Medicines and Medical Devices Bill

Lord Clement-Jones Excerpts

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

[Baroness Wheeler (Lab)]

My Lords, I am pleased to move Amendment 23, in the name of my noble friend Lady Thornton, and to support Amendment 29, in the name of the noble Lord, Lord Clement-Jones.

Our amendment is a probing amendment, which has two aims. First, it provides us with the opportunity to hear from the Minister why the Government consider that the extensive delegated powers on the hub and spoke model for pharmacies are needed at this present time under the Bill, rather than ensuring that any such proposals are instead contained in future planned and well-thought-out primary legislation—properly consulted on and worked through—that amends existing legislation and regulations.

Secondly, we understand that there has been some discussion with key stakeholders in the pharmacy industry since the Government’s intentions were revealed in the nine short paragraphs on dispensing medicines in the impact assessment for the Bill—as we know, hub and spoke dispensing centres are not referred to on the face of the Bill. Today is an opportunity for the Minister to update us on the Government’s response to the concerns and issues raised by MPs in the Commons and by noble Lords during the Bill’s Second Reading, and in representations from leading industry organisations, including the National Pharmacy Association and the Pharmaceutical Services Negotiating Committee.

We need far greater clarity on what exactly is proposed, how the Government intend to take all this forward and how the very limited proposals that we have heard so far fit into the NHS long-term plan vision for the transformation of community pharmacy as an integral part of local primary care. How will pharmacists’ enhanced role in the future limit the number of people who will not have to see their GPs, in the way that the Government envisage?

Amendment 23 would amend Clause 2, on the “Manufacture, marketing and supply” of human medicines, and would delete the Secretary of State’s power to make provision for the distribution of human medicines by wholesale dealing, as is proposed for hub and spoke dispensing in the delegated powers proposed in the Bill. I have deep concern about the extensive range of delegated powers proposed under the Bill, and I support the decisive views of both the Delegated Powers Committee and the Constitution Committee on this matter, which have been made crystal clear by my noble friend Lady Thornton at all stages of the Bill. Major changes such as those envisaged for the community pharmacy sector through the extension of hub and spoke dispensing should be on the face of the Bill, with appropriate safeguards on their development, including a full public consultation.

The impact assessment tells us that

“dispensing needs to become more efficient to free up pharmacists’ time for other activities”

and that this will be achieved if all pharmacies have access to more efficient hub and spoke dispensing. We strongly support the aim of freeing up pharmacists’ time, better use of the skill mix in pharmacies, extending prescribing duties for pharmacists and a greater role in clinical service delivery. We also fully acknowledge the work, expertise and development of the hub and spoke models, including automated prescription assembly facilities—PAS facilities—operated by the large pharmacists, such as Lloyds Pharmacy, within their community retail pharmacy operations.

The impact assessment acknowledges the scale, substantial up-front and running costs and slow timetables of setting up and then operating hub and spokes efficiently and effectively, which are in reality way beyond local groups of pharmacies not part of nationwide businesses to fund and operate. In a moment of understated frankness, the IA admits:

“The costs and benefits remain uncertain, as do some details around the policy design, and the changes would be provided for by regulations made under the Bill.”


The Minister will know that the NPA has serious doubts about the suggested economic efficiency of the hub and spoke model, particularly in light of the impact assessment’s uncertainty. Under the five-year community pharmacy contractual framework agreement, the PSNC is tasked with the role of agreeing hub and spoke models which will allow the sector to benefit fairly. Can the Minister explain to the Committee how it is envisaged that hub and spoke models will be able to operate to ensure that the arrangements are fair to all pharmacies?

The NPA has stressed that, without a level playing field, competition and choice in the pharmaceutical wholesale market could be reduced by the pressure to set up or join hub and spoke arrangements. The resilience of the medicines supply system could be impacted, and medicine prices could rise as a result. As the NPA says, huge barriers will need to be overcome to make any model fair and appropriate for independents, including the risk of introducing new process errors, lack of clarity on the ownership of problems between the hub and spoke, longer lead-in times and impact on procurement margins—essentially, a reduction in system resilience and problems caused by restrictive distribution arrangements.

The impact assessment stresses that the proposed regulatory change is intended to be entirely permissive, with pharmacy businesses developing hub and spoke arrangements only where they deemed it would be

“beneficial for them to do so”.

Paragraph 255 sets out three types of hub and spoke arrangement that could be entered into, underlying the complexity of the range of models and reinforcing the need for greater consideration and thought to be given as to how further hub and spoke models could be introduced.

The Company Chemists’ Association, the trade body for large community pharmacy operations, which include Boots, Lloyds, Asda, Morrisons, Tesco and Superdrug, has expressed particular concern at hub and spoke models being introduced through secondary legislation and stressed the importance of extensive consultation with the industry—in fact, the consultation on the future of the industry began in 2016 but has yet to be concluded. When and how will consultation on this vital matter, which sees the most significant changes to pharmacy in decades, commence?

