Plan outlined for European generics

The Director General of the European Generic medicines Association (EGA) has reiterated the association’s Vision 2015 plan, which aims to create a globally competitive generic industry, increase patient access to affordable quality medicines and ensure sustainable healthcare in Europe.

Speaking at the 9th edition of the EGA Scientific and Regulatory Affairs Conference in London (UK), Director General Greg Perry explained that “significant successes” had been achieved in the regulatory system since its reform in 2003, but also added “there is clearly room for improvement”.

“Generic medicines are one of the most competitive sectors in Europe, accounting more almost 50% of the medicines dispensed, bringing combined savings of 25–30 billion Euros yearly,” said Perry in a press statement issued by the EGA. “And 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.”

The EGA has outlined five steps that it believes are necessary to meet its objectives:

• Introduce more tax and R&D incentives for generic and biosimilar research and clinical trials to encourage innovation within the industry.
• Eliminate the barriers to generic competition. The patent process should be free from patent linkage and third party intervention in procedures that enable anti-competitive strategies and unjustifiable delays should be restricted. Additionally, products with little therapeutic value should be distinguished from real therapeutic innovations when considering innovation.
• Build on the current success of the European authorization systems and introduce better regulation, such as streamlining the Decentralized Procedure (DCP) and better adapting the Centralized Procedure (CP) to generic medicines — generic applications currently account for 85% of all DCP and 41% of all CP applications.
• More strictly adhere to the principle of Mutual Recognition to strengthen single market harmonization.
• Increase the information on generic and biosimilar medicines to patients and health care professionals across 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.”

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