Generic drugmakers have called for a “clear, open” European market to be created for generics and biosimilars, claiming that this will “benefit patients everywhere, spur innovation and generate considerable savings.”

Some of the reforms proposed by the European Generic medicines Association (EGA)’s Vision 2015 plans for amendments to the European Union (EU) regulatory framework will require new laws, but others can be achieved “by better application of the current law,” EGA director general Greg Perry told a conference in London this month.

According to Vision 2015, essential steps need to be taken to:
- enhance the competitiveness of the EU generic medicines industry by introducing more tax and R&D incentives for generic and biosimilar research and clinical trials - this would further spur innovation within the industry and safeguard the development of the European generic industry as a whole, it says;
- eliminate barriers to generic competition by restricting third-party intervention in procedures that enable “anti-competitive strategies and unjustifiable delays” in marketing authorizations (MAs). The regulatory process should be free from all patent linkage, and there needs to be clear regulation to prevent new hurdles such as the “early notice mechanism.” Also, when considering innovation, products with little therapeutic value should be distinguished from real therapeutic innovations;
- improve regulation by building on the success of the EU authorisation systems, including streamlining the Decentralised Procedure (DCP) and better adapting the Centralised Procedure (CP) to generic medicines. Generic applications currently account for 85% of all DCP and 41% of all CP applications;
- strengthen single-market harmonisation through stricter adherence to the principle of mutual recognition, with no repeat assessments by concerned member states and an enhanced role for the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, the CMD(h). This Group was set up by the Heads of Medicines Agencies (HMA) network to examine any questions relating to an MA in two or more EU member states, in accordance with the DCP or the mutual recognition procedure (MRP); and
- increase information on generics and biosimilars to patients and health care professionals across Europe, accompanied by measures to eliminated negative information campaigns.

Generic drugs account for almost 50% of all medicines dispensed across the EU, creating annual savings of up to 30 billion curos yearly, “yet numerous hurdles crop up as a result of anti-competitive activities that create unnecessary delays in the development and introduction of new generic medicines,” said Mr Perry.

The EGA has also welcomed the European Commission’s proposal, as part of its plans for modernising Europe's pharmacovigilance system, that EU MA holders should report all adverse reactions to one single point – the Eudravigilance database and data-processing network. This is “a breakthrough proposal and should not be dismantled” as it goes through the European Parliament and Council co-decision procedure, said Suzette Kox, the EGA’s senior director for scientific affairs.

Eudravigilance is the best available tool to detect early safety issues by using the maximum amount of information available, Ms Kox told the conference.

Moves to strengthen pharmacovigilance in the EU are one of three separate legislative proposals included in the Commission’s “package” of pharmaceutical legislation, the other two being measures to tackle the counterfeit medicines trade and to improve patient access to information on medicines and health. Progress on the latter initiative has been subject to ongoing delays because of continued disagreements within the Council, and it contains an initiative that is causing the EGA “major problems,” Ms Kox added.

This is its proposal to include in the product information a new “summary of the essential information necessary to use the medicine safely and effectively.” As this new section would not apply equally to all patients it would be confusing and misleading for many of them, “introducing new disharmony amongst products with the same active substance,” says the EGA.

This requirement would also be very expensive, said Ms Kox, who added: “any proposal should be proven to be of benefit to the patient before it is passed.”