Wednesday, 29 May 2013

Clinical trials committee vote: a good day for transparency!

Today the European Parliament's Environment, Public Health and Food Safety Committee voted on the new EU regulation on clinical trials. The MEP responsible for the report is British Labour MEP Glenis Willmott.

The regulation will make it easier for clinical trials to be undertaken in Europe while protecting patients and ensuring greater transparency of clinical trial data.

There have been some misunderstandings on social media today concerning some of the amendments on transparency, leading some to believe that pharma companies were going to be able claim "commercial confidentiality" to avoid publishing clinical trial data. You will be glad to hear this is NOT the case : )

What actually happened was the following:

  • Consolidated amendment 40 (to article 78, paragraph 3) relating to the EU database on clinical trials, which referred to clinical study reports not being considered as commercially confidential information was rejected.
  • Consolidated amendment 41 (to recital 20a) referring to clinical trial data being published in line with EMA (European Medicines Agency) guidelines on transparency, which do not consider information in clinical study reports to be commercially confidential, was adopted.

    • In addition another amendment to article 78 (ITRE committee amendment 61) was also adopted. This amendment states that what is considered as commercially confidential has to be in accordance with EMA guidelines and cannot override public health research interests.

    The ALDE (Liberal) Group voted against consolidated amendment 40 because we considered that consolidated 41 along with ITRE amendment 61 was a better way to achieve the same aims in relation to transparency. These two amendments would not have been adopted without the support of the Liberal group, including Liberal Democrat MEPs.

    The ENVI committee final report on the clinical trials regulation will now go on to be voted by the Parliament as a whole (in plenary session). After that negotiations with national governments will begin.

    Let's hope that the good result achieved in the ENVI committee today will be repeated in plenary and then agreed by national governments. Fingers crossed!

    For the policy geeks among you (I am one, I admit!), here below is the text of consolidated amendment 41 and ITRE amendment 61:


    Monday, 13 May 2013

    European Commission NOT seeking to restrict seeds; another Euromyth busted!

     During the last week I have received a number of emails from members of the public expressing concern about European Commission plans to "make seeds illegal unless they are registered with governments". Many of the people were keen gardeners who feared their hobby was being threatened by the EU.

    I am happy to report that this is NOT the case. Last Tuesday in the European Parliament's Environment, Public Health and Food Safety Committee, European Health Commissioner Tonio Borg said that rumours of the Commission trying to strangle the seeds industry were UNTRUE and may have been based on rejected drafts and/or rumours.

    Commissioner Borg explained that under current legislation, much of which dates back decades, all seeds need to be registered, but that the new regulation being proposed by the Commission will liberalise the seed registration system so that among other things:

      There will be no need for traditional seeds to undergo testing.

      Niche seeds made by micro enterprises will not have to be registered.

      Micro enterprises will be exempted from registration fees.

    It is also (of course!) completely untrue that:

      Individual gardeners producing seeds for their own use will break the law and be prosecuted by the Commission (the rules only apply to commercial seed growers).

      The Commission will decide on these rules with no input from the European Parliament.

    What will actually happen is that as the proposed regulation on seeds ( will be scrutinised by the European Parliament's Environment, Public Health and Food Safety Committee before being voted on by all MEPs at the same time as being scrutinised by all EU national governments. In other words, the usual co-decision procedure.

    Unfortunately, due to the poor quality and negative focus of most reporting on EU affairs in the UK media (a mixture of lies, false rumours, wilful misinterpretation and exaggeration, see article by my colleague Catherine Bearder here:, people are rather inclined to be taken in by such stories. It is irresponsible of journalists not to check facts especially when by not doing so, they unnecessarily worry a lot of people, this time British gardeners.

    There is also perhaps another reason why things are misreported and that is so certain organisations can claim they have affected policy change and show how effective they are. Commissioner Borg commented on this by noting that some organisations were claiming a "victory" in "persuading" the Commission to change its position on the seeds legislation, when in fact the position they were clamouring against never existed.