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23 MAI 2013. - Law regulating the qualifications required for non-surgical cosmetic medicine and cosmetic surgery

ALBERT II, King of the Belgians,
To all, present and to come, Hi.
The Chambers adopted and We sanction the following:
CHAPTER 1^{er. -} General provision
Article 1^er. This Act regulates a matter referred to in Article 78 of the Constitution.
CHAPTER 2. - Definitions
Art. 2. For the purposes of this Act:
1° non-surgical aesthetic medicine: any non-surgical medical technical act, carried out using any instrument, chemical substance or device using any form of energy, involving a passage through the skin or mucous membranes, and intended primarily to alter the physical appearance of a patient for aesthetic purposes, excluding any therapeutic or reconstructive purpose. Are included in devices using any form of energy devices using Class 4 or higher laser or intense pulsed light;
2° cosmetic surgery: any surgical act aimed primarily at modifying the physical appearance of a patient for aesthetic purposes, excluding any therapeutic or reconstructive purpose;
3° lipoaspiration: surgical operation consisting of aspiration of greasy clusters;
4° lipofilling: surgical operation consisting of fat injection;
5° dermabrasion: surgical operation consisting of abrasing the epidermis or the upper layers of the dermis.
CHAPTER 3. - Scope of application
Art. 3. The sole authority to perform acts relating to aesthetic surgery or non-surgical aesthetic medicine is the professionals referred to in this Act and to the sole extent of the authorization set out in this Act.
CHAPTER 4. - Medical art and patient rights
Art. 4. In Article 1^erbis, 3°, of Royal Decree No. 78 of 10 November 1967 concerning the exercise of the professions of health care, inserted by the law of 19 December 2008, the words "or to accompany it in the end of life" are replaced by the words ", to modify its bodily appearance for mainly aesthetic purposes or to accompany it in the end of life".
Art. 5. Article 2, § 1^er, of the same Royal Decree, as amended by the Act of 13 December 2006, is supplemented by two subparagraphs as follows:
"Also removes from the illegal exercise of medical art the usual accomplishment by a person not meeting all the conditions referred to in paragraph 1^er, in respect of a human being, of any medical technical act, involving a passage through the skin or mucous membranes, and primarily aimed at altering the patient's physical appearance for aesthetic purposes, excluding any therapeutic or reconstructive purpose.
The King may, pursuant to section 46ter, specify the acts referred to in paragraph 4. »
Art. 6. In the same Royal Decree, an article 46ter is inserted as follows:
"Art. 46ter. The King may specify the acts that fall within the meaning of non-surgical aesthetic medicine or cosmetic surgery, referred to in article 2, 1° and 2°, of the law of ... regulating the qualifications required to perform non-surgical cosmetic medicine and cosmetic surgery, after the advice of the Medical aesthetics council. »
Art. 7. Article 1^er of the Royal Decree of 25 November 1991 establishing a list of specific professional titles reserved for medical art practitioners, including dental art, last amended by the Royal Decree of 15 September 2006, is supplemented by the words "physician specialist in non-surgical aesthetic medicine".
Art. 8. In Article 2, 2°, of the Law of August 22, 2002 on the Rights of the Patient, the words "or to accompany it in the end of life" are replaced by the words ", to modify its bodily appearance for mainly aesthetic purposes or to accompany it in the end of life".
CHAPTER 5. - Empowerments
Art. 9. The sole authority to carry out all acts relating to non-surgical aesthetic medicine and aesthetic surgery, the holders of a particular professional title of a medical specialist in plastic, reconstructive and aesthetic surgery or a medical specialist in surgery referred to in section 1^er of the Royal Decree of 25 November 1991 establishing a list of specific professional titles reserved for medical art practitioners, including dental art, referred to as "the Royal Decree of 25 November 1991".
Art. 10. § 1^er. Holders of the special professional title of medical specialist in non-surgical aesthetic medicine referred to in section 1^er of the Royal Decree of 25 November 1991 are entitled to carry out all acts of non-surgical aesthetic medicine, with the exception of intra-mammary injections.
§ 2. Holders of the special professional title of medical specialist in non-surgical aesthetic medicine referred to in section 1^er of the Royal Decree of 25 November 1991 are also authorized to carry out the following acts of aesthetic surgery:
1° hair transplant;
2° lipofilling in all parts of the body, apart from the mammary area, with a maximum of 10 millilitres of liquid injected by act;
§ 3. The King may specify the acts referred to in paragraph 2, after the advice of the Medical Esthetics Council.
Art. 11. § 1^er. The holders of the special professional title of medical specialist in dermato-veenerology referred to in section 1^er of the Royal Decree of 25 November 1991 are entitled to carry out all acts relating to non-surgical aesthetic medicine, with the exception of intra-mammary injections.
§ 2. The holders of the special professional title of medical specialist in dermato-veenerology referred to in section 1^er of the Royal Decree of 25 November 1991 are also authorized to carry out the following acts of aesthetic surgery:
1° hair transplant;
2° dermabrasion;
3° lipoaspiration with a maximum of one litre of aspirated material by act, including infiltration fluid;
4° lipofilling in all parts of the body, apart from the mammary area.
