Things Heat Up In WIPO Debate On Patents And Health

The World Intellectual Property Organization patent law committee this week became the latest venue for the global debate over the system to provide incentives to the pharmaceutical industry to find new medicines while ensuring all patients have access to those medicines. Most developing countries want the committee to discuss the recommendations of the United Nations Secretary-General’s High-Level Panel on Access to Medicines, while most developed countries disagree. The tone is rising, and the issue could come as a hurdle as countries decide the future work of the committee.

The issue of patents and health was discussed yesterday and this morning during the 25^th session of the WIPO Standing Committee on the Law of Patents, taking place from 12-15 December.

A focus of the discussions was whether the SCP should look into the recommendations included in the report [pdf] of the UN High-Level Panel (HLP) on access to medicines. The views are unequivocal: developed countries are saying that the HLP is not a member state-driven process, and add that the HLP report has not been endorsed by member states. The European Union added that members of the HLP did not reach consensus on the recommendations in the report.

Developed countries further said that the 2012 so-called “trilateral report” [pdf] on access to medicines, jointly produced by the WIPO, the World Trade Organization, and the World Health Organization would be a good basis for discussion, despite the fact that it offers no recommendations. A number of developed countries said that the mandate of the HLP was too narrow and addresses only part of the issue of access to medicines, seemingly putting an undeserved blame on the patent system.

In general, developed countries find the HLP outside of the realm of the SCP discussion and mandate. Meanwhile, discussions at the WHO and elsewhere have dragged on for decades without result.

Developing countries, such as the African Group, and members of the Asia and Pacific Group, on the contrary, said the SCP is a logical forum to explore the recommendations of the HLP.

Nigeria, on behalf of the African Group, said the issue of patent and health has been “glaring” since the 1994 adoption of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). It is important, she said, to find new ways to address this issue in the SCP and in WIPO.

The same dissension was observed last week during the 39th meeting of the Joint United Nations Programme on HIV/AIDS (UNAIDS) Programme Coordinating Board (PCB) (IPW, Public Health, 12 December 2016).

Competing Proposals for Way Forward

On the table this week are competing proposals. One is from the African Group, and was submitted at the last session of the SCP. The African Group proposal [pdf] for a WIPO work programme on patents and health was supported by a number of developing countries during the discussions this week, such as Brazil, Egypt, Ethiopia, India, Indonesia, Iran and Sudan.

The proposal suggests three elements: “(i) the elaboration of studies to be commissioned by the WIPO Secretariat, following consultations with the Member States at the SCP, from renowned independent experts; (ii) information exchange among Member States and from leading experts in the field; and (iii) the provision of technical assistance to Member States, and particularly developing countries and LDCs, in relevant areas, and building upon work undertaken in the first two elements of the work program.”

In the context of the information exchange, the proposal envisions inviting the UN Special Rapporteur on the Right to Health to present the report to the Human Rights Council, the WHO to present the Consultative Expert Working Group on Research and Development: Financing and Coordination, and the Co-Chairs of the HLP to share their views on the HLP findings.

Some developing countries also referred to a 2011 joint proposal [pdf] from the African Group and the Development Agenda Group on patents and health.

Also on the table is a 2011 proposal [pdf] from the United States on patents and health, which was supported by Group B developed countries this week. The proposal suggests inviting the WHO to make a presentation to the SCP on the availability of generic medicines in developing countries and least developed countries, and the non-patent barriers to availability of safe and effective medicines.

The US proposal also suggests conducting a study on the positive impact of patent systems in providing “lifesaving” medicines to developing countries, and a study to examine the availability of such medicines that are not protected by patents, and the reasons for their lack of availability.

Civil Society Reacts: High Prices Global Problem, Life and Death Matter

James Love of Knowledge Ecology International said he was “dumbfounded” to hear some countries question the idea that there is a policy incoherence between IP and the human right of access to medicines. Suggesting there is no incoherence is like denying a fundamental conflict in the current system, he said.

As an example, he cited the case of cancer drugs. He said out of the 49 oncology new active substances analysed which were initially launched between 2010 and 2014, fewer than half were available to patients by the end of 2015, in all but six countries: the US, Germany, the United Kingdom, Italy, France, and Canada.

Of the drugs approved in 2014 and 2015 by a set of developed countries, only the US, France, and Scotland have included more than half of those on reimbursement lists at the end of 2015.

The Third World Network also remarked that high prices of cancer and hepatitis C drugs are unsustainable for any governments, whether in developing or in developed countries. The representative also remarked that the trilateral study was not a member state report but yet was discussed at the SCP, and “it would be unacceptable for WIPO to refuse to discuss a high level panel of the UN.”

Médecins Sans Frontières (MSF, Doctors Without Borders) noted that the discussion was really about life and death, and not only a developing country issue, and remarked it was precisely under the WIPO mandate to address the issue of patents and health as a specialised agency of the UN.