Manufacture, marketing and supply

Part of Medicines and Medical Devices Bill – in a Public Bill Committee am 12:30 pm ar 8 Mehefin 2020.

Danfonwch hysbysiad imi am ddadleuon fel hyn

Photo of Jo Churchill Jo Churchill The Parliamentary Under-Secretary for Health and Social Care 12:30, 8 Mehefin 2020

The clause allows for changes to be made to the law relating to the manufacturing, marketing and supply of human medicines. It provides an exhaustive list of matters on which amendments can be made by regulation, giving clarity and limits on what may be done by secondary legislation. I will take each subsection in turn as these are important areas for the Committee’s consideration.

Subsection (1)(a) provides that changes may be made to update regulations in relation to manufacturing to reflect advances and innovation in the way in which medicines are prepared. That will enable us to take a revised approach to regulation, ensuring that regulations do not become barriers to patient access and to medicines manufactured in new ways while maintaining high regulatory standards to protect patient safety.

Subsection (1)(b) allows for changes to be made to the law governing the import of human medicines. It will support the continued ability to ensure that imported medicines are safe. We also want to be able to ensure that no unnecessary additional burden is placed on companies so that the UK remains an attractive place to supply medicines while protecting patients.

Subsection (1)(c) allows for changes to be made to the law governing the distribution of medicinal products by way of wholesale dealing. A wholesale dealing authorisation is required to supply or sell human medicines to anyone other than the patient using the medicine. In the light of any emerging safety concerns or innovative new techniques or technologies, changes may be required to maintain the quality of, and ensure proper distribution of, medicinal products. That could include such matters as providing and maintaining staff, premises equipment and facilities for the handling, storage and distribution of medicinal products under a wholesale dealer’s licence as are necessary.

Subsection (1)(d) provides that changes may be made to the law relating to marketing authorisations for human medicines. We want to ensure that UK patients have access to high-quality medicines and new treatments, so we need a regulatory system that maintains and enhances the UK’s attractiveness as a place to market novel and generic medicines while ensuring that medicines are safe and efficacious. We could, for example, amend the current regulations to offer additional statutory rewards or incentives for a certain type of application for a marketing authorisation, which would encourage new medicines to continue to come to the UK in a timely fashion.

Subsection (1)(e) allows for changes to be made to the law governing the manufacture, import or distribution of active substances. An active substance is an ingredient used to make a finished medicinal product and gives medicine its therapeutic effect. The ability to amend and update regulations in relation to active substances is necessary to protect public health, because if there is not adequate control of an active substance, contamination can carry over to the finished medicinal product. The ability to change the rules governing active substances means that we can update the UK regulations to react in response to emerging public health risks resulting from issues relating to active substances and ensure continued supply.

Subsection 1(f) allows for changes to be made to the law governing the brokering of human medicines. The brokering of medicinal products consists of negotiating independently and on behalf of another person in relation to the sale or purchase of medicinal products. We need to be able to amend the rules governing brokering in response to any new industry practices that arise and risk infiltration of the supply chain with falsified medicines. We could use this provision to restrict such activities, thereby securing the medicine supply chain and reducing the risk to patient safety.

Subsection (1)(g) enables regulations to be made to amend the requirements on the registration of the premises of pharmacy businesses. While separate provisions cover the regulation of other parts of the supply chain, such as manufacturing and wholesaling, this provision would enable us to amend requirements regulating retailers, mainly retail pharmacy businesses and pharmacy premises, which goes back to the point made by the hon. Member for Nottingham North in the discussions about clause 1. This is necessary to maintain coherent regulation of the whole supply chain for human medicines, but also ensures that the UK has the power to keep the regulation of pharmacies up to date.

Subsection (1)(h) enables regulations to amend or supply the requirement around recording information about the supply of human medicines, ensuring the UK has the ability to amend existing record-keeping requirements. That is hugely important for the interest of patient safety as future models of supply evolve.

Subsection (1)(i) provides that amendment can be made to the law that governs the requirements for reporting safety data about medicines on the UK market. This will support continued improvement of pharmaco-vigilance in the UK to protect patient safety.

Subsection (1)(j) provides that amendments can be made to the law governing the labelling and packaging of medicines, and the information that must accompany them. This will enable innovation in the way in which information is provided alongside medicine. Patients may find digital routes to packaging information more accessible than paper copies. This subsection could enable us to require both paper and digital versions to be available. We have published an illustrative SI to show how this amendment could be made in regulations.

Subsection (1)(k) provides that amendments can be made to the law relating to the advertising of human medicines. Having the ability to make changes to the regulation of the advertising of medicines would enable the Government to ensure that advertising requirements can be updated to reflect developments in areas such as digital communication channels, while ensuring that patients and healthcare professionals continue to receive good information about the medicines they may use or prescribe. This would help ensure that the UK remains an attractive place to market such medicines.

Subsection (1)(l) relates to the supply of medicines online and would enable the UK to introduce and amend a bespoke national registration scheme for online sellers of medicines, and replace the EU distance-selling logo that is currently used. We have published an illustrative SI to show how the provision for a national scheme could be made. It is essential that there are appropriate protections in place to ensure the safety of supply of medicines online.

Subsection (1)(m) outlines the regulatory provision that may be made in relation to the requirements that need to be met for a prescription to be valid. For example, this might be used to update the particulars that must be included in a prescription or the types of products for which electronic prescriptions are valid.

Subsection (1)(n) deals with amendments made to the provisions that govern who can supply or prescribe human medicines. The provisions referred to are set out in subsection (2). The power gives the Government the ability to amend the rules around who can supply, administer and prescribe medicine in line with healthcare needs, where it is safe and appropriate to do so. The most recent change to prescribing responsibilities was in 2018, when legislation was amended to allow trained paramedics to act as independent prescribers. We have published an illustrative SI showing how the provision can be made to permit dental hygienists to supply and administer certain medicinal products in the course of their professional practice.