My Lords, I thank the Minister for introducing the Bill, all noble Lords for their contributions and all the organisations, including the Library, that have sent us briefings. I particularly thank the Delegated Powers and Regulatory Reform Committee and the Select Committee on the Constitution for their reports, produced in a timely fashion at the beginning of the recess, thus giving us all time to digest and reflect upon the issues concerning powers contained in the Bill.
We on these Benches recognise that this is an important Bill; indeed, the issues that it addresses are vital. I will concentrate on two or three, or maybe four, issues, most of which have been mentioned in the debate.
As the noble Lord, Lord Blencathra, said in his stirring contribution earlier, it seems that most of the Brexit Bills between now and Christmas will contain the same or similar constitutional challenges, so I think that we can anticipate some serious learned and constitutional debates throughout the autumn.
I am not sure whether I want to describe the Bill as a Trojan horse—something that has a seemingly innocent and benign exterior hiding huge and serious dangers within. Perhaps it is yet another example of the Prime Minister’s cavalier disregard for both timeliness and accountability, combined with our own Health Minister’s self-confessed aptitude for hustling, or perhaps it is all those things combined. However, it is worth recalling the words of one of our most distinguished Cross-Bench colleagues, the noble Lord, Lord Wilson, during the passage of the international healthcare arrangements Bill in February and March last year. On
“My assistant secretary was asked why we needed a particular power, and he rather flippantly replied, ‘Because I thought it might be useful’. Parliamentary counsel gave him a withering look and said, ‘I am not going to draft a clause for you simply because it might be useful. You have to know what you want it for’. He did not know, and we did not get that power.”—[Official Report, 19/2/19; col. 2185.]
It feels as if it is the same with this Bill. Powers have been thrown in just in case they might be useful. The Minister called it “agility”. We agree that agility can be useful, but if it is not linked to policy and what you want to do with it, it is a power that can be abused.
Do the Government know what they want, or are they are putting these powers in simply because they might be useful later? I suggest that they do know what they want: they want the power to do exactly as they decide, whenever they decide it, without scrutiny, accountability or due consideration. For our NHS and care services the important matters are whether medicines are available and how much they cost, the future of scientific research, fake medicines, proper safeguards for medical devices and putting patients at the heart of this. They deserve our full scrutiny and the best constructed Bill possible.
As my noble friend Lord Hunt said—this risk was amply illustrated in the stark narrative of the noble Earl, Lord Devon—leaving the EU’s medicines regulatory regime poses a significant risk to the UK. The Bill is crucial for maintaining the attractiveness of the UK’s life sciences sector and ensuring that patients continue to benefit from the excellent clinical research that takes place in the UK. Therefore, it is vital that we fully understand what constitutes “attractiveness” on the global stage.
Will the Minister reflect on the rumour that leaving the EU is likely to see the UK drop down the list of markets that companies will choose to trial and launch medicines in if mitigating steps are not taken? It is crucial that this legislation carefully defines what the Government mean when they talk about the UK’s attractiveness as a place to conduct clinical trials or supply human medicines. Does “attractiveness” equate to the speed of decision-making at every stage of the medicine pathway? How will patient safety be assured? Will the Minister set out what the Government mean when they talk about attractiveness, how they will apply this to medicines access and what he is doing to ensure that patients in the UK can access new therapies on the NHS as soon as countries such as France can?
The British Medical Association asked about the potential divergence in standards and suggested that this must be kept under constant evaluation to ensure that such changes do not negatively impact the timely supply of safe medicines to UK patients, as my noble friend Lord Turnberg said. The new EU regulation on medical devices is an example of a change coming through from the EU that the UK should seek to capture in the future regulatory framework around medical devices, as facilitated by the Bill. Expected to come into force in 2021, the revised rules were drafted in the aftermath of the metal-on-metal hip and PIP implant scandals. They will introduce stricter requirements on the bodies authorising medical devices and ensure greater post-market surveillance. Will UK patients benefit from changes such as these, which were orchestrated at EU level, when we are no longer part of the EU’s processes? How will that happen?
The impact of moving away from the existing collaborative approach between the UK and the EU could be substantial. The centralised processes that we are currently part of reduce the burden on the regulatory authority in each member state, create a larger European market for the pharmaceutical industry and medical device manufacturers, and thereby facilitate timely access to new therapies and technologies to patients across the EU and EEA. As many noble Lords have said, the EMA accounts for 25% of world sales of medicines, second only to the United States. By comparison, the UK accounts for only 3%.
On medical research, negotiating a formal agreement to maintain access to EU funding programmes, ensure alignment with clinical trials regulations and secure the participation of the MHRA in clinical trials that cross the EU and the UK to maximise collaboration between researchers in both is particularly important if UK researchers are to benefit from the EU’s new clinical trials regulation, which is due to be introduced in 2022 and is expected to significantly improve the current research climate via the introduction of a single clinical trial database and a centralised clinical trial portal. I have been talking to your Lordships’ House about this portal ever since the Brexit vote. It looks like we will not be part of it. I would like the Minister’s comments on that and an explanation of the disadvantage that this will bring to UK patients.
As many noble Lords have said, the Bill presents an opportunity to address the issues raised in the excellent report First Do No Harm, launched and led by the noble Baroness, Lady Cumberlege, whose remarks were very moving indeed in addressing the terrible sufferings of women at the hands of the NHS and the regulatory regimes that failed them so comprehensively. Surely we need to take this opportunity to provide for its recommendations. As other noble Lords have said, we need to consider amendments that will fall within the scope of the Bill and cater for the nine recommendations in the report. At the heart of the Bill lies the issue of patient safety in terms of medicine and medical devices, so it must be an appropriate vehicle with which to implement the report’s recommendations. Will the Minister bring forward amendments to remedy these omissions?
It is rumoured that there are mutterings, possibly among officials, about burying the proposed patient safety commissioner. I would really appreciate it if the Minister could take this opportunity to refute such rumours and commit to working with colleagues across the House—I include these Benches—to make sure that the necessary amendments happen.
I briefly turn to other issues. We are very supportive of extending the prescribing rights to additional healthcare professionals, as the noble Lord, Lord Ramsbotham, and my noble friend Lord Bradley outlined. It is time that this issue was resolved. We intend to support or table amendments in Committee requiring proposals and a timetable for additional prescribing rights.
We will seek clarification about Northern Ireland and regulatory divergence. We will probe the changes to the hub-and-spoke proposals. We will look closely at the work of the proposed patient safety commissioner, the medical devices register and, of course, the impacts of the Bill on animal medicine and veterinary regulation.
Although only 46 clauses, the Bill is a veritable cornucopia of medical and other proposals. We hope to work with the Minister, the Bill team and other noble Lords to improve it and make it worthy of the importance attached to it.