Medicines and Medical Devices Bill

Baroness Bennett of Manor Castle Excerpts

Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020 Grand Committee

[Lord Patel (CB) [V]]

My Lords, I am pleased to speak to government Amendment 131, merely to ask a question. The amendment will require reporting, which is positive and is to be welcomed. However, it leaves the matter of who is to be consulted to the discretion of the Secretary of State, because proposed new subsection (2) refers to

“such persons as the Secretary of State considers appropriate”,

while proposed new subsection (3)(a) requires the Secretary of State to take account of

“concerns raised, or proposals for change”,

but only those made by a person in accordance with subsection (2). Those persons are left to the discretion of the Secretary of State. It is not only the people who are consulted who are chosen; the list is produced by the Secretary of State.

To have any substance to it, the proposed new clause ought not to leave it to the whims of the individual Secretary of State to decide who ought to be consulted. There should be some minimal statutory list, or principles that can guide a list in practice, to give transparency and confidence. My question is quite simple: is it likely that the Government will produce a list of who they will consult?

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, I put my name down to speak on this group primarily to speak to Amendment 106 in the name of the noble Baroness, Lady Thornton, but I will comment briefly on the excellent Amendment 67A from the noble Baroness, Lady Jolly. It seems to address an obvious lacuna in the Bill and I hope that the addition of veterinary devices would be a really simple procedure that the Government could take on board. I also commend Amendment 67B in the name of the noble Baroness, Lady Jolly, and associate myself with the remarks from the noble Lord, Lord Patel, on the concerns about the apparent weakness of government Amendment 131.

I wanted to speak to Amendment 106 because many of us who have been in different roles in politics over many years are used to receiving cries for help from people who feel as if medical systems have made them more ill, treated them badly and failed to live up to the oath of “first do no harm”. It is very hard for a person in your Lordships’ House or in politics to make a judgment call on what can be done and how people can be helped—on how systematic the issue really is and where this should be going. What we really need is a place where records are kept overall; it does not feel as if that is happening at the moment. The amendment lays down a way to address that. Of course, we have not heard yet from the noble Baroness, Lady Thornton, so I am interpreting what her amendment says.

There is also a broader point here, which we need to address throughout the Bill, and which I have been thinking about in the context of Covid-19. We really have a huge problem of trust, given the concern among significant parts of the public about how systems are working and whether decisions are being made in the right interests. One thing we need to do is to make sure that the whole system is transparent and open, and that records are there and accessible. We know of so many cases—the noble Baroness, Lady Cumberlege, set out some—where there tends to be a particular issue with the way that medicine has treated women.

There is also an issue in that the people who come to us and are able to make a fuss are often those who, in one way or another, have some form of social capital in their education, knowledge and ability to reach out and seek help. If we do not have regular systems of keeping records to see problems arising, it may be the most vulnerable who suffer without really knowing how to speak out and initiate action. I commend Amendment 106 to the Committee and look forward to hearing further discussion on it.

[Baroness Wheeler (Lab)]

My Lords, our Amendment 106, which I am speaking to on behalf of my noble friend Lady Thornton, is in this group on reporting requirements under the Bill. Specifically, it would add a new clause providing for an annual report to Parliament on medical devices information systems established by NHS Digital under the powers conferred by Clause 16. I am grateful to the noble Baroness, Lady Bennett, for her support for this amendment.

Clause 16(1) gives the Secretary of State the power by regulations to make provision for NHS Digital to establish and operate

“one or more information systems”

for medical devices. Under the Bill, these relate to the safety, performance and

“clinical effectiveness, of medical devices … placed on the market; … the safety of individuals who receive or are treated with a medical device”,

or who have one implanted in them, and

“the improvement of medical device safety and performance through advances in technology”.

The annual report proposed in our amendment would provide for the operation of these information systems to include information on the overall data in relation to

“the number of patients who receive or are treated with a medical device, or into whom a medical device is implanted; … any safety concerns received; and … any regulatory action taken.”

Finally, the amendment would ensure that the Secretary of State provided a copy of the report from the information centre on these related areas to the devolved Administrations in Scotland, Wales and Northern Ireland.

