European Commission Debates Neglected Disease Effort – Outside The IP System

By Tove Iren S. Gerhardsen
BRUSSELS – When the European Commission’s plan to include neglected diseases in its next research programme was debated at a conference here, intellectual property rights played a rather small role. This is a good sign, the Commission said, but some participants disagreed.

The 8-9 November international conference on neglected infectious diseases is being held by the European Commission. It attracted some 260 participants from academia, government, industry and international organisations.

Neglected diseases are those for which there are no – or inadequate – medicines available mainly because the pharmaceutical industry does not perceive them as attractive markets. Some examples are dengue, plague, sleeping sickness and schistosomiasis. These tend to occur most in developing countries.

A number of speakers referred to the “90/10 divide,” meaning that only 10 percent of research and development (R&D) investments are being spent on infectious diseases making up 90 percent of the global disease burden.

Els Torreele of the Neglected Diseases Initiative (DNDi), s public-private partnership, said “the European Union has remained virtually absent” in terms of funding for neglected diseases.

But she welcomed the Commission’s draft seventh framework programme for research, which allocates some funding to HIV/AIDS, malaria and tuberculosis (the “big three”), but called for funding for the most neglected diseases as well. The framework programme will be launched in January 2007, will run over seven years, and has some €6.06 billion earmarked for health, Torreele said.

Dario Zanon of the EU Directorate General for Research told Intellectual Property Watch that neglected diseases would indeed be part of the framework programme, but only under the second “call” for funding applications, expected in the summer of 2007. He could not say how much money has been allocated.

“The EU is committed and willing to play its part,” said Member of Parliament and representative of London, John Bowis.

Bowis said there is a new sense of urgency for R&D funding to be expanded to other neglected diseases as well, and the Parliament had encouraged the Commission to do this in a 2005 report.

Absence of IP Discussion Leads to Debate

Bowis also referred to a speech made by the Director General of the World Trade Organization (WTO), Pascal Lamy, last month, urging developing countries to make use of the flexibilities found in the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), “stressing that no country has so far done so.”

But in the roundtable discussions at the end of the 8 November session (at which patients and non-governmental organisations were not represented), the chair, Sohail Luka of the Commission, asked why intellectual property had hardy been mentioned during the day, as IP aspects always tend to come up in the media.

Jacob Cornides of the EU Directorate General for Trade said that the fact that IP “has not come up [is] a good sign.” He said that when there is not a market, patents will not help create that market.

“It is good to steer this debate away from the IP issue” and look for other mechanisms that will provide R&D into new drugs, Cornides said, adding that this helps focusing on the real issue.

He said IP has been blamed but that is for drugs already on the market, such as HIV/AIDS drugs, “but not for neglected diseases.”

Nicoletta Dentico of DNDi asked why the discussion had not referred to the World Health Organization (WHO) report of the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH), which published some 50 recommendations including consideration of the use of compulsory licensing. This allows governments the breach of a patent without the consent of the patent holder.

Dentico also asked about the bilateral trade agreements of the EU, saying they often make access to medicines more difficult. She also questioned the political commitment the Commission and the Parliament have to the WHO intergovernmental working group that has been set up to take forward the work of the CIPIH (which was welcomed by Bowis).

Cornides said, “of course we will take the report into account.” But he said he did not understand how compulsory licenses relate to neglected diseases as there are no drugs, and no patents, for these diseases. He also denied that EU’s bilateral trade agreements limit access to health or the use of TRIPS flexibilities. The deals that contained IP provisions are related to trademark counterfeiting, Cornides said.

When the resolution setting up the intergovernmental working group was debated in Geneva in May, sources said that the Commission sent its trade, and not health.

But Kevin McCarthy of the Commission told Intellectual Property Watch that this had not been the case, and the Commission health people would continue to follow the intergovernmental working group discussions.

Dentico told Intellectual Property Watch that it was clear that Cornides had not read the CIPIH report. She said that considering the “huge role” the Commission is going to play in the WHO intergovernmental working group, she found it “disturbing” that just one month before the group’s December meeting, “nothing was said about the resolution” at the Commission meeting on neglected diseases.

Dentico said that instead of just looking at funding, a larger approach of considering policy, priority as well as funding for neglected diseases is needed. She said compulsory licenses are also needed for getting access to compounds used in R&D for neglected diseases, not just for medicines that are on the market.

Industry View

Robert Sebbag of the pharmaceutical company Sanofi-Aventis said that the industry wants partnerships on neglected diseases.

Sebbag said that in order to invest in R&D “you need profit, it is not a miracle,” adding that while the sub-Sahara African market is worth less than €1 billion, this is generated from one product on the market in the United States in a few months. The cynical thinking would be, “Forget it, Africa,” he said. Donation of drugs is also not sustainable, he said, but rather one should “transform the business model,” and change from a price to a volume policy. This could be done by developing some products at industry plants in developing countries, he said.

Tove Gerhardsen may be reached at tgerhardsen@ip-watch.ch.