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4 March 2008

Compulsory Licensing of Life-Saving Cancer Medication

In the face of opponents from the Pharmaceutical Association of America and pharmaceutical companies, the Thai government continues to abide by its compulsory licensing of essential, life-saving cancer medications to enable poor patients to access quality generic versions of patented medication.

In a letter dated 30 Jan 2008 by the Pharmaceutical Association to the United States Trade Representative (USTP), the association urged the USTP to downgrade Thailand to Priority Foreign Country instead of the country's current status on the Priority Watch List, based on claims that Thailand had not informed the patent holders prior to the announcement of compulsory licensing. Countries are ranked and placed in one of three categories: 1) Priority Foreign Country, 2) Priority Watch List, or 3) Watch List. The worst of these is Priority Foreign Country, subject to sanctions by the US. According to commentary by the Intellectual Property Alliance, Thailand will likely remain on the Priority Watch List.

Thailand currently enjoys low tariffs on 2,000 products exported to the US, but that would change if the USTP agrees to have Thailand put on the Priority Foreign Country list, in which case 20% of exports to the US, equivalent to 130 Billion Baht, would be taxed at a higher level and have adverse affects on Thailand's economy.

The Health Ministry has countered the accusation by the pharmaceutical association by stating that the ministry made efforts to negotiate a lower cost for drugs with the patent companies, yet the companies did not agree to the offer by the Thai government, stating they would lower costs progressively. One company stated that it would reduce the cost by 1 Baht per tablet. The Ministry reportedly had no recourse to take and, in an effort to save lives, made the decision to impose compulsory licensing on three major cancer drugs, Docetaxel, Erlotinib, and Lectrozole, produced by Sanofi-Aventis, Roche, and Novatis, respectively. Generic versions of Docetaxel cost 4,000 Baht per 89 mg injection compared to the patented version of 26,500 Baht. Generic versions of Erlotinib cost between 275-735 Baht per tablet, but the patented version 2,800 to 3,000. Lastly, generic versions of Lectrozole cost 7-10 Baht per tablet compared to the patented 230 Baht.

Law experts from Thailand, the US, and other countries have petitioned the current Prime Minister Samak Sudaravej to support compulsory licensing, stating that the action was lawful and in line with the World Trade Organization's TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement. Compulsory licensing is sanctioned by the WTO to allow governments to manufacture or buy generic versions of patented drugs to enable poor patients to have access to life-saving medications. Compulsory licensing enables a government to compel a patent holder to grant use of a patented product or process to others, based on certain conditions such as the patent holder receiving payment of "adequate renumeration". The TRIPS agreement has existed since January 1995, allowing for generic productions of a product for the domestic market. The Doha Ministerial Conference in 2001 and the General Council in 2003 clarified the use of compulsory licensing to allow for imports of generic pharmaceuticals for countries lacking technological know-how and infrastructure to produce generic products.

The Surayud Chulanont government and the former Public Health Minister Dr. Mongkol na Songkhla supported compulsory licensing. Dr. Mongkol commented that compulsory licensing for drugs such as cancer was a means to save life as the government did not have sufficient funds to import costly patented drugs. Media sources indicate that a number of health advocates are not approving of Chaiya's stance on the compulsory licensing issue. They are of the opinion that he favors pharmaceutical companies and the business sector as he has reportedly stated his fears that compulsory licensing may impact negatively on US-Thai trade. Chaiya has stated that he will review the decision to maintain or revoke compulsory licensing, but the decision would not be based on his ministry solely, but on the entire cabinet. The decision should be made by March 30. Current reports seem to indicate Chaiya's leanings towards compulsory licensing.

Studies by the National Cancer Institute estimate the number of new breast cancer patients in Thailand at 12,000 for this year and 14,400 for 2012. The National Cancer Institute and the Network of Patients Suffering from Cancer assess that use of the three generic cancer drugs, under compulsory licensing, would save the government 3 billion Baht over a period of 5 years.

Compulsory licensing is a new development in Thailand Intellectual Property law which is expected to save lives while at the same cost multinational pharmaceutical companies great financial loss.



Chaninat & Leeds assists with the translations of Supreme Court decisions. Chaninat & Leeds specializes in Thailand real estate acquisition. Chaninat & Leeds is managed by an American attorney who specializes in immigration with a focus on K1 Visa Thailand


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