EGA Press Release

Thursday, 27 November 2003

MEPs Give Mixed Blessing to the Future of Generic Medicines.

Today’s European Parliament Second Reading vote in the committee stage of the Review of EU Pharmaceutical Legislation gives a mixture of good and bad news for increasing patient access to affordable generics.

Concerning the Müller Report on the EMEA and Centralised Procedure, the EGA welcomes the decision of MEPs to:

• Re-introduce the “8+2+1”-year data exclusivity formula into the Centralised Procedure instead of the Council Common Position’s “10+1” formula. This will help reduce registration delays for generic equivalents of Centrally approved originator products;
• Allow generic manufacturers to exclude patented indications from their product information (SmPCs) and thus ensure that they do not breach patent law. However, this must also be clearly included in the Decentralised and Mutual Recognition systems.

Concerning the Grossetête Report on Human Medicines, the EGA welcomes the decision of MEPs to:

• Reject amendments which would have placed unprecedented restrictions

  on generic manufacturing and generic market authorisations;
• Improve the wording of the EU’s Bolar provision, which would encourage generic R&D work to take place in the EU - both for European and export markets;
• Implement the WTO Doha Agreement on access to medicines for countries with a lack of domestic manufacturing to meet urgent public health needs.

However, the EGA regrets the MEPs’ decision to:

• Reject the request by Acceding Countries to maintain the 6-year data exclusivity provisions of the current acquis, thus making access to generics and funding provision of healthcare more problematic in these countries.
• Adopt 3 years of data exclusivity both for OTC-switch and for any “new” uses of “Well-Established” Products. This will cause problems for the harmonisation of product and patient information and disproportionately reward changes of little or no real therapeutic use. However, the EGA notes that these two amendments were adopted by narrow majorities and therefore may not receive the required majorities at plenary stage.
• Change the scientifically agreed definitions of generic and bio-similar of the Common Position.

The EGA notes the adoption of the “8+2+1”-year data exclusivity formula for the Decentralised and Mutual Recognition systems as opposed to the “8+2+1”-years only of the Council’s Common Position. The EGA accepts this decision only as part of an overall compromise agreement under which the same is applied in the Centralised Procedure. It should be noted the “8+2+1”-year data exclusivity formula provides the strongest period of market and data exclusivity protection for pharmaceuticals in the world and dramatically increases current levels applicable in the EU-25.

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