Thiru Balasubramaniam, Geneva Representative, Knowledge Ecology International
Sara Crager, MD/PhD Candidate '12 at Yale University/Universities Allied for Essential Medicines
Nicoletta Dentico, Policy and Advocacy Advisor, DNDi
Lila Feisee, Managing Director for Intellectual Property, Biotechnology Industry Organization
Spring Gombe, Health Policy Analyst, Knowledge Ecology International
Amit Sen Gupta, All India Peoples Science Network and K.M.Gopakumar, Centre for Trade and Development (CENTAD), India
Ethan Guillen, Executive Director, Universities Allied for Essential Medicines
James Love, Director, Knowledge Ecology International
Greg Perry, Director General, European Generic Medicines Association
Sarah Rimmington, Attorney, Essential Action
Judit Rius Sanjuan, Attorney, Knowledge Ecology International
Tido von Schoen-Angerer, Director, Médecins Sans Frontières (MSF)’s Access Campaign
Christian Wagner-Ahlfs, Essential Innovation Campaign Coordinator, Health Action International
Guy Willis, Director of Communications, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
Thiru Balasubramaniam, Knowledge Ecology International. "WHO has been charged with finding a new paradigm for medical R&D that does not pit innovation and access against each other, but rather implemented both at the same time.
At the conclusion of these IGWG negotiations today (May 3, 2008), it was distressing to observe rich countries roadblock progress on remedying anti-competitive practices, and oppose in some sections of the text progress on the testing of incentives for R&D that are de-linked from product prices.
The highest income countries came to the IGWG with a strong-arm playbook to defend their industry policy objectives which in this case was to ensure that monopolies remain as the golden goose to stimulate innovation.
Barbados, Bolivia, Brazil, Chile, India, Thailand and Suriname showed great leadership in ensuring the hard won victories of Doha and the CIPIH were not rendered null and void. Prizes, patent pools and the R&D Treaty remain on the WHO agenda, evidence that the spirit of Geneva is not dead."
Sara Crager, Yale University/Universities Allied for Essential Medicines. "I found it almost cliche, the extent to which the block ofindustrialized countries so faithfully represented the interests ofthe pharmaceutical industry. Rather than a dedication to exploringways to effect real change, they appeared to have a deep commitment tothe status quo. I found this position unbelievably incongruous withthe reality of the state of health care in the vast majority ofdeveloping countries. It was underscored so many times how well ourcurrent system of intellectual property is succeeding. I am unable tosee how a system that leaves the majority of the worlds populationwithout adequate access to medicines qualifies as 'success'.
Despite the clearly lukewarm commitment of industrialized countries tomaking meaningful changes to our current system, there was somelanguage that has remained intact that I hope puts us on the rightpath to increase R&D for neglected disease and increasing the R&Dcapabilities of developing countries. I was quite pleased that amention of 'prizes' remained, as well as a commitment to increasingaccess to compound libraries. These two examples, however, I thinkunderscore the fact that at the end of the day these are just words,and there is a long way between what is now on paper and putting intomotion activities that will actually have a positive health impact forpeople living in developing countries. While the concept of prizesremained intact, the concept of a 'prize fund' was rejected with noproposed alternative funding strategies. I can't imagine that a prizethat is not worth any money will be provide much of an incentive forneglected disease research. In addition, as it is currently written,the elements meant to increase access to compound libraries don't haveany teeth. A compound library is just a collection of chemicals. This is not actually particularly useful without having access toscreening facilities with high tech robotics and computercapabilities, as well as personnel with a great deal of technicalexpertise. Going forward, there will need to be a concertedcommitment to creating an action plan that thoughtfully addressesthese and many other issues in order for the current language totranslate into real results."
Nicoletta Dentico, DNDi. "Uncertain lights looming, in a forest of thick shadows still. Yet, the IGWG negotiation is not finished. Hopefully, the "spirit of Geneva" so frequently evoked to feature this process will be used for the time being to kindle the lights, and finally clear, in the face of poor people's needs, the shadows."
Lila Feisee, Biotechnology Industry Organization. "I thought there were some good, robust discussions at the IGWG and I am looking forward to the WHA later this month."
