Brexit: Counterfeit Medicines

Baroness Walmsley Excerpts

Thursday 7th February 2019 Lords Chamber

Asked by

[Baroness Walmsley]

To ask Her Majesty’s Government what plans they have to protect patients from counterfeit medicines after the United Kingdom has left the European Union.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)]

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.

[Baroness Walmsley (LD)]

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?

[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.