New Plan for Generic Drugs in Europe

The director-general of the European Generic medicines Association (EGA) reiterated the group’s Vision 2015 plan, which is designed to create a globally competitive generic-drug industry, increase patient access to affordable quality medicines, and ensure sustainable healthcare throughout Europe.

At the Ninth EGA Scientific and Regulatory Affairs Conference in London, Director-General Greg Perry said “significant successes” had been achieved in the regulatory system since its reform in 2003, but added, “there is clearly room for improvement,” according to an EGA statement.

“Generic medicines are one of the most competitive sectors in Europe, accounting for nearly 50% of the medicines dispensed, bringing combined savings of 25–30 billion Euros yearly,” said Perry. “And yet numerous hurdles crop up as a result of anticompetitive activities that create unnecessary delays in the development and introduction of new generic medicines.”

EGA outlined the following five steps to meet its objectives:

1. Introduce more tax, research, and development incentives for generic and biosimilars and for clinical trials to encourage innovation within the industry.

2. Eliminate barriers to generic-drug competition. The patent process should be free from patent linkage and third-party intervention, according to the agency. Procedures that enable anticompetitive strategies and unjustifiable delays should be restricted. Products with little therapeutic value should be distinguished from real therapeutic innovations when considering innovation.

3. Build on the current success of European authorization systems and introduce better regulation such as streamlining the Decentralized Procedure (DCP) and better adapting the Centralized Procedure (CP) to generic drugs. (Generic-drug applications currently account for 85% of all DCP and 41% of all CP applications).

4. Strictly adhere to the principle of mutual recognition to strengthen single-market harmonization.

5. Increase the information on generic and biosimilar medicines to patients and healthcare professionals throughout Europe.

“Our vision will create a clear, open market that will benefit patients everywhere, spur innovation, and generate considerable savings,” said Perry. “Some reforms will require new law, but others can be achieved by better application of the current law.”