Spring Gombe, Knowledge Ecology International. "Why did the IGWG negotiators have to suffer through hours of debate over the absurd question of whether high prices of medicines restrict access to them? Why did the delegation of the USA, wherever possible, block language that would have obligated other countries to pay for research and development of medicines? What if anything was the European Union willing to do to change anything?"
Amit Sen Gupta, All India Peoples Science Network and K.M.Gopakumar, Centre for Trade and Development (CENTAD), India. "On a Road Named Nowhere: The Slippery Slope of Negotiations at the IGWG on Public Health, Innovation and Intellectual Property
As the negotiations wound down to a close at the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property, a familiar pattern unfolded. To the dismay of all those who saw in the IGWG an opportunity to make a real difference in a starkly iniquitous situation – a situation where medicines required the most for the world’s poorest and most vulnerable populations are rarely researched or made accessible and affordable – the conclusions arrived at, may well make little or no dent in the present situation.
Chicanery and doublespeak by developed countries: The week of negotiations, have been replete with instances of chicanery and doublespeak on the part of most developed countries, led by the United States. The principal thrust of their strategy has been to obstruct any forward looking measure that would promote the basic objectives of the IGWG, objectives that were designed to find real mechanisms that can promote both innovation and access to medicines that are required for the poor in developing countries. They have insisted on language in the draft strategy document being negotiated that is designed to defend IPRs even in situations where there is glaring evidence regarding how such rights stand in conflict with efforts to promote innovation and access to medicines. They have also obstructed provisions that are designed to provide for the WHO a bigger role in issues related to public health, access, and intellectual property. The catch phrases used by the negotiators from the North, in order to dilute all meaningful proposals have been “voluntary”, “if feasible” and “where appropriate”. Their strategy has received a huge boost from large delegation from pharmaceutical companies (attending the negotiations as NGOs!), who can be seen all over the corridors, lobbying various country delegations.
Developing Countries Forced to Negotiate Away Text: In the face of such an onslaught, developing country delegations have had to defend their positions, virtually with their backs to the wall. Their ability to do so has been compromised by the relative small sizes of their delegations, and the limited expertise they have been able to harness to back their arguments. They have also been further handicapped by the negotiations being repeatedly split into 2 or more negotiating groups, thereby helping countries in the North with large delegations and a wider pool of expertise in negotiations to draw from. There have been significant attempts to keep a semblance of balance in the negotiations by developing countries such as India, Brazil, Thailand, Bolivia, Barbados, Surinam, Kenya, etc. But it is fairly clear that such efforts have not been adequate.
A basic asymmetry in the negotiating strategies was also seen to unfold as the negotiations proceeded. Developed countries, operating from a position of strength, were secure in the knowledge that they had nothing to lose. Developing countries, acutely conscious that a fiasco in these negotiations would set back the agenda of innovation and access by years, if not decades, were repeatedly forced to negotiate away language in the text that is useful to them, just in order to ensure that the negotiations concluded on a positive note. Being forced to do so, we are dangerously close to a situation where they the negotiated text goes nowhere, and does not attempt to chart a course that could remedy the present situation.
Big Pharma comes away happy with Financing Mechanism: Such a situation has clearly emerged in the crucial Element 7 of the negotiated text, that deals with the promotion of sustainable financing mechanisms to secure resources for R&D that focuses on the specific health problems of developing countries. The Element had three negotiating points. The first deals with a proposal to set up a working group that would examine present financing mechanisms as well as new mechanisms to support desired R&D. The second deals with product development public-private partnerships, and proposals to document, analyse and support them. The third dealt with the proposal to set up an R&D fund to address the needs of R&D in areas of priority for developing countries. In a way, this Element is crucial to the success of the negotiations, as it is designed to secure resources for the process to go forward.
