New EU CT Reg: Headway, Concerns

Approved by the European Parliament in April 2014 is EU Regulation 536/2014, which replaces the decade-old Directive 2001/20/EC – the Clinical Trials Directive. While approved last year, it does not apply earlier than May 28, 2016-leaving interested parties only nine months to prepare for its arrival.

The benefits associated with the new Regulation include a single submission portal, standardized content of clinical trial applications, information about subject protection and informed consent, more stringent requirements for reporting trial progress and greater transparency about clinical trials. The operational database for clinical trials and a portal for submissions will be set up by the EMA by January 2016. The portal must have six months of functionality before the regulation comes into effect, thus determining the earliest date as May 28, 2016.

However, even with these benefits, the past Directive is linked with the uncertainty of the future regulation, as came to light in a recent survey. In June, Applied Clinical Trials and SCORR Marketing surveyed our audience on global regulatory issues, with the new directive central to the questionnaire. You can download the report here.

In the survey, we asked if Directive 2001/20/EC has impacted your organization. The majority-57%-said yes. When asked how, the respondents said increased costs followed by increased bureaucracy at 54% and 46% respectively. Our EU expert and Brussels correspondent Peter O’Donnell noted, “The nature of the impact is in line with general concerns expressed by the clinical trial community during and since the Directive’s genesis: the increased bureaucracy is nearly as inimical as the increased cost.”

Dr. Martine Dehlinger-Kremer, Global VP, Medical and Regulatory Affairs for SynteractHCR, said that the noted increase in costs is indicative of the greater administrative costs, which affects smaller biopharma even more than larger pharma. “What happened was before the Directive, when you just needed to submit the Clinical Trial Approval (CTA) some countries didn’t request all of the same information. But with the Directive there was a significant increase in the amount of data needed for the submission. There was also use among different Member States requesting different information, so you could not ‘re-use’ it for different countries,” Dehlinger-Kremer explained.

There has been concern that there is a marked decline in clinical trials placed in Western Europe, which is a direct result of the Directive 2001/20/EC. However, when asked if the Directive has made Europe a less attractive place to conduct clinical trials, 59% said no and 41% said yes. Said O’Donnell: “It’s worth noting [in that response] that before the Directive, EU was already becoming less attractive for clinical trials, so the Directive, bad as it was, hardly made that much difference to the ongoing decline.” That was reflected in the respondents’ choice that the Directive was not the offender in the decline, but part of a global trend.

The EU Regulation 536/2014 will be applied in full in all Member States, with no need for separate national legislation, with the hope the result will be consistent and uniform application throughout the EU. 

However, the respondents to our survey are equally divided on the potential positive benefits of the new Regulation. Do you feel that the introduction of the EU- CTR (EU) 536/2014 will go far enough to

address some of the obstacles to doing research in Europe? Yes, 51% and No 49%. O’Donnell paints these results as the general problems around a cohesive Europe. “Hopeless, helpless, divided and uncertain – but unsurprising, given some of the persistent imponderables of the new regulation. For example, there have been intensive discussions on how to make the single portal work, or how to corral ethics committees into faster decision-making – but still little in the way of solutions.”

Dehlinger-Kremer is a bit more optimistic, saying, “The Directive is not perfect, but it is better than what was in place.” She points that the previous Directive did try to standardize a lot, and that much has been resolved in the new Regulation. “Those that responded no, if they are a smaller company doing a study in only one or two countries, then the costs might going to be higher,” she explained. For companies with larger pockets, the compiling of the scientific data for the clinical trial application, is the same whether you are doing a study in one country or three countries. “There is more transparency in the process than what we have now. And I think that brings trust into Europe.”

Looking for insight to put the new regulation into practice?

This October, CBI is hosting a prep forum for the New EU Clinical Trial Regulation. Join industry thought leaders and early adopters to develop an implementation roadmap and evaluate the impact of the new directive on global programs. Click here to learn more and register.