I thank the hon. Gentleman for his intervention. We are in completely unusual times: I get to respond to his amendments before he has actually spoken to them himself, but we will crack on.
I recognise that the hon. Gentleman said at the time that he wished to return to these issues during the proceedings and I was expecting him to do so. We agree that patient outcomes and patient safety are matters that we would expect the House to consider very seriously.
Amendments 21, 22 and 23 all seek to establish a hierarchy of considerations applied by the Secretary of State or the appropriate authority when making regulations under the Bill, making safety the primary consideration. It is important to say at the outset that there is a consensus on both sides of the House on patient safety. It matters to us as individuals and as MPs representing our constituents, who rightly wish to know that their safety and their animals’ safety is of uppermost importance when we look to make regulatory change.
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Patient safety is critical, and through the Bill we are trying to do what is important for patients. The Bill includes changes such as adding prescribing professions for veterinary medicines, reflecting the desire to make medicines as accessible as possible while not compromising animal safety or the safety of the person administering the medicine. This could mean allowing a physician to prescribe a medication outside its licensed purpose, because it will give a better clinical outcome for that patient in those circumstances than no drug at all or a drug that will be harmful alongside another medicine that they are already taking. The Bill is about patient safety, but it is also about a combination of factors that deliver on behalf of patients.
Not all regulatory changes are made with the intention of changing the way in which a device or medicine makes its way to the patient, or are about whether the substance or device is safe to a patient. In 2013, changes were made to the Human Medicines Regulations 2012 so that brokers, importers, manufacturers and distributors of active substances could apply to make oral representations to the Medicines and Healthcare Products Regulatory Agency to have certain decisions, such as a decision to vary or suspend their registration, reviewed. That made no palpable difference to the safety of patients, but it did make a regulatory change that could be said to respond to the attractiveness consideration. Regulations are not the only route to protect patients. In addition, the MHRA, the NHS and the Department of Health and Social Care have multiple points at which the safety of medicines and patient safety are addressed and considered.
The NHS also has ways to interact with the regulator, such as the yellow card scheme, to raise patient safety concerns that can result in suspension of the use of medicines and devices. That is an example of our regulatory regimes in action, fulfilling the primary purpose they were created for: protecting patient safety. In addition, NHS Improvement established a patient safety strategy in July 2019, which it will continue to develop in consultation with clinicians and patients. There are also patient safety managers in hospital trusts, as well as leadership within DHSC responsible for ensuring patient safety. Those examples, in addition to the consultation required under the Bill, will feed into the decisions that are made when making regulations under the Bill, ensuring that consideration of any impact on the safety of medicines and medical devices is always well informed.
When it comes to the considerations set out in the Bill to be taken into account before making regulations, it is our view that there need be no hierarchy, because the combination of all three considerations provides the best outcomes for patient safety—the safety of the medicines and devices themselves, the availability of those medicines and devices, and a UK market that will encourage the continual development of innovative, more effective and, importantly, safe medicines and devices. It is not a choice between having safe medicines and a strong and secure supply chain, nor is it a choice between having safe medicines and being an attractive place for the development of new medicines. Those considerations go hand and hand and must continue to do so, so that our regulations continue to ensure that safe and effective medicines reach UK patients and that our vibrant life sciences sector is supported.
I was grateful to the hon. Member for Nottingham North for the points he made in Committee. We agree on the need to send a clear message about the importance of patients. We also agree that patients—be they human or animal—should and must come first in our consideration of regulatory changes that affect them, and that consideration must include the safety of medicines and devices, alongside availability and attractiveness of the UK market, to ensure the best outcomes for patients, which is what we are both working for.
Turning to sunset clause in amendment 20, the hon. Gentleman’s amendment is intended to limit the operation of the Bill to a three-year period after Royal Assent. It is similar to the one tabled in Committee. The practical consequence of a sunset provision is that, at its end, the Government would be compelled to return to Parliament with new legislation. There has been much consideration in this House and elsewhere of the extent of these powers in legislation, particularly legislation designed to ease our way out of the transition period and into the UK’s regulatory autonomy. The hon. Gentleman himself has said that the arrangements in the Bill could be said to reflect current arrangements, and I would argue that the arrangements in the Bill—there must be consultation before regulations may be made and they must be laid in draft before the House and subject to the affirmative procedure—are a significant increase in parliamentary scrutiny of any changes to the current framework.
The hon. Gentleman said in Committee that he wished to see proper consultation across the sector in order to set up a world-class, safe and effective regulatory regime. I would say that that is precisely what we wish to achieve through the Bill as it is drafted. Proper consultation does not mean simply the act of providing evidence to Parliament; rather, it is the ongoing consideration of changes to regulations that affect the sector. That is precisely what clause 40 is intended to produce.
