A global investment framework for the elimination of hepatitis B.

BACKGROUND & AIMS: More than 292 million people are living with hepatitis B worldwide and are at risk of death from 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 utilises 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 their investments - in the context of the WHO's 2030 viral 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. LAY SUMMARY: Hepatitis B infection is a major cause of death from liver disease and liver cancer globally. To reduce deaths from hepatitis B infection, we need more people to be tested and treated for hepatitis B. In this paper, we outline a framework of activities to reduce hepatitis B-related deaths and discuss ways in which governments could pay for them.

Global hepatitis C elimination: an investment framework.

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.

Innovative strategies for the elimination of viral hepatitis at a national level: A country case series.

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.

Does the political will exist to bring quality-assured and affordable drugs to low- and middle-income countries?

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?

Patent challenges in the procurement and supply of generic new essential medicines and lessons from HIV in the southern African development community (SADC) region.

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.

Pathways to ensure universal and affordable access to hepatitis C treatment.

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.

Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001-2016.

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.

Data exclusivity exceptions and compulsory licensing to promote generic medicines in the European Union: A proposal for greater coherence in European pharmaceutical legislation.

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.

Viewpoint: Counterfeit medicines and substandard medicines: Different problems requiring different solutions.

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.