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Lifting the Veil in the European Medicines Agency

Posted by jim on 28/08/14

I wrote a number of blogs on the apparent change of policy on transparency by the European Medicines Agency when it published a new draft policy for targeted consultation last May – see here, here, and here for example.

The Management Board of the agency were due to decide on this changes in June but a decision has been deferred to next October.

Curious about the reasons behind the changes in policy I made a request to the agency under Regulation (EC) 1049/2001 for access to various documents that might help to throw light on the issue.

Specifically,I asked for access to the following documents:

In connection to your agency’s public consultation on publication of and access to clinical trial data concluded on 30th September 2013:

All submissions or correspondence in written form, and any written records or notes of submissions or comments received in any other form, from any pharmaceutical industry association, between 31st May 2013 and 22nd May 2014.

2 All correspondence from 31st May 2013 to 22nd May 2014 between the agency and the European Commission relating to the publication or prospective publication of, and access to, clinical trial data, including but not confined to any submission or correspondence in relation to the public consultation described above.

(Apologies for the “legalese” in the above extract but any assertion of a right of access to documents in an institution must be precise.)

Anyway, the agency refused my request, citing Article 3.4 of the regulation under which a request may be refused if disclosure would seriously undermine the decision making process of the institution.

I cannot see how disclosure in this case might have seriously undermined the decision making process of the agency. There was strong industry opposition (from both sides of the Atlantic) to the earlier proposals of the agency, but I deliberately confined my request to submissions from pharmaceutical industry associations, and not individual companies. I assume there were not very many of these and that most or all would be in electronic form, and therefore relatively easy to disclose.

(I believe there is ALSO a public right of access to the submissions from individual pharmaceutical companies but, to keep things simple, I decided not to assert that right in this case.)

I asserted a right of access to communications to and from the Commission because it seems clear that the Commission played a significant part in the change of policy in the agency. In response to an enquiry from the Ombudsman, for example, the agency referred to a “clear message” from the Commission.

Even if disclosure might seriously undermine the decision making process, which I do not accept in this case, an institution may still have to give access to documents if there is an over riding public interest in doing so. The agency decided that there was no such over riding public interest in this instance.

See the full text of the refusal here

But, all is not lost. I decided to appeal against the refusal of my request and will reveal the next (thrilling?) instalment of this ongoing process in my next blog. END

Intermune Withdraws (partly)

Posted by jim on 09/06/14

Intermune have withdrawn one part of their legal challenge to EMA’s disclosure of documents concerning the medicine Esbriet. This needs careful explaining.

The cases started when Intermune took legal action to stop disclosure by the EMA of documents relating to the medicine. They also applied for and received an interim order prohibiting disclosure until the full hearing of the case – not unusual in such cases. After an appeal by EMA the application for the interim order was to be re-heard by the court.

Now Intermune have withdrawn their application for interim measures, but their main case still stands.

So, we have a strange situation here. Intermune want the court to block disclosure, but are not asking for a ban on disclosure before the full hearing of the court. The medicines agency is no longer subject to a court order banning disclosure.

It is difficult to see what all of this means. Will the medicines agency now disclose the documents – for example if a new applicant applies for access to them? Was the company comforted by the potential new limits on disclosure introduced recently by EMA? If the company is not looking for interim measures, why is it continuing with the full case? Was there some understanding between the company and EMA about (non)disclosure before the full hearing of the case?

And so, the evolution of public policy on transparency of clinical trial results continues to be shrouded in mystery.

Letter to EMA from Glenis Willmott MEP

Posted by jim on 06/06/14

Good news. Glenis Willmott MEP has written an open letter to the European Medicines Agency to express her concern about changes to its transparency policy.

Maladministration in the European Medicines Agency?

Posted by jim on 05/06/14

The latest version of the EMA transparency policy gives significant weight to copyright law and intellectual property rights (IPR). In responding to the Ombudsman’s concerns about changes in its transparency policy, the agency cited a “clear message” from the Commission of the requirement to respect intellectual property rights That requirement, whatever it is, is also one of the subjects in “ongoing discussions” with the Commission on access to documents in the agency.

A few days ago, the American Chamber of Commerce published a report strongly critical of the proposed new transparency policy of the EMA (and of the EU more generally). Much of its opposition relied on arguments in relation to IPR.

Clearly, the EMA must carefully assess what precise obligations it may, or may not, have under copyright and IPR law. The way it is going about it does not inspire trust or confidence.

