EMEA presents Road Map to 2015

"Access to drugs"

It has been reported that the European Medicines Agency (EMEA) will present their Road Map to 2015 to the Agency's Management Board on Thursday, this week. The initiative is a continuation of the 2010 Road Map, building on current achievements in the pharmaceutical industry.

Public consultation is expected to go out in January, while the report is also expected to take into account the Agency’s business drivers. According to news reports today and Noel Wathion, head of the agency's patient health protection unit, specifically, the Agency has identified three strategic areas for future focus, namely addressing public health needs, plus facilitating access to medicines and optimising their use.

At a meeting in London, held jointly by the EMEA and The Organisation for Professionals in Regulatory Affairs (TOPRA) last week, Wathion explained that in terms of improving access, there will be a focus on the drug development process, early assessment and continuation of dialogue. According to Wathion, this will be achieved by 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, thereby making "knowledge from this process available to the scientific community."

Assessment

Further to this, 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."

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

Lonngren went on to tell audience members that the second "E" in the EMEA's title, which originally stood for"“Evaluation," is now to be dropped. According to reports, however, while rebranding as EMA will mark a new era for the Agency, Lonngren could foresee no changes in "the way we run the industry."

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