Stage 1 report: Non-surgical Procedures and Functions of Medical Reviewers (Scotland) Bill

Under the exemption from the Bill’s provisions for procedures provided by health care providers for the prevention, diagnosis or treatment of an illness, the Committee notes that regulated healthcare professionals (who qualify as health care providers in this context) are defined as persons regulated by any of the eight councils listed in section 1(3). The Committee acknowledges that section 4(3) of the Bill goes on to define a shorter list of healthcare professionals who can provide or manage non-surgical procedures in an independent clinic registered with HIS – one of the categories of ‘permitted premises’ defined by the Bill. However, the Committee is concerned that listing these eight councils could create the impression that any of the healthcare professionals regulated by these eight councils could deliver these procedures in an independent clinic. Therefore, the Committee would recommend making clear in guidance accompanying the Act that, in order for an independent clinic to qualify as “permitted premises”, there must be a healthcare professional who meets the narrower definition in section 4(3) either providing the services or managing them.

The Committee acknowledges concerns expressed by some of those businesses currently providing non-surgical procedures about the Scottish Government's proposed approach to regulation of these procedures.

To alleviate these concerns, the Committee asks the Scottish Government to provide appropriate support and guidance to help responsible providers of non-surgical procedures to make the transition successfully to the new regulatory framework.

At the same time, the Committee recognises that patient safety must be the over-riding priority. It supports the two-tiered approach being taken by the Scottish Government where higher risk procedures will only be permitted to be undertaken in permitted premises under supervision from authorised medical practitioners, and lower risk procedures will be subject to a licensing scheme to be introduced via secondary legislation.

The Committee highlights significant evidence from its Stage 1 scrutiny that the Bill lacks detail on the question of clinical supervision including minimum requirements for supervision, clinical as well as managerial aspects of supervision, and minimum qualification requirements for those providing supervision. While acknowledging that a lot of this detail will need to be addressed in secondary legislation, the Committee calls on the Scottish Government, in responding to this report, to set out its proposed approach, including what precisely that secondary legislation will cover and provide the Committee with an update on discussions with the UK Government regarding UKIMA.

The Committee has gathered extensive evidence of a huge variability in the quality of training and qualifications available to and held or undergone by those currently providing non-surgical procedures. The Committee is firmly of the view that establishing clear and appropriate standards in this area will be critical to the Bill’s successful implementation and enforcement. In this context, the Committee seeks assurance from the Scottish Government that secondary legislation related to the Bill (including Scottish and UK legislation) governing training, qualifications and standards will address the following:
UK-wide alignment of education and training standards;
ensuring all providers are suitably trained and qualified in health protection and infection control;
ensuring all providers are similarly suitably trained and qualified to be able to undertake patient mental health screening and to ensure properly informed consent;
ensuring all providers have a suitable level of training and qualification to be able to manage complications safely and effectively should they arise;
ensuring that people are unable to act as providers if the training they have received falls short of recognised standards.

As highlighted earlier in this report, the Committee has also heard evidence that having the status of a regulated health care professional does not, of itself, demonstrate any prior experience of the non-surgical procedures covered by the Bill that would be necessary to fulfil the supervisory responsibilities envisaged by the Bill to a suitably high standard. The Committee therefore reiterates its call for the Scottish Government, in responding to this report, to set out what minimum training and qualification standards within the discipline of non-surgical procedures covered by the Bill supervising clinicians will additionally be required to demonstrate.

In accordance with the evidence it has received during its scrutiny, the Committee strongly supports the provisions of the Bill that would make it an offence to provide any non-surgical procedure covered by the Bill to someone under the age of 18.

The Committee has heard strong evidence to suggest that, as currently set out, the level of sanctions against those committing offences under the Bill will be an insufficient deterrent to those bad actors willing to commit repeat offences who may consider repeat fines to be an acceptable cost of continuing to operate outside the law. The Committee, therefore, calls on the Scottish Government to set stronger penalties for offences committed under the terms of the Bill.

The Committee also recognises that it may take time for responsible operators that want to comply with the law to take the steps necessary to achieve full compliance – and that there will also be a need for additional information and support to be provided to accompany the Bill’s implementation to help providers to take the steps necessary to comply with the law. The Committee calls on the Scottish Government to set out its plans in this area, including whether it plans to provide any financial support to businesses.

