December 16, 2013
According to rumour, we are making progress on transparency in the revision of the Clinical Trials Directive but the industry (and the Commission, apparently) are fighting back on two other fronts – the proposed free trade and investment agreement with the US (TTIP), and a recent proposal from the Commission for a directive on trade secrets.
The US and European pharmaceutical associations (PhRMA and EFPIA) want agreement in TTIP along the lines in the document attached. On transparency, they want a “harmonized list of clinical trial result data fields & agreement on which may be disclosed to public (uniform protection of confidential commercial info & trade secrets)” and “an EU/US aligned approach re disclosure of clinical trials data (impact on commercial opportunities in third countries should also be considered)” Other demands include changes in pricing and reimbursement policies in Europe, new legal remedies for applicants for medicines authorisations and compensation for patent office delays in the EU.
Depending on the final text, agreement on clinical trials in the TTIP could amount to making substantive law outside the normal decision making process of Commission, Parliament and Council. True, the Parliament would be consulted on any final draft agreement but could be faced with the choice of accepting a reduction in transparency as the price for some advantage such as increased access to the US market for EU farmers. Free trade agreements are agreed as an overall package, with concessions in some areas and advantages in others.
Furthermore, a trade agreement on transparency could make it much harder to move further in the future – on either side of the atlantic.
(As it happens I believe that trade liberalisation agreements often bring benefits to many – and not just the rich – but they should not be negotiated at any price.)
On trade secrets, the Commission proposed on 28th November a draft directive on the “protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure”. EFPIA ,the European pharmaceutical industry association, has welcomed the proposal pointing to to the need to protect trade secrets at all phases of drug development, including the clinical trial phase.
EFPIA also argues that transparency should be covered under this draft directive and not in the revision of the Clinical Trials Directive, which is not going their way entirely. No doubt they will try to regain lost ground through the directive on trade secrets and in the TTIP negotiations.
There are legitimate trade secrets in the pharmaceutical industry and elsewhere that merit protection but this proposal for a directive on trade secrets must not be used to reverse the trend towards more transparency and more open science on clinical trials.
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