WIPO Members Struggle To Define Work Programme On Patents And Health

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As the World Intellectual Property Organization’s patent law committee grapples with starkly differing positions on the topic of patents and health, the secretariats of WIPO, the World Health Organization and World Trade Organization presented to members how their first trilateral study on access to medical technologies and innovation could be used as an effective resource. While the secretariats emphasised the neutral, informative nature of the book, some members pointed to a need for greater analysis of the challenges developing countries face when trying to use patent flexibilities for access to medicines.

The 19th session of the WIPO Standing Committee on the Law of Patents (SCP) is meeting from 25-28 February with heavy pressure to finally come to an agreement on its future work programme. Meeting documents are available here. Delegates worked quickly through the first part of the agenda at the start of the week (IPW, WIPO, 26 February 2013).

Launched at the WTO on 5 February, “Promoting Access to Medical Technologies and Innovation” provides a description of options available for policies involving public health, IP, and trade. At the request of SCP members, the three secretariats presented the study to the committee on 26 February.

A Neutral Resource

Presenting on behalf of the WIPO secretariat, Hans Georg Bartels, senior program officer in the Global Challenges Division, emphasised that the book is meant to inform, not to evaluate. In particular, he noted that the factual account of policy options available for the promotion of medicine access and innovation, “does not promote a view, does not provide a conclusion, nor does it provide recommendations.”

Similarly, Antony Taubman, director of the Intellectual Property Division at the WTO, said that the trilateral study represents a “consolidation of many years of collaboration between the three institutions, especially concerning TRIPS.” He said the focus on access and innovation of the report is mirrored in the WTO Declaration on the TRIPS Agreement and Public Health, known as the Doha Declaration, which was “one step in a journey toward greater recognition that access to medicines requires the right mix of policy measures.”

Presenting from a public health perspective, Zafar Mirza, coordinator of the Department of Public Health, Innovation and Intellectual Property at WHO, pointed to the study’s emphasis on the strong link between access and innovation during his intervention [doc], calling them “two sides of the same coin.” From heat stable vaccines to effective medicines for neglected tropical diseases, he cited several examples of where innovation and access are equally needed.

In terms of specific policy measures covered in the study, Mirza pointed to the importance of robust regulatory harmonisation to ensure the circulation of quality medicines on international markets; the effect of tariffs on pharmaceutical products on access; IP protection issues and how different trade deals can affect access and innovation.

In reaction to the study presentation, SCP members widely congratulated the three secretariats for the “thorough quality” and the comprehensive nature of the resource, congratulating them on their work. However, several developing countries called for additional analysis.

Developing Countries See Knowledge Gap

On behalf of the Africa Group, Algeria said that while the study recognises that there are some limitations to the use of patent flexibilities, it “does not look at the constraints countries encounters using the flexibilities.” Additionally, the delegate said that many African countries are “overwhelmed by the formalities” and said that the proposal tabled by her group and supported by the Developing Agenda Group (DAG) would be an important contribution to this knowledge gap.

Namely, the African and DAG joint proposal on a patents and health work programme (SCP/16/17), suggests three elements including studies, information exchange, and technical assistance especially for least developed countries (LDCs). In terms of the studies, the proposal calls for an examination of “challenges and constraints faced by LDCs in making full use of the public health related patent flexibilities both in the pre-grant and in the post-grant stage.”

The delegate from India supported the proposal saying, “There is an urgent need to study flexibilities” and to “study their impact on the price of drugs.”

Brazil, on behalf of the DAG, also pointed to how further studies could build on the trilateral study. The delegate noted that the study showed that “public health policies demand wide and complex governmental intervention in order to be effective, and that competition policy is effective for enhancing access to medical technology and fostering innovation in the pharmaceutical sector. These matters could be further explored by the DAG/African Group proposal.”

US Says Flexibility Focus Would Jeopardise SCP Neutrality

On the opposite side of the policy spectrum, the US delegation’s proposal on patents and health (SCP/17/11) proposes an examination of the positive side of patents in providing medicines to developing countries. Additionally, the US proposal emphasises the “limited impact patent protection has on the availability of essential medicines” and that “greater uses of flexibilities are not useful in securing better availability of medicines.” Rather, the US suggests focussing on alternative voluntary licensing and funding schemes.

Addressing the plenary, the US delegate said that “patents do not prevent countries from access to health” and the removal of intellectual property rights would also not automatically improve access. Additionally, the delegate said that focusing on flexibilities would “jeopardise the neutrality of what we are doing here.”

Patents and health is certainly one of the most divisive issues the SCP is facing, with countries seemingly entrenched in their positions. However, a delegate from an African country noted that not all developing countries are as focussed on flexibilities as others. Another delegate from a developing country expressed concern about countries finding a compromise on the issue as continuing work on international patent standards is an essential part of the multilateral dialogue on the IP system.

The SCP chair is meeting with regional coordinators today as members endeavour to strike a deal on the future of WIPO’s patent committee.

[Update:] WIPO Observer Interventions

Several WIPO observers made interventions following the trilateral study presentation, including Knowledge Ecology International (KEI), which focussed remarks on cost-sharing approaches to the implementation Article 39.3 of TRIPS, which refers to the protection of regulatory data, and the human rights aspect of de-linking cost from the prices of medicines where markets are failing and the R&D treaty.

On Article 39.3, KEI noted that the trilateral report points to “cost-sharing as an alternative to data exclusivity which would permit the reliance on originator data provided that the ‘generic supplier participates in the costs of generating the data’.” KEI encouraged countries in trade agreement negotiations to consider this approach.

Additionally, KEI, long-time advocates of an R&D treaty for diseases of the poor, noted that the trilateral study highlights the human rights aspect as it relates to IP and trade, suggesting that member states pursue this avenue in ongoing international talks on the subject.

In particular, KEI pointed to a key related section in the study: “In the context of neglected diseases where innovation in medical technologies has not kept with the needs of developing countries, the right to health includes an obligation for states to promote R&D of new medical technologies.”

The Medicines Patents Pool (MPP), a Geneva-based group working to increase access to affordable, high-quality medicines for HIV/AIDS patients in low and middle income countries, noted that the trilateral study highlights the important role of patent pools in promoting access to medicines and enhancing the availability of cheaper generic medicines in developing countries. The cutting-edge organisation also invited countries to encourage pharmaceutical companies not yet with the pool to join. [end update]

IFPMA Releases Report on Incremental Innovation

Separately, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) launched a publication, “Incremental Innovation: Adapting to Patient Needs,” this week. The aim of the publication is to “highlight the benefits of incremental innovation for global health,” according to an IFPMA media release.

Incremental innovation refers to improvements on existing medicines such as expanding the number of medicines within a therapeutic class, increasing the number of available dosing options, discovering new physiological interactions, and improving other properties of existing medicine. The association linked the report to the SCP patent and health discussions.

“IFPMA welcomes discussions at the SCP on the important role patents play in the enabling innovation and advancing global health. Patents are an important incentive for both creating innovative treatments and improvements to first-in-class medicines. The various examples of incremental innovation described in our report often involve many of the same research and development challenges as breakthrough medicines, and contribute to widening the number of treatment options available to doctors and patients,” Andrew Jenner, director of innovation, IP and trade at the IFPMA, told Intellectual Property Watch.

Critics call the patenting of these innovations “evergreening,” as a tactic to prolong market exclusivity of a drug, blocking competition and affordability. Indeed, the delegate from Algeria, on behalf of the Africa Group, made reference to evergreening during her intervention on 26 February, calling for a need to further examine the topic in a future study.


Rachel Marusak Hermann may be reached at info@ip-watch.org.

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