- May 15, 2018
- Posted by: BHTA
- Category: Healthcare News, Members News
BHTA Position Paper on Brexit
The CBI has set out six principles that should guide the UK Government’s negotiation to leave the European Union and which are supported by the BHTA:
- A barrier-free relationship with our largest, closest and most important trading partner
- A clear plan for regulation that gives certainty in the short-term, and in the long-term balances influence, access and opportunity
- A migration system which allows businesses to access the skills and labour they need to deliver growth
- A renewed focus on global economic relationships, with the business community at their heart
- An approach that protects the social and economic benefits of EU funding
- A smooth exit from the EU, avoiding a “cliff-edge” that causes disruption
The BHTA has participated in discussions hosted by the MHRA (which included other Trade Associations) and which agreed a paper for Ministerial consideration. This said that any new ‘bespoke’ arrangements with the EU should be based on the following principles:
- the UK to remain part of the CE marking regime;
- UK Notified Bodies (NBs) remain within the network of 50 EU NBs;
- EU Authorised Reps can continue to be based in the UK, and are not required by UK manufacturers;
- MHRA retains influence over and oversight of the EU regulatory system;
- MHRA increases influence over global regulatory harmonisation; and
- while alignment with other industry sectors (particularly New Approach products) is desirable, it should never be to the detriment of patient safety or innovation.
This would require:
- mutual recognition of the CE-mark (at least for MedTech) between the UK and EU;
- UK Notified Bodies, overseen by MHRA, being designated to assess devices for the EU and UK market, and remaining members of TEAM-NB (EU network);
- formal engagement from MHRA in Commission’s new stakeholder body, the Medical Devices Co-ordination Group (MDCG); and
- full access to Eudamed (EU-wide pre and post-market data, registration of economic operators, details of clinical investigations etc.); and
- UK membership of the international medical device regulators forum (IMDRF).
Important, but not essential elements would include:
- MHRA having a formal role in resolving classification disputes;
- extensive informal MHRA engagement (accepting no formal voting rights) in future EU legislative changes;
- UK laboratories being eligible to apply to become EU Reference Laboratories;
- UK representation on the Commission’s expert panels for the new EU pre-market scrutiny procedure; SCENHIR (scientific committee on emerging and newly identified health risks) is an example of how this can work.
Many of these issues would of course be addressed without further negotiation if the UK remained part of a Customs Union with the EU. Many of the Trade Associations and Business organisations involved in the discussions hosted by the MHRA considered this to be desirable, but it was considered unlikely that the Government would agree to do this.
During the discussions, the concerns of BHTA members were expressed to DExEU about the need for time to prepare for any changes (including labelling requirements) and to avoid the danger of Brexit leading to the duplication of lengthy and costly regulation processes that will damage the interests of patients and business and hinder innovation. Arguments supporting the principle of a significant transitional period (before any changes in regulatory processes are required) have been accepted subsequently.
Progress has also been indicated recently by the Government’s stated intention to ‘maintain regulatory alignment with the European Medicines Agency (EMA)’ and by it saying that similar considerations should apply to the regulation of medical devices in future. The BHTA considers that it is an important principle to minimise (or ideally avoid) any divergence in future regulations agreed for either the UK or the EU. It would obviously be welcome if international standards converge in future to the benefit of all concerned.
Chris Rennard – Director of Communications
The House of Commons Select Committee on Health & Social Care recently published a report ‘Brexit: medicines, medical devices and substances of human origin’ (https://publications.parliament.uk/pa/cm201719/cmselect/cmhealth/392/392.pdf). This noted evidence in support of the best option for Britain being ‘continued membership of the Single Market and Customs Union or retaining a Norway type EFTA/EEA relationship’ but said that ‘the Government has ruled those options out’. This BHTA position paper therefore focuses on what is sought from bespoke agreements between the UK and the EU.