EU To Meet, Make Decisions About Clinical Trial Transparency Legislation

EU legislation requiring complete transparency of clinical trial data was passed in 2012 and was set to be implemented in January of this year. In the meantime however, it has suffered several delays as the EMA struggles to reconcile the aspirations of the law with concerns about innovation incentive and privacy.  The EMA recently announced it has scheduled another meeting to discuss its new transparency policy on October 2, Euractiv reported earlier this week.

According to the Euractiv article, EU Ombudsman, Emily O’Reilly remains emphatically in favor of the legislation. After her criticisms of the policy’s “screen-only” addendum which made it impossible to download or print data and therefore limited the dissemination of information, the EMA has redacted those restrictions.

This week, O’Reilly held a debate in the EU Parliament with industry representatives, lobbyists, and the EMA to discuss issues with the policy’s hold-up.

During the debate, O’Reilly said, "I will continue to examine closely whether the EMA continues to be committed to transparency and I'm looking forward to hear the evaluation by Rasi [EMA executive director] on the challenges he is facing in the area," O'Reilly said.

Rasi, in turn, expressed the EMA’s commitment to striking a fair balance with an amended policy which takes innovation and privacy into account. He stated he was confident that the data should be available by the start of 2016.

Clinical trial transparency has become a buzzword in the clinical space as of late, and there have been several studies done and new partnerships launched that suggest the industry is receptive to the establishment of trial transparency. Indeed, one such study, launched by The Faculty of Pharmaceutical Medicine (FPM) of the Royal Colleges of Physicians of the United Kingdom, recently gauged the industry’s reaction to the idea of clinical transparency. This study found that an overwhelming majority of U.K. doctors and industry experts were in favor. Indeed, 89 percent of respondents indicated a belief that “increased publication of clinical trial results (including negative results) will ultimately lead to better medicines and better healthcare for patients.”

However, while most agreed in theory, the survey found a marked difference in opinion with regards to the implementation.

The United States Chamber of Commerce (USCC) issued a report  in May criticizing the EMA legislation. While admitting that many countries including the U.S. were moving towards greater clinical transparency, the report suggested that the EMA legislation might be a case of “too much, too soon.”

In their concluding remarks, the USCC maintains, “It is also important to note that at least two other components of the biopharmaceutical R&D ecosystem — maintaining the privacy and confidentiality of patient data and protecting the intellectual property rights and trade secrets generated in the clinical trial phases — are part of the puzzle, and a balance among all of these pieces must be achieved.”

Discussions and dissension over the parameters and specifics of clinical transparency have had the legislation in a holding pattern for two years, and implementation has been pushed back to 2016.