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When problems strike in pharmacy, regulators want to be seen to be doing something. But is creating more rules really the answer? asks  Malcolm Harrison

The healthcare sector is rightly risk averse. We know that we must all work hard to ensure the highest possible standards for patient outcomes and safety, but is the balance now tipping too far towards a world where we unnecessarily regulate for every possible individual scenario, and is this stifling progress? 

This column is in no way a critique of regulation. At the Company Chemists’ Association (CCA) we absolutely see the necessity of rules, regulations and standards. In recent years we led the campaign for action against ‘pseudo-distance selling pharmacies (DSPs)’. 

As with any industry, there will always be instances of rogue actors and malpractice. This is exactly where regulation and its application are necessary.

What we must avoid, however, is always reaching to pull the lever for additional regulation. There have been several recent examples of calls for regulation, where in fact much wider issues were at play. 

Jhoots – a symptom of a lack of regulation? 

The first example is seen with the issues playing out at Jhoots pharmacies. Here, there was not a lack of necessary regulation per se, rather issues of identification and enforcement.

We know that multiple breach notices were issued to several branches, yet, when these did not lead to immediate and sustained improvements, it appears that additional action was not taken. It is unlikely that more regulatory powers would remedy situations like this, if they too are not enforced. What is needed is a greater understanding of the situation on the ground and more decisive enforcement of the regulatory powers in place. 

In the Jhoots case it is possible that a contributing factor was the fragmented system of oversight in England. The pharmacy contracts were located under the authority of different integrated care boards, with no single body providing national oversight. This added a layer of complexity, supporting the argument that it was not a lack of regulation, but inadequate enforcement, that was the fundamental issue in allowing these cases to drag on, and unnecessarily impact patients and neighbouring pharmacies.

This pattern is not isolated. Similar issues have emerged in the regulation of online pharmacies. 

The General Pharmaceutical Council’s (GPhC) revised guidance on providing services at a distance, issued earlier this year, also felt largely like a knee-jerk reaction. We recognise that there were legitimate public concerns about some online pharmacies and the remote provision of weight loss services. 

However, it seems that the updated guidance was driven by the council’s desire to be seen as acting on these concerns, following negative anecdotal press coverage. It seems there was little consideration of the wider benefits that access to online pharmacies brings to patients and the NHS. Further, the guidance drafted did not consult owners and operators of online pharmacies, emphasising how the regulation felt ‘knee-jerk’ rather than well-thought-through and reasoned.

Indeed, the underlying problem of online pharmacies not following the then existing guidance could have something to do with how such businesses were able to enter the register of pharmacies in the first place. To hear senior leaders from the regulator say that when the online pharmacies were first inspected it was found that the required processes and standards had never been in place, sounds almost like an admission of failure, rather than a lack of regulation.   

The GPhC now accepts that it is unfortunately struggling to keep up with oversight of online pharmacies. This raises the obvious question: why were these operators allowed on the register?

Within the regulatory sphere, private prescribing is at times unjustifiably assumed to be risky. A recent Department of Health and Social Care consultation reinforced this perception by seeming to assume that private prescribing has a greater risk profile than its NHS-based equivalent. While safeguards are of course needed, simply adding more regulation is not the answer. What is needed is a more rational and evidence-based understanding.

For the sector to survive, pharmacies must have the flexibility to diversify and innovate, particularly given the chronic underfunding of NHS services. This includes having the ability to offer private services. 

Treating private prescribing as a threat and rushing to place additional regulation around it creates a new risk: the risk of overburdening already stretched pharmacy teams and limiting their ability to adapt to evolving patient needs. 

Existing regulations and standards for prescribing should be sufficient, if they are applied in a consistent way that is agnostic of setting; NHS or private, online/remote or in person. 

There is, of course, an essential place for reasonable and pragmatic regulation across healthcare. However, the system must resist the impulsive urge to add more and more layers of bureaucracy whenever a new issue comes to light.  

Malcolm Harrison is chief executive of the CCA