The negotiated consensus text dilutes the intent of the first proposal by only talking of a “expert” working group that would be set up for the purpose of “examining” “sources” of financing, instead of the proposal earlier to look at “models of financing”. While the proposals on public-private partnership have been endorsed, the proposal on setting up of an R&D fund has been deleted. Thus, what we are left with is a mere promise to examine new funding mechanisms, without a matching commitment that such examination would lead to anything tangible. Possibly, the ones who would be the happiest with such a turn of events would be Big Pharma. They are left with no real threat of a possible challenge in the form of alternate mechanisms to their domination through control on R&D. On the other hand they can go back satisfied at having secured three loud cheers for public-private partnerships, which in many cases puts more money in the pockets of Big Pharma, in exchange for marginal benefits. In a curious turn of events, typical of how developing countries have had to compromise on useful text in these negotiations, India – which had proposed the text on the R&D fund in November – failed to defend its own proposal, and was virtually silent when the clause was deleted.
Too hasty in negotiating?: Given the lack of direction in the final text on concrete ways to start making a difference on how alternate mechanisms of R&D can be promoted, and how they are to be financed, there is a strong case to examine if developing countries have been too hasty to try to arrive at a forced consensus on most issues. There is perhaps a moral hidden somewhere in this. Developing countries, including many of the bigger ones with developed capabilities, came to these negotiations too ill-prepared. The most obvious gap was in the capability to understand and present opinions regarding S&T capabilities and R&D mechanisms. For example, some developing countries came ill-prepared to present their country’s own initiatives in drug discovery. Clearly, interdisciplinary co-ordination has been lacking in the process through which developing country delegations have been briefed. This is of particular concern, because such capabilities do exist in the larger developing countries, and it’s a pity that this capability was not harnessed. On the other hand, in some areas where country delegations were well briefed, they did a remarkable job in defending domestic and developing country interests — such as the Indian delegation on IP issues.
These deficiencies, at the end of the day, may well have made the crucial difference. Also lacking was the political will to follow through proposals that were clearly in domestic interest or in the broader interest of developing countries. The “fear factor” of being isolated in obstructing a manufactured consensus, seems to have also prevented delegations of developing countries for speaking out (in contrasts these negotiations have been replete with instances of text being marked as “consensus, pending US decision!). Finally, it was also clear that the developing block were not always working in tandem, and the lack of leadership being provided by the larger developing countries was often acutely felt. All is however not lost and the World Health Assembly and further work on the Plan of Action are opportunities to regain some ground."
Ethan Guillen, Universities Allied for Essential Medicines. "We were pleased to see the advancement in the negotiations of important issues like technology transfer that promotes innovation of and access to medicines for the developing world. We're hopeful that consensus recommendations on open licensing and other technology transfer provisions agreed to during this round will send a strong message to universities: they need to adopt policies that will free up the tools of innovation and make medicines discovered on campuses available at low-cost in the developing world.
However, the lack of bold commitment by most of the rich countries is surprising to say the least. That there had to be stiff negotiations on the idea that the cost of medicines impedes access in the developing world makes you wonder if some negotiators hadn't noticed that busloads of American retirees who have to hop across the U.S. border to Canada to get drugs they can afford. New incentive mechanisms are obviously necessary to promote R&D for medicines that don't have a market in the developed world.
Universities can lend a credible voice to the continuing effort but sadly, haven't yet positively engaged. Given that the process will now continue beyond the November elections in the U.S., they now have a renewed opportunity to work toward a stronger final strategy."
James Love, Knowledge Ecology International. "The IGWG, having agreed on many items, could not agree on others, is now over. The negotiations will continue into 2009, perhaps waiting for signals from the next US president.
The work product from this week was not terrible, and not great. There was surprisingly good progress on some topics (prizes, patent pools and the R&D treaty were all mentioned, and there were lots of good text other areas too), but the documents so far are pretty thin in important areas, and often weak on the details of the follow-through.
The IGWG did next to nothing on identifying R&D priorities, estimating funding needs, or creating a framework for sustainable funding for priority R&D, three tasks central to its mission. Every effort to create new norms, obligations or structures for funding R&D were blocked for now by the Europe Union and the United States.
The negotiation will spill over to the May WHA, with more follow-up for the Jan 09 EB meeting and the May 2009 WHA. It is looking also that the WHO DG wants to know what the next US president will want, which makes sense given the signals of the outgoing Bush Administration.
The European Union and the United States were basically in a mode to defend the status quo and to keep their pharma industry lobbyists at bay. There were no profiles of courage among the high income country delegates. There were some very impressive performances among the developing country delegates, including some several smaller countries."
