Brexit: Counterfeit Medicines

Lord Clark of Windermere Excerpts

Thursday 7th February 2019 Lords Chamber

[Baroness Blackwood of North Oxford]

I thank the noble Baroness for her Question. As stated in the response to the MHRA’s recent no-deal consultation, it is expected that stakeholders would no longer be able to comply with the requirement to verify and authenticate medicines, so legal obligations related to this would be removed. In this scenario, we have committed to evaluate options for a future falsified medicines regulatory framework, taking into account investment made by stakeholders. It is important to note that the majority of the FMD was already implemented in 2013, and also that the MHRA has 30 years of experience as a world-leading regulator of more than 3,500 medicines. We expect that patients will remain safe and that there will be continuity of supply so that we can have confidence in medicines and safety for patients.

[Lord Clark of Windermere (Lab)]

My Lords, I congratulate the noble Baroness on her appointment. As she knows, the European medicines verification system becomes effective this Saturday, I believe. Is she confident that we have sufficient personnel and procedures to implement it immediately? Will she also say whether, if the Commons were to approve the Prime Minister’s preferred agreement, this protection would be included?

[Baroness Blackwood of North Oxford]

I thank the noble Lord for his question. We are committed to meeting the 9 February deadline for the launch of FMD safety measures. We expect all stakeholders in the UK’s supply chain to be aiming to comply with the requirements. We know that much of the supply chain is already prepared, but it is a complex chain, setting up medicine supply across the EU. The main challenges concern error messages; several member states—including Denmark, Portugal, the Netherlands and Ireland—have noted, unrelated to Brexit, that there will be challenges in implementation. The MHRA has notified the supply chain that we will be taking a pragmatic approach to implementation. This is appropriate, to ensure patient safety and a continuation of dispensing.