More Bad News – Mr Juncker replies to Concerns on Medicines

Posted by jim on 25/09/14

Mr Juncker has replied by letter to the concerns of the health sector on the transfer of medicines from DG Sanco to DG Enterprise/Internal Market. The letter says that one of the main priorities of the new commission is to create “A Deeper and Fairer Internal Market with a Strengthened Industrial Base” and to that end to establish a new DG for legislation for internal market of products and service (apart from financial services) and including “medicinal products”.

The transfer is therefore part of a wider process to strengthen the European pharmaceutical industry. DG Enterprise will be responsible for strengthening the European pharmaceutical industry AND for medicines, medicines regulation, medicines safety, and the European Medicines Agency.

This is exactly what the health sector opposes.

There is not some large transfer of responsibility for products and services to the new DG Enterprise/Internal Market. Medicines (or “medicinal products,” as the letter describes them) are the ONLY goods for which responsibility is transferred to DG Enterprise.

Food law is a key element of internal market laws but is not transferred to the new super Enterprise DG although that DG is responsible for strengthening the European food industry. Why were medicines singled out for transfer?

(There was a time, as it happens, when DG Enterprise was responsible for much food law but the Prodi Commission transferred that task to a new DG Sanco, so as to separate responsibility for food law from responsibility for promoting the food industry. The second Barosso Commission did the same for medicines.)

General product safety is the responsibility of the new Justice/Consumers DG. This is also an important element in internal market legislation but is not transferred to DG Enterprise. Again, why only medicines?

The letter does say that all proposals for decisions on medicines will be prepared “jointly” (my emphasis) by DG Sanco and DG Enterprise. This may be significant in bureaucratic terms but less so in practical terms. At best, DG Sanco will remain the junior partner , if indeed it can be called a partner at all. With medicines assigned to DG Enterprise in the Commission internal organigramme, DG Sanco will not have the resources to build up the knowledge base, expertise, experience, research data, and ongoing daily interactions with the world of medicines to match those of DG Enterprise.

Remember Glenis Willmott’s experience as rapporteur for the regulation revising the Clinical Trials Directives;
“When I was negotiating the transparency laws for clinical trial results, it was DG Enterprise that wanted to water the rules down”. Now it is DG Enterprise which will responsible for implementing that regulation.

(On a wider level, Commission approval is required for all aspects of the transparency policy of the European Medicines and it is the Commission and not the agency that has the final decision on the authorisation of medicines.)

I can think of one excuse for this letter. When there is not a good reason for a decision, or when you do not want to admit the real reason, the only option is to put forward bad reasons.

Given that medicines are singled out for transfer to DG Enterprise, given that this is exactly and precisely what the industry demanded, given that the decision overturns a reform of only five years duration, and given that DG Enterprise is also responsible for strengthening the European pharmaceutical industry I would say something I don’t think I have ever said before. Unless this decision is reversed, patients and consumers cannot have confidence in the regulation of medicines at EU level. END

The Pharmaceutical Industry against Patients, Doctors and Pharmacists.

Posted by jim on 18/09/14

Joint letters with like-minded organisations are never easy to write, even among friends. Each organisation wants to add its own nuance.Different organisations may have different rules for sign-off on final drafts, and amendments can ping-pong from one to the other. I’ve been there.

Sometimes, however, an issue is so important and clear that a joint position is agreed and action taken in a very short time – as in the case of the 30 health-care organisations that have written to Mr Juncker to oppose the proposal to transfer responsibility for medicines, medical devices and health technology from DG Sanco to DG Enterprise.

And not just any organisations: the signatories include the European representative associations of national organisations of doctors, pharmacists, hospital physicians, hospital pharmacists, health mutuals and health insurance funds, hospital associations, social security funds, cancer leagues, heart foundations, medical bulletins, patients, the elderly, consumers and many others. Offhand, I cannot think of any major European healthcare representative voice that has not signed up – well, the pharmaceutical industry, perhaps, but they have their own agenda.

The editor-in-chief of the British Medical Journal, Fiona Godlee, has also written a joint letter with the review Prescrire, in the same sense.

I don’t think I have ever seen such a wide and immediate agreement between such a diverse range of professionals, patients and consumers on one issue. This is the united voice of the European healthcare sector. Will Mr Juncker listen?

The decision to make the transfer from health to the industry DG seems to have been at the demand of the European pharmaceutical industry. According to an article in Scrip on 12th September:
EFPIA said that commission president-elect Jean-Claude Juncker had “taken on our views and put together all units that are relevant for our business in Europe”. These, it said, were previously spread over three directorates general, SANCO (health), MARKT (internal market) and ENTR.