We don’t know precisely what conclusions the agency has come to about copyright law, we don’t know what the Commission said to the agency about copyright and IPR law and we don’t know what is being said about copyright and IPR in the ongoing discussions between the agency and the Commission about access to documents. (We don’t know either if the Management Board of the agency will have access to all the background documents when it meets to discuss the new transparency policy on 12th June.)

The new Head of Legal at the agency is Mr. Stefano Marino, who came from a long career at senior level in the industry, including seven years as Chairman of the Trademark Committee and thirteen years a member of the Intellectual Property Protection Committee of EFPIA, the pharmaceutical industry association. I’ve said before and I repeat here that I do not imply any personal impropriety or the slightest lack of integrity on Mr. Marino’s part, but there is an issue of public policy here. Has the EMA’s chief legal adviser played an important role in shaping the agency’s response to industry arguments about copyright, TRIPS and IPR – arguments that presumably he helped to shape over many years as a senior IPR expert in the industry association?

Is the EMA’s handling of this issue to date likely to increase public confidence in the agency? Emphatically not, in my opinion.

In my view, the agency should seek (and publish) independent external advice on the implications for transparency of copyright law and IPR law generally. This is no reflection on Mr. Marino – in private practice, lawyers who change employers are usually precluded for a time from dealing with issues in which they were previously involved for another interest. Something similar should be done here.

Secondly the agency should publish the advice it receives from any source, including the “clear message” from the Commission. On such a crucial and important issue, there must be full public scrutiny.

For the reasons outlined above, the Management Committee of the agency should not approve the recent changes in policy next Thursday. (A further reason is that the Ombudsman is still examining the recent practices of the agency here.)

The legal opinions and interpretations of complex law that form the basis of the agency’s new policy on transparency are not disclosed or subject to public scrutiny. This is bizarre and, to put it bluntly, mal-administration.

The current discussions behind closed doors will have wider effects. The same considerations of copyright and IPR will clearly feed into other, distinct, policy areas including access to documents, and the implementation of the new regulation on clinical trials. All the more reason for transparency. END

Transparency – Is the Commission Pulling the Strings in the EMA?

Posted by jim on 29/05/14

The European Medicines Agency has published its letter of reply to the Ombudsman’s concerns about changes in transparency – see my previous blog.

The letter makes the point that the new transparency policy is an initiative of the agency itself and is quite distinct from the access to documents regime under Directive 1049/2001, and also distinct from arrangements to be put in place under the new clinical trials regulation. I thought that was the case but remain concerned about the initiative itself.

In the letter the EMA offers assurances that data will be disclosed in a “user-friendly” manner to which the general public will have access, with freedom for academics to review, communicate etc. This is not the impression that I, or many other people, got from the latest targeted consultation.

However, the points in the letter that most worry me are the references to the Commission’s ‘clear message’ that the EMA must comply with “ national and international obligations that all European institutions have to comply with, including but not confined to TRIPs and copyright laws.” This is correct as a general principle, but what does it precisely mean in this case?

I know a little about these obligations in general terms but we need to know how exactly the Commission interprets them in relation to the disclosure of clinical trial results. Which if any of the more restrictive terms in the recent EMA consultation documents are there because of the Commission’s interpretation of these obligations? Can we see exactly how the Commission interprets these obligations? Did the Commission tell the (independent) agency what it could and could not do or did the agency make its own assessment of its obligations here? If it was indeed the agency which assessed these obligations, can we see that assessment?

Much more seriously, how will the Commission’s view of these obligations impact on the rules on access to documents under Directive 1049/2001, on which the EMA is having “ongoing discussions with the Commission”? The rules and procedures here seemed to be fairly well settled. Will they now be changed for the worse as a result of these ongoing discussions?

Even more seriously, how will all this affect the implementation (by the Commission) of the new clinical trials regulation, with its commitment on the part of the legislators to very much wider transparency? Does the Commission believe that the TRIPs agreements and copyright laws may frustrate the will of the legislators here, and if so how? We should be told.

The Commission position on TRIPs and copyright laws is having, and will have, a clear impact on EMA policy on transparency and access to documents, and on the future transparency of clinical trial results. If that position is not subject to full public scrutiny, I would have no confidence in the Commission and the EMA here.

