The European Medicines Agency (EMA) may in future decide not only if new drugs should be licensed for use but also whether one medicine is better than another. The idea of giving the European watchdog a wider role in comparing drugs is gaining traction as governments try to ensure value for money in healthcare - and the issue is a hot topic at a meeting of drug company executives in London this week.

Such a move would give a pan-European view on relative effectiveness, but would stop short of determining whether a particular drug was cost effective, since affordability will vary from country to country. Many drugs approved at present by the EMA are also assessed by health technology assessment (HTA) agencies like Britain's National Institute for Health and Clinical Excellence (NICE) and Germany's Institute for Quality and Efficiency in Healthcare (IQWiG), which often reach differing views on whether they are worth using. That can lead to frustrations among patients, doctors and drugmakers, with rejection by NICE or IQWiG often leading to bitter rows.

Andrew Witty, chief executive of GlaxoSmithKline and president of the European Federation of Pharmaceutical Industries and Associations (Efpia), said devolving some of the comparative work to the EMA could therefore make sense.

"There is a certain degree of appeal to having a rational evidence-based relative efficacy or effectiveness discussion once in Europe rather than having it 27 times and potentially answered 27 different ways," he said during Efpia's annual meeting on Monday. "Provided that didn't become a further reason to delay approval or access to the medicine, I think that is something that over time the industry could work towards."

Echo of U.S. Plan

EMA Executive Director Thomas Lonngren has in the past criticised the current set-up, warning back in 2008 that a growing number of new drugs for cancer and other conditions were likely to be approved but never reach patients because governments did not consider them cost effective. More recently, Lonngren has said he is ready for the EMA to help provide some underlying data for HTA organisations, although it would not get involved in drug pricing decisions.

Witty said there was growing interest among European member states for the EMA to do more in the field of relative drug effectiveness. A move to give the EMA a such a role would echo plans in President Barack Obama's recently enacted healthcare reform to set up an independent non-profit agency in the U.S. to compare treatments.

The Glaxo boss is a keen advocate of companies proving the value of medicines, rather than merely showing they are safe, effective and of good quality - the three things needed to win an regulatory green light. He said there had to be a "new dialogue" between industry and governments, with the onus on firms to show their products offered demonstrable added value.

(6/22/10)