Medicines and Medical Devices Bill

Baroness Henig Excerpts

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

When making regulations under Clause 1, the appropriate authority will need to take into account our international obligations, along with a wide range of other considerations and it is simply not appropriate to include all of them in the Bill, as envisaged in this amendment. However, having regard to patient health is central to good regulation. That is why last week I brought forward government Amendment 2, which will ensure that the Secretary of State, or appropriate authority, may make regulations only under the power at Clause 1 if satisfied that they would promote the health and safety of the public. I hope that this provides the noble Baroness with the assurances she was seeking and that, on that basis, she is content to withdraw Amendment 19.

[The Deputy Chairman of Committees (Baroness Henig) (Lab)]

I have received a request to speak after the Minister from the noble Lord, Lord Alton.

[Lord Alton of Liverpool (CB)]

My Lords, I thank the noble Lord, Lord Bethell, for the response he has given to the debate, but I have two questions I want to put to him. Like the noble Lord, Lord Stunell, and others, I accept that pharmaceutical companies will always want to and are entitled to reclaim research and development costs. On Monday, I referred to the phenomenal difference in the cost of remdesivir when purchased in the US at over $2,000 for a five-day treatment and Liverpool University’s estimate of $9 as the basic production cost. I asked how much public money went into developing that drug. If the Minister is unable to answer that question today, I would really appreciate it if he could undertake to write to us to let us know how much public money went into the development of that drug.

My second question is about Crown use licences, a question posed to the Minister by the noble Lord, Lord Sharkey. Are the Government considering using the Crown use licence, should the circumstances require that? It was used in the 1960s, and more recently the use of it was threatened in the case of an innovative new treatment for cystic fibrosis. The Government used the power, and that had the desired effect of bringing down the cost of that drug. Are the Government giving serious consideration to how they will use Crown use licences, should that become necessary?

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Clause 1, as amended, agreed.

[The Deputy Chairman of Committees (Baroness Henig) (Lab)]

We now come to the group beginning with Amendment 23. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.

Clause 2: Manufacture, marketing and supply

Amendment 23

Moved by

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[Baroness Penn (Con)]

My Lords, as we have heard, hub and spoke is an issue on which there was debate in the Commons and we return to it now.

I first want to explain the intention of the inclusion of Clause 2(1)(c) on wholesale dealing and why it is vital that it remains. Wholesale dealers, involved in moving products from manufacturers to the person supplying the product to the patient, are an essential part of the supply chain, ensuring patient access to medicines. More than one wholesale dealer may be involved in the supply chain for a particular medicine, but anyone who intends to sell or supply medicines to someone other than the patient using the medicine must obtain a wholesale dealer’s licence.

Clause 2(1)(c) allows amendments to be made to the law governing the distribution of medicinal products by way of wholesale dealing. This could include matters around providing and maintaining the equipment and facilities needed for the handling, storage and distribution of the medicinal products under a wholesale dealer’s licence. This is vital, particularly in light of emerging safety concerns, or innovative new techniques and technologies. Omission of this power would limit our ability to maintain the integrity of the supply chain. For example, some vaccines require storage and transport at ultra-low temperatures to ensure that they remain effective. Courier companies delivering medicines are exempt from certain licensing requirements.

If we could no longer make changes under Clause 2(1)(c), we could not amend the definition of wholesale dealing to support the transport of temperature -sensitive pharmaceuticals in different ways, if needed. Recent exemptions to wholesale dealer licensing during Covid have allowed for the swift and safe transfer of flu vaccines and other medicines for treatment of pandemic disease between NHS organisations. Through this flexibility, we have been able to quickly respond to patient need. The noble Baroness, Lady Wheeler, has indicated that, in addition to the question around the need for this power in particular, there is a question around its intention for use in delivery of the hub and spoke model. That is part of the intention behind Amendment 23.

