EGA Press Release

Friday, 2 October 2009

THE EU PHARMACEUTICAL SECTOR INQUIRY RECOMMENDATIONS - NOT TENDERING SYSTEMS - PROVIDE THE KEY TO INCREASING PATIENT ACCESS TO AFFORDABLE GENERIC MEDICINES

“Tendering is undermining the long-term patient access to generic medicines” and “it is urgent that governments start to see that pricing and reimbursement measures must be about more than just short term price decreases”, said Eric Gorka EGA President during his presentation at the 12th International Generic Pharmaceutical Alliance conference in Montreal, “Governments must create broader, balanced generic medicines policies that are suited to the existing local regulations and market characteristics.”

Mr. Gorka stressed that tendering systems are one of the key issues impacting the sustainability of the European generic medicines industry, giving as an example the substantial risk that a company might completely “fail” with any one product, for example where a company loses in an “all or nothing” tender process. Tendering may therefore result in increasing prices as prices for the “successful” products would have to cover the development and inventory costs of the “failed” products. Mr. Gorka also stated that tendering will drive companies out of tender markets, thus limiting access to generic medicines and the potential savings they can generate for governments and patients. Both points are supported in a recent OECD report*.

Mr. Gorka highlighted the pharmaceutical Sector Inquiry** recommendations as a major opportunity for governments to get the EU pharmaceutical sector right. These include immediate P&R approval for generic medicines, the removal of patent linkage, increased competition law scrutiny, the prevention of misinformation campaigns on the safety and efficacy of generic and biosimilar medicines, regulation of interventions by originator companies in generic marketing authorization processes, more rigid assessment of patent before granting and a unified patent court.

The recent EGA report “How to Increase Patient Access to Generic Medicines in European Healthcare Systems”*** presents recommendations consistent with those of the Sector Inquiry, including to:

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 medicines prescribing by physicians and generic medicines dispensing by pharmacists.

*Pharmaceutical Pricing Policies in a Global Market” from September 2008, the OECD Health Policy Studies, pages, 184 and 185
**For more information on the EC pharmaceutical sector inquiry please see the EC press release: http://europa.eu/rapid/pressReleasesAction.do?reference=IP/09/1098&format=HTML&aged=0&language=EN&guiLanguage=en
***For the download of the report please use this link: http://www.egagenerics.com/doc/ega_increase-patient-access_update_072009.pdf

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For further information contact Hugo Carradinha
Tel: +32 (0)2 736 84 11