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European drug regulator fears return to days of data secrecy

BMJ 2019; 367 doi: https://doi.org/10.1136/bmj.l6133 (Published 22 October 2019) Cite this as: BMJ 2019;367:l6133
  1. Rebecca Coombes
  1. The BMJ

The agency that regulates drugs in Europe is nervously awaiting the outcome of an industry driven court case that aims to curb public access to clinical trial documents.

Two drug companies have argued that the European Medicines Agency (EMA) should stop making public any information on clinical trials that businesses consider commercially confidential. An initial ruling in February 2018 found in the EMA’s favour and said that, in general, clinical study reports should not be considered confidential.

But, in an appeal ruling on 11 September, advocate general Gerard Hogan found that disclosure of the documents would harm the companies’ commercial interests. These cases, taken by Merck and by PTC Therapeutics, are now waiting on a final judgment from the European Court of Justice.

In a statement released after a management board meeting earlier this month the EMA warned that, if the Court of Justice agreed with Hogan, the “existing transparency policies would be impaired and have to be revised.”1

The board warned that such a ruling risked jeopardising the benefits of making public most of the data submitted to the agency. Transparency, its statement said, “generates trust in the EU regulatory network, broadens the scientific knowledge base, fosters the development of medicines and ultimately benefits public health.”

The EMA stance is that clinical data, in general, should not be regarded as commercially confidential information. Since 2010 the EMA has introduced new transparency policies to make more information on clinical trials available to the public. Under its first policy, clinical study reports submitted to the agency can be requested for disclosure, similarly to freedom of information. In the second policy, such reports are proactively made available on a publicly accessible EMA website.

“Narrow commercial interests”

Yannis Natsis, patient representative on the EMA board, said that the EU was at the forefront of clinical trial data transparency worldwide but that this position was threatened by the pending judgment.

He said, “This will mean that data secrecy will over-ride the public interest of disclosure which is now the default option. It will be a major blow to patient safety, scientific progress, and society at large.

“Pharmaceutical companies—one of the most secretive business sectors—have long fought against clinical trial transparency, harming patients. The public interest needs to prevail over narrow commercial interests.”

A spokesperson for BEUC, the European Consumer Organisation, said, “If the Court of Justice upholds the view that CSRs [clinical study reports] should benefit from a general presumption of confidentiality, it would change the rules of the game. Sadly, such a move could easily take us back to a situation where disclosure of clinical trial data is the exception, instead of being the norm.”

A spokesperson for the European Federation of Pharmaceutical Industries and Associations said that the federation believed that the disclosure of clinical trial results and appropriate sharing of clinical trial data were in the best interests of patients, clinicians, medical research, and the biopharmaceutical industry. It said that, while it could not comment on the ongoing cases, “responsible data sharing means supporting enhanced data sharing, while safeguarding patient privacy, respecting the integrity of national regulatory systems, and maintaining incentives for investment in biomedical research.” It was committed to “working with partners across the research community to develop a shared understanding and vision of where that balance lies.”

The judgment is expected in the next few months.

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