EMA Looks to Its Image

It you read Applied Clinical Trials, it's unlikely that you have no professional interest in the European Medicines Agency—and it's even likely that it influences your work, or that you have a connection with it or a frequent need for it. Which is why you may be interested in the agency's latest exercise in the image-obsessed world we are now all condemned to inhabit. EMA has launched a "communication perception survey"—and it is looking for honest views from among the widest audience on how well it is doing. (One is tempted to answer straight away that "communication perception" is the sort of expression one perhaps ought to avoid in trying to assess how people see you, but let that pass…)

So if you are—as it carefully lists in its appeal for input—a patient or carer, or a representative of patient or consumer organization, or a healthcare professional or representative, or an academic, or a regulatory or health technology assessment official, a pharmaceutical industry employee or consultant in regulatory intelligence, pharmacovigilance, e-submissions, preclinical or clinical development or a pharmaceutical industry organization… EMA wants to hear from you.

The questions it poses are unremarkable in themselves—but they offer prompts for answers that go wider than ticking a box. Respondents are being asked to rate whether EMA is sufficiently open and transparent in its activities—and how it compares in that respect with other regulatory authorities worldwide. Are its external communications useful, and timely, providing material when its audiences need information? And clear and easy to understand—especially for non-expert users? Is the material translated into enough languages—or is wider use of other languages necessary? Is information easy to find on its website, and complete? Does EMA engage sufficiently with patients, healthcare professionals, academia, industry…in its activities. And above all, is information objective, providing "balanced information about medicines?"

The apparently innocuous nature of these questions touches on some red-button issues in the healthcare environment. The strong competition in the regulatory world—despite increasing collaboration across borders—both for reputation and for effectiveness has led authorities to mount elaborate and energetic campaigns to win approval. The thinking is driven partly by the conviction that regulators that are considered the "best" are likely to attract more clinical trials, more marketing authorization applications for innovative products, better quality staff and experts, and more investment in the territory they cover. There is also sharper discussion than ever before of transparency—with regulatory authorities vying to strike the best balance: they want to meet the aspirations for information voiced by an increasingly demanding and alert public with the concerns of innovators, while at the same time respecting the desire of innovators for their proprietary information. The last few years have seen repeated clashes—and lawsuits—in Europe pitting these forces against one another. All this has been accentuated by the coronavirus crisis – and EMA has questions for its respondents on that, too. Has its communication on the pandemic been timely, clear, useful? And how can it improve?

Questions about the pandemic throw into sharp relief another hot-button issue – the quality of decision-making… already a decades-old issue in comparisons of the quality and speed of approvals in respect of EMA and other authorities – and notably the US FDA. Now the race to find vaccines and treatments for Covid-19 has lent a new strand to this debate: how politically independent are authorities? The tergiversations over hydroxyquinoline have offered a powerful example – and the competition to come up with the first vaccine raises the ante still higher. The disparaging responses around much of the world to Russia's claim to have a first vaccine are a perfect demonstration.

It's not a bad time to raise some questions and offer some views to EMA. The estimable Guido Rasi will shortly be vacating his position at its head, after piloting it through some deeply troubled waters, and the lead now passes to his successor, Irishwoman Emer Cooke, of whom much is now expected. She will have a lot more on her hands than just "communication perceptions"—but she is unlikely to disregard the importance of EMA's image. Let her know what you think. You can find the survey on https://ec.europa.eu/eusurvey/runner/perceptionsurvey2020 and you have until September 13thto respond. A brief distraction from other pressing matters of this challenging summer.