The Commission must also come clean on how exactly TRIPs and copyright laws may affect or frustrate the promise of transparency implied in the new clinical trials regulation. Was the work of the Parliament in vain here? Did the Commission brief the Parliament on these issues during the trilogue? END

Transparency – Why the Change in EMA Policy?

Posted by jim on 23/05/14

There has been an apparent volte-face by the European Medicines Agency on its earlier promise of a pro-active transparency policy that was about “establishing trust and confidence and enabling independent re-analysis of the evidence used by the EMA scientific committees to determine the benefits and risks of medicines

See here for a critique of the apparent changes.

The reasons behind the change of policy are not clear. The following is pure speculation on my part:

TTIP/Pressure from the Commission?

Elements within the Commission, including DG Trade and DG Enterprise, and perhaps some in DG Sanco, argued against the transparency provisions finally agreed in the regulation revising the Clinical Trials Directives, on the grounds that they would adversely affect TTIP negotiations or damage the industry. Did the Commission seek to influence the agency’s transparency policy here?

Settlement to Legal Challenge?

The agency reached an agreed settlement to the legal challenge by AbbVie to the agency’s transparency policy. We do not know the precise terms of this settlement but may they have fed into the apparent change of policy on the part of the agency?

Change of Senior Personnel at the Agency?

In July 2013, Mr. Stefano Marino was appointed Head of Legal at the agency. This was during the consultation phase on the agency’s new transparency policy and after the legal challenges mounted by AbbVie and Intermune, challenges that were strongly supported by EFPIA, the European pharmaceutical industry association. Mr. Marino came from a long career at senior level in the pharmaceutical industry including eight years as Chair of the Trademark Committee and 13 years a member of the Intellectual Property Policy Committee of EFPIA.

Let me be very clear: I do not imply any personal impropriety or the slightest lack of integrity on Mr Marino’s part, nor would I support a general ban on recruitment from the industry, but there are some issues of public policy here.

Did Mr. Marino play a significant role in the settlement with AbbVie and in the more recent development of the transparency policy, not long after he was presumably opposed to the agency’s position on these issues? What steps if any did the agency take to limit his involvement in these issues, given his recent association with, so to speak, the “other side”? In private practice lawyers who change employers may be precluded for a time from dealing with issues in which they were previously involved for another interest. Was anything similar done in this case? Furthermore, what steps if any did the EMA take to avoid a conflict of interest or the perception of a conflict of interest in these cases? Without more information on this, the agency’s efforts to inspire trust and confidence will be that bit harder. END

Does the Commission Support the European Medicines Agency?

Posted by jim on 14/05/14

In continuing to follow the legal challenge by Intermune against the European Medicines Agency I began to wonder if DG SANCO and the European Commission as a whole were fully supportive of the EMA’s initiative on transparency. Perhaps there were expressions of support but I had not seen any. I had also heard, at second or third hand, reports of a senior official in DG SANCO criticising the EMA initiative on the supposed grounds that it would damage the industry.

I am glad to say that I have been able to clarify this point because I recently had the opportunity to ask Commissioner Tonio Borg himself about it. My question was a short one and his answer even shorter.

“Does the Commission support the new transparency policy of the European Medicines Agency?” I asked.
“Yes, we do”. he replied.

No room for ambiguity there. I am grateful to the Commissioner for his positive and clear answer. END

Uh Oh – Did I Speak Too Soon?

Posted by jim on 03/04/14

Abbvie’s withdrawal of the case against the EMA was not entirely unilateral – it followed an agreement by the agency to accept a redacted version of the document they were going to publish in January 2013 and which was the subject of the legal challenge by Abbvie. Here is what the EMA said today:

EMA confirms withdrawal of two court cases concerning access to clinical-trial data
The European Medicines Agency (EMA) confirms that AbbVie has withdrawn both its court cases brought against the Agency concerning access to clinical-trial data. In particular, following the successful appeal against the interim rulings issued against the Agency in April 2013, the EMA was requested to consider an entirely new set of redacted documents and related justification for redaction proposed by the company. The very limited redactions proposed by AbbVie were consistent with the Agency’s redaction practices and also had no significant impact on the readability of the reports. Therefore, a decision accepting that new set of documents was notified to the company.
Another court case brought by InterMune against the Agency challenging a decision to grant access to clinical-study reports is still ongoing.

Without being able to see both documents, the version that the EMA originally intended to release and the version that they will actually release, it is difficult to assess the implications of the settlement in this case.

