INTELLECTUAL PROPERTY: WHO-WIPO-WTO JOINT TECHNICAL SYMPOSIUM
Access to medicines: pricing and procurement practices
Geneva-based delegations to the WHO, WIPO and WTO, representatives of international and philanthropic initiatives on the procurement of medicines, civil society organizations, and industry representatives participated in a technical symposium on access to medicines at the WTO on 16 July 2010.
Updated: 22 July 2010
Programme and presentations
09h00–09h45 — Opening Remarks: Creating Synergies Between Intellectual Property Rights and Public Health
Pascal Lamy, Director-General, World Trade Organization (WTO): remarks
Margaret Chan, Director-General, World Health Organization (WHO): remarks
Francis Gurry, Director General, World Intellectual Property Organization (WIPO): remarks
09h45–11h15 — Panel 1 Current Developments and Ongoing Work in WHO/WTO/WIPO
Procurement, prequalification, pricing, availability of drugs, Richard Laing, WHO
Access to patent information, competition policy, arbitration and mediation, Konji Sebati, WIPO
Moderator: Zafar Mirza, WHO
11h45–13h00 — Panel 2 Consumption Pricing and Availability
Data on pricing, Thuy Hung Ha and Sophie Logez, The Global Fund
Medicine prices, availability, affordability & price components, Margaret Ewen, Health Action International (HAI)
Moderator: Carsten Fink, WIPO
13h00–14h15 Lunch Break
14h15–15h30 — Panel 3 Experiences on Medicines Procurement
Zafar Mirza, WHO
Katy Athersuch, Medical Innovation & Access Policy Adviser, Médecins Sans Frontières Campaign for Access to Essential Medicines
Moderator: Hans Hogerzeil, WHO
16h00–17h30 — Panel Discussion: Taking Stock and Defining Future Needs
Jorge Bermudez, UNITAID
Rebecca Stevens, International Federation of Pharmaceutical Manufacturers Association (Novartis)
Yehudah Livneh, International Generic Pharmaceutical Alliance (Teva)
Denis Broun, Joint United Nations Programme on HIV/AIDS (UNAIDS)
Moderator: Antony Taubman, WTO
17h30–17h45 — Prospects for Future Dialogue and Cooperation
Ruth Dreifuss, former Swiss President and former Chairperson of the WHO Commission on Intellectual Property, Innovation and Public Health (CIPIH)
17h45–18h00 — Closing Session
Directors-General: opening remarks
Pascal Lamy, WTO
Ladies and Gentlemen,
I am delighted to welcome and acknowledge my colleagues Margaret Chan and Francis Gurry. The presence today of Directors General from the three collaborating agencies, WHO, WIPO and the WTO, highlights the firm commitment to practical cooperation between our three organizations, to strengthen our common knowledge base and practical coordination on pressing public health matters. Our joint participation also underlines the working relationship we enjoy personally.
Exactly one year ago, WIPO hosted a Conference on IP and Public Policy Issues, a timely initiative on the part of Francis Gurry. At his invitation, both Margaret Chan and I addressed the theme of “Strengthening Multilateral Cooperation on Intellectual Property and Public Health”. We took the occasion to articulate the need for partnership, dialogue and policy coherence within the international system, as the basis of an effective response to challenges of public health. There was a clear message that the whole is greater than the sum of its parts — within our distinct mandates, we can each bring our own areas of expertise and work towards stronger, more broadly based and effective outcomes.
The Symposium represents a further milestone in this collaborative effort. It demonstrates the value of bringing together our respective areas of expertise and data resources to the improve the collective base of information and knowhow, surely an indispensable basis for informed and effective policymaking. The WHO brings to the table a vast expertise in the areas of essential medicines, regulatory questions, pricing and other factors affecting access to medicines. WIPO is uniquely placed to help us work towards a truly global view of information on the patent status of key medicines in developing countries, and to lend its expertise on patent law and its interplay with public policy. And of course, since trade intersects with health in many different ways, the WTO is working on several aspects of trade policy that have direct relevance to public health policy. It offers a rich source of data and valuable information, including through its notification mechanisms. Today we will be exploring how best to harvest the potential of these reserves of knowledge and information, to strengthen cooperation towards a goal all can surely share: put simply, that of getting needed medicines to the people who are in most need.
The Symposium aims to improve and make more systematic the flow of practical information to guide and support technical cooperation in the future. This means taking a broad view of the question of access to medicines. We have a great deal to learn from the reported experiences of industry players, multilateral procurement initiatives, NGO procurement programs and pharmaceutical sector analysts. Within a single day’s packed program, all these diverse actors have been asked to share the practical insights of their experience and to reflect on how to improve the flow of information.
