The PSA – which oversees healthcare regulators including the General Pharmaceutical Council (GPhC) – published a report detailing the current state of professional health and care regulation in the UK earlier this week (September 6).

Regulators can face challenges holding corporate entities to account, as they are “outstripped financially” by them, the report noted.

This is because large pharmacy businesses “play an integral role in the delivery of healthcare in the community”, and “extreme action” from regulators could deprive patients of access to care, the PSA wrote.

While the GPhC currently holds inspection and enforcement powers, it is unable to issue fines for breaches of contract, for example, which regulators such as the General Optical Council can do, PSA director of scrutiny and quality Mark Stobbs told C+D.

The GPhC needs “an up-to-date set of powers to deal” with these businesses, Mr Stobbs suggested.

However, he noted that the GPhC does “extremely well with the powers [it currently has]”.

Meanwhile, PSA chief executive Alan Cramp thought “more enabling legislation” would help the GPhC regulate online pharmacies, which are currently seeing rapid development.

“All the regulators need to be able to respond to what’s happening now” in terms of technological innovations within the sector, Mr Cramp added.

“There’s always a bit of a risk that they’re trying to catch up with the technological changes.”

 

What did the PSA’s report propose?

 

The PSA’s report proposed a series of reforms to better calibrate regulatory functions across the UK.

It called for the “effectiveness and adequacy” of regulatory powers to “be reviewed”, taking into consideration whether these “are sufficient to protect the public and hold businesses to account”. It also suggested that UK governments extend business regulation powers to all regulators whose registrants work in high street practices.

The PSA holds that healthcare professions and high street premises should be regulated together, it stated.

The watchdog also proposed that regulators such as the GPhC should “consider whether they need to be more interventionist in their approach [to businesses’ commercial practices] where it is in the best interests of the public”.

It gave the example of the GPhC typically taking a “hands-off approach” towards commercial matters.

However, it chose to set this aside when penning a joint letter with the Competitions and Markets Authority to call out pharmacies charging inflated prices for essential products such as hand sanitiser, face masks and paracetamol during the pandemic.

The PSA called on governments to “use the regulatory reform programme to ensure that regulators have the agility to address the challenges brought about by new technologies”.

 

Actions the GPhC has taken

 

Although the GPhC could not yet provide a full response to the report’s recommendations, a spokesperson told C+D that the regulator had so far taken “robust action using [its] current powers to deal with patient safety concerns around online pharmacy”, having taken enforcement action against more than 50 online pharmacies since March 2019.

The GPhC has further restricted the registration of individual pharmacy professionals working for online pharmacies, and updated its guidance for pharmacy services at a distance.

It is also “working closely” with the Care Quality Commission, the General Medical Council and the Medicines and Healthcare products Regulatory Agency to address “how online pharmacy websites are set out, and how products and services are advertised”, the spokesperson said.

In an email to pharmacists last month (August 16), the regulator drew attention to the “serious patient safety concerns” it has over some online pharmacies and online prescribing services, revealing it had imposed interim orders on the registration of five pharmacists working for online providers in June and July.

 

Independent commissioner

 

One of the PSA’s overarching recommendations affecting all regulators is to implement a health and social care safety commissioner in every UK country.

Such a commissioner would address “the gaps between regulatory practice”, Mr Clamp told C+D.

Mr Stobbs added that the PSA would bring different regulators together to address problems that fall under their combined remits.

There is already a “basis” for this, Mr Clamp explained, as all UK regulators have signed up to the emerging concerns protocol – which allows regulators to share information about risks to service users

“I think that’s something that a patient safety commissioner could build on, and possibly extend,” he added.