EGA Press Release

Thursday, 02 October 2008 | Brussels

Patients Must Have Immediate Access to Affordable Generic Medicines
at Day One After Patent Expiry

Speaking today at the final meeting of High Level Forum on Pharmaceuticals, organised by the European Commission in conjunction with pharmaceutical stakeholders, EGA President Eric Gorka urged European regulators to guarantee patient access to generic medicines at day one after patent expiry.

Mr Gorka explained that

“Over €25 billion in savings is being secured for patients and healthcare systems by generic medicines competition, but this can only be effective, increased and sustainable on condition that generic medicines are ensured rapid market entry. A quick look at the market entrance of the top 35 off-patent molecules shows that in some cases the first generic medicine only entered the market up to 20 months after the patent expired.”

During his speech, Mr Gorka specifically asked the national competent authorities and the European Commission to remove all anti-competitive barriers to immediate post-patent generic entry. One major barrier in particular — known as “patent linkage” — is preventing generic companies from gaining their market authorisation, pricing or reimbursement status whilst a patent is in place. Although it is incompliant with EU legislation, there is a clear attempt by certain patent holders to link authorisation status and the price & reimbursement status to the patent status of a product. Another cause of delay is that EU governments themselves spend many months after market authorisation before granting a price or substitution status to a generic medicine despite its lower price and well-known use. “Patients and healthcare budgets are therefore losing out.”

In the past, attempts for patent linkage by patent holders were more focused on the level of marketing authorisation, but this has effectively been stopped by the BOLAR provision in the EU pharmaceutical legislation. However, we now see a clear shift of the pressure towards price and reimbursement authorities. Therefore, the EGA asks all member states to include in the national legislation — which regulates price and reimbursement of medicines — a provision on patent linkage. This should exclude any attempt to involve national regulatory bodies in patent discussions and to ensure that all preparatory administrative actions can be undertaken by generic medicines manufacturers to guarantee the availability of their products immediately after patent expiry to all patients in the European Union. In addition, as is supported by the Pharma Forum, generic medicines should receive immediate pricing approval upon market authorisation.

The EGA welcomes the adoption of the Final Conclusions and Recommendations by the High Level Pharmaceutical Forum, and especially the recognition that “Generic medicines provide an opportunity to obtain similar treatments at lower costs for patients and payers, while liberating budgets for financing new innovative medicines” and the need for “a sufficient level of competition amongst the different actors in the supply chain”. The EGA strongly emphasises the need for the European Commission and member states to gather further knowledge and experience on the utilisation of generic medicines as included in Recommendation 9 of the final report.

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