Pandemic influenza preparedness figures prominently on the agenda of the World Health Organisation’s board meeting this week, and countries are still deeply concerned about the lack of supply, according to sources.

One of them is Egypt. A domestic media debate erupted after it became known that the country has only been supplied with some 1,000 packs of Tamiflu — the medicine believed to be most effective in case of an outbreak of pandemic influenza in humans — instead of the 60-70,000 packs that Egypt had ordered for its 75 million people, an Egyptian government official said in an interview.

The lack of medicine (Tamiflu) is becoming a “huge problem” in Egypt, the official said. The country had placed the order with Swiss pharmaceutical company Roche, the only company marketing the product worldwide.

A Roche spokesperson told Intellectual Property Watch that it had been in talks with a number of companies to help it increase its production capacity. These arrangements do not require any licensing, which would require Roche to share its patent rights. Some 200 companies expressed interest, 12 of which Roche has chosen for further “talks in detail,” a spokesperson said.

But Roche also has granted two sub-licenses, under which it gives the companies the right to produce Tamiflu for a certain period of time under a different name despite Roche’s patent rights to the product. The companies would pay Roche royalties for sales of the products, the spokesperson said.

The two companies with sub-licenses are Hetero Drugs in India and Shanghai Pharmaceutical Group in China, the spokesperson said, adding that these companies were to produce their own version of Tamiflu that would have local brand names. He said that in these two cases Roche would provide the recipe for the compound oseltamivir, the active substance in Tamiflu.

The Shanghai company would only produce for the home market, however, while the Indian company would also be able to export the product to “some defined countries” under the deal, the spokesperson said. Roche has indicated that Hetero will be able to start supplying the drug during the first half of 2006, according to a Hetero press release, which also notes that the importing countries will be “other developing nations.”

The Roche spokesperson emphasised that it was in fact the US biopharmaceutical company Gilead Sciences that held the patent rights to oseltamivir, but Roche had licensed the rights from Gilead and developed the product further (IPW, Public health, 16 November 2005).

Avian Flu Discussed at the Board Meeting

At the board meeting a government official from Vietnam said that no cases of avian flu had been reported in that country within the past two months. He also said that it was vital to expand global production of vaccines and to develop clear policy guidance for stockpiling of medicines.

A government official from Thailand warned that countries that do not have any production capacity for medicines or vaccines for avian flu should “expect to be on your own.”

He said that a Tamiflu tablet used to cost US$3 in Thailand (a significant sum for people earning the lowest wage) but Thailand learned from Brazil how to lower prices. The government announced last month that it wanted to produce a generic version of the product, the official said, for $1.50 per tablet. The day after, the pharmaceutical industry replied that it was willing to sell its original product for $1.40 per tablet, he said.

At the board meeting, Margaret Chan, assistant director general of the communicable diseases cluster at the WHO, welcomed the “generous donation of Roche” of Tamiflu to the WHO. Earlier this month, Roche announced that it would donate a further two million treatment courses of Tamiflu to the WHO, taking the total WHO stock up to 5.125 million treatment courses, according to Roche.

While previous donations are stored centrally, these will be stored regionally in places to be determined by the WHO, Roche said.

WHO Director General Lee Jong-wook briefed the board meeting on the current issue of avian flu in Turkey, where 21 human cases of avian influenza have been reported by the national influenza centre in Ankara, of whom four have died. “One hundred thousand treatment courses of oseltamivir were delivered one day after the first cases were confirmed,” Lee said.

Lee said the WHO has drawn up a pandemic influenza strategic action plan for this year and next, and the draft containment plan will be posted on the WHO website by the end of this week. The board also will discuss how countries may voluntarily comply with selected provisions of the revised International Health Regulations, a binding global arrangement ensuring the best approach to preventing the spread of diseases, to come into force in June 2007, it says.

The board also noted the $1.9 billion that had been pledged in loans and grants at the international pledging conference on avian and human influenza in Beijing on 17-18 January. The WHO said that avian influenza has lead to 79 deaths globally so far, and over the past two years, six countries have reported outbreaks in humans. No cases of human-to-human transmission of the virus have been reported so far, the WHO said.