Worrisome EU proposal on clinical trials

Deregulation proposal that affects our medicines and health: Less dependable data, fewer safety requirements and little transparency.

Proposal for a Regulation of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC. 2012/0192 (COD)


First critical comments on the Commission proposal ( more and amendments to follow). David Hammerstein, TACD

1. Lowers requirements and insurance for so-called “low risk” and “on market” drugs. Establishes different level of safety and insurance demands between “low risk”or “low intervention” clinical trials and higher risk ones. “Lower risk” can be a known substance or one already on the market. This language is very ambiguous. The fact that a drug is already on the market does not necessarily lower the risk for patients. Not demanding insurance for trials comparing drugs A and B is not a responsible policy. Art. 2.3 and 72.

2. Easier industry manipulation of methodology to get results they want. Does not require all changes in way a clinical trial is being done to be forwarded and dated. Reduction of need to inform upon the modification of the protocol or methodology of a trial once the trial is underway unless a modification is “likely to have a substantial impact on the safety or rights of the subjects or on the reliability or robustness of the data generated in the clinical trial”. What is “substantial” is not defined and can be used as an excuse to conceal new industry-favourable methodologies introduced. It could be an invitation for fraud and arbitrariness. Art. 16-24

3. Ambiguous on Transparency: no clarity on what databases should be accessible. New medicine approval applications should be based only on “a publicly accessible database”. This is very ambiguous, open-ended language because a publicly accessible database can be anything, including the the industries own database that excludes uncomfortable data. Does not specify “EU database”. All clinical trials should be registered by the EU at their inception, before the first patient is asked for consent. Recital 20
4. Little transparency:Allows pharmaceutical industry to present only a summary of their data for EU database. “A summary of the results of each clinical trial should be placed on the EU database within one year of completion of the trial.” According to most doctors and scientists a summary is clearly not enough to assure safety and efficacy of health treatment. What is needed is public access to raw data from clinical trials with appropriate ethical, scientific and privacy safeguards, preferably from an EU repository. (art. 34.3)

5. Destruction of valuable clinical data:  Allows industry to destroy master files of clinical trial data after five years. In many EU countries the requirement is over 15 years while many researchers ask for the data to be kept indefinitely for ethical,         safety and scientific reasons. (art. 55)

6. Tricky wording to avoid reporting negative results. Adverse events do not have to be immediately reported by industry to the European Medicines Agency.  “Serious adverse effects must be reported immediately to a database set up by the EMA”. Events are not effects. “Events” are caused by the medicine while “effects” do not imply any causality, which means that a pharmaceutical company could argue that it is not caused by its drug. (art. 38)

7. Whose  benefit? Whose risk? Reporting to EU on safety problems only if it “affects benefit-risk balance”. Does not define what the indicators are to evaluate a “benefit -risk balance” and does not say who has to judge this crucial balance that seems to be left to the industry itself.. Art 50-51.

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