Pharmaceutical companies called on Thursday (27 April) for a phased transition in drug regulation after Britain leaves the European Union, in order to avoid supply disruption and protect public health.
Britain currently hosts the European Medicines Agency (EMA), which acts as a one-stop-shop for approving and monitoring the safety of drugs across the bloc, but there is uncertainty about the regulatory set-up after Brexit.
With Britain facing a general election on June 8, the Association of the British Pharmaceutical Industry (ABPI) said it was important for the next government to prioritise a smooth regulatory handover.
“It is in the mutual interests of our new government and the EU to minimise the potential impact to patient health and well-being. Agreeing a phased transition for the UK’s new relationship with the EU can help prevent ‘day one’ disruption,” the trade group said in its election “manifesto”.
Drugmakers hope Britain can still work closely with the EMA after Brexit through some system of reciprocal or mutual recognition – but this idea faces significant hurdles, since Britain will be outside the EU single market.
Many industrial companies, from aerospace engineers to makers of plastic mouldings, are concerned about the regulatory vacuum that could follow Britain’s divorce from the EU, scheduled for March 2019.
In addition to action on regulation, the ABPI also urged the government to adopt an industrial strategy that ensured Britain remained a leader in pharmaceuticals and called for healthcare investment to be increased in line with the G7 average.
ABPI listed four key issues as Britain leaves the EU:
- Innovation, including access to science funding and collaboration
- Regulation, including the European Medicines Agency
- Talent, including access to highly-skilled talent
- Commercial, including steps to enable ‘frictionless trade’