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Background and Aims More than 292 million people are living with hepatitis B worldwide and are at risk of death from liver cirrhosis and liver cancer. The World Health Organization (WHO) has set global targets for the elimination of viral hepatitis as a public health threat by 2030. However, current levels of global investment in viral hepatitis elimination programmes are insufficient to achieve these goals. Methods To catalyse political commitment and to encourage domestic- and international-financing, we used published modelling data and key stakeholder interviews to develop an investment framework to demonstrate the return on investment for viral hepatitis elimination. Results The framework utilizes a public health approach to identify evidence-based national activities that reduce viral hepatitis-related morbidity and mortality, as well as international activities and critical enablers that allow countries to achieve maximum impact on health outcomes from investment to achieve WHO 2030 elimination targets. Conclusion Focusing on hepatitis B, this health policy paper employs the investment framework to estimate the substantial economic benefits of investing in the elimination of hepatitis B and demonstrates how such investments could be cost-saving by 2030., Graphical abstract, Highlights • The WHO has set global targets for elimination of hepatitis B by 2030 • To date, global investment in hepatitis B elimination activities has been limited • We have developed a global investment framework for the elimination of hepatitis B to guide domestic and international investment • This Health Policy paper outlines evidence to support the financial returns on investment in hepatitis B elimination, identifies national and international activities to achieve hepatitis B elimination targets and identifies potential funding sources • The goal of this investment framework is to pave the way for countries to build the economic case for investment in national hepatitis B elimination programmes.

WHO has set global targets for the elimination of hepatitis B and hepatitis C as a public health threat by 2030. However, investment in elimination programmes remains low. To help drive political commitment and catalyse domestic and international financing, we have developed a global investment framework for the elimination of hepatitis B and hepatitis C. The global investment framework presented in this Health Policy paper outlines national and international activities that will enable reductions in hepatitis C incidence and mortality, and identifies potential sources of funding and tools to help countries build the economic case for investing in national elimination activities. The goal of this framework is to provide a way for countries, particularly those with minimal resources, to gain the substantial economic benefit and cost savings that come from investing in hepatitis C elimination.

Test data demonstrating the efficacy, safety and quality of a medicine is required by drug regulatory agencies before a new treatment obtains marketing approval and can be made available to patients. Because test data can be costly and time-consuming to produce, certain countries have ‘data exclusivity’ regimes that restrict use of test data to the originator company for a period of time. Generic and biosimilar companies rely on originator test data to obtain marketing approval for generic products, so data exclusivity periods can delay entry of lower-cost treatments to the market. While data exclusivity is not required by the World Trade Organization, countries such as the United States and the European Union often push their stronger data exclusivity provisions on other countries through free trade agreements (FTAs). While a small number of countries have waivers to data exclusivity for cases of emergency or other public health need, most do not. This can hamper the timely and affordable availability of needed medicines. Waivers to data exclusivity should be included in legislation to protect public health, and other ways to protect test data against unfair commercial use should be explored.

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Viral hepatitis is a leading cause of morbidity and mortality worldwide, but has long been neglected by national and international policymakers. Recent modelling studies suggest that investing in the global elimination of viral hepatitis is feasible and cost‐effective. In 2016, all 194 member states of the World Health Organization endorsed the goal to eliminate viral hepatitis as a public health threat by 2030, but complex systemic and social realities hamper implementation efforts. This paper presents eight case studies from a diverse range of countries that have invested in responses to viral hepatitis and adopted innovative approaches to tackle their respective epidemics. Based on an investment framework developed to build a global investment case for the elimination of viral hepatitis by 2030, national activities and key enablers are highlighted that showcase the feasibility and impact of concerted hepatitis responses across a range of settings, with different levels of available resources and infrastructural development. These case studies demonstrate the utility of taking a multipronged, public health approach to: (a) evidence‐gathering and planning; (b) implementation; and (c) integration of viral hepatitis services into the Agenda for Sustainable Development. They provide models for planning, investment and implementation strategies for other countries facing similar challenges and resource constraints.

High medicines prices increasingly pose challenges for universal access to treatments of communicable and non-communicable diseases. New essential medicines are often patent-protected which sustains high prices in many countries, including in low- and middle-income countries. To respond to the HIV/AIDS crisis of the late nineties and to increase access to antiretroviral treatment, certain flexibilities contained in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS flexibilities) have been clarified and in some respects strengthened at the global level. They have been applied by a number of countries to ensure access to lower-priced generic medicines to treat HIV/AIDS. Governments in the South African Development Community (SADC) have also used TRIPS flexibilities to gain access to lower-priced generic medicines. This paper documents 15 instances of the use of TRIPS flexibilities by eight SADC Member States during the period 2001–2016. Of those, six concerned least developed countries (LDCs) that declared non-enforcement of pharmaceutical patents pursuant to a new LDC transition provision. All instances occurred in the context of medicines procurement for HIV treatment. Such flexibilities can, however, also be used to overcome patent barriers to gain access to generic medicines for other diseases, including NCDs. The SADC, being a regional bloc with over 50% least developed country Members, can make use of the regional exception, a TRIPS flexibility that facilitates the production or procurement of generic medicines to the benefit of the entire region. SADC’s Pharmaceutical Business Plan proposes strategies for increased collaboration and pooled procurement of medicines.

