belgiquelex.be - Carrefour Bank of Legislation

13 DECEMBER 2006. - Act respecting various health provisions (1)

ALBERT II, King of the Belgians,
To all, present and to come, Hi.
The Chambers adopted and We sanction the following:
PART I^er. - General provision
Article 1^er. This Act regulates a matter referred to in Article 78 of the Constitution.
PART II. - Public health
CHAPTER I^er. - Amendments to Royal Decree No. 78 of 10 November 1967 relating to the exercise of health care professions with regard to midwives
Art. 2. In section 2 of Royal Decree No. 78 of 10 November 1967 on the Exercise of Health Professions, as amended by the Acts of 10 August 2001 and 2 August 2002, the following amendments are made:
1° in § 1^er, the words "§ 1^er or § 2" are deleted;
2° § 2 is replaced by the following provision:
“§2. By derogation from § 1^er, holders of the professional title of midwife approved in accordance with Article 21noviesdecies, are authorized to practice the delivery of the childbirth, subject to the conditions specified in Article 7.
Without prejudice to the exercise of medical art, is also the unlawful exercise of medical art, the usual accomplishment, by a person not meeting all the requirements required by paragraph 1^er of this paragraph, any act intended or presented as intended for the supervision of pregnancy, childbirth or post-partum, and any intervention related to it. "
Art. 3. In the same order, it is inserted a Chapter I^erquater titled "The exercise of the profession of midwife", including articles 21octiesdecies and 21noviesdecies, as follows:
"Art. 21octiesdecies. § 1^er. Without prejudice to the exercise of medical art as defined in Article 2, the exercise of the profession of midwife is understood:
1° the autonomous accomplishment of the following activities:
(a) diagnosis of pregnancy;
(b) the assurance, during pregnancy, childbirth and postpartum, of the monitoring of women and the dispensation of care and advice to women;
(c) the monitoring of normal pregnancies, the practice of childbirth and the dispensation of care to infants and infants;
(d) Preventive measures, research of risks in mothers and children;
(e) in the event of an emergency, the necessary actions pending specialized medical assistance;
(f) information and health education, in relation to women, the family and society;
(g) prenatal education and parenting preparation;
2° collaboration with the doctor, under the responsibility of the doctor, the care and treatment of fertility problems, pregnancies and at-risk births, and newborns who are in special conditions of illness that constitute a threat to their lives, as well as the care to be given in these cases.
§ 2. The King shall determine, after the advice of the Federal Council of Women, the acts that may be carried out under § 1^er by registered persons as holder of the professional title of midwife and, after the advice of the Federal Council of Wives, sets out the terms and criteria for accreditation to obtain the professional title of midwife.
§ 3. The King shall, after the advice of the Federal Council of Wise Women, establish the terms and conditions of special qualification allowing the holder of the professional title of midwife to prescribe medications.
The King, after the advice of the Federal Council for Women's Wise and the Royal Academy of Medicine, specifies the drug requirements that can be independently drafted as part of the monitoring of normal pregnancy, the practice of euocic births and the care of well-bearing infants in or outside a hospital. Contraceptive prescription is limited to three months after delivery.
§ 4. The King shall, after the advice of the Federal Council of Wise Women, set out the terms and criteria of particular qualification allowing the holder of the professional title of midwife to practice perineo-sphincterian rehabilitation.
§ 5. The King, after the advice of the Federal Council of Midwives, sets out the specific terms and criteria for qualification allowing the holder of the professional title of midwife to perform functional and non-morphological ultrasounds.
The King, after the advice of the Federal Council of the Wise Women and the Royal Academy of Medicine, specifies the list of reasons and situations in which the holder of the professional title of the Wise Woman can use ultrasound.
Art. 21noviesdecies. § 1^er. Accreditation as holder or holder of the professional title of midwife shall be granted ex officio to the holder of a higher education degree, issued by a school recognized by the competent authority, in the course of a specific education with at least 240 credits.
Up to 1^er October 2009, the accreditation of the professional title of midwife is granted ex officio to the holder of a higher education degree, issued by a school recognized by the competent authority, as part of a specific education with at least 180 credits.
Persons who, on the date of entry into force of the Act of 10 August 2001 on health care measures, are in possession of a diploma or title referred to as a birth attendant, are fully recognized as a holder or holder of the professional title of midwife.
§ 2. Accreditation as a carrier or holder of the professional title of midwife is granted by the Minister who has Public Health in his or her duties. In order to maintain the accreditation of the professional title of midwife, the midwife has the obligation to keep up to date on the evolution in the field of obstetrics by following a permanent training. The minimum duration and the modalities of permanent training are fixed by the King on the advice of the Federal Council of Women.
§ 3. Accreditation as holder or holder of the professional title of midwife may be withdrawn if, after receiving a warning, the interested party does not undergo permanent training. The terms and conditions for the withdrawal of the approval are set by the King on the advice of the Federal Council of Women.
§ 4. It is established with the Federal Public Service Public Health, Food Chain Safety and Environment, a Federal Council of Women's Wages, whose mission is to issue an opinion on any issue related to midwives within federal jurisdiction. "
Art. 4. In article 3, paragraph 1^er, of the same order, the words "§ 1^er or § 2" are deleted.
Art. 5. In Article 4, § 1^erParagraph 1^er, of the same order, the words "§ 1^er or § 2" are deleted.
Art. 6. In Article 5, § 1^er, paragraph 4, of the same order, as amended by the law of 9 July 2004, the words "and after the advice of the Royal Academy of Medicine" are replaced by the words ", after the advice of the Royal Academy of Medicine and after notice, each with respect to it, of the Federal Council of Women-Sages, the National Council of Nursing Art, the National Council of Kinesitherapy and the National Council of Paramedical Professions".
Art. 7. In Article 7, § 1^erParagraph 1^er, of the same decree, amended by the law of 6 April 1995, the words "at articles 2, 3, 4 and 21bis" are replaced by the words "at articles 2, § 1^er, 3, 4, 21bis and 21noviesdecies".
Art. 8. In Article 8, § 1^erParagraph 1^er, of the same order, amended by the law of 6 April 1995, the words "at articles 2, 3 and 21bis" are replaced by the words "at articles 2, § 1^er3, 21 bis and 21noviesdecies".
Art. 9. In Article 9, § 1^erParagraph 1^er, of the same decree, amended by the laws of 6 April 1995 and 25 January 1999, the words "at articles 2, 3, 4 and 21bis" are replaced each time by the words "at articles 2, § 1^er, 3, 4, 21bis and 21noviesdecies".
Art. 10. In article 12 of the same decree, the words "at articles 2, 3 and 4" are replaced by the words "at articles 2, § 1^er3, 4 and 21noviesdecies".
Art. 11. In Article 13, § 1^erParagraph 1^er, of the same order, amended by the law of 6 April 1995, the words "at articles 2, 3 or 4" are replaced by the words "at articles 2, § 1^er3, 4 or 21noviesdecies".
Art. 12. In Article 15, paragraph 1^er, of the same order, the words "at articles 2, 3 and 4" are replaced by the words "at articles 2, § 1^er3, 4 and 21noviesdecies".
Art. 13. In article 17, paragraph 1^er, of the same order, the words "at articles 2, 3 or 4" are replaced by the words "at articles 2, § 1^er3, 4 or 21noviesdecies".
Art. 14. In Article 18, § 2, paragraph 1^er, of the same decree, amended by the law of 6 April 1995, the words "at articles 2, 3, 4 and 21bis" are replaced by the words "at articles 2, § 1^er, 3, 4, 21bis and 21noviesdecies".
Art. 15. In article 19 of the same decree, amended by the law of 6 April 1995, the words "at articles 2, 3, 4 or 21bis" are replaced by the words "at articles 2, § 1^er, 3, 4, 21bis or 21noviesdecies".
Art. 16. In article 35ter of the same order, inserted by the law of 19 December 1990, the words "at articles 2, 3, 4, 5, § 2, paragraph 1^er, 21bis, 21quater and 22" are replaced by the words "at articles 2, § 1^er3, 4, 5, § 2, paragraph 1^er, 21bis, 21quater, 21noviesdecies and 22".
Art. 17. In section 35terdecies of the same order, inserted by the Act of 10 December 1997 and amended by the Act of 2 August 2002, the following amendments are made:
1 in point 1, the words "articles 2, 3, 4, 5, § 2, 21bis, 21quater and 22" are replaced by the words "articles 2, § 1^er3, 4, 5, 2, 21bis, 21quater, 21noviesdecies and 22";
2 in point 3, (b), the words "in articles 2, § 2, 3, 4, 5, § 2, 21bis, 21quater and 22" are replaced by the words "in articles 3, 4, 5, § 2, 21bis, 21quater, 21noviesdecies and 22".
Art. 18. In article 36, § 2, point 7, of the same decree, the words "two holders of the birth certificate" are replaced by the words "two holders of the professional title of midwife".
Art. 19. In Article 37, § 1^er, 2, b), of the same order, amended by the laws of 20 December 1974 and 6 April 1995, the words "at articles 2, 3, 4 or 21bis" are replaced by the words "at articles 2, § 1^er, 3, 4, 21bis or 21noviesdecies".
Art. 20. Article 38 of the same order, as amended by the laws of 20 December 1974, 13 December 1976, 22 February 1994, 6 April 1995, 17 March 1997, 10 August 2001 and 9 July 2004, are amended as follows:
1° in § 1^er(1)^er and 4, the words "at articles 2, 3, 4, 21bis or 51" are replaced by the words "at articles 2, § 1^er, 3, 4, 21bis, 21noviesdecies or 51";
2° in § 1^er3, the words "articles 2, 3, 4 or 21bis" are replaced by the words "articles 2, § 1^er3, 4, 21 bis or 21noviesdecies”;
3° in § 2, 2 the words "articles 2, 3, 4, 5, 6 and 21bis" are replaced by the words "articles 2, § 1^er3, 4, 5, 6, 21 bis and 21noviesdecies”;
4° in § 3, (a), the words "articles 2 or 3" are replaced by the words "articles 2, § 1^er3 or 21noviesdecies;
5° in § 3, (c) and (d), the words "at articles 2, 3 or 4" are replaced each time by the words "at articles 2, § 1^er3, 4 or 21noviesdecies".
Art. 21. In article 44bis, point 7, of the same order, inserted by the law of 14 June 1999 and amended by the royal decree of 25 February 2003, the words "Directives "Accoucheuses" are replaced by the words "Directives "Sages-emmes"".
Art. 22. Article 44 of the same order, inserted by the Royal Decree of 14 June 1999, is replaced by the following provision:
"Art. 44sexies. For the exercise of the profession of midwife is assimilated to the holder of the Belgian title of midwife, the European national, holder of a degree, certificate or other title of midwife meeting the provisions set by the Minister, in accordance with the provisions of the Directives "Women" and recognized by the Minister in accordance with Article 44octies, § 1^er. "
Art. 23. In article 45, § 2, of the same decree, amended by the laws of 6 August 1993 and 6 April 1995, the words "§ 1^er," are deleted each time.
Art. 24. In Article 45ter, § 1^erthe words "articles 2, 3, 4, 5, § 2, 21bis, 21quater and 22" are replaced by the words "articles 2, § 1^er3, 4, 5, 2, 21bis, 21quater, 21noviesdecies and 22".
Art. 25. In Article 46, § 1^er, of the same order, amended by the laws of 19 December 1990 and 17 March 1997, the words "in Article 2, Article 3, paragraph 3, Article 4, § 1^erand Article 5, § 2, paragraph 1^er"are replaced by the words "in Article 2, § 1^erArticle 3, paragraph 3, Article 4, § 1^erin Article 5, § 2, paragraph 1^er and Article 21octiesdecies, § 2".
Art. 26. In Article 49bis, § 1^erthe words "articles 2, 3, 4, 5, § 2, 21bis or 21quater" are replaced by the words "articles 2, § 1^er3, 4, 5, § 2, 21bis, 21quater or 21noviesdecies".
Art. 27. In article 49quater of the same order, inserted by the law of 22 February 1998, the words "articles 2, 3, 4, 5, § 2, 21bis, 21quater and 22" are replaced by the words "articles 2, 1 §^er3, 4, 5, 2, 21bis, 21quater, 21noviesdecies and 22".
Art. 28. Article 50 § 2, of the same order, as amended by the Act of 22 February 1994, is repealed.
Art. 29. Article 21noviesdecies, § 1^erParagraph 1^erthe same order, as set out in Article 3, comes into force on the date fixed by the King, by order deliberately in Council of Ministers.