So now we know. We have the industry on one side on this issue and on the other side the entire health care sector – doctors, pharmacists, patients, hospitals, mutualities, sickness and social security funds, consumers etc. The industry claims to play an important role in healthcare and indeed it does but that role is not always positive. END

A Bad Start for the New Commission

Posted by jim on 10/09/14

Some years ago, DG Sanco, the health directorate for public health, took over the lead role for medicines and medical devices from DG Enterprise the industry DG, which was responsible for promoting industry, including the pharmaceutical industry. The change was a good one, enabling a clearer focus within the Commission on medicines as an essential element of health policy.

Now in his line-up for the new Commission, Mr Juncker has announced that the units dealing with medicines, medical devices, and health technology will be moved back to DG Enterprise!

In the new Commission, DG Enterprise will be responsible for promoting the European pharmaceutical industry and for Commission policy on medicines and medical devices. Other DGs will have a say, of course, but DG Enterprise will take the lead and will be the main interlocutor with the industry on medicines and medical devices. This is a good day for the pharmaceutical industry, but a bad day for public health. The industry has great influence across a wide range of government policies but typically rather more influence on industry departments – and this is not to imply any impropriety on the part of DG Enterprise.

One DG should not combine the lead role for medicines policy with the lead role for the promotion of the pharmaceutical industry. This is not the way to achieve clarity in public health policy. The difficult task of balancing the interests of public health and the (legitimate) interests of the pharmaceutical industry should not take place within the one DG (and should not be well hidden from public scrutiny) .

There is also the difficulty of ensuring the right mix of skills within the one unit or DG – combining specialists on public health with expertise on industrial promotion.

This was how the change was announced:

Units SANCO B2 (Health Technology and Cosmetics), SANCO D5 (Medicinal Products – Authorisations, European Medicines Agency) and SANCO D6 (Medical Products – Quality, Safety and Efficacy) move from DG Health and Consumers (SANCO) to DG ENTR.

You can see the full announcement here.

The Commissioner–designate for Health and Food Safety is Vytenis Andriukaitis a former Minister for Health in Lithuania – and a surgeon, but he will not have responsibility for medicines, medical devices or health technology. That will be the task of Elżbieta Bieńkowska, a former Deputy Prime Minister of Poland, who is the Commissioner–designate for Internal Market, Industry, Entrepreneurship and SMEs, to give her full title.

The new Commission-designate must be approved by the European Parliament and I hope there will be strong voices there who think that medicines should be seen first and foremost as a matter of public health policy.

There is still time for the Commission to re-think this appalling decision. END

Ombudsman Publishes Commission/EMA Correspondence on Transparency

Posted by jim on 01/09/14

As I mentioned previously the Ombudsman had, on her own initiative, looked into the apparent change of policy on transparency in the European Medicines Agency. She has now published on her website copies of correspondence between the Commission and the EMA on the subject. For those of us who can sometimes get excited about such things, this is exciting and very interesting. You can see the correspondence here.

As readers know, I have complained to the Ombudsman about the refusal of the EMA to give me access to correspondence between the agency and the Commission. I don’t know yet if the documents just published by the Ombudsman would meet the full terms of that request – there is a lot of material here – but I will check.
I also asked for copies of correspondence between the EMA and pharmaceutical industry associations and have complained to the Ombudsman about the refusal to grant me such access.

If we can see correspondence with pharmaceutical industry associations, in addition to the material just published by the Ombudsman, we may have a better understanding of the reasons behind the change of policy in the EMA. END

Lifting the veil in the European Medicines Agency Part 2

Posted by jim on 01/09/14

In my previous blog, I covered the apparent change of policy on transparency in the EMA and told how I requested access to various documents in the agency. You can see their letter of refusal again here.

So, I appealed the refusal at some length (see here ). The response (attached) came within the time prescribed for such things but was again negative.

More reasons were given this time, including an explanation of why, in the EMA’s view, release of the documents at that time would undermine their decision making procedures, as in the following extract:

The disclosure of such information prior to the finalisation of the Policy may lead to unnecessary external pressure from various stakeholders that might compromise the final steps of the process and all Agency’s efforts made in the last 12 months to strike a balance between proactive data disclosure,the absolute need to protect personal data and the concerns relating to the protection of commercially confidential information..

The agency also referred to the administrative and other problems involved in disclosing the more than a thousand responses to the earlier public consultation on transparency.

Well, I did not ask for access to every submission but only to communications to and from the Commission and to and from pharmaceutical industry associations. I assume there were a lot less than a thousand of these.

Anyway, why not publish all responses to public consultations? There would be little administrative burden attached to putting in place a policy of publishing on a website a copy of all submissions on matters of public policy as soon as they are received (subject to limited exceptions for personal privacy and genuine commercial confidentiality).

More to the point I could not accept the argument that disclosure of the documents I requested would “seriously undermine” the decision-making process of the agency.

I have referred the refusal to the Ombudsman, and she will now consider it under the rules and principles that guide her work. More later… END

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

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