The UK Government Chequers White Paper Widely Acclaimed in Pharma - But Will It Be Adopted?

The full paper, entitled The Future Relationship between the United Kingdom and the European Union, is available online here.

In political terms, the paper marks a shift in the Government’s public position towards a 'softer Brexit', and has been widely acclaimed within the UK's pharma industry.

The key points are as follows:

• The Government is seeking an "association agreement" with the EU, a model specifically rejected by the Prime Minister in earlier iterations of her Brexit strategy, but long suggested as a possible model by commentators. The model is most closely associated with countries on the path to joining the EU (such as Ukraine) and it is unclear if the EU will be willing to open the route to a country looking to 'de-harmonise', rather than harmonise, with the EU.
• The paper confirms that the Government is seeking a "common rulebook" for goods to deliver frictionless trade (though it does not make any provision for services).
• The possibility of a preferential immigration deal for EU citizens is notably left open, which is a politically highly contentious point. The Paper notes that the Migration Advisory Committee report due in September will inform the detail of the Government’s proposals, with further details to be set out in "due course".

The Paper makes several important points which, if eventually agreed between the EU and the UK Government, would deliver a high level of continuity for the pharma and healthcare sectors after Brexit:

• The UK would participate in the European Medicines Agency, accepting its rules, and contributing fees, but notably the UK Government accepts that it would not have voting powers. This participation would allow the Medicines and Healthcare products Regulatory Agency (the MHRA) to continue to be a "lead authority" on the assessment of medicines as well as participating in other areas of EMA activity as it does now. The UK Government recognises that this proposed relationship goes beyond any model that currently exists.
• Regulations covering the pharmaceutical, med tech and healthcare products would all be included in the "common rulebook" covering the UK and EU markets. This would ensure continued free trade, without the need for regulatory checks at the border, through recognised common regulations between the UK and the EU. This would mean that:
  • Good Laboratory Practice and Good Manufacturing Practice codes are respected.
  • "Nominated persons" (including Responsible Persons) in the UK are recognised in the EU and vice versa.
  • Batch-release by qualified persons and pharmacovigilance qualified persons are both recognised in the UK by the EU and vice versa.
• The UK wishes to participate through association agreements in Horizon Europe (the successor to Horizon 2020) and seeks co-operation in policies and networks which benefit UK businesses and citizens. These include European Reference Networks and the European Research Infrastructure Consortia.
• The UK’s relationship with EURATOM would be governed by a Nuclear Cooperation Agreement, this would allow continued cooperation and information-sharing with the European Observatory on the Supply of Medical Radioisotopes.
• The UK supports the EU in looking for ambitious recognition of professional qualifications, particularly relevant in healthcare.
• Health security cooperation will continue, with the Health Security Committee able to continue to work closely with bodies such as the European Centre for Disease Prevention and Control (ECDC).
• European Health Insurance Scheme and State Pensioner health insurance would both continue as they currently do.

EMIG (the Ethical Medicines Industry Group) is taking a lead on helping small and medium sized pharma businesses plan for Brexit. We held our annual PING seminar in conjunction with EMIG in June this year - on Brexit.

EMIG Chair, Leslie Galloway, comments on the above developments: "It is clear the Government is taking account of the interests of patients and patient safety in seeking alignment with the European Medicines Agency and frictionless trade with the EU to increase the likelihood that the UK will continue as a primary launch market for new technologies and also that access to existing medicines will not be impeded. If the EU rejects these proposals, it will not be in the interests of patients across the EU and the Commission will be making clear that their agenda is to make an example of the UK at the expense of self harm to Member States.

EMIG (www.emig.org.uk) continues to lobby other EU Member States via its membership of EUCOPE (https://www.eucope.org) for a constructive healthcare and economic relationship with the EU in the interests of patients."

Comment

We await seeing what the EU's response is to the UK's White Paper. The EU has indicated that it will give the White Paper close consideration. I hope that it is widely accepted.

These comments from right across the pharma supply chain chime with what we are hearing from clients and what was said at the annual PING event in June, which we held this year on Brexit in conjunction with EMIG.

A sensible outcome would be where there is a deal between the UK Government and the European Commission that ultimately benefits patients and players within the pharma supply chain.

I want to see the EMA and MHRA continuing to work together, with continued ease of access to medicines and to regulatory talent. I feel that that is in the interests of pharma businesses and patients in both the UK and the rest of Europe. A sensible deal is now on the table from the UK Government, and I hope that the EU will take that up.

If you have any thoughts or questions around the issues affecting the pharma supply chain in light of Brexit or if you want to be introduced to EMIG and hear about their upcoming meetings, please contact Paul Gershlick in our Pharmaceuticals and Life Sciences team on 01923 919 320.