belgiquelex.be - Carrefour Bank of Legislation

10 AVRIL 2014. - Act on various health provisions

PHILIPPE, King of the Belgians,
To all, present and to come, Hi.
The Chambers adopted and We sanction the following:
PART 1^er. - INTRODUCTIVE PROVISION
Article 1^er. This Act regulates a matter referred to in Article 78 of the Constitution.
PART 2. - INAMI
CHAPTER 1^er. Mandatory health insurance and allowances
Section 1^re. - Administrative cooperation
Art. 2. In section 191, paragraph 2, of the Compulsory Health Care Insurance Act, coordinated on July 14, 1994, inserted by the Act of January 25, 1999 and amended by the Act of December 27, 2006, the following amendments are made:
1° the words "Code of taxes assimilated to the stamp" are replaced by the words "Code of various duties and taxes";
2° the same paragraph is supplemented by the following sentence:
"In order to have the information necessary for the collection of these supplements of contributions or premiums, of these recipes and deductions, the Institute may use the administrative cooperation established in the tax field, between Belgium and other Member States of the European Union, as referred to in article 211bis of the Code of Miscellaneous Duties and Taxes.".
Section 2. - Funding for rare diseases and orphan drugs
Art. 3. Section 56 of the Act, last amended by the Act of 26 December 2013, is supplemented by a paragraph 9, which reads as follows:
"§ 9. The Institute provides a unique financial intervention of 15,000 euros to the King Baudouin Foundation, to finance the missions given to the Rare Diseases and Orphaned Medicines Fund as part of the conference organised in the framework of EUROPLAN 2012-2015, the Belgian Plan for Rare Diseases and Orphanet. The response is fully charged to the 2014 budget for health care. "
Section 3. - Composition of the National College of Consulting Physicians and Local Colleges
Art. 4. In article 153, paragraph 3, paragraph 5, of the same law, inserted by the law of 19 December 2008, the words "or physiotherapists" are inserted between the words "practices of nursing art" and the words ", mandated by medical consultants of the insurers. ".
Section 4. - Accreditation Council
Art. 5. In Article 215, § 1^er, of the same law, amended by the laws of 24 December 1999 and 19 March 2013, the words ", 4° bis and 7° bis" are replaced by the words "and 4° bis".
Section 5. - Social benefits of logoped
Art. 6. In title III, chapter V, section IV, of the same law, the words ", logoped" are inserted between the words "pharmacists" and the words "and physiotherapists".
Art. 7. In Article 54, § 1^erParagraph 1^erin the same law, replaced by the Act of 22 December 2003, the words ", of the Convention Commission responsible for negotiating and concluding the national agreement between the logopeds and the insurers" are inserted between the words "of the Permanent Commission responsible for negotiating and concluding the national agreement between the pharmacists and the insurance organizations" and the words "or the Convention Commission responsible for negotiating and concluding the national agreement between the physiotherapists".
In the same paragraph, the words ", logoped" are inserted between the words "or for pharmacists" and the words "or the physiotherapists who adhere".
Art. 8. In Article 54, § 1^er, paragraph 3, of the same law, replaced by the law of 22 December 2003 and amended by the law of 19 December 2008, the words ", logopeds" are inserted between the words "pharmacists" and the words "and physiotherapists".
Art. 9. In section 54, § 2, of the Act, replaced by the Act of 22 December 2003, the following amendments are made:
1° in paragraph 1^erthe word ", logoped" is inserted between the word "pharmacians" and the words "and physiotherapists";
2° in paragraph 3, the word ", logoped" is inserted between the word "pharmacians" and the words "and physiotherapists".
Section 6. - Mariner Relief and Provident Fund and Overseas Social Security Office
Art. 10. Article 53, § 1^er, of the same Act, last amended by the Act of 19 March 2013, is supplemented by a paragraph written as follows:
"The King shall specify the terms and conditions for the application of the obligation to pay referred to in paragraph 13 by the Marine Relief and Provident Fund and by the Overseas Social Security Office."
