Legislation paving the way for wider use of hub-and-spoke dispensing is expected to receive royal assent in February 2021, the Department of Health and Social Care (DHSC) has said.
The Medicines and Medical Devices Bill will also lay the first steps towards building a replacement for the EU’s Falsified Medicines Directive (FMD) and supporting a wider range of professions to prescribe certain medicines.
The bill will provide the primary legislation needed to amend a variety of legislative frameworks, including the Human Medicines Regulations 2012 (HMRs).
These frameworks were previously amended through legislation that has since been repealed under the EU (Withdrawal) Act 2018.
The bill’s impact assessment set out the legislation’s implications “for how the powers may be used in the future” following secondary legislation, including “enabling hub-and-spoke arrangements across legal entities”, which will ultimately require a change to the HMRs.
This would mean that smaller pharmacies would be able to access dispensing hubs run by larger multiple pharmacies, for instance.
The DHSC confirmed to The Pharmaceutical Journal on 1 February 2021 that, despite amendments to the bill since it was laid before parliament in February 2020, the powers enabling changes to the regulation of pharmacies to be kept up to date, which would also enable hub-and-spoke dispensing, have not changed.
It added that the bill is in its final stages and the DHSC hopes it will achieve royal assent in February 2021.
Speaking during a debate on 27 January 2021, pharmacy minister Jo Churchill said the government plans to hold “a full public consultation” on broadening hub-and-spoke dispensing.
“The government will then report to parliament and include a summary of the concerns raised in the public consultation,” she said.
“To ensure that we get the right model to assist pharmacy going forward, we intend to be totally transparent.”
This comes after the government also committed to consulting the public on a new national scheme to detect falsified medicines in the supply chain within 12 months of the Medicines and Medical Devices Bill receiving royal assent.
The national scheme would replace the FMD, which was introduced across the EU in February 2019 and ceased to apply in Great Britain when the Brexit transition period ended on 31 December 2020.
The bill’s impact assessment listed “introducing a scheme to combat falsified medicine products” among a range of examples of how the powers may be used in the future following secondary legislation.
The bill could also enable hospitals to use patient tissue and DNA samples to tailor treatments for individual patients and allow hospitals, in their existing facilities, to develop drugs that have a shelf life of minutes and would otherwise be unavailable to them.
Medicine manufacturers may also be required to signpost patients to “up-to-date statutory information about certain medicines on a variety of digital platforms”, rather than include hard copy patient information leaflets in packaging, under proposals permitted by the bill.
The Medicines and Medical Devices Bill was first announced in the Queen’s Speech in December 2019 amid plans to introduce legislation to allow a wider range of healthcare professionals — potentially including pharmacists — in the NHS to prescribe ‘low-risk’ medicines.
Changes enabled by the powers in the bill will be made using secondary legislation at a later date, and any proposed legislative changes arising from the provisions in the bill will be subject to consultation, the DHSC said.