Medicines and Medical Devices Bill

Debate between Lord O'Shaughnessy and Lord Sharkey

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[Lord Sharkey (LD) [V]]

My Lords, I welcome the amendments in this group. They add clarity to the obligations laid on the Secretary of State in making regulations under Clause 1(1) and its counterparts.

I particularly welcome Amendment 12 in the names of the noble Baroness, Lady Thornton, and my noble friend Lady Jolly, as it seems particularly important. It requires the Secretary of State to publish the criteria used in determining the benefits and risks caused by regulation and to set out how they have been weighed against each other. This amendment touches on the whole issue of transparency in devising regulations. The level of transparency that Amendment 12 requires should certainly apply to the factors listed in the Minister’s Amendment 9. These factors, which the Secretary of State must have regard to, are the safety of human medicines, the availability of human medicines and the likelihood of the relevant part of the United Kingdom being seen as a favourable place in which to carry out research related to human medicines, conduct clinical trials, or manufacture or supply human medicines. These are all clearly important, and I am glad that the Minister has added manufacturing to this list, as I suggested in Committee.

The list contains three rather vague notions: “likelihood”, “favourable” and “being seen as”. For all these terms, we need to know what definitions will be used and what evidence will be required in support. For “being seen as”, the question arises: being seen as by whom? What weight will be given to different views from different sectors? If, for example, it turns out that academic researchers and pharma companies have different views about the favourability of the UK, how are they to be weighted? On “likelihood”, could the Minister say whether he considered the word “desirability” instead, which seems closer to what we want here?

I hope the Minister is able to give reassurance on the points I have raised and that he accepts the merits of Amendment 12 and its counterparts.

[Lord O'Shaughnessy (Con)]

My Lords, I will make three quick points about the government amendments in this group, which I broadly welcome. The first relates to Amendments 4 and 42, where the Minister has clearly listened carefully to the forceful arguments made by my noble friend Lord Lansley, the noble and learned Lord, Lord Woolf, the noble Baroness, Lady Jolly, and others in Committee. I am delighted that he has.

For those of us who have not been involved in the discussions, and following on from the points that the noble Baroness, Lady Thornton, made about why language from the European regulation has been adopted—“safeguarding public health”—it would be helpful if my noble friend could explain, on the record, why that language has been chosen. That is particularly the case given that he expressed some reluctance in Committee, bearing in mind that the regulations being referred to also had some relevance to operating the internal market, not simply medicines safety. It would be good to hear from him on that.

Secondly, on Amendments 8 and 44, unlike other noble Lords I did not believe that there was a suspect motivation behind the use of the word “attractive” by my noble friend and the Bill team, or any desire to reduce stringency to attract investment. But I would be grateful if my noble friend could confirm that the Government remain as determined as ever, if not more so, to grow the UK’s life sciences sector, and that it was never their intention to lower regulatory standards to achieve this.

Thirdly, on Amendments 9 and 45, I commend my noble friend on the subtle but important changes already referred to by the noble Lord, Lord Sharkey, in Clauses 1(3)(c) and 14(3)(c), especially the inclusion of manufacturing and broader medical research. The salience of these two parts of our overall supply chain has come to the fore during the pandemic, which has demonstrated our strengths in basic science but, unfortunately, exposed our weaknesses in manufacturing resilience. It seems right that this should be explicitly recognised in the Bill and I commend my noble friend for making those important changes and for demonstrating, once again, his ample appetite for listening and acting.

Medicines and Medical Devices Bill

Debate between Lord O'Shaughnessy and Lord Sharkey

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

[Lord O'Shaughnessy (Con)]

My Lords, I point out to noble Lords my interests as set out in the register. On Second Reading, when taking a somewhat unfashionable stance in defence of the delegated powers, I said that I was not going to die on that hill again—but, to mix my metaphors, I have been drawn, like a moth to a flame, back into this argument.

I want to make two brief points. The first has been perfectly well made already by my noble friend Lord Lansley, and is about the sheer impracticality of sunsetting legislation. Committing to an arbitrary deadline of that kind is not something that any Government could responsibly do, particularly at this time, and given the uncertainty that has already been discussed.

The second point is that many of the criticisms raised by the Delegated Powers and Regulatory Reform Committee and by the Constitution Committee have been dealt with, to some extent, by changes that the Minister, my noble friend Lord Bethell, has proposed to the affirmative procedure, which we are not discussing today. It is therefore worth recognising the progress that the Government have already made to try to meet those concerns, which were set out so well by the noble Baroness, Lady Thornton, and others, about the powers being given to the Government.

Again echoing my noble friend Lord Lansley, I would say that if we were to go down that route, the amendments tabled by the noble Lord, Lord Patel, represent the right approach, which is to commit not to a sunset clause, with all the cliff edges that that would involve, but to providing draft consolidated legislation. There is a good case in its own right for doing that, particularly in the circumstances. Like my noble friend Lord Lansley, I encourage my noble friend the Minister to look seriously at that idea.

