EGA Press Release

Wednesday, 05 November 2003

MEPs Under Pressure to Block Generic Medicines

MEPs are under pressure to adopt a series of amendments in an EP draft report on human medicines presented this week in committee in second reading. The amendments from the draft report by Françoise Grossetête (F-EPP) are designed to hinder competition from affordable generic medicines in the EU pharmaceutical markets.

These amendments include:

• Restrictive changes to the definitions of a generic medicine and a bio-similar medicine as currently defined by Member State scientific experts;
• Restrictions on the manufacturing of generic medicines in contradiction to current practice in international patent law;
• Special protection periods for products switching from reimbursed prescription to selfpayment/self-medication OTC status.

Additional draft amendments related to data exclusivity provisions are also expected which would further increase the period of time generics must wait before authorisation.

These amendments are being advocated by major pharmaceutical companies seeking ways to increase the barriers to competition from generic medicines. They are doing this to subsidise the loss of profits due to major blockbuster products coming off patent and their failure to create new innovative products to replace them. Big Pharma are putting pressure on MEPs to adopt these measures, arguing that they would stimulate pharmaceutical innovation in Europe.

According to Greg Perry, Director General of the EGA:

“These amendments have nothing to do with innovation. Promoting innovation can only be done by positive measures such as establishing a publicly funded European Centre for Pharmaceutical Research Innovation, by increasing and strengthening the links between academia and industry, by improving the registration procedure for new innovative products, and by improving the economic compensation for truly innovative medicines at the beginning of their life-cycle. Innovation is not stimulated by hindering competition from generic medicines. In fact, it is precisely the availability of affordable generic medicines which creates the impetus to develop new products.”

The market protection for pharmaceuticals in Europe is already the strongest in the world. Since 1992 the EU’s SPC Regulation has created over 6000 patent extensions for pharmaceutical products including new active ingredients, combinations and formulations. This has created a mutli-billion euro windfall for big multinational companies. EU Enlargement will generate further advantages for both US and EU companies as their share in the new markets are expected to increase further, mainly as a result of patent extensions and new data exclusivity provisions. This will only worsen the current large trade deficit in pharmaceuticals already run by the New Members States and create problems for sustainable health care in the region.

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