My Lords, if we enter an implementation period, the UK will remain part of the EU-wide system, with arrangements beyond that subject to negotiation. In the event that the UK leaves without a deal, we will review options for an alternative to the new EU falsified medicines system. In the meantime, patient safety remains our priority. As the lead enforcement authority, the MHRA will take a pragmatic approach to ensure supply during the initial phase of operation.
I thank the Minister for her reply and welcome her to Oral Questions. Under the falsified medicines directive, UK patients can have the confidence that their medicine is a genuine product and has not been tampered with, but if we have a hard Brexit we will have only seven weeks either to recreate the barcode system at great cost, which is impossible in the time, or agree a fee to remain part of the system. Has the UK had any preliminary negotiations about such an agreement? If so, is there an estimate of what it would cost to be part of the system as a third country? Is this not yet another cost of Brexit that the people were not told about in 2016?
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.
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?
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.
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.
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.
I congratulate my noble friend the Minister. Perhaps I might ask her to stress that the privatisation of our medicines agency, which is the most successful on the globe and which everyone else follows, enables us to sell widely and to contract with other member states in the EU and elsewhere. Our standards are global, and they can now buy in to us. It is a tremendous advance.
My noble friend is absolutely right that the MHRA is globally recognised, and that it has set the standards worldwide. We want to ensure that as we go into EU exit those standards continue, and that our reputation is maintained internationally.
My Lords, can we be assured that, in these and other areas where legislative responsibility is shared between the UK Government and the devolved Governments, that there are appropriate arrangements in place behind the scenes—despite the political disagreements—fully to engage the devolved Governments in discussions on preparations for any scenario over the next few weeks?