Applied Clinical Trials
On Europe Day, the agency itself is right now keener than ever to assess its worth and the value of its services to Europe and to Europeans.
On Europe Day-the annual celebration of the Schuman declaration that set the European ball rolling on May 9, 1950-it might seem irreverent to try to put a value on the European Medicines Agency, but the agency itself is right now keener than ever to assess its worth-and the value of its services-to Europe and to Europeans.
On a purely practical level, it has just launched a public consultation on how appropriate its fee system is-since EMA lives mainly on the charges it imposes on drug companies for evaluating, approving, and monitoring medicines. It wants to get broad input to help it to assess "the extent to which the current fee and remuneration system of the EMA is cost-based, fair, proportionate, and not unduly complex."
So it is asking for views on whether its fee system is clear and easy to understand and to apply, and whether the fees reflect the costs of the services for which it demands payment. It also wants to know whether the world outside believes that it provides "adequate incentives and support" through its concessionary prices for smaller firms or to academics, or for specific products such as orphan drugs, paediatric medicines, or advanced therapies.
It goes on to ask for comparative assessments of the EU system against the charges levied by the US FDA, the Pharmaceuticals and Medical Devices Agency in Japan, Health Canada, and the Therapeutic Goods Administration in Australia. It wants to hear about any difficulties encountered in relation to the EMA fee system-particularly when the dispute settlement procedure between the EMA and industry has been invoked. And it is anxious to learn from drug firms what proportion of typical expenditure on EMA fees is accounted for by charges for scientific advice and initial marketing authorization and how much for post-authorization operations such as variations, extensions, renewals, pharmacovigilance procedures, and annual fees.
Anyone wanting to express a view has until early August to do so, on https://protect-eu.mimecast.com/s/oTMXCOM00s5nZLzuEEisI?domain=ec.europa.eu.
But perhaps even more demonstrative of EMA's current determination to ensure public understanding and acceptance is the tone of its annual report for 2017, also released in early May. From the very first page, the agency appears to be defending itself against the multiple attacks launched on it over the last year or so-with accusations from politicians and health campaigners of being in the pocket of drug firms and ignoring wider health considerations, of ignoring the voice of patients and citizens, of operating secretively, or of turning a blind eye to conflicts of interest.
It is "strongly committed" to public health, EMA insists, at the top of a list of its "guiding principles". It makes "independent recommendations based on the best scientific evidence". It values "the contribution made by our partners and stakeholders to our work". It claims to "communicate in an open, transparent manner with all of our partners, stakeholders, and colleagues," and to "adhere to high standards of professional and personal integrity."
Few professionals in the healthcare arena would doubt any of these assertions-or indeed give undue credence to the accusations repeatedly made against the agency. But EMA is waking up, perhaps belatedly, to the reality that it operates in a world where the opinion of the public matters just as much-and maybe more, on occasions-than the opinion of professionals. The fact that the last year has seen the agency brought into the public spotlight by the highly-mediatized search for a new location post-Brexit has driven the message home to EMA management more clearly than ever before. If they don't win the public battle for the agency's reputation, they risk losing the tacit support on which its professional operations ultimately depend. Ultimately, they need everyone to know what the agency is worth-and to value it accordingly.
Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium