Regulation of independent health care - amendments: consultation

2. Proposals for reform

We are proposing to make three changes to the way independent health care in Scotland is regulated:

1. Enable Healthcare Improvement Scotland to regulate independent health care services provided by pharmacists and pharmacy technicians which are not provided under the terms of an NHS contract or from non-General Pharmaceutical Council (GPhC) registered premises;

2. Enable Healthcare Improvement Scotland to regulate independent medical agencies providing health care services which consist of or include the provision of services by a medical practitioner, dental practitioner, registered nurse, registered midwife, dental care professional, pharmacist, or pharmacy technician. This would include independent medical agencies operating entirely online. However, services provided by either a pharmacist or pharmacy technician in pharmacy premises registered with the GPhC or a nurse agency regulated by the Care Inspectorate (officially known as Social Care and Social Work Improvement Scotland) would be exempt; and

3. Enable Healthcare Improvement Scotland to cancel the registration of any independent health care service where there has been a failure to pay continuation fees.

We would propose to make these changes by amending provisions in the National Health Service (Scotland) Act 1978 that cover Healthcare Improvement Scotland's regulation of independent health care services.

2.1 Regulation of independent health care services provided by pharmacists and pharmacy technicians

Independent clinics where services are provided by a doctor, nurse, dentist, dental care professional or midwife have been regulated by Healthcare Improvement Scotland since 2016. However, independent clinics where services are provided by pharmacists and pharmacy technicians are not currently regulated in Scotland.

In response to the consultation in 2020, 90% of respondents agreed that services provided by pharmacists who undertake independent health care services outwith the terms of an NHS contract should be regulated by Healthcare Improvement Scotland. We are aware that some pharmacy professionals are offering non-surgical cosmetic procedures and other services, such as travel advice or weight loss clinics, in premises other than registered pharmacies or those where pharmaceutical services are provided under an NHS contract. Our proposal is for independent health care services provided by pharmacists and pharmacy technicians to be regulated by Healthcare Improvement Scotland in the same way as other independent health care services.

Since the 2020 consultation, the landscape has grown considerably from 8 to potentially 26 independent health care services provided by pharmacy professionals. Therefore we are taking this opportunity to engage further and ask whether independent health care services provided by pharmacists and pharmacy technicians which are not provided from a registered pharmacy or under an NHS contract should also be regulated by Healthcare Improvement Scotland.

2.2 Regulation of independent medical agencies, including online-only services

Online health care services are often a one-off intervention where clinicians do not have access to the complete health care record of the patient and rely on the patient giving an honest medical history. They can potentially be used by vulnerable people to access medicine or quantities of medicine that would be hard to obtain from a physical premises with a face-to-face consultation.

Section 10F(2) of the National Health Service (Scotland) Act 1978 (which was inserted into that Act by section 108 of the Public Services Reform (Scotland) Act 2010) defines "independent medical agency" as:

"an undertaking which is neither an independent clinic nor an undertaking comprised in a hospital and which consists of or includes the provision of services, other than in pursuance of this Act, by a medical practitioner".

However, the provisions which establish Healthcare Improvement Scotland's functions, in respect of independent medical agencies, have not yet been commenced. This means that services which fall into the definition of independent medical agency are currently not regulated by Healthcare Improvement Scotland. We therefore propose to commence Healthcare Improvement Scotland's functions in relation to independent medical agencies to allow oversight of health services falling in this definition.

In addition, there has been a small but increasing proportion of independent health care services who are now operating solely online, with no physical premises. While the majority of online providers headquartered in England are regulated by the UK Government through the Care Quality Commission, online-only health care services headquartered in Scotland are currently unregulated.

The proposed regulation of online health care under independent medical agencies will be consistent with the approach taken by regulators in Wales and Northern Ireland, which have similar regulatory framework to Scotland. The 4 UK home nations will work cooperatively to regulate and inspect the services based in their jurisdiction.

We are proposing to enable Healthcare Improvement Scotland to regulate these services. We would do this by amending the definition of an independent medical agency in section 10F(2) of National Health Service (Scotland) Act 1978 (as detailed above). The definition would be widened to include not just independent health care services provided by a medical practitioner, but also those provided by a dental practitioner, registered nurse, registered midwife, dental care professional, pharmacist or pharmacy technician. This would mean that any health care service provided in Scotland (whether online or otherwise) by any of these individuals would be regulated by Healthcare Improvement Scotland.

However, we propose that the definition of independent medical agency would not extend to (and therefore Healthcare Improvement Scotland would not regulate) services provided by:

• pharmacist or pharmacy technician in pharmacy premises registered with the GPhC
• premises where pharmaceutical services are provided under an NHS contract, or
• a nurse agency regulated by the Care Inspectorate (known officially as Social Care and Social Work Improvement Scotland (SCSWIS), and defined in schedule 12 paragraph 4 of the Public Services Reform (Scotland) Act 2010).

This is due to the fact that these services would already be regulated.

2.3 Non-payment of continuation fees

Healthcare Improvement Scotland's regulation of independent health care is intended to be funded by fees paid by its regulated independent health care services. To legally operate in Scotland, a service must be registered which includes paying a fee to Healthcare Improvement Scotland, and services are then charged continuation fees to maintain their registration. The money from the fees funds Healthcare Improvement Scotland's regulation activities, such as inspections.

Although being registered with Healthcare Improvement Scotland is intended to be conditional upon each service paying their continuation fees, services that fail to pay their fees cannot currently be removed from the register. This undermines Healthcare Improvement Scotland's ability to self-fund its regulatory activities and means that services that repeatedly fail to pay their fees can continue to operate in Scotland.

We are proposing to allow Healthcare Improvement Scotland to cancel the registration of any independent health care service that fails to pay its continuation fees within a certain notice period.