Licensing and further regulation of non-surgical procedures: business and regulatory impact assessment

Section 5: Next steps and implementation

Recommendations/ preferred options

The Scottish Government plans to give effect to the proposals included in the consultation response through a combination of primary and secondary legislation. This impact assessment is published following the introduction of the Bill before the Scottish Parliament. This Bill will give direct effect to the proposals by making it an offence to provide one of the procedures described in the consultation response as Group 2 and Group 3 procedures outwith a “permitted premises” which is defined as one of:

• An independent hospital registered with Healthcare Improvement Scotland (HIS), or an independent healthcare clinic registered with HIS and in which an appropriate healthcare professional provides services;
• A GP or Dental practice which provides NHS services; or
• A registered pharmacy.

In the context of this legislation an appropriate healthcare professional is one of:

• A medical practitioner (doctor);
• A dentist;
• A nurse or midwife who is an independent prescriber; or
• A pharmacist independent prescriber.

The Bill will also create an offence of providing a procedure regulated by the Bill to someone under the age of 18, and provide appropriate enforcement powers for HIS.

The Bill will also delegate additional powers to Scottish Ministers, both to allow them to make provision in respect of novel procedures or other changed circumstances, and to allow them to provide additional provision to give effect to the elements of the Scottish Government proposals relating to:

• Supervision of procedures;
• Restriction of certain procedures (group 3 in the consultation) to an appropriate healthcare professional; and
• Setting a training or qualification standard for procedures.

The Scottish Government proposes to address these issues in secondary legislation following the Bill, although this legislation would also have to await further consideration of the impact of the UK Internal Market Act 2020 (UKIMA).

In addition to the Bill and legislation under it, the Scottish Government proposes to establish a licencing scheme using powers under the Civic Government (Scotland) Act 1982. Under the proposals the Scottish Government intends to have both a premises and a practitioner licence. The premises element will be similar to existing licensing schemes already run by local authorities, whereas the practitioner licence will be more novel. The Scottish Government proposes that the premises licence should be implemented ahead of the practitioner licence. The Scottish Government is also considering the impact of UKIMA on the practitioner element of these proposals. Finally, additional secondary legislation will be required to make some changes to regulations under the National Health Service (Scotland) Act 1978, to support integration of new HIS functions and provide the proposed easement to the regulations relating to staffing of HIS settings.

Implementation considerations/ plan

The Bill and the proposed Order to establish a premises licencing scheme are intended to progress within the current parliamentary session. The date on which the licensing scheme comes into force will be discussed with local authority representatives and businesses and be set out in the legislation itself. The Scottish Government proposes to leave no less than six months between the Order being made and the licensing scheme coming into force. The commencement for the offences and other provisions of the Bill will be discussed with HIS and businesses once the Bill passes in Parliament and receives Royal Assent. The decision about commencement is to be deferred to allow for any changes that may be made to the Bill during its parliamentary process.

The matters included in this Bill will not all require the same adjustment period for businesses. The offence of providing a procedure to a person under the age of 18 is not considered to be a change that is likely to require a long preparation or adaptation time, as the Scottish Government understands that many businesses already decline to carry out procedures on persons under the age of 18, and they do not form an important part of many businesses models.

On the other hand the requirement for procedures regulated by the Bill to be conducted in permitted premises is likely to be more a more substantial ask for businesses as set out in this impact assessment, as such the Scottish Government proposes to provide time for businesses to reasonably adapt before the relevant offence comes into force. The Scottish Government will work with businesses, as well as HIS, in determining an appropriate schedule that balances the strong desire to regulate this sector against the need to support those businesses that are able to adapt. The Scottish Government will also continue to consider advice and support for businesses in this period.

The Scottish Government will consider the wider need for guidance as legislation progresses through Parliament. Engagement with businesses and other stakeholders over such guidance is likely to commence after the passage of the Bill or the making of the licensing Order. The Scottish Government also expects to work with businesses and practitioners around the appropriate level of training in advance of any training standard being put into place.

Timing of secondary legislation under the Bill to put in place a training or qualification standard, establish supervision requirements or to restrict procedures to appropriate healthcare professionals will be subject to several considerations:

• The development of the proposed training standard (with sufficient time being allowed for practitioners to attain additional training if required);
• Feedback from HIS and local authorities on the practicality of enforcement; and
• Further consideration of the potential impact of UKIMA.

Engagement with the UK Government and the other devolved administrations

As noted elsewhere in this impact assessment the UK Government is also progressing plans for further regulation in this sector. The Scottish Government will continue to engage with the UK Government on these plans. With different regulatory contexts it is unlikely that regulation of these sectors will be entirely harmonised, but where it would appear to increase clarity for consumers or businesses the Scottish Government will continue to work with the UK Government. This engagement will continue during the implementation of proposals, and may be especially relevant in terms of establishing any training standard, as such this may form a further consideration in the implementation of that standard.

Post implementation review

The Scottish Government will keep implementation under consideration as elements of the proposals are put into place. No formal review is currently planned, but once implemented proposals in the Bill will mainly have an impact on the scope of activity regulated by HIS. As such, it may be more appropriate to review the implementation of these proposals alongside wider HIS functions.

Declaration

I have read the Business and Regulatory Impact Assessment, and I am satisfied that it represents a fair and reasonable view of the expected costs, benefits and impact of the policy, and that these have been taken into account when making the policy decision. I am satisfied that business impact has been assessed with the support of businesses in Scotland.

I am also satisfied that officials have considered the impact on consumers as required by the Consumer Scotland Act 2020 in completion of the Consumer Duty section of this BRIA.

Signed:

Date:

Jenni Minto MSP

Minister for Public Health and Women’s Health