Millions of people, particularly in low- and middle-income countries, lack access to effective pharmaceuticals, often because they are unaffordable. The 2001 Ministerial Conference of the World Trade Organization (WTO) adopted the Doha Declaration on the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement and Public Health. The declaration recognized the implications of intellectual property rights for both new medicine development and the price of medicines. The declaration outlined measures, known as TRIPS flexibilities, that WTO Members can take to ensure access to medicines for all. These measures include compulsory licensing of medicines patents and the least-developed countries pharmaceutical transition measure. The aim of this study was to document the use of TRIPS flexibilities to access lower-priced generic medicines between 2001 and 2016. Overall, 176 instances of the possible use of TRIPS flexibilities by 89 countries were identified: 100 (56.8%) involved compulsory licences or public noncommercial use licences and 40 (22.7%) involved the least-developed countries pharmaceutical transition measure. The remainder were: 1 case of parallel importation; 3 research exceptions; and 32 non-patent-related measures. Of the 176 instances, 152 (86.4%) were implemented. They covered products for treating 14 different diseases. However, 137 (77.8%) concerned medicines for human immunodeficiency virus infection and acquired immune deficiency syndrome or related diseases. The use of TRIPS flexibilities was found to be more frequent than is commonly assumed. Given the problems faced by countries today in procuring high-priced, patented medicines, the practical, legal pathway provided by TRIPS flexibilities for accessing lower-cost generic equivalents is increasingly important.Des millions de personnes, en particulier dans les pays à revenu faible et intermédiaire, ne peuvent accéder à des produits pharmaceutiques efficaces, souvent en raison de leur prix trop élevé. La Conférence ministérielle de 2001 de l'Organisation mondiale du commerce (OMC) a adopté la Déclaration de Doha sur l'Accord sur les ADPIC (aspects des droits de propriété intellectuelle qui touchent au commerce) et la santé publique. Cette déclaration a reconnu les implications des droits de propriété intellectuelle, aussi bien pour le développement de nouveaux médicaments que pour le prix des médicaments. Elle a détaillé des mesures, appelées flexibilités des ADPIC, que peuvent prendre les Membres de l'OMC pour assurer l'accès de tous aux médicaments, comme l'octroi de licences obligatoires aux brevets de médicaments et la mesure de transition pharmaceutique des pays les moins avancés. Le but de cette étude était d'examiner le recours aux flexibilités des ADPIC pour accéder à des médicaments génériques moins coûteux entre 2001 et 2016. Dans l'ensemble, 176 cas de recours possible aux flexibilités des ADPIC par 89 pays ont été relevés: 100 (56,8%) concernaient des licences obligatoires ou des licences d'utilisation publique à des fins non commerciales et 40 (22,7%) concernaient la mesure de transition pharmaceutique des pays les moins avancés. Quant aux autres, il s'agissait d'un cas d'importation parallèle, de 3 exceptions de recherche et de 32 mesures sans lien avec des brevets. Sur ces 176 cas, 152 (86,4%) ont été mis en œuvre. Ils portaient sur des produits destinés à traiter 14 maladies différentes. Cependant, 137 (77,8%) concernaient des médicaments contre le virus de l'immunodéficience humaine et le syndrome d'immunodéficience acquise ou des maladies apparentées. Le recours aux flexibilités des ADPIC s'est révélé plus fréquent que ce que l'on supposait. Étant donné les problèmes que rencontrent actuellement certains pays pour se procurer des médicaments brevetés à prix élevé, le cadre pratique et juridique offert par les flexibilités des ADPIC pour accéder à des équivalents génériques moins coûteux revêt une importance de plus en plus capitale.Millones de personas, particularmente en países de ingresos bajos y medios, carecen de acceso a medicamentos efectivos, habitualmente porque no pueden pagarlos. La Conferencia Ministerial de 2001 de la Organización Mundial del Comercio (OMC) adoptó la Declaración de Doha relativa al Acuerdo sobre los ADPIC (Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio) y la Salud Pública. La declaración reconoció las implicaciones de los derechos de propiedad intelectual para el desarrollo de nuevos medicamentos y el precio de los mismos. La declaración describió medidas, conocidas como flexibilidades de los ADPIC, que los Miembros de la OMC pueden tomar con el objetivo de asegurar el acceso a los medicamentos para todos. Estas medidas incluyen concesión obligatoria de licencias de patentes de medicamentos y la medida de transición farmacéutica de países menos desarrollados. El objetivo de este estudio fue documentar el uso de las flexibilidades de los ADPIC para acceder a medicamentos genéricos de precio inferior entre el 2001 y el 2016. En general, se identificaron 176 casos de posibles usos de las flexibilidades de los ADPIC: 100 (56.8%) implicaron licencias obligatorias o licencias de uso público no comercial y 40 (22.7%) apelaron a la medida de transición farmacéutica de países menos desarrollados. El resto fue: 1 caso de importación paralela; 3 excepciones de investigación; y 32 medidas no relacionadas con patentes. De los 176 casos, 152 (86.4%) se implementaron. Cubrieron productos para tratar 14 enfermedades diferentes. Sin embargo, 137 (77.8%) implicaron medicamentos para la infección del virus de inmunodeficiencia humana y el síndrome de inmunodeficiencia adquirida o enfermedades relacionadas. Resultó que el uso de las flexibilidades de los ADPIC fue más frecuente de lo que comúnmente se espera. Dados los problemas que enfrentan hoy los países en la adquisición de medicamentos de alto precio y patentados, el camino práctico y legal que ofrecen las flexibilidades de los ADPIC para acceder a equivalentes genéricos de costo inferior es cada vez más importante.