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It’s Not All Bad News

Posted by jim on 24/10/14

In telling the Parliament on Wednesday that the units on medicines and pharmaceutical products will stay with DG Sanco Mr Juncker added “..I agree with you that medicines are not goods like any other”. I couldn’t have put it better myself.

This is good news and thanks to those who worked to achieve it, especially the European Parliament.

The new “DG Enterprise” will play an important role in internal discussions in the Commission on policies on food safety, medicines and medical devices because of its responsibility for industrial policy in these areas. There is nothing inherently wrong in this. I have spent a lot of time opposing the views of DG Enterprise on specific points but at national and EU level it is right  to take industrial policy (and the views of industry) into account in overall policy making. What is important is to achieve the right balance, and that would have been impossible if the same DG had been responsible for medicines and for promoting the pharmaceutical industry. In my opinion, that balance was skewed in the past when the two responsibilities were combined – I’m talking about you, Mr Bangemann.

In speaking to the Parliament Mr Juncker went on to say “ The relevant policy will be developed jointly by Vytenis Andriukaitis and by Elżbieta Bieńkowska, who showed her incredible talents in her hearing”. The word “jointly’ may mean, as I hope it does, simply a continuation of the a long standing agreement for close coordination on medicines (and food) policy between the two DGs.

There will, however, be a “gatekeeper’ in the new Commission in the form of the First Vice-President, Mr Timmermans, with responsibility for Better Regulation. There is also a strong political tide in favour of a less “interventionist” Commission. The merits of that can be debated but whatever happens it is still better that medicines and medical devices stay within the Health DG.

By the way, some members of DG Enterprise felt that my blogs were accusing them of favouring the industry over patient safety, but I meant nothing of the sort. Faced with a choice between the safety of a medicine and the demands of a pharmaceutical company I am sure they would all opt for safety. My concern was for achieving the right balance in the overall policy on medicines and health. There are important decisions to be made on such issues as transparency, relations between industry and health care providers, the evidence base for clinical decisions, and TTIP, to name just a few. It is too much to expect that the right balance can be achieved on such issues by giving one DG responsibility for medicines and for promoting the pharmaceutical industry.

The Commission will do better with a strong and well resourced internal voice for health.  With the units on medicines and medical devices working alongside its other health units, DG Sanco can be that voice, and I hope it will.END

Personal and Private? Correspondence between DG Enterprise and the Pharmaceutical Industry.

Posted by jim on 17/10/14

Citing Regulation (EC) 1049/2001, I asked last month for access to the following documents:

All communications in any form, and notes or records in any form of communications between DG Enterprise and any pharmaceutical Industry association concerning the policy, draft policy or decision making process of the European Medicines Agency on the issue of access to clinical trial results, after the closing of a public consultation on that issue on 30th September 2013 and before 21st May 2014’

I got a reply on 17th October with a copy of just 6 (yes, six) documents.

Three of the documents were requests to individual officials in DG Enterprise to fill in survey questionnaires relating to access to clinical trial data – one survey with five questions, and one with seven questions sent to two different officials on the same day. The questions and the answers, if any, were not included.

The fourth and fifth documents were a copy of an invitation to join an EFPIA webinar on access to clinical trial data, and a summary of the discussions at the webinar.

The sixth was an e-mail to DG Enterprise dated 10th March 2014. It contained (part of) a letter from the US and EU pharmaceutical associations to four DGs, the EMA, FDA, and US Trade Representative. The letter contained detailed suggestions for the EMA transparency policy and argued that the same principles be applied when implementing the regulation revising the Clinical Trials Directives. The letter also requested the Commission’s assistance in interpreting transparency Recital 20A of the new regulation in the light of other provisions dealing with commercial confidentiality.

And that’s it. According to the letter from DG Enterprise, disclosure of all other dealings between DG Enterprise and the pharmaceutical industry “would undermine the privacy and the integrity of the individual” and was therefore subject to the exceptions in Regulation 1049/2001. This applies across the board, it seems, even to things that DG Enterprise might have said to the industry. No documents at all from DG Enterprise were released – apart from a list of the six documents that were released.

