Situation

The United Kingdom will be leaving the European Union and this will affect as well as the freedom of movement of goods and people to and from the UK from the European Union.

Prime Minister Theresa May triggered Article 50 of the Lisbon Treaty in March 2017, meaning the UK will leave the EU on 30 March 2019.

Approved therapies and those in development are affected by this action.

 

Challenge

The challenge of Brexit for companies is the uncertainty of the future trading and regulatory relationship with the European Union.  This is compounded by a highly charged political situation within the EU and within the current UK Government.

Secondly, it is widely accepted that the legislative changes and working arrangements between the UK and the EU are going to be difficult to define, let alone the complexity.  

The timing for the UK exit from the EU is now set in stone and the deadline for agreeing on a final deal and trade agreement is as set out above.  Transition periods for the UK exit from the European Union are still subject to discussion and agreement.  But the advice from all quarters is that action is required as soon as possible on the assumption that a ‘hard Brexit’ will occur in March 2019.

We also recognize the pressure this decision has on the regulators to keep the mechanism of medicines regulation moving.  The MHRA in the UK has been a linchpin in the European Union medicines review and approval system.

If clients have significant commercial ties to EU customers, maintaining a direct presence in the European Union may be required.

So this leaves companies in a difficult position in terms of planning and preparation.

 

How can VCLS help you?

Clients will benefit from our unparalleled wealth of expertise across all aspects of product development and commercialization activity. Clients can expect to receive support from our experts in the following areas:

  • Preparing for the future – Scenario planning
  • Risk assessment of existing product development activity
  • Review of regulatory complexity that may impact on launch times
  • Review your development and risk management plans
  • Writing and/or amending your development plan
  • Assessing presence in the EU and impact on supply chain
  • Specific roles that may require relocation (e.g. Qualified Person, or QPPV)
  • UK market access and pricing determinants that may have international knock-on effects

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