يفتقر ملايين من الناس إلى إمكانية الحصول على المستحضرات الصيدلانية الفعالة وخاصة في الدول منخفضة ومتوسطة الدخل، وغالبًا ما يكون ذلك بسبب ارتفاع تكاليف تلك المستحضرات. وقد اعتمد المؤتمر الوزاري لمنظمة التجارة العالمية عام 2001 إعلان الدوحة الخاص بالاتفاقية المتعلقة بجوانب حقوق الملكية الفكرية المتصلة بالتجارة (اتفاق تريبس) والصحة العامة. وكان الإعلان الصادر قد أقر بالآثار المترتبة على حقوق الملكية الفكرية بالنسبة إلى تطوير أدوية جديدة وأسعار الأدوية على حدٍ سواء. كما حدد الإعلان التدابير المعروفة بأوجه مرونة اتفاق تريبس، والتي يستطيع الأعضاء في منظمة التجارة العالمية الاستفادة منها لضمان إمكانية وصول الأدوية للجميع. وتشمل تلك التدابير الترخيص الإلزامي لبراءات اختراع الأدوية وتدابير انتقال المستحضرات الصيدلانية في الدول الأقل نموًا. وكان الهدف من تلك الدراسة يتمثل في توثيق الانتفاع بأوجه مرونة اتفاق تريبس لتوفير الأدوية المكافئة الأقل سعرًا بين عامي 2001 و2016. وبوجه عام، تم الكشف عن 176 من حالات الاستفادة الممكنة لأوجه المرونة في اتفاق تريبس من قبل 89 بلدًا؛ حيث اشتملت 100 حالة منها (بواقع 56.8‏%) على التراخيص الإلزامية أو تراخيص الاستخدام غير التجاري العام، فما تم تسجيل 40 حالة (بواقع 22.7‏%) تم فيها اتباع التدابير الخاصة بانتقال المستحضرات الصيدلانية في الدول الأقل نموًا. وكان المتبقي من الحالات عبارة عن حالة واحدة من الاستيراد الموازي؛ و3 استثناءات بحثية؛ و32 براءة اختراع غير متعلقة بالتدابير. ومن بين الحالات البالغ عددها 176 حالة، تم تطبيق 152 حالة (بواقع ‏‏86.4%). وقد تضمنت منتجات لعلاج 14 مرضًا مختلفًا. وعلى الرغم من ذلك، فقد وردت 137 حالة (أي بنسبة ‏77.8‏%) والتي تعلقت باستخدام الأدوية المخصصة لعدوى فيروس عوز المناعة البشري ومتلازمة نقص المناعة المكتسبة أو الأمراض ذات الصلة. وقد تبين أن الانتفاع بأوجه مرونة اتفاق تريبس أكثر شيوعًا مما كان مفترضًا بشكل عام. وبالنظر إلى المشكلات التي تواجهها الدول اليوم في شراء الأدوية عالية الثمن والحاصلة على براءة اختراع، فإن المسار القانوني والعملي المتاح من خلال جوانب المرونة في اتفاق تريبس لتيسير سبل الحصول على الأدوية المقابلة والمكافئة منخفضة الثمن هو مسار متزايد الأهمية.数百万人口，尤其是中低收入国家的人们，往往由于负担不起而无法获得足够有效的药品。世界贸易组织 (WTO) 2001 年部长级会议通过了关于《与贸易相关的知识产权协议》(TRIPS) 和公共卫生的《多哈宣言》。该宣言审视了知识产权对新药开发和药品价格的影响。该宣言概述了 WTO 成员为确保所有人都可获得药品而采取的措施，即 TRIPS 灵活性措施。这些措施包括药品专利强制许可和最不发达国家药品流转措施。本研究的目的是记录 2001 年至 2016 年间使用 TRIPS 灵活性措施获取价格较低的非专利药品的情况。总计确认了 89 个国家 176 个可能使用 TRIPS 灵活性措施的案例：100 (56.8%) 例涉及强制许可或公共非商业使用许可证，40 (22.7%) 例援引了最不发达国家的医药流转措施。其余案例为：1 例平行进口；3 例研究异常；和 32 例非专利相关措施。在 176 个案例中，有 152 (86.4%) 例得以执行。它们涵盖了治疗 14 种不同疾病的药品。但是，有 137 (77.8%) 例涉及用于人类免疫缺陷病毒感染和获得性免疫缺陷综合征或相关疾病的药品。我们发现 TRIPS 灵活性措施的使用比通常假定的更为频繁。鉴于当今各国在获取高价专利药品方面所面临的问题，TRIPS 灵活性措施中提供的获取低成本通用药品药物的实用性合法途径变得越来越重要。.Миллионы людей, особенно в странах с низким и средним уровнем дохода, не имеют доступа к эффективным лекарственным средствам, чаще всего по причине их высокой стоимости. На министерской конференции Всемирной торговой организации (ВТО) в 2001 году была принята Дохинская декларация «Соглашение по ТРИПС (Соглашение по торговым аспектам прав на интеллектуальную собственность) и общественное здравоохранение». Декларация подтвердила значение прав на интеллектуальную собственность как для разработки новых лекарственных средств, так и для цен на лекарства. В декларации были изложены меры, известные как гибкие положения ТРИПС, которые могут принять члены ВТО для обеспечения широкого доступа к лекарственным средствам. Эти меры включают обязательное лицензирование патентов на лекарственные средства и переходный период в сфере обращения лекарственных средств в наименее развитых странах. Цель этого исследования заключалась в том, чтобы обосновать использование гибких положений ТРИПС для доступа к недорогим непатентованным лекарственным средствам в период с 2001 по 2016 год. В целом было выявлено 176 случаев возможного использования гибких положений ТРИПС в 89 странах: 100 (56,8%) из них были связаны с обязательным лицензированием или лицензиями на общественное некоммерческое использование, а 40 (22,7%) — с переходным периодом в сфере обращения лекарственных средств в наименее развитых странах. Оставшимися были: 1 случай параллельного импорта, 3 исключения из исследований и 32 случая, не связанные с патентами. Из 176 случаев было реализовано 152 (86,4%). Они охватывали лекарственные средства, предназначенные для лечения 14 различных заболеваний. Однако 137 случаев (77,8%) были связаны с лекарственными средствами, применяемыми при ВИЧ-инфекции (вирус иммунодефицита человека) и синдроме приобретенного иммунодефицита или связанных с ним заболеваний. Было установлено, что гибкие положения ТРИПС применяются чаще, чем это принято считать. С учетом актуальных проблем, с которыми сталкиваются страны при закупке дорогостоящих запатентованных лекарственных средств, все большее значение приобретает практический легальный путь, обеспечиваемый гибкими положениями ТРИПС для доступа к недорогим эквивалентам.

