Medicines and Medical Devices Bill

Lord Sheikh Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Lord Sheikh (Con) [V]]

My Lords, I support this Bill as it will enable us to put together and implement the various regulations governing human medicines, veterinary medicines and medical devices. We live in a world that is changing and the medical and veterinary sciences are constantly evolving. The Bill will enable us to innovate and ensure that all medicines and medical devices will be safe to be used by the public when needed. The Bill will enable us to amend the regulations periodically and we will be able to act and react swiftly through secondary legislation and be a world leader in the pharmaceutical industry.

In formulating the regulations, we must ensure complete patient safety. In the regulations, we need to ensure that all the important issues are full covered. I note that Parts 1, 2 and 3 of the Bill stipulate that the appropriate authorities must have regard to the safety, availability and conducting of clinical trials of medicines and medical devices. I fully agree with and support Part 4 of the Bill, as it states that the regulations under Parts 1, 2 and 3 will be subject to the draft affirmative process. The proposed legislation would be required to be fully scrutinised and approved by both Houses.

Furthermore, I note that under Clause 41, the relevant authority would be asked to approach such persons as the authority considered appropriate. This consultation will be essential. I note that under Chapter 3, the enforcement authority will issue notices in respect of compliance, suspension, safety and information. The right to issue these notices will be essential to consolidate the enforcement regime.

I noted the remedies under Clause 24, which include criminal convictions. Will the Minister say whether it is in order to do so under this Act? I welcome the proposals in Clause 27 and Schedule 1 to apply civil sanctions rather than impose criminal proceedings in relation to offences connected with medical devices.

I will talk briefly about Clause 5, which refers to fees, offences and powers of inspection. Under Clause 5(1)(b), it is stated that the regulations may create a criminal offence

“for failure to comply with a provision made in the regulations”,

which may be punishable by a prison sentence of no more than two years. Will the Minister tell us whether the creation of the criminal offence is in order under the regulations?

I will now discuss the provisions of Clause 35, which relates to the disclosure and sharing of information. My slight concern is the protection of data, particularly relating to the patient. We must ensure that there is complete protection in regard to this. Will the Minister comment on the issue of protection? Will the recommendations in the Cumberlege report be fully implemented, including the appointment of a patient safety commissioner?

Finally, I have three more questions for my noble friend to address. First, under Part 1 of the Bill, will there be provisions to regulate alternative medicines, as some of these can cause serious problems? Secondly, what measures are being taken to prevent the importation of medicines from countries where human organs have been removed for medical testing? Falun Gong and Muslim Uighurs are subjected to these horrible practices in China. I am also concerned about tackling antimicrobial resistance. Can the Minister assure us that this issue will be looked into as a matter of priority?

Medicines and Medical Devices Bill

Lord Sheikh Excerpts

Committee stage & Committee: 3rd sitting (Hansard) & Committee: 3rd sitting (Hansard): House of Lords
Wednesday 28th October 2020 Grand Committee

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

The noble Baroness, Lady Stroud, who is next on the list, has withdrawn so I call the noble Lord, Lord Sheikh.

[Lord Sheikh (Con) [V]]

My Lords, I fully support Amendment 24. The issue of organ harvesting was raised in the other place and at Second Reading by me and other noble Lords. The ability to use human tissue in medicines and transplants saves many lives and is a great achievement of modern science. However, we need to make sure that the way human tissue is obtained and used is completely ethical. At the moment, we do not have legislation that properly stops organs that have been obtained forcibly or without proper consent from entering the UK. That is completely unacceptable.

We should be greatly concerned about the treatment of Muslim Uighurs and Falun Gong in China. The detention and persecution of these innocent people is a crime against humanity. Millions are suffering in inhumane conditions. They are tortured and a great many have been murdered. Last year, the China Tribunal, chaired by Sir Geoffrey Nice QC, concluded that forced organ harvesting in China had been practised for a substantial time, involving a substantial number of victims. The tribunal also found that Muslim Uighurs were used as an organ bank.

The British Medical Journal found that 99% of studies that looked at organ transplants in China did not report whether the organs used were donated with consent. This is unacceptable and a disturbing violation of human rights. It is also illegal. Furthermore, The Economics of Organ Harvesting in China report found that large profits had been made from organ harvesting.

I appreciate that although the companies, including British ones, may not be directly involved with organ harvesting, they could be part of a wider system that provides devices, drugs, materials and know-how for transplantation. Sir Geoffrey Nice QC also stated that anyone interacting with the People’s Republic of China was interacting with a criminal state. If we do not have proper checks on human tissue entering the UK, we risk being complicit in this crime.

