Medicines and Medical Devices Bill

Baroness Masham of Ilton Excerpts

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

[Baroness Walmsley (LD) [V]]

My Lords, Amendment 3 makes clear the desirability of alignment with the EMA and the EU clinical trials regulations. It sets out early in the Bill the store for those of us who feel that the advantages we have gained from such alignment must not be sacrificed on the altar of some mistaken ideology of this failed Government. I point out to the noble Lord, Lord O’Shaughnessy, that we managed to introduce the HPV vaccine before we left the European Union.

Amendment 22 attempts to define the rather vague expression “attractiveness”. We have other definitions in later clauses; we certainly need to choose one of them but I will leave my preference for a later debate.

I support Amendments 34 to 39 to Clause 4 on clinical trials. As my noble friend Lord Sharkey pointed out, they tighten up the wording in the Bill to emphasise the benefits and avoid the damage of diversion from EU clinical trials regulations. British patients benefit from alignment, British bioscience research and development benefits, and the whole system is worth millions of pounds to the Exchequer. I and other noble Lords have received briefings from a number of organisations working on behalf of patients, such as the British Heart Foundation, emphasising that any diversion from these regulations will affect the rapid availability of new medicines and treatments to British patients. They are also concerned to protect the large amount of EU research funding that they currently receive. Diversion could also affect, to use the Government’s favourite word, the attractiveness of the UK as a place to conduct clinical trials. The problem is that the Government have not told us what they might want to change unilaterally in future, as a number of noble Lords have pointed out. I invite the Minister to tell us now.

Amendment 39 asks the Government to establish a clinical trials portal that aligns us with the EMA regulations for medicines for rare diseases. This is particularly important if we are independent from the EU as our population of 68 million is so much smaller than the EU population of more than 400 million, which would make it harder to find a big enough cohort of people with rare diseases for a clinical trial. The noble Lord, Lord Patel, pointed that out.

The EU clinical trials portal, which will come into play with the new and improved EU clinical trials regulations in 2022, was to a great extent designed by British participants. This shows how important it is considered to be by British scientists because it makes applications for clinical trials so much easier and less time-consuming. In its previous inquiry, the Science and Technology Committee heard from a number of witnesses about the issues with the current system, which wastes a lot of their time. So, like the noble Lord, Lord Lansley, I feel sad to know that we will be out of the system by the time the improvements are put in place.

Our current alignment also encourages British scientists to go abroad to broaden their expertise and EU scientists to come here and become part of our very successful research teams. I know the Government are in favour of that because I heard Amanda Solloway, the Science Minister in BEIS, say so last week to your Lordships’ Science and Technology Select Committee. I hope, therefore, the Minister will be minded to accept the amendment.

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

My Lords, I support this group of amendments, especially Amendment 22, but I first congratulate the Minister on his stamina and enthusiasm at this incredibly difficult time. I hope he will be able to answer some of our questions.

I spoke at Second Reading of the need to provide an attractive life science environment for researchers coming from abroad. If we are to recruit the brightest and the best to work in research and clinical trials with the highest standards, we must improve. How will this be achieved? Should they not feel welcome and needed?

Can the Minister assure your Lordships that there will be no barriers to access to medicines for UK citizens?

How can we still have a regulatory leadership role following the UK’s exit from the European Union and the European Medicines Agency? We must not become isolated. I hope we will still collaborate with the EMA and other international regulators. We desperately need new medicines for the very rare diseases. There is nothing more frustrating than other countries having medicines which are denied to people living in England.

I hope the Government will accept the need to incorporate these points, which have been expressed today, to make the Bill clearer and more positive and will put their own amendments down on Report to further improve it.

[Baroness Sheehan (LD) [V]]

My Lords, I will speak to Amendment 125 in the name of my noble friend Lady Jolly. Like other amendments, it aims to probe the Government on their plans for future regulatory alignment with the European Union following Brexit. It also seeks to ensure that we seek full membership of any bodies or agencies that help safeguard regulatory alignment and standards in medicines and medical devices.

The EU and UK markets for medicines and medical devices are closely linked. According to the Association of the British Pharmaceutical Industry, at least 45 million packs of medicines are exported monthly from the UK to the EU, and 37 million packs come the other way. The UK also relies heavily on the EU for its supply of medical devices, with more than half of its 5 billion imported medical technology originating in the EU.

The European Medicines Agency provides a centralised approval procedure for licensing to allow pharmaceutical companies to submit a single marketing authorisation which, once granted, is valid across the EU and EEA. Given its role in harmonising the regulation of clinical trials, about which we have heard much during this debate, it is clear that divergence would have a major impact on people in the UK and the EU. With respect to medicines, should the UK develop a significantly different regulatory process to the EMA for medicines regulation, the increased regulatory burden on pharmaceutical companies could lead them to prioritise the much larger EEA market over the UK’s. This could cause delays in new drugs being made available for patients in the UK and vice versa. What is the Government’s analysis of potential delays? Is it in the order of 12 to 24 months, as some have said?