The hon. Gentleman concluded in Committee by making two points, and I hope that I can address them both here. First, he asked whether this provision—the ability to make regulatory change via secondary legislation —would mean a diminution in protection. I would say absolutely not. This is not about reducing UK standards; it is about ensuring we can modify and adapt our regulatory regime so that we can take account of new technologies and ensure effective regulation that keeps pace with innovation. We have approached the drafting of the Bill with the intent of creating legislation that will stand for some time, and that is why we have focused on which regulations may be made to amend or supplement existing legislation. It is also why we have sought to consolidate the enforcement regime so that it is transparent and clear to companies and the MHRA how we ensure operation within the law.
The hon. Gentleman also asked whether the Government could accept that the liberty to make bold changes by the using delegated powers in the Bill should not give the Government the chance to make any changes they wanted. It is right that we take a sensible and proportionate approach to regulatory change. Small changes, such as adding Braille to packaging, are common sense, but I agree that changes such as how we approach community pharmacy and novel technologies are something else. I can assure him that we have no intention of making bold changes to regulations without full consultation
and bringing the issue back to the House with the expectation that we will be expected to justify those changes.
The amendment would mean returning to primary legislation within three years. In practical terms, that would be likely to mean within two years, given the need to have sufficient parliamentary time for the passage of the Bill. There are two months after Royal Assent before we can make the regulations, other than in emergencies, and those regulations are subject to a statutory consultation and then the affirmative procedure, which all takes time. This would mean that we would have 18 months, at most, of practical operation of the legislation before we had to go back to its principles. We would not know, for example, whether the civil sanctions regime had had the desired material effect, as it would simply not have had enough time to run. We would cease being able to disclose pertinent safety information from the MHRA to the NHS, and it would be unclear whether the registers facilitated by clause 13—or, indeed, the medical device information system introduced by the new clauses—would be able to continue to operate, or whether we were starting from scratch. Some regulatory changes take years to put into effect. Manufacturers, companies, hospitals and so on must expend financially on preparing for them, putting them into effect and sustaining them. We would like, as much as possible, to be certain that any regulatory change we have introduced in the UK is sustainable and ongoing. It is key that we get this right.
The Bill’s drafting, and our approach to making transparent the kinds of changes one might expect from the delegated powers, have been carefully thought out. Our approach has been consistent with the recommendations of the Delegated Powers and Regulatory Reform Committee in relation to the Fisheries Bill in the last parliamentary Session, 2017 to 2019. We have, in fact, gone beyond the work of that Bill and produced six illustrative draft statutory instruments. We have recognised the need for Parliament to have a greater role and, other than in specific circumstances, the affirmative procedure applies and is supported by a mandatory obligation to consult.
This is not a stopgap Bill to get us through the transition period. It is a proportionate approach to regulating an industry that moves quickly, with regulators who wish to take effective action and who are renowned for working with the industry in the best interests of patients, such as during covid. We can get this right now, and not suggest to industry, the regulators or patients that this is not the right answer for the future of regulation such that Parliament would need to revisit it swiftly by applying a sunset clause.
I turn to amendment 19, which was tabled by the hon. Member for St Helens South and Whiston. I recognise the great passion with which she spoke about this amendment in Committee. In particular, she raised the issue of human organs used in the development of medicines and medical devices where consent has not been obtained, and the matter was raised specifically in relation to China. I thank her for the additional context that she has shared on the amendment both in Committee and through subsequent correspondence. However, these issues are not best addressed through primary legislation dealing with the regulatory framework for human medicines in the UK. I have written to the Minister for Asia
regarding the issue and asked him to hold a meeting to discuss the matter further, and I believe that the relevant offices are in communication.
Comprehensive legislation that governs human organs and tissues for transplantation or the manufacture of medicinal products currently exists in the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the Human Tissue Act 2004. The safeguards provided by this legislation ensure the appropriate quality, safety and origin of human tissues by setting out requirements around the donation, procurement, testing, processing, storage and distribution of organs, tissues and cells intended for human application. The requirements apply to any products that are administered to humans and, crucially, include requirements around consent and the traceability of human tissues and organs. Amendment 19 would not provide for future amendments to be made to the legislation governing human tissues.
Although I am entirely sympathetic to the concerns of the hon. Member for St Helens South and Whiston, I reassure Members that the current legislation provides extensive safeguards to ensure the ethical and appropriate use of human tissues in medicines and medicinal products. Equally, although I am sympathetic to the hon. Member’s intentions, I do not believe that the amendment would have the intended effect. I look forward to hearing further contributions from hon. Members.