New Medicines and Medical Devices Act 2021

New Medicines and Medical Devices Act 2021

February 18, 2021

Last week the Medicines and Medical Devices Bill received royal assent and became law. The new Act will enable the Department of Health and Social Care (DHSC) to implement a number of policies to amend the existing regulatory frameworks, although generally regulations under the Act must first be introduced.

The potential changes include:

  • Supporting the availability of medicines: enabling hub and spoke arrangements between different legal entities, to ‘support wider use of automation to bring increased efficiencies’; requiring manufacturers to provide electronic patient information leaflets; and increasing the professions able to prescribe and supply certain medicines.
  • Protecting the public: developing a UK medicines verification system; introducing a national registration scheme for online sellers of medicines; and facilitating supply of medicines and medical devices during non-pandemic public health emergencies.

The new Act also makes provision for innovative regulation of novel therapies and updating existing clinical trials regulation. As well as improving the regulatory framework to manage innovations such as Artificial Intelligence, proposals under the Act will seek to be consistent with the ambition of the White Paper: Regulation of the Fourth Industrial Revolution.

The DHSC Impact Assessment for the new Act references the five-year deal agreed by DHSC, NHSE&I and PSNC on 22nd July 2019 and indicates that the ‘vision for community pharmacy across the UK is one of expanding clinical services, especially in relation to medicines safety and optimisation, urgent care, and prevention, reducing pressures elsewhere in the health and care system’.

The assessment indicates that, in principle, any gains in dispensing efficiency and efficacy could be shared between hub operators, spoke operators, patients and the NHS.

The assessment indicates that the benefits of hub and spoke dispensing may include ‘reduced staff time on dispensing at the spoke pharmacy (freeing up time to provide other services), potential for reduced rates of dispensing errors and potential for a calmer working environment at the spoke pharmacy’. But it adds that the costs and benefits remain uncertain and no pharmacy business would be required to set up, use or offer hub dispensing services.

During the passage of the Bill, PSNC submitted written evidence on the proposals, stressing key concerns and principles, including: the need for patient and public safety, fairness to the sector as a whole, questioning the efficiency claims (particularly claims of financial savings), and the need to safeguard the competitive purchasing of generic medicines by community pharmacies.

Read PSNC’s evidence on hub and spoke dispensing

Next steps on hub and spoke between different legal entities

DHSC has now entered a pre-consultation stage before a formal consultation begins on new regulations under the Medicines and Medical Devices Act. It is likely that there will be two further aspects to the regulatory framework: General Pharmaceutical Council (GPhC) regulation of relevant premises, individuals and, therefore, the systems and, NHS regulations for community pharmacy arrangements – in the five-year deal, DHSC committed to ‘agreeing with PSNC which models will allow the whole [community pharmacy] sector to benefit fairly’ from hub and spoke dispensing between different legal entities.

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