Earnest Efforts at Transatlantic Links for Medicines Regulators

The European Union's extensive transatlantic links have reached a further level of maturity with the completion at the end of 2014 of exchanges between the European Medicines Agency and Health Canada. An official from Health Canada has returned home after two years as a visiting national expert at EMA, where-among other things-he helped prepare the report to the European Commission on the agency’s implementation of pharmacovigilance tasks under the new EU legislation. At the same time, an EMA official has just completed a 14-month placement with Health Canada, where she contributed to a study on developing medicines for pediatric use, compiled by a 14-member panel of national and international experts with backgrounds in academia, the pharmaceutical industry, regulatory science, and clinical and medical fields. These exchanges come on top of existing regular sharing of information between the two agencies and interactions through topic-based expert ‘clusters’-notably, recently, on orphan drugs and labeling.

The links with Canada complement the far broader and deeper relations that EMA enjoys with the United States Food and Drug Administration. These are longstanding, but have recently benefited from new impetus. They date back to confidentiality arrangements since 2003, covering regulatory and scientific processes and early heads-ups on draft legislation, as well as information on the quality, safety and efficacy of medicines. The two agencies routinely share information on marketing-authorization procedures and changes through the exchange of assessment reports and review documents and regular tele- and videoconferences. The sharing extends to pharmacovigilance, scientific advice, biomarkers, and preparing for pandemics, too. And since 2011, a transatlantic task force on antimicrobial resistance has been in operation.

A recently-ended, three-year pilot has been exploring parallel evaluation of 'quality by design' aspects of applications submitted to the EMA and the FDA at the same time. A 'transatlantic administrative simplification action plan' is cutting through some of the red tape impeding interaction between regulators. And for five years now each agency has seconded a representative to the other's office. Late in 2014, a new degree of cooperation was attained on inspections. For several years the two agencies have employed common procedures for inspections of good manufacturing practice and good clinical practice, but in November FDA representatives held their first face-to-face meetings with a cross-agency team from EMA, the European Commission, and GMP experts from EU countries with a specific agenda to push forward mutual reliance on GMP inspections. This followed some practical shared experiences earlier in the autumn, starting with a week-long FDA observation of inspections in Sweden. EMA invited FDA officials to acquire on-the-ground acquaintance with European processes, and Dara Corrigan, director of the FDA's office in Europe, headed a team of colleagues that spent a week observing inspections and an audit of Swedish inspections conducted by officials from Norway. Now both sides are aiming to align their respective ambitions and define the scope and timelines for further progress.

The most striking example of transatlantic cooperation, however, is the continuing effort to achieve an agreement on TTIP, the Transatlantic Trade and Investment Partnership, which has a significant medicines component on its agenda-but is presenting real challenges to both sides. This has seen exchanges of views between negotiators on the exchange of commercially confidential information amongst regulators, transparency of clinical trial data, and alignment of the timing of submission of pediatric investigation proposals. The US has also requested that pricing and reimbursement be included in the negotiations-although this goes way beyond the brief of the EMA or the FDA.

Hilariously, in a response to wide public skepticism about TTIP in Europe, the EU has developed a "line to take" to guide member state pharmaceutical officials when they defend TTIP to hostile audiences. This urges the use of cautious statements such as "the negotiations have been largely devoted to an exploratory phase aiming to identify priority topics for the TTIP negotiations," and evocation of "substantial cooperation already ongoing between EU and the US on pharmaceuticals."  Officials are invited to stress that TTIP "should be seen as an opportunity to strengthen and formalize existing collaboration" with "a clear health dimension," and "should contribute by joining forces to a better use of the resources of authorities which is also in the interest of the patient." Other topics, which are, as it were, authorized for mention, include "opportunities for collaboration on generics and biosimilars with a view to ensuring similar requirements for authorization that could pave the way for further development of international guidelines, or streamlining requirements regarding pediatrics."

Big question marks remain over the future of TTIP, but they are unlikely to be removed by such crude attempts at message management. If the US side has taken analogous initiatives, they are likely to be a little more sophisticated-and it is to be hoped that the earnest attempts to strengthen transatlantic links will not fall victim to transatlantic disdain.