EGA Press Release

Wednesday, 04 June 2003

EU Health Council Increase Protection of Original Brand Pharmaceuticals

Monday’s decision by EU Health Ministers to increase the period of data exclusivity for branded products provides major advantages for originator pharmaceutical companies.

The data exclusivity periods of 10 years for decentralised and optional centralised procedure and 11 years for the compulsory centralised procedure provide the strongest market protection in the world.

European generic manufacturers acknowledge that the right to start generic registrations at 8 years for the decentralised and optional centralised procedure would go some way to help reduce delays in post patent marketing of generics. However they are disappointed that this has not been introduced into the compulsory centralised procedure. This could cause delays in generic versions of community approved products for treating aids, cancer, neuro-degenerative and diabetes.

“The European Generic medicines Association is disappointed with the outcome of Monday’s meeting. There is in fact no evidence that increasing protection on branded original pharmaceuticals results in improved innovation. The US has a shorter period of data exclusivity of 5 years, but is more successful in pharmaceutical innovations. That is why the EGA had originally called for harmonisation of data exclusivity at 5 or 6 years,” said Greg Perry, Director of the EGA.

There is a major concern that long data exclusivity provisions will jeopardise patient access to affordable generic medicines in Europe, especially in the ten acceding countries where generics account for up to 70 % of medicines dispensed to patients. Acceding Member States were strongly opposed to this provision but had no vote in Council.

The EGA welcomes Monday’s agreement to include provision for bio-similar products, the creation of the European Reference Product and the legal basis for the harmonisation of SmPcs (product information). Some concerns, however, still remain over the wording of the EU Bolar provision. As currently stated, it may not be clear enough to ensure coverage for all activities required for preparatory work and registration.

Once the Council of Ministers agreement has been formalised into a Common Position it will be sent back to the European Parliament for a second reading.

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