On 14 December 2017 groups representing the life sciences industry across the UK and Europe published a position paper on Brexit, which is available here. It follows a joint letter written in July 2017 to the UK and EU negotiating teams.
It shows the industry adopting a united front in seeking that medicines are dealt with as a priority in the Brexit negotiations and it aims to educate the negotiators as to the complex issues in play.
The paper addresses four key areas:
- People and access to medicines
- Intellectual property and the legal framework
- Regulatory issues including manufacturing and supply, clinical trials and pharmacovigilance
The paper emphasises the need to protect the supply of medicines to patients and that having a period of transition beyond March 2019 will be “critical” to ensure industry and the regulatory authorities, including the EMA, will be able to bring about the necessary changes. The conclusion of the position paper is that any transitionary period should be at least 2 years.
The paper includes a number of ‘asks’ as well as a number of proposed solutions, which will hopefully assist both sides as the Brexit talks move up a gear.