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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The European Medicines Agency (EMA) confirms that AbbVie has withdrawn both its court cases brought against the Agency concerning access to clinical-trial data.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

Medicines, Industry and Trade

Posted by jim on 10/03/14

For years, BEUC and many other organisations pressed for the transfer of responsibility for medicines from DG Enterprise to DG Sanco. It seemed wrong that one DG should combine responsibility for medicines with responsibility for promoting the European pharmaceutical industry. It was not, in my view, a question of impropriety but rather that it would be difficult for one DG to have a clear headed view of the two issues simultaneously. (I don’t know of any national government where the regulation of medicines is the responsibility of the industry rather than the health ministry.)

We got our wish at the beginning of the current Commission (Barosso II).

We had been often told that the Commission worked as a college and that it did not really matter which DG had which tasks. I think it did matter. I think there would not have been so much transparency on clinical trials under the previous arrangement, with DG Enterprise in the lead.

Internally within the Commission DG Enterprise was opposed to the new provisions on transparency put forward by the Parliament. By some accounts, DG Sanco was not enthusiastic about these new provisions either but they did hold the line and agree to them eventually. I believe the outcome might have been different if DG Enterprise had been the lead DG here. It would have been difficult in that case for DG Sanco to change the Commission position.

Internally, DG Trade was also opposed to the transparency provisions on the grounds that they would create difficulties in the negotiations on TTIP. I think this was scandalous. It is one thing to argue against a proposal that is contrary to an existing agreement; it is quite another to argue pre-emptively that the EU should not make its own decision on medicines in case it might cause difficulties in future negotiations. This was to use, not an existing agreement but the possibility of a future agreement, to try to limit the EU’s freedom to regulate now.

The European and US pharmaceutical industry associations were very much opposed to the transparency provisions in the revision of the clinical trials directive, as they are opposed to the new transparency policy of the European Medicines Agency. They will try to use the TTIP to roll back these provisions and policies. I will say more about this in my next blog. END

Some MEPs Work Very Hard

Posted by jim on 21/01/14

I sometimes feel sorry for MEPs, and not just at Christmas. I’m thinking of those who do a good job as rapporteur on important dossiers, such as the revision of the Clinical Trials Directive. They put this on their website and in their press releases but in most cases their constituents have no idea what it means. “What is it you were? “A rapporteur? That’s nice” is the most common response, if there is a response.

The job of a rapporteur is to steer legislation through the European Parliament in much the same way as a minister steers legislation through a national parliament, but the rapporteur does not have a government department for support or a governing majority. MEPs belong to different political groups but there are no government and opposition parties in the parliament.

Rapporteurs take a proposal from the Commission, and analyse it with a small team of assistants. Proposals can be extremely technical – as is often the case with chemicals, tax, medicines, financial regulation and so on. They may have to seek expert help but rapporteurs remain responsible for preparing a report and drafting amendments for a parliament committee.

Rapporteurs from other political groups (“shadow rapporteurs”) propose their own amendments and the main rapporteur has to consult with the shadows in the hope of reaching agreement. Ultimately the committee votes up or down on the amendments. Later there is a vote in the full parliament where again the rapporteur has to negotiate with the other political groups to seek agreement, or majority support, for the rapporteur’s favoured amendments.

The Council (28 governments) will have their own views on the proposal and the parliament, council and commission usually have to get together in a “trilogue” to reach agreement on a final text. The rapporteur leads the negotiations for the parliament, based on an agreed mandate.

Given the importance of rapporteurs, they are a magnet for many of the twenty-thousand or so lobbyists based in Brussels (and in the rapporteur’s home country). About seventy staff of pharmaceutical companies have access passes to the European Parliament, with far greater numbers back in their offices and in consultancies acting on their behalf.

Although not all-powerful, rapporteurs can “set the agenda” for the European Parliament, by choosing expert advice and writing the first draft of a Parliament opinion. They have more power and responsibility than most members of national parliaments.

