The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Merron) (Lab)

My Lords, the legislation before us today is part of a wider programme of common-sense reform to modernise pharmacy regulation and to cut red tape, which will enable pharmacies to thrive and will make pharmacy services quicker and easier for patients to access, as well as maintaining high levels of patient safety. The Government recognise that the current legislation we have in place is outdated and restricts practice, putting restrictions on the quality of service to the public. So I am very pleased to bring forward today another measure that, if approved, will mean that pharmacists will be able to spend more time delivering clinical care and registered pharmacy technicians will be able to manage more dispensing processes autonomously. I draw your Lordships’ attention to the fact that these measures are voluntary, and take-up will of course vary across the measures that I will describe. I turn to the detail of the SI. It proposes to amend the Human Medicines Regulations 2012 and the Medicines Act 1968, using powers under the Health Act 1999. The legislation broadly extends across the UK, but I point out that some of it does not in practice apply to Northern Ireland—I will return to that. I wish to set out three core proposals. The first covers who must supervise the dispensing of pharmacy and prescription-only medicines. Currently, the situation is that a pharmacist must carry out or supervise all stages of the preparation, assembly, dispensing, and sale and supply. Case law has led to restrictive practice and different interpretations of the law. Many of these activities can and should be delegated to registered pharmacy technicians, who are competent and ready for these changes. The first proposal will allow a pharmacist to authorise a registered pharmacy technician to undertake or supervise others to undertake these activities without the pharmacist needing to supervise. In giving an authorisation, the pharmacist can set conditions. For example, they may wish to exclude certain categories of drugs and ensure that staff know when to consult the pharmacist. The law demands that a pharmacist must have due regard to patient safety when giving an authorisation. This means in practice that a pharmacist will be authorising only staff who are trained, competent and confident to undertake a task. The pharmacist will still be expected to undertake a clinical check, which is critical to make sure that a medicine is safe and appropriate for each patient. A further reassurance is that professional standards and guidance will be updated to support the safe implementation of these changes in practice. The second proposal aims to stop the only-too-familiar situation we will all know about, whereby patients who arrive at a pharmacy find they cannot be handed their medicine because the pharmacist is absent for some reason or another. For example, they may be with a patient or taking their well-earned lunch break. This will be resolved by allowing a pharmacist to authorise any member of the pharmacy team to hand out checked and bagged prescriptions in their absence. This change in the regulations allows the pharmacist to decide who it is professionally appropriate to authorise to hand out medicines in their absence. This is likely to be a pharmacy technician, or a dispensing or counter assistant. Again, the pharmacist is required to have due regard to patient safety and to have already done a clinical check—in other words, they must be content that the medicine is appropriate for that patient and no further consultation is required. The third proposal relates to how hospital aseptic facilities are managed and run. These are highly specialised services delivering sterile medicines for cancer patients, premature babies and other vulnerable patients. At the moment, the law states that only a pharmacist can run this type of facility. But the reality is that pharmacists are not the only staff capable of running such facilities. There is a cohort of pharmacy technicians who have undergone additional education and training and who are competent and capable of managing these important facilities. So, this legislation will allow registered pharmacy technicians to lead these facilities. The Royal Pharmaceutical Society is updating its 2016 professional standards for the quality assurance of aseptic preparation services. This will define the required knowledge and training for both professions to support and ensure safe implementation. I turn to the scope and timescales. It is important to note—I made reference to this earlier—that, while the statutory instrument extends across the UK, proposals one and three will not apply in Northern Ireland until pharmacy technicians become a registered profession in Northern Ireland. At this point, we will, of course, work with the Department of Health, Northern Ireland to bring in these measures as soon as possible. With regard to timescales, we are proposing a phased implementation. The measures relating to the handing out of completed prescriptions in the absence of a pharmacist will enter into force 28 days after the regulations receive royal approval. This means that patients will benefit immediately, thereby taking pressure off already busy pharmacy teams. The aim is to bring the other measures into force following a one-year transition period. This will be enacted by a separate Order in Council. This will allow time for the development and publication of professional standards and guidance and will ensure that these measures are implemented into practice safely. I hope that I have been able to set out the purpose, alongside a clear rationale on the need for change. I look forward to what will be, I am sure, an informed and constructive debate. I beg to move.