CHAPTER II. - Health care
Art. 30. In section 49ter of Royal Decree No. 78 of 10 November 1967 on the Exercise of Health Care Professions, inserted by the Act of 22 February 1998 and amended by the Act of 27 December 2005, the following amendments are made:
1° in paragraph 1^er, the words "even unrecognized" are deleted;
2° in paragraph 4, the words "and related to clinical training of a doctor" are inserted between the words "as defined in paragraph 1^er"and "can not be granted";
3° paragraph 4, 2°, is replaced by the following provision:
"2° he began a training of specialist physician in a non-member third country of the European Union, of which he was successful at least the first year or was recognized as a general practitioner or specialist in a non-member third country of the European Union and wishes to acquire a particular technique or expertise in his field; ";
4° the article is supplemented by the following paragraph:
"Request for special exemptions referred to in paragraph 1^er must be introduced at least three months prior to the start of the training, using the form prepared by the Minister who has Public Health in his or her duties and must be accompanied by the evidence in this form. »
CHAPTER III. - Amendments to the Act of 5 July 1994 on blood and blood derivatives of human origin
Art. 31. In the Act of 5 July 1994 on blood and blood derivatives of human origin, an article 3bis is inserted, as follows:
"Art. 3bis. The King may set the rules for the traceability of blood and blood derivatives as defined in paragraph 2.
This traceability implies the ability to trace the path of each unit of blood or blood derived from the donor to its final destination, whether it is a receiver, a manufacturer of medications or a place of disposal, and inversely.
This traceability involves the establishment of a system that allows to identify and record without any equivocation each unit of blood or derived from received blood and thus to trace the path of each unit of blood or derived from the donor's blood to its final destination and vice versa.
The King may set specific conditions for establishments or persons to whom blood or blood derivatives may be delivered, in order to guarantee the aforementioned traceability. »
Art. 32. Article 16, § 1, 2°, of the same law is repealed.
Art. 33. The following amendments are made to section 21 of the Act:
1° to § 1^erParagraph 1^er, the words "medecins-public servants designated by the King" are replaced by the words "the staff of the SPF Public Health, Safety of the Food Chain and Environment or the Federal Agency for Drugs and Health Products, designated by the King";
2° in § 1, paragraph 4, and in § 2, the words "doctors-staffs" are replaced each time by the words "the staff of the Federal Agency for Medicines and Health Products or the SPF Public Health, Safety of the Food Chain and Environment designated by the King".
CHAPTER IV. - Federal Centre for Health Care Expertise
Art. 34. In Article 270, § 1^er, of the Programme Act (I) of 24 December 2002, as amended by the Act of 23 December 2005, the following paragraph shall be inserted between paragraphs 5 and 6:
"The Ministers shall appoint and revoke alternates for the members referred to in 3°, 4° and 5° respectively, on the proposal of each of these effective members. »
CHAPTER V. - Amendments to the Act of 29 April 1996
social provisions
Art. 35. Section 156 of the Act of 29 April 1996 on social provisions, as amended by the Acts of 22 February 1998, 24 December 1999, 12 August 2000, 22 August 2002 and 24 December 2002, are amended as follows:
1° to § 3, paragraphs 2 and 3 are replaced by the following paragraphs:
"All the data that are necessary on the one hand, to analyse the links between health care insurance expenditures and the treated condition, and on the other hand, to the development of funding rules, accreditation standards and quality conditions under an efficient health policy, are directly made available to the federal public service, the Institute and the Centre for Health Care Expertise.
The federal public service, the Institute and the Federal Centre of Health Care Expertise use the data referred to in the previous paragraph, only as part of their legal missions or under the law.
The last paragraph of this subsection applies to all data communications to members of federal service advisory or management bodies, the Institute or the Federal Health Care Expert Centre.
The King may determine more specific rules regarding the application of paragraphs 2 and 3.
For the provision and use as referred to in paragraphs 2 and 3, no authorization is required, nor under the Privacy Protection Act of 8 December 1992 for the processing of personal data, nor under the Act of 15 January 1990 on the institution and organization of a Bank-Carrefour of Social Security. » ;
2° to § 4, paragraph 1^er, the words "as referred to in § 3" are replaced by the words "as referred to in § 3, last paragraph".
Art. 36. Article 1^er of the Royal Decree of 18 October 2001 implementing Article 156, § 3, of the Act of 29 April 1996 on social provisions is repealed.
Art. 37. The first sentence of Article 2, § 1^er, of the same order is replaced by the words "Any data transmission pursuant to Article 156, § 3, last paragraph, of the Act of 29 April 1996 on social provisions is necessary for the execution of the missions of the persons who request it. » .
Art. 38. Article 37 shall cease to be in force on a date to be fixed by the King.
CHAPTER VI. - Cancer register
Art. 39. At Royal Decree No. 78 of 10 November 1967 concerning the exercise of health care professions, an article 45quinquies is inserted, as follows:
"Art. 45quinquies. § 1^er. The State may, together with the insurance organizations referred to in the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994, and for cancer-related illnesses, establish a foundation of public utility, as set out in the law of 27 June 1921 concerning non-profit associations, international non-profit associations and foundations, for the following purposes:
1° to report on the incidence of different forms of cancer, as well as its prevalence and survival of patients;
2° conduct studies (case control and cohort study) on the causes of cancer;
3° perform an analysis of the geographical distribution of different forms of cancer, its incidence, tendency and consequences in order to be able to examine possible causes and to compare risk factors;
4th report to the relevant international bodies, including the World Health Organization.
The King may set out other terms relating to the competence of this Foundation as well as to the manner in which they are executed.
§ 2. The Foundation collects and records the following data:
1° the patient's Social Security Identification Number (SIN)
2° the clinical data collected as part of the mandatory participation in the registration of cancer as referred to in Article 11, § 1^erof the Royal Decree of March 21, 2003, setting out the standards to which the basic oncology care program and the oncology care program must meet to be approved:
(a) where they relate to cancer cases that come into account for the reimbursement of the multidisciplinary oncology consultation, the data is supplemented by the doctor coordinator of the multidisciplinary consultation who transmits them to the patient's health care doctor, using the standardized cancer registration form.
The medical advisor of the insurer transmits these data to the Foundation;
(b) where the clinical data relate to cases of cancer that do not come into account for the repayment of the multidisciplinary oncology consultation, the same clinical data, along with the patient identification number, must be transmitted by the responsible physicians, using the standardized cancer registration form, to the Foundation via the medical advice of the patient insurer;
3° data from the laboratories of pathological anatomy and clinical biology/hematology.
Physicians in each laboratory of anatomopathology, clinical biology or hematology must record the results of the tests confirming a diagnosis of cancer.
They use classifications of pathology or hematology, approved by the Oncology College in consultation with the "Consilium Pathologicum Belgicum", the Belgian Association of Hematology and the Belgian Association of Clinical Biology.
They transmit the recorded data, along with the identification number and the report and its conclusions directly to the Foundation;
4° survival, geographical location data.
Insurers complete anatomo-pathological and hematological clinical data by:
- the date of death;
- a geocode or geographical code;
- other data, including socio-economic indicators, treatment data and disability insurance benefits, after authorization from the Privacy Commission;
5° where physicians advice from insurance organizations, on the basis of benefits reimbursed by compulsory health care insurance, are informed that a patient has a cancer diagnosis or has undergone a cancer screening examination, they may contact the responsible physician in order to be able to transmit the required data to the Foundation;
6° the Oncology Coordinator of a recognized Oncology Basic Care Program and/or a Oncology Care Program may apply to the Foundation and insurers to transmit directly data sets to the Foundation. The Foundation determines the frequency and formats of data transmission;
7° a Oncology Approved Care Program may, upon request, receive from the Private Foundation an electronic copy corrected or supplemented with the data it transmitted to it.
§ 3. The Foundation is also responsible for:
1° in collaboration with physicians advice from insurers or their collaborators, trained for this purpose, of the conversion, in the required international classifications, of clinical information that was provided through standardized cancer registration forms;
2° of the reconciliation of data on the basis of the patient's Social Security Identification Number (SIN);
3° of all uncoded data analyses;
4° the coding of the patient's Social Security Identification Number (SIN)
5° of the quality control of the data collected. Quality control means the completeness of the recording and the completeness, accuracy and consistency of the data provided.
As part of this quality control, the Foundation may establish direct or indirect contacts, via physicians advice from insurers, with data providers and may request corrections or additional information necessary for the quality recording of cancers;
6° of the conclusion of the conventions establishing the terms of data transfer, quality criteria and security requirements, the frequency of data transfer;
7° after the Commission for the Protection of Privacy, the collection of personal data, including through investigation, to cancer patients, when they are intended to be coupled with those of the Foundation;
8° after authorization from the Commission for the Protection of Privacy, the transmission of the coded copy of cancer registration data to the Federal Health Care Expert Centre, the National Disability Insurance Institute and the Intermutualist Agency;
9° after authorization of the Commission, the transfer of the data referred to in number 8°, to other instances for research purposes and on the basis of a search protocol that meets the rules established by the King;
10° update and storage of these data according to physical and logical security rules;
11° of the provision of reports and results with aggregate data, intended for the Minister who has Public Health in his or her responsibilities, to the Minister who has Social Affairs in his or her responsibilities, the Communities and the College of Oncology;
12° to establish reports for health policy, the public and international organizations.
§ 4. With respect to the application of this section, the Foundation is the management institution referred to in section 31bis of the Privacy Protection Act of 8 December 1992 with respect to the processing of personal data.
The Foundation is obliged to take strictly all organizational and technical measures to ensure data protection, including:
1° to draft the data security plan, which is communicated to the health data sector committee;
2° to designate its security adviser, particularly responsible for:
- the preparation of minimum standards for physical and logical information security;
- the preparation of a checklist to assess compliance with minimum standards for physical and logical information security;
- the provision of advice to the Privacy Commission;
3° to designate a doctor who is responsible for ensuring the confidentiality of the data and ensuring that his staff have access only to the data they really need to perform their tasks;
4° to include a confidentiality clause in the contract of all persons employed within the Foundation who have access to the data.
§ 5. The King may determine the terms and conditions of execution of this article.
Art. 40. The King shall determine the effective date of section 39.
CHAPTER VII. - Sectoral Health Data Committee
Art. 41. In the Privacy Commission, a Sectoral Health Data Committee is established.
The Committee is composed of three effective or alternate members of the Commission, including the Chairperson of the Commission, except where he or she renounces it, and three external members, including two doctors, with experience in the management of health data, who are appointed by the House of Representatives. A representative designated by the Parliament of the French Community and a representative designated by the Flemish Parliament may attend the Committee as observers.
The Sectoral Committee shall be presided by the Chairperson of the Commission, or, if waived, by another member of the Commission on the proposal of its Chair. In the event of a parity of votes, the Chair of the Sectoral Committee has a predominant voice.
The Chair of the Sectoral Committee may submit to the Commission a file submitted to the Committee; the Commission shall fine or reform, if any, the Committee ' s decision replacing its own decision.
Art. 42. § 1^er. The Federal Public Service Public Health, Food Chain Safety and Environment, the National Institute for Disability Health Insurance are the management institution, referred to in section 31bis of the Act of 8 December 1992 on the protection of privacy with respect to personal data processing, for the Sectoral Committee for Health Data.
§ 2. In order to protect privacy, the Sectoral Committee has the following expertise:
1° grant an authorization of principle to make personal data available to third parties, referred to in section 86 of the Hospitals Act, coordinated on August 7, 1986;
2° with respect to the registration referred to in Article 45quinquies of Royal Decree No. 78 of 10 November 1967 relating to the exercise of health professions, grant authorization to:
(a) the linking of the Foundation ' s personal data to external data;
(b) the transmission of the coded copy of cancer registration data to the Federal Health Care Expert Centre, the National Disability Insurance Institute and the Intermutualist Agency;
(c) the transfer of data referred to in (b) to other instances for research purposes and on the basis of a search protocol that meets the rules established by the King.
§ 3. Unless expressly derogated from the above provisions, section 31bis is applicable to the Health Data Sector Committee.
The King determines, by order deliberately in the Council of Ministers, the complementary modalities for the composition and functioning of this Sectoral Committee, in accordance with article 31bis above.
§ 4. The chair of the Sectoral Health Data Committee is a part-time mission at 20 per cent.
