The report was launched at the 15th EGA Annual Conference in Barcelona by Mr Greg Perry, Director-General of the EGA, who highlighted the role of the European generic medicines sector in ensuring sustainable and affordable healthcare, especially in light of the current financial crisis. He stated that “despite intense competition between generic medicines companies, the generic medicines industry continues to be confronted with barriers to market entry” and 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”, he said.

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. Governments and the competent authorities should create sustainable generic medicines pricing systems, 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. They should also enforce clear criteria for innovation, defined as synonymous with added relative therapeutic efficacy or safety to eliminate evergreening practices, introduce mechanisms to promote generic prescribing by physicians and generic dispensing by pharmacists. A key point is guaranteeing 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.