The pharmacy regulatory model was ‘designed in a different era’ and could need a creative rethink in order to be ‘right for the future’, the chief executive of the General Pharmaceutical Council (GPhC) has said.
In an evidence session to the parliamentary Health and Social Care Committee (HSCC) today, Duncan Rudkin highlighted ‘gaps’ in current regulatory arrangements, as well as issues around regulating pharmacy premises and online providers.
And Mark Koziol, chair of the Pharmacists’ Defence Association (PDA), suggested that regulatory change to incorporate business entities and non-pharmacist managers would be helpful.
Mr Rudkin highlighted that pharmacy businesses were unique among the health professions in that their premises are regulated by the GPhC rather than the Care Quality Commission (CQC), which regulates other healthcare premises.
‘That regulatory jurisdiction of ours based on a building, the premises being registered, that made sense, perhaps, when it was originally designed,’ Mr Rudkin said.
But he suggested that the issue of premises regulation was ‘something that needs to be looked at’, explaining that pharmacy services now often operated ‘in a way that is not necessarily tied to a particular building’.
He added that there was ‘entirely sensible’ discussion to be had’ around whether pharmacy business entities should be regulated in the way that opticians are, rather than the regulation being tied to each pharmacy premises.
And he highlighted that under the current system it was possible for issues to fall outside of the jurisdiction of any regulator.
‘I think it's incumbent on us working with the other regulators, including, in England, particularly the CQC and MHRA [Medicines and Healthcare Regulatory Agency], to make sure that between us we don't allow anything to fall between the cracks,’ Mr Rudkin told the HSCC panel.
For instance, he drew the committee’s attention to the fact that when a business uses pharmacists to provide clinical care, but does not do so through a registered pharmacy, it would not be liable to be regulated by either the GPhC or CQC.
According to Mr Rudkin, the two regulators have asked the government to look at this issue in particular.
‘I mention it as an example really, of just needing to look perhaps creatively at the regulatory furniture to make sure that it is right for the future – not an old model that's not serviceable,’ Mr Rudkin added.
The GPhC is set to look at the issues from the pharmacy regulator’s perspective in more detail over the next year, he noted.
Mr Koziol then shared the PDA’s long-held position that community pharmacy premises should be regulated by the CQC, while the GPhC should regulate pharmacy professionals.
And he suggested that non-pharmacist managers and pharmacy businesses as an entity should also be regulated.
‘We've got to involve the regulation of people who operate the businesses and the non-pharmacists in the healthcare space,’ he said.
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