By derogation from section 31bis, § 4, of the above-mentioned Act of 8 December 1992, the chair of the Health Data Sector Committee shall be entitled to compensation in lieu of treatment equal to 20% of the salary and other benefits that he would receive if he was an advisor to the Court of Appeal. This right, however, is not enforceable when the chair of the Sectoral Health Data Committee is provided by the chair or vice-chair of the Privacy Commission, who in this case are entitled to double the presence token referred to in section 36, paragraph 2, of the aforementioned Act.
The means necessary for the operation, in accordance with the above provisions, of the Sectoral Committee for Health Data are charged with the staffing of the Commission for the Protection of Privacy; These include engagement within a doctor's secretariat.
§ 5. With regard to the registration of cancer pathologies, referred to in article 45quinquies of the aforementioned Royal Decree of November 10, 1967, the Foundation referred to in the same Article shall, by derogation from § 1^erthe management institution referred to in section 31bis of the Privacy Act of 8 December 1992.
§ 6. Until the installation and appointment of the Sectoral Committee referred to in this article, the Privacy Commission is responsible for the tasks referred to in § 2, 1 and 2°.
§ 7. The King determines what to hear by "health data".
CHAPTER VIII. - Hospitals
Section 1^re. - Limitation of patient charge supplements
Art. 43. In section 90 of the Hospitals Act, coordinated on August 7, 1987, replaced by the Act of January 14, 2002, the following amendments are made:
1° § 2, paragraph 1^er, is completed as follows:
"(d) where the admission relates to a child accompanied by a parent during the hospital stay. »;
2° in § 2, paragraph 2, the words "and (d)" are inserted after the words "in paragraph 1^er, c) ".
Art. 44. Article 91, paragraph 1^erin the same Act, replaced by the Act of 14 January 2002, the following amendments are made:
1° (a) is completed as follows:
"as well as all additional supplies and miscellaneous expenses;"
2° in point b), the words "and billed" are inserted between the word "communicated," and the words "to the patient".
Art. 45. Section 138 of the Act, replaced by the Act of January 14, 2002, is amended as follows:
1° § 1^er, paragraph 3, is supplemented as follows:
"The King also defines the categories of day hospitalization patients admitted to two patients' rooms or in common rooms in respect of which paragraphs 1^er and 2 are applicable to all benefits. »;
2° in § 2, paragraph 2, the words "with the exception of the patients referred to in Article 90, § 2(c)," are inserted between the words "of the patients referred to in § 1^erParagraphs 1^er and 2," and the words "prices";
3° in § 2, paragraph 2, the words "and (d)" are inserted between the words "vised in Article 90, § 2, (c)" and the words "tariffs";
4° § 2, paragraph 3, is completed as follows:
"The King also defines the categories of day-to-day hospitalization patients admitted to two-patient rooms or in common rooms in respect of which paragraph 2 is applicable for all benefits. »;
5° in § 4, paragraph 1^er, the words "with the exception of patients referred to in Article 90, § 2, (c) and (d)," are inserted between the words "of patients referred to in § 1^erParagraphs 1^er and 2," and the words "prices";
6° § 4, paragraph 2, is supplemented as follows;
"The King also defines the categories of day-to-day hospitalization patients admitted to two patients' rooms or in common rooms, in respect of which paragraph 1^er is applied for all benefits. »;
7° the article is supplemented by a § 6, written as follows:
“§ 6. The doctors referred to in §§ 1^er2 and 4 may, without prejudice to § 1^er, paragraph 2, apply, in respect of patients admitted into individual chambers, tariffs deviating from the rates of the agreement, to the extent that maximum rates are set by the general regulation referred to in section 130 and are met by the physicians concerned. This element of the general regulation must, prior to its application, be communicated by the manager to the Joint Hospital Medical Board and, through the National Disability Insurance Institute, to insurers. »;
8° the article is supplemented by a § 7 written as follows:
“§ 7. The doctors referred to in §§ 1^er, 2 and 4, may not apply supplements for lump sum fees payable by admission and/or day of hospitalization for clinical biology or medical imaging services. "
Art. 46. The King may, by order deliberately in the Council of Ministers after the advice of the National Medico-mutualist Commission, amend the scope of section 138 of the Hospitals Act. Orders under this section shall cease to produce their effects 18 months after publication, if they have not been confirmed by law.
Art. 47. § 1^er. Article 138, § 2, paragraph 2, of the Hospitals Act, coordinated on 7 August 1987, as amended by Article 45, paragraph 3, comes into force, with regard to paediatricians, on 1^er January 2007, as long as:
1° The King, pursuant to Article 35, § 2, of the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994, made provisions to revalue the supervision fees of hospital paediatricians;
2° the King did not take an order under Article 46.
§ 2. With regard to the other specialists, Article 138, § 2, paragraph 2, of the Hospitals Act, coordinated on 7 August 1987, as amended by Article 45, 3°, comes into force on a date fixed by the King by decree deliberately decreed in the Council of Ministers, after the advice of the National Medico-mutualist commission.
Section 2. - Patient rights
Art. 48. The following amendments are made to section 17novies of the Hospitals Act, coordinated on August 7, 1987, inserted by the Act of August 22, 2002:
1° paragraph 3 is replaced by the following paragraph:
"The patient has the right to receive information from the hospital regarding the nature of legal relations between the hospital and the professional practitioners working there. The contents of the information referred to, as well as the manner in which it is to be communicated, are determined by the King, after notice of the commission referred to in article 16 of the Act of 22 August 2002 on the rights of the patient. »;
2° Paragraph 4 is replaced by the following paragraph:
"The hospital is responsible for the breaches committed by the professional practitioners working therein, with respect to the patient's rights under the above-mentioned Act of 22 August 2002, unless the hospital has communicated to the patient, explicitly and prior to the intervention of the professional practitioner, in the context of the communication of the information referred to in paragraph 3, that he was not responsible for the professional practitioner, given the nature of the legal relations referred to in paragraph 3. Such a communication may not prejudice other legal provisions relating to liability for acts committed by others. "
Section 3. - Status of nursing management
Art. 49. In article 17bis, paragraph 2, 1°, second sentence, of the Hospitals Act coordinated on August 7, 1987, inserted by the law of December 29, 1990 and amended by the law of January 14, 2001, the words "must be a graduated or birth attendant nurse and" are deleted.
CHAPTER IX. - Medical implants and devices
Section 1^re. - Amendments to the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994
Art. 50. In Part III, Chapter 1, of the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994, Section IXter, repealed by the Act of 5 August 2003, is reinstated in the following wording:
"Section IXter. The Board of Reimbursement of Invasive Implants and Medical Devices".
Art. 51. Section 29ter of the Act, repealed by the Act of 5 August 2003, is reinstated in the following wording:
"Art. 29ter. It is created within the Institute a Board for Reimbursement of Invasive Implants and Medical Devices.
This Commission is composed of experts working in a university institution, representatives of insurance organizations, professional organizations of doctors and hospital pharmacists, representatives of manufacturers, importers and distributors of implants and invasive medical devices, representatives of hospital managers and representatives of the Minister, the Minister with Public Health in his or her responsibilities, the Minister who has the Budget in his or her responsibilities and the Evaluation Service. Representatives of manufacturers, importers and distributors of invasive implants and medical devices, hospital managers, the minister who has the budget in his or her duties, the Minister with Public Health in his or her duties, the Minister with the Budget in his or her duties and the Medical Evaluation and Control Service have a consultative voice.
The Commission is chaired by an expert in the field of invasive implants and medical devices, designated for a period of up to 6 years renewable by the Minister who has the Social Affairs in his or her responsibilities.
The Reimbursement Commission for Invasive Implants and Medical Devices is responsible for:
1. to formulate proposals and carry out the tasks referred to in section 35septics;
2. provide advice, at the request of the Minister, on aspects of the policy on the reimbursement of invasive implants and medical devices.
The King shall determine, on the proposal of the Minister, the detailed composition and operating rules of the Commission. The members of the Commission are appointed by the King.
Art. 52. Article 34, paragraph 1^erthe same Act, as amended by the Acts of 24 December 1999, 24 December 2002 and 5 August 2003, are amended as follows:
1° on 4°, is replaced by the following provision:
"4° the provision of eyeglasses and other eye prostheses, hearing aids, carttes, bandages, orthotics and external prostheses;"
2° it is inserted an article 4°bis, which reads as follows:
"4°bis. the supply:
(a) implants, except those under 1°, e) including osteo-integrated implants used in dentistry, including:
- active implantable medical devices as referred to in Article 1, 2.(c) of Council Directive 90/385/EEC of 20 June 1990 concerning the approximation of the laws of the Member States relating to active implantable medical devices;
- non-active implantable medical devices as referred to in Annex IX to Council Directive 93/42/EEC of 14 June 1993 on medical devices
(b) Invasive medical devices as referred to in Annex IX " of Council Directive 93/42/EEC of 14 June 1993 on medical devices. »;
3° on 20°, is replaced as follows:
"20° the supply of medical devices, except those referred to in 4° and 4°bis;".
Art. 53. Article 35, § 1^erthe same Act, as amended by the Acts of 10 August 2001, 9 July 2004 and 27 December 2005, are amended as follows:
1° the first paragraph shall be replaced as follows:
« § 1^er. The King shall establish the nomenclature of health benefits, with the exception of benefits referred to in section 34, paragraph 1^er(b), (c), (d) and (e);
2° in paragraph 2, third and fourth sentences, the words "implants or" are deleted.
Art. 54. In the same Act, an article 35septics, which reads as follows:
"Art. 35s. § 1^er. In order to allow compulsory health care insurance and compensation to fulfill its mission in respect of benefits under section 34, paragraph 1^er, 4°bis, as long as it is implants, each firm that puts or puts an implant on the Belgian market, with the exception of the implants referred to in Article 1^er§ 2, 4° and 5°, of the Royal Decree of 18 March 1999 concerning medical devices and those referred to in Article 1^er§ 1^er4° and 5°, of the Royal Decree of 15 July 1997 on active implantable medical devices, notifies it to the Institute's Health Care Service.
The King may, for a maximum period of one year following the entry into force of this provision, provide for a transitional regime for implants that are already in the Belgian market at that time.
The company communicates this notification to the care providers concerned.
The notification is not applicable to the implants referred to in Article 1, 2, (d) and (e), Council Directive 93/42/EEC of 14 June 1993 on medical devices and those referred to in Article 1, 2, (d) and (e), Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices.
In addition, the King may, on the basis of price or category, determine for which implants no notification is required.
The King determines to which other health benefits under section 34, paragraph 1^er, 4°bis, the notification referred to in the first paragraph may be extended.
The King sets out the conditions under which notification and publication must be made.
The costs of unnotified implants, which on the basis of the provisions of this paragraph are not exempt from the reporting obligation, do not come into account for mandatory insurance intervention and cannot be borne by the beneficiaries.
§ 2. The King sets out the list of repayable invasive medical devices and implants referred to in section 34, 4°bis, no later than six months after the entry into force of this provision.
This list may be amended by the Minister on the proposal of the Board for Reimbursement of Invasive Implants and Medical Devices, with the exception of the cases provided for in § 7. Firms that put invasive implants and medical devices on the Belgian market, below referred to as applicants, or the Minister, may ask the Commission to make a proposal, or the Commission may make a proposal on its own initiative. The changes in the list may consist of the registration and removal of invasive implants and medical devices and the modification of the terms and conditions of the listing.
The Minister may, on an annual basis, proceed in full and without taking into account the procedural rules set out in this Act when the full list of reimbursable implants and medical devices is republished, without making any changes to the content.
§ 3. The amendment of the list includes a decision regarding the reimbursement base, refundable indications, refund terms and the reimbursement category and is made after assessment of one or more of the following criteria:
1° the therapeutic value of the invasive implant or medical device: this therapeutic value is expressed in one of the following two surplus-value classes:
- Class 1: Invasive implants or medical devices with a proven therapeutic surplus value compared to existing therapeutic alternatives;
- Class 2: Invasive implants or medical devices that do not have a demonstrated therapeutic surplus value compared to existing therapeutic alternatives;
2° the price of the invasive implant or medical device and the refund base proposed by the applicant;
3° the interest of the invasive implant or medical device in medical practice based on the therapeutic and social needs;
4° the budgetary impact for compulsory health care insurance;
5° the relationship between the cost for compulsory health care insurance and the therapeutic value.
The King may define the criteria in a more detailed manner and determine how the class of surplus-value of an invasive implant or medical device is determined as well as the criteria listed from point 2° to point 5°, which must at least be evaluated, depending on the class of surplus-value which was mentioned by the applicant of the implant or the invasive medical device in question. The King may subdivide the classes of surplus-value into subclasses and determine which criteria are listed from point 2° to point 5°, which must at least be evaluated.
