourage explicit focus in health indicators of WHO’s Global national governments to work systems strengthening Monitoring Framework on NCDs; as much as possible with WHO

CONTENTS EXECUTIVE SUMMARY BACKGROUND CHALLENGES AND OPPORTUNITIES TAKING ACTION A CALL TO ACTION TAKING ACTION RECOMMENDATION 2 INVEST IN & BUILD CAPACITY OF FRONTLINE HEALTH WORKERS FOR IMPROVED ACCESS TO ESSENTIAL MEDICINES

rontline health care into lack of access to essential • Support task shifting and guidelines on the prevention, professionals — i.e., medicines. For these reasons, it empower “non-specialized management and treatment community health is crucial to invest in the health workers to prescribe priority of cardiovascular diseases workforce as a key pathway to interventions,” especially in and other non-communicable workers, nurses or improving access to medicines. under-served, remote or diseases, and disseminate physicians — are the rural areas; 62 them to health workers at Ffirst to initiate diagnosis all levels; • Include learning modules and treatment, dispense We urge governments — and in particular Ministers and skills building relevant to • Support the medicines and make of Health, Finance, Education access to essential medicines recommendations of the referrals. As such, their role and Labour — to: in the education curricula of High-Level Commission on is key in ensuring rational health care professionals, Health Employment and • Make appropriate including in rural and under- Economic Growth and of the dispensing and improving investments in recruiting, adherence to treatment. served areas; World Health Organization’s retaining, incentivizing and Global Strategy on Human • Incorporate lifelong learning training health workers Resources for Health 2030. and training for health In remote, rural or low-income and ensure their equitable workers on access to essential areas, where health facilities are distribution across their medicines, appropriate scarce, frontline health workers countries and health systems, 61 dispensing, rational use and covering large areas may be the and especially in low- adherence to treatment; only link that people living there income, remote and 19 have with the health system. And rural settings; • Streamline access to essential in many settings, lack of access medicines in national to a health worker translates IMPROVING ACCESS TO ESSENTIAL MEDICINES FOR CIRCULATORY DISEASES RECOMMENDATION 3 RETHINK HEALTH FINANCING FOR ACCESS TO ESSENTIAL MEDICINES THROUGH WIN-WIN-WIN TAXATION

roviding WHO’s best • Alcohol consumption leads to an Policy for Health suggests that policies on tobacco and sugar- buys, namely a basket estimated 3 million deaths every raising excise taxes on unhealthy sweetened beverages respectively, of medicines for those year, representing 5 percent of commodities benefit the young shows that taxation can have win- deaths worldwide; and low-income consumers the win-win outcomes for the health at risk of CVD and a • Overweight, obesity and diabetes most. This is because low-income of populations, both in terms of prevention package combined kill an estimated households tend to have the preventing NCDs and reducing Pfor cervical cancer, is 6.1 million people every year. highest consumption of tobacco the consumption of unhealthy estimated to cost only USD$ Unhealthy diets, rich in processed and sugary drinks and shoulder commodities, and for a country’s 2.5 dollars per person a year foods and added sugars, the heaviest burden of health and revenue streams. The Philippines, economic consequences.70 for example, used the tax revenues in upper-middle income contribute significantly to obesity and diabetes.65 to “almost triple the health countries, less than USD$ coverage of low-income citizens Mounting evidence from the 1.5 dollars in middle-income and subsidize the insurance Philippines and Mexico, which have countries and USD$ 1 dollar Unhealthy commodities do not coverage of senior citizens. 71 implemented successful excise tax per person in low-income only significantly impact people’s 63 health but also cause substantial countries. economic losses to countries. Estimates show that smoking Harnessing the potential of cost the global economy USD$ EFFECTIVE FISCAL POLICIES AND fiscal policies is a field ripe with 1.4 trillion in 2012, including 20 opportunities, especially since the expenditure associated with estimates that only 50 smoking-induced diseases and INVESTMENTS IN HEALTH COULD REDUCE percent of developing countries productivity losses; similarly, are successful in raising taxes that alcohol consumption generated THE HEALTH FINANCING GAP FROM are equivalent to 15 percent of their losses equivalent to one percent gross domestic product, and that of the GDP in middle- and high- a combination of effective fiscal income countries in 2009.66 policies and investments in health could reduce the health financing The Task Force on Fiscal Policy for USD$ 176 BILLION gap from USD$ 176 billion to Health found that a 50-percent between USD$ 114 and 122 billion increase in excise taxes on TO BETWEEN by 2030. 64 tobacco, alcohol and sugar- sweetened beverages by all The World Heart Federation countries would save 50 million USD$ 114 AND 122 BILLION urges Governments to raise people from premature deaths excise taxes on unhealthy over the next 50 years and add BY 2030 products such as tobacco, USD$ 20 trillion in additional alcohol and sugar-sweetened revenues.67 Even a smaller, beverages and use those 20-percent increase of excise revenues to increase access to taxes by all countries on the three essential medicines for CVD and categories of unhealthy products INCREASE IN EXCISE TAXES ON other NCDs, strengthen health would save 21 million people and regulatory systems, and from a premature death and TOBACCO, ALCOHOL AND recruit, retain and train health add USD$ 11 trillion in revenues workers at all levels. over a period of 50 years. These SUGAR-SWEETENED BEVERAGES scenarios would significantly 50% benefit low- and middle-income BY ALL COUNTRIES WOULD SAVE Taxing unhealthy commodities countries, where most lives would makes sense from a health be saved. 68 perspective, considering that: 50 MILLION PEOPLE FROM PREMATURE DEATHS • Consumption of or exposure to tobacco accounts for 13 percent Evidence from The Lancet OVER THE NEXT 50 YEARS of annual global deaths Taskforce on NCDs and Economics (8 million people); and the Task Force on Fiscal