Access to medicines has been a fierce battleground in global health, with the most polarising debates focused on medicine prices and the role of patent monopolies. The way ‘access to medicines’ has been framed has evolved considerably since the 1970s, when the focus was primarily on rational use of generic drugs widely available in developing countries. In the 1990s the advent of the WTO TRIPS Agreement clashed directly with a growing global HIV crisis; the politics of ‘access to medicines 1.0’ that emerged centred squarely on antiretrovirals for HIV/AIDS and intellectual property rules. Subsequently, significant ideational and political shifts have resulted in an ‘access politics 2.0,’ characterised by an expansion of concerns to all diseases, tighter linkages between innovation and access concerns, and shifting political dynamics as high-income countries began to experience directly the challenge of high drug prices. These shifts imply a more complex and potentially more consequential politics of access to medicines in the future.

Основные лекарства удовлетворяют приоритетные потребности населения в области здравоохранения. Политика, основанная на концепции основных лекарств, имеет решающее значение в улучшении здоровья и достижении устойчивого развития. Цель устойчивого развития 3.8 конкретно упоминает важность «доступности безопасных, эффективных, качественных и доступных по цене основных лекарств и вакцин для всех» в качестве центрального компонента всеобщего охвата медицинской помощью (ВОМП), а цель устойчивого развития 3.b подчёркивает необходимость разработки лекарств для устранения постоянно возникающих пробелов в отношении лечения. Признание важности основных лекарств - не новость. В 1985 г. на конференции в Найроби по рациональному использованию лекарств представители правительств и другие заинтересованные стороны предложили всеобъемлющий комплекс мер по разработке политики в области основных лекарств. Через 30 лет была созвана «Комиссия журнала Ланцет (Lancet) по основным лекарствам» (далее Комиссия) для изучения следующих вопросов: Какого прогресса удалось достичь? Какие проблемы ещё остаются для решения? Какие уроки были извлечены для информирования будущих подходов? И как можно использовать политику в области основных лекарств для продвижения ВОМП и внесения вклада в повестку глобального устойчивого развития? В настоящем докладе рассмотрены эти вопросы с намерением репозиционировать политику в области основных лекарств в повестке глобального развития. Комиссия определила пять областей, имеющих решающее значение для политики в области основных лекарств: оплата корзины основных лекарств, обеспечение ценовой доступности основных лекарств, гарантия их качества и безопасности, мероприятия, способствующие их качественному использованию, и разработка недостающих (отсутствующих) основных лекарств. Комиссия позиционировала политику в области основных лекарств в контексте текущих глобальных дебатов о балансировании политики в области торговли и интеллектуальной собственности с правами человека, об обеспечении безопасности здравоохранения, укреплении систем здравоохранения, ориентированных на людей, и улучшении доступности основных технологий. Во всех областях политики особое внимание было уделено совершенствованию принципов равенства и справедливости в доступе, укреплению соответствующих институтов и созданию подотчётности. В каждой из определённых областей Комиссия сформулировала рекомендации к действию, подтвердив тем самым позицию политики в области основных лекарств в качестве центрального компонента глобального здоровья и здравоохранения и повестки развития.