Covid-19: NHS Long-term Plan

Baroness Masham of Ilton Excerpts

Tuesday 15th September 2020 Lords Chamber

[Lord Bethell (Con)]

We are enormously proud of the commitment to early intervention on cancer. This is the absolute core of our life science priorities. It is envisaged that we will have a revolution in the diagnostic capabilities of the NHS in order to hit these targets and, where necessary, face-to-face GP appointments will be made available. However, I am not sure that every single appointment needs to be face to face. One of the learnings of more than half of the 100 million consultations that took place between March and June was that telephone and video appointments can be extremely productive.

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

My Lords, is the Minister aware that late diagnosis causes many disasters in many health specialties? Does he agree that the respiratory programme is vital and has been highlighted by Covid-19? Should we not be training and employing more doctors, nurses and physiotherapists as respiratory specialists across the country in the long-term NHS plan?

[Lord Bethell (Con)]

I completely agree. It is a grave shame that too many diagnoses happen late. We are proud of our acute care, but it is this Government’s mission to move to a priority around early intervention which will have a huge impact on the quality and length of people’s lives and make modern healthcare more affordable. The noble Baroness is entirely right that respiratory interventions are an important priority.

Covid-19 Update

Baroness Masham of Ilton Excerpts

Thursday 10th September 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, I entirely welcome the challenge from my noble friend but, respectfully, I completely disagree with his approach. I want to flag two issues. The first is the enormous public support for the Government’s response to Covid and their adherence to the measures we have introduced. The second is the recent King’s College survey, published today, showing that on top of the deaths, 300,000 people in the UK have reported symptoms that last more than a month and 60,000 have been ill for more than three months. The effects of this disease go far beyond the “simply recover the next day” effects of flu; it is a profound illness that we are right to try to suppress.

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

My Lords, how is new technology being brought to the front line to deliver critical care and services across the country? Is the Minister aware of the desperate shortage of doctors and nurses working on the front line of infections, and that they are exhausted? What can be done to solve this problem?

[Lord Bethell (Con)]

The noble Baroness absolutely speaks my language when she talks about the technology that is being brought into the front line. My sincere hope is that Covid will bring a benefit to the healthcare system by being an inflection point whereby we introduce new technologies in a whole host of fields to bring in much greater community-based treatment for people, digital technology and the more effective sharing of data, among a wide range of technical advances. Regarding the workforce, I completely sympathise with the noble Baroness’s comments. I pay tribute to those who work hard on the front line and am aware of the challenges and difficulties they face. This Government have committed to recruiting 50,000 more nurses. We are more than half way there already, and we will continue to recruit to ensure that we have the human resources needed to meet our commitments.

Medicines and Medical Devices Bill

Baroness Masham of Ilton Excerpts

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

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

My Lords, I have a personal interest in this most important Bill, as medicines have saved my life on several occasions, and I use several medical devices. But most important to me is the safety of our country in this difficult time of coronavirus and leaving the EU.

The Secretary of State has an immense responsibility in providing safe functions relating to medicines for humans and animals and to medical devices. Leaving the EU means that we will not have the advantage of voting at the European Medicines Agency, where we were among the leaders, and it puts extra stresses and strains on our MHRA. The MHRA works so well with the European Medicines Agency, which has now moved from London to Amsterdam. I ask the Minister: will the MHRA be given more support and funds to carry out its extra and vital work? What will happen with clinical trials in the UK, which are based on the EU clinical trials directive and operate through the MHRA? It is not expected to apply in the EU until after the end of the transition period. This means it will not be part of the EU law, so what will the UK do about this important matter? My noble friend Lord Kakkar also stressed this.

Thousands of clinical trials seeking new treatments for diseases, including cancer, heart disease and many rare conditions, have been suspended or abandoned in the wake of the Covid-19 pandemic. Charities that raise money to provide funds have lost millions of pounds in revenue that would go a long way to helping to research new medicines and therapies that are desperately needed. Coronavirus has cast a shadow across the world. We should work together to fight this disease. But the emphasis on the attractiveness of the UK to conduct clinical trials or develop medical devices must not be put before patient and user safety.

The Bill covers so many aspects of safety. I have been involved with the disaster of sodium valproate, the drug given to pregnant women with epilepsy; their children were born with autism. I hope that the recommendations of the Cumberlege report will be accepted, especially the creation of the post of patient commissioner. I am pleased that the Bill addresses the dangers of falsified medicines. However, the Company Chemists’ Association would like to avoid the unintended consequences of data being used for purposes other than to ensure that medicines are safe. It is asking for “any purpose” to be amended to “in agreed framework”.

