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January Brexit Update

17 January 2018

Brexit

AUTHOR: Antony Appleyard



MHRA & HPRA Brexit Updates

The MHRA open the year with a position statement on Brexit and the progression to the second stage of negotiations [1 & 2]. But what is new?

This notification is a statement of intent, but it is difficult to see what couldn’t have been said earlier, unless withheld due to negotiating strategy. The statement does align with messages that have been stated by MHRA in conferences and off line. MHRA reiterate that the UK continues to bid for EMA work and expects those bids to be considered on merit. “On merit” requires that the departure of the UK from the EU must be taken into consideration. So, it seems likely that the UK’s share of workload would be significantly reduced compared to previous experience.

What is welcome in this update is the formal acknowledgement that MHRA will be pragmatic with regards to the evolution of the UK regulatory framework and the implementation of continuity plans, license maintenance and availability of medicines. But the negotiations still have a long way to go and much clarification will be required at the appropriate time.

 

Meanwhile, HPRA released a thorough yet concise guidance document covering a multitude of issues related to Brexit [3]. The document is also a call to action to consider Ireland as reference member state. Useful facts in relation to UK-Ireland specific considerations are provided. This is a welcome update for what is acknowledged to be a significant issue for the continuity of medicines supply in this region due to the existing pooling of license and supply strategies for Ireland and the UK. Understandably, at this stage of negotiation, the guidance is devoid of a creative hybrid solution but consideration for pragmatic approaches and joint labelling with UK and other member states is suggested.

Our message remains consistent, EMA and HMA have been clear about the responsibilities of Market Authorisation Holders (MAH). In the absence of new political agreements, MAHs need to ensure that EU licenses are held in an EU entity and some adjustments to licenses (e.g. RMS) and supply chains will need to be made before 29th March 2019. Regulatory strategy dictates that companies need to review their development pipeline and product portfolio working back from 29th March 2019. Companies must then analyse and assess the risk and identify the bespoke UK and EU needs for their product portfolio. Simultaneously, all agencies need to step up practical measures to support companies to maintain the safe provision of medicines in the EU and the UK.

 

  1. gov.uk/government/news/mhra-update-to-pharmaceutical-companies-on-exit-preparations

  2. gov.uk/government/news/medicines-and-healthcare-products-regulatory-agency-statement-on-the-outcome-of-the-eu-referendum

  3. hpra.ie/docs/default-source/publications-forms/guidance-documents/hpra-brexit-guidance---human-and-veterinary-medicines.pdf?sfvrsn=6
17 January 2018

Brexit

AUTHOR: Antony Appleyard