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Should pharmacy fear a super regulator?

28 Mar 2018

How would Government plans to merge health regulators into one super-sized organisation affect community pharmacists? Léa Legraien investigates

Complicated and, in some cases, controversial, the regulation of healthcare professionals is intricate and costly. In 2016/17, the nine existing health regulators spent £308m on carrying out their duties – an increase of nearly £113m since 2010 – according to their annual reports.

To those outside the profession, it may also seem unnecessary that there are so many different health regulators when, on the surface at least, their aims appear to be similar.

This may have been what the Department of Health and Social Care (DHSC) was thinking last year when it sought views  on how the regulation of healthcare professionals could become more efficient. Keen to update a system that is, in some cases, more than 150 years old and eager to streamline a sector made up of nine different regulatory bodies, the DHSC consulted on whether or not it should merge the health regulators into one so-called ‘super regulator’.

Pharmacy, of course, is already regulated by the General Pharmaceutical Council (GPhC) in England, Scotland and Wales; and Northern Irish pharmacy professionals by the Pharmaceutical Society of Northern Ireland (PSNI). So what would it mean for pharmacy if all nine regulators were merged into one super-sized organisation?

Would a super regulator save money?

Research from the Centre for Health Service Economics and Organisation (CHSEO) suggests that health regulators are most efficient when they have between 100,000 and 200,000 registrants. But more than half of them currently have less than 100,000 registrants, which ‘contributes to additional costs of the regulatory system’, according to the DHSC.

The CHSEO estimates that a whopping £38m would be saved each year if all health regulators but the Nursing and Midwifery Council (NMC) were consolidated into a super regulator of 640,000 registrants.

There is also great variation between the various regulators’ fees, with annual fees ranging from £90 to £890 per registrant.

Therefore, not only would fewer regulators ‘deliver greater consistency in the way that professional regulation is carried out but also cost savings by spreading some fixed costs across a greater number of registrants’, argues the DHSC.

But the GPhC remains unconvinced by this argument. It believes that many of these savings could be made through the regulators simply working more collaboratively, rather than by actively merging them together.

Ade Williams, superintendent pharmacist at Bedminster Pharmacy in Bristol, believes that ‘a change simply viewed as a measure to reduce administrative cost won’t serve anyone well’.

He says: ‘Any change must be evidence led, with well-presented arguments made convincingly, detailing how it would support professionals to provide better care and how public safety would be improved.

‘In a world of super regulation, I fear that pharmacy would be one of many voices.’

Would pharmacy’s voice get lost in translation?

If the proposals come into effect, both the GPhC and the PSNI could be scrapped, as they have 89,377 and 2,470 registrants, respectively.

According to its consultation response, the National Pharmacy Association (NPA) fears that getting rid of pharmacy’s bespoke regulators could mean that the sector’s specific needs wouldn’t be met.

Nitin Sodha, chair of the NPA’s policy and practice committee, says: ‘As the third largest healthcare profession, pharmacy requires a bespoke regulator in line with the medical and nursing professions.’

If pharmacy regulation were merged with other healthcare professions, the ‘GPhC could lose its expert understanding of practice and standards, with the risk outweighing the possible benefits of efficiencies through size’, says law firm Charles Russell Speechlys (CRS), in its consultation response.

David Reissner, a partner at the firm, says: ‘Pharmacy doesn’t have enough in common with other healthcare professions to warrant bundling pharmacy in with them.

‘Pharmacy regulation is least in need of reform because it has one of the newest regulators and the most up-to-date regulatory regime of all the healthcare regulators.’

Would a super regulator understand pharmacy’s needs?

There are huge differences between healthcare professions, and what might apply to one may not work for another.

The potential danger of a super regulator resides in its lack of understanding of the sector. A non-pharmacy specialist regulator may well have fewer pharmacists in leadership positions and therefore less understanding of the different roles within the profession.

The NPA says: ‘Clarity is needed about the makeup of the council following an amalgamation of regulators.

‘While we can see some benefit from a multi-professional council aligning with a need for the delivery of healthcare to be better integrated, we have an overwhelming concern about a lack of both depth and breadth in the understanding of professional matters in a super regulator.

‘Currently, both [the GPhC and the PSNI] have pharmacists on their respective councils and their respective personal experience would facilitate the various discussions at council meetings which in turn may influence current policy.’

Would pharmacy regulation become more lenient?

Compared with other professions, pharmacy is heavily regulated. The GPhC is responsible for the regulation of both registrants and premises as well as having a statutory inspectorate, which other healthcare professions aren’t.

Pharmacy also has numerous statutory provisions whose breaches, such as inadvertent dispensing errors, were criminal offences until recently.

CRS says: ‘A regulator that isn’t dedicated to pharmacy may struggle to get to grips with the raft of regulation and criminal offences that are unique to pharmacy.

‘It would be anomalous to have one profession that is subject to a raft of criminal offences.’

What would happen to issues that really matter to pharmacists?

Any changes would undoubtedly lead to costs alongside amendments to regulatory legislation.

Mike Holden, principal associate at consultancy company Pharmacy Complete, thinks that ‘it would be an administrative and a cultural challenge, as regulators all operate very differently’.

‘Managing change is always a challenge for everybody. If you’re not careful, you end up managing the change and not the job.

‘It would be a very significant piece of work to make it happen. We need the right people doing the right things for the right reasons.

‘That change would need investment. You may have an increase in cost, which would have to come from somewhere,’ he says.

In 2013, the DHSC introduced the Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board – which is made of pharmacists, regulators and patient representatives – to develop proposals to balance the sector’s legislation and regulation.

The board has been considering the ongoing decriminalisation of dispensing errors and is currently looking into supervision.

As the GPhC and PSNI sit on the board, discussions and decisions to date have been predicated on the two regulators.

The NPA argues that if these two regulators were to disappear, ‘there would be a strong possibility that this work would need to be revisited’.

Mike Hewitson, superintendent pharmacist at Beaminster Pharmacy in Dorset, says: ‘How can you empower
a regulator when you have no idea who that regulator is, let alone how they will behave or what level of understanding of pharmacy they’ll have?

‘If the new regulator has the power to decide how long a pharmacist could be absent from the pharmacy, this could have a major impact on the way pharmacy services are delivered.’

So will a super regulator ever exist?

Whether there will ever actually be a super regulator or simply fewer regulatory bodies still remains unclear.

However, there is a strong case to be made that pharmacy needs financial support to keep thriving and delivering its services to patients.

Bedminster Pharmacy’s Mr Williams says: ‘The absence of a clearly stated vision of what the DHSC expects from pharmacy makes it very difficult to determine what steps, including legislatively, are needed to get to that place.

‘It also kills ambition. Even before we start that journey, there is a need to build a consensus that the direction is right and the best one for the profession.

‘Trust certainly also needs rebuilding to carry everyone along after the events of the past few months,’ says Mr Williams.

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