At WTO, governments, health advocates see benefit from TRIPS; LDC waiver urged

Co-organised by Médecins Sans Frontières (MSF), the Third World Network (TWN), UNAIDS, and the Peoples Health Movement (PHM), the panel sought to take stock of the state of access to medicines and innovation, twenty years after the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) was adopted.

Mariangela Simao, director of the Rights, Gender, Prevention, and Community Mobilization Department at UNAIDS, and former director of the Department of Sexually Transmitted Diseases and AIDS at the Health Ministry of Brazil, mentioned the adoption of the United Nations post-2015 sustainable development agenda last month.

People living with HIV have longer and better lives than before, but it is imperative that the 50 million in treatment receive a sustainable treatment, and that 90 more million patients have access to treatment in the next five years, she said.

Generic competition has dramatically brought down prices for first line HIV drugs, said Simao, but for second and third generation drugs, the price is still extremely high in some countries.

She cited the Global Commission on HIV and the Law, chaired by the UN Development Programme (UNEP), and said the commission had delivered specific recommendations on IP and HIV. Some of those recommendations are visionary and need to be taken seriously, she said (IPW, Public Health, 9 July 2015).

UNAIDS is about to launch a new organisational strategy, according to Simao. UNAIDS a few months ago worked with a think tank to advise on the new strategy, which suggested that countries be supported to remove IP-related barriers to access to HIV treatments, she said.

To Grant or Not To Grant Pharma Extension to LDCs

Michael Wamai, first secretary at the mission of Uganda, detailed the request of the Least Developed Countries (LDCs) to extend the IP waiver they currently enjoy until the end of the year on pharmaceutical products.

LDCs have an increasing health burden and non-communicable diseases are rising sharply, and they need to strengthen their local production capacity and to be able to import accessible medicines, he said.

The LDCs’ request has met resistance from some developed countries, he said. Some have questioned the relevance to agree to a separate extension on pharmaceutical products when there is a general exemption running until 2021.

A number of bilateral meetings have been held, involving developed and developing countries. A majority of countries agree with the LDC request, he said, and he noted the particular support of the European Commission and Norway.

The process for approval of the LDC extension is first the TRIPS Council and then it “goes through” the General Council, but would not be a matter for the WTO ministerial.

Flexibilities in the TRIPS agreement have been invaluable for access to medicines in LDCs, he said. In the absence of insurance that countries do not have to enforce intellectual property rights, suppliers of medicines and procurement agencies would be reluctant to export patented medicines to LDCs for fear of being sued for infringement, he said.

TRIPS Flexibilities Paramount

For Ellen ‘t Hoen, Medicines Law and Policy consultant, the TRIPS agreement laid down important obligations in the area of IP protection but also provided important flexibilities for governments to ensure public health could be protected.

The 2001 Doha Declaration on TRIPS and Public Health came in support of flexibilities relating to public health, she said, and flexibilities have been used much more widely than is generally understood.

The Doha Declaration created an environment where initiatives such as the Medicines Patent Pool (MPP) could thrive, she said. ‘t Hoen is the former executive director of the MPP, and former Médecins Sans Frontières Access to Essential Medicines Campaign coordinator.

In particular, paragraph 7 of the Doha Declaration gave the LDC the possibility to avoid granting and enforcing patents on pharmaceutical products, she said. The waiver was widely used in procurement of medicines, she said, at a time when licenses were not available.

The practical implication of the LDC waiver is that an LDC through simple declaration can authorise the importation or production of a medicine regardless of its patent status in the country, she said.

A specific waiver for pharmaceuticals is important, she said, as many LDCs have “patent laws on the books.” She also said that with countries covered by MPP voluntary licensing agreements that the MPP only covers HIV and AIDs. Finally, she said the LDC waiver is the best-used measure for access to medicines at WTO, so it “sends the wrong message” not to extend it. “Why on earth would you do that, unless you are completely without heart,” she said.

She also pointed out that the World Health Organization recently put some important medicines on the Essential Medicines List it keeps, including medicines that are “extremely highly prized” and still under patent.

Agreement on the LDCs’ request will not solve challenges for other countries, she said. The world is struggling with the ever-increasing prices of medicines, she said, and that has to be addressed, adding that the “IP maximalist” agenda pushed in regional trade talks is of great concern.

Hu Yuanqiong, legal and policy advisor for MSF Access Campaign, said the expansion of the global patent regime impedes access to medicines for all. HIV is a telling example of how generic competition drove prices down.

The second and third line HIV drugs pose a real access challenge, she said, with the price of a third-line regimen being more than 14 times higher than the recommended first line. The problem is particularly acute for middle-income countries.

Hepatitis C is not only affecting developing countries, she said, and the price of a sofosbuvir treatment is about US$84,000 in the United States. Millions of people living with hepatitis C in middle-income countries are excluded from treatment, she said, with 30 million in China alone.

Health systems in developed countries are struggling with hepatitis drug prices. Some 5 grams of Bristol-Myers Squibb’s dataclavir is worth more than the same weight in diamonds, Hu said.

Gilead’s key sofosbuvir patent has been rejected in Egypt, India and China, she said, and has been challenged in Brazil, Argentina and other countries for lack of novelty.

Some TRIPS-compliant ways for patent offices to avoid the ever-greening of patents for patent offices,, she said, include strict patentability criteria, a robust substantive patent examination system, and procedures to challenge underserved patents with pre-grant oppositions. As an example, she mentioned the Patent Act Section 3(d) of the revised India Patent Act.

She called on South Africa “to do better” with its patent law reform, and include in particular strict patentability criteria.

Non-Violation Complaints Under TRIPS: Danger Zone

Separately, Srikar Mysore, first secretary at the mission of India to the WTO, talked about non-violation complaints in the context of the TRIPS agreement.

Non-violation complaints (NVCs) refer to the ability of a government to bring a dispute to the WTO, based on loss of an expected benefit caused by another member’s action, even if no WTO agreement or commitment has been violated, according to the WTO.

Discussions on this topic are ongoing in the TRIPS Council as delegates are expected to provide a recommendation on the indefinite extension of the current waiver exempting TRIPS from non-violation complaints to the December WTO ministerial conference in Nairobi.

Developing countries have concerns that NVCs under TRIPS could affect the agreement’s flexibilities, Mysore said. There is a serious possibility that many IP regimes or measures could be challenged under TRIPS, he said.

Asked whether developed countries might also face challenges, for instance for “TRIPS-plus” measures in bilateral and regional agreements, he said it would be better not to find out.

NVCs under TRIPS would create a lot of legal ambiguity, and could “open a Pandora’s box” as the TRIPS flexibilities allow for a certain course of action that could be hard to justify under NVCs, he said. It might be a “lawyer’s paradise,” but the mere threat of a dispute could act as a deterrent for using flexibilities or taking balanced policies, he said.

Most countries are in favour of extending the moratorium indefinitely, said Mysore, except for the United States and Switzerland. The European Union supported the extension of the moratorium, as well as Canada, he said.

Source: Intellectual Property Watch