WTO: 2010 NEWS ITEMS

INTELLECTUAL PROPERTY

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NOTE:
THIS NEWS ITEM IS DESIGNED TO HELP THE PUBLIC UNDERSTAND THE DISCUSSION IN THIS EVENT. WHILE EVERY EFFORT HAS BEEN MADE TO ENSURE THE CONTENTS ARE ACCURATE, IT DOES NOT PREJUDICE THE POSITIONS OF THE VARIOUS ORGANIZATIONS OR THEIR MEMBER GOVERNMENTS. IT IS NOT AN OFFICIAL RECORD.

THE PRESENTATIONS CAN BE FOUND HERE

  

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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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