Everyone to whom I have spoken agrees that we should maintain the highest possible standards of patient and animal safety. I hope that we can work globally and not become isolated.

Covid-19: Social Care Services

Baroness Masham of Ilton Excerpts

Thursday 23rd April 2020 Lords Chamber

[Baroness Masham of Ilton (CB)]

My Lords, I thank the noble Baroness, Lady Wheeler, for securing this debate. That so many people are speaking shows how important this extraordinary virus is.

I have had many disabled people contact me. One was the wife of a man who has multiple neurological problems. His conditions, because he has several, were not on the high-risk list. He was told that he should work, even though he is vulnerable. Her Royal Highness the Princess Royal is patron of the Spinal Injuries Association and I am its president. Princess Anne has written a personal encouraging letter. I shall quote one sentence: “I want to let you know that you are not forgotten.”

We do not understand why people with spinal injuries, who can be very vulnerable, are no longer on the most vulnerable list. One tetraplegic died because he was denied ventilation. Many disabled people live in their own homes and have live-in carers. With Brexit and then coronavirus, it has become very difficult to get helpers. Will the Government recognise this predicament and relax immigration rules for people coming from Europe, as they make very good carers? This is not only for people living in their own homes, it is for hospitals and care homes. We really are at risk.

Wuhan Coronavirus

Baroness Masham of Ilton Excerpts

Tuesday 11th February 2020 Lords Chamber

[Baroness Blackwood of North Oxford]

I believe there are some legal specialists in the Chamber. I note the noble and learned Lord, Lord Judge, sitting at the front on his Bench, who may be able to answer more effectively than I can. However, I believe that the regulations as they have been drawn up are legally appropriate and proportionate. As I have said, they apply only to coronavirus, are in force for only two years and are triggered only by a serious and imminent threat to public health and where a person has not complied, or will not comply, with public health advice and is therefore putting themselves and others at risk. This is well in line with other legal measures.

[Baroness Masham of Ilton (CB)]

My Lords, will the Minister give more information on people, including parliamentarians, attending conferences and functions in various parts of the world? Is there a risk of picking up coronavirus at airports and on long-haul flights? Many of your Lordships attend conferences and one noble Lord has asked me to relay this question.

NHS: Targets

Baroness Masham of Ilton Excerpts

Thursday 6th February 2020 Lords Chamber

[Baroness Masham of Ilton (CB)]

My Lords, I thank the noble Lord, Lord Hunt, for this debate, which is of the utmost importance. There is nothing more important than the safety of patients. It is thanks to the press and relatives that some of the neglect and horrifying bullying of patients in some hospitals has been highlighted over the years. I hope that the Government agree with me that we need a transparent and open way of reporting concerns. Members of staff, friends and relatives should not be punished and penalised for doing this; perhaps we need another word to replace “whistleblowing”.

It is of great concern that some ambulances have not been able to meet their targets. It is not acceptable that patients have to wait for hours on trollies in corridors. This illustrates the pressure on beds and staff. Recently, a member of my household was admitted to Harrogate District Hospital. One night, a nurse came to him in tears, saying she had 12 patients to look after. She could not give them enough of the care they needed. Well-trained nurses should be a priority if patient safety is to be safeguarded. In Birmingham, some cancer patients having treatment, such as radiotherapy, for their conditions, and who have to travel many miles, can stay free and look after themselves in a hostel—part of the hospital—during the week while having treatment. This alleviates them of the stress and exhaustion of travelling. I hope that this excellent plan can be extended across the country.

I belong to several all-party parliamentary health groups. When taking evidence, there is one overriding similarity: late diagnosis. Many people are told to go home and take paracetamol. This can happen several times. In the end, it can turn out that they have a serious long-term condition. What can the Government do to improve this dangerous problem?

I am president of the Spinal Injuries Association. Many of our members who are patients of the spinal unit at Stoke Mandeville Hospital cannot get appointments or new patients cannot be admitted because non-spinal patients are being placed in the allocated spinal beds. This illustrates the pressure on beds in a busy hospital. It also means that patients with life-threatening injuries, resulting in paralysis, are treated in intensive care beds without specially trained spinal nurses in general hospitals—blocking these beds while waiting for a transfer to a spinal unit.

I end by paying tribute to Brian Gardner, who was a spinal injuries surgeon at Stoke Mandeville. He was an outstanding doctor and always had time for patients and advised GPs on their needs. He died of cancer a few weeks ago. We need more doctors like Brian. He was one of the SIA’s advisers and is missed by very many people. He was an excellent communicator. Better communication throughout the NHS is what is needed. If public health, NHS England, social services and voluntary bodies do not work in co-operation, patients will not be safe. I add my congratulations to the maiden speaker for her passionate speech.

