International Herald Tribune Letter: Thai medicines policy follows WTO rules; has significant public health benefits

by Sarah Rimmington and Robert Weissman, Essential Action
Submitted to the International Herald Tribune

To the Editors,

A recent story (_”Head of Thailand’s Food and Drug Administration resigns after one week,”_ March 3, 2008) incorrectly describes the international legal rules governing Thailand’s decision to provide affordable generic versions of important treatments for HIV/AIDS, heart disease and cancer to low-income Thais. The article says international trade rules “allow a government to issue a compulsory license to manufacture a generic version of a drug only in case of a national public health emergency.”

In fact, World Trade Organization rules stipulate that governments can issue compulsory licenses — an authorization of generic competition for products that remain under patent — under circumstances of their own choosing.

It is true, as the article says, that the drug companies dispute whether Thailand should have issued compulsory licenses. But the public health benefits are undeniable: thanks to the lower prices from already implemented compulsory licenses, thousands of Thais are being given life-saving treatments for HIV/AIDS and heart disease they otherwise would have been denied.

Robert Weissman, Director, Essential Action, Washington, DC, USA
Sarah Rimmington, Attorney, Essential Action, Access to Medicines Project, Washington, DC, USA

Here is the article referred to in the letter above.

Head of Thailand’s Food and Drug Administration resigns after one week
Monday, March 3, 2008
The Associated Press
Published at The International Herald Tribune

BANGKOK, Thailand: The recently appointed head of Thailand’s Food and Drug Administration resigned Monday amid controversy over the new government’s plan to review a policy of overriding patents on several expensive cancer-fighting drugs.

Chatree Banchuen was named secretary general of the FDA last week, making him the government’s chief negotiator with multinational drug companies over pricing and licensing terms.

Chatree said he decided to resign because he felt “uncomfortable with the politics,” explaining that critics had brought up old, unproven allegations linking him to corruption in a computer procurement project in 2003. He called the allegations “politically motivated and groundless,” without elaborating.

Chatree’s predecessor, Siriwat Thiptharadon, was transferred to an inactive post last Tuesday by the new government of Prime Minister Samak Sundaravej. Siriwat called his transfer unfair, charging it was because he supported compulsory licensing of drug patents.

Compulsory licensing is intended to make some drugs more affordable by taking away the patent holder’s ability to control the drug’s price, a benefit of being a drug’s exclusive supplier. International trade rules allow a government to issue a compulsory license to manufacture a generic version of a drug only in case of a national public health emergency.

Siriwat was the architect of the government’s policy leading to the issuing of compulsory licenses on Jan. 4 for four cancer-fighting drugs.

In the past two years, the Thai government has also issued compulsory licenses for several drugs used to treat AIDS and heart disease, drawing criticism from companies holding patents on the drugs.

The drug companies dispute whether the circumstances in Thailand qualify for such licenses.

Newly appointed Public Health Minister Chaiya Sasomsup said Monday the ministry will review the licensing policy on the cancer-fighting drugs, while ensuring patients have affordable access to the medicines.

He said that if negotiations fail to get drug companies to lower their prices, compulsory licensing would be maintained.

Chaiya earlier said the government planned to review the drug licensing policy because U.S. drug manufacturers might ask Washington to apply trade sanctions against Thailand.

The four drugs issued compulsory licenses on Jan. 4 are Novartis’ Imatinib and Letrozole, Sanofi-Aventis’ Docetaxel, and Roche’s Erlotinib.

Novartis AG and Roche Holding AG are Swiss, and Sanofi-Aventis SA is French.