EGA Press Release

Thursday, 3 February 2005

GENERICS INDUSTRY FAST BECOMING
EU’s MAIN SOURCE OF MEDICINES

Creating the proper competitive and legal environment is essential for the industry to continue meeting the challenge of providing high volumes of cost-effective generic equivalents to European healthcare systems.

Speaking today before a record attendance of industry representatives, Commission officials and medicines regulators from the EMEA and some 20 EU Member States at the 8th Annual EGA Regulatory Affairs Conference in London, Greg Perry, Director General of EGA, stressed the growing importance of the generic medicines industry in Europe. Mr Perry also underscored the urgency of creating the proper competitive and legal environment for the industry to continue meeting the challenge of providing high volumes of cost-effective generic equivalents to European healthcare systems.

Mr Perry said,

“The generic pharmaceutical industry is fast becoming the principal supplier of medicines for EU citizens. Generics already account for 60-75% of medicines in Central and Eastern Europe and 40-55% in a number of north European countries such as the United Kingdom, Germany, Denmark and the Netherlands. These countries have discovered they can rely on generics to provide a safe, and effective supply of quality medicines at significantly reduced prices. In countries such as Portugal, France and Spain, where generics currently account for 10-15% of medicines, governments are fast implementing measures to increase cost-effective medicines delivery to patients, too.”

Mr Perry pointed out that 35% of major pharmaceutical molecules are now off patent and open to market competition. As a result, the generic industry is currently the major user of the Mutual Recognition Procedure for market authorisation. The industry will quickly become the largest user of the new Decentralised Procedure once it is fully implemented, and represents an important source of new users for the Centralised Procedure.

The rapidly aging population in Europe and the dramatic rise in prices for originator pharmaceuticals have created what Mr Perry called “the generic necessity”. As health authorities become increasingly dependant on low-cost pharmaceuticals, it becomes more urgent to create an adequate competitive environment to ensure continued supply of generic medicines.

EU legislators recognized the role of generics in last year’s review of EU pharmaceutical legislation when they chose to bolster the legal framework to encourage the rapid introduction of generic products onto European markets. Ensuring the full and proper implementation of these provisions into national law will be key to the success — or failure — of the legislation.

Potential pitfalls to avoid include: any attempts to extend data exclusivity beyond the intent of the law; all measures designed to undermine the European Reference Product; inadequate transposition of the so-called “Bolar Provision”; and making the new guidelines for biosimilar products a barrier rather than a pathway to developing European biogeneric medicines. Mr Perry also pointed out that common sense must be applied when implementing the new sunset clause requiring producers to place a product on the market within three years of receiving market authorisation. This clause must be adapted to the 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.

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