Regulatory Focus™ > News Articles > Top EMA Regulators Say Despite Opposition, Data Transparency Would be Good for Industry

Top EMA Regulators Say Despite Opposition, Data Transparency Would be Good for Industry

Posted 22 October 2013 | By Alexander Gaffney, RAC

Efforts by the European Medicines Agency (EMA) to more fully open up clinical trials data for public consumption and scrutiny has garnered fierce opposition on the part of the pharmaceutical industry, which has gone as far as to sue the agency to halt the proposal and issue a trans-Atlantic data transparency policy of its own.

Now EU regulators are seeking to change the tone of the debate, arguing in a new position paper in the New England Journal of Medicine (NEJM) that its data transparency proposals would actually be "a boon to drug developers."


EMA has been moving toward a formal policy of clinical data transparency since at least November 2010, when it first announced its intent to eventually publish all research data provided to it in support of a regulatory dossier or application.

That plan has won rave reviews from some transparency advocates, including those behind the AllTrials campaign, which is campaigning for the release of all clinical data. Industry, however, has been far less supportive, with at least two-AbbVie (formerly of Abbott Laboratories) and InterMune-suing the agency to stop it from releasing what they called "commercially confidential information."

In April 2013, Abbvie and InterMune won a legal victory in the EU General Court ordering EMA to stop moving forward with its transparency plan. At the time of the order, EMA said it remained "committed to transparency and openness of information to meet the legitimate public interests to enable scrutiny of the Agency's recommendations on medicines."

As an interim measure, the agency said it planned to allow select access to the contested documents on a "case-by-case" basis-a measure already in place and responsible for the release of nearly 2 million documents since November 2010, when its access-to-documents policy first began.

Good for Industry?

But until now, EMA regulators have primarily been focusing on what trials transparency measures might mean for the public. Its new NEJM editorial stands in stark contrast to these prior efforts, making the case that industry, too, has much to gain from opening up its trials data for public consumption.

 "Pharmaceutical-industry organizations … have expressed concern that 'one of the risks to innovation is disclosure to competitors of companies' trade secrets and proprietary information that could allow others to `free ride' off of the substantial investments of innovators'; they fear "degradation of incentives for companies to invest in biomedical research," observed EMA Executive Director Guido Rasi, Senior Medical Officer Hans-Georg Eichler, EMA Biostatistician Frank Pétavy, and EMA Oncologist Francesco Pignatti.

However, the regulators argue that the real focus of industry shouldn't be on these hypotheticals, but rather on the very real challenge of the rising costs of drug development.

"Contrary to industry fears, we argue that access to full - though appropriately deidentified - data sets from clinical trials will benefit the research-based biopharmaceutical industry," they wrote. "We predict that it will help to increase the efficiency of drug development, improve cost-effectiveness, improve comparative-effectiveness analysis, and reduce duplication of effort among trial sponsors."

Four Benefits

Among the four primary benefits hypothesized by the group as being available to industry under the transparency proposal:

  • improvements in the design and analysis of subsequent trials, allowing industry to validate certain prognostic factors and reduce "unwanted variability" and Type I/II error rates
  • insights about the heterogeneity of treatment, allowing streamlined drug development and better information about a drug's value to patients, enhancing the reimbursement status of a drug
  • better positioning (relative to current indirect comparison methods) of products through enhanced comparative-effectiveness information
  • reduced repetition of trials and projects that others have already shown to be futile, better protecting both patients and profits

And while the regulators conceded that protecting patient anonymity will be of the utmost concern, they said the "array of potential uses of patient-level data suggests that their wide availability will facilitate research and drug development," helping both other patients and industry.

What remains to be seen is whether industry will agree with their take on the subject, or if industry's concerns about the value of commercial confidential information (CCI) take precedence over regulators' arguments.

NEJM Article

EMA Press Statement

Companion NEJM Article on Responsible Data Sharing

Tags: Transparency

Regulatory Focus newsletters

All the biggest regulatory news and happenings.