Background: Increased coverage with antiretroviral therapy for people living with HIV in low- and middle-income countries has increased their life expectancy associated with non-HIV comorbidities and the need for quality-assured and affordable non-communicable diseases drugs . Funders are leaving many middle-income countries that will have to pay and provide quality-assured and affordable HIV and non-HIV drugs, including for non-communicable diseases. Objective: To estimate costs for originator and generic antiretroviral therapy as the number of people living with HIV are projected to increase between 2016 and 2026, and discuss country, regional and global factors associated with increased access to generic drugs. Methods: Based on estimates of annual demand and prices, annual cost estimates were produced for generic and originator antiretroviral drug prices in low- and middle-income countries and projected for 2016–2026. Results: Drug costs varied between US$1.5 billion and US$4.8 billion for generic drugs and US$ 8.2 billion and US$16.5 billion for originator drugs between 2016 and 2026. Discussion: The global HIV response increased access to affordable generic drugs in low- and middle-income countries. Cheaper active pharmaceutical ingredients and market competition were responsible for reduced drug costs. The development and implementation of regulatory changes at country, regional and global levels, covering intellectual property rights and public health, and flexibilities in patent laws enabled prices to be reduced. These changes have not yet been applied in many low- and middle-income countries for HIV, nor for other infectious and non-communicable diseases, that lack the profile and political attention of HIV. Licensing backed up with Trade-Related Aspects of Intellectual Property Rights safeguards should become the norm to provide quality-assured and affordable drugs within competitive generic markets. Conclusion: Does the political will exist among policymakers and other stakeholders to develop and implement these country, regional and global frameworks for non-HIV drugs as they did for antiretroviral drugs?

Direct-acting antivirals (DAAs) have dramatically changed the landscape of hepatitis C treatment and prevention. The World Health Organization has called for the elimination of hepatitis C as a public health threat by 2030. However, the discrepancy in DAA prices across low-, middle- and high-income countries is considerable, ranging from less than US$ 100 to approximately US$ 40,000 per course, thus representing a major barrier for the scale-up of treatment and elimination. This article describes DAA pricing and pathways to accessing affordable treatment, providing case studies from Australia, Egypt and Portugal. Pathways to accessing DAAs include developing comprehensive viral hepatitis plans to facilitate price negotiations, voluntary and compulsory licenses, patent opposition, joint procurement, and personal importation schemes. While multiple factors influence the price of DAAs, a key driver is a country's capacity and willingness to negotiate with pharmaceutical companies. If negotiations do not lead to a reasonable price, governments have the option to utilise flexibilities outlined in the Agreement on Trade-Related Aspects of Intellectual Property Rights. Affordable access to DAAs is underpinned by collaboration between government, civil society, global organisations and pharmaceutical companies to ensure that all patients can access treatment. Promoting these pathways is critical for influencing policy, improving access to affordable DAAs and achieving hepatitis C elimination.

New interest in the 'pandemic' of falsified medicines has resulted in efforts to put in place a treaty on 'medicines crime'. If the goal is to protect the interests of people and public health, an international agreement to ensure that all proven effective and necessary medicines are affordable, available, and of assured quality will do far more to combat falsified and substandard medicines than an agreement that deals primarily with the criminal aspects of problematic medicines production and distribution.

