EGA Press Release

Thursday, 2 February 2006

NEW STRATEGY ON PATENT LINKAGE IS CONTRARY TO
EU LAW AND THREATENS ACCESS TO COMPETITIVE GENERIC MEDICINES

Greg Perry, Director General of European Generic medicines Association, announced today in London that growing pressure on European medicines authorities to apply patent linkage constitutes one of the biggest threats currently facing the generic medicines industry in their efforts to deliver affordable medicines to patients. Patent linkage is the practice of linking market approval — or the pricing and reimbursement status — for generic medicines to the patent status of the originator reference product.

Mr Perry described to a gathering of over two hundred industry representatives and medicines authorities at the 5th annual EGA Regulatory Affairs Conference how national medicines authorities have recently come under pressure to refuse marketing approval or reimbursement status during the patent period. So far national agencies are resisting such pressure, but the strategy is intensifying, warned Mr Perry. Pressure to link the approval process with patent status is being exerted on the European authorities by the originator pharmaceutical industry, either directly, or through the offices of the US Trade Representative, to deliberately delay entry of lower priced generic products onto the market.

“It is important to stress that patent linkage is contrary to EU regulatory law and undermines the recently introduced Bolar provision which seeks to encourage quick access to the post patent market for EU generic medicines. Moreover, linking generics approval to patent status would push medicines authorities into the domains of patents, a far cry from their true role in scientifically assessing the quality, safety and efficacy of pharmaceutical products. Medicines agencies in the EU are already under unprecedented pressure on resources as a result of the new EU Pharmaceutical Legislation. This sort of added pressure is simply unacceptable”, said Mr Perry.

“Indeed”, Perry emphasised, “just as the patent offices possess neither the legal competence nor the scientific expertise to assess the quality, safety and efficacy of medicines, the national medicines authorities do not have the mandate nor the expertise to judge and assess the validity of patents or confirm their status.” Mrs Suzette Kox, EGA’s Senior Director of Scientific Affairs, also speaking in London, explained that under the WTO’s TRIPS Agreement, no reference is made to any obligation to link the registration or reimbursement of a product to its patent status. On the contrary, the TRIPS preamble recognises that IP rights are “private rights” and, as such, must be protected by the patent holder, not the public medicines authorities.

Mr Perry concluded by informing his audience that the proponents of patent linkage are purposefully confusing this issue with practices in the United States, practices which have no application to the EU regulatory system. Any attempt to create patent linkage in Europe is a clear abuse of the EU regulatory system, contrary to EU practice, and in conflict with the EU’s commitment to build a strong, globally competitive EU generic medicines industry. “This patent linkage practice must not be allowed to take hold if we are to ensure a continued supply of affordable medicines to Europe’s patients” said Mr Perry.

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