Organ harvesting is not limited to China. There are gangs and traffickers all over the world that exploit vulnerable people to obtain organs without any proper aftercare. This coercion is also illegal and must be stopped. Through this amendment we can prevent this happening and close the gaps in our existing legislation. For instance, the Human Tissue Act 2004 has strict consent and documentation requirements for tissue in the UK, but does not enforce the same standards for imported tissue. Instead, it advises only that the same standards should be applied. Although the human tissue regulations 2007 ensure that there is proper documentation and tracking from donor to recipient, they request details on how consent was obtained and look into whether the donation was voluntary or unpaid or not with consent at all. This means that there is no legislation against importing organs that have been obtained involuntarily and without consent.

We must accept this amendment so we can make better regulations that uphold human rights and values. By including the ability to make provisions about the origin and treatment of human tissue used in developing and manufacturing medicines, this amendment means that we can make regulations if there are any concerns as to whether consent has been given. This amendment would require that informed, unforced and properly documented consent must be given for all tissue entering the United Kingdom. At present we do not have appropriate safeguards against forced organ harvesting or human tissue. Innocent people are tortured and killed while businesses and some Governments have made a profit.

This amendment is an opportunity to take a proper stand against organ harvesting and to have a statutory commitment. Through this amendment we can ensure that all human tissue imports are ethical. During Second Reading, my noble friend Lord Bethell stated that the idea that any British companies profit from these trades is abhorrent. This is an abhorrent practice. We must put a stop to it and therefore we need to pass this amendment. I emphasise that it is our moral duty to do so.

[Baroness Northover (LD) [V]]

I am very pleased to have added my name to Amendment 24. The noble Lord, Lord Hunt of Kings Heath, is to be commended for his determination on this issue. Given his previous service as a Health Minister as well as his career-long engagement at different levels of the NHS, no one can say that he does not have a good grasp of all the implications of his amendments. As he made clear, this amendment gives the power to the Government to take action in this area. It closes a gap between what is expected in terms of the origins and uses of human tissue in the UK and that which may be brought in from overseas.

As we have heard, the Human Bodies exhibitions were able to slip through this gap. It cannot be said that no problem can be envisaged. The noble Lord, Lord Alton, laid out the potentially horrendous origins of those bodies. Like the noble Lord, Lord Hunt, the noble Lord, Lord Alton, has been determined and assiduous in pursuing such cases and he is remarkable in his ability to never pass by on the other side. He made a powerful and passionate contribution here as usual.

Medicines and Medical Devices Bill

Lord Sheikh Excerpts

Committee stage & Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Tuesday 17th November 2020 Grand Committee

[Lord Sheikh (Con) [V]]

My Lords, I commend my noble friend Lady Cumberlege on putting forward this important amendment, which has my full support.

I referred to this issue when I spoke at Second Reading. At the outset, I congratulate my noble friend on her thorough and excellent review, including the bravery of its participants. The Cumberlege review was clear that there is an urgent need for action. I welcome this Bill, which aims to put patient safety first.

We need to listen to the review’s recommendations and create an independent patient safety commissioner through the enactment of this amendment. This commissioner would be a trusted voice for patient safety and would ensure that the Primodos, valproate and mesh scandals, or any other previous scandals, are not repeated. As the Cumberlege review shows, the harm caused should have been avoided—and could have been, if patients’ concerns had been properly listened to and acted on.

Furthermore, Sir Cyril Chantler, one of the review’s panel members, rightly said that if such a commissioner had existed before, there would have been no need for this latest inquiry as the Primodos, valproate and mesh scandals would have been dealt with at an early stage, thus preventing the high number of patient incidents that were allowed to occur. Instead, thousands of patients and their families suffered for many years. Many of them were not listened to even though they were right. If this Bill is to succeed in its goal of promoting patient safety, we must accept this amendment.

Patients should not have to fight to be heard. They should not be made to feel that they are in the wrong. Patients and their families need to be consulted, listened to and given a voice. Through this amendment, the patient safety commissioner would be that voice. As is stated in the amendment, the commissioner would

“promote the views and interests of patients”

and would be able to

“receive direct reports from patients and other members of the public”.

This way, all concerns will be listened to and properly acted on. The amendment also states that the commissioner will be able to produce

“reports regarding patient safety … with respect to the use of medicines and medical devices.”

This information will be essential in making patients aware of any potential risks or harms so that they can make fully informed decisions about their treatment. I am glad to see that the commissioner would be independent so that the public know that any information is accurate and unbiased.

Our healthcare system is one of our greatest assets. I would like to state my gratitude for all the marvellous work that the NHS has done and continues to do. As we have seen during this pandemic, NHS staff have done sterling work and work effectively as a team. Unfortunately, some key workers have paid the ultimate price and we are for ever grateful to them.

The NHS is a very large organisation that does many great things but it cannot do everything right. Sometimes it is better when activities are undertaken by outside bodies that have specific duties and expertise. This is where a patient safety commissioner will play an important role in overseeing the whole system. Furthermore, as in this amendment, an advisory board will support the commissioner in their work, using its wide range of experience.

