Africa Regional Group Proposes Patents And Health Programme At WIPO

This week in the World Intellectual Property Organization patent law committee, the African Group submitted an updated proposal for a work programme on patents and health that would help developing countries tailor patent law to their circumstances.

The effects of the monopoly created by patents on access to medicines are described in different ways. Broadly speaking, developing countries view this monopoly as a blank check for high prices and limited availability, while developed countries view patents as the main way to provide incentives for their pharmaceutical industry to invest in research and development for new cures.

The 24th session of the WIPO Standing Committee on the Law of Patents (SCP) is taking place from 27-30 June.

The SCP could not agree on a work programme for this session of the committee at its last meeting in December (IPW, WIPO, 6 December 2015). However, some sessions ago, the committee agreed on five topics to be discussed by the SCP: patent quality; exceptions and limitations to patent rights; patents and health; confidentiality of communications between clients and their patent advisors; and transfer of technology.

Today, the African Group presented an updated version [pdf] of an older proposal [pdf] submitted by the African Group and the Development Agenda Group in 2011 for a WIPO work programme on patents and health.

The Nigerian delegate, on behalf of the African Group, remarked on the chronic lack of access to medicines in developing and least-developed countries (LDCs), the Ebola and Zika virus epidemics, as well as the growing threat of antimicrobial resistance. She underlined the need for new ways of financing research and development (R&D) and innovation.

The proposed work programme of the African Group seeks to help developing countries and LDCs to tailor their patent regimes to make full use of the flexibilities available in the international patent system, according to the proposal, and includes three elements:

“- the elaboration of studies to be commissioned by the WIPO Secretariat, following consultations with the Member States at the SCP, from renowned independent experts,

– information exchange among Member States and from leading experts in the field, and

– 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.”

The proposal foresees a half-day information session at the next SCP session to which the UN Special Rapporteur on the Right to Health would be invited to present the report to the Human Rights Council on Intellectual Property Rights and Access to Medicines. Also invited would be the World Health Organization to present the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination.

The two co-chairs of the UN Secretary-General’s High-Level Panel on Access to Medicines would also be invited to share their views on the objectives and findings of the panel.

According to the proposal, “it is important for the SCP to be a significant facilitator in the critical work of analyzing the patent-related challenges and questions at the intersection of public health, access to medicines and patent rights.”

Among the studies suggested by the proposal is an analysis of the interface of competition law and patent rights in the context of pharmaceuticals in different countries.

The UN Development Programme in 2014 issued a guidebook entitled, “Using Competition Law to Promote Access to Health Technologies,” (IPW, Public Health, 19 May 2014).

Other proposed studies would explore alternative incentives for R&D such as a levy for pharmaceutical companies not engaging in research to tackle antimicrobial resistance, de-linkage of research funding and drug pricing, technology transfer, compulsory licences, exhaustion of rights to allow parallel trade, and a globally accessible licence database for compulsory and voluntary licences.

Several developing countries supported the proposal while some developed countries said they need more time to consider the African Group proposal.

Some developing country sources said the SCP has no choice but to join the global conversation on patents and access to medicines.

Group B (developed nations), in its statement on the subject of patents and health delivered on 28 June, said patent protection is “critical for research & development” in the field of pharmaceuticals. However, patent incentives are not the only factor to consider, the Greek delegate said on behalf of the group. Small markets, for example, may need additional incentives to support research, she said.

Group B called for the need to consider “the whole context” rather than focusing on patents. For example, the delegate said, “we would be interested to better understand why unpatented medicines do not reach the intended patients.”

“The availability of safe and effective medicines is a multifaceted problem, which impinges on many areas of law, national policy, physical infrastructure, social, education and economic factors, to name only a few,” she said.

Civil Society Call for Urgency

Among the civil society groups, Knowledge Ecology International (KEI) in its statement said that governments and health systems all over the world are struggling to cope with the high cost of medicines for cancer, hepatitis C, HIV, rare diseases, and the growing challenge of antimicrobial resistance. The KEI representative cited several examples where patients group petitioned against high prices of medicines in the United Kingdom, and in Colombia. He commented on the pressure by several developed countries to prevent Colombia from using flexibilities provided in the World Trade Organization Agreement on Trade-Related Intellectual Property Rights (TRIPS).

KEI urged the SCP to commission a framework study by leading independent experts to examine the implications of international trade agreements on access to medicines.

Third World Network (TWN) said the report of the 2015 edition of the Social Forum shows that there are two billion men, women and children who do not have access to essential medicines. “The lack of access to patented medicines is cause by the high prices of medicines emanating from the patent monopoly. Non-action to curb the abuse of patent monopoly by Member States violates their international human rights obligations such a right to health and right to science,” the TWN representative said.

Access to medicines “should not be predicated on upon the charity of pharma companies or even private ordering such as patent pools,” he said.

Future Work Wish Lists

According to some sources, the main issue of this session of the SCP is to agree on the future work of the committee. This is a prickly issue since delegations have divergent interests. This afternoon, most group coordinators and countries which took the floor called for a “balanced agenda,” but the concept of balance is open to interpretation.

For example, developing countries are calling for more work on exceptions and limitations to patent rights to address development concerns. Some also call for sufficient disclosure in patent applications, in particular the disclosure of the International Non-proprietary Names of active pharmaceutical ingredients.

The Group of Latin American and Caribbean countries (GRULAC) are in favour of a revision of the 1979 WIPO Model Law for Developing Countries on Inventions, as proposed by the group in 2015 in order to update the instrument (IPW, WIPO, 30 July 2015). In July, GRULAC said the revision is needed to respond to increasing demand from WIPO member states for legislative and policy assistance in line with the 2007 WIPO Development Agenda Recommendations.

Greece for Group B called for the work programme to include the five previously agreed agenda items of the SCP, and underlined the importance of work sharing to promote a more efficient search and examination of patent applications. The group also deems important the confidentiality of communications between clients and their patent advisors.

Each country referred to previous proposals for the SCP work, which have not been agreed upon.

SCP Chair Bucura Ionescu (Romania) called for regional coordinators to meet with her at the end of the afternoon today. Informal negotiations on the potential work programme are expected to take place until tomorrow afternoon when the formal plenary resumes.

Then it will be known if Ionescu’s assessment of member states being wiser than in December is realistic.