Nobel Laureate, Other Experts Hail WHO Effort On Medicines R&D Framework

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The annual World Health Assembly being held this week has a rare chance to achieve a breakthrough on health research for the global poor if it can agree to move forward on a proposed convention, proponents said at a recent meeting.

The World Health Organization Consultative Expert Working Group: Finance and Coordination (CEWG) has issued its mandated report and among its recommendations is to negotiate a binding convention on research and development on diseases predominantly affecting poor populations, for which there is an insufficient market to incentivize private sector R&D.

The CEWG report is available here.

The proposed convention would not affect the existing intellectual property rights-based system but would de-link R&D from pricing and treat it as a public good in the case of neglected diseases, according to John Arne Røttingen, a professor at the University of Oslo and chair of the CEWG.

He said the diverse group agreed that market mechanisms should be used where they can work, but that there is a need for a global framework on this type of R&D which has shown to be a market failure. The recommendation is that countries should commit to spend a small portion of their GDP toward such R&D.

“We need a solid convention,” Røttingen said at a 4 May conference at the Graduate Institute in Geneva. “If not, I fear it will be wishful thinking. I hope member states at the WHA are able to take this forward.”

At the conference, Joseph Stiglitz, a Columbia University professor and Nobel Prize winner in economics, spoke strongly in favour of the convention.

“This is really something that has been needed for a long time. This is a milestone in moving forward.”

Stiglitz called the CEWG report “very impressive,” noting the difficulty in getting a divisive group of stakeholders to agree.

The inherent problem, he said, is that “industry spends more on hair products than on the needs of the poor.” Also, intellectual property “does not lead to an efficient allocation of resources,” he said. Too much is spent on “me-too” drugs (those that follow profitable blockbusters).

When one person uses knowledge, it does not preclude someone else from using it, Stiglitz said, but the patent system says the opposite, giving monopoly power to the patent holder.

“In the IP regime we fund research by creating an inefficiency,” he said. So the IP system must be well-designed, as patents could restrict the use of knowledge and deter innovation. He cited past examples of last century’s development of the airplane and the automobile, which were held back by patents until they were over-ridden.

“There is a bias in our system toward excessive patenting,” he said, adding that it is “well-known” that patents are used to block progress.

But knowledge, Stiglitz said, is a global public good, involving non-rivalrous consumption, and a public good requires collective action. He noted that collective action is usually about a “global bad,” such as toxic waste, so this is different. He said the philosophy behind developing something with global benefit is that once it is discovered, the benefits should be distributed as widely as possible.

He also mentioned a recommendation by the CEWG to pursue a prize system to reward innovation in these areas, which he said would not replace the patent system nor government research. Another recommendation from the CEWG is to pursue patent pools.

In the recommendation from the CEWG, he said many things were left out that he would have included, but that the narrower version might mean agreement is attainable. He mentioned the issue of data exclusivity, in which generics competitors cannot access the marketing data for years, which delays their entrance into the market once the patent expires.

Stiglitz and others also cited the benefits to developed countries as well as developing countries. This includes stopping infections that start in the developing world from spreading worldwide, and unforeseen benefits from research into these neglected areas. It also would create a more efficient system, he said.

The total being sought for the convention to work would be about $6 billion per year, which Stiglitz called “a very modest effort.” By comparison, the United States spent that amount every 10 days on the war in Iraq. “This is not overspending,” he said.

Røttingen said CEWG was a group of “pragmatists,” seeking to “achieve results,” and “if the world is not able to show results, the issue will just come up stronger and stronger.”

Liu Zhenmin, China’s ambassador to the UN in Geneva, said that funding research for innovation for neglected diseases is an “unfinished agenda, as recognised by the CEWG report.

“Careful study and coordination are needed among member states,” he said, adding a call for support for the CEWG proposals. The market failure needs to be addressed, and there is a moral perspective as “people suffer and die due to lack of access to medicines that already exist in developed countries.” He also cited the UN right to health for all.

But, the ambassador said, financing is the most difficult part, and both governments and the private sector have a role to play. In sum, he said, a global framework is needed to ensure implementation of the report recommendations.

Kenyan Ambassador Tom Mboya Okeyo said the question before the WHA is how to move to the next step. The effort began with a Kenya-Brazil proposal that led to a 2006 WHA resolution. Now, he said, there is no need for further study or delay. “We now know what needs to be done,” he said.

Mboya said the effort should go forward in the context of WHO reform, and urged action at this WHA. “The people who are sick and dying cannot wait any longer,” he said. “We cannot play this game any longer.”

However, Sally Davies, the United Kingdom chief medical officer, spoke instead about the need to address noncommunicable diseases, which are of greater concern to developed countries. She said a flexible approach will be needed to implementation of the report recommendations. The UK supports patent pooling, she noted, and re-affirmed that the WHO has a central role in these issues.

The UK supports the Swiss proposal to spend the next year deepening the understanding of the recommendations, she said. In sum, she called the recommendations a “very helpful set of suggestions, many of which we hope we can negotiate through successfully.”

Suerie Moon, co-chair and research director of the Forum on Global Governance for Health at the Harvard Global Health Institute and Harvard School of Public Health, told the Graduate Institute event that it is the responsibility of governments to ensure access to medicines for their populations, and that the WHO is still the central convening body for global public health issues.

Moon praised the effectiveness of soft norms, but said they are “clearly not enough,” as a more reliable, predictable, coherent and binding set of global rules for R&D are needed. Funding is precarious and administration can be ad hoc, she said.

Finally, she said the rules need to be global because the world is becoming increasingly interdependent when it comes to health, and the economic and political power is changing in middle income countries.

James Love, president of Knowledge Ecology International, said the hardest part is the financing, and said there could be a pooling mechanism where countries could have a say in what funds are spent on, allowing them to leverage what they already are spending.

He also said “it’s a mistake to see this as a big fight about the patent system.” Instead, it’s about getting together to solve a problem.

Stiglitz noted that the discussion is about a modest investment for “the health needs of the vast majority of the world population.”

William New may be reached at wnew@ip-watch.ch.

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