Our current complaints system is too complex and there have been issues with reports being misplaced and poor co-ordination between the different departments and actors. As the commissioner would be constantly reviewing patient safety and be completely aware of any potential issues, they would be able to keep the Minister and the Cabinet Office informed, for the benefit of patients. The commissioner will be able to join the dots in our big healthcare system so that nobody gets lost, and will provide a more straightforward direction.

I am also supportive of this amendment because it requires the commissioner to publish an annual business plan. As a businessman, I know how important this is in creating a clear strategy to bring together different stakeholders and respond to current issues. This annual plan, alongside establishing and updating the principle of patient safety, will help guide the whole healthcare system. I am also glad to see that subsection (6) of the proposed new clause means that these principles must

“be drafted in consultation with the public.”

This will make them more accurate, and help build public trust.

Unfortunately, the Primodos, valproate and mesh scandals are not the only cases of a lack of patient safety and we must learn from previous historic mistakes. In 1958, Distaval was licensed in the UK. It was sold as a wonder drug for insomnia, coughs, colds and headaches. It also gave many women relief from morning sickness symptoms, but this drug contained thalidomide and had not been tested on pregnant women.

In November 1961, it was withdrawn from sale and, in May 1962, the Government released an official warning against its use by pregnant women. Thalidomide harmed the development of unborn babies, causing serious life-threatening birth defects, and affected 10,000 babies worldwide, and many more are thought to have died before birth. The drug led to the arms or legs of the babies being very short or incompletely formed, as well as causing deformed eyes, ears and hearts. In the UK, more than 400 adults are still living with these consequences.

In 1968, the UK producer Distillers paid 62 families of thalidomide-affected babies compensation amounting to 40% of assessed damages. A similar amount was paid to a further 367 children in 1973. However, it later became clear that these settlements were not large enough to support those affected in their day-to-day lives. Only in the last 10 or 15 years since the scandal have significant settlements been made and provided by Distillers, now part of Diageo, as well as by the UK Government.

Although there have been many improvements in drug testing since the thalidomide scandal, the delays in dealing with potential risks and proper compensation were totally unacceptable. I comment again that, if there had been a patient safety commissioner, the scale of harm would have been limited, action could have been taken more quickly and compensation may have been paid earlier.

It is imperative that we learn from these historic scandals and the more recent scandals related to Primodos, valproate and mesh. Therefore, we must have a patient safety commissioner. We have to support this amendment, and I welcome its objective to lay reports before Parliament and committees. It is important to take quick and appropriate action against any harmful medicines or medical devices before they become a scandal. It also means that the correct bodies and people can be held to account so that the right improvements can be made.

Independent commissioners have been incredibly valuable in certain areas; for example, the Children’s Commissioner, which was established in 2004. Since the start of the pandemic, 14 different reports and policy briefs have been produced by the Children’s Commissioner. They have provided key information on how children are affected, different vulnerabilities and how the Government—

[The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)]

My Lords, excuse me. The Grand Committee will adjourn for five minutes because there is a Division. We will reconvene at 6.16 pm.

--- Later in debate ---

[The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)]

My Lords, the Grand Committee will reconvene again, and I call upon the noble Lord, Lord Sheikh, to finish his contribution.

[Lord Sheikh (Con) [V]]

Thank you. My Lords, I have nearly finished. I conclude by saying that a patient safety commissioner will be a champion to mobilise changes and deliver necessary improvements. This is vital for creating a healthier system that works for everyone because it can listen to everyone. We must ensure that historical or recent scandals are not repeated, and we must therefore accept this amendment.

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

My Lords, I would support an independent patient safety commissioner, as its aim would be to

“promote and improve patient safety with respect to the use of medicines and medical devices,”

which is vital. In the past years there have been some tragic cases: patients have been left in long-term pain after operations with medical mesh; pregnant women have taken medicines that have caused disabilities in their children; and people have died due to the wrong dose of morphine or potassium chloride by the wrong button being pressed on the infusion pump.

I hope that, if established, the patient safety commissioner would be able to help patients from the private health sector as well. There have been some unfortunate incidents in plastic surgery, for example.

I would like to ask a few questions, but I do not know whether it is the noble Baroness, Lady Cumberlege, or the Minister who can answer them. The NHS is so huge and has so many different bodies and groups. Many people get confused about who does what. Would the patient safety commissioner co-operate with the Healthcare Safety Investigation Branch and the Citizens’ Partnership, which will work with HSIB on healthcare safety investigations?

AvMA—Action against Medical Accidents—which works for patient safety and justice, would be happy to work with an independent patient safety commissioner. Would that be helpful? Many all-party groups take evidence from patients and experts on safety issues. Would the safety commissioner be interested in collecting the data and promoting what is appropriate? A great deal of time, energy and experience goes into producing these reports.

There are still cover-ups and fears about reporting safety issues. Patients and their supporters need to feel that their voices are heard and will be acted on independently, and that they will stay safe and not be victimised for reporting patient safety matters. I thank the noble Baroness, Lady Cumberlege, for her report and for bringing this subject up the agenda to where it should stay, with the lead of a patient safety commissioner.