Licensing and Regulation of Healthcare in Malta
The licensing and regulation of healthcare providers and professionals in Malta
i) Regulators
Public health, healthcare providers, and professionals are subject to regulatory oversight by the Maltese national competent authorities, in particular the Superintendent of Public Health that falls under the Ministry for Health. In the case of medicinal products the Licensing Authority (the Superintendent of Public Health) and the Medicines Authority. The regulatory supervision covers all procedures and operations in manufacturing, wholesale dealing, pharmacies, selling, and dispensing medicinal products. The layered regulatory system, consists of laws, primarily the Public Health Act, and the Medicines Act and subsidiary legislation. The latter implements European Directive 2001/83 with underlying regulations, licensing conditions, and guidance documents published by the Medicines Authority which interpret standards included in statutory provisions.
ii) Institutional healthcare providers
Licensing of private medical clinics
The Licensing of Private Medical Clinic Regulations (SL 458.23) regulates the licensing of private hospitals and day-care medical clinics. Medical practitioners’ consulting rooms are explicitly excluded. Licence applications are made in writing to the Health Minister and sent to the Ministry for Health. The licence may be refused for any of the reasons listed in the Regulations and the issuance of a licence is subject to conditions, including the number of patients that can be treated.
Revocation of licences
Article 5 of the Private Medical Clinic Regulations states:
(1) the Minister may refuse to issue or renew, or may withdraw a licence in respect of a clinic if he is satisfied
- (a) that the applicant, or any person employed or proposed to be employed by the applicant to assume responsibility for the clinic is not of good conduct; or
- (b) that for reasons connected with the physical location, construction, state of repair, accommodation, staffing or equipment, the clinic is not fit to be used as a clinic; or
- (c) that the clinic is, or any premises used in connection therewith are, used, or proposed to be used, for purposes which are not related to the clinic or which are in any way improper, unethical or not lawful; or
- (d) that the clinic or any premises to be used in connection therewith consist of or include works executed in contravention of the Development Planning Act; or
- (e) that the arrangements for the management and control of the services provided at the clinic are not adequate.
Appeals
Where a licence has been refused or is not renewed or has been withdrawn, the applicant or licensee, as the case may be, may within 30 days of receipt of notice of refusal, non-renewal or withdrawal of licence, appeal to a tribunal to be appointed by the President of Malta and made up of a person who has, for at least seven years, been in possession of a warrant to practice the legal profession in Malta as chairman, and two other members, one from among the medical profession and the other who shall be a representative of the department.
iii) Healthcare professionals
The Health Care Professions Act (Chapter 464 of the Laws of Malta) regulates the licensure, registration, and conduct of healthcare professionals.
Licences
Medical practitioners, dental surgeons, pharmacists, and midwives must be in possession of a licence issued by the President of Malta, fulfil Maltese/EU citizenship or work authorisation criteria, be of good conduct, and must be registered as a member of the profession by one of the following relevant councils:
- the Medical Council;
- the Pharmacy Council;
- the Council for Nurses and Midwives; and
- the Council for the Professions Complementary to Medicine.
A ‘specialist’ means a medical practitioner or dental surgeon whose name is included in the relevant part of the specialist register kept by The Medical Council in accordance with the Health Care Professions Act. Inclusion in the specialist register is subject to conformity with qualification and accreditation requirements prescribed by EU and Maltese law.
Community pharmacists
In Malta, registered pharmacists should carry out at least one of the functions listed in the regulations, such as the preparation of the pharmaceutical form of medicinal products, manufacturing medicinal products, and dispensing to and supporting patients. The concurrent practice of medicine, as a medical practitioner, and pharmacy is not permitted. Pharmacists are bound to comply with national laws and regulations, and the Pharmacy Council’s Code of Ethics for the Pharmaceutical Profession.
Pharmacy licence
All countries in the WHO European Region, including Malta, require a licence to open and operate a community pharmacy. In Malta the licence is attached to a specific location and premises, subject to inspection before the licence is issued by the national authority – in Malta’s case, the Superintendent of Public Health. The law imposes obligations on owners or licence holders of pharmacies, who may be non-pharmacists. The official title to designate the responsible pharmacist is ‘managing pharmacist’.
A pharmacist that takes up or ceases his or her obligations as responsible pharmacist (RP) must inform the Medicines Authority.
In Malta medicinal products, including over-the-counter medicines, are dispensed to patients by a pharmacist from a licensed pharmacy. The main applicable laws are the Medicines Act (Chapter 458 of the Laws of Malta) and the Pharmacy Licence Regulations (Subsidiary Legislation 458.16). Pharmacies must comply with the standards, and maintain premises, stock, reports, and registers as established by law. The law limits the number of pharmacies that may operate in Malta. Any licence holder may transfer an existing pharmacy licence to another person by means of an application to the Licensing Authority.
Published by Lexology on 7 September 2022 as an extract from the Malta chapter of The Healthcare Law Review 8thedition authored by Dr Anthia A Zammit
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