As we have heard, enabling hub and spoke dispensing arrangements where both the hub and spoke pharmacies are not part of the same pharmacy chain is one such example of how powers in Clause 2 could be used, including under Clause 2(1)(c), as we may need to amend the definition of wholesale dealing to support hub and spoke dispensing models. Under current regulatory provisions, only a subset of pharmacy businesses are realising the benefits of hub and spoke. For hub and spoke dispensing, our intention is to give all community pharmacies the same flexibility to explore efficiencies of scale and use of automation that some larger pharmacies already enjoy. Removing this barrier would level the playing field for all community pharmacies and enable them to make use of this type of dispensing model.

However, we have heard from the noble Lord, Lord Clement-Jones, in speaking to his amendment, the noble Baroness, Lady Wheeler, and all other noble Lords in this discussion the concern around how these matters were consulted on in 2016 and what the Government’s intention is for consultation on changes to this model. I reassure noble Lords that there is a difference between then and now. The proposed use of hub and spoke and changes to support it have the support of the Pharmaceutical Services Negotiating Committee, and the five-year deal under the community pharmacy contractual framework for 2019-20 to 2023-24 included a commitment to pursue legislative change so that all pharmacies may benefit from these efficiencies.

We have of course also in recent months had the changes Covid has brought. The pharmacy landscape has changed and adapted in this environment. I pay tribute to the work of community pharmacists and their teams in responding to the challenges of the pandemic. They have been on the front line supporting patients throughout this very challenging time.

The Government agree with the spirit of all noble Lords’ comments, particularly in relation to the amendment from the noble Lord, Lord Clement-Jones, on the need for proper consultation before any changes are brought in, and on the importance of the sector’s engagement to deliver hub and spoke. That is exactly what we intend to achieve. I assure noble Lords that it is absolutely the case that hub and spoke would be taken forward only on the basis of a fresh consultation, based on the current state of play in community pharmacy. Our approach to hub and spoke dispensing models is to consult and make use of productive stakeholder engagement to develop the policy, then to set out in detailed secondary legislation the new regulatory provisions. We are keen to ensure that strong engagement with stakeholders is fed into the development of this policy.

We recognise that there are some important considerations to make use of this type of dispensing model safely and to enable efficiencies. We want to consult specifically on the right approach to hub and spoke, including any patient data safeguards that may be needed, to ensure that our proposals are safe and in the public interest before legislating. To meet the requirement of the government amendment tabled later in the Bill, this would of course be a public consultation.

On the specific points in the amendment from the noble Lord, Lord Clement-Jones, it is critical that we consider how patient data will be safeguarded, as he said at Second Reading. I of course recognise that patients’ healthcare information is confidential and must be handled in accordance with data protection regulation. Handling patient information appropriately and confidentially is of course a routine part of a pharmacy’s business. As part of their professional standards, pharmacists must respect and maintain a person’s confidentiality and privacy, and owners of pharmacy businesses must make sure that they comply with all legal requirements, including data protection legislation.

The noble Lord is right that in considering changes to pharmacies’ operating models we must consider the security of patients’ data and the integrity of the supply chain carefully, drawing on the input from stakeholders. I am happy to put on record that that will be part of the forthcoming consultation on hub and spoke.

My reservation with the noble Lord’s amendment is that placing a timeframe in the Bill, as he proposes, will force the Government to consult in haste. Rather than an arbitrary deadline, which could lead to ill-considered policy development, we want to be able to consult with stakeholders fully and thoroughly on proposals. It is important that we take the time needed to get this right—noble Lords have made that very clear in the debate—first by engaging with stakeholders, as well as with formal consultation. We want to take forward this work as soon as possible, subject to the Bill’s passage.

Noble Lords raised a couple of other points relating to community pharmacy. I agree with all noble Lords on the integral role of community pharmacy in the delivery of health services. Hub and spoke is one way the Government envisage the potential for pharmacists’ skills to be better deployed in patient-facing care.

On financial support to the sector, we are consulting the PSNC on this and other matters as part of the year 3 community pharmacy contractual framework discussions. We also intend to continue discussions with the PSNC on the additional costs that Covid has placed on community pharmacies.

The Government absolutely value and support the work of community pharmacies. I hope noble Lords have heard enough by way of reassurance and that the noble Lord and the noble Baroness feel able not to press their amendments.