The Committee recommends that the Scottish Government engages meaningfully with independent aesthetic practitioners to understand how they will be impacted by the Bill, what forms of support would be most helpful and to ensure they are kept informed during the implementation process.

The Committee is therefore strongly supportive of a staged approach to enforcement that gives responsible operators the time and support they need to achieve full compliance while appropriately punishing those irresponsible operators that commit repeat offences and show no signs of taking the necessary steps to comply with the law.

The Committee has heard concerns as to whether Healthcare Improvement Scotland has sufficient capacity and resources to be able to enforce the Bill effectively once implemented. While acknowledging Healthcare Improvement Scotland's long term ambition that its enforcement functions will become self-financing from registration fee income, the Committee seeks assurances from the Scottish Government that, in the short term, it is committed to putting in place the necessary additional funding to allow HIS to properly enforce the Bill from the outset and to amend the Financial Memorandum accompanying the Bill to reflect this.

The Committee calls on the Scottish Government to publish an implementation route map to ensure HIS has the systems and resources in place to adequately inspect and enforce the provisions of the Bill should it become an Act. This should include details and timescales for when suitable training, digital systems and evidence handling processes will be in place. It should also include details of how HIS will be expected to work with other agencies including Police Scotland and local authorities to enforce the provisions of the Bill and the related licensing scheme that is proposed to be regulated under the Civic Government (Scotland) Act 1982.

The Committee has concluded from evidence that the implementation of this Bill offers an opportunity to gather much more systematic data on non-surgical procedures, including rates of complication and rates of success by individual procedure. More systematic data-gathering is also a prerequisite for effective implementation and enforcement of the Bill and to monitor and evaluate its impact.

The Committee further notes suggestions that Health Improvement Scotland would be well placed to fulfil a data-gathering function as part of its enforcement of the Bill but that fulfilling such a role would require the commitment of additional resource. The Committee therefore calls on the Scottish Government, in responding to this report, to set out what additional data-gathering it anticipates taking place as part of the Bill’s implementation, who will be responsible for gathering this data and what, if any, additional resources will be made available to support data-gathering.

The Committee notes a general consensus in evidence around the need for the Bill’s implementation to be accompanied by a public information campaign to raise awareness of the risks associated with certain non-surgical procedures and to explain how the law is changing in this area. The Committee therefore calls on the Scottish Government to commit the necessary resources to support such a campaign and to amend the Financial Memorandum accompanying the Bill to reflect this.

While acknowledging that the regulation of advertising of non-surgical procedures is outside the scope of the current Bill and is a policy area largely reserved to the UK Government, the Committee calls on the Scottish Government to set out what further steps it intends to take, in collaboration with the UK Government where appropriate, to tackle the negative impact of misleading advertising of non-surgical procedures.

The Committee is similarly concerned by evidence it has received regarding the classification and regulation of certain substances used in non-surgical procedures. It therefore calls on the Scottish Government to indicate what further action it will take to address these concerns, where appropriate in coordination with the UK Government and the Medicines and Healthcare products Regulatory Agency.

The Committee acknowledges concerns that a rise in costs and reduced accessibility of procedures covered by the Bill resulting from its implementation could result in some consumers engaging in cosmetic tourism to access these procedures elsewhere in the UK or abroad. The Committee concludes that this risk further reinforces the case for a public information campaign to accompany the Bill’s implementation to allow individuals to make properly informed decisions about whether, how and where they access these procedures.

The Committee is supportive of the changes proposed in Part 2 of the Bill, noting that allowing interested persons to request a review of a MCCD even when it has already been randomly selected for review will make the process more fair and that removing the need for further authorization when someone has died outwith Scotland but within the UK will avoid unnecessary delays and duplication of work.

In conclusion, the Health, Social Care and Sport Committee draws its conclusions and recommendations on the Bill to the attention of the Parliament and recommends that the general principles of the Bill be agreed to.

The Committee is supportive of the changes proposed in Part 2 of the Bill noting that allowing interested persons to request a review of a MCCD even when it has already been randomly selected for review will make the process more fair and that removing the need for further authorization when someone has died outwith Scotland but within the UK will avoid unnecessary delays and duplication of work.

The Health, Social Care and Sport Committee draws its conclusions and recommendations on the Bill to the attention of the Parliament and recommends that the general principles of the Bill be agreed to.