EC adopts plan to change trial rules, yet to decide on non-EU inspections

17-Jul-2012 - Last updated on 18-Jul-2012 at 16:36 GMT

European lawmakers still need to decide how to inspect clinical trials in non-EU countries under proposed regulatory reforms adopted by the EC.

The European Commission (EC) formally adopted a plan to replace the clinical trials directive with a set of rules designed to halt the decline in the number of studies conducted in Europe, according to health and consumer policy Commissioner John Dalli speaking yesterday.

“Clinical trials conducted in the EU have declined 25 per cent in recent years. One of the factors is the current regulatory environment that has led to high administrative burdens,” Dalli said, suggesting that current rules have resulted in an average two-fold increase in the number of staff needed to conduct a trial and an 800 per cent hike in what it costs to insure such research.

Proposals

Key among the proposed law changes is the plan to allow sponsors to submit trial proposals electronically to a centralised body rather than various national authorities, although ethical considerations would still be assessed at a national level.

Dailli explained that: “The scientific and technical aspects of a clinical trial will be assessed by the concerned member states in a co-ordinated way…each member state will then take a single decision within the shortened deadlines on all aspects of the trial,” predicting that “these measures will facilitate clinical research in particular multinational trials.”

The laws governing assessment of risk will also be revised if the proposals are accepted with research deemed to be of lower risk having reduced reporting and insurance obligations as well as shorter approval deadlines.

The other headline grabbing part of the plan is the requirement that all clinical trials are registered in a public registry before they begin. This Dalli said is designed to ensure that authorities have access to all results from a trial – positive, negative or inconclusive – warning that failure to do so would mean the data will not be considered in approval applications.

Implementation by 2016

The EC’s adoption of the proposals had been expected since Dalli outlined them at a meeting of the European American Business Council (EABC) in Washington, DC last month and was welcomed by industry groups.

The European Federation of Pharmaceutical Industries and Professionals told Outsourcing-pharma.com that: “EFPIA calls the European institutions to take an ambitious and pragmatic approach during the legislative debate and to come to a rapid agreement on this regulation in order to foster clinical research in Europe and allow patients' access to new treatments.”

Now they have been adopted the next step is to discuss the proposals in the European Parliament in a process that could mean they are not fully implemented until 2016.

EC spokesman Frédéric Vincent confirmed the timeline and told Outsourcing-Pharma.com that: “Once tabled by the Commission, it takes between 18 and 24 months for a Regulation to be adopted by the Council and European Parliament. Let's say Regulation is adopted in 2014, full implementation will be effective by 2016.”

He went on to explain that there is still work to do, particularly regarding inspections of clinical trials conducted outside the EU.

“Some issues still have to be engraved in stone, for example how the inspection system in third-countries will function. It will be discussed at a later stage.”