EU Regulations regarding clinical trials

Speaking during the Address to Seanad Éireann by Commissioner Máire Geoghegan-Quinn

I am involved in clinical research and I am troubled by the track record and future plans of the European Commission in this field. In 2001, the European clinical trials directive was put in place that was widely seen by those in the field as a disaster. It achieved one goal, and one goal only – harmonisation. I am not a eurosceptic, I am a europhile, but harmonisation should not be a goal of its own. It only works when trying to harmonise things to a high quality. Making everything the same as it is everywhere else, when it is bad in other places, is not the way to do it, but it is what the Commission tried to do.

Thankfully it was only a directive, although we did not quite realise at the time. We thought there would be a catastrophe but it turned out we could not ignore it because it was a directive, not a regulation. Now, however, one regulation is coming down the pipeline on clinical trials and another on data protection. Huge collateral damage will result. Two of the biggest advances in cancer therapy in the last few years could not have been achieved under the regime that will apply after the data protection directive is put in place. It will require explicit consent from people, which must be spelt out, for the use of their bodily materials for research purposes when many of these people are already deceased. The research has led to cures for some breast cancers and to huge improvement in treatment for chronic myeloid leukaemia. It required looking at specimens from patients who were archived and stored. They were treated with respect and anonymised. I hope the Commissioner will give this her attention as there is a real risk of disaster here.

One Response to “EU Regulations regarding clinical trials”
  1. ladyportia27 says:

    “The research has led to cures for some breast cancers and to huge improvement in treatment for chronic myeloid leukaemia. ??

    Please specify the cure for breast cancer John as I have not heard of it.

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