§ 4. 1 In the event of an application to amend the list of reimbursable implants by an applicant, the Invasive Implants and Medical Devices Reimbursement Commission provides a reasoned proposal.
The King determines the terms and conditions under which an application must be filed.
Within 45 days of receipt of the file, the secretariat of the Invasive Implants and Medical Devices Commission decides on the admissibility of the application.
If the information provided in support of the application is insufficient, the secretariat shall immediately notify the applicant of the detailed additional information required. A further 45-day period begins when the secretariat of the Invasive Implants and Medical Devices Refund Commission receives missing information.
The King determines the conditions and modalities under which the applicant is informed of the reasoned decision on admissibility.
The overall timeframe for the formulation of the proposal by the Invasive Implants and Medical Devices Reimbursement Commission is up to 180 days, from the date provided by the secretariat of the Invasive Implants and Medical Devices Reimbursement Commission to which the file is declared admissible.
If the elements attached to the application are insufficient after an assessment to be able to formulate a proposal, the 180-day deadline is suspended and the Invasive Implants and Medical Devices Reimbursement Commission shall promptly indicate which additional elements are required.
The King sets out the conditions under which the aforementioned 180-day period may be suspended.
Within 60 days after the expiry of the 180-day period, the Minister shall, after agreement of the Minister who has the Budget in his or her powers, make a reasoned decision with respect to the Commission's proposal or, in the absence of a proposal by the Commission, with respect to the application for registration on the list.
In the absence of a response from the Minister who has the Budget within 30 days of the application for agreement, the Minister's agreement that has the Budget in its powers is supposed to be tacit.
The King shall, by deliberate order in the Council of Ministers, establish the conditions and conditions under which the Minister may derogate from the proposal of the Board of Reimbursement of Invasive Implants and Medical Devices within 60 days as referred to in paragraph 9.
If the Minister fails to make a decision within the time limit, the decision is assumed to be in accordance with the proposal of the Invasive Implants and Medical Devices Refund Board.
In the absence of a proposal from the Invasive Implants and Medical Devices Refund Board within 180 days and if the Minister has not, in this case, made a decision within the time limit, the amendment request is assumed to have been rejected.
2° Except where an application to amend the list of reimbursable implants has been filed by an applicant, a firm that puts the implant on the Belgian market, to which the procedure and deadlines are applicable in accordance with paragraph 1 of this paragraph, the Minister shall decide on an application to amend implants or invasive medical devices reimbursable on the basis of the proposal made by the Board for the Reimbursement of Invasive Implants and Medical Devices. The King determines the procedure for the introduction of applications.
The Minister shall, after agreement of the Minister who has the Budget in his or her powers, make a reasoned decision on the proposal to register on the list of the Invasive Implants and Medical Devices Refund Commission.
The King shall determine by order deliberately in the Council of Ministers the terms and conditions under which the Minister may derogate from the proposal of the Board of Reimbursement of Invasive Implants and Medical Devices.
§ 5. No later than the first day of the second month following the decision to amend the list, as referred to in § 4, 1 and 2°, the Health Care Services of the Institute is responsible for notifying this decision.
The King shall determine the terms and conditions under which the decisions referred to in this paragraph are communicated
§ 6. If, no later than September 30 of a year, the Minister made a positive decision on listing, as referred to in § 4, 1 and 2°, or if it is assumed to have confirmed a positive proposal for listing in the list of the Invasive Implants and Medical Devices Repayment Commission, the Minister's decision shall take effect no later than 1^er January following that decision.
If, after September 30 of a year, the Minister made a positive decision regarding the listing, as referred to in § 4, 1 and 2°, or if it is assumed to have confirmed a positive decision to register in the list of the Board of Reimbursement of Invasive Implants and Medical Devices, the Minister's decision shall take effect no later than 1^er January of the second year following that decision.
§ 7. The King may determine the cases in which the Institute's Health Care Service may propose changes to the list to the Minister without the intervention of the Invasive Implants and Medical Devices Refund Board in the event of technical error corrections.
Art. 55. In section 37 of the Act, amended by the Act of 20 December 1995, the Royal Decree of 12 December 1996 and the Act of 24 December 2002, are amended as follows:
1° to § 5, paragraph 1^er the words "seen to article 34, 2°, 3° and 4°" are replaced by the words "seen to article 34, paragraph 1^er, 2°, 3°, 4° and 4°bis";
2° to § 14ter, paragraph 3, the words "article 34, paragraph 1^er, 20°" are replaced by the words "article 34, paragraph 1^er4°bis.
Art. 56. In Title III, Chapter V, of the same law is inserted a "Section XVIbis entitled: "Section XVIbis- Claimants' obligations for the repayment of invasive implants and medical devices" including section 75bis.
Art. 57. In Title III, Chapter V, new section XVIter, of the same law, is inserted an article 75bis, which reads as follows:
"Art. 75bis. § 1^er. In the context of health care insurance and subject to other legal provisions, the applicant is required to comply with the following obligations on the basis of the entry into force of the refundability of invasive implants or medical devices for which the applicant has applied:
1° to ensure continuity in the market of this invasive implant or medical device;
2° immediately inform the Invasive Implants and Medical Devices section of the Health Care Service of the Institute of the Removal of the Implant or Invasive Medical Device or its withdrawal from the market;
3° communicate the number of implants or the number of invasive medical devices that were issued on the Belgian market the previous year;
4° communicate to the secretariat of the Invasive Implants and Medical Devices Reimbursement Commission any changes to one of the elements of the refundability request;
5° communicate without delay any dysfunction or adverse effects of the implant and the invasive medical device to the secretariat of the Board of Reimbursement of Invasive Implants or Medical Devices;
6° take the necessary measures according to the existing warranty conditions to adequately cover past health damages that result directly from a malfunction or adverse effect of the implant or invasive medical device.
The King determines which invasive medical implants or devices may be exempt from the communication requirement referred to in the 3rd of the preceding paragraph.
§ 2. When a firm that markets an invasive implant or medical device on the Belgian market, as referred to in article 34, 4°bis, wishes to permanently cancel the repayment of this implant or this invasive medical device and continues to market the implant or invasive medical device, it must apply for the removal of the list of invasive implants or medical devices admitted to the repayment referred to in section 35sept
The King sets out the procedures for the removal of invasive implants or medical devices and the effective date of this removal.
§ 3. When no claim for reimbursement has been made for certain invasive implants or medical devices, these invasive implants or medical devices may be admitted to reimbursement when the Minister finds that beneficiaries are deprived of an insurance intervention for valid therapeutic means.
The King sets out the procedure whereby the invasive implants or medical devices concerned may be eligible for reimbursement under the terms referred to in the preceding paragraph. »
Art. 58. The provisions of this section come into force on a date to be determined by the King.
Section 2. - Amendment of the Hospitals Act, coordinated
7 August 1987
Art. 59. In section 95 of the Hospitals Act, coordinated on August 7, 1987, amended by the Acts of December 22, 1989 and December 24, 2002, the following amendments are made:
1° point 4° is replaced by the following provision:
"4° the costs associated with active and non-active implantable medical devices, as referred to in section 34, 4°bis, (a), of the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994, with the exception of:
(a) implants for which no notification was made as referred to in section 35ses, § 1^erthe same law, without having been, on the basis of the same article, exempt from the obligation to notify;
(b) Implants, from the date of publication of the Minister's decision, referred to in section 35s, § 5, of the Compulsory Health Care and Allowance Insurance Act, until the time of the coming into force of the above-mentioned decision;
(c) implants for which a mandatory health care insurance intervention is fixed but which, on the basis of their selling prices at the hospital, included T.V.A., cannot be considered for an effective intervention.
In the case of (b) of the preceding paragraph, the costs of the implants covered are borne by the budget of the financial means up to the amount and the terms and conditions of reimbursement that would be applicable from the coming into force of the decision to take care of compulsory health care insurance. »;
2° the article is supplemented by points 5° and 6°, as follows:
"5° the costs associated with other medical devices other than those referred to in 4° when they are subject to mandatory health care insurance intervention under the prescribed reimbursement conditions;
6° the costs related to other medical devices than those referred to in 4° and 5° as defined by the King. »
Art. 60. Section 59 comes into force on a date to be determined by the King.
CHAPTER X. - Patient rights
Art. 61. In Article 3, § 1^er, of the law of 22 August 2002 on patient rights, the words "contractual and extra-contractual" are inserted between the words "legal reports" and "private law".
Art. 62. Article 7, § 2, paragraph 3, of the Act is replaced by the following provision:
"The patient has the right to be assisted by a trusted person or to exercise his right to the information referred to in § 1^er through it. Where applicable, the professional practitioner notes, in the patient's file, that the information was communicated, with the patient's consent, to the trustee or was communicated to the patient in the presence of the trustee, and notes the patient's identity. In addition, the patient may explicitly request that the above data be included in the patient's file. »
Art. 63. The following amendments are made to section 9 of the Act:
1° § 2, paragraph 4, is supplemented by the following provision:
"If applicable, the patient's request is written and the request, as well as the identity of the trusted person, is recorded or added to the patient's file. » ;
2° § 3, paragraph 1^er, is amended to read:
(a) the words "at cost" are deleted;
(b) the paragraph shall be supplemented by the following provision:
"The King may fix the maximum amount that may be requested to the patient by copied page, a copy given under the above-mentioned right to obtain a copy or other information medium. »
Art. 64. In Article 14 of the Act, a § 4 is inserted, which reads as follows:
“§4. The right to introduce a complaint referred to in Article 11, may, by derogation from §§ 1^er and 2, be exercised by the persons referred to in these paragraphs, as designated by the King, by order deliberately in the Council of Ministers, without having to respect the order provided.
The King may, by order deliberately in the Council of Ministers, set more precise rules for the application of this paragraph. »
CHAPTER XI. - Provisions applicable to health-risk situations
Art. 65. The purpose of this chapter is to ensure the management of health-risk situations and to enable the Minister who has public health in his or her powers, on the proposal of the network referred to in Article 67, § 2, 2°, of this Act, if necessary, to take immediate emergency measures, proportionate to the risks involved and limited in time in order to combat the spread and reduce the harmful consequences for the health of the population.
Art. 66. For the purposes of this chapter, the following means:
- Health-risk situation: the combination of circumstances that significantly increase the likelihood of an adverse outcome to the health of the population;
- Estimate of risk: qualitative and/or quantitative estimate, including the uncertainties associated with it, the probability of occurrence and severity of adverse health effects, known or potential, on a given population, based on hazard identification, effects appreciation and exposure appreciation.
Art. 67. § 1^er. It is created a health-care network with public and private institutions which, by their purpose, collect information useful to health surveillance. The arrangements for the organization and operation of the network are determined by the King.
§ 2. The purpose of the network is to:
1° to strengthen the detection, diagnosis and control of health-risk situations;
2° immediately inform the Minister who has the Public Health in his or her responsibilities when the result of the risk estimate identified by one of the network's institutions, calls for immediate emergency measures and that appropriate measures to protect the population exceed the area of intervention of the institution or when the feared event is likely to damage the health of the population.
Art. 68. § 1^er. Exceptionally, where it is imperatively necessary and within the limits set out in section 65 and on the proposed network referred to in section 67, the Minister who has Public Health in his or her powers may:
1° imposing on hospitals the obligation to transfer their patients to the care institution or the care institutions it designates;
2° to obtain from third parties the communication of anonymous or anonymous data.
§ 2. It shall be terminated without delay the obligations referred to in § 1^er as long as they are no longer necessary.
Art. 69. The Minister who has public health in his duties regularly informs the Council of Ministers and members of the Inter-Ministerial Public Health Conference of the measures taken.
Art. 70. § 1^er. To ensure the transparency and completeness of the available information, the Minister who has Public Health in his or her functions organizes the dissemination of information on events throughout their course.
The purpose of the communication is to:
- to reduce the vulnerability of the population by measures that generate appropriate behaviour;
- to minimize the counter-productive effects of irrational attitudes and harmonization defects in practices by professionals, explain the limits of the measures taken.
§ 2. It ensures, where appropriate, the notification to European and international bodies and the necessary coordination with them.
Art. 71. Each health-risk situation is subject to a systematic assessment to assess what has been done in terms of quality and efficiency and to take advantage of the teaching that has been acquired in order to harmonize skills and promote expertise.
