SEOUL - Roche's Tamiflu (oseltamivir) and GlaxoSmithKline's Relenza (zanamivir) could be manufactured under compulsory licensing in South Korea if the country faces an emergency swine flu threat in the coming months, Health, Welfare and Family Affairs Minister Jeon Jae-Hee said.

Jeon's comment, made in Beijing on the sidelines of an international symposium on the A/H1N1 virus organized by the World Health Organization, was released in a prepared statement by the ministry; the statement marks the first time a South Korean leader has mentioned the possibility of compulsory licensing.

"If we implement compulsory licensing now, when we have the drugs, it doesn't comply with international rules," Jeon was quoted as saying by the South Korean health ministry. "But, if it turns into an emergency, we should do it," the minister said. Yet Jeon added that "cooperation from patent-holding companies in the production of generics and vaccines at a time of the spread of the flu is their responsibility beyond their profit."

Jeon was quoted as saying that South Korea is already set to import A/H1N1 vaccines from other countries including China to fight a potential epidemic in October or November in South Korea.

South Korea's FDA last week rejected local press reports that the government - jittery over rising A/H1N1 cases - would soon consider "compulsory licensing" to produce generic versions of Roche's Tamiflu.

KFDA Chief Yun Yeu-Pyo reportedly told ruling party lawmakers that health authorities should allow SK Chemicals to produce a generic version of Tamiflu (Also see "Korea FDA Rebuts Reports Of Compulsory Licensing For Roche's Tamiflu" - Scrip, 21 August, 2009.).

But a KFDA spokesman told PharmAsia News that imminent licensing was not in the cards, and would be considered only in an emergency.

Last week, Roche said it has not been approached by South Korean health authorities on more Tamilflu supplies or a possible compulsory licensing situation.

A health ministry official who asked not to be identified said Jeon's remarks in Beijing were a "reiteration of the basic Korean government stance" on compulsory licensing in the case of a full-blown emergency.

"Minister Jeon just wanted to say that the Korean government will depend on compulsory licensing when an emergency situation occurs in our fight against the flu," the official said.

South Korea, like other countries, has expressed concern that recent spikes in the number of patients diagnosed with the A/H1N1 flu ahead of the normal winter flu season raised concerns about Tamiflu and Relenza supplies even though the government has stockpiled enough doses of both drugs for 5.3 million people, or 10 percent of population.

On Monday, President Lee Myung-Bak ordered that stockpiles of the drugs should cover 20 percent of the population to better fight the A/H1N1 flu in October or November, when schools reopen after summer vacation, though no details were mentioned about specific purchases of Tamiflu and Relenza.

Also on Monday, Jeon ordered the distribution of 250,000 doses (150,000 of Tamiflu and 100,000 of Relenza) to government hospitals across the country as the government moves to have swine flu tests covered by the national health insurance system.

A South Korean pharmaceutical company, Green Cross, has been asked to bring A/H1N1 flu vaccines into the market as soon as possible after receiving virus strains from the U.K. National Institution for Biological Standards and Control and from the U.S. Centers for Disease Control (Also see "South Korea's Green Cross Begins "Test Production" of Flu Vaccine" - Scrip, 8 July, 2009.).

- Peter Chang (p.chang@elsevier.com)

Roche, GSK Face Compulsory Licensing Of Antivirals If Swine Flu Emergency Hits - South Korean Health Minister

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