Major Trauma Centre: Westminster

Baroness Masham of Ilton Excerpts

Thursday 30th January 2020 Lords Chamber

Asked by

[Baroness Masham of Ilton]

To ask Her Majesty’s Government whether they have any plans to establish a major trauma centre in the immediate vicinity of Westminster to treat casualties in the event of any terrorist attack in the area.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)]

My Lords, the NHS has well-tested plans and capability for responding to a terrorist attack and treating casualties. The attacks in London and Manchester in 2017 tested our capability. London has four major trauma centres where casualties will be triaged and treated, and this will include casualties from an attack in the vicinity of Westminster.

[Baroness Masham of Ilton (CB)]

My Lords, I thank the Minister for her reply. Is she aware that thousands of people come into Westminster, including tourists from all over the world, people coming to work here, the police, demonstrators and both Houses of Parliament? Are we not a special case? Would it not be very good to have a special trauma unit at St Thomas’ Hospital? When there is a lockdown, we cannot move in Westminster.

[Baroness Blackwood of North Oxford]

My Lords, I pay tribute to all the brave members of the public, the NHS and Members of this place who so often have responded incredibly bravely when terrorist attacks occur. We owe a great debt of gratitude to all those individuals who do not think of their own lives in responding to protect others.

On the noble Baroness’s specific question about our capabilities in responding to risks that occur, we have a specific arrangement that has been put forward with the trauma network. The decision about the location of the trauma centres allows full geographic coverage while ensuring that the full package of care is available for patients when they come forward, which includes treatment for burns, orthopaedic injuries and neurosurgery. I know the noble Baroness knows there are four major trauma centres located in London at St Mary’s Hospital, St George’s Hospital, the Royal London Hospital and King’s. They are all adult and children’s major trauma centres and are all approximately three miles from Westminster.

More importantly, we have specialist ambulance capability in responding wherever an attack may occur in London. We can be very proud of the response that we have seen not only from the hazardous area response teams but from the tactical response units. Those responses have been in very short order and have meant that, although these were appalling incidents, their impact was much reduced.

--- Later in debate ---

[Baroness Blackwood of North Oxford]

The noble Lord makes a very sensible suggestion to look at ways in which we can encourage individuals to save lives. It may be appropriate in situations other than terrorist attacks and I am happy to look into it.

[Baroness Masham of Ilton]

My Lords, many people think that St Thomas’ has a trauma centre and are very surprised when they hear that it does not.

[Baroness Blackwood of North Oxford]

I thank the noble Baroness for her comment. I think I have made the point that there is a trauma network across London to ensure full coverage for trauma across the city and enable individuals to get the best trauma service, wherever they may be.

Wuhan Novel Coronavirus: Threat to UK Citizens

Baroness Masham of Ilton Excerpts

Wednesday 22nd January 2020 Lords Chamber

[Baroness Blackwood of North Oxford]

We have indeed. First, three direct flights from Wuhan arrive into Heathrow and a team of public health experts, which will include the principal port medical inspector, the port health doctor, the administrative support and team leader and a translator, will meet every direct flight from Wuhan. We believe that this is a scalable solution, which could respond to a developing health challenge. In addition, before a flight lands a message will be broadcast to passengers in several languages to encourage them to report illnesses to flight staff and the captain will be required to provide an early warning of any illnesses on the aircraft one hour before arrival, which allows a much more appropriate response on landing. We believe that this is a manageable and effective response. The NHS has a very good record of responding to similar situations, whether with Ebola or monkeypox. We can be very proud of our public health record in these areas and can be confident in how bodies will respond to this incident.

[Baroness Masham of Ilton (CB)]

My Lords, does the Minister agree that this has come at a very difficult time, because we are the middle of the flu season and this is difficult to diagnose? Does she realise that 15 health workers have been diagnosed in China? Therefore, will all health bodies be told to be aware?

[Baroness Blackwood of North Oxford]

The noble Baroness is absolutely right: there is great pressure on the NHS and we need to make sure that the appropriate information is given to the system so that there is no undue anxiety in that regard. As I said, the NHS has a tremendous record in responding to similar incidents. Clinicians in primary and secondary care have already received advice covering initial detection, investigation of possible cases, infection prevention and control and clinical diagnostics. NHS England and NHS Improvement have developed an algorithm to support NHS 111 to identify suspected cases and a central alerting system alert will be issued to the front line by the Chief Medical Officer, the medical director of Public Health England and the medical director of NHSE and NHSI to increase awareness of the situation and actions if potential cases present.

As I said to the noble Lord, Lord Patel, there are a number of infectious disease units around the country that can take suspected patients and are accustomed to responding in this way. Of course, the UK is one of the first countries outside China that has a prototype specific laboratory test for this novel disease. I want to emphasise, though, that there are no confirmed cases in the UK.