CONTENTS EXECUTIVE SUMMARY BACKGROUND CHALLENGES AND OPPORTUNITIES TAKING ACTION A CALL TO ACTION TAKING ACTION RECOMMENDATION 4 HARNESS INNOVATIONS FOR ACCESS TO ESSENTIAL MEDICINES

cross the world, used to shape processes along essential medicines for technologies are the R&D and supply chain circulatory diseases; continuum, governments can harnessed to • Identify, prevent and address no longer ignore the power shortages of essential track and improve and challenges of health medicines for and circulatory supply chains, technologies for access to diseases; Aassist consumers and essential medicines. regulatory agencies in We strongly support the • Test and monitor the quality assessing the quality and harnessing of evidence- of essential medicines. safety of medicines, deliver based digital and mHealth diagnosis, and follow-up solutions to: When considering the with patients to ensure • Provide lifelong learning to recommendations above, adherence to treatment healthcare professionals on Governments are encouraged to also consider the ethical and the appropriate use access to essential medicines, rational use and adherence implications, evidence-base of medicines. to treatment for circulatory and appropriateness of health diseases; technologies and digital From mHealth to digital solutions for each setting. • Raise awareness among initiatives and, in recent years, consumers and patients artificial intelligence being 21 on the use and quality of

MAPPING OF WHF’S RECOMMENDATIONS IN RELATION TO WHO’S ROADMAP ON ACCESS TO MEDICINES AND VACCINES

World Heart Federation recommendations WHO’s Roadmap on Access to Medicines and Vaccines

Streamline access to essential medicines in health, Regulatory systems strengthening regulatory and surveillance systems Assessment of the quality, safety and efficacy/performance of health products through prequalification

Market surveillance of quality, safety and performance

Invest in & build capacity of health workers for improved Appropriate prescribing, dispensing and rational use access to essential medicines

Rethink health financing for access to essential Improving equitable access medicines through win-win-win taxation

Harness innovations for access to essential medicines for CVD Improving equitable access IMPROVING ACCESS TO ESSENTIAL MEDICINES FOR CIRCULATORY DISEASES

ABOUT THE WORLD HEART FEDERATION

WHF is the only CVD of our 200 plus members. commitment to address non-governmental Together, we are working to cardiovascular health at the organization (NGO) end needless deaths from policy level, generate and exposure to tobacco and other exchange ideas, share best in official relations risk factors, lack of access practice, advance scientific with the World Health to treatment, and neglected knowledge and promote Organization (WHO), and conditions like rheumatic knowledge transfer to tackle a member of the NCD heart disease which kills CVD. We are at the heart of Alliance. hundreds of thousands of driving the CVD agenda and children each year. advocating for better heart health — enabling people to WHF works at the international live longer, better and more Across 100 countries, we are and national levels through heart-healthy lives, whoever acting now to build global our own activities and those and wherever they are.