§ 3. The King may specify the acts referred to in paragraph 2, after the advice of the Medical Ethics Board.
Art. 12. The holders of the special professional titles of a medical specialist referred to in the Royal Decree of 25 November 1991, listed below, are entitled to carry out all acts related to aesthetic surgery or non-surgical aesthetic medicine, each within the limits of the anatomical framework of their specialty, as set out below:
1° doctor specialized in ophthalmology: orbital-palpabrale region;
2° doctor specialized in stomatology: lips and oral region;
3° doctor specialized in oto-rhino-laryngology: ear pavilion and nasal region;
4° doctor specialized in gynaecology-obstetrics: breast gland, abdominal region and female genitalia;
5° doctor specialized in urology: male and female genital organs;
6° doctor specializing in the special professional title of doctor specialist in oral and maxillofacial surgery: face and neck.
Art. 13. Physicians who hold the position of general practitioner referred to in section 1^er of the Royal Decree of 25 November 1991 which follows a vocational training as a medical specialist in non-surgical aesthetic medicine referred to in section 1^er the same royal decree may continue the practice of general medicine during their training and for the two years following the obtaining of the title of medical specialist in non-surgical aesthetic medicine referred to above.
Art. 14. The holders of one of the special professional titles reserved for the holders of a legal degree from the Licensee in Dental Sciences referred to in Article 3 of the Royal Decree of 25 November 1991 are entitled to carry out all acts related to aesthetic surgery or non-surgical aesthetic medicine in the intraoral region.
Art. 15. The beauticians with professional skills established by the King are empowered to use the grade 4 laser removal techniques or by intense pulsed light, if they have followed a training set by the King.
This training allows the targeted beauticians to have minimal practical and theoretical knowledge about the hazards associated with the use of Class 4 lasers and intense pulsed light, and on the precautions of using these techniques.
For the use of a technique referred to in paragraph 1^er, the King may, in addition, make mandatory the prior consultation of a health care professional referred to in Royal Decree No. 78 of 10 November 1967 concerning the exercise of health care professions.
Art. 16. Without prejudice to the application of the ministerial order of 30 April 1999 setting out the general criteria for the approval of specialist physicians, internship masters and internship services, training doctors for one of the specific professional titles referred to in articles 9 to 12 are entitled to perform the same acts as the holders of the particular professional title of this specialty under the supervision conditions provided for in the legislation relating to the training of trained doctors for a particular professional title.
Art. 17. Acts related to non-surgical aesthetic medicine or cosmetic surgery can only be performed on a minor through the written consent of the legal representative or legal representatives of the minor.
Any act related to non-surgical aesthetic medicine or cosmetic surgery on a minor is the subject of prior consultation between the minor, his legal representative or his legal representatives and a psychiatry specialist or a psychologist. This consultation is the subject of a written report which is an integral part of the medical record of the minor patient.
CHAPTER 6. - Information and consent
Art. 18. § 1^er. Prerequisitely to any act of cosmetic surgery or non-surgical aesthetic medicine, the responsible practitioner shall provide the following information to the patient and, where applicable, to his or her legal representative or legal representatives:
1 the techniques and conditions for the realization of the act;
2° potential major risks and possible major consequences and complications;
3° the type of implanted or injected product including its name and characteristics (volume, measurements, quantity);
4° the contact information of the producer and, where applicable, the importer of the implanted material or injected product;
5° the identity and professional title of the practitioner or practitioners performing the planned act;
6° a detailed fee assessment when the amount of the fee related to the planned act is valued at more than 1,000 euros. This amount is indexed to 1^er January of each year following the following indexing formula: base amount x new health index/basic health index. The basic health index is the one effective December 31, 2012. The new index is the one that will successively take place on December 31 of each year.
§ 2. For any act of cosmetic surgery, the responsible practitioner provides the information referred to in paragraph 1^er in a prior consultation.
§ 3. The information referred to in paragraph 1^er are the subject of a written record, dated and signed by the patient or, where appropriate, its legal representative or legal representatives and the practitioners concerned. This report is an integral part of the patient's medical record.
When several identical acts, at the level of the technique and product used, are carried out in the same treatment, the information referred to in paragraph 1^erare the subject of a single report as referred to in the previous paragraph.
§ 4. The text of this article is reproduced on the record referred to in paragraph 3.
§ 5. The information referred to in paragraph 1^er shall be provided to the patient, and, where appropriate, to his or her legal representative or legal representatives, without prejudice to any other information to be provided under other provisions, or to the manner in which such information shall be communicated or maintained.
Art. 19. The signature of the record referred to in Article 18, § 3, paragraph 1^er, by the parties shall make the period provided for in Article 20.
Art. 20. For any act of aesthetic surgery, a minimum period of fifteen days is between the signature of the record referred to in Article 18, § 3, paragraph 1^er, and the planned act.
During this period, the practitioner may not be required or obtained for this act any consideration or financial commitment except for the fees for the prior consultations of the act.
