World Health Assembly: Draft Of NCD Action Plan Shows Compromises On IPRs

Negotiators worked late last night to reach some compromise on the intellectual property-related component of the emerging World Health Organization action plan on non-communicable diseases.

The resulting draft text, as of 10:00 last night and obtained by Intellectual Property Watch, shows the areas of compromise that were found, in general keeping the document neutral on the sensitive issue of IP rights, but retaining some key references.

The annual World Health Assembly is taking place from 20-28 May.

Drafting group negotiations on the NCD action plan are continuing today, and were expected to shift to finalising the draft resolution on the issue to go before the full Assembly next week. A third document, a “draft comprehensive global monitoring framework and targets for prevention and control of noncommunicable diseases,” is not expected to be reopened in the drafting group, according to a participant. The framework is reproduced as Appendix 2 to the draft action plan. More reporting on these documents is available here (IPW, WHO, 22 May 2013).

The WHO is focussed on four groups of NCDs: cancer, diabetes, cardiovascular and chronic respiratory diseases.

Last night, the drafting group worked through the section of the global action plan on access, which deals with IP rights issues. In general, participants say the talks in the closed room have had a positive tone, and disagreements have been worked through. Some changes were made to the draft action plan in the area of IP.

One area that did not change was a reference in the draft action plan text under Article 48 (e) on access to the flexibilities developing countries have in applying IP rights, as stated in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

The first part of Article 48 (e) states:

“Access: Policy options to improve equitable access to prevention programmes (such as those providing health information) and services, essential medicines and technologies, with emphasis on medicines and technologies required for delivery of essential interventions for cardiovascular disease, cancer, chronic respiratory disease and diabetes, through a primary care approach, include:

• Promote access to comprehensive and cost-effective prevention, treatment an dcare for the integrated management of noncommunicable diseases, including, inter alia, increased access to affordable, safe, effective and quality medicines and diagnostics and other technologies, including, where appropriate, through the full use of flexibilities and policy options under the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement).”

Also under Art. 48 (e) a change was made as proposed by Canada to weaken a reference to generic drugs. It originally said:

“Promote procurement and use of safe, quality, efficacious and affordable generic medicines for prevention and control of noncommunicable diseases….”

Now it states: “Promote procurement and use of safe, quality, efficacious and affordable medicines, including generics….”

In Article 49 (b) on technical cooperation, a disagreement led to a simple compromise.

The original draft Art. 49 (b) stated:

“Encourage countries to improve access to cost-effective prevention, treatment and care including, inter alia, increased availability of affordable, safe, effective and quality medicines and diagnostics and other technologies and support the application and management of intellectual property and other relevant trade-related factors in a manner that maximizes health-related innovation, promotes access to health products and is consistent with the provisions of the TRIPS Agreement and related instruments, as well as other WTO agreements, and meets the specific research and development needs of Member States.”

Now it states:

“Encourage countries to improve access to cost-effective prevention, treatment and care including, inter alia, increased availability of affordable, safe, effective and quality medicines and diagnostics and other technologies in line with the Global Strategy and Plan of Action in Public Health, Innovation and Intellectual Property.”

This change was reflected in the non-paper from the informal meetings that took place prior to the WHA.

The 2008 Global Strategy and Plan of Action set out a mandate for addressing the lack of research and development for neglected diseases, those primarily affecting developing countries, for which there is little market incentive for northern companies.

But tensions have arisen over subsequent proposals in recent years at WHO to fill the gap in R&D that might undermine or weaken the intellectual property system. This is playing out in another track at the WHA, related to the Consultative Experts Working Group (CEWG). The CEWG came up with a short list of ideas for financing R&D for neglected diseases, including an R&D treaty, but it has been taken off the table by developed countries and replaced by a plan to study the issue for 3 years.

Meanwhile, a third area of change in the NCD action plan was an effort by the European Union to remove another reference to the TRIPS flexibilities, in Article 54 (b).

The original Art. 54 (b) stated:

“Technical cooperation: Provide technical assistance upon request to strengthen national and regional capacity: (i) to incorporate research, development and innovation in national and regional policies and plans on noncommunicable diseases; (ii) to adopt and advance WHO’s prioritized research agenda on the prevention and control of noncommunicable diseases, taking into consideration national needs and contexts; and (iii) to formulate research and development plans, enhance innovation capacities to support the prevention and control of noncommunicable diseases, including, where appropriate, through the full use of flexibilities and policy options under the TRIPS agreement.”

Now it shows a strikethrough of the line:

“including, where appropriate, through the full use of flexibilities and policy options under the TRIPS agreement” as requested by the EU. But it says Brazil, India and Thailand asked to retain it. The EU proposal was first made in the non-paper from the informal meetings before the WHA. This section is still in brackets reflecting lack of consensus.

Separately, according to one participant, an attempt was made by a government to introduce a statement about de-linkage of drug prices from R&D costs, which is a core principle underlying the effort to find alternative solutions to neglected diseases. The Pakistan chair intervened to try to block the proposal based on “chair’s prerogative,” but member states argued that a chair does not have that right. Nevertheless, the proposal did not make it into the text.

In general, WHO officials and northern industry representatives have played down the possibility of problems related to patenting and access to treatments for NCDs by poor populations. But it is not clear how they will afford high-priced cancer medicines or the latest drugs for other NCDs as they are developed.