Medicines and Medical Devices Bill

Baroness Masham of Ilton Excerpts

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

[Lord McColl of Dulwich (Con) [V]]

I fully support the amendments in the name of my noble friend Lady Cumberlege, and pay tribute to her for all the hard work that she put in—and for her coping with such harrowing experiences.

I hope very much that the Bill will prevent any such disaster as the use of mesh in operations in the pelvis. If experts had been consulted, they would almost certainly have warned that putting rigid materials under tension in such a position would run a very serious risk of acting just like a cheese cutter.

I emphasise what my noble friend said about safety, which is of overriding importance. I feel certain that, as many speakers have already said, it must become an essential part of the Bill.

[Baroness Masham of Ilton (CB) [V]]

My Lords, I wholeheartedly support Amendment 74 and similar amendments in this group. Nothing is more important than safety in all medicines and medical devices. First Do No Harm, the excellent report by the noble Baroness, Lady Cumberlege, highlights that patients should be listened to. They are the people taking medicines and using medical devices. In the last few months, coronavirus has cast a shadow over other needs, but safety is paramount for everyone. Masks and all PPE are in demand worldwide. Has the UK got an ongoing adequate supply?

The correct dressings for patients with wounds is an important safety issue. There is a lack of tissue viability nurses to give expert advice in rural areas. If NHS trusts and CCGs had joint working in local areas, this would increase capacity and save resources. If the correct treatment is not given, there can be long-term problems.

Patient safety will be improved if patient experience is listened to. Patient groups, academic researchers and medical research charities should work together to find the best solutions. Some of the technologies for blind people and people with speech problems are amazing. It is essential for the safety of patients that all staff and patients using medical devices should be trained in their use. A medical device turned off when it should be on can cause a disaster; the wrong substance in a drip can be fatal; and not listening to patients or their families about allergic reactions to medication, with doctors ignoring this information and prescribing the wrong medicine, can be a serious safety issue.

I hope that the Minister agrees that safety in everything should be paramount and should be the overriding consideration of this Bill. I hope that the Minister will do his very best to help with this matter.

[Lord Kakkar (CB) [V]]

My Lords, I would like to support Amendments 10, 12, 74 and 75, in the name of the noble Baroness, Lady Cumberlege, and in so doing recognise the very powerful and thoughtful interventions by many noble Lords on this group.

It is clear that there is really no dispute in recognising that safety, availability and attractiveness are all important elements in securing, promoting and safeguarding public health. The question simply is whether safety should be given priority. The report of the noble Baroness, Lady Cumberlege, is clear in having identified, in a number of specific instances, why the system failed because safety was not at the forefront of the obligation and, in particular, the regulatory obligation.

The question is how best to ensure safety going forwards when as a country we have the opportunity to establish a new regulatory environment for medicines, medical devices and veterinary medical products. The four amendments in the name of the noble Baroness, Lady Cumberlege, and other noble Lords provide the opportunity to explore the Government’s thinking in this regard.

Why would Her Majesty’s Government not prioritise safety over the other two important objectives? The noble Lord, Lord O’Shaughnessy, in his thoughtful intervention, has suggested that there may be potential for patients to be denied experimental or targeted interventions as the result of inadvertent limitation by way of the regulatory regimen. At present, of course, we have the capacity to intervene with such medicinal products to ensure that, where it is appropriate, sensible and in the interests of the individual patient, interventions can be provided with less extensive clinical evaluation. However, as a general rule, for the entirety of the population where there is broad and relatively unfettered prescription, surely it is right that fellow citizens should expect that interventions—medicinal or medical devices—that are available to their clinicians for a prescription in their individual cases are, first and foremost, safe.

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[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

That was commendably brief. I call the next speaker.

[Baroness Masham of Ilton (CB) [V]]

My Lords, in supporting Amendment 61 and the others in this group, I declare an interest as I have a farm and I often use vets, who supply veterinary products and medicines. I must say that vets have been exceedingly careful and all precautions have been taken that have been put in place for protection over Covid-19. The Veterinary Medicines Directorate protects animal and public health and the environment. This needs our support, which this amendment provides, as it ensures that safety remains a priority.

In recent years, over half the veterinary surgeons who register in the UK each year have qualified elsewhere in the EU and the EEA—38.5% from the UK, 52% from the EU and EEA, and 9.5% from other countries. Free movement of people has had an enormous impact on our veterinary workforce. Additional barriers to the movement of EEA-qualified vets to the UK will have significant consequences for animal health and welfare, public health and trade. If understaffing happens, it will become a safety issue. Some 95% of the veterinary workforce in abattoirs graduated overseas, mainly from the EU. This information comes from the British Veterinary Association. Does Regulation (EU) 2019/6 on veterinary medicinal products aim to make more medicines available in the EU to treat and prevent diseases in animals through simplifying our procedures for obtaining a marketing authorisation and reviewing incentives for breakthrough medicines? The Bill provides the means to make “corresponding or similar provision” to both regulations. Will the Minister give an assurance that that will happen? It is a safety issue and very important.

To make the UK an attractive place to do research and development, the much-needed bright people coming from abroad should feel wanted and safe. It is time that the UK realises that we cannot achieve the high standards that we want without help from others in veterinary science. We should be welcoming and kind to each other. I hope that the Minister will help to prioritise safety in this important Bill. I send my best wishes to the noble Baroness, Lady Jolly, and hope that she gets better soon.

[Lord O'Shaughnessy (Con) [V]]

My Lords, I echo the point made by the noble Baroness, Lady Masham, about the noble Baroness, Lady Jolly. I am sure that we all send her our very best wishes.

I speak on the amendments tabled by my noble friend the Minister. However, on a quick clarification on something that the noble Baroness, Lady Thornton, said in the last debate, which is germane to this debate, I was not making the point that I believe that there can be trade-offs between safety and attractiveness as the Bill currently defines it. Rather it was around the effectiveness and efficacy of medicines and medical devices—points that were, thankfully, made much more clearly by my noble friend Lord Lansley than they were by me—and the impact on what that means for safety and its overridingness as a priority, even if it is always our most important consideration.

On the substance of the amendments, I am sure that my noble friend was not expecting complete consensus around his amendments and he certainly has not found it yet. However, I applaud him for his clarifications on the impact of the attractiveness subsection and also applaud him for moving so quickly in response to noble Lords’ concerns. None the less, there is an issue around this, which the noble Lord, Lord Hunt, brought out. It is an unfortunate truth that the NHS has a poor history of performance in scaling up innovative medicines and devices. I know that that is something that my noble friend is very concerned about.

I have a specific question in this area. In asking it, I draw attention to my entry in the register of interests, in particular as an adviser to Healthy.io. Do my noble friend’s plans for improving the attractiveness of the UK include improving the attractiveness of the UK as a place to develop, trial and scale data-driven health technologies? I know that we will come to that topic later, when the noble Lord, Lord Freyberg, has his amendments, but can my noble friend confirm that they are included in the definition of devices and explain his intentions in this regard?