Art. 72. A fine of 100 to 1,000 euros and imprisonment of eight days to six months or one of these penalties shall be punished only by persons who refuse to transfer patients in accordance with Article 68, § 1^er, 1°, and one third to the network that refuses to communicate the data referred to in Article 68, § 1^erTwo.
CHAPTER XII. - Drugs
Section 1^re. - Prices and reimbursement base
Art. 73. In section 35bis of the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994, inserted by the Act of 10 August 2001 and amended by the Acts of 24 December 2002, 22 December 2003, 9 July 2004, 27 April 2005 and 27 December 2005, a paragraph 2bis is added, as follows:
Ҥ 2bis. The setting of the reimbursement base is based on the rules and conditions specified by the King, taking into account the principles set out below.
For the pharmaceutical specialties of Class 1, it is taken into account the demonstrated therapeutic surplus-value, while for the pharmaceutical specialties of Classes 2 and 3, the setting of the reimbursement base is made by reference to the existing therapeutic alternatives. The refund base is in no case greater than the maximum selling price to the public authorized by the Minister who has the Economic Affairs in his or her powers, but is lower when the applicant has declared itself ready to apply a lower price.
The public price, which is also listed, is, however, always equal to the refund base, except as follows:
1° when applying section 35quinquies;
2° where the basis for reimbursement of a speciality referred to in section 34, paragraph 1^er, 5°, (b) or (c), 1), was reduced under section 35ter or section 35quater;
3° where the basis for reimbursement of a speciality referred to in section 34, paragraph 1^er, 5°, c), 1) or 2), has been diminished pursuant to article 35bis, § 4, paragraph 6, 2°.
Except in the cases referred to in paragraph 3, 1°, 2° and 3°, the principle of the equivalence of the public price and the refund base is therefore that, at the time when a legal or regulatory provision that provides for a full adjustment of the refund base produces its effects, the public price is also adapted in full right. »
Art. 74. In section 35quinquies of the Act, inserted by the Act of 27 April 2005, paragraph 1^er is replaced as follows:
"In addition to the application of articles 35bis, § 4, paragraph 6, 2°, 35ter or 35quater, it is not possible to disconnect the public price of a pharmaceutical specialty from its refund base, unless the difference resulting from this disconnection is taken over by the applicant referred to in section 35bis, under the conditions and in accordance with the royal decreed Minister rules. »
Section 2. - Cheap specifications
Art. 75. In Article 73, § 2, paragraph 4, of the same Act, inserted by the Royal Decree of 17 September 2005, the following amendments are made:
1° the words "refundable pharmaceutical specialties referred to in articles 34, 5°, (c), 1), for which section 35ter is applied" are replaced by the words "refundable pharmaceutical specialties referred to in articles 34, paragraph 1^er, 5°, (b) and (c), 1), to which Article 35ter §§ 1^er and 3, 3°, is, possibly through section 35quater, applicable no later than the last month of the evaluation period";
2° the words "whose price no later than the last month of the evaluation period is not greater than the refund base" are deleted.
Section 3. - Technical corrections
Art. 76. In section 35bis, § 4, paragraph 5, of the Act, inserted by the Act of 27 April 2005 and amended by the Act of 27 December 2005, the following amendments are made:
1° the words "and/or efficiency" are replaced by the words "and/or utility";
2° in the Dutch version, the words "het comfort" are replaced by the words "de gebruiksvriendelijkheid" in the words "ongewenste effecten" are replaced by the word "bijwerkingen".
Art. 77. In section 35quater of the Act, inserted by the Act of 27 April 2005 and amended by the Act of 27 December 2005, the following amendments are made:
1° the words "Article 34, paragraph 1, 5°, (c), 1) unless" are replaced by the words "Article 34, paragraph 1^er, 5°, c), 1) and 2), unless";
2° the words "and/or efficiency" are replaced by the words "and/or utility";
3° in the Dutch version, the words "het comfort" are replaced by the words "de gebruiksvriendelijkheid" in the words "ongewenste effecten" are replaced by the words "bijwerkingen".
Section 4. - Group review procedure
Art. 78. In section 35bis, § 4, of the same law, inserted by the law of 27 April 2005, the following amendments are made:
1° to paragraph 6, point 1°, the words "proportionally to the refund base proposed by the applicants" are deleted;
2° Paragraph 6, item 2°, is replaced as follows:
"2° within the same repayment category, reduce the repayment base for all specialties to a level equivalent to the lowest repayment base";
3° § 4 is supplemented by the following paragraphs:
"For 18 months after the decision taken at the end of the group review procedure only, or in part, because of budgetary considerations, requests for price increases for a speciality concerned by the decision are inadmissible.
Requests to amend the terms and conditions of reimbursement introduced by the applicant for a speciality concerned by the decision are also inadmissible during that period, unless the applicant invokes, evidence in support, an event that is completely foreign to the applicant and independent of his or her will, reasonably unpredictable and humanly insurmountable, renders the maintenance of the existing terms of reimbursement impossible or extremely harmful.
In addition, the King may provide for specific rules, applicable during this 18-month period, relating to:
- the admission to the list of new specialties, and, in particular, to the fixing of the reference specialty and to the fixing of the repayment base of the new speciality allowed according to the fixed reference specialty;
- the determination of the price and the basis for reimbursement of the specialties referred to in article 34, paragraph 1, 5°, (c), (2), concerned by the decision taken under paragraph 6, 1°;
- the non-availability of a speciality concerned by the decision taken under paragraph 6, 1°, when the supply of co-producers for this specialty is interrupted for a period of at least one month, in order to allow for a temporary rehabilitation of the classification in the different categories of reimbursement;
- or the deletion of a speciality concerned by the decision taken under paragraph 6, 1°, in order to allow for the rehabilitation of the classification in the different reimbursement categories. »
Section 5. - Contributions
Art. 79. Article 191, paragraph 1^erthe following amendments are made:
1° at point 15°quater, § 1^eramended by the laws of 2 August 2002, 22 December 2003, 9 July 2004, 27 December 2004, 27 April 2005 and 27 December 2005, the words "2004 and 2005" are replaced by the words "2004, 2005 and 2006";
2° to point 15°s, § 2, paragraph 5, inserted by the law of 27 December 2005, the words "will be counted when the following contribution is collected under point 15°" are replaced by the words "will be refunded no later than 2 months after the publication of this provision adapted to the Belgian Monitor, provided, however, that the deposit referred to in 15°novies, paragraph 8, has been paid";
3° to point 15°octies, paragraph 6, inserted by the law of 27 December 2005, are amended as follows:
(a) the words "of the previous year that is declared in accordance with the provisions of 15°novia, paragraph 4," are inserted between the words "of turnover" and the words "that must be paid";
(b) Paragraph 6 is supplemented as follows:
"From 2007, for the purpose of fixing this turnover, it is not taken into account, according to the conditions fixed by the King by deliberate decree in the Council of Ministers, refundable pharmaceutical specialties which are dispensed to the beneficiaries who are covered in categories of hospitals defined by the King and who, in accordance with the provisions of Article 37, § 3, are refunded on the basis of a lump sum. »
Art. 80. For the purposes of section 191, paragraph 1^er, 15°s, § 2, of the same law, inserted by the law of 27 December 2005, it is necessary to understand, by the mention "business figures made during the year 2004 on the Belgian market of medicines of that applicant which are registered on the list of repayable pharmaceutical specialties" in paragraph 2, and by the mention "business figures realized during the year 2004" in paragraph 3, the revenue referred to in paragraph 3,^er, 5°, (b) and (c), 1), is valid for the calculation of the economy referred to in paragraph 3, and that, on the other hand, the turnover that is made with specialties referred to in article 34, paragraph 1^er, 5°, c), 2), is applicable to the calculation of the economy referred to in paragraph 5.
Section 6. - Package
Art. 81. Article 37, § 3, paragraph 3, of the Act, replaced by the Act of 27 December 2005, is supplemented by the following sentence:
"The list of refundable pharmaceutical specialties referred to in section 35bis may be appropriated in full by the Minister to take into account the exceptions on the above-mentioned list of drugs that are not refunded on a lump sum basis. »
Section 7. - Radio-isotopes
Art. 82. In section 35, § 2ter, of the same law, replaced by the law of 27 December 2005, the words "The King" are replaced by the words "On the proposal of the Technical Council of Radioisotopes, or after the opinion of the latter, the King".
Section 8. - Adaptations of references
Art. 83. Article 34, paragraph 1^er, 5°, of the same law, as amended by the law of 27 December 2005, point (c), 2), is replaced as follows:
"(2) specialties authorized in accordance with Article 2, 8°, (a), 2 and 3, of the Royal Decree of 3 July 1969 concerning the registration of medicines or specialties authorized in accordance with Article 6bis, § 1^er, paragraph 5, second dash or article 6bis, § 2, of the Act of 25 March 1964 on drugs, under conditions to be determined by the King; "
Art. 84. In section 35bis, § 2, of the same law, as amended by the law of 27 December 2005, the definition of Class 3 is replaced as follows:
" - Class 3: Specialties authorized in accordance with Article 2, 8°, a), 2 and 3, of the Royal Decree of 3 July 1969 concerning the registration of medicines or specialties authorized in accordance with Article 6bis, § 1^er, paragraph 5, second dash, or article 6bis, § 2, of the Act of 25 March 1964 on drugs, under conditions to be determined by the King; "
Section 9. - Reproductive Medicine Program
Art. 85. In article 34, paragraph 1^er, 26°, of the same law, inserted by the law of 27 December 2005, the words "in accordance with Article 9ter of the Hospital Law, coordinated on 7 August 1987 and indicating the articles of the Hospital Law applicable to them" are replaced by the words "as defined in Article 2, § 1^erof the Royal Decree of February 15, 1999 establishing the list of care programs, referred to in section 9ter of the Hospitals Act, coordinated on August 7, 1987, and indicating the articles of the Hospitals Act applicable to them and other care related to the care of fertility disorders".
Section 10. - Contribution - Indexation
Art. 86. Section 225, paragraph 5, of the Act of 12 August 2000 on social, budgetary and other provisions is replaced as follows:
"The royalties referred to in paragraph 1^er are adapted annually, depending on the September index, to the evolution of the UK Consumer Price Index. The starting index is that of September prior to the publication to the Belgian Monitor of the Royal Decree setting the amount of the contribution or retribution. The indexed amounts are published in the Belgian Monitor and are due from 1^er January of the year following that during which the adaptation was made.
By order deliberately in Council of Ministers, the King may adapt the royalties referred to in paragraph 1^er. »
Art. 87. In article 13bis of the Act of 25 March 1964 on drugs, inserted by the law of 29 December 1990 and amended by the Royal Decree of 22 February 2001 and by the laws of 27 December 2004 and 1^er May 2006, paragraphs 2quater and quinquies are inserted, as follows:
§ 2quater. The King may, by order deliberately in the Council of Ministers, for the products referred to in § 1^er, imposing a dependant contribution from the one who puts them on the market, distributes them or delivers them. On this occasion. It sets out the modalities of their perception. This contribution is based on the public health risks associated with these products and related activities.
Royal arrests under paragraph 1^er are repealed in full law, where they have not been confirmed by the legislator no later than 18 months after their entry into force.
§ 2quinquies. Contributions and awards referred to in § 1^er, 2, 2ter and 2quater, are adapted annually, according to the September index, to the evolution of the UK consumer price index.
The starting index is that of September prior to the publication to the Belgian Monitor of the Royal Decree setting the amount of the contribution or retribution.
The indexed amounts are published in the Belgian Monitor and are applicable to assessed contributions and awards due from 1^er January of the year following that during which the adaptation was made. »
Section 11. - Act of February 24, 1921 - Adaptations
Art. 88. In section 2quater of the Act of 24 February 1921 concerning the trafficking of poisonous, soporific, narcotic, psychotropic, disinfectant or antiseptic substances and substances that may be used for the illicit manufacture of narcotic and psychotropic substances, inserted by the Act of 3 May 2003, the following amendments are made:
1°) in the introductory sentence, the words "Regulation (EEC) No. 3677/90 of the Council of 13 December 1990 on measures to be taken to prevent the diversion of certain substances for the illicit manufacture of narcotic drugs and psychotropic substances" are replaced by the words "Regulation (EC) No. 273/2004 of the European Parliament and the Council of 11 February 2004 on precursor drugs and Regulation (EC) No. 111
2°) the 4°, the second dash is replaced as follows:
"the sale or shipment without having adequately notified the Minister who has the Public Health in his or her duties, in the cases determined by the RoI. - The King sets out how this warning must be made. »
CHAPTER XIII. - Accountability of care providers
Art. 89. In section 2, n, of the Compulsory Health Care and Compensation Insurance Act, coordinated on July 14, 1994, as amended by the Act of December 24, 1999, the words "Assimilated to care providers for the purposes of sections 73bis and 142, the natural or legal persons who employ them, who organize the dispensation of care or the collection of sums due by the health care insurance system;" are inserted".
