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Full access to clinical trials is step too far, says Itre committee

MEPs have rejected a draft opinion on a proposal to increase transparency for and access to data gained from clinical trials involving humans.

The European Parliament’s committee on industry, research and energy (Itre), voted yesterday against an opinion by one of its members on regulation proposed by the European Commission to improve research data transparency.

In her draft opinion on the proposal, Itre rapporteur Michèle Rivasi, a Green MEP for France, argued that the public should get full access to clinical trials data, not just summaries. “Experience gained so far show that submission of a summary is not sufficient to protect patient’s rights and interests,” she said.

The Itre committee gave no reason for the rejection. But critics of widespread access to clinical trials data have said that demanding too much information from researchers can overburden them unnecessarily. Such access could also create data protection problems, intellectual property conflicts and could harm competition between companies, critics say.

The Commission has proposed that researchers should provide summaries only of clinical trials results, regardless of their outcome, which would be stored in a public database. The proposal, made in July 2012, would update the existing EU directive, under which clinical trials results frequently go unpublished.

In her draft opinion, Rivasi warned that, apart from not going far enough in terms of data provision, the Commission’s proposal also weakens the role of EU ethics committees. The EU should show “due respect for human rights, patient safety, and high standards of ethical scrutiny”, by strengthening the role of ethics committees through the regulation, she said.

“Without such guarantees, the pharmaceutical industry can continue to conceal crucial information on medications’ effects,” she said, referring to the need for independent ethics committees and data transparency.

Although the Itre committee rejected the proposal, “the fight goes on,” Rivasi said in a statement. The regulation has yet to be voted on by the committee on Environment, Public Health and Food Safety (Envi), the lead committee on the report, before it goes to the plenary to be voted on by the Parliament as a whole.

The Envi committee’s vote is scheduled for April, to be followed by negotiations with the Council of Ministers.