The Minister has rightly praised the contribution of independent pharmacies, particularly during the Covid pandemic. However, we know that, before Covid, more than half reported operating at a loss, a situation greatly exacerbated by Covid and extra costs, which led to their income decreasing while their role in the community became more important than ever, working long hours with often reduced staffing numbers, providing advice and support and supplying medicines. In rural areas, such pharmacies have always played a key role as often the only source of information and advice as well as of prescriptions and medical equipment. During Covid, in many areas they were and are the only primary healthcare professionals that patients can still see in person. What progress has been made in the discussions with the sector about additional funding on Covid costs? The £370 million provided in July was an advance payment to an already struggling industry rather than new money. Can the Minister place on record how much additional funding has been provided? My noble friend Lord Hunt will expand on this issue of funding community pharmacies and the wider pharmaceutical industry in relation to the price regulation scheme.

I want briefly to express support for Amendment 29 in the name of the noble Lord, Lord Clement-Jones, which would place a duty on the Secretary of State to consult the pharmaceutical, wholesale and pharmacy sectors and their regulators on an agreed framework for the safe transfer of patient data, prescription information and dispensed products between separate hubs and spokes. This and other provisions in the amendment would provide some vital safeguards if hub and spoke models are developed in future secondary legislation. We strongly support the noble Lord’s approach.

As I stressed earlier, the nine paragraphs of the impact assessment do not represent a strong or coherent case for moving forward at this time under the secondary legislation enabled by the Bill. Instead, they demonstrate the need for more thought, analysis and development of proposals for the future delivery and transformation of pharmacy services, with full involvement of and consultation with the industry, including on extending hub and spoke models. That would ensure a fair and level playing field and the survival of the independent local community pharmacies so valued by patients and their families and carers. I beg to move.

[Lord Clement-Jones (LD)]

My Lords, I want to speak to Amendment 29 in my name and those of the noble Lord, Lord Hunt, and my noble friend Lady Jolly. I thank the noble Baroness, Lady Wheeler, for her support and comprehensive exposition of the issues involved with regulation in respect of hub and spoke.

Like the noble Baroness’s amendment, mine is an attempt to flesh out concerns about the lack of detail in the regulation-making powers under Clause 2(1)(c) as regards authorising hub and spoke arrangements and the process by which new regulations will be agreed. For the record, I should say that “hub and spoke” describes how prescriptions are sent from a community pharmacy “spoke” to a central premise, or “hub”, for assembly, often using automated technology. The assembled medicines are then distributed back to the community pharmacy “spokes” for collection by patients. By removing elements of the existing workload in pharmacies, centralised automated assembly can give the pharmacist and their team more time to deliver healthcare services and advice and to support patients who have urgent and acute needs. This is not the same as an online-only pharmacy or a delivery system. It is not a means to enable home delivery of prescription items. There are significant costs of both setting up and running hub and spoke facilities, but it frees up capacity.

It is not blindingly clear on the face of it but, as a result of powers given under the Medicines and Medical Devices Bill, the Government intend to enable medicines assembly through hub and spoke models across legal entities, which is not allowed under current legislation. It is important that this technology is harnessed for the benefit of patients and the NHS within an agreed framework.

Over the past decade, many pharmacists have invested significantly in hub and spoke technology and use it to release capacity in their community pharmacy branches. It is hoped that, if wider use of the hub and spoke model can be permitted, this capacity can be used to enable community pharmacy teams to provide more clinical services to patients.

Noble Lords participating in Committee will be only too aware that community pharmacy is already helping the NHS in providing services and wants to deliver more. At a recent meeting with pharmacists I heard how, through freeing up capacity, hub and spoke arrangements support the delivery of essential and more advanced pharmacy services such as medicines use reviews, diabetes control, support during taking new medicines, minor ailments and vaccinations. NHS England, likewise, wants to open up the market to new technologies and enable greater efficiencies to be found in medicines supply, but the major pharmacy players believe that this can happen only if other barriers to automation are addressed through the community pharmacy contractual framework at the same time.

The noble Baroness, Lady Wheeler, mentioned the impact assessment and the need for much greater clarity on how the Government will deal with the barriers on the way to realising the efficiency benefits of hub and spoke. These barriers, over and above those mentioned by the noble Baroness, include, first, original pack dispensing. Very often, the quantities prescribed by doctors do not match the amount of medicines in the packs produced by the manufacturers. Pharmacy teams in England and Wales manually “snip” the plastic strips of pills to either add or take away from the manufactured quantity. Snipping is a time-consuming and expensive manual intervention that cannot be automated or delivered at scale.

A second barrier is the need for government support for infrastructure investment. Despite its potential, less than 10% of prescription items are currently dispensed using hub and spoke technology. The industry has already invested tens of millions of pounds in this technology. Government capital investment is needed for it to expand further.

A further barrier relates to fair community pharmacy funding, mentioned by the noble Baroness. The level of remuneration for pharmacy has been a challenge for some time. It needs to be addressed to help the sector to deliver the urgent care and services that the NHS badly needs, especially in the current Covid environment. This is even more important if pharmacy capacity is increased and there is a real prospect of enhancing pharmacy services to fill it.