Art. 90. In article 35bis, § 10, paragraphs 2 and 3, of the same law, inserted by the law of 10 August 2001 and amended by the law of 24 December 2002, the words "at the conditions of refund fixed" are replaced by the words "at the recommendations referred to in article 73, § 2, paragraph 2".
Art. 91. Section 73 of the Act, replaced by the Act of 24 December 2002 and amended by the Royal Decree of 17 September 2005 and by the Act of 27 December 2005, are amended as follows:
1° to § 2 :
(a) in paragraph 1^erthe word "141, § 2" is replaced by the word "146bis";
(b) in paragraph 2, the word "141, § 2" is replaced by the word "146bis" and the last sentence, the words "is considered manifestly deviant with respect to the recommendations referred to in this paragraph" are replaced by the words "must be considered with respect to the recommendations referred to above";
(c) in current paragraph 3, which becomes paragraph 4, "141, § 2", is replaced by "146bis";
2° to § 3, paragraph 1^er, in the second sentence, the words ", initiative or proposal of the minister" are inserted between the word "definit" and the words "indicators";
3° in § 3, paragraph 2, in the second sentence, the words "six months" are replaced by the words "three months";
4° to § 4, the following amendments are made:
(a) in the first sentence, "141, § 3" is replaced by "146bis";
(b) in the second sentence, the word "/or" is added between the word "and" and the word "institutions".
Art. 92. Section 73bis of the Act becomes section 73ter.
Art. 93. In the same law, an article 73bis is inserted, as follows:
"Art. 73bis. Without prejudice to possible criminal and/or disciplinary proceedings and notwithstanding the provisions of the conventions or agreements referred to in Part III, caregivers and assimilated are prohibited under penalty of the measures set out in Article 142, § 1^er :
1° to prepare, prepare, issue or issue regulatory documents referred to in this Act or its enforcement orders where the benefits have not been made or provided;
2° to prepare, prepare, issue or issue the above-mentioned regulatory documents where the benefits do not meet the conditions set out in this Act, its enforcement orders or the agreements or agreements entered into under this Act;
3° to prepare, prepare, issue or issue the above-mentioned regulatory documents where benefits are neither curative nor preventive within the meaning of section 34;
4° to perform benefits under section 34, superfluous or unnecessarily expensive within the meaning of section 73;
5° to prescribe benefits under section 34, superfluous or unnecessarily expensive within the meaning of section 73;
6° to prescribe pharmaceutical specialties referred to in Article 35 bis, § 10, paragraph 2, by exceeding the thresholds set by the indicators and by complying with the recommendations referred to in Article 73, § 2, paragraph 2;
7° to make, after a written warning by one of the officials referred to in section 146, breaches of strictly administrative formalities that do not jeopardize the essential conditions of reimbursement of benefits;
8° to induce caregivers to the prescription or performance of superfluous or unnecessarily expensive benefits. »
Art. 94. In Part VII, Chapter II, of the same Act, the title of Section I^re "Medical Evaluation and Control Service" is replaced by the following title: "The Medical Evaluation and Control Service and the Medical Evaluation and Control Service Committee".
Art. 95. In section 139 of the Act, as amended by the Act of 24 December 2002, the following amendments are made:
1st paragraph 1^er is replaced by the following paragraph:
"It is established within the Institute a Medical Evaluation and Control Service, composed of a central service, ten provincial services and a bilingual service for the Brussels-Capital Region. The ten provincial services and bilingual service in Brussels-Capital are regional services within the meaning of section 32 of the Acts of July 18, 1966 on the employment of languages in administrative matters. »
2° paragraph 2, 5°, is replaced by the following provision:
"5° to enforce the decisions taken by its officer-in-chief, its Committee, the Trial Chambers and the Boards of Appeal referred to in Article 144;"
3° paragraph 2 is completed as follows:
"6° to appeal to the Trial Chambers of disputes with the caregivers on the application of section 73bis, subject to the competence assigned to the officer-director under section 143.
The Medical Evaluation and Control Service further informs each month of the Business Committee that it has introduced to the Trial Chambers, of those that it proposes to close by a warning or notice, and of those in which the care provider voluntarily reimbursed the value of unduly certified benefits;
7° to appeal the decisions of the Trial Chambers or to appeal administrative cassation before the State Council against the decisions of the Boards of Appeal, without prior authorization or subsequent approval of the Committee. »
Art. 96. In section 140 of the Act, replaced by the Act of 27 December 2004, the following amendments are made:
1° § 1^erParagraph 1^er, 1°, is replaced by the following provision:
"1° of a president and two vice-presidents, advisers to the court of appeal or the court of work or members of the public prosecutor's office near the court of appeal or the general auditory near the court of work;"
2° to § 1^erParagraph 1^er2°, the following modifications are made:
(a) the word "huit" is replaced by the word "six" and in the Dutch version, the words "doctor in de geneeskunde" are replaced by the word "artsen";
(b) the words "effective member or alternate member" shall be inserted after the word "less";
3° in § 1^erParagraph 1^er, 3°, the word "huit" is replaced by the word "six" and in the Dutch version, the words "doctor in de geneeskunde" are replaced by the word "artsen" and the word "geneesherenkorps" is replaced by the word "artsenkorps";
4° to § 1^erParagraph 1^er4°, the following modifications are made:
(a) the word "four" is replaced by the word "two";
(b) a second sentence is inserted, as follows:
« ; they have an advisory voice";
5° to § 1^er, it is inserted a 4°bis written as follows:
"4°bis of two effective members and two alternate members, members of the Councils of the Order of Pharmacists selected from the candidates nominated by the National Council of the Order of Pharmacists, double the number of mandates to be assigned; they have an advisory voice;"
6° to § 1^erParagraph 1^er, it is inserted a 6°bis, written as follows:
"6°bis of two effective members and two substitute hospital pharmacists selected from the candidates nominated by the representative organizations of the hospital pharmacists, double the number of the mandates to be assigned;"
7° to § 1^er, paragraph 5, the word "141, § 1^er, 16°" is replaced by the word "146bis";
8° to § 4, the word "141, § 1, 16°" is replaced by the word "146bis";
9° to § 5, paragraph 1^erthe following modifications are made:
(a) in the first sentence, the word "attribute" is replaced by the word "competence";
(b) in the first sentence, "141, § 1, 16°" is replaced by "146bis";
(c) in the last sentence, the words "recourse can be done" are replaced by the words ", it can be appealed".
Art. 97. In section 141 of the Act, amended by the Royal Decree of 25 April 1997 and by the Acts of 24 December 1999, 24 December 2002, 22 December 2003 and 27 April 2005, the following amendments are made:
1° § 1^er, 11°, is replaced by the following provision:
"11° to exercise disciplinary power in respect of inspectors, pharmacists-inspections, nurses-controllers and social controllers referred to in section 146, as well as medical consultants referred to in section 153;"
2° § 1^er, 16°, is replaced as follows:
"16° to propose to the King the adaptations of the conditions mentioned in Article 143, § 1^erdistributing cases between the officer-in-chief of the Medical Evaluation and Control Service and the Trial Chambers referred to in section 144;"
3° §§ 2, 3, 5, 6 and 7 are repealed;
4° the current § 4 becomes § 2.
Art. 98. It is inserted in Part VII, Chapter II, of the same Act, after section 141, section I^rebis, entitled "Disputations between care providers and the Medical Evaluation and Control Service", including sections 142 to 145.
Art. 99. Section 142, repealed by the Act of 24 December 2002, is reinstated in the following wording:
"Art. 142. § 1^er. Without prejudice to possible criminal and/or disciplinary sanctions, the following measures are applied to caregivers who do not comply with the provisions of Article 73bis:
1° the reimbursement of the value of unduly certified health-care benefits and an administrative fine of between 50% and 20% of the amount of the refund in the event of an offence under section 73bis, 1°;
2° the reimbursement of the value of unduly certified health insurance benefits, and/or an administrative fine of between 5% and 15% of the amount of the value of the same benefits in the event of an offence under section 73bis, 2°;
3° the reimbursement of the value of unduly certified health insurance benefits and an administrative fine of between 5% and 100% of the amount of the refund in the event of an offence under section 73bis, 3°;
4° the reimbursement of the value of unduly certified health insurance benefits and an administrative fine of between 5% and 100% of the amount of the refund in the event of an offence under section 73bis, 4°;
5° an administrative fine of 500 euros to 50,000 euros in case of violation of the provisions of Article 73bis, 5°;
6° an administrative fine of 500 euros to 20,000 euros in case of violation of the provisions of Article 73bis, 6°;
7° an administrative fine of 50 euros to 500 euros in case of violation of the provisions of Article 73bis, 7°;
8° an administrative fine of 1000 euros to 250,000 euros in case of violation of the provisions of Article 73bis, 8°.
In the event of a breach of the provisions of Article 73bis, 1° and 3°, the refund shall cover the total value of the benefits unduly borne by the health care insurance. In the cases referred to in 2° and 4° of section 73bis, the refund is the financial damage incurred by health care insurance, estimated by the Medical Evaluation and Control Service, provided that it has not yet been repaired on the basis of another provision of this Act.
In the event of a breach of the provisions of Article 73bis, 8°, the administrative fine may only be imposed after the decision made on the basis of 4° and 5°, with the care provider sanctioned for having prescribed or executed superfluous or unnecessarily expensive benefits, has become final.
§ 2. The material elements constituting the offence referred to in section 73bis are found by a record prepared by the sworn officials referred to in section 146.
These minutes must be issued, barely forfeited, within two years of the date on which documents relating to contentious facts are received by insurers.
§ 3. A penalty of foreclosure:
1° the disputes referred to in Article 73bis, 8°, shall be decided by the officer-in-chief or the official designated by him, within two years of the final decision referred to in Article 142, § 1^er4° and 5 to 6°;
2° the disputes referred to in article 73bis, 2° and 7°, which fall within its jurisdiction, shall be decided by the officer-in-chief or the official designated by him, within two years after the date of the record;
3° the disputes referred to in Article 73bis which are of the competence of the Trial Chambers in accordance with Article 144, § 2, 2°, shall be brought to these Chambers within three years after the date of the record.
The periods referred to above shall be suspended during the course of any civil, criminal or disciplinary proceedings in which the dispensor is a party where the outcome of the proceedings may be a determining factor in the examination of the case by the officer-in-chief or the Trial Chamber.
The judgment of disputes with caregivers referred to in Article 73bis is the exclusive competence of the bodies referred to in Articles 143 and 144.
Art. 100. Section 143, repealed by the Act of 24 December 2002, is reinstated in the following wording:
"Art. 143. § 1^er. The officer-in-chief of the Medical Evaluation and Control Service, or the employee designated by him, is in dispute with respect to:
1° to offences referred to in article 73bis, 1°, 2° and 3° of the law:
(a) if in the five years preceding the finding of the offence, the caregiver has not been subjected to any action imposed by the Restricted Chambers or their Appeals Boards, by the Supervisory Board or its Appeals Board, by the Committee or by the Boards of Appeal provided for in section 155, by the officer-in-chief and the Trial Chamber and that of Appeal provided for in section 144;
(b) in the absence of fraudulent maneuvers;
(c) if the value of contentious benefits is less than 25,000 euros.
These conditions are cumulative;
2° to offences referred to in article 73bis, 7° and 8°.
The division of business between the officer-in-chief of this Service and the Trial Chambers, referred to in section 144, will be the subject of an initial assessment three years after the entry into force of this provision.
§ 2. The officer-in-chief or designated official shall notify, by registered letter to the post, the offender of the offences that have been found in his or her office. The recommended letter is expected to be received on the second working day after the date of shipment.
The Committee invites the offender to provide, by registered letter to the position, his defence within two months.
§ 3. In the event of a breach of the provisions of Article 73bis, 2°, 7° and 8°, the officer-in-chief or the official designated by him shall, within three months of receipt of the defence or, if not, within three months of the expiry of the period provided for in Article 143, § 2, paragraph 2, the measures set out in Article 142.
