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This followed a day-long technical symposium on
“Access to Medicines: Pricing and Procurement Practices” at the WTO, which
heard international agencies describe their experiences and the amount of
information that is now available to them.
The three organizations feel they are now well
placed to continue to work together closely to harvest information about
access to medicines and to support well-informed policymaking on this
pressing question.
They are encouraged by an improved flow of data
and the more effective use of diverse sources of information, which allow
cooperation to be designed better and policy debates to be grounded more
firmly in practical experience.
The heads of the three organizations underscored
their determination to continue to join forces to bolster the information
available and their cooperation, in order to pursue shared policy goals on
public health, intellectual property and trade.
They said the strengthened dialogue between
their organizations and others involved in the issues would improve
understanding and lead to better policies on public health and
intellectual property.
“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,” WTO director-general Pascal Lamy told participants.
WHO Director-General Margaret Chan welcomed
“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.”
WIPO Director-General Francis Gurry agreed: “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,” he said.
He added: “Any new medicines will come from
innovation. So we need to find a way of encouraging innovation.”
Strategies for procuring reliable and affordable
supplies of medicines are important in determining how easy or difficult
it is for patients in poorer countries to receive the treatments they
need. The symposium’s emphasis was on data and real-life experiences as a
means of understanding the situation.
As one speaker put it, the meeting was designed to meet “an appetite to focus on the empirical rather than the theoretical.”
The directors-general
In the opening session, the three
directors-general outlined their views on how to create synergies between
the intellectual property system and public health, and sketched out the
broader policy context for the work of the symposium.
WTO Director-General Pascal Lamy (full text available here) called for “a broad view” on 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,” he said.
The WTO has also taken a broad view, drawing on
a range of experiences and sources of practical information, he went on.
Its contribution to the symposium would be a technical and practical
overview of the range of factors in the multilateral trading system that
have a bearing on access to medicines: intellectual property, procurement
and competition policies, tariffs, and regulation to ensure 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,” he said.
He explained that this symposium is completely
separate from ongoing assessments of how well the flexibilities in the
Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement are
working — there are other meetings designed for that, including in the WTO’s
TRIPS Council, he stressed, where WTO members are currently actively
debating how to take forward the policy review of how effectively
flexibilities were being used.
WHO
Director-General Margaret Chan (full text available here)
spoke of the deep mistrust and suspicion that often cloud the debate on
medicine prices, trade and intellectual property. The concerns have to be
taken on board in order to reach consensus on how to make public health
policies and their results more equitable, she said.
“Countries unskilled in trade negotiations fear
they will be tricked or duped,” she said. “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.”
She welcomed the opportunity to collaborate with
WTO and WIPO on drug procurement, pricing, and intellectual property from
a public health perspective.
“We face two bottom-line realities,” she went
on. “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.”
Tensions arise between the motives of a
profit-driven industry and ethically-driven public health, but these can
be circumvented, if not entirely overcome, Dr Chan said.
WIPO Director-General Francis Gurry (full text available
here) emphasized the importance of making data and information on the intellectual property system available and accessible.
“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,” he said.
The objective, he said, is to provide a
strengthened empirical basis that will allow “high-integrity policy-making.
… I think we are all well placed as institutions to be able to contribute to
a better knowledge base for these processes.”
He underlined WIPO’s commitment to serve as
the world reference for information about intellectual property, which he
said plays an important part in innovation. However, “there is no point in
having new medicines unless they can
benefit those who
need them.”
This, he went on, raises the question of 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.”
The balance is extremely complex, he went on.
“Many things enter into the picture, including of course pricing and
procurement policies.
There is no
simple legislative fix, which is not to say that legislation doesn’t 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.”
Presentations and discussion
> The presentations are here
Speakers focused on the large and growing amount
of global information that is now available on wide range of subjects
related to access to medicines. Some did touch on more political issues
such as whether the flexibilities of the WTO’s TRIPS Agreement are
effective, and the recent seizures or detentions of generic medicines in
transit in the EU.
Available resources:
Several speakers described the resources they now have online. These
include data and information on:
The WHO, WIPO and WTO believe that there are now
enough data available online to guide them in their future work — in
collaboration, and separately in their own areas — and are looking to
build this information more systematically into technical cooperation.
More than prices:
Several speakers pointed out that prices are not the only factor
determining whether the sick in poor countries can receive medicines. For
the organizations procuring affordable medicines, quality and reliability
are also important. A number of factors are involved.
The prices themselves can be affected by poor
procurement practices, marketing policies such as differential pricing
(where different prices are set in different markets), mark ups (the
profit margins companies add to the cost), and border measures such as
tariffs, other government charges, import licences (which can also affect
availability), some speakers said.
As a result, prices vary from country to
country, between the public and private sectors, and between different
medicines.
Even then, data show that buying in large
volumes, including when purchases are pooled, is not enough to ensure the
best price, they said.
But buying in large volumes or as a group of
organizations can make the orders and their payment more reliable, which
is important for procurement, some speakers said. Other advantages include
better quality control.
Speakers also stressed other factors that can
affect access to medicines, such as the procuring organizations’ decisions
on what particular medicines to buy, where to obtain them, and how much,
how to be sure that the quality is good, and how to monitor this. The
principles applied to an organization’s procurement have to be
transparent, fair, competitive and workable in order to be effective, they
said.
Another obstacle that procurement agencies face
is finding information. One difficulty is information about patents.
On the one hand, although patents are seen as an
obstacle, this is not necessarily the case. Some speakers highlighted the
fact that at present the vast majority of medicines on the WHO essential
medicines list are not under patent protection — but the more advanced
treatments are under patent, such as the next wave of HIV/AIDS drugs
(known as “second line antiretroviral treatments”) and for drug-resistant
tuberculosis, speakers said.
On the other hand, some speakers described the
challenge of trying find out whether a particular medicine is under patent
protection in different developing countries, which can affect whether the
medicine can be sent to a particular country.
WIPO’s PATENTSCOPE database is starting to provide some answers.
The picture is further complicated because a
product, its ingredients or its use in combinations of medications can be
covered by several patents, with potentially different scope and effect in
different countries, some speakers said.
Patent pools were discussed as one way of dealing
with the complexity of patents for fixed dose combinations, especially for
children’s medicines, and to reduce prices through voluntary licences. This
is where several related patents are brought together so that the right to
use the invention can be voluntarily granted to others.
UNITAID an international drug purchase facility providing funds for treating HIV/AIDS, malaria and tuberculosis in developing countries, is one organization promoting this.
Another method described was the development and distribution of medicines through partnerships between the public and private sectors.
For the future:
Among the topics mentioned as needing further study were: the procurement
and pricing of medicines, the role of competition policy, the transparency
of intellectual property information and the various factors affecting
larger scale roll-out of patented medicines.
Closing the symposium, former Swiss President
Ruth Dreifuss underscored the theme struck by the three directors-general.
She said the three organizations need to ensure that their policies are
designed well enough to be coherent.
She described how the WHO Commission on
Intellectual Property, Innovation and Public Health, which she had chaired
when it reported to the WHO four years previously, had been torn between
pessimism — the “dramatic” inability to meet the health needs of the poor
and to resolve the tension between different interests involved in
healthcare — and optimism — from the many developments within the three
organizations and others to tackle the problems.
This symposium was an “important moment”, and a
first step in exchanging information and developing “knowledge-based”
solutions, she said. She urged the three organizations to continue to
drive forward their collaboration and to listen to a range of voices.
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