New legal regulation of polish aesthetic medicine procedures is coming

New legal framework for the aesthetic medicine

For a long time, there has been a discussion about the admissibility of qualifying aesthetic medicine treatments within the scope of the definition of a health service regulated in Article 2 section 1 point 10 of the Act on Medical Activity  as: ‘activities aimed at preserving, saving, restoring or improving health and other medical services resulting from the treatment process or separate provisions regulating their performance’.

The case was finally decided on 26th of May 2021 by the Supreme Court, issuing a decision in the case conducted under file ref. no. I KK 23/21.

Briefly recalling the circumstances of the mentioned ruling, it should be pointed out that the defendant, found guilty of the alleged professional malpractice, in the form of a violation of Article 10 section 1 of the Code of Medical Ethics, in conjunction with Article 2 section 2 of the Act on the Profession of Physician and Dentist in conjunction with Art. 53 of the Act on Medical Chambers, in her cassation against the decision of the Supreme Medical Court she alleged, on the basis of Article 2 section 2 of the Act on the Profession of Physician and Dentist in conjunction with Article 2 section 1 point 10 of the Act on Medical Activity, that the breast augmentation procedure was wrongly classified as a health care service. According to the defendant, the medical court was not entitled to establish liability for the procedure performed because it constituted a “service to the consumer” and not a health service. From this argumentation, it was deduced that the common court should have jurisdiction in the case. The Supreme Court, not sharing this interpretation, stated:

“Without analysing at this stage the very concept of a health care service (more on this later), it must be emphasised that a violation of the principles of professional deontology by a doctor or a dentist may occur not only in connection with the provision of a health service understood in accordance with the definition contained in Article 2 section 1 point 10 of the Act of 15 April 2011 on therapeutic activity (…), but also in connection with other activities recognised by the legislator as ‘practising the profession of a doctor’.”

In addition, the Supreme Court pointed out that, as interpreted by the Supreme Medical Court, the classification of a breast augmentation procedure by injecting Aquafilling into a patient’s breasts as a health service. According to the Supreme Court, this follows directly from Article 90 section 1 of the Act on Medical Products, according to which the preparation used was classified in Class III of medical products, which was unambiguously expressed in the instructions for use of Aquafilling, which explicitly stated that only a doctor may apply it. The Supreme Court ruled:

“The Supreme Court expresses this position being fully aware of the lack of precise legal regulation concerning the performance of so-called non-therapeutic aesthetic medicine procedures. Undoubtly, this area requires urgent intervention by the legislature, as pointed out by the participants in the cassation proceedings. The Supreme Court also notes that the jurisprudence of administrative courts has repeatedly expressed the view that non-therapeutic aesthetic medicine procedures are not health services (cf. inter alia the judgment of the Voivodship Administrative Court in Warsaw of 30 May 2016, VII SA/Wa 385/16). However, it was not the responsibility of the Supreme Court hearing this case to formulate general principles in this area. It is clear that the notion of non-therapeutic aesthetic medicine procedures encompasses a variety of activities, with a very different degree of invasiveness, carried out using a variety of devices, including medical products. When hearing the cassation in this case, the Supreme Court only examined, and in the light of the cassation charges raised by the defence counsel, whether the Supreme Medical Court did not commit a gross violation of the law by holding the defendant – a dentist – professionally liable for taking medical action with the use of a medical device (specifically, performing a medical procedure reserved exclusively for doctors) in a subject matter other than that provided for in Article 2 section 2 of the Act on the Profession of Physician and Dentist.”

This ruling has therefore strongly actuated the need to regulate the market for aesthetic medicine services

On 11th of August 2022 a draft of the Regulation of the Minister of Health on the professional skills of physycians and dentists, according to which there will be a new catalogue of types and codes of professional skills regulating the qualifications of doctors and dentists who will be able to apply for certification of professional skills. The Regulation will be the implementation of the statutory delegation contained in Article 17, section 26 of the Act on the Profession of Physician and Dentist. It should be emphasised that the right to grant a certificate of professional skills will be reserved to a scientific society of national range conducting scientific activity for at least 5 years prior to the date of submission of the first application for certification of a given professional skill or to a state research institute referred to in Article 21 of the Act of 30 April 2010 on research institutes (Journal of Laws of 2022, item 498), participating in the health care system, competent for a given professional skill entered in the register kept by the director of the Centre for Medical Postgraduate Education. Remarkably, doctors who acquire practical skills through specialisation training and whose number of procedures performed, as defined in the specialisation programme, is sufficient to be recognised as professional skills, no longer need to reconfirm these skills through certification.

There are two annexes to this draft, which respectively contain a list of the professional skills in which a doctor or dentist can obtain a professional skills certificate (Annex 1) and a list of the qualifications of a doctor and dentist as a condition for applying for a professional skills certificate, set out in Annex 2.

Aesthetic medicine services await a regulatory revolution

In accordance with the Supreme Court’s demand expressed in the aforementioned ruling, aesthetic medicine is included in Annex 1 to the published draft regulation of the Minister of Health under item 26 with professional skill code 026. In accordance with that, all medical and medical-dental specialities will be required to apply for a certificate of professional competence in this area.  Respectively the title of doctor or dentist authorised to practise will be decisive. The explanatory memorandum to the project emphasises that the procedure introduced by the regulation will constitute the exclusive means of achieving certification of professional skills of a doctor or dentist.

The community of doctors and dentists engaged in aesthetic medicine procedures anticipates the addition of a catalogue of procedures falling within the scope of certification to the draft regulation. At this moment, on 29th of January 2021 a position on the adoption of a definition of aesthetic medicine was taken by the Supreme Medical Council (Position No. 1/21/VIII) by proposing the following definition:

“Aesthetic medicine consists of health services, involving interference with human tissues, provided by doctors and dentists for the purpose of restoring or improving the physical and psychological well-being and social functioning of the patient by altering his or her appearance.”

In summary, services from the aesthetic medicine industry are facing a regulatory revolution. All treatments that will fall under the as yet vague conceptual scope of ‘aesthetic medicine’ will only be able to be performed by doctors or dentists who are authorised to practise their profession and who hold a certificate of professional competence under code 026 or have completed a first or second degree specialisation in this field. A broader analysis will be possible once the scope of the term ‘aesthetic medicine’ has been defined in a binding manner.