WHO Members Reach Preliminary Agreement On TRIPS And Malaria

By Tove Iren S. Gerhardsen
A preliminary agreement has been reached at the World Health Assembly on a draft proposal on malaria and the use of flexibilities in trade law to promote access to preventive technologies, sources said.

After being discussed at the World Health Organization Executive Board meeting in January (IPW, Public Health, 6 February 2007), there were two proposals, mainly from the United States and Kenya, for consideration in the draft malaria resolution heading into the 13-23 May World Health Assembly (IPW, Public Health, 10 May 2007).

The first option, supported by Kenya and others, urged member states to provide in their legislation for full use of the flexibilities found in the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), “in order to increase access to anti-malarial medicines, diagnostics and preventive technologies.”

Option two favoured by the United States, Switzerland and Japan, among others, stated that countries should consider, whenever necessary, adapting their legislation to allow full use of the TRIPS flexibilities, but not linking this language to access to the products, instead inserting a reference in brackets in the following paragraph, according to the draft resolution (EB120.R16).

Japan also supported this option, saying it was up to member states whether and how the flexibilities were adopted depending on their circumstances.

The new draft appears to be a compromise as the language referencing TRIPS was included in a paragraph linking it to access to “preventive technologies,” with an explanatory footnote, while the language on anti-malarial medicines is found in a separate paragraph.

Among the TRIPS flexibilities are the use of compulsory license which allows use of a patented material under certain circumstances without the authorisation of the patent holder, or the immediate introduction of generic medicines upon patent expiry.

But after small-group discussions mainly among the United States and Kenya, the parties have reached an agreement, resulting in new, unbracketed (brackets indicate that there is not yet agreement), a Kenyan official told Intellectual Property Watch, adding that this was a serious attempt at consensus. The United States was not available for comment. The new draft will have to be discussed and adopted by all members.

New Draft

According to the 19 May document, “Malaria, including proposal for establishment of World Malaria Day, Draft resolution proposed by a working group” (A60/A/Conf.Paper No.8 Rev 1), there are now two new paragraphs both parties have agreed to. Member states are urged:

“To provide, whenever necessary, in their legislation for use, to the full, of the flexibilities contained in the Agreement on [TRIPS] in order to promote access to pharmaceutical products,” with a footnote explaining that this would mean any patented product of the pharmaceutical sector or active ingredients, as stated in the WTO Doha Declaration from 2001, which explains TRIPS in the context of public health. This was the paragraph Kenya wanted, the official said.

The next paragraph reads: “To aim at reducing or interrupting malaria transmission, wherever feasible, through integrated vector management, promoting improvement of local and environmental conditions and healthy settings and increasing access to basic health services, anti-malarial medicines, diagnostics and preventive technologies in order to reduce the diseases burden.” Preventive technologies include anything that stops the spread of malaria, such as nets and prophylaxis, a source said.

Non-governmental Side Events on Patents, Medicines

Separately, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) held a 16 May event alongside the assembly, at which it presented new search functions of its clinical trials portal and where representatives from Sweden, including the Swedish industry association, LIF, presented its website, which provides extensive patient information. Sweden is known for its “open source” and transparency policy as all public documents are supposed to be available for the public. For LIF, this means transparency and availability of information on clinical studies to patients, it said.

Anders Milton, president of the European Red Cross and Red Crescent Societies Network against HIV/AIDS and Tuberculosis, said that it was a “fundamental right” for patients to have access to information in their mother tongue.

IFPMA also presented an updated version of the book, “Partnerships to build healthier societies in the developing world.” Divided into disease categories, it lists the various initiatives and programmes from companies towards the United Nations Millennium Development Goals, for example, which companies are involved in “Pediatric Formulations or ARVs [antiretrovirals used against HIV/AIDS].”

On 18 May, the Christian Medical Commission held a briefing with non-governmental organisations including Médecins Sans Frontières, Oxfam, Third World Network and Knowledge Ecology International, at which patents’ effects on medicines prices and access was highlighted.

An Oxfam International representative said that the Philippines, which has the second highest medicine prices in Asia after Japan, was in the process of implementing four TRIPS flexibility safeguards in their law, and was to vote in Congress next month. He called on WHO to get engaged in the debate. He said the Philippines had been challenged by industry to have the Bolar provision (immediate introduction of generics once the patent expires) in its law.

Peter Beyer from Switzerland’s Intellectual Property Office, speaking in his own capacity, said Switzerland was in the process of adopting the Bolar provision in its amended IP law, referring to recommendations from the WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH). He said the debate should move from arguing whether patents are good or bad, and said that WHO “can’t really negotiate TRIPS.”

Eric Noehrenberg from IFPMA said that as for the industry, “we are doing our part,” and said that the IP system “is developing new drugs.” He said it would never be enough, but said the parties should work together, “instead of conflict.”

Speaking as a Kenyan involved in the process of the WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property, Ahmed Ogwell, head of international health relations at Kenya’s Health Ministry, said the process had stopped being technical, and was now political. He said the parties had to move out of their “relatively prejudiced cocoons.” He said a lot could be done by the private sector as well as governments, adding that he hoped WHO would, “be an arbiter whose bias is always going to be public health.”

On 17 May, the International Policy Network (IPN), a free-market think tank, held an event entitled, “A Global Medical Research and Development Treaty: An answer to global health needs?” This is the same title as a study written for IPN, which is supported by pharmaceutical companies generally seen as favouring the status quo. Study author Andrew Farlow of the Said Business School, University of Oxford, faced off on a panel with James Love, director of KEI, a consumer-oriented think tank which seeks to change the current system.

Love presented a proposal he has helped develop to establish a medical R&D treaty that could help reduce prices on drugs by changing the current system of companies paying for R&D through higher prices. The proposal is to establish a large “prize” fund to pay companies for their research so prices could be lower, especially for sick people in poor countries who now cannot afford treatment. Love tied the problem of access and pricing to intellectual property rights, and offered a range of proposals from large to small that could ameliorate the situation. He referred to the WTO TRIPS agreement as a “12,000-word R&D treaty” because of its legal effect on that area. “We want a new deal,” he said.

Farlow took issue in his study and on the panel with many aspects of the “resource allocation” treaty proposal, pointing out questions that remain to be addressed. He focused on issues of implementation, the setting of weights on countries’ spending obligations, measurement, equity and developing country buy-in, and efficiency. He particularly targeted a suggestion that tradeable government credits for public health R&D, as are used in global environmental economics, might be a good model. He also raised issues of enforcement, and said the model would be overly dependent on the participation of the United States. Farlow suggested improving the existing system before dramatically changing it.

But Love argued that change is necessary and that details of how to address unresolved public health problems are already being negotiated by governments. “Unless Bill Gates [the Microsoft chairman who has funded a foundation addressing public health issues] is going to be the entire public health system, there’s going to have to be some sort of mechanism” to address the persistent problems, he said.

Tove Gerhardsen may be reached at tgerhardsen@ip-watch.ch.