My Lords, I will speak to Amendment 125 in the name of my noble friend Lady Jolly. Like other amendments, it aims to probe the Government on their plans for future regulatory alignment with the European Union following Brexit. It also seeks to ensure that we seek full membership of any bodies or agencies that help safeguard regulatory alignment and standards in medicines and medical devices.
The EU and UK markets for medicines and medical devices are closely linked. According to the Association of the British Pharmaceutical Industry, at least 45 million packs of medicines are exported monthly from the UK to the EU, and 37 million packs come the other way. The UK also relies heavily on the EU for its supply of medical devices, with more than half of its 5 billion imported medical technology originating in the EU.
The European Medicines Agency provides a centralised approval procedure for licensing to allow pharmaceutical companies to submit a single marketing authorisation which, once granted, is valid across the EU and EEA. Given its role in harmonising the regulation of clinical trials, about which we have heard much during this debate, it is clear that divergence would have a major impact on people in the UK and the EU. With respect
to medicines, should the UK develop a significantly different regulatory process to the EMA for medicines regulation, the increased regulatory burden on pharmaceutical companies could lead them to prioritise the much larger EEA market over the UK’s. This could cause delays in new drugs being made available for patients in the UK and vice versa. What is the Government’s analysis of potential delays? Is it in the order of 12 to 24 months, as some have said?
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Turning to medical devices, establishing a separate system for their accreditation in the UK would be likely to lead to delays in devices developed in other countries reaching the UK market and vice versa. In the case of medical devices, this would be particularly detrimental to the UK as most are imported. The Government have not been clear about their position on the regulatory alignment between the UK and the EU. Given the huge implications for patients in diverging from the EMA, it is vital to get a commitment to ensuring patient safety. I hope that the Minister will give us a clearer indication of which direction the Government aim to go there.
As a number of noble Lords have mentioned, a number of international organisations are key to ensuring harmonisation and regulatory alignment. It is important that we seek full membership of these organisations post Brexit. Have the Government considered that point? The ABPI has recommended that we seek full membership of, for example, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the International Organization for Standardization, although the latter is outside the scope of the Bill. I hope to hear from the Minister in some detail.