Negotiating on IP and public health: the WHO IGWG

The IP world is abuzz this weekend with the meeting of the members of the World Health Organisation (WHO) on issues of innovation and IP in public health, with a focus on the needs of developing countries, and neglected diseases. The Intergovernmental Working Group (IGWG) hopes to design a consensus strategy paper to be presented at the World Health Assembly later in May.
An excellent overview of developments thus far can be found on IP Watch, which has been following the meeting (which ends later today) very carefully. There is little need to reproduce the entire article here, however, I shall highlight some of the issues that have been discussed thus far, as culled from this report.

The mood of the meeting was set by WHO Director-General Margaret Chan who said that an “agreed framework can make the cycle of product discovery, development and delivery more efficient and more sensitive to health needs in the developing world”.

But differences in whether and how consensus can be achieved remain: developed countries want to end discussion this week with a definite consensus, ideally wishing for WHO withdrawal from IP issues; while others, particularly developing country representatives, are wary of hasty decisions.

The fulcrum of the debate is nothing new: that the IP system, as it exists today, does not create economic incentives for private players to invest in research and development (R&D) for neglected diseases (i.e., diseases endemic in low-income populations in developing regions of the world that are unable to pay high prices to recover R&D costs. Fatalities from these diseases are estimated to equal those from HIV-AIDS.)

While the fundamental problem is being assimilated by member countries, a larger debate ensues: should WHO should engage in IP matters at all, and not leave such issues to the WTO or WIPO or individual member states. Critics believe WHO’s mandate of focussing on public health has been put on the back burner by introducing IP into its discussions. Again, this is a classic concern of global public policy: of policy coordination. All three organisations operate in overlapping disciplines, but with different mandates. And while all of them parrot the mantra of coordination (everyone wants to coordinate), noone wants to BE coordinated!

So, what next, we ask: One option would be to hand over the reins to a solitary organisation to deal with all IP issues with the assurance of non-interference from others. Another option would be to introduce a new overseeing coordinating entity, that will consolidate multiple mandates and interpretations of economic incentives, intellectual property, etc. But both of these come with an obvious set of problems – creating and sustaining legitimacy; and the mammoth task of consolidating multiple perspectives which will presumably result in “watered down” regulations that reeks of compromise. Read this article for a take on the downside of establishing a new global bureaucracy to regulate drug R&D.

Now, I don’t tout this as a solution to the issue, but I do believe that we should be worried that the organisations are unable to overcome their bureaucratic pomposity and persist in conducting independent fora, talking at cross-purposes, and head down what appear extremely divergent paths. They would do well instead to sit down together, at the same table (take a deep breath and focus!), conduct a joint assessment of needs, collectively prioritise issues, and draft a pragmatic and coherent policy sequencing pattern. But of course, this is cloud cuckooland! Getting to Yes is no easy task, and we return to IGWG developments…

The meeting seems to have gotten stuck at one particular element of the draft strategy, dealing with the application and management of IP to contribute to innovation and promote public health. The politics that beset an international organisation like the WHO has meant a watered down set of agreements. IP Watch says, “consensus is being achieved through a relative weakening of provisions, often, but not always, along north-south lines. Compromises involved the insertion of phrases like ‘possible’ and ‘appropriate.” [click on the image on the left to see a ‘re-envisioning’ of the world map, and maybe even of global politics!]

Among the debates and developments thus far include:

Promotion of research and development:
Art. 2.2.b that deals with accessibility to libraries and technical support to create compound libraries in developing countries was agreed upon. But the US dissented to three related articles, dealing with the creation of open databases and compound libraries ( 2.4.c), the dissemination of publicly or donor-funded medical inventions and know-how (2.4.d); and the “incorporation of research exemptions in legislation of developing countries” for public health purposes (Article 2.4.e).

Art. 2.4.d, the dissemination of publicly or donor-funded medical inventions and know-how: it comes as little surprise that India trumpeted the open source and open licensing model for innovation in drugs (I link to a selection of SpicyIP’s coverage on this issue here, here, here, and Mrinalini’s interview with Dr Samir Brahmachari here). The North-South divide was apparent in this debate, with Brazil and Jamaica strongly backing India, and opposition from US with Korean support. As it turns out, a compromise was reached with the phrase “including but not limited to open licensing.” Now, I am not sure what the import of this re-written provision is eventually. The draft strategy is scheduled to be put up soon, which I shall attempt to discuss in a subsequent post.

Art. 2.4.e: reads thus – “consider the incorporation of research exemptions in legislation of developing countries to address public health needs, consistent with the TRIPS and the Doha declaration on TRIPS and Public Health.” the US wanted to delete the entire paragraph which will be dealt with in the IP chapter (element 5). Here, it got some support from Japan, citing an ambiguous definition of “research exemption”. Counter-attack spiralled back, with references to the term in TRIPS and in US legislation. I am still unsure of the status of this section, and await a look-see at the draft before commenting further.

Art 5.1.f: speaks of the creation of digital libraries of traditional knowledge (and by extension, traditional medicines) in order to prevent misappropriation, but objections arose of such databases being counter-productive since they only opened up access to the knowledge. Readers might recall SpicyIP’s posts on this subject, most recently from Prashant, who ran a curtain-raiser on the India-USPTO conference on TK and on-going efforts making a consolidated digital database available in the public domain. This is an incredibly contentious and sensitive issue, and whether agreement of any consequence can be arrived at is a moot point.

The ethics of clinical trials has also come up for some debate, with the south American state of Suriname in the vanguard. It argued that trials were being conducted in developing countries, aiding medical innovation on drugs that were subsequently out of the price range of the same people who had participated in trials.

Phew! I think this is my longest post ever. But you are not going to be let off this easily… This is just the first instalment in what I hope will be a handful of posts on the IGWG, not least with a discussion on the eventual draft strategy itself, whenever that is made available. In my next post I will draw attention to civil society’s position on the issue in India and elsewhere, to “contextualise” the debate, as Kruttika recently reminded us to indulge in!

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