And institutionally, too, we have tried to take a broad perspective, drawing on all those areas of expertise and information about the multilateral trading system that may shed light on access to medicines scenarios. Today, as a contribution from the WTO at a technical level, we aim to provide an overview of the range of practical information that has bearing on all aspects of the access equation — intellectual property policy settings, procurement and competition policies, tariffs, and regulatory matters ensuring the quality, safety and efficacy of medicines. The aim is to have as complete a factual picture as we can, drawing on all the resources we have available, not to establish a parallel policy forum, nor to assess or debate existing legal instruments, nor to come up with policy recommendations.
No connection is planned or intended between this process and the ongoing policy and legal debates within the WTO about the scope and effect of TRIPS flexibilities, especially the work of the TRIPS Council. Since the Doha Declaration in 2001, WTO Members have rightly stressed the need for the effective use of the IP regime and of the flexibilities in the TRIPS Agreement. As discussed in Doha, TRIPS needs to be part of the wider national and international action to address public health problems. It was agreed that TRIPS does not and should not prevent members from taking measures to protect public health. So there is no doubt about the centrality of this element of the access equation. It has led to the first, and so far the only, amendment agreed to the entire package of WTO law since the ink dried in Marrakech over 16 years ago — the so-called paragraph 6 mechanism.
WTO members continue to review the implementation of this mechanism, and are undertaking an important debate, focussed in the TRIPS Council, about how to progress and strengthen the review process. The TRIPS Council has decided to set aside the second day of its October meeting specifically for the System’s annual review. And the TRIPS Council Chair, Martin Glass of Hong Kong China, is consulting on how best to prepare for the review, including the call by a number of WTO Members for a dedicated open-ended workshop on the Paragraph 6 System. This continuing policy debate is a member-driven process.
Today’s Symposium, I must stress, is not part of that TRIPS Council review process. We are not trying to second guess, influence or pre-empt the policy choices and options for conducting the process that lie rightly in the hands of our members.
Hence the Symposium is pitched at technical level, and concentrates on gathering sources of information and at pooling practical experiences across the board relating to access to medicines in all dimensions. The idea of hosting such a technical symposium is a longstanding one, a natural step in the evolving program of trilateral cooperation. Driven by demand from our members, our own technical cooperation work has progressed from a formal overview of treaty standards, to a richer exchange of information about actual policy choices and practical experiences with their implementation. In one sense, we have moved from formally defining the contours of the policy space, to understanding how members have chosen to work within that policy space in practice. And we know that it is pointless to attempt to do this without the close involvement of our multilateral partners.
The WHO, WIPO and WTO Secretariats have, over the last decade, progressively enhanced their cooperation on the interface between the intellectual property regime and public health. We have worked to improve coordination of technical cooperation and capacity building programmes, including through mutual participation in our respective activities and the more systematic pooling and sharing of the practical information that informs technical cooperation. Our cooperation thus takes place within the boundaries of the policy and legal framework established and agreed by our respective memberships, and does not aim to intrude in the member-driven debate on the broader public policy questions.
Intensified global concern over access to medicines led to the Doha Declaration in 2001, and continues to press this issue forward on the policy agenda. The Declaration has clearly helped to illuminate and clarify the flexibilities and policy options under TRIPS. It has also served as a benchmark for multilateral cooperation. The Declaration is cited by two more recent and equally significant international instruments, WHO’s Global Strategy and Plan of Action and the WIPO Development Agenda. Taken together, these three instruments constitute a strong conceptual and policy framework for our joint efforts on technical cooperation.
Global public health is a complex puzzle, Getting it right is a teasing challenge, involving effective use of the full set of applicable policy tools. But it is also a practical craft, rather than a theoretical excursion — meaning that we can and should learn from the actual experiences of others in their efforts to create and disseminate needed treatments. The full perspective needs to cover the international trade dimension, but also consider domestic policies and practices, and above all, the evolving state of the actual global disease burden, priority setting for front line treatments, and patterns of production and dissemination of medicines. I hope today’s program will help illuminate this far bigger picture, so that we can get on with our specific areas of work with the benefit of greater understanding about how all the elements interact, and what priority targets we should be aiming at — a task that can only be undertaken by our public health colleagues.
Today’s programme is ambitious, consciously so. It covers a wide range of issues, and brings in as many different practical perspectives as we could accommodate within one crowded day’s discussions. I have no doubt that today’s discussions will leave us an appetite for further dialogue, and identify specific areas where more in-depth work will be needed. So today will also be an opportunity to reflect on issues and priorities for follow up activities. I urge you not to waste the opportunity to share with us your thoughts on future directions.