[The Deputy Chairman of Committees (Baroness Henig) (Lab)]

There are no requests to speak after the Minister, so I now call the noble Baroness, Lady Wheeler. Oh, apologies, I call the noble Lord, Lord Clement-Jones.

[Lord Clement-Jones (LD)]

I was very struck by the support for pharmacists and pharmacy services throughout this debate. It is not often we get a really good opportunity to talk about pharmacists’ potential. I chaired the London School of Pharmacy, which then merged into UCL. I used to see bright, bushy-tailed MPharms depart the School of Pharmacy, all expecting the bright future for pharmacy promised by plan after plan from Government after Government. To use their clinical skills in particular was the great goal.

Sadly, we are still not in the right place with community pharmacy. I was very struck by what the noble Lord, Lord Lansley, said: we have never achieved as much as we should. That is absolutely apposite in the case of pharmacy. We have all these highly skilled people, many of them very young, who are capable of taking on all kinds of clinical work in the community, with consultation and so on. We seem to ebb and flow in the services we think we can make available in pharmacy.

I am very grateful for what the Minister said about the need for proper consultation being a given and that there will be consultation to develop the policy and so on. She of course talked about the five-year plan, but many people are worried that the plan will run out and there will not be resources for hub and spoke to develop further. She talked about the fact the amendment would limit the time available but, as the noble Lord, Lord Hunt, pointed out, pharmacists have been talking about this since 2016. It is not as if we are imposing too harsh a timetable.

Underlying all this is the question: where is the plan to use that additional capacity? That is really what pharmacists are after. On the basis that automation is augmentative and will help community pharmacists free up capacity, they want to deliver more clinical services in particular. Where is the plan? That is what we all want: to use their expertise in and knowledge of the community, and the trust they have. We have talked about the access people have to the local pharmacy. I wish there was a better relationship between many general practitioners and the pharmacy profession. There is still that rather standoffish attitude to pharmacists. Be that as it may, this is a really important aspect that could deliver much greater capacity, but I do not feel that the Government have yet really picked up the ball and started running with it.

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[Baroness Penn (Con)]

I will pick up on the noble Lord’s point about timing. The Government acknowledge that this has been committed to for a long time. However, I also pick up on the point that when this process started in 2016 it might not have been as consultative as it could have been. Therefore, there is a balance to be struck between making progress and making sure that progress happens through engagement with stakeholders and proper consultation.

On the immediate timeframe in the noble Lord’s amendment, while I would be incredibly supportive of swift progress, we need to recognise, as some noble Lords have, the pressures that Covid has placed on the sector and other parts of the healthcare system. While we are committed to making progress on this, such a firm deadline could mean that the process again did not run as well as it might, given that the Covid pressures still exist and we are not sure when that situation will change exactly. We are enthusiastic about making progress, but we need to ensure it is done properly. A deadline placed in the way it would be by the amendment might not be supportive of that.

[The Deputy Chairman of Committees (Baroness Henig) (Lab)]

The noble Lord, Lord Hunt, would also like to come in at this point.

Covid-19

Baroness Henig Excerpts

Tuesday 20th October 2020 Lords Chamber

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

My Lords, I am grateful for the questions from the noble Baroness, Lady Thornton. If the noble Baroness, Lady Jolly, returns, I shall be happy to answer her questions, too.

The noble Baroness, Lady Thornton, asked a lot about the testing programme. Let me reassure her with some statistics about last week’s processes. Some 1,892,000 test were done in the week from 1 to 7 October—I repeat, 1,892,000 tests. That is a colossal number, and the vast majority of them were done promptly, accurately, and to the satisfaction of those involved. Of those, 89,874 results were positive, which is a substantial increase of 64% compared to the previous week. That is 89,874 people who would not have had a test six months ago, because we simply did not have the capacity, the knowhow or the systems to do that.

The number of people transferred to the test and trace programme since the beginning of August has increased by 10 times; 67,511 were reached, of whom 57,000 provided details of one or more close contacts. In other words, 67,511 people were taken out of the chain of transmission and asked to isolate, were provided with a financial supplement to care for them and were phoned—sometimes many times, it would appear but, generally, once or twice a week—in a pastoral call to ensure that they had access to local authority, charity and financial support. Of those non-complex cases, 55.9% were reached within 24 hours. That is not good enough, and we need to work on it more, but 55.9% is enough to make a serious impact on the progress of this virus. Without the test and trace programme, we really would not be match fit to combat this virus at all.

