Scottish Cosmetic Interventions Expert Group Report July 2015

4. Existing regulation in Scotland

History

Regulation of cosmetic interventions provided by the independent health care sector in Scotland was set out in the Regulation of Care (Scotland) Act 2001. There are a range of National Care Standards published by the Scottish Government which apply to various services including:

• Independent hospitals
• Private psychiatric hospitals
• Independent specialist clinics
• Independent medical consultants and GP services

The regulation of independent hospitals and private psychiatric hospitals was introduced but the remainder of the powers to inspect independent clinics and independent medical agencies were not commenced.

Following reports on the provision and regulation of cosmetic surgery in England, the Chief Medical Officer for Scotland requested the Scottish Medical and Scientific Advisory Committee (SMASAC) to review the situation in Scotland in 2005. Their report in December 2006 included recommendations on professional accountability, training and patient safety. A key recommendation was the regulation of all remaining parts of the independent health care settings should commence. There is a lack of clarity on the rationale for the non-progression of the recommendations from the SMASAC report. However, the challenges in implementation included the rapidly evolving nature of the sector, with its diverse range of providers and consumers.

In addition, prior to the commencement of those sections of the 2001 Act the responsibility for regulating independent health care transferred to Healthcare Improvement Scotland (HIS) on the 1st April 2011 via the Public Service Reform (Scotland) Act 2010. This Act uses the same definition of an independent clinic as the Regulation of Care (Scotland) Act 2001 i.e. "means a clinic which is not comprised in a hospital and in or from which services are provided, other than in pursuance of this Act, by a medical practitioner or a dental practitioner". As comments had been received that the extant legislation was insufficient, the Scottish Government consulted on the future arrangements for the regulation of independent health care in Scotland and sought views on the definition and scope of these services. The report on the consultation was published in 2011^[6].

From 2010 to 2012 the Poly Implant Prothese (PIP) silicone breast implant fraud dominated much of the cosmetic industry workload. The results of these events ultimately led to the setting up of SCIEG.

Protection and gaps

As the above indicates, for over a decade regulation providing some protection has been in place for those receiving cosmetic procedures in independent hospitals. Regulated health care professionals working in any setting are also responsible to their regulatory bodies for their practice and therefore need to adhere to guidance on consent, prescribing, clinical care and reporting adverse events. In non-health care settings there is a range of health and safety legislation applicable to beauty therapists, most of whom have trained for a minimum of three years. The guidance on the delivery of botulinum toxin, a medicine that must be prescribed has been regularly updated. In 2013, the General Medical Council (GMC) updated its guidance on remote prescribing, stating:

"62. You must undertake a physical examination of patients before prescribing non-surgical cosmetic medicinal products such as Botox, Dysport or Vistabel or other injectable cosmetic medicines. You must not therefore prescribe these medicines by telephone, video-link, or online".^[7]

The Nursing and Midwifery Council and the General Dental Council have similar guidance on the delivery of botulinum toxin.

The gaps identified both in the 2011 consultation report and in the work of the SCIEG are any inspection of the premises and all staff in independent clinics; the definition of a clinic in terms of which regulated health care professional provides the services; and the lack of any regulation apart from health and safety legislation of the provision of non-surgical procedures in any facility other than a hospital.

In the UK the gaps include the use of dermal fillers, some of which are not subject to the EU's Medical Devices Directive and therefore only subject to General Product Safety Regulations. The replacement of the Directives for Regulations currently going through the European Parliament process seeks to ensure that a range of currently unregulated cosmetic products are included by extending the scope to include "certain implantable or other invasive products without a medical purpose that are similar to medical devices in terms of characteristics and risk profile (e.g. non-corrective contact lenses, implants for aesthetic purposes);" As part of the replacement of the Directives for Regulations, the Member States and the European Commission are in discussion on whether to introduce legislation as proposed to mandate the recording of device unique device identifier (UDI). The impact will be that once a UDI is recorded electronically, it will give speedier and better information on use and traceability. The outcome of the debates for new legislation will be known in 2015/6, and the SCIEG backs this development.

The CAP provided updated guidance on marketing both surgical and non-surgical cosmetic interventions in 2011^[8] and new guidance on the social responsibility of time-limited deals for cosmetic interventions^[9]. SCIEG supports these guidance documents with non-confirmed reports of a reduction in unacceptable marketing campaigns but poor practice is still occurring. It is not clear whether the general public and relevant businesses know that these guidance documents exist.

National Care Standards

The Standards were first published in 2002 and based on "outcomes for services users". They have informed the process by which Healthcare Improvement Scotland inspects services, such as independent hospitals. As the environments have changed in terms of day services, more complex care, and as the care of users has become more multi-focal, the Scottish Government undertook a review in 2014^[10].

Responses to the consultation provided support for a shared set of standards for health and care to be developed so that people working in health and care services have a common understanding of what quality means and work to common core values.

Legal implications

To improve regulation usually requires legislative changes. Major primary new legislation (ie a new Bill or section of one) has to compete for Parliamentary consideration. The timescale for introducing new Bills is long and Parliamentary time is very limited. It is possible to make secondary legislative changes to existing laws through Statutory Instruments which have a formal but faster process as they are adapting extant legislation. For example, commencing the inspection of independent clinics requires a Statutory Instrument, while linking the use of dermal fillers to regulated health care professionals requires new legislation.