CHAPTER 7. - Criminal provisions
Art. 21. Without prejudice to the application of the penalties provided for in the Criminal Code, as well as, if it is purchased, the application of disciplinary sanctions, the doctor or dentist who, in violation of articles 9 to 16, performs an act of aesthetic surgery or non-surgical aesthetic medicine skillfully without being authorized in accordance with this Act, shall be punished by imprisonment of one month to one year and a fine of ten euros
Art. 22. Without prejudice to the application of the penalties provided for in the Criminal Code and, where applicable, to the application of disciplinary sanctions, the practitioner referred to in this Act who commits an offence under section 17, 18 or 20 shall be liable to imprisonment for eight days to six months and to a fine of two hundred and fifty euros to five thousand euros or only one of these penalties.
CHAPTER 8. - Medical Esthetics Council
Art. 23. It is created a Medical Esthetics Council.
The King defines the composition and functioning of this Council. This Council consists of holders of the Physician degree and for half of holders of the special professional title of a doctor specializing in plastic, reconstructive and aesthetic surgery, referred to in section 1^er of the Royal Decree of 25 November 1991. The Commission also includes holders of the special professional title of a medical specialist in non-surgical medical aesthetics and holders of the special professional title of a medical specialist in dermato-veenology.
CHAPTER 9. - Transitional measures
Art. 24. § 1^er. A period of exercise of non-surgical aesthetic medicine, of at least three years of full-time or of a part-time equivalent duration, may be validated as a valant for all or part of the training leading to the particular professional title of a non-surgical cosmetic medicine specialist. The application must be filed within two years after the entry into force of Article 10.
§ 2. Holders of a master's degree in medicine or equivalent that may justify a regular experience of more than five years of non-surgical aesthetic medicine practice on the day this article comes into force are allowed to practice non-surgical aesthetic medicine.
The application for authorization must be filed within one year of the entry into force of this section.
During this period, holders of a master's degree in medicine or equivalent who may justify a regular experience of more than five years of practice of non-surgical aesthetic medicine on the day of the entry into force of this article remain permitted to practice non-surgical aesthetic medicine.
§ 3. The holders of a master's degree in medicine or equivalent that may justify a regular experience of more than five years of practice of lipoaspiration on the day of the entry into force of this article are entitled to practice this act, with a maximum of one litre of aspirated material by act, including infiltration fluid. The authorization request must be filed within one year of the entry into force of this section. During this period, holders of a master's degree in medicine or equivalent who may justify a regular experience of more than five years of practice of lipoaspiration, on the day of the entry into force of this article, shall remain entitled to practice this act, with a maximum of one litre of matter sucked by act, including infiltration fluid.
§ 4. Requests referred to in paragraphs 1^er, 2 and 3 are processed according to the procedure applicable to applications for accreditation for the special professional title of a medical specialist in non-surgical aesthetic medicine.
§ 5. As long as the training referred to in Article 15, § 1^er, will not have been defined by the King, without this period exceeding one year from the entry into force of this article, the requirement of this training is replaced by a statement on the honour of the relevant esthetician, certifying that it has the skills required for the use of grade 4 laser removal techniques or by intense pulsed light.
§ 6. Until the entry into force of Article 10, holders of a master's degree in medicine or equivalent are empowered to perform all acts of non-surgical aesthetic medicine and acts of aesthetic surgery referred to in Article 10, § 2.
CHAPTER 10. - Entry into force
Art. 25. Article 10 comes into force on a date to be fixed by the King and no later than 1^er September 2014.Promulsify this Act, order that it be clothed with the seal of the State and published by the Belgian Monitor.
Given in Brussels on 23 May 2013.
ALBERT
By the King:
Minister of Social Affairs and Public Health,
Mrs. ONKELINX
Seal of the state seal:
The Minister of Justice,
Ms. A. TURTELBOOM
____
Note
Documents of the Senate:
5-62 - S.E. 2010:
N° 1: Proposal by Ms. Tilmans, Mr. Claes, Ms. Temmerman, Lijnen and Thibaut, Mr. du Bus de Warnaffe, Ms. Piryns, Mr. Brotchi and Mrs. de Bethune.
5-62 - 2010/2011:
No. 2: Opinion of the State Council.
5-62 - 2011/2012:
No. 3: Amendments.
No. 4: Opinion of the State Council.
5-62 - 2011/2012:
No. 5: Amendments.
Number 6: Report.
No. 7: Text adopted by the commission.
No. 8: Amendments.
Number 9: Report.
No. 10: Text adopted by the commission.
No. 11: Text adopted in plenary and transmitted to the House of Representatives.
5-62 - 2012/2013:
No. 12: Draft amended by the House of Representatives and referred to the Senate.
Number 13: Report made on behalf of the commission.
No. 14: Decision to join the draft amended by the House of Representatives
Annales du Senate: April 18, 2013.
Documents of the House of Representatives:
Doc 53 2577/ (2012/2013):
001: Project transmitted by the Senate.
002 and 003: Amendments.
004: Report.
005: Text adopted by the commission.
006 : Erratum
007: Text adopted in plenary and referred to the Senate
Full report: 21 March 2013.