On 24 May 2008, the 61st World Health Assembly, the World Health Organization’s highest governing body, adopted the Global Strategy on Public, Innovation and Intellectual Property. As stated by James Love (Director, Knowledge Ecology International) in his random-bits posting (31 May 2008)
[t]his has been a long and difficult negotiation at the WHO. KEI invested enormous effort into the negotiations, and we are very pleased with the outcome. The official documents are long, and will not be published until next week. As the story by William New [IP-Watch] reports, the negotiation covered a wide range of topics covering both innovation and access in the field of medicine and medical devices. The ambition of the negotiation was unique in that it sought to reconcile both innovation and access in the same policy document, and to move governments and stakeholders toward new paradigms for supporting both.
Santiago Luis Bento Fernandez Alcazar, Minister, Head of the Department of International Affairs, Ministry of Health Brazil
Perhaps the most important result of the adoption of the Global Strategy and Plan of Action by the 61st World Health Assembly is a mind shift in the perception of the complex relation of public health and intellectual property. There has been and undeniable advance in accepting concepts that will have a profound consequence on how to deal with important matters such as, for example, the recognition that the IP regime is limited in its scope to deliver products that are crucial for developing countries, as well as the urgent need to rethink the basis for innovation. There is in this recognition an undisclosed acceptance of a crisis in the R&D and innovation cycle in which WHO, in its strengthened role, will have a strategic and central role. And all this was agreed by consensus, which shows the workings of the empowerment of developing countries in delicate and difficult matters in multilateral diplomacy.
Dr. Kumariah Balasubramaniam, Advisor and Coordinator, Health Action International Asia – Pacific
“Following the Doha Declaration in 2001, the outcome of 61st WHA and the adoption of the WHO global strategy on public health, innovation and intellectual property is yet another phase in the ongoing peaceful revolution that will shift the focus of R & D in pharmaceuticals towards meeting the priority needs of developing countries. This also moves WHO towards the central stage in international intellectual property policy making. Hopefully WHO will soon regain its role as the lead UN agency in international public health.
Dr. Margaret Chan, Director-General, World Health Organization
You have taken a huge step forward with the item on Public Health, Innovation, and Intellectual Property. With this, public health leaps ahead in addressing two fundamental and long-standing needs: to improve access to existing interventions, and to include diseases of the poor in the drive to develop new products.
This is a major breakthrough for public health, and I congratulate you all. This is a breakthrough that will benefit many millions of people for many years to come. This is a contribution to fairness in health, and this is pro-active public health at its very best.
Erika Dueñas, Economic and Trade Counselor Embassy of Bolivia in Washington, DC
Strengthening the role of WHO and its regional offices on the complex interaction between public health, innovation and intellectual property is vital to appropriately implement the Global Strategy and Plan of Action. The results of the 61 WHA are only good steps in order to achieve essential health innovation and access to lifesaving medicines or medical technologies. There is no doubt that this negotiation process was an enormous challenge, particularly for an active participation of small developing countries, but at the same time we realized a valuable world recognition of this responsibility. We further encourage small countries to constantly follow the effective implementation of all WHA Resolutions on this topic and the recommendations of the CIPIH Report.
This is comparable to the victory of the Doha Declaration because we still need practical solutions, change directions when necessary, and that is an important part of the IGWG results, to reaffirm the principles of Doha but also explore sustainable alternatives to promote innovation and fill the acknowledged gaps of the current patent system. We need to promote a new umbrella for the coming negotiations or domestic legislations taking into consideration basic health concerns.
Dr Huda Gashut. Minister Counsellor (Health Affairs). Permanent Mission of the Libyan Arab Jamahiriya and Chair of the IGWG Committee of the Plan of Action
The 61st WHA has been an intensive work experience. The drafting group that negotiated the completion of the strategy and plan of action on public health, innovation and intellectual property, represented at least 3 different views.
There have been many objectives that were impossible to achieve for some, there have been some concessions that were impossible to be made by others, In spite of these differences, I felt that everyone wanted to alleviate the suffering and the death of the most in need.
The CONTROVERSY between these groups views was clearly the how much each group was ready to pay to achieve this.
Our expectations were high , still not high enough for the needs of poor and sick people.
I learned that to reach the top you have to climb step by step, working hard and as long as it takes. I think that our resolution is the beginning of a long way to go, and that we are on the right path.
Now we all, recognize we need to share some of the knowledge. How much knowledge need to be shared to achieve our objectives remains our next issue .
Developed countries and developing countries need, not only to increase cooperation, They need to learn to share.
We need to share the right for health and the right for life.
Maryam Karga-Hinds, Director of the Barbados Drug Service
We may not have gotten 100% what we wanted, but I am very pleased with the outcome. The fact that the role of WHO in public health, innovation and intellectual property matters has been endorsed is very comforting and promising. The commitment of Margaret Chan as shown by her presence in the late night negotiations, and the tears of joy she shed at the end of the IGWG meeting are signals of her personal commitment. In her personal capacity and asthe WHO Director General, I am comforted that the outcomes and future activities to be undertaken are in good hands. What remains to be done is a commitment by member states who have invested so much in this negotiations, to carrry it forward. WHO alone, with all the good intentions will not be able to make everything happen. The member states will be the flag bearers in terms of working with WHO to ensure that the outcomes of IGWG and the resolutions taken from WHA61 are taken to fruition.
