HDA UK raises fundamental concerns on Government Hub and Spoke Proposals
- Hub and spoke technology is at a very early stage and its impact is unclear
- Crucial to make distinction between hub and spoke and centralised dispensing
- The MHRA should be responsible for regulating hub-to-spoke transportation
London: 19th May 2016: The Healthcare Distribution Association (HDA UK) has responded to the Government’s Human Medicines Regulations 2012 Consultation by agreeing that the hub and spoke playing field should be levelled to allow independent pharmacies access to the same technology as vertically integrated chains.
However, it has raised fundamental concerns regarding the Government’s proposals which do not recognise that hub and spoke technology is at a very early stage and the consequences of its introduction are not fully understood. Therefore, estimates that 45% of medicines will be dispensed through hub and spoke appear on the high side.
The HDA also has concerns that removing the current legislative impediment could open medicines distribution to new providers who might not be required to match the same high quality and safety standards, mandated by the MHRA, and provided by HDA member companies through their commitment to the MHRA-endorsed HDA Gold Standard of Good Distribution Practice. Although these new providers would be subject to GPhC pharmacy regulations, the distribution standards are not compatible with those currently in place for wholesale distribution. The HDA therefore argues that:
- The MHRA should be responsible for inspecting hubs and hub-to-spoke transportation to ensure they comply with wholesaling levels of European Union regulations for Good Distribution Practice (GDP).
- Pharmacy regulations for the appropriate storage and transportation of medicines should be reviewed to take into account the changes in pharmacy storage and transportation models prompted by hub and spoke.
It is also imperative that the distinction is made between hub and spoke and centralised dispensing. The HDA feels it is crucial that the patient-pharmacist relationship is maintained and therefore does not support centralised dispensing which sees prescriptions sent directly to patients. It is a model that has been shown to be challenging and a substantial risk to patients receiving their medicines safely and in a timely manner. However, hub and spoke technology does have the potential of freeing-up the time of ‘spoke’ pharmacists to deliver further patient-centric services.
Finally, the HDA has asked the Government to look into additional issues raised by the consultation, namely:
- The impact from hub and spoke on the implementation of the EU Falsified Medicines Directive (FMD)
- The need for contingency planning as a result of stock being centralised in large hubs
- The potential disruption to the certainty of supply of medicines, which could be caused through the challenging of any existing supply arrangements between pharmaceutical manufacturers and wholesalers