BioWorld International Correspondent
BRUSSELS, Belgium - The European Medicines Agency started the New Year with a declaration of intent to boost its professionalism, in a new bid to reassure skeptics that the widening membership of the European Union risks diluting the sharpness of its scientific judgment.
At the top of its list of priorities in a new work plan are ensuring the availability of top quality scientific expertise, strengthening the development of regulatory competence across the 27 member states, and strengthening and extending peer-review systems in the agency's work.
Ever since the agency's foundation more than 10 years ago it has battled to defend itself against suggestions that the EU's "one-vote-per-country" approach to regulation offered too much scope to politics and too little to tough science.
As with many EU institutions, the balance between respecting distinct national cultures and ensuring the best-quality decision-making has never been easy. But since the EU grew to 27 members over the last three years by admitting small Mediterranean islands and most of the European countries from the former Soviet bloc, anxieties have resurfaced in the face of questions over the calibre of some of the officials or experts nominated by countries with different scientific and medical traditions.
Diplomacy prevents such concerns ever being officially voiced, but the agency's New Year work plan demonstrates how real the challenge to its credibility is. It focuses on "a further strengthening of the EU regulatory system network" among the 27 national regulatory authorities, and on "a reinforcement of the existing firm partnership," explicitly aimed at "ultimately resulting in a network of excellence." It also will be "exploring alternative practical ways" to provide the agency's scientific committees and working parties "with the necessary specialist input."
The work plan also emphasizes "a strengthening of the science and the methodology that underpins [drug] safety monitoring. This should enable to move up the evidence in accordance with the principles of the best evidence concept." Similarly, it foresees work at the level of it scientific committees "on a strengthening of the methodology for benefit/risk analysis to improve consistency of opinion making."
At the same time, the plan is a constructive reaction to innovation both in terms of medicines development and in terms of related EU legislation. It foresees additional resources and attention following the introduction of the EU's new legislation for advanced therapies (including setting up the new committee on advanced therapies envisaged, and preparing guidance for regulators and the pharmaceutical industry). It aims to extend the existing scientific advice procedure for human medicines to include biomarkers. And it will introduce "the necessary measures to maintain consistency" for opinions on centrally authorized biosimilar medicines.