Preparing to succeed

'Any intelligent fool can make things bigger and more complex. It takes a touch of genius - and a lot of courage - to move in the opposite direction." - Ernst Friedrich Schumacher, economic thinker

A major problem with a fast-moving industry like pharmaceuticals is that technology develops at such high speed that the regulatory framework constantly lags behind. Urgent issues are often dealt with by revising or adding to existing legislation, but the "bolt-on" approach eventually leads to an over-complicated, unwieldy regulatory system that increases the bureaucratic burden and duplicates work.

The most recent review of EU pharmaceutical legislation highlighted a number of gaps that could not be addressed at the time: counterfeits, pharmacovigilance and the dissemination of information to patients. After several delays, proposals for all three areas were put forward in a Commission communication at the end of last year, and judging by the reaction of the audience at the recent TOPRA conference in Brussels, the wait has been worth it.

The event was remarkable not for the number of high-powered Commission officials on the podium, nor the free and open exchange of views, but for the degree of consensus over the proposals. This was not only a meeting of some of the major players in the field of regulatory affairs, but also a meeting of minds on some of the most controversial issues facing the pharmaceutical industry.

Legislative bodies are often criticised for putting forward hasty, ill-thought out proposals. But it was clear at the TOPRA meeting that much careful preparation had gone into the communication with a view to getting the proposed measures through with the minimum of delay.

The meeting was also noteworthy because the Commission representatives were there not only to speak but also to listen and take note of the views of national organisations, industry, consumer and special interest groups, as well as those of the audience. The juggernaut that is the EU legislative process is frequently the target of criticism and the butt of many jokes. But as one speaker put it: "The days when we could decide on a whim to allow only straight cucumbers are long gone".

When the Commission published its communication last December its aim was to set out a vision for the future of the European pharmaceutical industry. Now the industry is getting a glimpse of that future and so far it seems to be a vision that everyone can share.