awaiting further information…

Posted on Thursday 12 June 2014

Press Release
European Medicines Agency
June 12, 2014

European Medicines Agency agrees policy on publication of clinical trial data with more user-friendly amendments

EMA Management Board to formally adopt policy in coming weeks

The European Medicines Agency Management Board on 12 June 2014 agreed the policy on publication of clinical trial data, together with more user-friendly amendments proposed by EMA Executive Director Guido Rasi, that will not only allow the Agency to proactively publish clinical trial data that are submitted as part of marketing authorisation applications, but also give the possibility to download, save and print the trial data for academic and non-commercial research purposes.

In light of discussions at the Board, the wording of the policy, including practical arrangements for academic and non-commercial research users, will now be finalised with a view to its adoption by the Board through written procedure by mid-July 2014, and will be effective from 1 October 2014. Importantly, the Agency will ensure that the policy will not prejudice citizens’ rights under existing access to documents legislation and the new clinical trials regulation.

Since embarking on its plans for the proactive publication of clinical trial data, the Agency has aimed to achieve the broadest possible consensus among its stakeholders and their often competing views and interests. After an extensive consultation phase that took place between June and September 2013, the Agency carried out a second round of targeted consultation in May 2014 that showed broad support for the policy, but highlighted concerns over the proposed view-on-screen-only access.

The Agency’s policy is an important step forward towards achieving increased transparency in the regulation of medicines in Europe. It takes the Agency beyond its legal obligations and provides an unprecedented level of access to clinical trial data that are used as part of decision-making for new medicines…

News
European Medicines Agency
June 11, 2014

European Medicines Agency responds to concerns on its publication of clinical trial data policy

The European Medicines Agency Management Board meeting on Thursday 12 June 2014 will be asked to consider a draft policy on the publication of clinical trial data. The draft policy arises from the Agency’s commitment to increase access to clinical trial data and has been shaped by the many comments we have received during the consultation phase.

The Agency was faced with an unprecedented level of response and range of divergent interests during its public consultation. Many stakeholders made their views known, including pharmaceutical industry, academia, patients and healthcare professionals, health-technology-assessment bodies and national medicines regulators. At the EU-level, contributions also came from members of the European Parliament, the European Ombudsman and European Commission.

Some parties argued that the Agency’s policy would encourage unfair commercial use of data outside of the EU, that it would provide a disincentive to innovation in Europe and risk companies moving their research and development activities outside of the EU, and even that it could endanger international agreements on intellectual property protection.

On the other side, some saw the policy as limiting the ability of researchers and academics to carry out meaningful re-analysis of data on medicines, as offering limited benefit for public health, even as restricting rights to access documents and going against the principles of transparency and openness.

The Agency stands by its commitment to increase access to clinical trial data and continues to believe that this will benefit the research-based pharmaceutical industry. In a July 2013 article published in the New England Journal of Medicine, the Agency argued that it would “help to increase the efficiency of drug development, improve cost-effectiveness, improve comparative-effectiveness analysis, and reduce duplication of effort among trial sponsors.”

The EMA has also publicly recognised the potential benefits for public health of independent re-analysis of data by independent academics and researchers after a medicine has been approved, and acknowledged that regulators do not have a monopoly on science.

The draft policy is a compromise approach that takes into account different stakeholders’ competing interests, in the absence of any specific current legal provision mandating the EMA to publish documents submitted by third parties. If agreed, the policy will serve as a useful complementary tool ahead of the implementation of the new clinical trials regulation when it comes into force no sooner than May 2016. The policy is without prejudice to citizens’ rights under existing access to documents legislation and the future clinical trials regulation.

The Agency welcomes the debate that has been generated since the launch of its initiative in November 2012 and recognises that stakeholders have been willing to shift their position towards greater transparency. The policy takes the Agency beyond its legal obligations and is an ambitious step forward towards achieving increased transparency in the regulation of medicines in Europe.

The Agency has aimed at finding a workable solution for all its stakeholders. A second round of consultation took place in May 2014 that showed broad support for the policy, but highlighted concerns over the proposed view-on-screen-only access. Guido Rasi, EMA Executive Director, said, “I remain open-minded and will explore with the Board possible alternative approaches, especially more user-friendly ways of providing access to data and meeting the reasonable expectations of academics and researchers.”…
  1.  
    June 12, 2014 | 3:37 PM
     

    no kidding, i’m holding my breath too.

    gonna read these babies over a few times and see where they’re trying to nail us (the one liner to sebelius in that sunshine act was a beaut).

    the headlines make it seem encouraging, so does the first quote

  2.  
    Johanna
    June 12, 2014 | 5:34 PM
     

    It sounds to me like the ridiculous “screen-only” data access system is dead – but all the other evils of this agreement live on. Like the two sets of CSR’s, with the redacted ones being for public consumption. Like the legal insanity of the “Terms of Use” where you have to agree to their right to sue you (in the UK, yet). Worst of all, the denial of patient-level data, without which even the best CSR could be a whitewash of serious problems.

    We’d better take a good look at those articles by Peter Gotzsche’s team on duloxetine (Cymbalta). Both the one Mickey printed on Sunday … and even more, the followup one where they started digging into the individual patient data:

    http://www.bmj.com/content/348/bmj.g3555

    Completed suicides and “indisputable” suicide attempts were accurately recorded, they found – but in some other cases all sorts of suicidal thoughts and plans got coded as “depression.” If that’s what happened on the suicide front, how about all the other 1,001 drawbacks of Cymbalta?

    It’s nice to have one Orwellian dodge off the table. But please, let’s keep on fighting!

  3.  
    Johanna
    June 12, 2014 | 5:44 PM
     

    I should explain: the Cymbalta studies by Maund & Gotzsche were based on documents the EMA released BEFORE the AbbVie-InterMune suit was filed and the injunctions came down. They are exactly the kind of work that will no longer be possible under this allegedly “user-friendly” new policy.

    As a Cymbalta Survivor© I took this kind of personally, and scribbled a Rapid Response letter to the BMJ on behalf of RxISK.org: http://www.bmj.com/%5Bfield_highwire_a_cpath-raw%5D-4?tab=responses

  4.  
    June 15, 2014 | 9:40 PM
     

    Johanna, are you fully recovered from your Cymbalta experience?

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