PharmExec Blog

EU Pharma Policy 2010: Resolutions? Yes. Solutions? Maybe.

Guest blog post by Reflector, Pharm Exec Europe’s Brussels correspondent.

There was a new air of hope and confidence among officials and diplomats at the turn of the year in Brussels — or at least there would have been if anyone had been at work. 2010 promises a new beginning with the entry into force of the Lisbon Treaty, a renewed European Commission, improving prospects of economic recovery, and an energetic new presidency.

The new treaty gives the EU additional powers in public health, aimed at boosting its ability to improve quality of life and responding to cross-border issues that could affect European citizens. And from now on, the European Parliament, the Council of Ministers and the Economic and Social Committee and the Committee of the Regions all acquire an explicit role in contributing to these objectives, through adopting “measures setting high standards of quality and safety for medicinal products and devices for medical use.”

The new Commission — once it clears the final hurdles to its installation during January — will “be decisive in steering Europe towards sustainable recovery and a smarter, greener social market economy that works for people”, promises its president, José Manuel Barroso.

And Spain, which takes over the six-month rotating presidency of the Council of Ministers for the first half of the year, says it is determined not only to pilot the EU through to calmer economic waters, but also to promote research, innovation, patent protection, and health.

But how much use will all this be for the pharmaceutical industry? The new duties for the EU institutions in legislating on medicines safety and quality could be a two-edged sword. An emphasis on those two objectives, vital though they are, could easily lead to neglect of the equally vital considerations of innovation and profitability.

The personality battles that take place with every five-yearly renewal of the European Commission are certainly exciting for gossip columnists, but they tend to slow down EU business for months as the new team finds its feet. The EU policy machine has already been idling for months as the last Commission wound down, and the hiatus is likely to continue until the spring at least. In addition, the shift envisaged for responsibility for pharmaceuticals policy in the new Commission will (as I commented on recently) risk diluting the views of industry, and also threatens months of administrative confusion as officials are relocated and chains of command are disrupted.

And the Spanish presidency promising of “an ambitious European innovation plan” and action to reinforce patents, while welcome, can deliver nothing of real value in the foreseeable future. The decades-long wait for a simplified EU patent, for instance, remains years away — partly because of Spain’s refusal to allow applications that are not translated into Spanish. Instead, in the face of continuing tight public finances, the industry’s chances of winning better economic treatment for medicines remain slender. To make matters worse, member states’ growing stockpiles of unused — and, it is increasingly alleged — unnecessary vaccine against H1N1 are now starting to fuel resentful suspicions that the pandemic and the public health response to it were the result of cynical manipulation and scare-mongering by drug industry lobbies.

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