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Emily O'Reilly

European Ombudsman

European Ombudsman

EO/14/8

2 April 2014

Clinical trials vote is a triumph for transparency in EU healthcare

The European Ombudsman, Emily O'Reilly, has welcomed the European Parliament's vote this evening on new rules for clinical trials. The new legislation, which contains an obligation to make clinical trials information public, could save countless lives according to the Ombudsman.

Emily O'Reilly stated: "Over the last five years, my office has dealt with several complaints from citizens who were refused access to clinical trials data. Thanks to the new rules, the results of all clinical trials in Europe will be publicly accessible online. 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.

I would like to congratulate the Parliament, in particular Glenis Willmott MEP and the shadow rapporteurs, for having successfully steered this legislation through to a very positive outcome."

Over a dozen Ombudsman inquiries about the Medicines Agency

In the last five years, the Ombudsman has conducted over a dozen inquiries into the European Medicines Agency. 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.

The Ombudsman met with Parliament's Rapporteur, Glenis Willmott MEP, earlier this year following the unanimous approval of her Report in Committee. She took the opportunity to discuss the Ombudsman's recent and ongoing cases concerning the European Medicines Agency.

The European Ombudsman investigates complaints about maladministration in the EU institutions and bodies. Any EU citizen, resident, or an enterprise or association in a Member State, can lodge a complaint with the Ombudsman. The Ombudsman offers a fast, flexible, and free means of solving problems with the EU administration. For more information: http://www.ombudsman.europa.eu

For press inquiries: Mr Ben Hagard, Head of the Communication Unit, tel.: +33 6 14 56 04 46, Twitter @EUombudsman


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