§ 4. Each year, the officer-in-chief prepares a report referring to the decisions it has taken to allow the Committee to verify that a uniformity of jurisprudence has been respected. »
Art. 101. In Part VII, Chapter II, of the same Act, it is inserted, after section 145, a Iter section, entitled "From the right of investigation of the Medical Evaluation and Control Service", including sections 146 and 146 bis.
Art. 102. In section 146 of the Act, as amended by the Acts of 25 January 1999, 24 December 1999, 12 August 2000 and 24 December 2002, the following amendments are made:
1° paragraphs 1^er current paragraphs 1 to 3^er to 3, § 1^er;
2° to § 1^erParagraph 1^er, the words "141, § 1^er, first paragraph, 1°" are replaced by the words "139, paragraph 2, 2° to 4°";
3° current paragraphs 4 and 5 form 1^er and 2 of § 2;
4° to paragraph 4, which became paragraph 1^er§2, in the Dutch version, the word "onderzoeking" is replaced by the word "investigation" and the word "bevinding" is replaced by the word "vaststelling";
5° in paragraph 5, which became paragraph 2 of § 2, the first sentence is replaced by the words "He invites them to voluntarily return the value of the benefits that have been paid unduly" and "141, § 5" is replaced by "142, § 1^er";
6° current paragraphs 6 to 9 form subparagraphs 1^er to 4 of § 3.
Art. 103. In Part VII, Chapter II, Section Iter, of the same Act, an article 146bis is inserted, as follows:
"Art. 146bis. § 1^er. The Medical Evaluation and Control Service collects after information received from insurers, profile commissions or on its own initiative data relating to the benefits affected by the indicators referred to in Article 73, § 2.
The findings of the profile commissions have probative force to prove otherwise. They are used as such by the inspectors of the Medical Evaluation and Control Service to find the offences referred to in Article 73bis, 6°.
After analyzing the data collected, the Service informs, where appropriate, the health care provider that it has exceeded the manifest deviation indicators and invites it to communicate its written defences within one month.
After reviewing these defences, the officer-in-chief of the Medical Evaluation and Control Service may either categorize the file without further action or place the practice of the monitoring care provider for the services concerned.
Monitoring placement consists of an assessment of the practice of prescription and execution of a care provider on the basis of the indicators referred to in Article 73, § 2.
The monitoring placement takes place for a minimum period of six months. This measure of investigation and its date of commencement are brought to the attention of the care provider, it is also reminded of the recommendations of application to its practice and the measures that may be taken in the event of an offence under section 73bis. No appeal is open against this measure.
Profile commissions may invite the Medical Evaluation and Control Service to place monitoring care providers on the basis of a motivated file. The manager informs the Committee of the follow-up to requests from profile commissions.
If, upon the expiry of the monitoring, the care provider does not show any adaptation or insufficient adaptation to the consistency with good medical practice, the Service requests the service to provide its explanations in writing within one month of the date of the application.
The explanations are submitted to the Committee which may:
1st file without further action;
2° close the file with a warning;
3° load the National College of Consulting Physicians to assess, on a sample basis, compliance with the recommendations referred to in Article 73, § 2, paragraph 2. If, on the basis of this assessment, the College finds that, in at least 20% of the cases, the recommendations are insufficiently respected, the College shall notify the Medical Evaluation and Control Service that transmits the file to the Committee. The findings of the National College of Consulting Physicians have proved to the contrary. They are used as such by medical inspectors of the Medical Evaluation and Control Service to determine the offences referred to in section 73bis, 6°.
The Committee may then take one of the measures referred to in 1°, 2° or 4°.
The methodology for the preparation of the sample and analysis is defined by the National College of Consulting Physicians and forwarded to the appropriate dispenser;
4° instruct the officer-in-chief to refer the matter to the Trial Chamber.
The decisions referred to in 1° and 2° may be contested by the officer-in-chief of the Medical Evaluation and Control Service in the Trial Chamber.
§ 2. The Medical Evaluation and Control Service collects after information received from insurers, a profile commission or its own initiative, data relating to benefits referred to in Article 73, § 4. The findings of the profile commissions have probative force to prove otherwise. They are used as such by medical inspectors of the Medical Evaluation and Control Service to determine the offences referred to in section 73bis.
The monitoring placement takes place for a minimum period of six months. This investigation measure and its start date are brought to the attention of the care provider, and it is also reminded of the recommendations that apply to its practice and the measures that may be taken in the event of an offence under section 73bis. No appeal is open against this measure.
Profile commissions may invite the Medical Evaluation and Control Service to place monitors on the basis of a motivated file. The manager informs the Committee of the follow-up to requests from profile commissions.
After analysis of this data, the officials referred to in Article 146, § 1^er, make a record of finding that is notified to the care provider in accordance with Article 142, § 2, by inviting him to communicate his written means of defence within one month.
Such means shall be communicated to the Committee, which, after its consideration, may decide:
1° to file the file without further action;
2° to close the file with a warning;
3° to charge the officer-in-chief to refer the case to the Trial Chamber.
The decisions referred to in points 1 and 2 of the preceding paragraph may be contested by the officer-in-chief of the Medical Evaluation and Control Service before the Trial Chamber. »
Art. 104. Section 151 of the Act, replaced by the Act of 24 December 1999, is replaced as follows:
"Art. 151. Physicians, pharmacists-inspectors, nurses-controllers, social controllers and administrative staff are, in each province and in the bilingual region of Brussels-Capital, placed under the supervision of a doctor-inspector.
Physicians-Guide Inspectors are placed under the direction of two doctors-inspectors-general, under the direction of the doctor-director-general, officer-in-chief. »
Art. 105. In section 155 of the Act, as amended by the Acts of 28 December 1999, 22 August 2002 and 24 December 2002, the following amendments are made:
1° to § 1^er, 1°, after the words "pharmacians-inspectors," the words "infirmary-controllers" are inserted;
2° to § 2, the following amendments are made:
(a) in the Dutch version, the word "tuchtrechtelijke" is inserted between the word "de" and the word "beslissingen";
(b) the words "and referred to in Article 144, § 1^er"are inserted after the words "instituted for this purpose";
3° in § 4, the words "infirmary-controllers" are inserted after the words "pharmacians-inspections,"
4° in § 5, the words "the doctor, pharmacist or social controller" are replaced by the words "the doctor counseling, the doctor-inspector, the pharmacist-inspector, the nurse-controller or the social controller";
5° § 6 is repealed.
Art. 106. The title of Section V of Chapter II of Part VII of the Act is replaced by the following title:
"Decisions of the officer-in-chief of the Medical Evaluation and Control Service and decisions of administrative courts to the Medical Evaluation and Control Service."
Art. 107. Section 156, repealed by the Act of 24 December 2002, is reinstated in the following wording:
"Art. 156. § 1^er. The decisions of the officer of the Medical Evaluation and Control Service or of the official designated by him, referred to in section 143, the decisions of the Trial Chambers referred to in section 142, and the decisions of the Boards of Appeal, referred to in sections 142 and 155, shall be enforceable by reserve, notwithstanding any appeal. Payment times may be granted.
The sums produce interest in full right at the legal rate from the day after the date of the decision.
If the debtor fails, the Administration of the value added tax, registration and domains may be responsible for the recovery of amounts due in accordance with the provisions of section 206bis of the Act.
In the notification of the decision of the Trial Chambers, it is mentioned that, in the absence of admissibility, an appeal may be brought before the Boards of Appeal in the month, beginning with the notification of the decision. The deadline takes place on the day of the shipment of the recommended letter to the post, the stamp of the position being authentic. - The appeal does not suspend the execution of the decision. The notification shall incorporate the relevant provisions of the rules of procedure.
In the notification of the decision of the Boards of Appeal, it is mentioned that, in the absence of admissibility, an appeal for administrative cassation may be brought before the Council of State, administrative section, within sixty days of notification of the decision. The appeal does not suspend the enforcement of the decision. The notification also mentions that the administrative referee before the Council of State, as referred to in articles 17 et seq. of the coordinated laws of 12 January 1973 on the Council of State, is not admissible for decisions in the contentious cases referred to in article 14, § 2, of the same laws.
§ 2. In the decision of the officer of the Medical Evaluation and Control Service or of the employee designated by him, it is mentioned that, in the absence of admissibility, an appeal may be brought before the Trial Chambers within one month of the notification of the decision. This period begins to run on the day of the shipment of the recommended letter to the post, the stamp of the post being sent. - The appeal does not suspend the execution of the decision. The notification shall incorporate the relevant provisions of the rules of procedure. »
Art. 108. In the same Act, section 157, repealed by the Act of 24 December 2002, is reinstated in the following wording:
"Art. 157. § 1^er. The enforcement of decisions in respect of administrative fines referred to in section 142 may be partially or totally suspended for a period of one year to three years when neither an administrative fine nor any other measure decided by an administrative or judicial proceeding established with the Institute, the officer-in-chief or the official designated by him, the Restricted Chambers or their Appeals Boards, the Supervisory Board or its Appeal Board, the Board of Appeal,
When the same act constitutes several offences, the strongest administrative fine is pronounced alone.
Where, within three years of the date on which the decision applying a measure referred to in section 142 has become final, the caregiver commits a new breach, the fine may be increased to a maximum of two.
A fine imposed for violation of Article 73bis, 7°, or Article 141, § 5, paragraph 4, c, repealed by the law of (...), does not entail the application of the preceding paragraph or the loss or revocation of the stay referred to in the first paragraph.
§ 2. The internship master is responsible for the failures committed by the trainee in the course of his or her internship plan, as these breaches are attributable to him.
The care provider who initiates superfluous or unnecessarily expensive services within the meaning of Article 73, § 2 or § 4, is responsible in the same way as the care provider who has continued to prescribe or execute them. It is liable, as the case may be, to the penalties provided for in Article 142.
§ 3. The decisions of the officer-in-chief or official designated by him, the Trial Chambers and the Boards of Appeal, except the disciplinary measures referred to in section 155, shall be published anonymously at the INAMI Internet address.
§ 4. The total of fines and amounts to be reimbursed is paid on the Institute's account and is a health care insurance recipe. »
Art. 109. Section 164 of the Act, as amended by the Acts of 20 December 1995, 24 December 1999, 14 January 2002, 24 December 2002 and 13 December 2005, are amended as follows:
1° to paragraph 1^er, "141, §§ 2, 6" is replaced by "142, § 1^er";
2° to paragraph 4, "141, §§ 2, 6" is replaced by "142, § 1^er";
3° in paragraph 5, the words "94 of the laws on State accounting, coordinated on 17 July 1991" are replaced by the words "206bis of the law".
Art. 110. In section 174 of the Act, as amended by the Acts of 20 December 1995 and 24 December 2002, the following amendments are made:
1st paragraph 1^er, 10°, is replaced by the following provision:
"10° for the application of Article 142, § 1^er, the findings shall, barely invalid, intervene within two years:
(a) from the day on which documents relating to contentious facts are received by insurers;
(b) from the day on which the findings from the profile commissions or the National College of Consulting Physicians are received by the Medical Evaluation and Control Service;
2° to paragraph 3, the words "to the Medical Evaluation and Control Service Committee and the Appeals Chamber referred to in section 155, § 6", shall be replaced by the words "to the officer-in-chief referred to in section 143 and the Trial Chambers and the Boards of Appeal referred to in section 144";
3° to paragraph 3, last sentence, after the words "final decision", the words "of the Committee or the Board of Appeal" are replaced by the words "of the officer-in-chief, the Trial Chamber or the Appeals Chamber".
Art. 111. In section 191, 17°, of the same Act, replaced by the Act of 24 December 1999, the words "refunds referred to in sections 146, 156 and 157" are replaced by the words "administrative fines or refunds referred to in sections 142 and 143 and voluntary refunds referred to in section 146".
Transitional provision
Art. 112. Article 216bis, as follows, is inserted in the same law:
"Art. 216bis. § 1^er. The facts committed before the date of entry into force of this Act are subject to the provisions of Articles 73 and 141, §§ 2, 3, 5, 6 and 7, paragraph 1^er at 5°, as they were in force before that date.
§ 2. Procedures for the facts referred to in § 1^er are of the competence:
(a) of the Executive Officer in accordance with Article 143, § 1^ereven if they have already been submitted to the Committee;
(b) Trial Chambers in accordance with Article 144, § 2, even if they have already been submitted to the Committee;
(c) the Boards of Appeal referred to in Article 144. The Boards of Appeal referred to in section 155, § 6, repealed by the law of the..., shall be held in full right of appeals initiated before the coming into force of this Act. "
Entry into force
Art. 113. The provisions of this Chapter shall enter into force on a date to be determined by the King.
