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.

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.

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.

A quiet revolution in global public health: The World Health Organization's Prequalification of Medicines Programme.

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.