Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

Lord Goddard of Stockport Excerpts

Wednesday 2nd December 2020 Lords Chamber

[Lord Goddard of Stockport (LD) [V]]

I do not intend to take up too much of the time of the House, but I want to make a couple of comments and ask the Minister three questions about the SIs and the context in which they sit. These instruments are technical in nature, but the subject area—the regulation of medicines and medical devices—is a key issue for millions of people across the United Kingdom.

It is clear that in a no-deal EU exit scenario, the UK’s current participation in the European regulatory network for medical devices would end. The MHRA would then take on the responsibility for the UK market currently undertaken through the EU system, to ensure the continued safety of patients. The instruments are designed to enable the regulation of medical products and devices across the UK to be continued beyond the implementation period, so the regulations need maximum scutiny.

The EU and the UK markets for medicines and medical devices are closely linked, and enormous numbers are involved. I doubt whether the general public have any idea of the scale. According to the Association of the British Pharmaceutical Industry, every month at least 45 million packs of medicines are exported from the UK to the EU, and 37 million packs are supplied from the EU to the UK. The UK still also relies heavily on the EU for its supply of medical devices, with more than half its £5 billion budget for imported medical technology being spent on devices originating from the EU.

From January 2021, changes to legislation on these issues will no longer flow through from updates at EU level. I therefore hope that the Government will explain clearly how this vital supply chain will be not only maintained but improved. A number of issues in relation to the Medicines and Medical Devices Bill have raised concerns about the Government’s approach to the future regulation of medicines and medical devices. I will pick out just three for the Minister to consider.

The first issue is patient safety. There is a balance to be struck between innovation and patient safety. The Government need to provide assurances that patient safety will be an overarching consideration in their approach to new devices, some of which have been controversial in the past. The scandal of the women affected by mesh implants is an obvious example of where things have gone wrong.

The second issue is about alignment and collaboration. The EMA centralises the process for licensing and the monitoring of drug safety. Pharmaceutical companies could prioritise the EEA market over the UK market if the processes diverge too far, leading to delays in medication and medical devices being available in the UK.

The third issue—to me, possibly the most important—is patient data. The Government need to provide assurances that patient data will be protected and used appropriately. That should be front and centre of their approach, to give confidence that patient data will be protected and will not be shared with third parties.