Jim Murray: New fronts in the struggle for transparency

jim_murrayThe European Court of Justice has struck down and ordered a rehearing of the cases for an interim injunction to stop the European Medicines Agency’s new transparency policy on clinical trial results. The two companies, AbbVie and Intermune, will have to give more specific arguments as to why the relevant data should not be disclosed, instead of asserting a general claim of commercial confidentiality. This decision does not settle the cases but is good news nonetheless.

However, the industry (and the European Commission) is working on two other fronts against more transparency in the shape of the Transatlantic Trade and Investment Partnership (TTIP) free trade negotiations with the US, and by way of a proposal for a new directive on trade secrets.

In an agreed position [1]  the US and European pharmaceutical associations (PhRMA and EFPIA) demand, inter alia, that the TTIP  establish a harmonised list of clinical trial result data fields, “and agree on which of these data fields may be disclosed to the public.”

In testimony to Congress, [2] PhRMA also attacked EMA’s transparency policy and urged the US government to engage with the EU to ensure “responsible data sharing.” PhRMA also want compensation for patent office delays in the EU, and an extension of regulatory data protection for biologics in the EU to twelve years from the current ten. I assume EFPIA support PhRMA here.

The use of TTIP to make substantive law is dangerous. Free trade agreements (which as it happens I tend to support in principle) are agreed as a package. Concessions are made in one area in exchange for agreement on other points. For example, the Commission might agree concessions on, say, transparency in exchange, say, for more access for European farmers to the US market as part of the wider give and take of trade negotiations.

Furthermore, if rules on transparency are embodied in a trade agreement it will be harder to improve them in the future.

In the negotiations on the revision of the Clinical Trials Directive, DG Sanco represents the European Commission, but the overall Commission position is largely determined by DG Trade and DG Enterprise, who fear the effect of more transparency on the TTIP negotiations and on the pharmaceutical industry.

On trade secrets, the Commission proposed on 28 November a draft directive [3] on the “protection of undisclosed know how and business information (trade secrets) against their unlawful acquisition, use, and disclosure.” EFPIA welcomed the proposal, [4] which it sees as applying to all phases of drug development including clinical trials. EFPIA  also argues [5] that transparency should be an issue for specific legislation on trade secrets and not for the regulation on the revision of the Clinical Trials Directive.

There are legitimate trade secrets in the pharmaceutical industry that merit protection but this proposal on trade secrets, and the TTIP, will need careful scrutiny to ensure they do not block the trend towards more transparency and more open science on clinical trials.

(1) http://www.uschamber.com/sites/default/files/grc/PhRMA_0.pdf

(2) http://energycommerce.house.gov/hearing/us-%E2%80%93-eu-free-trade-agreement-tipping-over-regulatory-barriers

(3) http://europa.eu/rapid/press-release_IP-13-1176_en.htm

(4) http://www.efpia.eu/mediaroom/129/44/EFPIA-welcomes-the-Commission-39-s-Proposal-on-the-protection-of-undisclosed-know-how-and-business-information-quot-Trade-Secrets-quot

(5) http://www.efpia.eu/documents/93/48/EFPIA-position-on-Clinical-Trials-Regulation-trialogue

Competing interests: I declare that that I have read and understood the BMJ Group policy on declaration of interests and I have no relevant interests to declare.

Jim Murray is a former director of BEUC, the European Consumers’ Organisation, having previously been the first director, Consumer Affairs and Fair Trade, in Ireland. He writes here in a personal capacity. During his time with BEUC, he was a founder and one time president of the Transatlantic Consumer Dialogue. Currently he is a member of the European Commission’s high level group on administrative burdens, and president of the European Foundation for Financial Inclusion.