EMA widens public access to documents (2)
[the original article has hyperlinks to all documents; WB]
The Ombudsman to the Rescue, but what about TRIPS?
Posted by Jim Murray on 02/12/10
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
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
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
-An Irishman, whose son had tragically committed suicide sought access to
documents on adverse drug reactions to the drug Roaccutane, an anti-acne
-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
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
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
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.