I don’t feel sorry for all rapporteurs, and certainly not for those who simply let an industry group write their reports, saving themselves time and thought. It can happen.

It did not happen with the revision of the Clinical Trials Directive where Glenis Willmott was the rapporteur. The proposal itself ran to 107 pages, plus 127 pages of impact assessments. Her first report ran to 52 pages with 74 amendments but a total of 731 amendments were submitted to the main committee voting on the proposal. Her task was to decide which amendments to back, not just on the basis of what was good but on what was possible in negotiations with her fellow MEPs, and with the Council, and Commission. I don’t think she got all she wanted, and I would have liked to have seen more on academic and post marketing trials, but the final text is potentially a great advance for transparency, and more than I believed to be possible a year ago. Rapporteurs matter. END
This is from my BMJ blog but I thought it might also be relevant here.

New battles in the struggle for transparency

Posted by jim on 16/12/13

According to rumour, we are making progress on transparency in the revision of the Clinical Trials Directive but the industry (and the Commission, apparently) are fighting back on two other fronts – the proposed free trade and investment agreement with the US (TTIP), and a recent proposal from the Commission for a directive on trade secrets.

The US and European pharmaceutical associations (PhRMA and EFPIA) want agreement in TTIP along the lines in the document attached. On transparency, they want a “harmonized list of clinical trial result data fields & agreement on which may be disclosed to public (uniform protection of confidential commercial info & trade secrets)” and “an EU/US aligned approach re disclosure of clinical trials data (impact on commercial opportunities in third countries should also be considered)” Other demands include changes in pricing and reimbursement policies in Europe, new legal remedies for applicants for medicines authorisations and compensation for patent office delays in the EU.

Depending on the final text, agreement on clinical trials in the TTIP could amount to making substantive law outside the normal decision making process of Commission, Parliament and Council. True, the Parliament would be consulted on any final draft agreement but could be faced with the choice of accepting a reduction in transparency as the price for some advantage such as increased access to the US market for EU farmers. Free trade agreements are agreed as an overall package, with concessions in some areas and advantages in others.

Furthermore, a trade agreement on transparency could make it much harder to move further in the future – on either side of the atlantic.

(As it happens I believe that trade liberalisation agreements often bring benefits to many – and not just the rich – but they should not be negotiated at any price.)

On trade secrets, the Commission proposed on 28th November a draft directive on the “protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure”. EFPIA ,the European pharmaceutical industry association, has welcomed the proposal pointing to to the need to protect trade secrets at all phases of drug development, including the clinical trial phase.

EFPIA also argues that transparency should be covered under this draft directive and not in the revision of the Clinical Trials Directive, which is not going their way entirely. No doubt they will try to regain lost ground through the directive on trade secrets and in the TTIP negotiations.

There are legitimate trade secrets in the pharmaceutical industry and elsewhere that merit protection but this proposal for a directive on trade secrets must not be used to reverse the trend towards more transparency and more open science on clinical trials.


Could it happen here?

Posted by jim on 09/12/13

There have been many serious cases of mis-selling and off-label promotion of medicines in the US. Could the same thing be happening here, or do pharmaceutical companies behave better on this side of the Atlantic?

For my BMJ blog I compiled a table of cases taken by the US Department of Justice since 2004 involving off-label promotion, where the company had to pay over $300 000 in fines, penalties and/or settlements – you can see the table here.

Of the seventeen companies listed, at least seven were among the top ten companies by sales in recent years – see below (1)

Of the medicines involved, at least twelve were among the top ten selling branded medicines for one year or more – the kind of medicines that would be followed closely by the CEO and other senior executives of the companies concerned -see below (2).

It seems clear therefore that off-label promotion was more than a temporary lapse or oversight by just a few companies.

In some cases the company pleaded guilty to one or more charge. In others, a settlement was agreed without any admission on the part of the company.

