Key areas for healthcare professionals

Gordons Partnership

The Medicines and Medical Devices Act received royal assent on 11 February 2021. It is a workhorse of an act that enables the legislation covering human and veterinary medicines and medical devices to be amended in a post-Brexit world.

The very wide powers of the Act are limited by the overarching objective that regulations relating to human medicines and medical devices must safeguard public health.  In the case of veterinary medicines, the overarching objective is to promote the health and welfare of animals; the health and safety of the public; or the protection of the environment.

What else does the Act do?

As to be expected in an Act that attracted considerable debate as it went through Parliament there is a lot going on.  Focussing on the parts that will be important (and familiar) to healthcare professionals, the key issues are:

Patient safety

Following a debate on the Bill and the review by Baroness Cumberlege’s team, “First do no Harm” (the report of the Independent Medicines and Medical Devices Safety Review), patient safety has been elevated to Part 1 of the Act. With this there is a new role of Patient Safety Commissioner, providing independent oversight and guidance on patient safety elements relating to the device and medicinal product use and surveillance.

The Act states the Commissioner’s core duties will be:

  • promoting the safety of patients with regard to the use of medicines and medical devices; and
  • promoting the views of patients and other members of the public in relation to the safety of medicines and medical devices.

At the Report Stage, Baroness Cumberlege asked for reassurance that the Patient Safety Commissioner should be able to seek information from any public body necessary and that manufacturers of medicines and medical devices should be required to cooperate and share information with the Commissioner. These requirements are set out in Schedule 1 to the Act.

Hub and Spoke arrangements

The impact assessment for the Bill summarised Hub and Spoke arrangements as:

“arrangements where a retail pharmacy, notionally at the end of a spoke, receives prescriptions and sends them electronically to a remotely located hub, which in turn takes in prescriptions from multiple spokes. At the hub, medicines are selected, packaged and labelled and then transported back to the spoke to be checked by the pharmacist and collected by the patient”.

Hub and Spoke has been the subject of much debate. Key concerns highlighted by pharmacy stakeholders when submitting written evidence during the passage of the Bill included patient and public safety and competition and fairness for the pharmacy sector. One issue is that as the NHS community pharmacy network comprises a mixed economy of independent pharmacies and multiple businesses, any changes to legislation should not favour any one ownership model.

The Minister with responsibility for primary care, Jo Churchill, said the Government will give smaller community pharmacies the same opportunity that large pharmacy businesses already enjoy. “We will support them and remove the legal barrier that allows such an arrangement only when the spoke pharmacy and the central dispensing hub are part of the same retail pharmacy business.”

The Act gives powers for medicines legislation to be amended, following consultation, to permit Hub and Spoke arrangements.

Falsified medicines

Pharmacists and others involved in dispensing spent much time in 2019 and 2020 preparing for and implementing the Falsified Medicines Directive (FMD)(2011/62/EU) and delegated regulations (2016/161). The Act, to some extent, answers the question about what is going to replace the FMD. Powers are introduced allowing regulations to be made to prevent the supply of falsified human medicines. This may include establishing a national system based on the unique identification of individual packs that enables medicines to be authenticated and identified if tampered with.

Medical devices

Medical devices are covered by Part 4 of the Act, which effectively allows the Secretary of State to amend or supplement the Medical Devices Regulations 2002 (SI 2002/618), the UK’s statutory instrument for medical device regulation.

As well as the overarching objective mentioned above, there are three factors that the Secretary of State must consider when making regulations that affect medical devices, namely the:

(a) safety of medical devices;

(b) availability of medical devices; and

(c) attractiveness of the United Kingdom as a place in which to develop or supply medical devices.

These three factors are also reflected, with relevant alterations, in the sections relating to human medicines and veterinary medicines.

What happens next?

Not all parts of the Act are in force immediately. The provisions relating to the Patient Safety Commissioner and some provisions relating to human medicines, veterinary medicines and medical devices are in force two months from the day on which the Act is passed i.e. 11 April 2021. Provisions relating to enforcement and disclosure of information will be brought into force by statutory instrument at a date not yet determined.  Many of the regulations to be brought in will be subject to public consultation so debate on the matters above will continue. In addition, there will be a report to Parliament about how it is all working in five years’ time.

 

Susan Hunneyball

25.02.21