HIP: What is your assessment of the WHA’s discussions on the CEWG report?
MPK: It is absolutely clear that Member States are very interested in the CEWG report. It is an agenda that many of them want to push forward to accelerate the development of medicines and medical technologies and promote greater access to heath in developing countries. However, the CEWG report contains over 250 pages of recommendations. It calls for actions that go beyond the scope and mandate of ministries of health. Member States were almost unanimous on the impossibility to come to an agreement on the substance during the May 2012 World Health Assembly.


HIP: So why did it take so long to reach consensus on the way forward?

MPK: Long debates – around 17 hours in a drafting group – allowed Member States to craft the terms of the resolution very carefully and agree to hold further discussions at the next Executive Board and World Health Assembly. These discussions will be preceded by consultations at national and regional level. I understand that some groups would have liked a more substantive decision in May. But this approach seems very reasonable. I don’t think that any other outcome would have been feasible at this time.

HIP: Now that the decision on the CEWG’s recommendations has been postponed, and the matter sent back to national and regional level for further analysis and discussions, how do you reckon things will move forward? What do you expect to come out of this process?
MPK: We expect that countries will consult all parties that have a say at national level. This would include ministries of science & technology, finance, trade and industry, etc. We hope that the national discussions and the regional consultations will give a clearer view of countries’ proposals, and possibly suggest complementary models, to bring this agenda forward.
The CEWG has formulated quite a number of recommendations, some of them very technical. We need not lose sight of these as they can contribute much to increasing research on the diseases targeted by the GSPA.
The idea of a binding Research and Development (R &D) treaty to frame all the interventions that the CEWG has prioritised needs to be put on the table once and for all; it has been lingering for years. But it is one of the possible frameworks, consensually identified as the best by the CEWG. There are alternative models that Member States want, legitimately, to look at. These other models would be more or less binding; other options could be envisioned, including the creation of funds, which would be non binding. The national and regional discussions will hopefully table these alternative models, with their pros and cons.

HIP: What is WHO planning to do to support the decentralized consultations?
MPK: We have immediately alerted the regional directors about the WHA’s request to WHO to support these national consultations. The WHO HQ staff will not be involved, since our focus will be on preparing for the open-ended group meeting. We will of course participate in the Regional Committees Meetings and provide all information and technical support needed to our regional colleagues. They will in turn orchestrate the regional discussions and be involved, when requested by member states, in the national discussions.
Thailand has already held a first national consultation on the issue. The SEARO Regional Director has planned to convene a session of member countries in Bangkok prior to its Regional Committee meeting. We are following up with the other regions. EURO and PAHO are also very active in their preparations.

HIP: You mentioned that Member States’ discussions in the assembly crystallised around the treaty. At the same time, some of the CEWG’s other recommendations were not disputed and could be readily implemented. Do you foresee that happening? Some people indeed regretted the decision of sending back the discussion to national and regional level, as it would postpone the implementation of other recommendations that could already be acted upon.
MPK: Well, I think that all the recommendations need further work, before they can be implemented. Even the idea of an R&D global observatory, for instance, which is quite dear to our heart, cannot be immediately implemented. We need to hold discussions with a variety of stakeholders about its scope, the diseases to be covered, and its detailed goals. Such discussions have already started. This item is also on the agenda of the national and regional consultations; we hope that the Member States’ discussions will enrich the concept prior to its implementation. We really think that most, if not all, CEWG recommendations will benefit from further national and regional discussions.

HIP: What in your view are some of the necessary conditions to ensure the meaningful participation of Member States in these definitely crucial national and regional consultations and avoid, for example, reopening issues that have been painfully negotiated over a long period of time?
MPK : In order to have meaningful discussions, I think, it will be key for our regional colleagues to help country officials formulate the appropriate questions for the national dialogues. The national discussions will have to consider the technical as well as political aspects. For instance, the role of ministries of finance is essential. The debate on potential taxation strategies and sources of funds to secure sustainability is at the heart of the question. I very much hope that parliamentarians will be strongly involved in the debates, so as to ensure the best standards of countries’ accountability.

HIP: You have pointed out that many actors need to be engaged in discussing the CEWG’s recommendations at the country and regional levels, as well as at global level. This would include both governmental and nongovernmental groups. How can representatives of civil society at both the national and regional level contribute effectively to what some describe as complex discussions, requiring in-depth knowledge of the intricacies of this debate?
MPK: It is true that those who have followed the debate at the WHA and elsewhere are mainly international NGOs. But these international NGOs do have contacts in countries and know the groups that could be involved. So I think it would be very good if, at the time of the preparation, international NGOs that have an interest in that area contact NGOs at local level and inform them of the debate, inform them of the content of the report and of the recommendations so that they can meaningfully participate in the national discussions.

HIP: During the WHA discussions, some delegates made a connection between the ongoing WHO Reform and the possibility of a new R & D treaty process, based on Article 19 of the WHO Constitution. What is your view on this matter?
MPK: As you know, the GSPA started well before the beginning of a discussion on the WHO reform. The WHO has already used Article 19 for the tobacco convention. So I would not say that the potential negotiation of a treaty on R&D and the reform of the organisation are linked. The link one could find is that Member States want a stronger normative role for the WHO, which would call for the negotiation of legally binding instruments. But apart from that, I think the two processes have started independently and are progressing independently.

