When the European Medicines Agency (EMA) relocated from London to Amsterdam after the UK announced its decision to leave the European Union, some analysts feared that Britain could become left behind in terms of alignment with the world’s top regulatory bodies. Perhaps cognizant of this, the UK regulatory agency for medicines – the MHRA – has joined up with its equivalents in four other mid-sized, high-income economies to form an ‘Access Consortium’ working to solve some of the most pressing issues in regulatory science today.
While the fast pace of technological advancement and innovation within the healthcare industry represents a boon to patients, regulators are constantly playing a game of catch-up when it comes to the evaluation and approval of these new platforms and therapies. With increasingly constrained resources, regulatory agencies have to educate themselves on cutting-edge treatments like cell and gene therapies while maintaining an attractive environment for innovation. In an attempt to manage heavy workloads more effectively, regulators globally have banded together to ease the burden on individual agencies and to foster more international collaboration. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a prime example, having been founded in 1990 to foster greater globally harmonisation on the scientific and technical aspects of drug registration.
In a recent interview US FDA Center for Drug Evaluation and Research (CDER) director Dr Janet Woodcock predicted, “the future is one of regulatory convergence and of working much more closely together,” justifying, “that is really necessary in the drug world. We are no longer islands out here. We used to make drugs here, test the drugs here and take the drugs here. None of that happens anymore. They are used worldwide, made worldwide and tested worldwide. So, the stronger the systems we have worldwide, the better off we are going to be.”
Global regulatory convergence may be a ways off but individual regulators have invested in various initiatives to move towards that direction. The Australia-Canada-Singapore-Switzerland (ACSS) Consortium, which was established in 2007 and comprised the regulatory agencies of the four named countries, welcomed its fifth member in October 2020: the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom. The Consortium has therefore changed its name to the ‘Access Consortium’. The MHRA’s official work with the Consortium will commence from January 2021. With the MHRA’s addition, the Consortium will serve a combined population of approximately 145 million people.
The five countries see themselves as good partners because they are all like-minded medium-sized regulatory authorities facing similar challenges like an increasing workload, intensifying complexity, as well as growing resource constraints. The Consortium is directed by the heads of the participative regulatory authorities, who try to meet at least twice a year, typically face-to-face during other conferences or meetings. Some of the areas in which the Consortium cooperate include the registration of generic medicines, the assessment of new prescription medicines, the alignment of IT systems, and the development of technical guidelines.