The story that the noble Baroness told of her friends was distressing. Anybody who has had the virus will know that it is a miserable affair. For the entire family to have had it is very sad, and my feelings are sincere when I say that I am sorry to hear about her friends who have had coronavirus. But the guidance is relatively straightforward. You are to isolate for 14 days from the original infection. That would have been the advice that they had on the telephone and, if their app said otherwise, the telephone supersedes anything that the technology might have told them.

On getting tests at all, I acknowledge that the general public are not at the top of the priority list right now. The top priority is to protect clinicians and NHS workers, as well as those in hospital care who have the threat of nosocomial infection. Secondly comes social care—protecting those who are vulnerable and live either in residential or domiciliary care. Those people are at the top of the list. We are building our capacity dramatically; we are on course to hit our ambition of 500,000 tests per day by the end of October, and many more beyond that.

The tests that the noble Baroness, Lady Thornton, described are incredibly impressive. The saliva testing is much easier to use, and the LAMP testing is phenomenally accurate. The capacity for those LAMP tests to be rolled out across social care and hospitals is enormous, and we are investing considerably in that.

The noble Baroness, Lady Thornton, also asked about Manchester, and there the situation is distressing. I cannot hide the fact that the increase in prevalence in Manchester is a source of enormous sadness, but I reassure her that the extra measures that have been taken there have been accompanied by the offer of extremely generous financial measures.

Those financial measures have been accepted by Lancashire and by Blackpool—but not, it seems so far, by Manchester. We hope very much indeed that Manchester will remain at the table. The negotiations being undertaken by the Government are generous and open hearted. We have already made available £465 million to help local authorities implement and enforce restrictions. Greater Manchester will definitely receive £22 million of this, and we will continue to work with the Greater Manchester councils to ensure that testing and local contact tracing are allocated in the right way. We will continue with those negotiations. The negotiations with Manchester were entirely proportionate to the support that we have given to the Liverpool City Region and to Lancashire, and it is a source of enormous regret that the mayor decided to reject it.

[The Deputy Speaker (Baroness Henig) (Lab)]

We now come to the 30 minutes allocated for Back-Bench questions. I ask that questions and answers be brief so that I can call the maximum number of speakers.

Health Protection (Coronavirus, Collection of Contact Details etc and Related Requirements) Regulations 2020

Baroness Henig Excerpts

Wednesday 7th October 2020 Lords Chamber

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

My Lords, the virus continues to spread. We will put in place measures to break the chain of transmission and to protect the NHS, but at the same time our strategy is to support the economy, keep our schools open and, wherever possible, maintain normal life—for friends and family to meet and for businesses to remain open. These regulations play an important part in that objective by contributing to enhanced contact tracing, some, but not all, through the NHS app.

The instrument before the House requires designated venues to collect contact details and display an official NHS QR poster. To give a sense of the impact of these regulations, as of 9 am this morning there were 16,302,038 users of the NHS Covid app. Any one of them can check in at 634,488 posters that have been downloaded by designated venues. We know that this is proving popular, because there have been an astonishing 19,721,804 check-ins so far. I encourage noble Lords to exercise their digital skills and take advantage of this important protocol.

If local public health officials determine that one of these venues is linked to an outbreak, they can send a message with the necessary health advice to all those whose timing and proximity coincides with the infection. This might include a requirement to isolate for 14 days.

Privacy is key. An individual who has been in one of the venues in scope of this policy can rest assured that their contact details will be shared confidentially with local public health officials. This will then allow the individual to receive the necessary health advice. Alongside other requirements, this will increase public confidence to go out and use these venues.

