When the Pharmacy Order 2010 created the General Pharmaceutical Council (GPhC), it gave the regulator a legal duty to protect members of the public who use pharmacies and ensure anyone running a pharmacy business adheres to standards considered necessary for safe and effective practise.
The GPhC introduced standards for premises two years later, but the means to enforce those standards is not in place. The order included a system for inspectors to serve improvement notices. Failure to comply with a notice was expected to be a criminal offence, but the government never brought this system into effect. Now it has accepted a Law Commission recommendation that matters such as these should be dealt with by registration sanctions rather than the criminal courts.
Last month, the government published a draft new law. The intention is to move away from a checklist approach to compliance and instead allow pharmacy owners the freedom to decide how to meet the GPhC’s standards. We can expect those standards to cover broader areas than now, such as working arrangements, working environments and governance arrangements. There will be less emphasis on specific activities, such as record keeping, standard operating procedures (SOPs) and incident-reporting mechanisms.
Unlike now, the obligation to comply with standards will rest with pharmacy owners alone, not with a company’s superintendent pharmacist. In another significant change, the scope of the GPhC’s regulation will extend to non-pharmacy premises, which might include warehouses or premises where electronic data is stored.
When the new law comes into force, GPhC fitness-to-practise committees will have the power to disqualify premises from being used as a pharmacy. Pending a full hearing, committees will also have the power impose an immediate suspension on the use of premises as a pharmacy, if this is considered necessary for the protection of members of the public or if it is in the public interest.
The new premises standards will also give the GPhC the power to publish its inspection reports, but not the rating it gives them. It will be important for the GPhC to train its inspectors to write reports that will be read by the public; and it will be especially important to ensure that the contents of these reports are not only accurate, but are also fair to pharmacies.
David Reissner is senior healthcare partner at law firm Charles Russell Speechlys ([email protected])