Does the Roadmap for Access to Medicines 2019–2023 Neglect TRIPS Flexibilities?

The article below is part of the‘WHO-Watch’ program, which is an effort of the People’s Health Movement. The programme works towards democratising global governance for health and involving young activists in following the governing body meetings of the World Health Organisation – the Executive Board meeting in January and the World Health Assembly in May – every year.

It is well-recognised that access to affordable and quality healthcare is a global concern. One of the main contributors to this is the high proportion of health spending on medicines owing to the exorbitant prices of many of these medicines.

Roadmap for Access 2019-23

Recently, the 72nd World Health Assembly held during May 20-28, 2019, discussed the steps that need to be taken to make medicines more accessible were discussed and passed a resolution, the ‘Roadmap for Access 2019-23”. The roadmap, as it is referred to, is a continuation of decisions taken in 2018 at the WHA, where the Director-General of WHO was mandated to come up with recommendations that would outline WHO’s work on access to medicines and help countries in addressing issues such as high prices, medicines shortages and stockouts, and quality of medicines.

Compulsory patent protection under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is one of the major causes of high prices of medicines. This article looks at the roadmap’s proposals for addressing the challenges of accessing patented medicines through the use of TRIPS flexibilities. A separate article will examine the issues of pricing of medicines and the interventions initiated by Italy for promoting greater transparency around medicine costs.

What did member states say about TRIPS flexibilities?

Africa and Euro joint statement delivered by Botswana: “[The] Roadmap identifies many important areas towards the realisation of better access to quality and affordable medicines. We note that there are areas where ongoing actions can be strengthened for results even in the short term. Areas such as building and strengthening health systems, better use of TRIPS flexibilities, regulatory capacity, ensuring the safety of medicines, fostering research and development of medicines and vaccines for communicable and non-communicable diseases.”

Also read: Can Public-Private-Partnerships Help Stop Non-communicable Diseases?

South East Asian Regional Office (SEARO) statement delivered by India: “Urgent efforts should be made to make advances in new affordable, safe and quality health products and medical devices widely available in developing countries including leveraging international intellectual property agreements which contain flexibilities that could facilitate increased access to pharmaceutical products by developing countries as recommended in the report of Commission on Intellectual Property Rights, Innovation and Public Health.”

What does the road map say about TRIPS flexibilities?

The roadmap comprises of two strategies: “The first is to ensure quality, safety, and efficacy of health products”, and the second is “improving equitable access” (WHO). The following table lists the specific activities that fall under each strategy.

One of the activities to improve equitable access is “application and management of intellectual property to contribute to innovation and promote public health”, which spells out the details of using TRIPS flexibilities. Under this activity, the following actions are to be carried out: “Foster innovation and access to health products by appropriate intellectual property rules and management” and “provide technical support and capacity building”.

The deliverables under each activity are as follows:

• Foster innovation and access to health products by appropriate intellectual property rules.

• Promotion of public health-oriented licensing agreements and transparency regarding the patent status of existing and new health technologies.

• Information provided on country experiences promoting public health approaches in the implementation of health-related provisions of the TRIPS agreements, including relevant TRIPS flexibilities and intellectual property management.

• A review of mechanisms and incentives for access to affordable health technologies enabled by publicly funded research and development.

• Support for the expansion of the Medicines Patent Pool to patented essential medicines and patented medicines included in WHO treatment guidelines through the identification of potential products for licensing.

Also read: ICD-11, a Milestone in Era of Digital Technology: WHO

There are two deliverables focussing on voluntary licensing. The roadmap mentions that it will assist in expanding the Medicines Patent Pool (MPP) to include patented medicines that are either on the WHO’s essential medicines list or treatment guidelines by identification of potential products for licensing. This initiative to assist in the facilitation of voluntary licensing stands to be a tricky considering that the MPP is an NGO. WHO’s normative mandate should ideally be to focus on Member State-driven initiatives such as assisting with the use of TRIPS flexibilities, rather than facilitating a private ordering through a voluntary license. This excessive focus on voluntary licenses gives an impression that WHO’s preferred route to manage intellectual property is through private ordering, i.e. voluntary licenses, rather than using the compulsory licenses or government use licenses as mechanisms for increasing access to medicines.

Provide technical support and capacity building

• technical support provided (as appropriate, upon request, in collaboration with other competent international organisations), including to policy processes and to countries that intend to make use of the provisions contained in TRIPS, such as the flexibilities recognised by the Doha Declaration on the TRIPS Agreement and Public Health and other WTO instruments related to TRIPS, in order to promote access to pharmaceutical products.

• Support for the consideration of public health implications when negotiating bilateral or multilateral trade agreements.

• Facilitation of the assessment of the patent status of essential health products at national and regional levels, in collaboration with competent partners

• Continued strengthening of the trilateral collaboration between WHO, WIPO, and WTO, including to implement this road map, as well as with other relevant international organisations such as United Nations Conference Trade and Development (UNCTAD) and United Nations Development Program (UNDP).

The technical assistance to the Member States would be provided “as appropriate, upon request”. This would mean that a Member State’s request is a precondition for WHO to provide technical assistance to use TRIPS flexibilities. Since developed countries continue to threaten smaller and low and middle-income countries with trade sanctions when they try to use of TRIPS flexibilities, it is unclear whether these countries would by themselves come forward to make use of the TRIPS flexibilities and request WHO’s assistance. It is not clear whether WHO would prepare materials and carry out training to assist the Member States to enhance their capacity to use the TRIPS flexibility.

The roadmap’s deliverables related to patent status in collaboration with potential partners and trilateral cooperation also raises some concerns. In both cases, World Intellectual Property Organisation (WIPO) may be a partner. The involvement of WIPO, which has a mandate to strengthen patent protection and receives substantial revenue from patent application fees, raises concerns about conflicts of interest. In fact, the generic industry raised concerns about WIPO’s patent database, Pat -INFORMED, in collaboration with the International Federation of Pharmaceutics Manufacturers Associations (IFPMA). In a letter to the WIPO DG they state, “Given the many issues the IGBA (International Generic and Biosimilar Medicines Association) has identified with respect to its potential impact on pharmaceutical competition, procurement, and public health, we believe WIPO should reassess its involvement in this initiative and whether the inclusion of a link to the database on its website is appropriate for a United Nations agency”.

Also read: India’s Production of Affordable Generic Drugs is Under Attack by the United States of America

In the absence of monitoring the implementation of the above-mentioned deliverables activities by Member States and civil society organisations (CSOs) there is a danger of legitimising patent monopolies, instead of encouraging processes that ensure that intellectual property regimes are applied and managed so as to secure both product innovation and equitable access to medicines.

The above article is compiled with contributions from Alane Ribeiro ( Brazil), Ana Vracar (Croatia), Ben Eder (UK), Gargeya Telakapalli(India) Sun Kim ( South Korea), Stuti Pant (UK), Lucy Singh (UK), Maira Mathias (Brazil), Sophie Gepp (Germany) and Andrew Harmer (UK).