The Government’s own Amendment 131, providing a new clause after Clause 41 on consultation provisions and requirements, limits itself to the provision of a biennial report to Parliament starting:

“As soon as reasonably practicable after”


the Bill has passed on the operation of regulations laid on human medicines, veterinary devices and medical devices. The amendment is part of the Government’s response to the Delegated Powers and Regulatory Reform Committee. It also provides for regulations to be subject to public consultation before they can be made and requires the Secretary of State to include in the biennial report, as part of a consultation process, a summary of the concerns expressed or proposals put forward and, in consulting, to set out how the key issues of safety, availability and attractiveness have been taken into account.

The Minister’s letter to Peers of 13 October, which, as my noble friend Lady Thornton has already pointed out, we did not receive until after the amendments had been laid, underlines the importance of the Government’s amendments in providing a reporting obligation on the Secretary of State which

“will inform Parliament of the outcome of consultations on regulation made under Clauses 1, 8 and 12 during the two-year period under consideration, and provide a look ahead to expected regulatory change in the future”.

While consultation before the preparation of the report and information on the consultation, concerns and proposals are welcome, we do not accept that Amendment 131 fully meets the concerns of the DPRRC. We consider that an annual report to Parliament is essential, given the vital importance of the scrutiny and accountability that Parliament must be able to exercise.

We also consider that the government amendment should make a specific commitment to consultation with the devolved Administrations in Scotland, Wales and Northern Ireland, and not just to the Secretary of State consulting such persons as he/she considers appropriate. We will take up the key issue of consultation with the devolved Administrations in our later amendment and I look forward to the Minister’s response to the question of the noble Lord, Lord Patel, on these areas.

Finally, I strongly support Amendments 67A and 67B from the noble Baroness, Lady Jolly, which call for reviews to be laid before Parliament of the regulation of veterinary devices and the Bill’s impact on veterinary medicines after the Act is passed. The noble Baroness made a pretty convincing case for these amendments. The delegated powers in Part 2 of the Bill to amend the Veterinary Medicines Regulations 2013 are wide-ranging. Close scrutiny of the impact on animal welfare, human safety and the environment, together with full consultation with key stakeholders and recommendations on the need for further regulation, will be crucial. Similarly, the review of the Act’s impact on veterinary medicines, to be published one year after it is passed; on safety in relation to animals, humans and the environment; on availability in the UK; and on the UK’s participation in the development and supply of veterinary medicines would ensure full scrutiny of how the provisions in Clauses 9 and 10 were working in respect of these key issues.

I have two further points. During the Commons Committee on the Bill, we raised the importance of the availability of veterinary medicine services, as well as medicines across the country, and of ensuring that they are available in rural and urban settings. This would ensure that we do not have a two-tier system whereby there is better access to veterinary medicines and services in certain communities. We also called for a full assessment of the capacity of the veterinary industry to meet the regulatory and other requirements set out in the Bill. These are key issues which the review process set out in the amendments of the noble Baroness, Lady Jolly, would address. Can the Minister tell the Committee what work is being undertaken with veterinary sector stake- holders, including the British Veterinary Association and the Royal College of Veterinary Surgeons, on these issues —particularly to ensure that, post Brexit, we have the sustainable, diverse and modernised UK veterinary infrastructure and skilled workforce that we need to ensure a safe environment for humans and animals?

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[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, it is a great pleasure to follow two such wonderfully informed and informative speeches and I thank the noble Lords for tabling this amendment. So that the Committee can understand my position in this, I will say that I wrote part of a master’s thesis 20 years ago on artificial intelligence. That of course is an age in terms of these things, but I had cause to engage with the issues of medicine and artificial intelligence just last year when I was asked to take part in a debate on the subject. One of the things that I found was that a lot of the language has not changed. Twenty years ago, AI was almost there and now, while we have a great deal of big data, how much closer we are to actual artificial intelligence is another question. The noble Lord, Lord Clement-Jones, referred to what happened this year with the exam results fiasco, which was very much a cautionary tale about the use of this.