Medicines and Medical Devices Bill

Debate between Baroness Masham of Ilton and Lord Kakkar

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

[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.

Medical Innovation Bill [HL]

Debate between Baroness Masham of Ilton and Lord Kakkar

Friday 23rd January 2015 Lords Chamber

[Baroness Masham of Ilton (CB)]

My Lords, having tabled an amendment to the Bill on patient safety, I am happy to support the amendment.

[Lord Kakkar (CB)]

My Lords, I declare my interest as professor of surgery at University College London and as a member of the General Medical Council, although I do not speak for the council in this Chamber.

I thank the noble Lords, Lord Winston and Lord Saatchi, for having tabled this important amendment. It goes to the heart of good medical practice, of course, always to innovate—but always to innovate, first and foremost, with absolute regard to patient safety. The fact that the amendment will now appear in the Bill will provide absolute clarity on what is required to discharge that patient safety responsibility with regard to innovation, as described in the Bill, which is vitally important. I strongly support the amendment. Once again I thank the noble Lord, Lord Winston, for his contributions in the passage of the Bill and, in particular, for tabling this important amendment.

--- Later in debate ---

[Baroness Masham of Ilton (CB)]

My Lords, I am very pleased to support this amendment, to which I have added my name. Within the rare disease community, there is significant unmet medical need, and research and innovation are seen as the means through which new therapies for currently untreatable conditions will be developed. For this to make a difference to patients, the barriers to medical research and the adaption and integration of research and innovation into the NHS need to be addressed. Therefore, it is vital to ensure that registries are created to enable the collection and exploitation of real-world patient data and to promote the sharing of research findings and best practice.

The Royal College of Pathologists says that, unfortunately, this Bill, allowing the results of new tests and treatments to go unrecorded, will hinder its work and medical science more widely. Without the mandatory recording of results of such treatments, unexpected adverse outcomes and irresponsible activity will be harder to detect and prevent.

All results of innovative treatments should be centrally recorded, reported and publicly accessible. This must include both positive and negative outcomes and feedback from patients. Without the mandatory recording of results, the public benefits of medical innovation will not be achieved and the advantages to future patients will be lost.

I am pleased that the noble Lord, Lord Saatchi, is supporting this amendment. I hope that the Government will, too. I would like to ask whether patients from both the NHS and the private sector are covered by the Bill. In my view, all patients who wish it should be able to benefit from innovation as long as it is fully explained to them and is felt to be as safe as possible.

There are many splendid trusts which support medical research. I hope that if this Bill becomes an Act they may find it possible to help fund the register.

[Lord Kakkar]

My Lords, I remind noble Lords of my interests, stated earlier, as professor of surgery at University College and as a member of the GMC, but I do not speak for the council in this Chamber.

I thank the noble Lord, Lord Hunt of Kings Heath, for once again bringing this issue to your Lordships’ House. It is critically important, and probably one of its most vital elements is that there is the opportunity for registration of innovative interventions and therapies.

Clearly, providing transparency and the opportunity for sharing the outcomes of such innovations rapidly and broadly across clinical communities in this country and internationally is of so much importance. It will allow colleagues to understand what has been achieved and not achieved; it will allow those with other ideas to build on knowledge gained from experience to date; and it will ensure that through transparency we have the best opportunity to ensure the greatest patient protection. I am very grateful to the noble Lord, Lord Saatchi, for having considered this issue carefully and having come to the place where he has put his name to the amendment and supports it. I hope that Her Majesty’s Government will be able to consider this issue. The measure enjoys substantial support and will be a vital contribution to this long journey with regard to innovation, ensuring that we can do the best for patients as rapidly as possible without undermining the very best practice and the ability to share knowledge, and ultimately ensuring that this Bill enhances patient safety.