The challenge of providing access to high-priced patented medicines is a global problem affecting all countries. A decade and a half ago the use of flexibilities contained in the World Trade Organization Agreement on Trade Related Aspects of Intellectual Property Rights, in particular compulsory licensing, was seen as a mechanism to respond to high-price medicines for the treatment of HIV/AIDS in low- and middle-income countries. Today a number of upper-income European Union (EU) Member States are contemplating the use of compulsory licensing in their efforts to reduce expenditure on pharmaceutical products. EU regulation of clinical test data protection and the granting of market exclusivity interfere with the effective use of compulsory licensing by EU Member States and can even prevent access to off-patent medicines because they prohibit registration of generic equivalents. EU pharmaceutical legislation should be amended to allow waivers to data and market exclusivity in cases of public health need and when a compulsory or government use license has been issued. Such an amendment can be modelled after existing waivers in the EU Regulation on compulsory licensing of patents for the manufacture of pharmaceutical products for export to countries with public health problems outside the EU. Allowing a public health/compulsory license exception to data and market exclusivity would bring greater coherence between EC regulation of medicinal products and national provisions on compulsory licensing and ensure that Member States can take measures to protect public health and promote access to medicines for all.

Developing and delivering appropriate, affordable, well-adapted medicines for HIV/AIDS remains an urgent challenge: as first-line therapies fail, increasing numbers of people require costly second-line therapy; one-third of ARVs are not available in pediatric formulations; and certain key first- and second-line triple fixed-dose combinations do not exist or sufficient suppliers are lacking. UNITAID aims to help solve these problems through an innovative initiative for the collective management of intellectual property (IP) rights – a patent pool for HIV medicines. The idea behind a patent pool is that patent holders - companies, governments, researchers or universities - voluntarily offer, under certain conditions, the IP related to their inventions to the patent pool. Any company that wants to use the IP to produce or develop medicines can seek a license from the pool against the payment of royalties, and may then produce the medicines for use in developing countries (conditional upon meeting agreed quality standards). The patent pool will be a voluntary mechanism, meaning its success will largely depend on the willingness of pharmaceutical companies to participate and commit their IP to the pool. Generic producers must also be willing to cooperate. The pool has the potential to provide benefits to all.

The view that strong intellectual property (IP) protection is necessary for drug development forms the backbone of the current health research and development paradigm. But the evidence shows how this system is fundamentally flawed. Neglected diseases, which count for 12 per cent of the disease burden, but for only 1 per cent of all drugs developed, are an example. The World Health Organization (WHO) Commission on Intellectual Property, Innovation and Public Health is a significant addition to this body of evidence. The report outlines how, despite ever stronger IP regimes through the implementation of the Trade-Related Aspects of Intellectual Property Agreement, the quality and quantity of medical innovation is declining. The report concludes that innovation is meaningless if the products developed can not be accessed by those who need them most. It calls for a global plan of action to identify mechanisms that will stimulate the discovery, development and delivery of health tools that address diseases affecting the poor. In a resolution adopted at the 2006 World Health Assembly, countries took heed of this call and committed to looking at ‘securing an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries’. Governments, and the WHO, must not squander this opportunity.

Medicines of uncertain quality, safety and efficacy can be worse than no treatment at all. It is the responsibility of national medicines regulatory authorities to protect patients from harm. Yet, there are great disparities in regulatory capacity globally, preventing large populations from accessing the benefits of advances in the pharmaceutical field. This article describes the main regulatory functions and how they are applied to assure the quality, safety and efficacy of different types of medicines in different environments. It gives examples of initiatives that have increased access to good quality medicines worldwide and – more importantly – are laying the groundwork for collaborative approaches aiming to ensure that pharmaceutical products meet the same, stringent quality standards in all parts of the world.

Ellen 't Hoen reports on the Médecins Sans Frontières' push in Seattle to ensure that the WTO recognizes that public health takes priority over trade. Their aim is to work within WTO to consider the impact of trade policies on people in developing and least developed countries, and provide a public health framework for the interpretation of key features of WTO agreements. Development (2000) 43, 101–105. doi:10.1057/palgrave.development.1110155

Ellen 't Hoen argues that one-third of the world's population lacks access to essential drugs and the new international trade rules may lead to an even worse situation in the near future. She discusses access problems related to cost, insufficient production, lack of research and development and consequences of global trade regulation and concludes that new approaches are needed to protect and further the basic human right to access to health care. Development (1999) 42, 87–91. doi:10.1057/palgrave.development.1110092

Problems with the quality of medicines abound in countries where regulatory and legal oversight are weak, where medicines are unaffordable to most, and where the official supply often fails to reach patients. Quality is important to ensure effective treatment, to maintain patient and health-care worker confidence in treatment, and to prevent the development of resistance. In 2001, the WHO established the Prequalification of Medicines Programme in response to the need to select good-quality medicines for UN procurement. Member States of the WHO had requested its assistance in assessing the quality of low-cost generic medicines that were becoming increasingly available especially in treatments for HIV/AIDS. From a public health perspective, WHO PQP's greatest achievement is improved quality of life-saving medicines used today by millions of people in developing countries. Prequalification has made it possible to believe that everyone in the world will have access to safe, effective, and affordable medicines. Yet despite its track record and recognized importance to health, funding for the programme remains uncertain.