I will now set out why this measure is necessary and how uptake has increased following the introduction of the regulations. On July 2, the Government issued guidance to the hospitality sector and asked designated venues to collect contact details. This led to manual, handwritten logs in some venues, and homemade and commercial logging systems in others. The guidance was in place for two months, but there was a growing level of non-compliance. Surveys indicated that around two-thirds of respondents were asked for their contact details some or all of the time, but many were not. According to our surveys, only 43% of people said that they were asked for contact details in all the venues they visited. We saw video evidence as part of media reports showing multiple establishments not adhering. My experience endorsed this coverage: I pay tribute to the Prince Bonaparte pub in Notting Hill for its diligent commitment to these protocols, but I shall not mention some other pubs I have visited where standards have been more lax.

This uneven application of voluntary rules meant that local public health officials often struggled to obtain the contact tracing information they needed. In one instance, a pub in Bolton had been identified as a potential outbreak source, as many of the positive cases had been on the premises. Unfortunately, when contact tracers contacted the venue to access its logs, they contained only names and postcodes. It took up significant amounts of precious time, using appeals on social media, to trace potential infection. This prevented public health officials providing targeted public health advice to those who had been at risk and raised needless worry among others. This is only one of many examples, and something needed to be done to address this significant risk at a time when daily case numbers were rising rapidly across the country.

This instrument has made the requirement on businesses clear. It has given local authority officials powers to enforce penalties on businesses which do not comply. Since bringing in this measure, we have seen the public and business community embrace this policy. It is hugely significant. If an outbreak is then linked to a venue, a message can be sent to the app user on the advice of local health protection teams, providing the necessary public health advice.

We know that the Covid pandemic has disproportionately affected vulnerable groups such as the elderly and people living in high deprivation. These at-risk individuals are less likely to have access to smartphones, so it is essential that a system is in place to contact-trace people who do not have the app. The logs that designated venues must have achieve this. From a recent engagement with industry, we know that designated venues are implementing these requirements. For example, one trade association found that 95% of businesses were fully compliant. Two-thirds of members are capturing data electronically in advance through online or telephone bookings, whereas remaining businesses have introduced customer and visitor logs.

Research in New Zealand, which has a similar system to ours, has assessed that rapid case detection and contact tracing, combined with other basic public health measures, has over 90% efficacy against Covid at the population level, making it as effective as many vaccines. This shows the importance of ensuring that NHS Test and Trace can reach more contacts overall, meaning that more people are provided with appropriate public health advice when they need it.

While these measures apply to England only, we have learned from the approach taken in Scotland and Wales. Colleagues have found a marked improvement in compliance, and although these regulations have been in place for less than three weeks in England, we are already seeing positive signs.

Because of the issues I have just described, we have used emergency powers to introduce these regulations. I recognise that in different circumstances, it would have been preferable to publish them in plenty of time before they were laid and to have brought them before the House before their enforcement. This point has been made in the past, it is acknowledged, and it is understood. We have put together a register of future potential regulations in an effort to improve our housekeeping. However, perhaps I may say a few words in mitigation.

We were hesitant about mandatory enforcement, as we seek to apply Covid-related regulations through voluntary compliance wherever possible. However, we decided to act because of the increasing rate of positive Covid cases, the evidence of non-compliance and the feedback from local public health officials, who were unable to contact people who may be infectious to provide the necessary public health advice.

I know these regulations place additional requirements on businesses and other sectors, which we have sought to mitigate. To reassure noble Lords, we continue to work closely with the sectors in scope to ensure that these measures do not cause undue burdens. Furthermore, the regulations set out that a review must take place within six months of their coming fully into force, and the Secretary of State for Health and Social Care keeps their necessity under consideration between formal review points. We will have these measures in place only for as long as necessary.

This instrument is already benefiting individuals and businesses, and as your Lordships have heard today, individuals and businesses recognise that this is a key tool to prevent further societal and economic restrictions, which we all desperately want to avoid. These regulations are enabling NHS Test and Trace and local public health officials to suppress the virus, to support the economy to remain open, and to protect individuals and their loved ones. The public should therefore be confident to visit and work in these venues, knowing that they will be contacted if they have been exposed to the virus. Providing this reassurance is essential to returning to a more normal way of life and supporting businesses to prosper. I beg to move.

[The Deputy Speaker (Baroness Henig) (Lab)]

As the noble Lord, Lord Liddle, is not contactable at the moment, I call the noble Baroness, Lady Barker.