The European Medicines Agency is at battle stations as the new year unfolds—and don't be surprised if you get a slightly grumpy
response from them. It said at the end of 2012 that it expected about 100 applications for human medicines during 2013, including
more than 50 applications for new medicines. This does not include designated orphan medicines, of which it is expecting about
20 new applications. Alongside, some 20 generic applications are expected. The figures are broadly similar to 2012, and the
agency's predictions are in some respects a measure of optimism against a rather somber background.
At the most local level, the agency itself is strapped for cash and resources, while its responsibilities are increasing.
It foresees "a difficult economic environment." It will be operating on a budget of €231.6 million ($307 million), slightly
up from 2012, assuming fee revenue from services provided to companies reaches the planned level of €179.8 million ($238 million).
At the same time, as a faithful servant of the European Union, it will have to put new legislation into effect.
The EU pharmacovigilance rules in force since mid-2012 are the most evident example. In 2013 the agency has to collect key
information on medicines; prepare guidance for patient reporting; ensure better analysis and understanding of data and information;
take regulatory action, particularly coordination of pharmacovigilance inspections; and widen its communications. But, as
the agency points out, the fees that companies will have to pay for pharmacovigilance services are not expected before 2015.
And on top of the pharmacovigilance rules, new EU legislation to prevent falsified medicines getting into the legal supply
chain also comes into force in 2013. This will require the agency to become involved in developing an EU database of certificates
of good manufacturing practice and good distribution practice from the 27 member states.
The strains are compounded by the obligation to conduct a constantly growing range of activities which generate no fee revenue
(such as greater support to the scientific committees, monitoring conflicts of interests more sharply, or early-stage consultation
and advice to applicants), and which have to be funded through cross-subsidisation from fee-generating activities. An internal
program aimed at increasing efficiency of operations will continue, including bringing in a new information and communication
And above all, the agency is still going to be under close scrutiny from the European Parliament on many of the issues that
plagued it in the preceding two years—not just the high-profile issues of avoiding conflicts of interest, but also financial
and human resources management, and transparency. Guido Rasi, the Executive Director, has made big changes since he took over,
but he now has to make a success of one of his flagship exercises in transparency—widening access to clinical trial data.
Following a workshop on the subject in late 2012, the plan is to start a consultation process at the beginning of 2013, with
a view to publishing a policy in early 2014 on the release of data from clinical trials.
There are other clouds on the agency's horizon. Not only the European Parliament has been examining the agency's operations.
The Court of Auditors—the European Union's main watchdog—released a critical report on the agency's management practices in
October 2012. The criticism was partly out of date because the report itself was nearly a year old when it was published,
but the auditors are not going to let the agency out of their sights now that they have entered the fray.
Even more significantly, the European Commission has committed itself to a root-and-branch review of all its specialized agencies—there
are more than 30 of them, dealing with subjects as diverse as trademarks and occupational health and safety, but the medicines
agency is one of the most prominent. There is a growing feeling within the commission that these agencies are getting out
of control—and control is one of the commission's principal roles within the European Union. So nothing can be excluded as
the commission tries to bring new coherence to a plethora of these subsidiary operations set up more or less at random over
the last 20 years: the result could be changes in their constitution, their mission, their scope of operations, their funding,
or their supervision. The only thing it is almost certainly not going to result in is greater autonomy and independence.
So treat the agency gently if you want it to treat you gently over the coming months.