The European Medicines Agency (EMEA) Road Map to 2015 will be presented to the Agency’s Management Board this Thursday (December 10), and is expected to go out for public consultation in January, officials have said.

The proposed new initiative is a continuation of the 2010 Road Map, building on current achievements but also taking account of the Agency’s business drivers, and has as its draft title The Agency’s Contribution to Science, Medicines and Health, according to Noel Wathion, head of the agency’s patient health protection unit, speaking at a meeting in London held jointly by the EMEA and The Organisation for Professionals in Regulatory Affairs (TOPRA) last week.

The Agency has identified three strategic areas for future focus, namely addressing public health needs – with a focus on gaps in medicine development, new and emerging science and public health threats - plus facilitating access to medicines and optimising their use, Mr Wathion told the meeting.

With the aim of improving access, there will be a focus on the drug development process, early assessment and continuation of dialogue through, for example, boosting the scientific advice process, strengthening the involvement of stakeholders in guideline development and providing incentives to sponsors of drugs which have failed to make it through the development process to make knowledge gained from this process available to the scientific community, he added.

There will also be greater emphasis on the assessment and communication of risks and benefits and on relative effectiveness, while activities around optimising the use of medicines will emphasise post-authorisation follow-up, patient safety, “authoritative” sources of information and outcomes research, with monitoring of drug use, said Mr Wathion.

Discussing the increasing use of health technology assessment (HTA), the Agency’s executive director, Thomas Lonngren, noted that the process is not standardised – throughout the European Union (EU) there are 30 different systems and interpretations, he said.

However, in order to avoid duplication of scientific advice, the Agency has begun informal talks on coordination with the National Institute for Health and Clinical Excellence (NICE) in England and Wales and Sweden’s medical products regulatory agency, the Lakemedelsverket, two HTA bodies which offer such advice, he said.

Mr Lonngren also told the meeting that the second “E” in the EMEA’s title, which originally stood for “Evaluation,” is now to be dropped. He also said that he foresees no changes in “the way we run the industry,” now that responsibility for the EMA at European Commission level is set to move from DG Enterprise and Industry to DG Sanco, which is responsible for health and consumer affairs.