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EGA Press Release

Thursday, 18 December 2003

Generic Medicines Industry Endorse New Pharmaceutical Law

European producers of generic medicines have endorsed the new EU Pharmaceutical Legislation adopted by the European Parliament in Strasbourg on Wednesday, 17th December.

The EGA, which recommend MEPs to vote in favour of all aspects of the so-called “compromise package”, believes that whilst there could be delays in patient access to affordable healthcare caused by increased periods of data exclusivity, the law will nonetheless create the foundation for a more efficient regulatory system for the authorisation of all medicines in the European Union.

Key points specifically affecting the generic competition in the new EU Legislation include:

• The “8+2+1” data exclusivity formula for both the Centralised and Decentralised/MRP procedures. This increases the overall data exclusivity for new products to up to 11 years (currently 6 or 10 in the EU). Importantly, however, it allows generic companies to begin registration in the 8th year. It is also very significant that the law clearly states that the increased data exclusivity periods will only apply to reference products for which an application for authorisation is submitted after the law has been implemented. This will delay the negative impact of the data exclusivity extension for 6-year countries, particularly in the new Members States, which rely heavily on the savings from using generic equivalents to fund their healthcare systems.
• New 1-year non-cumulative data exclusivity periods for both OTC switch products and new uses of well-known (WEU) products. Here the generic industry has concerns over the effects this may cause on the harmonisation of product information and substitution laws.
• Definitions of generic medicines and bio-similar medicines, which aim to clarify the registration requirements of these medicines and re-enforce consumer confidence in their quality, safety and efficacy.
• Provisions to allow generic manufacturers to exclude patented indications and dosage forms from product information (SmPCs), thus preventing breaches of patent law.
• 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ensure that generics can be marketed where originators have, for commercial reasons, either not placed their product or withdrawn their products from the market.
• A long overdue EU “Bolar Provision”, allowing generic R&D during the patent period, and putting the EU generic industry on equal footing with competitors in USA, Canada and Asia.

Greg Perry, Director General of the EGA concludes:

“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’s 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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