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09h00–09h45 — Opening Remarks: Creating Synergies Between
Intellectual Property Rights and Public Health
Pascal Lamy, Director-General, World Trade Organization (WTO):
Margaret Chan, Director-General, World Health Organization (WHO):
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
Relevant multilateral trade policies and available data,
Download as zip file
Access to patent information, competition policy, arbitration and
Konji Sebati, WIPO
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)
Carsten Fink, WIPO
13h00–14h15 Lunch Break
14h15–15h30 — Panel 3 Experiences on Medicines Procurement
Zafar Mirza, WHO
Athersuch, Medical Innovation & Access Policy Adviser, Médecins
Sans Frontières Campaign for Access to Essential Medicines
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)
Antony Taubman, WTO
17h30–17h45 — Prospects for Future Dialogue and Cooperation
17h45–18h00 — Closing Session
Directors-General: opening remarks
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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
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
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
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.
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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
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
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
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
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
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.
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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
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
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.
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