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European Parliament's vote turns health into a trade secret

14 April 2016
by epha -- last modified 14 April 2016

The European Parliament approved today a new Directive on Trade Secrets, a position that would signal that trade secrets outweigh the public interest. The impact will be negative for health, by declaring information on safety of medicines commercially confidential and to be kept secret from patients, regulators and the public.


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The Trade Secrets Law would gag journalists and whistle-blowers, undermining freedom of expression and preventing vital information reaching the media and public. With regard to public health, the new rules would erect a barrier to public access to data on the safety and efficacy of medicines.

As a result, Europe could soon be stripped of its hard-won global leader position on clinical trials transparency. The proposals for the Trade Secrets Directive are clearly intended to increase commercial confidentiality in the interest of drug makers who seek to keep clinical trials results secret, and would weaken patient safety protection and halt further research and independent analyses. The worrying lack of legal guarantees preventing companies from abusing the concept of trade secrets opens the way for unethical repetition of clinical trials on people, and the injection of public resources spent on therapies that are no better than existing treatments, do not work, or do more harm than good.

"This vote weakens recent efforts by European Institutions to increase sharing and transparency of essential health data. Clinical trials data transparency is key for patient safety, for access to affordable medicines, for public health research and innovation." stated Nina Renshaw, Secretary General of the European Public Health Alliance. "Today's vote is clearly designed to undermine the Clinical Trials Regulation, on which the ink is barely dry, which was huge progress for patient safety and access to medicines, but has always been opposed by the pharmaceutical industry which prefers to conduct trials in secrecy. It also seems to be aiming at smoothing the way for the pharmaceutical industry in the EU-US TTIP negotiations, and would lower transparency requirements in the EU to be closer in line with much weaker rules in the US."

Today's vote creates dangerous uncertainty around the issue of trade secrets, particularly for medicines. It opens the way for pharmaceutical companies to use and abuse this Trade Secrets Directive, leaving only rulings from the European Court of Justice to determine the outcome and judgement of future litigations on a case-by-case basis.

The Council of the EU will vote on this Directive on 26 May -a vote that will likely be in line with the Parliament's stance.

In another vote in the European Parliament Plenary today, new rules were adopted on the EU Data Protection Regulation. In contrast to the Trade Secrets vote, the result on Data Protection is good news for health as it includes proportionate safeguards on how personal data is used in health research.

The European Public Health Alliance (EPHA) is a change agent – Europe's leading NGO advocating for better health. We are a dynamic member-led organisation, made up of public health NGOs, patient groups, health professionals, and disease groups working together to improve health and strengthen the voice of public health in Europe. EPHA is a member of, among others, the Social Platform, the Health and Environment Alliance (HEAL), the EU Civil Society Contact Group and the Better Regulation Watchdog.

EPHA