PharmExec Blog

Europe Wrestles with Outdated Clinical Research Rules

By Reflector, Brussels correspondent.

Man can live as a free being only when he is free to develop his innate abilities, maintained Baruch Spinoza, that quintessential European, back in the 17th century. He might have been talking about the aspirations in the European pharmaceutical sector, which is currently struggling to articulate a clear plan for escaping the shackles of outdated rules on clinical research.

“Divergences in requirements and processes, which appeared across countries and continue changing across time, have considerably complicated the registration of clinical trials in the European Union”, according to Celgene, in a recent submission to the EU authorities.

Bristol-Myers-Squibb says new rules should be introduced to “drive consistency” across Europe, notably by “eliminating country-specific required documents”. Any proposal “will only work if countries stop requiring additional pieces to the clinical trial application dossier”.

The same point has been made over recent months by companies as diverse as J&J, MSD, Pfizer and Sanofi – and by the leading European drug industry associations. As EuropaBio, the European association for bioindustries, observes, “it is important to improve the competitiveness of the EU as a location for clinical research and the development of new, innovative medicines”.

The European Union has received 143 responses to a recent consultation on how it should update its clinical trials rules – with hospitals, investigators and non-commercial or academic sponsors the loudest in raising their voices. The pharmaceutical industry big and small, including contract research organisations, were well represented too – but so were national health authorities, ethics committees, and patient organisations. And in true European style, their views do not always correspond.

But not everyone favours radical reform. There is a highly vocal lobby – particularly in academia –for maintaining separate approaches in different countries, partly on the grounds that this generates valuable competition on speed and efficiency of approvals, and partly because it offers a better hearing, they say, to patients. Centralising clinical trials authorisation would be unacceptable to the public, who demand a national perspective, say the defenders of autonomy. “Divergence and variability of assessment is not necessarily negative”, commented an EU official, summarising the inputs.  Organisations ranging from patient organisations to the European Conference of Bishops (really!) maintain that the reformists risk focusing too much on cutting costs and regulatory burdens, and not enough on ethics.

How Spinoza — as a Jew of Portuguese extraction, writing in Latin on questions of ethics posed by the philosophers of classical Greece, and living in cosmopolitan Amsterdam on the eve of the enlightenment — would have relished the debate!


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One Comment

  1. Posted December 13, 2011 at 10:37 pm | Permalink

    There is room in the EU community to reach a “happy median” on this issue. As big Pharma looks to reduce overhead at an all time high, you will see more of the clinical trials being conducted in poorer countries. Without the reduced burden by regulatory agencies, there will be less and less actual clinical research being conducted in the EU. While there will be approval regulatory issues still present, the chance for ethicial issues will increase in these poorer countries.

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