Thailand approves generic versions of two drugs

By Apiradee Treerutkuarkul

Thailand is the first developing country to invoke compulsory licensing under the World Trade Organisation's rules for a non-Aids related drug. The WTO allows a government to declare a "national emergency" and licence the production or sale of a patented drug without the permission of the foreign patent owner.

Public Health Minister Mongkol na Songkhla on Monday shrugged off pharmaceutical giants' threats to freeze investment in Thailand in protest at his decision to allow generic, inexpensive versions of heart disease and Aids drugs.

"Most of these costly drugs are produced somewhere else, not in Thailand. Nobody knows if they produce these drugs cheaply in other countries and just import into Thailand for expensive and profitable sales," the minister said.

Dr Mongkol said he had issued compulsory licences for two drugs - Kaletra, an advanced anti-Aids drug, and Plavix, a blockbuster treatment for heart disease.

The minister invoked article 51 of the 1992 Patent Law to import or produce a generic version of the two drugs. In November, the ministry invoked the same law to import and produce the anti-Aids drug Efavirenz.

The Pharmaceutical Research and Manufacturers Association last week released a statement disapproving of the ministry's move, saying that compulsory licensing would only force more companies to relinquish patents for heart and anti-Aids drugs and could lead to the isolation of Thailand from the global biotechnology investment community.

Kaletra is manufactured by Abbott Laboratories, and Plavix by Sanofi-Aventis and Bristol-Myers Squib.

Dr Mongkol insisted compulsory licensing was essential as Thailand was facing an increase in the number of HIV-positive people. About 108,000 of 500,000 people living with HIV/Aids depend on GPO-VIR, the budget version of the first-line anti-retroviral therapy produced by the Government Pharmaceutical Organisation (GPO).

An estimated 20,000 HIV-positive people have developed a resistance to the drug, and need the combination drugs of lopinavir and ritonavir, which is marketed as Kaletra.

The patented regimen cost 11,580 baht a month per patient and this could be cut to a third under compulsory licence, Dr Mongkol said.

In addition, over 200,000 Thais with heart disease problems currently take the drug clopidogrel, sold as Plavix, to reduce the risk of heart attack or stroke, and treat established peripheral artery disease and poor circulation in the legs that may cause pain during exercise, according to the National Health Security Office.

The patented version of the heart disease drug costs over 70 baht per tablet.

Thawat Sundarachan, head of the Disease Control Department, said the agency aimed to import the generic version of these two drugs from India and later ask the state-owned GPO to set up for local production.

This was expected to slash the price of Plavix by 90% to six baht per tablet.The ministry would issue a compulsory licence for Kaletra for a period of five years.

The compulsory licence for Plavix would run until the government could find another regimen to substitute for this heart disease medicine, he said.

Plavix inhibits platelets in the blood from clotting.

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