TTIP threatens EU's transparency on clinical trials

Public access to clinical trials information is crucial to preserving the wellbeing of Europe's citizens, argues Margrete Auken.

By Margrete Auken

30 Sep 2014

Last year we finally managed to agree on stricter EU-regulation for clinical trials. It was an important and long awaited step towards true transparency in the medical sector.

Health ministers across the EU finally came to acknowledge what the parliament had long been stressing: our medicine has to be safe and of the best possible quality. At the same time, it must never be reduced to a cash cow for a profit-maximising medical industry.

"Rather than lowering our new European standards, the US government should embrace the decision by European regulators and follow the EU's lead by adhering to a more transparent approach to clinical trials"

The adopted regulation obliges companies to publish clinical test reports for medicine allowed on the EU market, which strengthens the possibilities for public oversight of medication.

This transparent approach to clinical trials ensures that the diseases we are trying to cure are met with state of the art medical treatments. Often enough new cures have been no better than existing medicines, except perhaps for investors profiting from higher selling prices.

Entering effect from 2016, the regulation states that information from clinical studies "should not generally be considered commercially confidential". This will help independent scientists, journalists and others expose the medicinal products that have problematic side-effects, or that are no better than current medicines or that simply harm patients instead of helping them.

However, the positive progress on transparency is already being threatened by the transatlantic trade and investment partnership (TTIP) negotiations. Huge economic interests are at stake and medical companies on both sides of the Atlantic ocean are doing their best to limit data disclosure, a fact brought to daylight in the leaked BigPharma wish list. Rather than lowering our new European standards, the US government should embrace the decision by European regulators and follow the EU's lead by adhering to a more transparent approach to clinical trials.

Limiting public access to clinical trials will damage the health and wellbeing of European citizens. We cannot gamble with our health in order to achieve possible economic gains. Neither should we forget that the thousands of citizens, Europeans as well as Americans, taking part in the clinical trials have given their consent in order to move science forward rather than to be used for economic gains by businesses.

Therefore it is of utmost importance that the TTIP does not impair the positive developments of the clinical trials regulation. The commission should keep in mind that parliament is capable of voting down a final TTIP, should the agreement aim to overrule the EU's democratically adopted regulations.

 

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