Intellectual Property

European Commission warns Thailand against compulsory licensing

The European Commission has formally expressed its concern over Thailand's use of compulsory licensing¹. In a letter addressed to the Thai Ministries of Commerce and Public Health, Peter Mandelson, the European Union (EU) trade commissioner, said that compulsory licensing would be detrimental to the patent system and the development of innovative medicines.

To date, Thailand has issued compulsory licences to allow local manufacturers to break the patents for, and produce generic versions of, two HIV/Aids drugs, Merck's Stocrin (efavirenz) and Abbott's Kaletra (lopinavir/ritonavir), and a generic version of Sanofi-Aventis' heart disease drug Plavix (clopidogrel bisulfate)².

In the letter, Mr Mandelson said that Thailand's actions could lead to the country's isolation from the biotechnology investment community. He warned that a policy of applying compulsory licences wherever medicines exceed certain prices is not justified by the 2003 waiver to the World Trade Organization's (WTO) TRIPS agreement (Trade-Related Aspects of Intellectual Property Rights). The 2003 waiver is a mechanism which allows developing countries to produce or import essential medicines without the permission of patent holders, if there is a public health emergency.

The opinion of the European Commission was supported by the US Embassy in Thailand, which suggested that the issue of compulsory licensing could increase tension between the US and Thailand³. The US Trade Representative (USTR) has added Thailand to its Priority Watch List because of the country's poor protection of intellectual property rights⁴. Countries placed on the list are closely monitored by the USTR to determine whether any action (such as the imposition of sanctions) is necessary.

The Thai Ministry of Commerce has replied to the European Commission's letter, saying that any compulsory licences issued are for the purpose of public, non-commercial use, in accordance with the TRIPS agreement⁵.

These events have coincided with the European Parliament's motion for a resolution to amend the TRIPS agreement and make permanent the 2003 waiver⁶. The parliament is now in summer recess and will reconvene on 5 September 2007 to vote on the issue⁷.

References

1. European Commission letter to Thai Ministry of Commerce, 10 July 2007

2. The Regulatory Affairs Journal - Pharma, 2007, 18(5), 339-340

3. US Embassy letter to Prime Minister of Thailand, 20 July 2007

4. The Regulatory Affairs Journal - Pharma, 2007, 18(8), 568-569

5. Thai Ministry of Commerce letter to European Commission, 8 August 2007

6. The Regulatory Affairs Journal - Pharma, 2007, 18(8), 558-559

7. European Parliament website, accessed 24 August 2007, www.europarl.europa.eu/sides/indexPartSession.do?reference=2007-09&language=EN