EGA Press Release

Monday, 2 June 2008 | Paris

NEW EGA REPORT IDENTIFIES PATENT-RELATED BARRIERS TO
AFFORDABLE GENERIC MEDICINES

The European Generic medicines Association launched its latest report today on the barriers hindering the access of generic medicines to European markets and to patients. The report, entitled: “Patent-related Barriers to Market Entry for Generic Medicines in the European Union: a review of weakness in the current European patent system and their impact on the market access of generic medicines”, was presented in Paris at the 14th EGA Annual Conference during a specially organised session featuring a panel discussion of key experts from the European healthcare and intellectual property community.

Earlier in the morning, Eric Gorka, president of EGA, reminded the 400 conference delegates that generic medicines play a key role in providing lower-cost medicinal care to millions of Europeans, thus helping to ensure the affordability and sustainability of European public healthcare systems. For this reason, he said, “it is imperative to ensure that no hurdles exist to hinder the access of generic medicines to markets immediately upon patent expiry.”

The EGA’s new report details a number of these hurdles resulting from weaknesses in the European patent system. It focuses on three main areas in which the patent system and the surround legal and regulatory framework fail to ensure an appropriate balance between incentives and competition:

1. Failings in the system for granting quality patents;
2. Patent thickets and follow-on patents; and
3. Patent litigation procedures.

In addition, the report identifies several related types of barriers, including patent linkage, statements to the authorities, using marketing campaigns to shift consumer demand, and granting SPCs based on incorrect information.

Greg Perry, director general of EGA, emphasised that of these, “the introduction of patent linkage presents the single biggest barrier to generic competition.” Patent linkage is a regulatory scheme which prohibits the granting of market authorisation or price and reimbursement status to a generic medicine until all patents have expired or until it has been determined that the patents are not being infringed, or are invalid or unenforceable. This practice forces the scientific pharmaceutical experts at the medicines agencies and the price & reimbursement authorities to make ill-informed judgements on complex patent issues that normally can only be determined in specialised courts. “Patent linkage”, Mr Perry continued, “is inconsistent with European law and must not be allowed to become ensconced in practice.”

The report points out that patent linkage is just one of the many ways that patents—of often questionable quality—are being used today to prevent innovation and competition rather than to stimulate the creation of truly innovative products. When misused in this manner, patents can present an almost insurmountable barrier to the entry of generic medicines onto the market, negatively affecting the quality and sustainability of healthcare delivery to Europe’s citizens.

More about the Report

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