EU Parliament Votes to Release Clinical Trial Data

4 April 2014

The European Parliament voted April 2 to make public information about clinical trials for drugs.

The new law is expected to go into effect in 2016 and will affect only new clinic trials. (See Reuters report.)

“The vote, which confirms an informal deal reached in December between Parliament and the European Union’s 28 member states, is a victory for activist groups who want trials data out in the open,” wrote Science Magazine.

European Ombudsman Emily O’Reilly, praised the decision, saying, “It will now be possible to verify whether medicines are as effective as they are claimed to be and whether they have potentially dangerous side effects. This will provide better protection for patients and could save countless lives across Europe.”

In the last five years, the ombudsman has conducted over a dozen inquiries into the European Medicines Agency, according to a statement by the Ombudsman’s office:

“Many concerned refusals to make public documents regarding the authorisation and regulation of medicines by the Agency, including medicines for treating multiple sclerosis, acne, bacterial infections, and obesity. Thanks to the Ombudsman’s intervention in these cases, the Agency agreed that it should release such documents on request. The Agency also declared that it would make all similar information publicly available proactively. The Ombudsman strongly supports this aim and will work tirelessly to ensure that it is achieved.”

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