If passed, the Medicines and Medical Devices Bill – which has just completed the public bill committee stage in the House of Commons – could give ministers the power to modify the law relating to human medicines and medical devices without the need for primary legislation.
This could mean that changes to regulations on medicines supply and hub-and-spoke dispensing are introduced by ministers “without sufficient parliamentary scrutiny and democratic accountability”, the NPA said in a submission to MPs last week.
The Medicines and Medical Devices Bill would replace powers currently contained in EU legislation, set to expire at the end of the transition period of the UK's departure from the trading bloc.
A lack of "equivalent delegated powers” could lead to “negative impacts on patient outcomes, population health and the UK’s competitiveness in the food and life sciences sectors”, according to the Bill's impact assessment.
“Overblown” hub-and-spoke benefits
The NPA believes that claims about the benefits of the hub-and-spoke model “are overblown” and argues that it could reduce “competition and choice in the pharmaceutical wholesale market without a level playing field”.
“Other unintended consequences could be less resilience of the medicines supply system and rises in medicines prices,” it added.
In its submission to ministers, the NPA said that “it is a concern that the government has acknowledged in its own impact assessment of this bill that the costs and benefits [of the hub-and-spoke model] remain uncertain.”
The NPA is therefore calling for the Bill to “require both full consultation with stakeholders and sufficient parliamentary scrutiny”, NPA chief executive Mark Lyonette said last week (June 12).
Debate in Parliament
Last week (June 8), MPs discussed an amendment to the Bill that, if adopted, would mean ministers only had powers to modify the regulations for two years.
Shadow health minister Alex Norris, who introduced the amendment during the debate, said the hub-and-spoke model is a “very live debate in the field of pharmacy” and that it would mean a “radical change” for the sector.
Mr Norris invited MPs to accept the amendment and have a “proper consultation with the sector and with citizens”.
However, pharmacy minister Jo Churchill said she does not see the benefits of amending the Bill. Endorsing the amendment could instead “run the serious risk that we would cease to have the legal powers” required to make the changes necessary to “address a patient safety risk or to improve access to medicines and all innovative therapies,” she said.
“We wish to empower small pharmacies to be able to use a hub-and-spoke model to secure their place on the high street and to ensure that, with appropriate training for technicians, the clinician can be freed to move forward, as per the pharmacy contract, to give advice to patients as part of the primary care team,” Ms Churchill added.