The aesthetic medicine and healthcare sector associated with aesthetic treatments has experienced significant growth in recent years. At the same time, there has been a considerable increase in regulatory scrutiny by the Portuguese authorities, particularly by the Portuguese Health Regulatory Authority (Entidade Reguladora da Saúde – “ERS”).
Between 2023 and the end of the first half of 2026, the ERS received complaints and reports concerning at least 476 establishments suspected of providing healthcare services in the field of aesthetics without all legally required conditions being duly met.
As a result of the inspection and enforcement actions carried out, 21 suspensions of activity were ordered, with a significant proportion of these cases relating to the identification of professionals who did not hold the appropriate qualifications to perform the procedures in question.
One of the issues that most frequently arises in this sector is precisely where, from a legal perspective, a purely aesthetic activity ends and the provision of healthcare services begins.
In this regard, the use of descriptions such as “beauty centre”, “beauty institute”, “beauty clinic” or “medical spa” does not, in itself, exclude the application of healthcare legislation.
What is legally relevant is the specific nature of the treatments performed, the products and equipment used, the degree of invasiveness of the procedures and the professional qualifications required of the individuals carrying them out.
Procedures such as the administration of botulinum toxin, injectable hyaluronic acid, biostimulators, thread lifts, platelet-rich plasma, certain laser treatments and other invasive procedures may fall within the regulatory framework applicable to the provision of healthcare services.
Accordingly, one of the first questions that any operator in this market should consider is:
Are the services we provide legally classified as aesthetic services or do they constitute healthcare services?
The answer to this question will, to a large extent, determine the legal and regulatory framework applicable to the business.
Where the activity constitutes the provision of healthcare services, there may be an immediate obligation to register the establishment with the ERS. This registration constitutes a separate legal requirement and should not be confused with the licensing or authorisation required for the operation of the establishment.
Depending on the nature of the activity carried out, it may also be necessary to comply with the specific requirements applicable to medical clinics and consulting rooms, including requirements relating to premises, equipment, human resources, clinical management, clinical records, insurance and internal procedures.
Accordingly, before opening an establishment, or whenever a clinic intends to introduce new treatments or techniques, it is essential to verify whether the existing authorisations, registrations and licences remain adequate for the activities actually being carried out.
Furthermore, not all treatments may be performed by any professional. The use of certain medicines, medical devices or invasive techniques may be legally restricted to professionals holding specific qualifications or professional authorisations.
A clinic’s management should therefore not limit its assessment to whether a particular practitioner has experience or has completed private training courses in relation to a specific treatment.
It is necessary to assess, in each case: (i) the legal classification of the procedure; (ii) the professional qualifications legally required; (iii) whether the products used qualify as medicinal products or medical devices; (iv) the legal conditions governing their use; and (v) whether the specific activity falls within the legally permitted scope of practice of the relevant professional.
This assessment is particularly important because the provision of healthcare services by professionals who do not hold the necessary qualifications has been one of the principal grounds for suspension of activity ordered by the ERS.
One of the most significant risks for any clinic is the possibility of inter-interim or precautionary measures being imposed.
Where the ERS considers that there is a serious risk to the health or safety of patients, it has powers to order the immediate suspension of specific acts, procedures or activities.
In practice, this means that regulatory irregularity may cease to be merely an administrative compliance issue and may quickly become a significant operational, financial and reputational risk for the business.
For a clinic, a suspension of activity may result in cancelled treatments, loss of revenue, client complaints, reputational damage and potential liability towards third parties.
In addition, certain circumstances may be referred to the Portuguese Public Prosecutor’s Office where there are indications of possible criminal offences, particularly where procedures have been performed by individuals who do not hold the qualifications required by law.
Regulatory scrutiny is not, however, limited to what takes place inside the clinic.
Healthcare advertising is subject to specific legal requirements relating to transparency, lawfulness, accuracy and objectivity.
Statements such as “guaranteed results”, “completely risk-free”, “entirely safe treatment” or other absolute claims may give rise to legal and regulatory concerns where they are not supported by sufficient technical and scientific evidence.
Particular care should also be taken with the correct identification of professionals, the presentation of their qualifications, the manner in which treatments are described and promoted, and the expectations that advertising campaigns may create among consumers.
Depending on the subject matter involved, the supervision and inspection of these activities may involve a number of different authorities and regulatory bodies, including the ERS, ASAE, INFARMED, the Directorate-General for Consumer Affairs (Direção-Geral do Consumidor), the relevant professional regulatory bodies and the Public Prosecutor’s Office.
This coordination between different authorities means that an inspection initially prompted by one specific issue may ultimately identify non-compliance in other areas, ranging from establishment licensing and the use of medicines or medical devices to advertising and consumer protection requirements.
In a sector that is particularly exposed to regulatory scrutiny, adopting a preventive compliance strategy is therefore of fundamental importance.
Before any potential inspection, clinics and other operators are advised to carry out a comprehensive review of their legal and regulatory position, including, in particular:
- compliance with applicable registration and licensing requirements;
- the professional qualifications of personnel;
- agreements entered into with doctors and other healthcare professionals;
- clinical management arrangements;
- the medicines and medical devices used;
- informed consent documentation;
- internal procedures and protocols;
- insurance policies;
- the Portuguese Livro de Reclamações (Complaints Book);
- price information and price lists; and
- advertising published through the various channels used by the clinic, including websites and social media.
In many cases, a preventive legal review can identify and rectify potential irregularities before they are detected in the course of an inspection or regulatory enforcement action.
Against this background, carrying out a preventive legal audit of a clinic’s activities may be a particularly effective tool for identifying regulatory risks, assessing the level of compliance and implementing, in good time, any corrective measures that may be required.
Belzuz Abogados, S.L.P. is an International law firm headquartered in Madrid, with offices in Lisbon and Oporto, advising clinics, companies and professionals operating in the healthcare and aesthetics sectors on their legal and regulatory framework, registration and licensing requirements, dealings with the ERS and other public authorities, healthcare advertising, contractual matters, consumer protection and the implementation of internal compliance procedures.