I close by expressing my sincere thanks to all collaborators who have made this possible, and to my colleagues, Margaret and Francis, who have done so much to advance the international agenda on public health, access to medicines and innovation.
Dr Margaret Chan, WHO
Mr Pascal Lamy, Dr Francis Gurry, colleagues in health and development, ladies and gentlemen,
I welcome this opportunity to jointly explore how drug procurement practices, intellectual property policies, competition policies, and ultimately prices can improve access to medicines.
Of all the issues discussed at WHO governing bodies, access to medicines consistently sparks the most heated, sometimes divisive, and potentially explosive debates. This is all the more so since these discussions almost inevitably turn to questions of prices, patents, intellectual property protection, and competition.
The debates are often clouded by suspicions: suspicions that the rules governing international trade in pharmaceutical products are rigged to favour the rich and powerful; that economic interests will trump health concerns; that medicines are being treated just like any other commodity, despite their health-promoting and life-saving roles; and that the social context is forgotten when the rights of patent holders are more important than the right to health.
The debates are further complicated by deep mistrust. Countries unskilled in trade negotiations fear they will be tricked or duped. Countries seeking to use the flexibilities under TRIPS fear they will be punished by trade sanctions imposed in retaliation. Countries fear that pharmaceutical companies will use unfair tactics, really, every trick in the book, to reduce competition from lower-priced generics.
I understand these suspicions and expressions of mistrust. It is my job to understand them. Taking these concerns on board is part of the quest for consensus on ways to make public health policies, and health outcomes, more equitable.
In a sense, there is nothing new about the main focus of these debates. Improving access to medicines has been a priority for WHO since the Organization began its work in 1948. WHO model lists of essential medicines date back to 1977.
But while the problem of access to medicines is nothing new, the context today is strikingly different than in the past. A quest for greater fairness, in income levels, in opportunities, in access to medicines and health services, has become a strategy for coping with the unique pressures of a globalizing world.
In a world of radically increased interdependence, lives and opportunities, including prospects for better health, are governed by international systems that create benefits, yet have no rules that guarantee fair distribution of these benefits.
The world has changed, and not at all for the better in the roughly one billion people who live on the margins of survival. The gaps in health outcomes are greater today than at any time in recent history. A person in a wealthy country can expect to live more than twice as long as someone from a poor country.
A woman in sub-Saharan Africa faces a risk of dying during pregnancy and childbirth that is more than 100 times greater than a woman living in Europe. These are largely preventable deaths, in which lack of access to essential medicines plays a major role.
This is not a healthy situation, also in terms of social cohesion and stability.
Ladies and gentlemen,
I welcome this opportunity to collaborate with WTO and WIPO as we jointly consider policies for drug procurement, pricing, and intellectual property from a public health perspective. Access to medicines is an appropriate, and a challenging, focus for our joint efforts, which I know will be continuing.
As we seek a common understanding of challenges and potential solutions, let me set out a few big-picture issues and facts. These help explain why access to medicines is such an emotive topic, especially when viewed from the perspective of the developing world.
We face two bottom-line realities. First, the essence of the ethical argument is straightforward. People should not be denied access to life-saving or health-promoting medicines for unfair reasons, including those with economic causes.
Yet the pharmaceutical industry operates in response to economic factors and market forces. This is a profit-driven industry, and not a philanthropist, not a humanitarian enterprise. What incentives does this industry have to fix prices according to their affordability among the poor?
Second, price has a decisive impact on access to medicines. Access is influenced by many other factors, like remoteness, lack of staff, poor procurement practices and delivery systems, and the absence of health insurance schemes. But price can be an absolute barrier to access for the poor. For the poor, access and affordability are usually one and the same.
WHO learned a great deal during the negotiations that eventually led to adoption of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property. Some of the tensions between the motives of a profit-driven industry and ethically-driven public health can be circumvented, if not entirely overcome.
Better procurement practices is an area where WHO and UNICEF have extensive experience and some lessons to offer, as you will be hearing later. Government procurement practices have an impact on both the availability and the price of medicines, and are a good entry point for exploring ways to make medicines more accessible.
Let me illustrate the challenge, and the importance of addressing it, with a few facts and figures.
Up to 90% of the population in developing countries purchase medicines through out-of-pocket payments. Medicines account for the second greatest household expenditure, right behind food. As I said, price matters.
The organization of a country’s pharmaceutical sector, its capacity for efficient and impartial procurement, quality control, regulation, and enforcement, affect the availability and price of medicines.
Efficient distribution is also important. When facilities in the public sector experience stock-outs, patients turn to the private sector, where the prices of medicines and the quality of care are often beyond regulatory control.
Surveys conducted in 30 low-income countries found that generic medicines, obtained in the private sector, cost more than 6 times more than their international reference price.
