Open Medicine EU

As mentioned in my previous post, the European Medicines Agency has announced a new transparency policy.

Not before time.

-In an article in the BMJ in April this year the authors cited earlier research indicating that the EMA was very much less transparent that the FDA in a number of key areas, including information on clinical trials.

-In an editorial in May this year the Lancet called for a more open proactive policy in relation to licensing decisions and adverse reactions reports.

-The German medicines agency IQWIG in an article in the BMJ in October called for the release of all clinical studies .

-This call was echoed in the same issue of the BMJ, in an editorial on Missing Clinical Trials

Under the new transparency policy, the EMA is still bound to balance the commercial interest against public interest in deciding whether or not to release, say, clinical trial documents filed with an application for authorisation.

Previously, the agency seemed to give too much weight to the commercial interest in refusing requests for such documents. Given that the law has not changed, will the agency change?

I am sure it will, not least because of the intervention of the European Ombudsman.

-An Irishman, whose son had tragically committed suicide sought access to documents on adverse drug reactions to the drug Roaccutane, an anti-acne medicine.

-The Nordic Cochrane Collaboration sought the release of documents relating to the clinical trials of two anti-obesity medicines.

In both cases, the agency initially refused to release the documents but later agreed to do so, following a recommendation from the Ombudsman.

The Ombudsman’s detailed opinion in the Cochrane case gives more hope for the future. He considered the arguments for and against release, analysed the facts, inspected dossiers and, crucially, drew on the case law of the European (General) Court as to the proper definition of “commercial interest” and other points.

The court decisions cited by the Ombudsman took a narrow view of commercial interest – so much so that the Ombudsman concluded that the agency had not shown in this case that release of the clinical trial documents would undermine commercial interests. Therefore there was no need even to consider the public interest question.

Replying to the Ombudsman’s recommendation, the EMA said that in the light of European case law it shared the Ombudsman’s reasoning and would change its policy accordingly. Good news.

The EMA also pointed out that it would still have to consider each case on its merits – no question of a blanket policy to release all clinical trial documents automatically. Assuming, however, that they apply the Ombudsman’s reasoning to future cases, I expect that the number of refusals may be small. In time too, the agency has promised to develop a more pro-active policy of releasing documents without waiting for a request.

The agency also said it may have to edit some documents in order to protect personal privacy. This is uncontroversial, although there was a hint that protecting personal privacy might mean not disclosing the names of the clinical investigators and authors of the studies. This is a question for another day.

The Ombudsman welcomed the announcement of the new transparency policy and the agency’s commitment to apply his reasoning in future cases.

But, there was a sting in the tail. One argument made initially by the agency was that Article 39.3 of the TRIPS agreement prevented them from releasing the documents. That article reads:
“Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.”

The Ombudsman did not accept the agency’s arguments in this specific case but was careful to say that he could not exclude the possibility that there may be cases where the TRIPS provision may apply.

As if TRIPS or the abuse of TRIPS has not done enough damage….

This is not to criticise the Ombudsman, I think his reasoning is correct, but it would be good to explore the question of TRIPS more closely. I would welcome comments on this, and particularly whether there are any cases where TRIPS has been invoked to challenge disclosure of clinical trial or other data.

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