EGA Press Release
Tuesday, 16 December 2003
MEPs Recommended to Accept EU Pharmaceuticals Compromise
Despite concerns that the new EU Pharmaceutical Legislation will delay patient access to affordable healthcare, European producers of generic medicines have today formally endorsed the proposed compromise package negotiated between the Council and the European Parliament. The EGA recommends MEPs vote in favour of the compromise package on December 17th. The Association stresses, however, that if any subsequent changes are made – especially to data exclusivity provisions or the definitions of generic or biosimilar products – then the package should be rejected and the entire Pharmaceutical Review be re-considered after Accession of the 10 New Member States.
The EGA endorses - as part of a compromise package - the following key measures:
- The “8+2+1” data exclusivity formula for both the Centralised and Decentralised/MRP procedures. We welcome the public endorsement by EFPIA to “support allowing authorised generics to enter the market at ten years” and consequently the 8+2 standard formula for both procedures. The 8+2 approach will help reduce registration delays for generic equivalents caused by the overall increase in data exclusivity in the EU-25. In the same spirit, the EGA has endorsed EFPIA’s request for both procedures to include the +1 data exclusivity increase.
- The delicately agreed definitions of generic and bio-similar medicines. Although no public health justification exists to modify the definitions in the Common Position agreed by Member States, we endorse the compromise text on the understanding that it is based on a scientific approach acceptable to the EU’s 25 Member State medicines agencies. However, we remain concerned by the continuous attempt by certain commercial interests to undermine patient confidence in generic medicines and EU medicines agencies by promoting misleading press statements concerning the registration and assessment of generic medicines in the EU.
- New 1-year non-cumulative data exclusivity periods for both OTC switch products and new uses of well-known (WEU) products. However, we remain concerned that the new data exclusivity for WEU products will disproportionately reward changes of little therapeutic value and will cause problems for the harmonisation of product and patient information.
- Provisions to allow generic manufacturers to exclude patented indications and dosage forms from product information (SmPCs) thus preventing breaches of patent law. However, it must be clarified that this relates to both the Centralised Procedure and the Decentralised Procedure/MRP.
- The introduction of the European Reference Product and the Single Market Authorisation which will ensure that generics can be marketed where originators have, for commercial reasons, either not placed their product or withdrawn their products from the market.
The EGA regrets that the compromise does not include:
- A clearer wording of the Bolar provision, which would encourage generic R&D in the EU.
- The right of Acceding Countries to maintain 6-year data exclusivity provisions. However, we note that prospective application could mitigate some of the problems caused by the over-all increase in data exclusivity for patients’ access to affordable healthcare in these countries.
- A provision to implement the WTO Doha Agreement on access to medicines. However, the Commission must keep its commitment to present appropriate implementing legislation.
“The adoption of the legislation should now draw a final line on the need to extend market protection in the paharmaceutical sector. Measures to promote both innovation and affordability should now be focused in other areas, such as increasing generic market competition, reviewing pricing systems, and creating a European Centre for Pharmaceutical Research to rival the US’ National Institutes of Health. All sides of industry should benefit from the new system and work together with other stakeholders to ensure pharmaceutical healthcare is accessible to all citizens in the new enlarged Europe.”
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