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.