HIP: Work around the CEWG report is going to be the focus of the activities of the WHO Department of Public Health, Innovation, Intellectual Property and Trade (PHI) in the coming months. But this is one component – however key - of the GSPA: element 7. What about the other elements? Four years after the GSPA adoption by Member States, what is your assessment concerning its overall implementation?
MPK: It is fair to say that implementation of the GSPA has been unequal, in various areas and in various parts of the world. There has been progress in many countries. There is also an increasing recognition of the importance of the innovation and access agenda. WHO is meant to report on the 4 years implementation; we will prepare a report in 2013. It is fair to say that at the WHO level we have been slow in starting, too. We needed to pull together the necessary resources, human as well as financial. But we are now moving steadily forward. We are working with PAHO towards establishing an innovation platform that allows for monitoring progress of the GSPA implementation. Two successive efforts focused on the financing of R&D, first with the Expert Working Group Report in 2010, then with the CEWG report in 2012. Again, this has taken more time than originally envisaged but there is visible progress right now.

HIP: There is widespread appreciation for the CEWG’s efforts, and expectations from the national and regional consultations at this stage. But speaking to different actors, from different constituencies and parts of the world, the perception is that the implementation of GSPA at country level remains limited at best. In your view, what are the main obstacles that slow down implementation? What challenges exist for countries with limited resources? And what would be needed to ensure the sustainable implementation of the GSPA in countries?
MPK : You are right. In certain countries, there has been a lot of progress recently, though, and a substantial increase of governments’ investment into this agenda. I would say that the most significant obstacle is the lack of sustainable funding. That is why the CEWG report agenda is so important. As the CEWG report advocates, all countries should invest in R&D for medical products against diseases of the poor, including poor countries themselves. So I really hope that, whatever the mechanism emerging from the CEWG recommendations will be, the need for securing national investments will be preserved. Increasingly, the GSPA implementation is recognised not only in terms of an aid agenda, but also as everyone’s responsibility, including the poorest countries. Hopefully, this will translate into a new a reality of collective engagement, and national investment.

HIP: Given your long experience in R&D, what do you consider the most important measures that need to be taken to promote and support needs-driven innovation for health and sustain greater access to medical products in developing countries?
MPK: Once all countries recognise their responsibilities in the implementation of the GSPA, there needs to be a discussion at national level on ways to manage this development. Luckily, we have had a project financed by the European Union on helping to develop the conditions for local production of medicines. Phase one has just been completed; the most important result of the analysis thus far is that, in order for local production of medicines to benefit public health, there must be an implicit convergence of the public health and the industrial policies of the country. Medicines can indeed be locally developed and produced, but they may easily be of no benefit for the health of the people of the manufacturing country. If medicines’ production is meant only for export, it will certainly be good for the country’s GNP, but not for its public health. We are convinced that governments will use the lessons learned from these studies, when they seek to increase access to medicines for their people. Now that the WHO has embarked on phase 2 of this EU supported project, aimed at the development of local productions, we hope to be able to better assist countries in the GSPA implementation.

HIP: I guess this would be focused on a number of good potential candidates. Have you already selected them?
MPK: We are in the selection process. Much will depend on available funding. We would certainly like to have a couple of countries in Africa, and one in South East Asia.

HIP: As you rightly pointed out, the GSPA agenda is a very crucial issue for WHO. Given the current financial crisis, do you get sufficient funding to continue pushing for this important agenda?
MPK: Of course, there are many priorities at WHO, a fact we need to keep in mind. In the context of the reform, I hope that the extraordinary session of the Programme and Budget Advisory Committee, to be held next December, will result in more predictable financing for WHO, so that we can operate in a world where the funding is better aligned with the priorities recognised by Member States. For the time being, only 20% of the WHO budget comes from regular contributions of Member States, as you know. The organisation does provide some resources for the GSPA, but we need more and count on Member States who support this agenda to provide the resources needed to enable WHO to more effectively support this work. We have received designated funding from the EU as already mentioned. The Government of Japan has recently seconded an expert to PHI. We have also received some funding from the Government of the United Kingdom. However, funds remain limited. We need to mobilize resources now for the preparation of the open-ended working group to come.

HIP: The calendar of events calls for national and regional consultations that will feed into the Regional Committees Meetings in the fall. They will be followed by an open-ended working group in November of this year. Is this correct?
MPK: Absolutely. We have a potential slot relatively early in November but I personally would like it to start a bit later in order to take stock of the Regional Committees’ discussions, as the AFRO Regional Committee has been postponed to October. Therefore, I would rather have a little bit more time between the end of the last Regional Committee meeting and the November meeting. The WHO Secretariat will prepare a working document to inform the discussions.

In conclusion, I want to reiterate the considerable importance of the GSPA agenda for improving access to health, which calls for avoiding divisive debates and moving forward with implementation. The Director General is focusing on universal health coverage. That includes access to medicines and the development of medicines that do not exist for the time being. Needs-driven innovation is a priority for us and for countries, no doubt about this.


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