Review Of WHO Public Health And IP Strategy: Help Needed On TRIPS Flexibilities

International organisations, in particular the World Health Organization, should help poor countries implement the flexibilities enshrined in international trade rules, a number of developing countries said at the World Health Assembly on 26 May. WHO members in committee hailed and noted a report on the UN agency’s strategy on public health, innovation and intellectual property, the first part of an overall review. Civil society had another take on the report, and deplored slow progress on access to medicines.

The World Health Assembly (WHA) is taking place from 22-31 May.

An independent review [pdf] provided by Capra International on the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA) was noted by WHO member states. Most countries taking the floor, particularly developing countries, expressed satisfaction with the report, its findings and recommendations.

It is expected that an overall programme review will be initiated in 2017 and will be informed by the review.

The 2008 GSPOA aimed “to promote new thinking on innovation and access to medicines and to secure an enhanced and sustainable basis for needs-driven essential health research and development relevant to diseases that disproportionately affect developing countries,” says the review.

The GSPOA, whose timeframe was extended earlier from 2015 to 2022, includes eight elements: (a) prioritizing research and development needs, (b) promoting research and development, (c) building and improving innovative capacity, (d) transfer of technology, (e) application and management of intellectual property to contribute to innovation and promote public health, (f) improving delivery and access, (g) promoting sustainable financing mechanisms, and (h) establishing monitoring and reporting systems.

The looks at the implementation of the GSPOA at country level and provides key findings, achievements, and gaps and challenges identified for each of the eight elements.

For example, on (e), application and management of IP to contribute to innovation and promote public health, the review found that the GSPOA “acknowledges the need for strengthening innovation capacity and the capacity to manage and apply IP in developing countries. This includes the use of flexibilities provided in the [World Trade Organization] Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to take measures to protect public health.”

The review found that at country level, “traditional IP models appear to support predominantly large companies, and it is difficult to promote alternative (non-commercial) IP models.” The review further found that “Resources and know-how required for the implementation of TRIPS flexibilities are still scarce in most countries, coupled with reluctance to use these or other legitimate mechanisms to advance access to medicines.”

A number of countries remarked on the importance of affordability and accessibility to medicines, such as Russia, South Africa for the African region, and the Philippines.

 Help in Implementation of TRIPS Flexibilities

Many countries called for support in the implementation of TRIPS flexibilities, which are defined by the WHO as a way for countries to “have a certain amount of freedom in modifying their regulations and, various options exist for them in formulating their national legislation to ensure a proper balance between the goal of providing incentives for future inventions of new drugs and the goal of affordable access to existing medicines.”

Indonesia asked the WHO to support its member states to implement TRIPS flexibilities, in particular for compulsory licences and parallel importations of medicines. The Indonesian delegate said IP should not jeopardize public access to medicines and vaccines.

The WTO defines compulsory licences as “when a government allows someone else to produce the patented product or process without the consent of the patent owner.” This happens once negotiations between the country and the medicine producer to bring prices down have failed.

Parallel importations are “When a product made legally (i.e. not pirated) abroad is imported without the permission of the intellectual property right-holder (e.g. the trademark or patent owner),” according to the WHO glossary.

The Philippines still has one of the highest drug prices in Asia, said the Philippines delegate, underlining the importance role of TRIPS flexibilities for access to medicines. The Philippines has not maximised the use of TRIPS flexibilities to its advantage, he said. The delegate also underlined the recommendations of the UN Secretary General’s High-Level Panel on Access to Medicines, especially on delinking the cost of research and development from the price of the end product, and the need for transparent drug pricing within and across countries.

Ecuador said the help of international organisations to support low- and middle-income countries to implement TRIPS flexibilities would be very useful. IP, he said, is very useful in order to develop social innovation, adding that governments should have strong, robust, transparent and effective mechanisms to draw benefits from patents, and ensure that the system is tailored to the needs of the population.

Malaysia voiced concern about so-called TRIPS-plus provisions in bilateral and regional trade agreements, which describes IP rules as going beyond the TRIPS requirements in terms of protection and enforcement measures. She said countries need capacity-building to mitigate the effects of TRIPS-plus measures in trade agreements.

Switzerland remarked positively on the way the report has taken a differentiated approach referring to countries in function of their income rather than bringing a large number of member states under the single term of “developing countries.” This allows for a more tailored response, the delegate said, adding that this approach should be kept for the overall review.

Some NGOs Not So Happy

A number of civil society groups took the floor to comment.

Knowledge Ecology International (KEI) said the GSPOA agenda to promote new thinking on innovation and access to medicines “has moved at glacial speed.” In particular KEI noted that the Capra report did not mention the notion of delinkage [between the cost of R&D and the price of medicines].

“How can you evaluate a strategy for new thinking and then ignore delinkage, the most important and controversial reform, and the only one that would eliminate the conflicts between innovation and access?” asked the KEI representative.

Médecins Sans Frontières (MSF, Doctors Without Borders) also underlined in its statement the need for member states, “under the leadership of WHO,” to act now to meet the GSPOA aims “to promote new thinking on innovation and access to medicines and provide a medium-term framework for securing an enhanced and sustainable basis for needs-driven essential health research and development relevant to diseases that disproportionately affect developing countries.”

MSF said “the evaluation’s conclusion on the role of market mechanism and publicly-funded R&D, the recommendation that member states simply ensure that ‘health R&D at national and sub-national level is prioritized,’ is at best vague and at worst deliberately obscure.”

The Medicines Patent Pool said its own mechanism is one concrete example of the successful implementation of the GSPOA.

 

Image Credits: WHO