Background/Introduction
Independent hospitals are regulated by Healthcare Improvement Scotland (HIS) from 1 April 2011 and from 1 April 2016, independent clinics where services are provided by a doctor, dentist, registered nurse, registered midwife or dental care professional are also regulated by HIS.
Following a consultation in early 2023 on various aspects of the regulation of independent healthcare services, we intend to amend the current regulations so that:
1. regulate independent health care services provided by pharmacists and pharmacy technicians, which are not provided under the terms of a NHS contract or from the non-General Pharmaceutical Council (GPhC) registered premises;
2. regulate independent medical agencies that provide health care services that consist of or include the provision of services by a physician, dentist, registered nurse, registered midwife, dental care professional, pharmacist, or pharmacy technician. This would include independent medical agencies that operate entirely online.
You can find the analysis of the consultation here. This further consultation is required to ensure that the fees required for effective regulation of independent healthcare services are applied fairly.
Section 10Z5 of the National Health Service (Scotland) Act 1978 (the 1978 Act) states that HIS must impose fees in relation to:
a. applications for registration or cancellation of registration of independent health care services;
b. the annual continuation of any such registration;
c. applications to vary or remove a condition of registration under the 1978 Act; AND
d. issues a new certificate of registration to a person-
(i) at the instance of that person;
(ii) upon any application by that person; OR
(iii) on the basis of any new information given by that person in pursuance of regulations under this set of sections (within the meaning of section 10S(2)(a)).
In fixing fees under section 10Z5 of the Act of 1978, HIS shall have regard to his reasonable expenses in the performance of his functions.
The Healthcare Improvement Scotland (Fees) Regulations 2016, which came into effect on 1 April 2016, set out the current maximum fees for registration, continuation, cancellation and an application made to vary or remove a condition of registration that may be imposed by Healthcare Improvement Scotland. .
Health care regulation independent of HIS must be self-financed. However, the Scottish Government agreed to provide HIS £260,000 per year from 2022-23 as HIS advised that fee income was not keeping pace with growth and neither was the cost of regulating independent healthcare services. The fee increase will work towards addressing the gap in funding required for independent healthcare regulation, however we anticipate a year SG the fund will be required to address any shortfall.
Since the maximum charges that HIS is able to charge to regulate independent healthcare services established in 2016, HIS continues to review its costs of carrying out its regulatory functions every year and consults with independent healthcare services before any increase in charges.