The forms of mis-selling were many and various – promoting for children medicines approved only for adults, selling on the basis of symptoms when the same symptoms (e.g. dementia) may have many different causes, withholding publication of inconvenient trial results, citing partial results of trials that were never subject to regulatory review, paying doctors to recommend off-label uses etc.

So, is this also happening in Europe? We don’t know. We have 28 member states, with nearly as many languages, with medicines agencies and enforcement authorities of varying size and sophistication. There is also a problem of transparency. Compared to the US, we know little about payments to doctors (or political parties) in Europe. Access to data in national medicines agencies is often very limited.The lack of public access to clinical trial data also facilitates mis-selling. Information on sales, marketing and the uses of medicines can be very patchy, or expensive to obtain.

Against that background it is difficult to believe that pharmaceutical companies behave very much better here than in the US.

Anyone care to comment?

(1) Abbott, Eli Lilly,GSK, J&J, Merck, Novartis, Pfizer
(2) Abilify, Aranesp, Epogen, Lexapro, Lyrica, Neurontin, Oxycontin,Paxil, Risperdal, Seroquel, Vioxx, Zyprexa,

Blogging at the BMJ

Posted by jim on 31/10/13

The British Medical Journal have invited me to be a guest blogger. My first effort has just been published, and you can see it here

But, don’t worry! I will continue with this blog.

Submission to the European Medicines Agency

Posted by jim on 08/10/13

I made a personal submission to the EMA Consultation on the Publication and Access to Clinical-Trial Data, which you will find here.

As I said in the submission, public consultations are more effective when it is possible … to comment on submissions from others. My submission was partly in the form of a comment on the submission from EFPIA – which you can find here.

EFPIA continue to support the attack on the EMA transparency policy through the courts.


Posted by jim on 17/09/13

Are you aware you are working in a health care industry with patients and human beings?” It Is not often you hear a regulator putting this question to a speaker from the pharmaceutical industry but this happened (twice) at a meeting I attended a couple of weeks ago.

The speaker was Neal Parker, a lawyer from AbbVie, and the occasion was the presentation of the principles on transparency agreed by EFPIA, the European Federation of Pharmaceutical Industry Associations, and their American counterparts. If the purpose was to present the EFPIA project in the best possible light, Mr Parker did not help.

Broadly, the EFPIA principles are a voluntary code of transparency under which a company would make clinical trial data available to suitable independent researchers under the condition, among others, that they should not share the data with the company’s competitors. You can read the Code here.

Mr Parker stressed the importance of commercially confidential information (CCI) and made it clear that his company would not release such information except under the most limited and conditional of circumstances. Furthermore, it was for the company to decide what was and was not confidential and what to release or withhold in any given case. In response to a question from me he said that the company’s judgement on CCI could be challenged – in the courts. I doubt if we will find many independent researchers with the resources to take on a pharmaceutical company in the courts.

Mr Parker showed a slide. The blue information is information that would normally be disclosed when a medicine is put on the market – it is not CCI. The information in yellow is generally CCI but may be released in a specific case and on the company’s terms to independent researchers. The information in white was a company asset, the ”intellectual output of our scientists”. It was commercially confidential and generally would not be released.

It was this analysis that provoked the question from the Dutch regulator. (A representative of the European Medicines Agency added that he was “flabbergasted” by Mr Parker’s presentation.) The admission that adverse effects might sometimes be considered confidential may have contributed to the vehemence of the regulators, but I think they were reacting also, as I would, to his key point that “..each company needs to be allowed to decide what they don’t want to release..” This is a long way from a commitment to abide by a set of key principles.

You can see and hear Mr Parker here . His presentation begins 11 minutes, 31 seconds into the video, the regulators intervene at 20’58”, and you can even see me at 39’30” onward.

American lawyers are often more adversarial in their presentations than their European counterparts. A European lawyer might have been “softer” in his or her presentation but we would have been less wise as a result.

I will look more closely at the EFPIA Principles in a future blog.END

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