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.