Dear Member of the European Parliament,
As researchers, doctors, scientists and civil society representatives we are asking you to support the inclusion of strong transparency provisions in the Clinical Trial Regulation that is currently being discussed. Please find attached our letter in which we highlight how important it is to disclose the complete clinical study reports (CSR) and to ensure that the Regulation is in alignment with the principles enshrined in the Helsinki declaration.
Most specifically, we ask you to support amendments that favor transparency ,namely:
– CA 1 (Article 2 – paragraph 2 – points 1-4): which clarifies the definitions of a clinical trial, and that of a low intervention clinical trial thus protecting public health;
– CA 2 (Article 3): which requires the evaluation of the ethical acceptability prior to granting authorization to conduct a clinical trial;
– CA 4 (Article 6 – paragraph 4): which requires that the reporting Member State includes the view of the concerned Ethics Committee in his assessment report since scientific and ‘ethics’ assessment can’t be separated;
– CA 5 (Article 34 – paragraph 3 – subparagraph 1), AM 6 (Recital 52), AM 14 (Article 2 – paragraph 2 – point 30 a (new)) and AM 530 (Article 34 – paragraph 3 – subparagraph 1): which define clinical study reports, and require clinical study reports (and not just a summary of trial results) to be published on the EU portal in order to allow and support independent analysis;
– AM 19 (Article 6 – paragraph 5 a (new)): which encourages transparency (having the final assessment report from a clinical trial application made publicly available on the EU portal);
– AMs 23 and 24: which protect against tacit authorization when ethical issues are at stake (The current Directive 2001/20/EC does not allow tacit authorisation by competent authorities when an Ethics Committee has not approved the clinical trial)
– AM 27 (Article 34 – paragraph 3 a (new) and 3 b (new) and 28 (Article 34 – paragraph 3 – subparagraph 1): which ensure compliance with the requirement to publish of clinical trials’ results, in alignment with Helsinki’s declaration.
– AM 37, 38, 39 and 40 (Article 78): which encourage transparency and clarify that clinical trials data are scientific data.
– AM 52 : which require the investigators to register serious adverse drug events in the EU database;
– AM 62, AM 72, AM 87: which require new medicines to be tested in comparative clinical trials against the ‘best current proven intervention’
On the other hand, we would like to highlight the problems with the following amendments, which we consider to be have a negative impact:
– AM 53, AM 54, AM 142, AM 147, AM 159, AM 162, AM 164: which impair transparency. Clinical trials data are scientific data and the interest in their disclosure is of a public nature. Public interests in disclosure must override commercial confidentiality protection measures.
– AM 109: Member States would be unable to disagree from the reporting Member States conclusions on ethical grounds! (prefer AM 121 allowing Member States to opt out in case of disagreement)
– AM 118, 119 and 120: which reducing timelines that are already untenable.
We remain at your disposal for any questions or doubts you might have. We hope that you hold our recommendations into consideration.
Teresa Leonardo Alves
International Policy Adviser
La Revue Prescrire
on behalf of the endorsing organizations:
The Cochrane Collaboration
International Society of Drug Bulletins
Medicines in Europe Forum
Transatlantic Consumer Dialogue