In refusing access to these documents DG Enterprise made no reference to Article 4.6 of Regulation 1049/2001, which states “If only parts of the requested document are covered by any of the exceptions, the remaining parts of the document shall be released”.

In response to requests in other areas, correspondence between industry and commission has been released. What is so different about the dealings between DG Enterprise and the pharma industry? Does DG Enterprise have its own interpretation of Regulation 1049/2001? Do most dealings between DG Enterprise and the industry over an eight month period contain such private or personal information that they cannot be disclosed? Can DG Enterprise not tell us even one thing they might have said to the industry over that period? Is this good administrative practice?

DG Enterprise did invite me to put forward arguments that disclosure of these documents, which I have not seen, would NOT undermine the privacy and integrity of (unnamed) individuals. Not an easy task.

Regulation 1049/2001 is part of EU law and confers certain rights on citizens and others. Those rights must be respected, and the regulation must be applied faithfully, by all EU institutions.

This case isn’t over yet.END

Clearing the Air on Transparency Decisions, and on Industry Demands to the Juncker Commission.

Posted by jim on 01/10/14

At the Ombudsman’s recent conference two points were made that seem to contradict things I’ve said here. It is nice to have a blog to answer back.

I said that the Commission had the final say on EMA’s transparency policy (Article 80 of Regulation (EC) No 726/2004 ). I was immediately contradicted by a member of the EMA, who said that the EMA Board took the final decision “with the agreement of the Commission”. Two members of DG Sanco (at least for the present) made the same point in conversation later. Here is my answer, which is based on the correspondence between EMA and Commission, as released by the Ombudsman. In each case I give the relevant page number in the (171 page) pdf document that you can download from here:

Seven weeks after the end of the public consultation on transparency last year, the EMA presented to the Commission a detailed report of the 27 main industry objections to the proposed transparency policy – under the headings of Patient Confidentiality (6 objections), Clinical Trials Format (3), Rules of Engagement (7), Analysis of Results (4), and Legal Aspects (7) – pages 15-29. This seems to have been before the same material was sent to the EMA Board.

At the EMA Board meeting in December, the representative of DG Sanco said that other commission DGs would be affected by the proposal and should be consulted – page 36

At the Board meeting in March 2014, the Commission said that some other parameters should be evaluated “such as interaction with the TRIPS Agreement and the European patent system” – page 93.

On 20-23rd May the draft policy was discussed in detail with DG Sanco – page 127.

On 28th May Dr Rasi wrote to Director General of DG Sanco requesting the Commission’s agreement to the draft new transparency policy that was to be submitted to the EMA Board – page 146.

The draft transparency policy was discussed again in a meeting in June 2014 between the EMA and DGs Sanco, Enterprise (three representatives), Trade, Research and the Legal Service – page 165.

DG Sanco wrote back on 11th June giving their agreement, subject to certain amendments and conditions – page 169.

To claim that the Board takes the final decision is formally, bureaucratically, pedantically correct but, in the real world, wrong.

Also at the Ombudsman’s conference, the Director General of EFPIA said that the industry association had not requested the transfer of responsibilities for medicines to DG Enterprise or any specific DG. Talking to me later, he said that they had asked that the three Commission units dealing with medicines should be brought together into one, but had never specified into which DG they should be put.

So, where did the industry expect the new medicines unit to end up – in DG Fish? In fact they clearly did not have to specify which DG they had in mind.

The industry clearly asked the new Commission to put together the unit dealing with medicines and medicines safety and the unit charged with promoting the pharmaceutical industry. This is exactly what the entire health sector opposes. No one unit or DG should have responsibility for medicines safety/transparency AND responsibility for strengthening the European pharmaceutical industry. Member states do not normally assign responsibility for medicines to the industry ministry and this should not be done at EU level either. END

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.

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