Report from the Commission – Annual report (2010-2011) on the application of Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines

This is the seventh annual report foreseen under Article 11 of Regulation (EC) No 953/2003, which is designed to prevent parallel trade in discounted medicines intended for the least developed countries. This report covers the period from 1 January 2010 to 31 December 2011.

As in previous reports, the volume of sales of registered tiered priced medicines has further declined in 2010 and 2011. This is again explained by the fact that eleven voluntary licenses have now been granted by the applicant for the manufacture and supply of medicines for the treatment of HIV/AIDS (ARVs), as opposed to eight in 2009.

In view of the absence of newly registered medicines by (other) pharmaceutical companies since 2004, the European Commission will consider organising a public consultation with stakeholders on the implementation of Regulation 953/2003. The consultation could assist in the evaluation of the role of Regulation 953/2003 in promoting the accessibility of affordable essential medicines to the poorest developing countries.

EUR-Lex: COM(2012)775: Follow the progress of this document through the decision-making procedure http://eur-lex.europa.eu/legal-content/EN/HIS/?uri=COM:2012:775:FIN

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