Pharmacy Voice flags flawed assumptions in Human Medicines Regulations consultation

Pharmacy Voice today expresses significant concerns on the Department of Health consultation on Human Medicines Regulations (HMR) 2012 and the Medicines Act 1968. Publishing its response Pharmacy Voice – which represents AIMp, the CCA and the NPA – criticises the short timeframe and content of the consultation and calls on the Department of Health to publish the evidence used to justify their proposals around hub and spoke dispensing.

Rob Darracott, Chief Executive of Pharmacy Voice commented,
“The proposed changes to enable ‘hub and spoke’ dispensing were first announced against a backdrop of uncompromising and arbitrary funding cuts being imposed on the community pharmacy sector. This subsequent consultation does not shed any further light on what basis the Department of Health believes the proposed changes to the HMR 2012 will make the dispensing process more efficient or how it will lower operating costs.
Importantly, there is still no consistency in the terminology being used to describe what the Government is trying to achieve, and there is no indication of how the consequent complex legal and professional issues will be resolved. The opportunity for constructive, informed policy engagement has been constrained by the rushed and poorly timed consultation.
Pharmacy Voice believes it is a flawed assumption that hub and spoke dispensing must be more efficient, cost-saving or safer and we do not recognise the validity of the assumptions which are proposed to form the basis of the impact assessment. Currently there are no ‘hub and spoke’ dispensing models operating across different legal entities and therefore no data that could be used to extrapolate from. If the Department has such data or hypotheses we call on them to publish it without delay.
With regard to proposals to display medicine pricing on labels we do not believe there is substantiated evidence from the UK that it will improve quality or efficiency, or indeed have the effect the Secretary of State wants, which is to remind people that NHS services – including items which may be free at the point of use – are funded by taxpayers. Until we have this we are opposed to introducing pricing on labels which could compromise patient safety and dissuade many from adhering to their prescribed medication.
We hope our response and the significant concerns of our members are heeded and amendments are not rushed through to meet any further arbitrary deadlines.”

About the consultation:
The Department of Health consultation seeks comments and views on a number of proposed changes to the Human Medicines Regulations 20121 and the Medicines Act 19682. The regulations are UK-wide.
The proposals address four separate issues with the aim to:

• Enable the use of ‘hub and spoke’ dispensing models by ‘spoke’ pharmacies that do not form part of the same retail pharmacy business as the ‘hub’ pharmacy;
• Permit dispensing labels to include the indicative cost of a medicine and a statement about how that cost is met, should this be required under NHS terms of service for medicines dispensed as part of the NHS pharmaceutical services;
• Clarify the dispensing label requirements of the Human Medicines Regulations 2012, in particular by updating the labelling requirements for monitored dosage systems to reflect current practice and by ensuring products supplied under patient group directions have a dispensing label in line with professional guidance; and
• Redesign the ‘exemptions for pharmacists’ in section 10 of the Medicines Act 1968 in respect of the preparation and assembly of medicines, using the clarification of the law provided by the Court of Justice of the European Union (CJEU) in a recent judgment, so that businesses can be confident that the uses they are making of the relevant exemptions are legally secure.

Our full response is available below:

PV Response_DH_HMR2012_200516