EGA Press Release

Friday, 25 October 2002

European Parliament Vote Undermines EU Governments’ Measures to Promote Affordable Generic Medicines

Measures by EU Governments to promote affordable Generic Medicines could be seriously undermined as a result of Wednesday’s vote in the European Parliament on new pharmaceutical legislation(1).

At present over €12 billion are saved each year in the EU by the dispensing of generic medicines. These savings could be doubled over the next few years as brand products come off patent and governments introduce measures to promote generics.

European generic medicines manufacturers are particularly concerned by MEPs’ support for new use and new market protection periods for products changes(2), as well as restrictive definitions of generic and bio-similar medicines(3).

Greg Perry, Director General of the EGA, said “These amendments, if they ever become law, would enable brand pharma companies to play around with formulation and minor chemical changes to prevent the marketing of equivalent generic versions of their products. It is disappointing that as the US is seeking to reduce obstacles to generic medicines, as announced this week by President Bush(4), than MEPs agreed to increase the hurdles in Europe.”

The manner in which these amendments were adopted also puts into question the way the EU Parliament makes decisions. Many of the anti-generic amendments adopted in plenary were rejected by the committee on the environment, public health and consumer policy. The committee has spent one year on its report, however the rejected amendments were re-tabled by the centre right PPE-DE group only a few days before the final vote. This gives no time for proper debate or opportunity for interested groups to explain the implications to a wide number of MEPs.

Despite the negative amendments for generics, the EU Parliament did adopt an amendment to limit the Commission’s proposed increase in the period of time that prevents submission of generics applications. “If implemented this would help reduce time delays for the marketing of generics after expiry of the brand’s patent” stated Greg Perry. “Moreover the amendment was adopted by an overwhelming majority(5) of MEPs. The EU Commission and Member States should take this into account when deciding how to respond to the European Parliament’s amendments.”

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(1) Grossetête Report on the proposal for a European Parliament and Council directive amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (COM(2001)404).

(2) Amendments 38, 40 and 155.

(3) Amendments 156, 167 and 168.

(4) FDA Proposed Rule: Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug is Invalid of Will Not Be Infringed [Docket No. 02N-0417].

(5) 454 votes in favour/ 92 votes against.

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