BACKGROUND: Cytomegalovirus (CMV) is a late-stage opportunistic infection in people living with human immunodeficiency virus (HIV)/AIDS. Lack of ophthalmological diagnostic skills, lack of convenient CMV treatment, and increasing access to antiretroviral therapy have all contributed to an assumption that CMV retinitis is no longer a concern in low- and middle-income settings. METHODS: We conducted a systematic review and meta-analysis of published and unpublished studies reporting prevalence of CMV retinitis in low- and middle-income countries. Eligible studies assessed the occurrence of CMV retinitis by funduscopic examination within a cohort of at least 10 HIV-positive adult patients. RESULTS: We identified 65 studies from 24 countries, mainly in Asia (39 studies, 12 931 patients) and Africa (18 studies, 4325 patients). By region, the highest prevalence was observed in Asia with a pooled prevalence of 14.0% (11.8%-16.2%). Almost a third (31.6%, 95% confidence interval [CI], 27.6%-35.8%) had vision loss in 1 or both eyes. Few studies reported immune status, but where reported CD4 count at diagnosis of CMV retinitis was

Purpose of review The purpose of this study is to review relevant literature published from January 2011 to July 2012 that specifically addresses the impact of intellectual property protection on access to antiretroviral drugs. Recent findings The articles reviewed discussed the relation of intellectual property protection and access to medicines. For most authors, the World Trade Organization (WTO) Trade-Related Intellectual Property Rights Agreement (TRIPS) and the 10-year anniversary of the 2001 WTO Doha Declaration on TRIPS and Public Health formed an important background for the review of the current state of play. Summary Intellectual property plays an important role in implementing policies to ensure HIV treatment and care programmes. From the review, three main themes emerged: the implementation of the Doha Declaration, the role of generic competition in antiretroviral treatment scale-up and innovative licensing mechanisms. The attention for the effects of intellectual property on access to HIV medicines opened the path for new initiatives for the management of patents using public health objectives as the key driver such as the UNITAID-backed Medicines Patent Pool. Some of the literature addressed the question whether more fundamental changes in the intellectual property architecture were necessary.

Over the last two decades, recognition has grown that the current system for the research and development (R&D) of new medicines does not adequately meet the needs of the majority of the world's population [1]–[4], over 80% of which lives in low- and middle-income countries (LMICs) [5]. (We use the general term “medicines” to refer broadly to drugs, vaccines, diagnostics, and other medical products.) The clearest illustration of these shortcomings is the lack of new medicines for the “neglected diseases”—those that primarily affect populations with little purchasing power, and therefore offer an insufficient incentive for industry to invest in R&D. However, the problems with the existing system extend far beyond the narrow notion of neglected diseases. The challenge is better understood as one of “neglected populations”—that is, of ensuring that the global R&D system meets the needs of all, especially of the poorest and most vulnerable populations. Such needs include not only new treatments for neglected diseases, but also access to antimicrobials, affordable medicines for diseases with global incidence such as diabetes and cancer, and products well-adapted for use in resource-limited settings. Thus far, the existing system has largely failed to deliver on these objectives. These problems have prompted extensive international debate and proposals for reform. After a 2-year intergovernmental negotiation, in 2008 governments agreed upon the World Health Organization (WHO) Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, which recognized that the current system fell short in meeting the needs of developing countries with respect to both communicable and non-communicable diseases [4]. In April 2012, the WHO Consultative Expert Working Group on R&D: Financing and Coordination (CEWG) recommended that governments begin negotiations over a global medical R&D convention to address some of these problems in a systematic way [6] (see Box 1). Why might a binding international convention be needed? Box 1. A Binding WHO Convention on R&D The idea of a binding international convention on RD carry stronger normative force, even in the absence of enforcement mechanisms; and can be more enforceable at national level [65]. An important precedent was set with the 2005 Framework Convention on Tobacco Control, the first public health treaty negotiated within WHO, which has contributed significantly to global tobacco control efforts [63],[66].