[Lord Sharkey (LD) [V]]

My Lords, we have Amendment 139 in this group. It would require all the delegated powers in the Bill to expire on the third anniversary of its passing. We chose the three-year time limit because that had been discussed in the Commons. But, having heard what other noble Lords have said on the issue of expiry, I am persuaded that two years may be more appropriate, as the noble Baroness, Lady Thornton, has argued, given the wide-ranging and carte-blanche nature of the delegated powers. I am also persuaded that a sunset provision is absolutely necessary.

As many noble Lords noted on Second Reading, this is a skeleton Bill. It contains no, or very little, policy, and allows policy to be made by secondary legislation. This clearly avoids meaningful parliamentary scrutiny, and is a direct and flagrant abuse of the delegated powers system.

In its 16th report of the 2017-19 Session, The Legislative Process: The Delegation of Powers, our Constitution Committee noted that the Government had designated

“functions for which delegated powers may be appropriate”.

These included

“providing for the technical implementation of a policy; filling in detail that may need to be updated frequently or is otherwise subject to change; and accommodating cases where the detailed policy has to work differently in different circumstances. Such purposes constitute reasonable uses of delegated powers.”

The Constitution Committee’s view of all this was clear. It considered the use of delegated legislation to formulate policy, or to create new criminal offences or public bodies, to be “constitutionally unacceptable.”

The Delegated Powers and Regulatory Reform Committee, in its recent report on the Bill, points out that the Government say nothing about why it would not be appropriate to have aspects of the regulatory regimes which are not detailed or technical on the face of the Bill, combined with more focused delegated powers to fill in the detail. This is still the case.

General Practitioners: Indemnity Scheme

Debate between Lord O'Shaughnessy and Lord Sharkey

Monday 16th July 2018 Lords Chamber

[Lord Sharkey]

To ask Her Majesty’s Government what plans they have to introduce a state-backed indemnity scheme for general practitioners in England.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord O’Shaughnessy) (Con)]

My Lords, in October 2017, the Secretary of State for Health and Social Care announced his intention to develop a state-backed indemnity scheme for general practice in England. The state-backed scheme is being designed to provide more stable, affordable cover for GPs and patients. We are working with stakeholders to design the scheme and are committed to implementing it from April 2019.

[Lord Sharkey (LD)]

Will the proposed scheme cover all GP-related healthcare staff who provide services for the NHS and, if not, who will be excluded? Will the scheme cover historical liabilities, as was the case when the NHS clinical negligence scheme for trusts was introduced? What additional costs will the new scheme generate for the NHS?

[Lord O’Shaughnessy]

The scheme is intended to cover primary medical care services, which will also include integrated urgent care services and NHS primary care provided in secure environments. The scheme will certainly cover future liabilities, and cover for historic liabilities will depend on discussions with stakeholders and achieving value for money. As for the cost, this is a complex negotiation with multiple partners, and we are not in a positon to give costs at this point without prejudicing commercial interests. Suffice it to say, one intention of the scheme is to provide better value for money than those currently in existence.

NHS: Clinical Negligence

Debate between Lord O'Shaughnessy and Lord Sharkey

Wednesday 31st January 2018 Lords Chamber

[Lord Sharkey]

To ask Her Majesty’s Government what progress they have made in reducing (1) the amount set aside in NHS budgets for clinical negligence claims, and (2) the annual level of payment for such claims.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord O'Shaughnessy) (Con)]

My Lords, the Government are committed to tackling clinical negligence costs. To do so, we have proposed to fix the amount that legal firms can recover from clinical negligence claims, proposed a scheme so that families whose babies experience severe, avoidable birth injuries have an alternative to lengthy court proceedings, and brought forward our ambition to halve maternal and neonatal deaths, brain injuries and stillbirths from 2030 to 2025.

[Lord Sharkey (LD)]

I thank the Minister for that Answer. Last year, the NHS paid out £1.7 billion in settlements for negligence claims—a 15% increase on the year before. A substantial part of that enormous amount was intended for the provision of private sector care. That is because Section 2(4) of the Law Reform (Personal Injuries) Act 1948 requires claims to be calculated on the basis of private healthcare, not the NHS. Allowing claims to be made on the basis of costs to the NHS would dramatically reduce costs. Does the Minister agree that repealing Section 2(4) would save the NHS an enormous amount of money?

[Lord O'Shaughnessy]

I recognise the issue the noble Lord has raised; it has been raised by a number of people who are concerned about and interested in this issue, as we all are. The problems are significant. The annual costs of dealing with these injuries and other issues has quadrupled over the last 10 years. That is the scale of what we are dealing with. We have to act—indeed, the National Audit Office has implored us to act. It is one of the issues we are considering as part of a cross-government strategy that will report in September. I am not in a position to give more detail at this stage, but it is an area we are looking at.