Change Looms for Drug Safety in Europe

At first glance, document number ENTR/F/2/SF D(2009) 32674 from the European Commission (EC) does not exactly appear to be the most riveting read of the year. My pulse certainly didn’t quicken markedly when I first came across it on the web via this link.

On closer inspection, however, the 32-page consultation paper, published on October 9th, could have important implications for everybody involved in clinical trials in Europe. It is well worth a closer examination.

The document is about how the EU Clinical Trials Directive (2001/20/EC) is working in practice. The analysis gets really interesting from about page 18, when the authors give some examples of inconsistent application of the directive. Under the heading, “Example 2: Reporting of SUSARs” (suspected unexpected serious adverse reactions), the following text is more than a little unsettling:

“While these provisions seem straightforward, they have led to a multitude of different regimes in the Member States, which has led in turn to multiple reporting of the same SUSAR, lack of reporting and unreliability of the Community data on SUSARs. Moreover, the number of SUSARs received diverges disproportionately among the Member States.”

Today, each national competent authority receives around 5,700 SUSAR reports per year.  This represents a six-fold increase compared to 2003, even though the number of trials has not changed significantly since 2003, according to the authors.

This is as close as we are likely to get to an admission by the EC that the current system of safety reporting is in disarray and unworkable, and it will be fascinating to see how industry, patient groups, and others respond to the document over the coming weeks. It is very difficult to see any simple solutions to what has become a major headache for many people.

As noted on page 32 of the document, there is a deadline of Friday January 8, 2010 for feedback and comments. A particularly busy time for pharmacovigilance specialists lies ahead.