Independent hospitals have been regulated by Healthcare Improvement Scotland (HIS) since 1 April 2011 and from 1 April 2016, independent clinics where services are provided by a medical practitioner, dental practitioner, registered nurse, registered midwife or dental care professional have also been regulated by HIS.
Following a consultation in early 2023 on various aspects of the regulation of independent healthcare services, we intend to amend current regulations in order to:
1. regulate independent healthcare 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. regulate independent medical agencies providing healthcare 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.
The analysis of the consultation be found here. This further consultation is required to ensure that the fees required for the effective regulation of independent healthcare services is fairly implemented.
Section 10Z5 of the National Health Service (Scotland) Act 1978 (The 1978 Act) states that HIS must impose fees in respect of:
a. applications for registration or for cancellation of registration of independent healthcare services;
b. the annual continuation of any such registration;
c. applications for the variation or removal of a condition of registration under the 1978 Act; and
d. issuing to a person a new certificate of registration—
(i) at the instance of that person;
(ii) by virtue of any application by that person; or
(iii) by virtue of any new information provided by that person in pursuance of regulations under this group of sections (within the meaning of section 10S(2)(a)).
In fixing fees under section 10Z5 of the 1978 Act, HIS must have regard to its reasonable expenses in carrying out its functions.
The Healthcare Improvement Scotland (Fees) Regulations 2016, which commenced on 1 April 2016, prescribe the current maximum fees for registration, continuation, cancellation, and application made for the variation or removal of a condition of registration which may be imposed by Healthcare Improvement Scotland.
The regulation of independent healthcare by HIS should be self-funded. However the Scottish Government agreed to provide HIS £260,000 annually from 2022-23 as HIS advised that income from fees was not keeping pace with the growth in, nor the cost of regulating, independent healthcare services. The increase in fees will work towards addressing the gap in funding required for the regulation of independent healthcare, however we anticipate an annual SG fund will be required to address any shortfall.
Since the maximum fees that HIS is able to charge to regulate independent healthcare services were set in 2016, HIS continues to review its costs for carrying out its regulatory functions annually and consults with independent healthcare services prior to any increases in fees.
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