ABOUT THE GLOBAL SUMMIT ON CIRCULATORY HEALTH 22 The Global Summit is an 4. Catalyze action for circulatory Health was launched as the only invitation-only event for health through civil society network of international, regional leaders who are shaping and policy engagement and national organizations advocating for increased the future of circulatory prevention, control and These objectives lead directly to health. It aims to create treatment of all the intended outcomes of the a space where speakers circulatory diseases. Summit, namely to: and participants with diverse experiences — from The 3rd Global Summit explored • Foster greater connectedness governments, international the theme of Access to Essential between participants organizations, academia, Medicines and Technologies and the private sector — • Issue a collective call to action by bringing together influencers in light of the urgent need can network, debate and and leaders from circulatory • Discuss concrete next steps for health and policymaking to place critical issues of programme implementation propose concrete Calls to circulatory health in a wider Action to drive action on global health context while cardiovascular diseases. staying hungry for more ONE SUMMIT, THREE ideas, conversations and The 4th Global Summit (Paris, exchanges. CONTINENTS AND 29-30 August 2019) explores the issue of Innovations in Circulatory Care and The objectives of the Summit COUNTING… Technologies. are to: The first Global Summit, held in 2016 in Mexico City, resulted in 1. Convene and mobilize the first Declaration on Circulatory advocates in circulatory health Health —­ the Mexico Declaration 2. Coordinate stakeholders and — signed by 29 leading global policymakers around shared organizations, including the World goals Health Organization. 3. Campaign for circulatory Following the second Summit, health with a collective voice held in 2017 in Singapore, the and a clear message Global Coalition for Circulatory A CALL TO ACTION WORLD HEART FEDERATION

