update

Trade secret laws adopted by MEPs create legal uncertainty for pharma whistleblowers says HAI

By Gareth Macdonald contact

- Last updated on GMT

European Parliament in Strasbourg, France
European Parliament in Strasbourg, France

Related tags: European union, Law, European parliament

Trade secret laws adopted by the European Parliament mean employees who raise concerns about drug safety and efficacy face legal uncertainty says HAI.

The Directive on the protection of Trade Secrets​ – which was adopted by the European Parliament yesterday – is intended to “help businesses obtain legal redress against theft or misuse of their trade secrets​” according to French MEP Constance Le Grip from the centre-right Group of the European People’s Party.

Le Grip said: “Fighting against economic and industrial espionage, and giving companies the means to protect their know-how and professional information against any unlawful acquisition throughout Europe provides better protection for innovation, competitiveness and employment in Europe.

'Trade secret'

But critics like Amsterdam-based NGO Health Action International (HAI) say the definition of ‘trade secret’ is too broad and “its lack of clarity on exceptions to unlawful use or disclosure, create legal uncertainty​.”

One of HAI’s main concerns is that the laws place the burden of proof on individuals, including industry insiders – ‘whistleblowers’ – that raise concerns about drug safety and quality.

The NGO’s policy advisor Tessel Mellema told us “Whistleblowers have exposed a wide range of wrong-doings and are immensely beneficial in improving transparency within the pharmaceutical sector. 

She added that under the laws whistleblowers “could face costly trials against big corporations and, if they lose, could endure substantial economic penalties. It’s also possible they could receive jail time because, under the Directive, Member States have the ability to enact far-reaching provisions.​”

Interpretation

The Directives states it will “not affect the application of public disclosure obligations by EU and national institutions.​”

However, according to HAI it is not yet clear if this will apply to either issues raised by whistleblowers or other information deemed that industry deems commercially sensitive like clinical trial data.

 “The European Medicines Agency and national medicines agencies may take a safe course of action in their interpretation of what constitutes commercially confidential information and become less inclined to disclose information—such as clinical trial data—that is in the public interest.

Mellema added that: “We’d have preferred that the Directive only provide protection of business information against use by competitors with economic intent. Researchers, journalists and whistleblowers who want to expose information that is crucial to the public good should not have been included.

Patients, consumers and healthcare professionals must have the right to know the true effects of the medicines they take and prescribe​.”

Related topics: Regulatory & Safety, Regulations, QA/QC

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