The European Parliament’s Committee on Environment and Public Health has unanimously adopted rapporteur Glenis Willmott’s amendments to the Commission’s proposed regulation on clinical trials, including provisions requiring sponsors to publish full Clinical Study Reports once a marketing-authorisation decision has been taken.

Under the proposals endorsed by the Environment Committee, all trials would have to be registered on a publicly accessible EU database and their main findings reported within a year of the study ending. Non-compliance with the transparency provisions would result in sponsors being fined.

Transparency campaigners such as the AllTrials initiative had been concerned about the lack of measures in the proposed regulation overhauling the Clinical Trials Directive to ensure comprehensive registration and reporting of trials of medicines currently in use.

Willmottt’s proposals only go some distance towards allaying these concerns, though, as the transparency provisions would not apply retroactively.  

Article 34, paragraph 3 of the text published by the Commission last July only required sponsors to submit a “summary of results” to the EU’s clinical-trial database within one year of a study ending.

Mandate to negotiate

The Environment Committee said Willmott, who is leader of the European Parliamentary Labour Party and Labour member of the European Parliament for East Midlands in the UK, had “received a mandate to negotiate an agreement with EU ministers”.

Speaking after the Committee’s vote, Willmott insisted a clinical trial “is not a marketing tool but an assessment of a drug's safety and effectiveness. In the interest of public trust in medicine and good science we need access to detailed summaries of results and, when a new drug is authorised, Clinical Study Reports”.

She also emphasised that the proposed regulation as it stood would lower the costs of running trials for companies and academic researchers.

For example, the Environment Committee had supported proposals that would significantly reduce the “astronomical” insurance costs for clinical studies.  

“When governments and the EU give out medical research grants, a lot of the money is going straight to insurance companies, so it makes sense for the state to insure the trial themselves through a national indemnification system,” Willmott commented.

Unbalanced approach

The European Federation of Pharmaceutical Industries and Associations (EFPIA), while welcoming the Environment Committee’s support for an “effective, safe, simplified and robust clinical trials authorisation process” in Europe (i.e., a single portal for applications, single submission and single decision at Member State level), said it was concerned about the “unbalanced approach adopted by the Committee on the issue of confidentiality of clinical data”.

All EFPIA member companies “support enhanced sharing of their clinical trial information as a tool to broaden knowledge about our medicines in the best interest of patients and public health”, EFPIA stated.

At the same time, though, there was a need to protect patient confidentiality and commercially sensitive information.

Complex implications

Several of the amendments supported by the Environment Committee “will jeopardise patient privacy, the integrity of regulatory systems, and incentives for investment in biomedical research in Europe”, EFPIA warned.

The issue of data sharing has “complex implications for patients, researchers, industry and our legislative and regulatory framework”, it insisted. “These need to be fully understood before the issue can be addressed in legislation.”       

Enhancing the “diverse means” of sharing clinical-trial data to general benefit calls for industry, regulators, researchers and society to work together “to ensure that patient privacy, the integrity of regulatory systems, and incentives to invest in biomedical research are maintained”, EFPIA said.

“Together with our international colleagues, we are now working to enhance data sharing with researchers and to enhance access to clinical study results after approval in the interests of advancing science and patient health,” commented director general Richard Bergström.

“The details and mechanisms will be developed in the next few months in close collaboration with stakeholders including the scientific and patient community.”