EGA Press Release

Wednesday, 5 October 2005

“THE DEVIL IS IN THE DETAIL”
FOR IMPLEMENTING NEW MEDICINES LEGISLATION

Speaking today at the 2nd Annual TOPRA Symposium on “New Medicines Legislation”, Greg Perry, Director General of EGA, underscored the role of generic medicines in increasing access to pharmaceutical care for EU patients, stimulating medical innovation through competition, and providing budget headroom for financing genuine innovations. Mr Perry also pointed out the heavy involvement of the generic medicines industry in developing new formulations, methods of delivery and uses of well established medicines in both the prescription and the over-the-counter sectors.

EU legislators recognized the role of generics in last year’s review of EU pharmaceutical legislation. Mr Perry stressed, however, that the “devil is in the detail” and that the key to ensuring the success of this new legislation lies in avoiding the labyrinth of potential pitfalls to delivering the full benefits of these provisions to Europe’s patients.

Mr Perry noted the following key threats:

• Attempts to circumvent the Global Marketing Authorisation provisions as this could be used to extend data exclusivity periods. The additional +1 year of data exclusivity must be linked to a new indication, and justified by comparative clinical trials indicating significant clinical benefit. The accumulation of rewards for a single investment must be avoided.
• Efforts to limit the “Bolar Provision” by creating patent linkages. The role of the medicines agency is to assess the quality, safety and efficacy of a product, not the validity of patents or other considerations such as pricing.
• Undermining the European Reference Product. The approach to data exclusivity and information sharing must respect the letter and the intent of the law to ensure the presence of a generic medicine in all EU markets, even where the originator has opted not to be present.
• Failing to adapt the sunset clause to the market realities of generic medicines that cannot go immediately to market due to delays caused, for example, by data exclusivity requirements and legal challenges over patents from originators.
• Turning the new guidelines for biosimilar products into a barrier rather than a pathway to developing European biogeneric medicines. The EMEA must ensure the scientific approach adopted so far by EU policy makers, and must ensure the independence of experts, academics, patients associations, clinicians and pharmacists who comment on the guidelines.
• Creating obstacles to using the Centralised Procedure for generics through national usage patents, single name requirements, disharmony between SmPCs, and high duplicate fees.

In closing, Mr Perry expressed his gratitude for being granted an Honorary Lifetime Membership in TOPRA for his contribution to the field of pharmaceutical regulatory affairs during his more than 10 years as head of the European Generic medicines Association.

• Presentation Slides (PDF - 260Kb)

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