Perhaps there is a case for a request for access to the original document?

Two days – two pieces of good news

Posted by jim on 03/04/14

Yesterday (2nd April) the Plenary Session of the European Parliament approved the final text of the Regulation revising the Clinical Trials Directive. The announcement from the Parliament can be seen here. Since this text was negotiated with the Commission and Council (the national governments) it will soon be agreed formally in Council.

Today (3rd April) I hear from BEUC that Abbvie are withdrawing their legal challenge to the new transparency policy of the European Medicines Agency. This may not be a coincidence since I think it would be harder for them to win their case with the passing of the new Regulation. At any rate, their decision is the right one for all kinds of reasons.

At time of writing I have no news of the position of Intermune who have launched a similar challenge against the EMA.

Attached is the text of the new Regulation as adopted by the Parliament. Strictly speaking it is a provisional text at this stage but I do not expect any significant changes.

Someone said recently that “Victory has a thousand fathers, but defeat is an orphan.” In this case I think the European Parliament has a special claim to paternity (or maternity in the case of Glenis Willmott MEP) but credit also to the European Commission (DG SANCO) and the 28 member governments in the Council.

Comments on the Proposal for a Directive on Trade Secrets

Posted by jim on 19/03/14

These are my notes for a speech I made today in the European Parliament on the proposal for a directive on trade secrets.
1 I will not say anything here about the proposal itself in terms of its principal objective but will talk about some possible indirect effects.
- in relation to journalists, whistleblowers and activists such as consumer advocates who may see, and wish to disclose, information or documents that are trade secrets as defined in the proposal.
- in relation to access to information under 1049/2001 and related measures.

2 On clinical trial results there have been two pieces of good news recently.
-The EMA announced a new policy of greater transparency, including publication of “Clinical Study Reports” received in applications for medicines approvals. In taking their initiative the EMA followed a careful analysis by the Ombudsman as to what was and was not commercially confidential information in this context. Two companies, Abbvie and Intermune, have taken legal action to block publication of the CSRs.
-In the revision of the Clinical Trials Directives the Parliament inserted an amendment to require that CSRs be placed on a central database/portal within one month of a decision on an application for a medicines approval. The Parliament also inserted a recital to the effect that CSRs should not generally be considered as commercially confidential – thereby opening the way for access to the CSRs under 1049/2001.
CSRs have scientific value and in many cases would fit the definition of trade secret in the current proposal.
Crucial to both these initiatives is the definition of commercially confidential information. If you can widen the definition from that set out by the Ombudsman you can limit access to Clinical Study Reports.
3 The industry, on both sides of the Atlantic, were strongly opposed to the requirement to publish CSRs. They argued that the TTIP should “establish harmonized list of clinical trial result data fields & agree on which may be disclosed to public (uniform protection of confidential commercial info & trade secrets)” . More generally they will seek to widen the definition of what is commercially confidential information, with the aim of restricting disclosure under 1049/2001.

4 The proposal on trade secrets explicitly states in recital 9 that disclosure under 1049/2001 or other laws on access to information “should not be considered unlawful..”. However, this still leaves open the possibility that the definition of trade secrets in the current proposal may have the effect of changing what is seen as commercially confidential information under 1049/2001 and similar measures.
5 The remedies in the proposal can clearly be used against journalists, whistleblowers and activists/advocates in certain cases — to demand the return or destruction of documents and for damages in certain cases.
However Article 4.2 requires member states to block remedies under the proposal when disclosure is
-for making legitimate use of the right of freedom of expression and information
-for revealing an applicant’s misconduct, wrongdoing, or illegal activity
-for protecting a “legitimate interest”..
Is this enough?
6 Possible Problems
In relation to journalists will the proposal reduce national protections in some (of the more progressive) member states?
Will the burden of proof be on the respondent/journalist to prove “legitimate use of the right of freedom of expression”?
Will this affect procedural law or protections in (some) member states?
What is the scope and implication of the reference to a legitimate interest?
Does it include the public interest in knowing that some medicines (or other product) do not work in certain circumstances?
Is the advancement of science, or human health, a legitimate interest – or should it be?
7 Possible amendments
Give more positive protection (an exemption is hardly possible) to journalists, whistleblowers, and activists without any commercial interest in disclosure.
No damages/compensation for disclosure in the absence of a commercial motive.
Exclude disclosure to a competent public authority.
Allow a wider public interest defence.END

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