Consumers Misled In Tamiflu Debate, Workshop Argues

Consumers worldwide are being left in the dark as to governments’ stockpiles in case of an avian influenza pandemic, and the pharmaceutical industry has been unclear about the medicine supplies available, concluded an intellectual property right panel in Geneva recently. But the industry says it has its priorities in the right place.

Neither the European Union nor Roche, the Swiss company producing the anti-influenza medicine Tamiflu (oseltamivir), has been able to provide data on how much avian flu medicine various countries have in stock, according to James Love, head of the Consumer Project on Technology (CPTech), which co-sponsored the workshop with Consumers International.

Efforts also seemed to have been made to mislead people in terms of production capacities of Tamiflu, Love said. He linked the avian flu threat to Hurricane Katrina that struck New Orleans this autumn, referring to the lack of planning and people trusting the government. “We have to be tougher” about asking our governments questions, he said.

Love also pointed out that the stockpiling issue is related to the price of the drug. The lower the probability that a pandemic will occur, the less cost-effective it would be to stockpile medicines. Love presented a “contingent royalty proposal,” according to which governments would acquire medicines freely from generics suppliers and pay the patent owner royalties if the medicines were actually used.

William Haddad, chairman and CEO of the United States Research and Development Corporation, a generic drug producer, represented “views from a generics manufacturer.” He has volunteered to assist the Indian generics company Cipla in its Tamiflu operations and has previously worked on reducing the price of drugs for HIV/AIDS and malaria, he said, emphasising that his companies did not produce any of these drugs.

Haddad argued that there was neither a shortage of the active substance oseltamivir used for Tamiflu, nor a production problem. Haddad said Roche has argued that the active substance is in short supply, and can only be derived from four regions in China, and that although the company has geared up its production facility, there is still a supply issue.

According to Haddad, oseltamivir has been manufactured through a fermentation process patented by Professor John Frost at Michigan State University, who had issued Roche a voluntary license. But once the media picked up on the Tamiflu production issue, Roche stopped its collaboration with Frost, Haddad said. Frost could not be reached for comment.

Haddad argued that there are at least 50 biotechnology plants that would be able to produce oseltamivir because the production methods are not as complicated as Roche claimed.

There also is an issue with “corporations’ pressure on politicians,” Haddad said. “They constructed the ballpark and now they ask us to play in their ballpark.”

Roche Prioritises Flu Season

A Roche spokesperson confirmed that the company had, together with Frost, “developed a special fermentation process, using a special E. coli strain which, when overfed glucose, over-produces shikimic acid.”

The synthesis of Tamiflu can start with shikimic acid, although it does not have to, and shikimic acid can be extracted from star anise, a commonly found spice, according to sources.

Roche said that other options offered by Frost for the production of shikimic acid manufacturing “might be valid, but might take too long to realize large-scale production in the current situation for pandemic planning,” the spokesperson said, but adding, “We are in discussions with Frost to evaluate these options further.”

As for reports on shortages, the Roche spokesperson emphasised that Roche’s priority was to ensure that Tamiflu would be “available for seasonal use to patients and to fulfil government pandemic orders.”

“Therefore, over the next few weeks, only limited stocks of Tamiflu may be available in some countries to ensure Tamiflu is available at the start of the influenza season,” she said. She noted that there was no influenza circulating at the moment and the threat of a pandemic had not materialised.

“We are asking people to act responsibly so that Tamiflu is available to patients who need it once the influenza season starts,” the spokesperson said.

As for production, Roche was expanding its own capacities and was working with a network of partner companies.

WIPO Overview Of Patent Information

At the workshop, Antony Taubman said that the World Intellectual Property Organisation, WIPO, was working on developing an overview of basic patent information on various countries. He said the confusion as to which patent is valid where related to the “information dilemma of the day.”

WIPO also is working on broadening the pipeline for innovation and improving access to new medicines, especially in developing countries, he said.

Sisule Musungu of the South Centre noted that it would be difficult for WIPO to get information from developing countries. He also found WIPO’s aim of improving access to information and some of its new regulations “contradicting issues.”