1 Martin McKee, Oana Scarlatescu, David Wood, Jean-Luc Eisele, Pablo Perel and Salim Yusuf, 38 World Heart Federation, Chagas Disease. “Access to Essential Medicines for Circulatory Diseases: A Call Action,” Global Heart, 13(2019): 143. 39 Wirtz, “Essential Medicine for Universal Health Coverage,” 406. 2 McKee et al, “Access to Essential Medicines.” 40 Wirtz, “Access to Medications,” 2084. 3 World Health Organization, “Access to Medicines: Making Market Forces Work for the Poor;” 41 World Health Organization, “Saving Lives, Spending Less. A Strategic Response to Klaus Michael Leisinger, Laura Faden Garabedian and Anita Katharina Wagner, “Improving Noncommunicable Diseases,” 2018, 3. Access to Medicines in Low- and Middle-Income Countries: Corporate Responsibilities in 42 Context,” Southern Med Review (2012):3. Peter C. Rockers, Richard O Laing, Paul G Ashigbie, Monica A Onyango, Carol K Mukiira, Veronika J Wirtz, “Effect of Novartis Access on Availability and Price of Non-communicable 4 Leisinger et al, “Improving Access to Medicines,” 3. Disease Medicines in Kenya: A Cluster-randomised Controlled Trial,” The Lancet Global 5 World Health Organization, Report by the Director General, “Addressing the Global Shortage Health, 7(2019):1. of, and Access to, Medicines and Vaccines,” Executive Board 142nd Session, EB142/13, 12 43 Geordan D. Shannon, Hassan Hagparast-Bigdoli, Winnie Chelagat, Joseph Kibachio January 2018, 7. and Jolene Skordis-Worrall, “Innovating to Increase Access to Diabetes Care in Kenya: An 6 Hilde Stevens and Isabelle Huys, “Innovative Approaches to Increase Access to Medicines in Evaluation of Novo Nordisk’s Base of the Pyramid Project,” Global Health Action 12(2019):1. Developing Countries,” Frontiers in Medicine, 4 (2018):1-2. 44 Sachiko Ozawa, Daniel R. Evans, Sophia Bessias, Deson G. Hayne, Tatenda T. Wemeke, 7 Veronika Wirtz et al, “Essential Medicine for Universal Health Coverage,” The Lancet Sarah K. Laing et al, “Prevalence and Estimated Economic Burden of Substandard and Commissions, The Lancet, (2017):422 Falsified Medicines in Low- and Middle-Income Countries. A Systematic Review and Meta- 8 Global Coalition on Circulatory Health, “Driving Sustainable Action for Circulatory Health. Analysis,”JAMA Network Open, 4(2018):1. White Paper for Circulatory Health,” September 2018, 4, 7. 45 Jenny Lei Ravelo, “Tech Solutions to Fight Fake Medicines,” Devex, 11 June 2019; Lagos 9 Global Coalition on Circulatory Health, “Driving Sustainable Action for Circulatory Health,” 7. Business School, “LBS Alumnus, Adebayo Alonge, Becomes First African to Win the Hello Tomorrow Global Challenge.” 10 United Nations, “Sustainable Development Goals,” https://sustainabledevelopment.un.org/sdg3. 46 Breakout session on “Monitoring and Surveillance of Access to and Affordability of Essential 11 United Nations, “Sustainable Development Goals.” Medicines and Technologies,” 3rd Global Summit on Circulatory Health, 4 December, 12 World Heart Federation, “Strategy 2018-2020. Because Every Heart Beat Matters,” 2018. Panellists Shiva Raj, Augustin Odili and Abishek Sharma, Moderator Pablo Perel. 13 United Nations, “Sustainable Development Goals.” 47 Wirtz, Essential Medicines for Universal Health Coverage, 446. 14 World Health Organization, “Access to Medicines: Making Market Forces Work for the Poor;” 48 Wirtz, Essential Medicines for Universal Health Coverage, 447. Leisinger et al, “Improving Access to Medicines,” 3. 49 Rosengren et al, “Socioeconomic Status and Risk of Cardiovascular Disease,” 748. 15 Leisinger et al, “Improving Access to Medicines,” 3. 50 Mayagah Kanj and Wayne Mitic, “Health Literacy,” paper presented as a working document 16 World Health Organization, Report by the Director General, “Addressing the Global Shortage,” 6. for discussion at the 7th Global Conference on Health Promotion, “Promoting Health and 17 World Health Organization, Report by the Director General, “Addressing the Global Shortage,” 7. Development: Closing the Implementation Gap,” Nairobi, Kenya, October 2019, 20. 51 18 World Health Organization, Report by the Director General, “Addressing the Global Shortage,” 6. United Nations, High-Level Commission on Health Employment and Economic Growth, “Working for Health & Growth: Investing in the Health Workforce,” 2016, 15. 19 Lukas Roth et al, “Expanding Global Access to Essential Medicines: Investment Priorities for 52 Sustainably Strengthening Medical Product Regulatory Systems,” Globalization and Health Wirtz, “Access to Medications,” 2081. (2018):1. 53 Siobhan Fitzpatrick, “Developing a Global Competency Framework for Universal Health 20 World Health Statistics 2018, “Noncommunicable Diseases and Mental Health,” 7. Coverage,” 6 April 2018. 54 21 Veronika Wirtz et al, “Access to Medications for Cardiovascular Diseases in Low- and Middle- World Health Organization, “Key Components of a Well-Functioning Health System,” 1. Income Countries,” Circulation (2016): 2077. 55 World Health Organization, Report by the Director-General, “Medicines, Vaccines and Health 23 22 Darryl P Leong et al, “Reducing the Global Burden of Cardiovascular Disease, Part 2. Products. Access to Medicines and Vaccines,” Executive Board 144th session Provision Agenda Prevention and Treatment of Cardiovascular Disease,” Circulation (2017): 695-710. Item 5.7, 5 December 2018, 7. 