The Medicines and Medical Devices bill was given royal assent last week (February 11), giving way to the Medicines and Medical Devices Act 2021. This means the government can now make changes to UK medicines law through “secondary legislation”.
The bill includes proposals to roll out a hub-and-spoke dispensing model across community pharmacy, which pharmacy minister Jo Churchill said last month would be subject to a “full public consultation” before it is implemented across the sector.
Noel Wardle, partner and head of healthcare regulation at Charles Russell Speechlys LLP, told C+D today (February 15) that under current legislation, the hub-and-spoke model can be “carried out by pharmacies owned by the same legal entity”.
“Now that the Medicines and Medical Devices Act 2021 is in force, it will be easier for the government to change the restrictions on hub-and-spoke dispensing, for example, to allow the assembly to be carried out by company A for supply to the patient by company B, through amending regulations,” he added.
Benefits for independents
David Reissner, solicitor and chair of the Pharmacy Law & Ethics Association, told C+D that these regulatory changes will make it easier for independents to outsource dispensing, as multiples have been able to do for many years.
However, there are “issues” to consider before the sector rushes to implement the model, he warned.
“GDPR needs to be considered when the hub sends patient data to the spoke. Supervision by a pharmacist will be required at both the hub and spoke, but there may need to be clarification of where any clinical assessment is carried out,” he said.
Mr Reissner also pointed at the issue of criminal liability for picking errors. “If a picking error is made and a patient is harmed as a result, criminal liability may attach to the spoke rather than the hub. A patient could probably sue the owner of both the spoke and the hub so accuracy checking will probably still be needed at the spoke,” he said.
“Since hubs will typically be automated, the systems in use will be designed with original packs in mind. This may cause some logistical problems,” Mr Reissner warned.
Finally, while the Department of Health and Social Care (DH) “seems to take for granted” that the model will bring financial benefits to contractors, some questions remain unanswered, he pointed out.
“What will hubs charge spokes for providing a service? What impact will that have on the finances of pharmacies? Will some independents be able to afford to outsource dispensing? What happens to any that cannot?” Mr Reissner asked.
Which other legislative changes would the Act enable?
The Medicines and Medical Devices Act 2021 will also enable secondary legislation for the introduction of a national system to replace the EU Falsified Medicines Directive (FMD), which contractors in Great Britain were instructed to turn off after December 31 last year.
In an update on January 25, the DH said it is “committed” to consult the public on the need for an alternative FMD scheme and that it aims to issue a “public consultation within 12 months of royal assent, subject to other priorities around medicines regulation”.
When the government first proposed the Medicines and Medical Devices bill in October 2019, the DH said it needed powers to expand the range of health professionals who can prescribe low-risk medicines, changes that would be subject to public consultations.