April 11, 2016
Genval, 11th April 2016. – Because trade secret is so widely defined that it includes clinical trials data, and despite of vague exceptions, it can well affect clinical trials transparency which is key for patient safety and new drug development. There is no guarantuee that Pharmaceutical companies will not abuse it.
Why are Trade Secrets on the public agenda?
Because there is a ‘Proposal for a Directive of the European Parliament and of the Council on the protection of undisclosed know-how and business information (tradesecrets) against their unlawful acquisition, use and disclosure’ which is now under negotiations among the European Parliament, the Council (Member States) and the Commission (trilogue negotiations). As I argued earlier ‘Did We (Temporarily) Loose the Trade Secrets Directive?’ the final countdown is about to come: the European Parliament is supposed to vote about it on 14th April. If it passed, it could be a serious threat to public health.
What is a trade Secret?
Look at the definition. Does it include ‘clinical trials’ data? Yes, it does. Actually, the definition is so broad that whatever could fit into it a company considers appropriate.
For the purposes of this Directive, the following definitions shall apply:
(1) ‘trade secret’ means information which meets all of the following requirements:
(a) is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question;
(b) has commercial value because it is secret;
(c) has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret;
Why is it a problem?
Because ‘unlawful’ disclosure of ‘trade secrets’ could imply tough sanctions, including huge compensation costs which could have a dissuasive effect.
Are there safeguards for Clinical Trials data?
Yes, and no. Yes, there are texts which intend to protect publications of trade secrets, but no, they are not strong enough. In light of article 1 and 4, the Trade Secrets Directive cannot block the application of the European Regulation on clinical trials (n. 536/2014), but as clinical trials are not exempted from the trade secret definition, nothing can prevent a company suing the European Medicines Agency (EMA) and arguing that the sanctions of the Trade Secrets Directive would apply if EMA decided for publishing the commercial information (clinical trials data). And going even further, it should be enough for the company to ‘threat’ EMA with such a proceeding and it can have a chilling effect on the agency and the EMA could decide itself not risking such a lengthy and costly procedure against a company.
Subject matter and scope
2. This Directive shall not affect:
(b) the application of Union or national rules requiring trade secret holders to disclose, for reasons of public interest, information, including trade secrets, to the public or to administrative or judicial authorities for the performance of their duties.
Member States shall ensure that the application for the measures, procedures and remedies provided for in this Directive is dismissed when the alleged acquisition, use or disclosure of the trade secret was carried out in any of the following cases:
(e) for the purpose of protecting a legitimate interest recognised by Union or national law.
Why clinical trials data are so important for health?
Publishing the results of clinical trials data used for new drug development is crucial to avoid unecessary and unethical duplication, to motivate research and development and to have new medicines with therapeutic added value which are universally accessible and affordable for everyone. Moreover, clinical trials data transparency is essential for public health research which is the fuel for new drug development and treatment.
What are the next steps?
Plenary vote. The European Parliament has now the opportunity to correct that mistake and reject that piece of legislation in its current form as this piece of legislation does more harm than good for public health.Zoltán Massay-Kosubek