Thailand to break HIV drug patent

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Thailand to break HIV drug patent

 

Aids groups praise 'brave' decision to make a cheap version of Efavirenz

 

 

The Public Health Ministry yesterday announced it would break the patent of the drug Efavirenz due to its high price. The important life-saving drug is needed by thousands of people living with HIV/Aids yet only a small number can afford it.

 

 

The so-called government compulsory licensing took effect immediately following yesterday's announcement and the Govern-ment Pharmaceutical Organisa-tion (GPO) was expected to start mass production of a generic version of the drug in six months.

 

 

Although the compulsory licensing would be valid for only five years, the move was recorded as a first in Thailand's history since the Drug Patent Act was passed 27 years ago.

 

 

It allows compulsory licensing to be enforced by the state in the case of certain drugs being critically needed to save people's lives - that the state is unable to afford.

 

 

There were about 500,000 HIV-infected people who needed to use anti-retroviral treatments yet only about 100,000 had access to the drugs because of the high prices - as well as insufficient budgets - said Public Health Minister Dr Mongkol na Songkhla.

 

 

"This is quite a small amount and since the state budgets are not enough to cover all of the people who need the drug, we have to make the drug cheaper," he said.

 

 

"It's not breaking any rules. The state is simply using a loop allowed under Thai law," said Mongkol, adding he had already informed Prime Minister Surayud Chulanont on Tuesday and he had approved.

 

 

The compulsory licensing of Efavirenz is expected to enable the National Health Security Office to increase the number of HIV-infected people who need the drug to about 100,000 - from the current 25,000.

 

 

The locally-made version would cost more than half that of the original drugs sold in Thai-land, said Dr Thawat Suntrajarn, the director-general of the Disease Control Department.

 

 

Efavirenz is a second-line drug used to save the lives of HIV-infected people who were resistant to the six first-line drugs - or basic regimens - available in the country, said Thawat.

 

 

Compared to another second-line drug Nevirapine, Efavirenz is much better in terms of effectiveness and side-effects, he said, adding the latter was found to have only a 5 per cent chance of side effects - compared to 25 per cent in the former.

 

 

Thawat said yesterday the ministry had sent a letter to Merk Sharp and Dohm, the American company that owns Efavirenz, as well as the Department of Intellectual Property and other concerned organisations.

 

 

The foreign company will receive compensation equivalent to 0.5 per cent of the sales in Thailand.

 

 

"Of course, the company will do something to oppose this but we're doing everything according to not only the country's law, but also international law," he said.

 

 

This compulsory licensing of Efavirenz is also according to the international trade agreement known as Agreement on Trade-Related Aspect of Intellectual Property Rights (TRIPs agreement), said Dr Vichai Chokeviwat, the chairman of the GPO's board.

 

 

Thailand is not the first country to do this, he said, adding Brazil and even the US and Canada had used compulsory licensing.

 

 

While preparing to produce a generic version of Efavirenz, the GPO will import a generic version of Efavirenz - presumably from India - for use until the GPO could start producing its own generic drug in the next six months.

 

 

The ministry's announcement was warmly received by non-governmental organisations working on HIV/Aids.

 

 

Boripat Donvorn of the Thai Network of People Living with HIV/Aids, said he was forced to stop taking anti-retroviral drugs last year when he could no longer afford the second-line ones.

 

 

It cost him about Bt15,000 a month, while the Social Security Fund covered only Bt5,000, he said, adding: "Even if I spent my whole salary I still could not have enough to buy the drug."

 

 

"Thank you for the courage of the Public Health Ministry. It's remarkably brave," said Nimitr Tienudom, the manager of Aids Access.

 

 

Thailand is the third country in the region to use compulsory licensing on HIV/Aids drugs after Malaysia and Indonesia.

 

Arthit Khwankhom

 

 

The Nation