Since 2000, access to antiretroviral drugs to treat HIV infection has dramatically increased to reach more than five million people in developing countries. Essential to this achievement was the dramatic reduction in antiretroviral prices, a result of global political mobilization that cleared the way for competitive production of generic versions of widely patented medicines. Global trade rules agreed upon in 1994 required many developing countries to begin offering patents on medicines for the first time. Government and civil society reaction to expected increases in drug prices precipitated a series of events challenging these rules, culminating in the 2001 World Trade Organization's Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health. The Declaration affirmed that patent rules should be interpreted and implemented to protect public health and to promote access to medicines for all. Since Doha, more than 60 low- and middle-income countries have procured generic versions of patented medicines on a large scale. Despite these changes, however, a "treatment timebomb" awaits. First, increasing numbers of people need access to newer antiretrovirals, but treatment costs are rising since new ARVs are likely to be more widely patented in developing countries. Second, policy space to produce or import generic versions of patented medicines is shrinking in some developing countries. Third, funding for medicines is falling far short of needs. Expanded use of the existing flexibilities in patent law and new models to address the second wave of the access to medicines crisis are required. One promising new mechanism is the UNITAID-supported Medicines Patent Pool, which seeks to facilitate access to patents to enable competitive generic medicines production and the development of improved products. Such innovative approaches are possible today due to the previous decade of AIDS activism. However, the Pool is just one of a broad set of policies needed to ensure access to medicines for all; other key measures include sufficient and reliable financing, research and development of new products targeted for use in resource-poor settings, and use of patent law flexibilities. Governments must live up to their obligations to protect access to medicines as a fundamental component of the human right to health.

The Commission on Intellectual Property, Innovation and Public Health (CIPIH) was given the task of reviewing existing research and development (R&D) efforts, examining the role of intellectual property (IP) in stimulating innovation, and to make concrete proposals for action by national and international stakeholders, both public and private, to encourage R&D for diseases that disproportionately affect developing countries. The Commission focussed exclusively on the application of IP to pharmaceuticals, and did not address the public health implications of copyright law, or genomic patents, which are covered elsewhere in this issue. The report (1) presents a wealth of evidence and analysis in support of the view that the current system of drug development is fundamentally flawed and leaves huge health needs unmet, because of its reliance on patents and commercial incentives for the priority-setting and financing of medical R&D. The report calls for improved mechanisms that promote research that responds to patients' needs, and that ensure access to innovations for all. However, it fails to provide alternatives and concrete new proposals. Many of the data presented in the report illustrate the urgent need for change. I will discuss some of the Commissions more salient conclusions, on intellectual property rights, international trade, access to medicines, and global frameworks. Intellectual property rights The report recognizes that IP is a means and not an end. It concludes that IP is irrelevant in stimulating innovation in developing countries where markets have limited purchasing power, confirming the same finding by the UK Commission on Intellectual Property Rights in September 2002. (2) The report says: "There is no evidence that the implementation of the TRIPS Agreement in developing countries will significantly boost R&D in pharmaceuticals on Type II and particularly Type III diseases. Insufficient market incentives are the decisive factor." (1) The report also points out that even in regions with strong IP protection, innovation results are declining. In the USA for example, medical R&D spending has doubled between 1995 and 2002, while in the same period, the registration of new products has declined, as well as the therapeutic significance of products reaching the market. In other words, although worldwide patent standards have been strengthened since 1995 as a result of the TRIPS Agreement, and global spending on medical R&D has increased, pharmaceutical innovation has declined both in quantity and quality. Furthermore, the report draws attention to the fact that patents can actually hamper innovation, by blocking follow-on research or access to research tools. The CIPIH identifies patent pools, compulsory licensing, and the application for research exemptions as potential solutions to overcome barriers caused by patenting. International trade and competition The report warns against trade agreements that include so-called "TRIPS-plus" measures. The Commission concludes: "Bilateral trade agreements should not seek to incorporate TRIPS-plus protection in ways that may reduce access to medicines in developing countries." (Recommendation 4.21). (1) "Data exclusivity" is one example of a TRIPS-plus provision often included in bilateral trade agreements with the US. The report offers much awaited clarity on issues related to the protection of data submitted by companies to obtain marketing approval for new medicines. WTO Members are obliged to protect undisclosed test or other data against unfair commercial use. But this does not imply property rights, nor a right to prevent others from using the data, or from relying on the data for the marketing approval of the same product by a third party--except where unfair, dishonest commercial practices are involved. Developing countries have been pressured during bilateral talks to accept TRIPS-plus provisions including data exclusivity rules that would delay the introduction of generic medicines. …

Summary The first WHO essential drugs list, published in 1977, was described as a peaceful revolution in international public health. The list helped to establish the principle that some medicines were more useful than others and that essential medicines were often inaccessible to many populations. Since then, the essential medicines list (EML) has increased in size; defining an essential medicine has moved from an experience to an evidence-based process, including criteria such as public-health relevance, efficacy, safety, and cost-effectiveness. High priced medicines such as antiretrovirals are now included. Differences exist between the WHO model EML and national EMLs since countries face varying challenges relating to costs, drug effectiveness, morbidity patterns, and rationality of prescribing. Ensuring equitable access to and rational use of essential medicines has been promoted through WHO's revised drug strategy. This approach has required an engagement by WHO on issues such as the effect of international trade agreements on access to essential medicines and research and development to ensure availability of new essential medicines.