My Lords, the Bill is necessitated by Brexit but, as many noble Lords have said, it does not provide the detail required to address the concerns about protecting patient safety, promoting innovation and helping British businesses at such a difficult time.
Soon after the Brexit vote, I attended a meeting convened by the MHRA involving many of the trade associations representing businesses in the healthcare sector. There was a strong feeling that the best way of addressing some of these issues would be for transitional arrangements to continue for quite some time, if not indefinitely. This case has been strengthened by the Covid crisis.
The UK has been a powerful player within the licensing framework for European medicines and medical devices for many years. The crucial role played by our scientists has been greatly appreciated across the EU and has benefited everyone, so the principle of dividing scientific expertise into two camps, one covering the UK and one covering 27 EU member states, is not a good one.
The case for the UK becoming an independent regulator of medicines and medical devices has never really been made convincingly and we have yet to see any real evidence that the risks and difficulties are likely to be outweighed by any benefits. Patients in the UK may find themselves accessing the latest innovations significantly later than patients in the EU. Businesses are told that they may benefit from different licensing arrangements in future, but if they are different, approval may well still be needed for export to the EU or to other countries which have learned to rely on EU standards. Likewise, patients who might benefit from new products licensed by the EU may not be able to get them until the UK has also approved them.
Two sets of licensing processes will mean two sets of applications, two sets of costs and two potential sets of delays, with the consequence that businesses may be less inclined to invest in innovation than they are under present arrangements. In future, we really need closer alignment in regulation between the UK, the EU and other international standards bodies.
The government case is that the UK will now be able to give more of a lead and to deal with approval processes more expeditiously, but the Bill lacks any detail showing how this could be the case. We might hope that in future greater emphasis will be placed on regulating areas of emerging and cutting-edge science where the UK has significant expertise, such as cell and gene therapies. We may aim for the UK to be seen more widely as a destination for the regulation and trialling of innovative and advanced medicines.
We should want the UK to be an attractive place for companies to undertake research and launch new products and therapies, but we have no real evidence yet that the UK will be able to achieve any of these things alone, and everything appears to be left to government Ministers to decide how things will be done at a time when confidence in some Ministers is very low. Greater detail and greater provision for parliamentary scrutiny may provide greater hope of progress on some of the worthy aspirations that have been outlined.