Recently, the UK House of Commons Health and Social Care Committee published a report on its two-stage investigation into Brexit’s effect on the life sciences sector: “Brexit: medicines, medical devices and substances of human origin”.

 

Given the key relevance of life sciences to public health, throughout its report the Committee emphasises the paramount need to assess fully the impact of Brexit on the sector and to future-proof on that basis. In that vein, the Committee encourages the Government to negotiate a post-Brexit state as closely aligned to the current position under EU life sciences legislation as possible, and discourages deviations (and therefore the “no deal” exit model) to the largest extent possible.

 

In addition to the abovementioned overriding position, the Committee makes several key substantive recommendations as follows:

 

  • The Government should plan for and provide clarity regarding the transitional period post-Brexit– a list of issues affecting the sector should be drawn up and mechanisms to address these risks (particularly in respect of the Department for Health and Safety’s Single Department Plan) should be implemented

 

  • The Government should ensure the UK retains its standing as world-leaders in the sector by continuing membership in key bodies (ICH, EMEA), maintaining a close relationship with the EU and being transparent about its post-Brexit plans (including by publishing funding regarding the same) 

 

  • The Government should encourage the EU to adopt the Prime Minister’s proposal for a sectoral approach to regulatory alignment – and the UK should align with the EU as much as possible in the life sciences sector and periodically review its alignment with the EU

 

  • The Government, in addition to transposing the EU law on clinical trials (Clinical Trials Regulation) into local law, should secure continued participation of the UK in EU clinical trials regime and provide clarity to UK citizens currently engaged in EU trials

 

  • The Government should plan for and publish a list of  life sciences supply chain issues likely to be faced post-Brexit

 

  • To secure UK’s pre-eminence in future research and development in the life sciences sector, the Government should ensure UK retains appropriate memberships (Horizon 2020, Innovative Medicines Initiative), provides funding to these bodies, and has a future immigration policy that allows life sciences researchers to come to the UK

 

  • The Government should seek access to EU pharmacovigilance systems and organisations and seek mutual recognition of its studies

 

  • The Government should seek to ensure product compliance is minimally affected and divergence from the EU position is not significant, and have Qualified Persons (QPs) from UK to be recognised by EEA countries

 

 

The Committee’s report supplements the European Medicines Agency’s (EMA) guidance for UK to retain its access to the EU medicines regime. Whilst it has no binding effect on the Government, it should inform the Government in its negotiation strategies on the topic.

 

For manufactures of medicines, medical devices and substances of human origin it will be a tense wait to see whether Government adopts the Committee’s proposals, and the negotiations with the EU for Brexit are successful on that basis. If they are, the shift in regulatory management in the sector post-Brexit might not be as burdensome or divergent from the current practices as first envisaged.

 

Posted by Sarah-Jane Dobson

International products lawyer, Cooley LLP