Prangtip Kanchanahattakij, First Secretary, Permanent Mission of Thailand to the United Nations and other International Organizations in Geneva
Not only developing countries, but also developed countries should be applauded for this achievement. It’s a collective effort to reflect a fundamental problem. For the unfinished business, it’s only a matter of time.
James Love, Director, Knowledge Ecology International
Six and a half years after the Doha Declaration, and five years after the CIPIH was created, the WHO has taken a big step forward to change the way we think about innovation and access to medicines. In a lengthy and substantive document, the World Health Assembly has reached consensus on a plethora of difficult and important topics, sometimes with impressive detail and clarity, on topics that were considered controversial only a short time ago. We are particularly impressed that the WHA was:
strong on the use of compulsory licensing and other flexibilities in protecting public health,
recommended that drug registration requirements confirm to the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects,and continues and expands its support for
work on a biomedical R&D treaty,
the collective management of intellectual property rights, and
the use of new mechanisms, like prizes, to provide innovative incentives that are not linked to product prices.
It is unfortunate that the WHA has yet to address the estimation of funding needs for priority R&D, or created a framework for sustainable sources of funding. Also, the WHO Secretariat has yet to engage on the issue of new mechanisms that de-link R&D incentives from product prices. These and other issues will be the subject of the next round of negotiations, which will begin very soon.”
Greg Perry, director-general, The European Generic medicines Association (EGA)
EGA director-general Greg Perry welcomes a commitment to “take into account, where appropriate, the impact on public health when considering adopting or implementing more extensive intellectual-property protection than is required by [the World Trade Organization’s agreement on] trade-related aspects of intellectual-property rights (TRIPS)”. The measure to avoid TRIPS-plus provisions, he believes, includes reviewing the impact of data exclusivity.
EGA is also pleased by an explicit pledge to support Bolar-type early-working legislation in developing countries, as well as by an acknowledgement that measures might need to be taken to avoid abuse of intellectual-property rights. It is also welcomed that counterfeiting and information-sharing on data exclusivity had been dropped from the global strategy and plan of action.
Tim Reed, Director, HAI Global
The fact that there is now a resolution which sets out a global strategy is very positive. It represents a momentous paradigm shift that should translate theories into action around innovation and intellectual property. So, we are now soundly on the right track. But there is still a long way to go and the enthusiasm and energy of past effort must not be lost if the resolution is to lead to real outcomes that change the lives of those in need of innovative treatments.
Moreover, WHO needs a clear mandate to lead the way forward, to uphold the agreed strategy, and offer Member States support and technical capacity. And let us not forget the vital role of Civil Society Organisations as this plan evolves – Civil Society has the technical expertise and political will to contribute to every aspect of the roll-out and hold to account those who hinder its progress.
Sarah Rimmington, Attorney, Essential Action
The world community has taken a bold step today by agreeing on a way forward to reform a global system of medical research and development that has largely failed to meet the needs of people in developing countries.
After a difficult round of negotiations, countries have finalized a very good global strategy aimed at spurring the development of medicines and other products that will meet priority health needs, and make those products available on an affordable basis. Up until now the current patent-monopoly based system of R&D has treated innovation and access as contradictory objectives that must be counterbalanced to each other. Because of IGWG, the nations of the world have for the first time acknowledged that innovation and access are complementary public health objectives; that we can have “innovation plus access.”
At the same time there is critical work that remains to be done to promote R&D models that will work for the developing world. Member countries must actually implement the innovative approaches to R&D agreed upon today at the WHA. For the promise of IGWG to be realized, it is crucial that countries take concrete steps to advance experiments with new institutional arrangements for R&D, such as the non-patent prize proposals to address priority health needs of developing countries put forward earlier this month by Bolivia and Barbados. This work will begin very soon when the WHO convenes the R&D financing working group mandated by the WHA.
Sangeeta Shashikant, Third World Network
The Global Strategy was an achievement in the sense that concepts such as open licensing, open source approaches, need for new incentives and a concrete role for WHO in the area of public health and IP were accepted by the developed countries after about 2 years of debate. Now it is time for WHO to show leadership in developing solutions on innovation and access to overcome health problems in developing countries.
Ellen F.M. ‘t Hoen LL.M. Director, Policy Advocacy, Medecins sans Frontieres Access to Essential Medicines Campaign
The Doha Declaration was historical because it outlined the mechanisms to address high medicines prices and patent monopolies. The IGWG has gone a few steps further by also addressing the need for changing the way research
and development of essential health products is financed. The IGWG has in particular highlighted the need to look at de-linking paying for the R&D cost from the price of the product.
The WHO now has to play a central role in the implementation of the strategy which varies from immediate action such as determining the priorities for essential health R&D and find new ways to finance the R&D and support to countries that struggle to bring the cost of patented medicines down by using the TRIPS/Doha flexibilities, to taking the lead in political processes with a more long term effect such as, the essential R&D treaty. The Strategy does not lack action points, but national and international policy makers need to deliver to make sure access and innovation become reality.