Prices for both originator and generic medicines, in both the public and private sectors, are substantially much lower if procurement and distribution procedures were more efficient, corruption-free and mark-ups were reasonable.
These are some of the problems that can be addressed through more efficient procurement policies. This is a joint opportunity that we are wise to seize.
Francis Gurry, WIPO
A very good morning to you all. I join Margaret in welcoming the coherence of participation that we see here at WTO as well as at WIPO and WHO.
Let me say how much WIPO values the cooperation that exists between our three Organizations — the World Trade Organization (WTO), the World Health Organization (WHO), the World Intellectual Property Organization (WIPO) — on this question which, I believe, lies at the heart of the politics of health, at the heart of the politics of innovation and at the heart of politics of trade, namely, access to medicines.
As Thomas More recognized several centuries ago in Utopia, without health everything else in life is without value. It is not surprising, then, that access to medicines that maintain or restore health is a question that excites a great deal of policy attention.
We owe a debt of gratitude to Pascal Lamy for the enhanced cooperation that exists between our three institutions. If I am not mistaken, I believe it was at the beginning of last year or at the end of 2008 that Pascal invited Margaret and me to join him in a discussion on how our three institutions could join together and how we could, in bringing three different perspectives to essentially the same subject matter, arrive at clearer focus and a more complete vision of the subject matter itself.
Let me affirm what both Pascal and Margaret have said to be the objective of both this event and of the enhanced cooperation between our three institutions. That is to provide an empirical basis, or a better empirical basis, for the policy-making process, and thus to contribute to a high-integrity policy-making process. I think we are all well placed as institutions to be able to contribute to a better knowledge base for these processes.
I am not going to enter into the details of today’s subject matter. I am going to leave that to the experts whose presence I welcome and whom I thank for being here. I just want to make several general remarks about innovation and intellectual property.
Innovation and intellectual property, and indeed WIPO, have fundamental roles to play in this area. It is a truism, of course, that any new medicines will come from innovation. So we need to find a way of encouraging innovation, encouraging innovation not only in the sense of development of new inventions, or medicines, but also in the sense of providing a framework for bringing new inventions or new medicines from the early stage right through a very complex process to a marketed product.
Encouraging intellectual property plays a very important role in this regard. But we also know that there is no point in having new medicines unless they can benefit those who need them. And so there is the question of balance, which I think lies at the heart of all of intellectual property, whether we are talking about cultural creations or new medicines, a balance between, on the one hand, the incentive to create and, on other hand, the diffusion of the social benefit of the innovation or the new creation. Or a balance, otherwise said, between producers and consumers, whether they be individual producers and consumers, or country producers and country consumers.
This balance is an extremely complex matter and many things enter into the picture, including pricing and procurement policies. There is no simple legislative fix, which is not to say that legislation does not have a role. But there is a vast area of practical cooperation, which is very important in the achievement of this balance between creation, on the one hand, and diffusion of the social benefit of creation, on the other hand.
Let me point very briefly to several of the practical factors that operate in this field, particularly as regards the World Intellectual Property Organization (WIPO).
First of all, we have a need for better knowledge tools, or information tools, and knowledge infrastructure. I would point in this regard to our own tool that we continue to develop, PATENTSCOPE, which has a coverage now of nearly 4 million patent applications. We need to have the capacity to be able to create, rather simply, for policy makers, patent landscapes which show where there are rights in relation to knowledge, and medicines. PATENTSCOPE is becoming a very well respected instrument which is user friendly. And you will see it improve further in the course of this year and in the course of the coming years. It will also have some interesting linguistic features, because we have to be aware, in today’s world, that nearly one third of new technology is being produced in Chinese, Japanese and Korean. In order to create a truly global picture of knowledge rights and the role that they may play in respect of access to medicines, we need to be able to navigate in this increasingly diverse linguistic landscape.
Secondly, there is great scope for practical platforms, particularly between the public sector and the private sector. We have seen many of these deployed in the course of the last ten years to significant advantage. Such platforms can help compensate for market failure. Where there are no markets, it is necessary to develop platforms and compensate for their absence — neglected tropical diseases being one very obvious and significant example. The experiments that have gone on have been productive, but we need to work further on the development of these public-private partnerships. Platforms can also be very important vehicles for improving the functioning of markets, and for transparency to technology markets. We have a number of projects in this regard at WIPO, again between the public and private sectors which I think can help. Finally, platforms themselves can provide important vehicles for improving access. This is at the heart of what we will be talking about today.
Once again, I thank Pascal Lamy for the initiative of this event today and for instigating the enhanced cooperation between our three institutions, and I thank both Pascal and Margaret for this very good cooperation.