EGA Press Release

Thursday, 04 June 2009

REPORT PROPOSES MEASURES TO INCREASE PATIENT ACCESS
TO GENERIC MEDICINES

“EU governments need to ensure fast generic medicines uptake, as market access and low market volume in key EU countries is still a real problem and is having a major negative impact on patient access to more affordable treatments”. This is the key message Greg Perry, director general of the EGA, made at the European Generic medicines Association’s 15th EGA Annual Conference at Barcelona during the launch of a report entitled “How to Increase Patient Access to Generic Medicines in European Healthcare Systems.”

Mr Perry highlighted the role of the European generic medicines sector in ensuring sustainable and affordable healthcare, especially in light of the current financial crisis, stating that “Despite intense competition between generic medicines companies, the generic medicines industry continues to be confronted with barriers to market entry.” He welcomed the EU sector inquiry into the pharmaceutical industry that has identified unjustifiable anti-competitive factors operating against generic medicines. The loopholes identified in the patent and regulatory system need to be addressed and possible solutions are outlined in the EGA response* to the sector enquiry.

Mr Perry stressed that other issues impacting the sustainability of the European generic medicines industry must also be resolved. These include dramatic government-forced price reductions, restrictive tendering systems, increasing regulatory costs, delays to market caused by post-market authorisation procedures for establishing price and reimbursement status, patent linkage and continued price linkage after generic medicines market entry, and the general lack of EU national government measures to stimulate greater patient access to and use of generic medicines.

The report states that by eliminating the barriers to entry for generic medicines, European governments will be creating more effective competition in the pharmaceutical sector which in turn will generate significant economic savings for them. For an industry such as generic medicines which is essentially driven by volume, attaining substantial market share is crucial to the sustainability of the sector and European healthcare systems.

The report includes a series of recommendations to governments and the competent authorities to increase patient access to generic medicines uptake. These are:

1. Create sustainable generic medicines pricing systems;
2. Grant automatic pricing and reimbursement status for generic medicines upon market authorisation and ensure that this can take place during the patent period to avoid post-patent delays;
3. Enforce clear criteria for innovation, defined as synonymous with added relative therapeutic efficacy or safety to eliminate evergreening practices;
4. Introduce mechanisms to promote generic prescribing by physicians and generic dispensing by pharmacists. A key point here is to deploy mechanisms to guarantee that pharmacists are rewarded for dispensing generic medicines as it is currently not economically attractive for pharmacists to dispense generic medicines in some markets due to their lower price.

Read the FULL REPORT | Revised & Updated Edition

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* The EGA concerns in this area are addressed in other publications and submissions (eg, the EGA submission to the inquiry, “Patients Must Have Immediate Access to Affordable Generic Medicines at Day One After Patent Expiry”; EGA Report “Patent-related Barriers to Market Entry for Generic Medicines for Generic Medicines in the European Union”; EGA submission to the Public Consultation Process Initiated by the European Commission on “The Future of Pharmaceuticals for Human Use in Europe”).

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