CHAPTER XIV. - INAMI
Section 1^re. - Reimbursement conditions
Art. 114. In Part VII of the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994, a new chapter Vbis, including section 174bis, is inserted as follows:
"Chapter Vbis. Payment conditions
Art. 174bis. In the event of a change in insurability data, by which the personal intervention in the pharmaceutical benefits, as referred to in section 165, is reduced, the insurance agency can aggregate the refunds due to the beneficiary until a sum of 5 euros is reached. "
Section 2. - Special Solidarity Fund
Art. 115. Article 25s, § 2, of the same law, inserted by the law of 27 April 2005, is supplemented as follows:
" - a request for derogation from the College of Physicians' decisions on orphan drugs. » .
Section 3. - Katz Scale
Art. 116. In section 37quater, § 2, of the Compulsory Health Care Insurance Act and Coordinated Benefits on July 14, 1994, inserted by the Act of December 22, 2003, the following paragraph is inserted between paragraphs 2 and 3:
"As part of the controls carried out for the purposes of this paragraph, the medical data collected by a medical consultant shall be deemed to the contrary and may be used by the doctors and inspectors referred to in section 169 for the purposes of finding the offences. » .
CHAPTER XV. - Effective loss of the moderator ticket
Art. 117. In Article 37, § 17, of the Compulsory Health Care and Compensation Insurance Act, coordinated on July 14, 1994, the words "The King may extend this obligation to other benefits or provide for derogations from that obligation" are replaced by the words "The King may extend this obligation to other benefits, provide for derogations to that obligation or set a minimum proportion of benefits to which this obligation applies".
Art. 118. In the same Act, an article 168quater is inserted, which reads as follows:
"Art. 168quater. A care provider who fails to reach the minimum proportion of benefits to which the obligation to receive the personal intervention of the beneficiary is applied, as provided in section 37, § 17, may be fined administratively.
The Social Inspectors of the Administrative Control Service are empowered to report on the offences referred to in paragraph 1 on the basis of the data provided by the insurers at the Institute.^er.
A copy of the report shall be notified to the care provider, by registered letter to the post, within fourteen days of the finding.
Prior to the issuance of any administrative fines, the care provider is invited to apply his defence to the officer of the Administrative Oversight Service.
The fine is fixed by the King; the amount of the latter may not be less than 125 euros and not exceed 12.500 euros.
The administrative fine is calculated on the basis of the total amount of the insurance intervention in benefits that are affected by the obligation referred to in paragraph 1^er and the proportion of actual perception of personal intervention observed during a reference period established by the RoI. In case of recidivism, the fine can be doubled.
The fine is imposed by the Chief Administrative Oversight Officer and the decision is sent to the care provider by registered letter to the position. The recommended letter is considered to be received on the first business day following the handover to La Poste. This notification includes the reasons for the award, the amount of the administrative fine and the terms of payment to the Institute. It further states that the decision is subject to appeal before the Labour Court and specifies the forms and deadlines of the appeal.
The King sets out the data to be transmitted by the insurers to the Institute, referred to in paragraph 2, and the terms and conditions for calculating the fine.
In the event of a debtor's failure, the final fines are forwarded for recovery to the Administration of the value added tax, registration and domains, in accordance with Article 94 of the State Accounting Laws, coordinated on 17 July 1991.
The proceeds of fines are paid to the Institute. "
CHAPTER XVI. - Assurability of minors
Art. 119. In section 2, (k), of the Law on Compulsory Health Care and Compensation Insurance, coordinated on 14 July 1994, amended by the Law of 24 December 1999, the words "1° to 16° and 20°" are replaced by the words "1° to 16°, 20° and 22°".
Art. 120. Section 32 of the Act, amended by the Acts of 4 August 1996, 25 January 1999, 23 March 2001 and 24 December 2002 and the Royal Decrees of 18 February 1997 and 25 April 1997, are amended as follows:
1st paragraph 1^er is completed as follows:
« 22° persons under the age of 18, referred to in Article 5 of Title XIII - Chapter VI of the Programme Law (I) of 24 December 2002 relating to the guardianship of unaccompanied foreign minors, who have for at least three consecutive months attended the teaching of the fundamental or secondary level in a school approved by a Belgian authority, or who have been exempted from the school obligation by the « Commissie van advies voort
However, persons under 18 years of age who are or may be beneficiaries of the right to health care under section 32, paragraph 1^er, 1° to 21° of this Act, or under another Belgian or foreign health care insurance regime, or which may assert a quality of holder or dependant under an order, taken in accordance with section 33, § 1^erParagraph 1^er. The King may determine what is appropriate to hear by another Belgian or foreign health insurance regime for the purposes of this provision. » ;
2° in paragraph 2, the words "13° to 15°" are replaced by the words "13° to 15° and 22°".
Art. 121. Article 33, § 1^erParagraph 1^er the same Act, as amended by the Royal Decree of 25 April 1997 and by the Acts of 25 January 1999 and 9 July 2004, is supplemented as follows:
"7° to persons under the age of 18, registered as dependants of the holders referred to in 1°, when they do not meet the conditions to maintain their right to health care. » .
Art. 122. In article 118, paragraph 2, of the same law, amended by the law of 24 December 1999, the words "1° to 16° and 19°" are replaced by the words "1° to 16°, 19° and 22°".
Art. 123. Article 121, §§ 1^er and 2, of the same law, amended by the Royal Decree of 25 April 1997, the words "1° to 16° and 20°" are replaced by the words "1° to 16°, 20° and 22°".
Art. 124. Articles 119 to 123 come into force on 1^er January 2007.
CHAPTER XVII. - National Commission dento-mutualiste
Art. 125. In section 26, paragraph 3 of the Compulsory Health Care Insurance Act, coordinated on 14 July 1994, the words "and the National Commission dento-mutualiste" are deleted.
CHAPTER XVIII. - Amendments to the Act of 7 May 2004 relating to experiments on the human person
Art. 126. Section 2, 4°, paragraph 2, of the Act of 7 May 2004 on experiments on the human person is replaced as follows:
"In addition, in order to be authorized to carry out the tasks set out in this Act, with the exception of giving notice on items 4°, 6° and 7° of § 4 of Article 11, the Ethics Committee shall demonstrate to the Minister, in the report referred to in Article 30, § 5, that it has analyzed, in the previous year, at least 5 new protocols of multicentric experiments under at least one new committee »
Art. 127. In section 24 of the Act, the following amendments are made:
1°) § 1^er is replaced by the following provision:
« § 1^er. For the manufacture and importation of experimental drugs, authorization granted by the Minister is required. Authorization is also required if the experimental drug is manufactured for export. The King sets out the terms and conditions for cases where this authorization is required, the terms and conditions to be met in order to obtain it, and the obligations and modalities to which a licensee must meet. It also sets out the principles and guidelines for good practices in the manufacture of experimental drugs that must be respected. » ;
2°) in § 2, the words "at the conditions provided for in Article 12 of the Royal Decree of 6 June 1960 referred to above" are replaced by the words "at the conditions fixed by the King";
3°) to § 3 are made the following amendments:
(a) in the introductory sentence, the words "the qualified person referred to in Article 15 of the above-mentioned Royal Decree of 6 June 1960, without prejudice to his relations with the manufacturer or importer, has the responsibility, within the framework of the procedures referred to in Article 14 of the Royal Decree of 6 June 1960 referred to above, to ensure:" are replaced by the words "the qualified person referred to in § 2, without prejudice to his relations with the manufacturer or
(b) in point (a), the words "in accordance with the requirements of Appendix II to the above-mentioned Royal Decree of 6 June 1960 establishing the principles and guidelines of good manufacturing practices for human medicines" are replaced by the words "in accordance with the principles and guidelines of good manufacturing practices referred to in § 1^er";
(c) in point (b) the words "to those provided for in Schedule II of the Royal Decree of 6 June 1960 referred to above" are replaced by the words "to the principles and guidelines referred to in § 1^er";
(4) § 5 is replaced by the following provision:
Ҥ 5. The distribution of experimental drugs is subject to the authorization referred to in section 12ter of the Drugs Act".
Art. 128. The following amendments are made to section 30 of the Act:
1° to § 2, the following paragraphs shall be inserted between paragraphs 3 and 4:
"The Minister may annually, after the advice of the Bioethics Advisory Committee, assign a maximum of 10% of the amount referred to in paragraph 3 to the payment of projects to provide administrative or computer support for the performance of the duties of all ethics committees under this Act.
The remaining amount is allocated to ethical committees as follows:
- 1 point is assigned for the review of a new multi-centric experimentation protocol as a committee entitled to render the notice unique;
- 1 point is assigned for the review of a new phase 1 test protocol as a committee that is authorized to issue the single notice;
- 0.25 point is assigned for the review of a new protocol under a non-qualified committee to issue a single notice;
- 0.25 point is assigned for the examination of a new monocentric experimentation protocol, with the exception of the case in which this experiment is a phase 1 test and the case in which it is carried out as part of the work required for a graduate degree;
- 0.1 point is assigned for the examination of a new protocol for experimentation in the event that it is carried out as part of the work required to obtain a graduate degree.
The value of a point is determined annually by dividing the amount remaining by the total number of points allocated to all ethical committees in accordance with the provisions of the preceding paragraph.
As a transitional measure, all amounts referred to in this section will be subject to a comprehensive settlement for the years 2004 and 2005 and will be paid in 2006. »;
2° in § 6, the words "or applicants or holders of an authorization referred to in this Act" are inserted after the words "on the charge of the promoter";
3° the article is supplemented by a § 7, which reads as follows:
Ҥ 7. The King may, by deliberate order in the Council of Ministers, impose a dependant contribution on the promoter of a clinical trial. On this occasion, He sets out the modalities of their perception. The amount of this contribution is based on the public health risks associated with these experimental drugs and related activities.
Royal arrests under paragraph 1^er, are repealed in full law, where they have not been confirmed by the legislator no later than 18 months after their entry into force.
§ 8. The contributions and awards referred to in §§ 2, 6 and 7 are adapted annually, according to the September index to the evolution of the UK Consumer Price Index.
The starting index is that of September prior to the publication to the Belgian Monitor of the Royal Decree setting the amount of the contribution or retribution.
The indexed amounts are published in the Belgian Monitor and are applicable to assessed contributions and awards due from 1^er January of the year following that during which the adaptation was made. »
CHAPTER XIX. - Amendments to the Judicial Code
Art. 129. Section 1017, paragraph 2, of the Judicial Code, as amended by the Acts of 30 June 1971 and 22 April 2003, is replaced as follows:
"The conviction at the expense is, however, always pronounced, except in the event of a tenacious or vexatious application, by the authority or body responsible for the application of the laws and regulations provided for in sections 580, 581 and 582, 1° and 2°, with respect to applications filed by or against social insured persons.
By social insurance, it must be understood: social insurance persons within the meaning of article 2, 7°, of the law of 11 April 1995 to institute the "Chart" of the social insured. »
Art. 130. Conviction on costs, pursuant to section 129, shall be pronounced by the judge in the proceedings before him by an application that was filed after the coming into force of this Act.
Promulgation of this law, let us order that it be clothed with the seal of the State and published by the Belgian Monitor.
Given in Brussels on 13 December 2006.
ALBERT
By the King:
Minister of Social Affairs and Public Health,
R. DEMOTTE
Seal of the state seal:
The Minister of Justice,
Ms. L. ONKELINX
____
Note
(1) Regular session 2005-2006.
House of Representatives:
Parliamentary documents. - Bill No. 51-2594/1. - Amendments, No. 51-2594/2. - Report made on behalf of the commission, No. 51-2594/3. - Text adopted by the commission, No. 51-2594/4. - Text adopted by the commission, No. 51-2594/5. - Amendment submitted after the tabling of the report, No. 51-2594/6. - Complementary report on behalf of the Commission, No. 51-2594/7. - Text adopted by the commission, No. 51-2594/8. - Text adopted in plenary and transmitted to the Senate, No. 51-2594/9.
Annales parliamentarians. - Discussion and adoption. Session of July 13, 2006.
Senate:
Parliamentary documents. - Project referred to by the Senate, No. 3-1812/1. Amendments, No. 3-1812/2. - Amendments, no. 3-1812/3. - Amendments, No. 3-1812/4. - Report made on behalf of the commission, No. 3-1812/5. - Text corrected by the commission, no. 3-1812/6. - No. 3-1812/7.