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Compulsory Licences on HCV Patents in Romania

10 March 2015. KEI Europe submitted a request to the Government of Romania, seeking a compulsory licence on patents concerning drugs for the treatment of the hepatitis C virus (HCV). KEI Europe asked that the government take steps to permit the importation of generic versions of certain medicines used in the treatment of HCV. Romania has either the highest or second highest rate of HCV infection in Europe, and incomes, as measured by GNI per capita, that are considerably below the median for the European Union. The combination of high infection rates and lower incomes is currently associated with a lack of access to the new, highly effective but extremely expensive drugs to treat HCV. The proposal for compulsory licences on HCV patents is designed to provide a lawful pathway to universal access to affordable versions of the new HCV drugs.

Complete submission to the Minister of Health of Romania:

• KEI Europe Request for non-exclusive compulsory licences on patents to expand access to medicines for hepatitis C.
• KEI Europe Proposed Order for the Granting of a Compulsory Licence on the Use of Patents for the Treatment of HCV.

This proposal followed our earlier efforts to obtain voluntary licences from Gilead and BMS.

• KEI Europe request to Gilead for patents used for treatment for the Hepatitis C Virus. 29 July 2014.
• Gilead Sciences letter of response to KEI Europe's request. 26 August 2014.
• KEI Europe request to Bristol-Myers Squibb for patents used for treatment for the Hepatitis C Virus. 29 July 2014.
• Bristol-Myers Squibb letter of response to KEI Europe's request. 16 September 2014.

KEI Europe Side Event on Access to Affordable HCV Medicines

30 May 2015. In conjuction with the EASL Conference on liver disease in Bucharest, Romania, KEI Europe hosted a side event on access to affordable HCV medicines.

Pathways to Widespread Access: Affordable HCV Medicines in Romania
Date: 10:00-12:00 Saturday, 30 May 2015
Venue: Novotel Bucharest City Centre, Conference Room Lyon (Mezzanine Floor)

A Panel Discussion:

• Peter Beyer, World Health Organization (WHO). Access to Medicines and Intellectual Property Rights.
• Andrew S. Goldman, Knowledge Ecology International (KEI). KEI’s Compulsory Licensing Request to the Romanian Government..
• Vlad Mixich, MedAlert. Transparency and Cost/Volume Negotiations for new HCV medicines.
• Dr. Victor Olsavszky, WHO Country Office Romania. Use of RO “Special Needs” Legislation for medicines.