The noble Baroness has explained the concerns over secondary legislation. I hope that the Minister will address some of these issues in her response and explain how she sees the extension of the hub and spoke dispensing model taking place and how consultation and agreement on a framework will take place.

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

My Lords, I speak in support of the intention of Amendment 27 in the names of the noble Lords, Lord Patel and Lord Hunt of Kings Heath. As noble Lords know, I made my views on the Brexit approach of working with other regulators clear on the first day in Committee and I do not intend to rehearse them—I am sure that noble Lords will be relieved—but I was struck by how this might work in practice. While listening to the noble Lord, Lord Patel, who gave an excellent exposition, I reflected on his story about CAR-T therapies and how that provides a good example of what we need to guard against as we move out of the EMA post Brexit.

In September 2017, I went on a visit to Pennsylvania and had the opportunity to go to Penn Medicine, which is where CAR-T was developed, in a lab sponsored by Novartis. I remember sitting down afterwards and being told about the amazing progress they had made, how this was rolling out to patients and indeed how they were thinking about the next iteration of this medicine, how useful it would be and how much demand there would be for it to be given to American dogs—that is right, dogs. I was sitting there at a time when UK patients did not have access to CAR-T therapies, but American dogs were about to get access. This in a way exemplifies a problem that we have today as part of the EMA but are likely to have tomorrow: our unwillingness to accept the decisions of other stringent regulators who make good decisions and whose processes we trust.

The idea of how we could work with other regulators as expressed in this amendment is incredibly important and could be carried out in two ways. The first is, as I said, in accepting decisions from other stringent regulators, including the FDA, the EMA, of course, and others. There has been resistance—there certainly was in my time as a Minister—about so-called rubber-stamping of other decisions and the implications for legal liability if things go wrong, but I am absolutely confident that these can be overcome. Our regulator should be prepared to accept the paperwork submitted to other regulators and the decisions of other stringent regulators where we have confidence in their processes. Ideally, as the noble Lord, Lord Hunt, said, this would be in the form of mutual recognition, but it is perfectly possible for us to do that unilaterally as well. That would go a long way to assuaging the concerns of industry.

The second way, and they are not mutually exclusive, is that the UK could lead the creation of a third global market to go alongside the FDA and EMA by working with independent regulators in Switzerland, Australia, Singapore, Canada and so on. As I say, these are approaches that we could follow in tandem as part of, I hope, a global move towards a single approach.

I am confident that we can follow these routes without causing any harm to patient safety while improving patient access. I am not convinced that they require legislation. I can understand why the noble Lord has tabled the amendment and I support its intention; I do not know that we need to change the law. What I would like to hear, and I hope other noble Lords would like the same, is a commitment from my noble friend the Minister that the Government intend to take this kind of approach. We look forward to speaking to the director of the MHRA on precisely this issue, as she has kindly agreed to meet us next week.

[Lord Clement-Jones (LD)]

My Lords, I am very glad that I put my name down to speak on this group of amendments. I had designed my contribution to be about the government amendments. Having heard the noble Lord, Lord Patel, I am reassured that I am not tilting at windmills. I hope that when the Minister winds up on this group she will be much more explicit about the purpose behind Amendments 48 and 109 and the limitations on their use. There are very thin explanatory statements accompanying the amendments. I heard the helpful paraphrase from the noble Lord, Lord Patel, but, regrettably, I did not receive the Minister’s letter although I have spoken on health data issues in the Trade Bill at some length. I share the noble Lord’s concerns.

I have a series of questions to put to the Minister in relation to those amendments. Can the Minister confirm that they do not, as such, permit the sharing of NHS patient data, whether related to medicines or medical devices and whether anonymised or not? The new UK-Japan trade agreement permits either party, in its Article 8.73, to share source codes and algorithms for regulatory purposes. This is directly relevant to modern medical devices. Is this why the Government are seeking the provision inserted by Amendment 109? In agreeing the trade deal, did the Government realise that they did not have a clear power to do so? How widely do the Government interpret these two amendments? What is their essential purpose and subject matter? I am raising this and the noble Lord, Lord Patel, raised it. What are the constraints as the Government see them?

Of course, there is an important patient safety issue in terms of the operation of medical devices. I entirely take the point raised by the Lord, Lord Patel, that there is no specificity in the article about that but does that mean that UK medical device manufacturers will, as a matter of routine, need to reveal their source codes and algorithms? Is this to be a standard provision in trade agreements, permitted by these provisions? What safeguards will there be against IP infringement and know-how theft in these circumstances?

I am sorry to throw these questions at the Minister in this fashion, but it comes as a result of me not having any brief from the Minister in the first place. We have all commented on the fact that the government amendments, tabled as they have been, need a fair bit of explanation. I hope the Minister can answer some of these questions and I look forward to her reply, but it may be that she prefers to write after Committee.

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

I understand that the noble Lord, Lord Lansley, has withdrawn so I call the next speaker on the list, the noble Baroness, Lady Jolly.