The White Paper appears largely positive for the life sciences industry, incorporating many of the key asks from the industry across its priority areas of regulation, trade, people and innovation. On regulation, the proposed "common rulebook" for goods would mean continued regulatory alignment between the EU and UK for medicines and medical devices.
The White Paper appears largely positive for the life sciences industry, incorporating many of the key asks from the industry across its priority areas of regulation, trade, people and innovation. On regulation, the proposed "common rulebook" for goods would mean continued regulatory alignment between the EU and UK for medicines and medical devices. The White Paper proposes that goods should only need to undergo testing once in either the EU or UK in order to be placed on both markets, supported by arrangements covering all necessary compliance activities. Of particular note, the activities listed include specific reference to manufacturing and quality assurance processes such as GMP, the role of nominated individuals such as "responsible persons", batch release by a Qualified Person in the UK or EU, the role of QPPVs, and accreditation of conformity assessment bodies. The White Paper proposes that the UK should continue to be an active participant in the European Medicines Agency (EMA) under new arrangements that involve accepting the rules of the EMA and contributing to its costs, but without voting rights. UK regulators would continue to carry out technical work and act as a leading authority, and also participate in pharmacovigilance monitoring activities and the upcoming centralised EU clinical trials framework. On trade, the proposed "facilitated customs arrangement" would mean the continuation of no tariffs on UK-EU trade in medicines and devices, and avoid additional delays at the border, both of which are key for the complex international supply chains in the medicine and device sectors. On people, the proposed reciprocal arrangements to allow UK and EU citizens to travel freely for temporary business activity and to support business to move talented people would help address industry's concerns about access to EU scientists and highly skilled workers. On innovation, the White Paper proposes a new cooperative accord for science and innovation that provides for the UK to continue participating in EU research funding programmes. Many other provisions in the White Paper, such as on continued cooperation on health security, continued free flow of personal data between the UK and EU, and exploring new models for regulatory cooperation on artificial intelligence and other digital technologies, are also relevant to life sciences companies. The UK Government has taken on-board much of the feedback from the industry and recommendations in Select Committee reports on life sciences. However, this is only a starting point for negotiations and the next question for the life sciences industry is how much of this positive wish list will be agreed?