56 23 Global Coalition for Circulatory Health, “White Paper for Circulatory Health,” 7. Maryam Bigdeli et al, “Access to Medicines from a Health System Perspective,” Health Policy and Planning (2013):693. 24 Global Coalition for Circulatory Health, “White Paper for Circulatory Health,” 20. 57 Bigdeli, Peters and Wagner eds, “Medicines in Health Systems. Advancing Access, 25 Global Coalition for Circulatory Health, “White Paper for Circulatory Health,” 9. Affordability and Appropriate Use,” Alliance for Health Policy and Systems Research and 26 Rasha Khatib et al, “Availability and Affordability of Cardiovascular Disease Medicines and World Health Organization, 2014, 13. Their Effect on Use in High-Income, Middle-Income, and Low-Income Countries: An Analysis 58 World Health Organization, Report by the Director-General, “Medicines, Vaccines and Health of the PURE Study Data,” The Lancet (2016): 61. Products,” 9. 27 Wirtz, “Access to Medications,” 2077. 59 World Health Organization, Report by the Director-General, “Medicines, Vaccines and Health 28 Khatib, “Availability and Affordability of Cardiovascular Disease Medicines,” 61; Martin McKee Products,” 10. et al, “Access to Essential Medicines,”. 60 World Health Organization, Report by the Director-General, “Medicines, Vaccines and Health 29 Availability was defined as medicines present at the pharmacy when surveyed. Products,” 8. 30 Khatib, “Availability and Affordability of Cardiovascular Disease Medicines,” 61. Affordability 61 Pablo Perel et al, “Reducing Premature Cardiovascular Morbidity and Mortality in People was defined as the ration of expenditure on medications (cost to patient) to total household with Atherosclerotic Vascular Disease. The World Heart Federation Roadmap on Secondary resources. Prevention,” World Heart Federation, 2015, 103. 31 Annika Rosengren, Andrew Smyth, Sumathy Rangarajan, Chinthanie Ramasundarahettige, 62 World Health Organization, Report by the Director-General, “Medicines, Vaccines and Health Shrikant I Bangdiwala, Khalid F AlHabib et al, “Socioeconomic Status and Risk of Products,” 8. Cardiovascular Disease in 20 Low-Income, Middle-Income, and High-Income Countries: the 63 Wirtz, “Access to Medications for Cardiovascular,” 2084. Prospective Urban Rural Epidemiological (PURE) Study,” The Lancet, 7(2019):749. 64 International Bank for Reconstruction and Development / The World Bank, “High- 32 For the purposes of this paper, we follow the United Nations definition of a household as Performance Health Financing for Universal Health Coverage. Driving Sustainable Inclusive “(…) the arrangement made by persons, individually or in groups, for providing themselves Growth in the 21st Century,” 2019, 5. with food or other essentials for living. A household may be either: (a) a one person 65 household, that is, a person who makes provisions for his own food or other essentials for The Task Force on Fiscal Policy for Health, “Health Taxes to Save Lives. Employing Effective living without combining with any other person to form part of a multi-person household, or Excise Taxes on Tobacco, Alcohol and Sugary Beverages,” April 2019, 6-7. (b) a multi-person household, that is, a group or two or more persons who make common 66 The Task Force on Fiscal Policy for Health, “Health Taxes to Save Lives,” 8. provision for food or other essentials for living, The persons in the group may pool their 67 The Task Force on Fiscal Policy for Health, “Health Taxes to Save Lives,” 3. incomes and have a common budget to a greater or lesser extent; they may be related or 68 unrelated person or a combination of both.” World Health Organization, “Health and the The Task Force on Fiscal Policy for Health, “Health Taxes to Save Lives,” 15. Family. Studies on the Demography of Family Life Cycles and Their Health Implications,” 1978, 8. 69 Jan S, Laba TL, Essue BM, Gheorghe Adrian, Muhunthan J, Engelgau M, Mahal Ajay et al. 33 Wirtz, “Access to Medications,” 2079. Action to address the household economic burden of non-communicable diseases. The Lancet Taskforce on NCDs and Economics 3. The Lancet. 2018 Apr; 391: 2049–50; & The Task 34 Wirtz, “Access to Medications,” 2078. Force on Fiscal Policy for Health, “Health Taxes to Save Lives,” 9. 35 World Health Organization, “Essential Medicines and Basic Health Technologies for 70 The Task Force on Fiscal Policy for Health, “Health Taxes to Save Lives,” 8. Noncommunicable Diseases: Towards a Set of Actions to Improve Equitable Access in 71 Member States,” WHO Discussion Paper, 2 July 2015, 7. Global Coalition for Circulatory Health. Driving Sustainable Action for Circulatory Health. White Paper on Circulatory Health. Geneva, Switzerland. 2018, 27, 33. 36 Stevens and Huys, “Innovative Approaches to Increase Access”, 1. 37 Wirtz, “Access to Medications,” 2077. A CALL TO ACTION WORLD HEART FEDERATION IMPROVING ACCESS

IMPROVING ACCESS TO ESSENTIAL MEDICINES FOR CIRCULATORY DISEASES: 24 A CALL TO ACTION

WORLD HEART FEDERATION /worldheartfederation 32, rue de Malatrex, 1201 Geneva, Switzerland (+41 22) 807 03 20 /worldheartfed [email protected] /world-heart-federation www.worldheart.org