Brexit: Counterfeit Medicines

Lord Patel Excerpts

Thursday 7th February 2019 Lords Chamber

[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.

[Lord Patel (CB)]

My Lords, does the Minister agree that, with the implementation of the falsification of medicines regulation, which also goes with the European register for the verification of medicines, it would be rather unusual if the UK—even in a no-deal Brexit—did not have access to the European medicines register? That would mean it would not be possible for the decommissioning of any medicine to go on the register; any medicine that is dispensed in this country has to be decommissioned. I hope the Minister agrees that the MHRA will have to work with the European Medicines Agency to achieve this.

[Baroness Blackwood of North Oxford]

I thank the noble Lord, Lord Patel, for his question; obviously he has great expertise in this area. The Government have been clear that life sciences is a key sector for the United Kingdom, and have stated in the political declaration that we want to have close alignment with the European Union, and to continue close collaboration between the EMA and the MHRA going forward. This will be subject to negotiation, depending on the outcome of the exit. However, the MHRA is a world-leading organisation. We can be proud of its expertise in licensing, devices, inspections, batch release and pharmacovigilance. It is globally recognised and respected, and we want to ensure that shared experiences continue, for the benefit of both UK and EU patients.