A Brexecutive Briefing on the pharma sector…
The Confederation of British Industry (CBI) says that although non-EU pharma trade is growing faster, the EU still accounts for around 56% of UK pharmaceutical exports, totalling £53bn (US$69bn). Post-Brexit trade in pharma products is therefore a key concern within the industry, as is regulatory control.
The London-based European Medicines Agency, which employs 600 people and approves drugs on behalf of all Member States, will have to move out of the UK. If Britain and the EU operate entirely separate regulatory processes, there is a risk that companies may decide to re-locate to a market that gives them access to 500 million potential customers rather than simply 50 million.
Currently, most of the regulations on quality standards, intellectual property rights, clinical trial rules and criteria for product approval are harmonised across all 28 EU Member States. As an EU member, the UK has a seat at the table where new rules governing the pharmaceutical sector are devised and existing rules are reviewed and amended. The sector generally welcomes this harmonisation and views it as a way of reducing costs. There is growing concern that once the UK is free to make its own rules, costs will escalate.
There is also some uncertainty over future R & D funding. Although the UK is a net contributor to EU budgets, it has for years been a net benefactor of EU funding for research in health and biosciences. Indeed, because of its outstanding reputation for high quality science, the UK is the second-biggest receiver of EU financial support for research, including for life sciences, a sector that employs 70,000 people. Only Germany gets more. Can the government in post-Brexit Britain plug this gap and will investor confidence in the UK’s biotech sector continue to support massive venture capital funding, much of which has traditionally come from within the EU?
Building a modern, flexible and attractive post-Brexit environment for the pharma sector must be a priority item on the agenda for the UK government. The challenge will be to convince the rest of the world that the UK is still the best place, with the best scientists and the best universities to develop and bring new medicines to market. If Britain is to remain a major research and development hub and a global leader for the production and trade in medicinal products, then pharma companies need to start preparing their post-Brexit strategies now. The B2Brexit pharmaceutical team is ready to ensure that your company has the best possible strategy in place to mitigate the risks created by Britain’s departure from the bloc. From location and workforce planning to regulatory and legal advisory service, B2Brexit lays the groundwork to guarantee business continuity.