Greg Perry, European Generic Medicines Association/International Generic Pharmaceutical Alliance. The European Generic Medicines Association and the International Generic Pharmaceutical Alliance, represented by Greg Perry, said data exclusivity must not be used to create market exclusivity beyond patent protection. Concerning the counterfeiting of medicines, Greg Perry said that IGWG should refer to the WHO definition of counterfeit medicine which says that a counterfeiting product is a product which has been mislabelled. It is important to note that medicines which are not patented can also be counterfeited; counterfeiting is essentially a trademark issue and not a patent issue. EGA has been raising serious concerns about attempts to confuse the anti-counterfeiting issue with patent infringement and the need to enforce patents. Finally, Greg Perry also asked to stop any attempt to introduce patent linkage provisions. Patent linkage is the practice that creates a link between the patent status of a product and the application for a marketing authorisation which prevents the registration and authorisation of generic medicines until after the expiry of the patent, and consequently considerably delays generic market entry.
Sarah Rimmington, Essential Action. "The world community met this week at the IGWG because the current corporate sector system of medical R&D – which is based on patent monopolies – has largely failed people in developing countries. Despite difficult and incomplete negotiations, delegates took an important first step by agreeing to explore some common sense measures to address this failure and promote developing country focused innovation plus access. This includes an agreement to explore R&D incentives like prizes that do not rely on patent monopolies and the prospect of charging high drug prices as a reward, and to encourage future discussions of an R&D Treaty. Despite this progress, much work remains to be done to promote R&D models that will work for the developing world. Consensus was not reached on concrete proposals to actually implement the urgently needed new incentive mechanisms because of resistance from developed countries such as the United States, the EU, and Canada. A significant amount of negotiating time was lost debating core principles such as the role of patents in creating barriers to access to medicines, and the importance of promoting the use of already-agreed to flexibilities available under international trade law to promote access to affordable generic medicines where patent protections remain a problem.
It is hard not to wonder if pressure from the brand-name pharmaceutical industry – which is based in developed countries and remains ideologically committed to patent monopolies – influenced this disappointing outcome.
But it's not too late. Member countries have another year to finalize the R&D agreement; they must use this time wisely by taking concrete steps such as coming to an agreement on financing proposals for the new incentive mechanisms."
Judit Rius Sanjuan, Knowledge Ecology International. "The IGWG negotiation finished today in Geneva with some good outcomes but also with important text still in brackets. For example, WHO Member States agreed to continue the work towards a Health and Biomedical R&D Treaty last November, but during this week’s meeting they failed to finalize the plan of action and argued intensely about the relevant stakeholders. The United States and Switzerland strongly opposed the inclusion of WHO and governments as stakeholders, trying to dilute the process, while governments like Brazil, South Africa and Suriname indicated that they are ready to give governments and WHO a clear mandate on this proposal which aims to change the way the world pays for and incentivizes medical R&D."
Tido von Schoen-Angerer, Médecins Sans Frontières (MSF)’s Access Campaign. "What we wanted to see was governments prescribe some change to a broken system, but they have not risen to the challenge. Concrete proposals to ensure urgently needed drugs and diagnostics are developed for developing country diseases have not received support. Considering the colossal needs we see in MSF daily practice, this is a lost opportunity.
Sticking to the status quo and putting all our faith on philanthropic organisations alone is not going to solve the problem. What we need to see is a wider, more ambitious framework for R&D and political leadership, in particular from WHO. The negotiations have left the greater part of the job undone.”
Christian Wagner-Ahlfs, Health Action International. "The outcome of the IGWG process is remarkable. Even if not every desired thing was achieved and some elements concerning basic conflicts of health and trade still remain, the IGWG process as such is a big step forward. Governments found consensus on items which some years ago they would not have even talked about."
Guy Willis, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). "No other non-government entity has mounted a sustained not-for-profiteffort that approaches the breadth and depth of that undertaken by theR&D pharmaceutical industry to help improve health in developingcountries. We are therefore pleased that the IGWG process has resultedin agreement on many practical measures to help address remaining gaps."