Youth and beauty (on the edge between cosmetics and medicine)

AI experiment

As part of our AI experiment in roadmap24, we have curated a few prompts and asked AI about this article. Take a look and find out what ChatGPT responded*:

So, if the solution is that obvious, why are we humans so desperately trying to reverse the effects of aging? The AI again offered several logical motives, like peer pressure or cultural and social norms. Being lawyers, we chose to focus on a less subjective factor: the laws.

The concept of "rejuvenation" does not exist within the European Union as a specific legal framework. It typically refers to various EU law contexts, such as consumer protection, product safety, medical devices, cosmetics, pharmaceuticals, advertising, labelling, liability and medical malpractice.

In fact, it turns out that non-surgical aesthetic procedures like Botox, dermal fillers, chemical and laser therapies, hair transplants, CoolSculpting, dental implants, stem cells and hormone therapies inhabit the boundary between medical and cosmetic services. Their legal status is not always obvious.

We have therefore embarked on an investigation into the laws on the character of these procedures in Austria, Bulgaria, the Czech Republic, Poland, Slovakia, Slovenia and Romania. None of these countries explicitly defines or clearly differentiates between medical and cosmetic rejuvenation procedures. This means that for every procedure it is necessary to review whether it is still "cosmetic" or already a "medical intervention".

Naturally, each of these countries has laws on medical services, all of which basically state that the diagnosis and treatment of disorders and medical conditions fall within the professional profile of physicians. All measures to promote, maintain, restore or improve health are also part of the activities of the health professions. This medical reservation serves to protect patients and provide quality assurance. It also means that physicians have an exclusive right to carry out medical activities in the field of regenerative medicine.

There is no general rule, however, that all medical devices may only be operated by physicians or persons in the medical technical service, or that they may only be used for medical purposes. Thus, the same medical device may be used both for medical and cosmetic procedures. The type of procedure will depend on the type of device, the specific manner of use and the purpose of the procedure.

Invasive aesthetic mesodermal interventions are considered medical services in the laws of all seven countries we investigated.

Austria, Bulgaria, Czech Republic, Poland, Slovakia, Slovenia and Romania

In Bulgaria, these procedures are explicitly listed in the medical standard for "Plastic-restorative and aesthetic surgery".

Being medical services, they can be performed only by healthcare professionals and in healthcare establishments. This is the case in all seven jurisdictions we examined. The educational requirements for healthcare professionals and the legal requirements for the healthcare establishment are defined in detail by the laws of each jurisdiction.

The Czech Trade Licensing Act prescribes requirements for two trade licences that might fall under the term "cosmetic practices". These are cosmetic services, such as the application of cosmetic products encompassing decorative cosmetics intended for the care of the entire skin. Then there are activities during which the integrity of human skin is violated, like permanent makeup, tattooing and piercing.

In Austria, the same practices are generally considered "cosmetic practices". They only require one trade licence. As a regulated trade, proof of qualification must be provided. For piercing and tattooing, the qualification must be obtained and proven in addition to the general skin care and decorative cosmetics qualification as laid out in the relevant ordinance.

The Slovak Trade Licensing Act also prescribes requirements for a trade licence that could relate to "cosmetic practices", where the cosmetic services may also include deep cleansing and non-invasive oxygen skin refreshment. The Bulgarian legislator takes a similar view.

Slovenian law does not explicitly outline "cosmetic practices". From the Slovenian Crafts Act they can be understood as permanent, small-scale manufacturing or services based on individual orders that do not use automated production processes or require significant personal involvement. Specific craft types are detailed in the Craft Activities Regulation. Individuals performing cosmetic activities in Slovenia should have upper secondary technical education as cosmetic technicians.

Generally, in all seven countries, cosmetic activities do not require a medical degree. The educational requirements may vary depending on the invasiveness of the procedure.

Due to recent legislative developments, Poland and Romania will be outlined in more detail.

Poland

Polish law only defines medical practice, and more specifically curative activity, which means activity in providing health services. Curative activity can only be carried out by doctors, nurses and physiotherapists. Invasive aesthetic interventions such as Botox applications, fillers, DHI and the like would be classified as curative activities.

The law differentiates between a cosmetologist and cosmetic services technician. However, neither of these professions grants the title of doctor, nurse or physiotherapist, and the law does not indicate the differences in these professions. Beauty salons can be registered as a civil partnership, commercial partnership or sole proprietorship.

The discussion at this point is revolving around aesthetic medicine. The Ministry of Health issued a Decree, dated 13 June 2023, to organise the medical activity. Aesthetic medicine is still not defined in Poland, but "aesthetic-restorative medicine" has been included as a professional skill of doctors and dentists. The regulation again does not specify but presents a very general framework. Unfortunately, this does not fix the problem of defining aesthetic medicine. It is therefore unclear which treatments are invasive enough to be performed only by doctors and which may be performed by a cosmetologist or cosmetic services technician. The most precise act here is the Presidium of the Supreme Medical Council of 15 April 2021 on the authorisation of procedures included in aesthetic medicine, which advocates for all procedures involving an injection or autologous collection to be performed only by doctors.

Romania

Given the rise of innovative treatments and procedures and the need to upgrade the legal framework, in August 2023 Romania's Ministry of Health released a draft regulation for hygiene norms for beauty salons, tattoo, piercing and dermal implant studios. While still subject to amendments, the draft notably aims to also cover body care, aesthetic procedures and innovative treatments. Body care may involve the application of cosmetic products and new technologies for relaxation, fat reduction and non-invasive body remodelling procedures that tone muscles and skin, restore skin elasticity, refresh and revitalise.

It is envisaged that the following advanced practice aesthetic procedures may be performed in beauty salons: aesthetic appliance procedures, derma-pen mesotherapy, chemical peeling, microdermabrasion, radiofrequency, laser therapy and body contouring treatments.

Also, advanced practice aesthetics includes aesthetic services in the following categories:

• advanced exfoliation, microdermabrasion, chemical or enzymatic exfoliation and other exfoliation methods that go beyond the stratum corneum;
• advanced skin care treatments using electrical energy treatments, including light therapy, galvanic current, microcurrent, high frequency, radio frequency and sound waves, lymphatic drainage, advanced extractions, laser;
• mesotherapy
• other personal cosmetic services on the epidermal layer of the skin;
• innovative treatment carried out in compliance with the manufacturer of the instruments/devices.

On the other hand, facial recontouring and rejuvenation procedures, as well as lip recontouring and augmentation, may not be performed in beauty salons.

The draft regulation is expected to clarify the line between cosmetic and medical procedures. It also seems to suggest that some procedures may be performed by specialists in cosmetic procedures. Others, like hair implants or other invasive procedures, may be performed only by specialised medical doctors.

authors: Iliyana Sirakova, Elena Todorova, Monika Voldánová, Libuše Dočekalová, Peter Devínsky, Paulina Klimek-Woźniak, Miriam Gajšek, Oana Constantinescu