Section 7. - internees
Art. 11. Article 56, § 3, paragraph 1^erthe same law, inserted by the law of 27 December 2004 and amended by the law of 11 July 2005, is supplemented by the following sentences:
"The amount of 27,659 thousand euros is adapted from 2006 to the evolution of the arithmetic mean of the health index of the month of June and the indexes of the previous three months between June 30 of the last year and June 30 of the preceding year. In 2013, the amount of this intervention was up to 34.522 thousand euros. From 2014, this amount will be adapted to the evolution of the arithmetic mean of the June Health Index and the indexes of the previous three months between June 30 of the last year and June 30 of the year preceding."
Art. 12. In article 56, § 3bis, paragraph 3, of the same law, inserted by the law of 27 December 2005, the words "vised in §§ 1^er and 2" are replaced by the words "see paragraphs 1^er and 2".
Section 8. - Anatomopathology
Art. 13. In the same Act, title III, chapter V, section VIII, is replaced by the following:
"Section VIII. - Clinical biology and anatomology services provided to hospitalized and non-hospital beneficiaries".
Art. 14. Article 59, paragraph 1^erin the same Act, replaced by the Act of 23 December 2009, the following amendments are made:
1° the words "and the overall budget of the financial means for the whole Kingdom for the services of anatomopathology as fixed by the General Council" are inserted between the words "as fixed by the General Council" and the words "as well as";
2° the words "this budget" are replaced by the words "the budgets".
Art. 15. Article 67, § 2, of the same law, inserted by the law of 24 December 1999, is supplemented by the words "and Article 65".
Section 9. - Conclusion of conventions with the Scientific Institute of Public Health
Art. 16. Section 22 of the Act, last amended by the Act of 15 December 2013, is supplemented by the 20th drafted as follows:
"20° concludes with the Scientific Institute of Public Health - WIV-ISP a convention of collaboration whenever he intends to entrust him with a mission:
(a) to establish and use databases to increase knowledge of the health of the population in order to increase epidemiological, clinical and other knowledge. For these purposes, the Scientific Institute of Public Health - WIV-ISP is responsible for:
1° to develop technical platforms to collect data, use existing databases, possibly via coupling, using the services of an intermediate organization, as defined in Article 1^er, 6°, of the Royal Decree of 13 February 2001 implementing the Act of 8 December 1992 on the protection of privacy with respect to personal data processing;
2° to coordinate and support data collection;
3° to validate and analyze collected data;
4° to prepare aggregate reports on collected information;
5° to prepare evaluation reports on baseline parameters for those who participated in the data harvest;
6° to develop scientific research to improve public health policy, health care policy and health care.
(b) in the context of reference centres for human microbiology:
1° ensure the diagnosis of certain rare or difficult to diagnose pathogens;
2° to confirm the diagnosis in peripheral laboratories;
3° to participate in data harvests as part of warning and monitoring systems on the collection, recording, processing and analysis of health care data.
The Insurance Committee is also empowered to conclude a Framework Convention, which determines the general contractual rules applicable to all of the collaborative agreements it concludes for the above-mentioned purposes with the Scientific Institute of Public Health - WIV-ISP.
Section 10. - Help granted by the C.P.A.S.
Art. 17. Article 16, § 1^erthe same Act, as amended by the Acts of 30 December 1995, 30 December 2001, 22 August 2002, 24 December 2002, 10 December 2004, 27 December 2006, 17 June 2009 and 19 May 2010 and by the Royal Decrees of 25 April 1997 and 17 September 2005, is supplemented by a 16th drafted as follows:
"16° sets the amount of the lump sum financial intervention referred to in Article 56, § 8.".
Art. 18. Section 56 of the Act, last amended by the Act of 26 December 2013, is supplemented by a paragraph 8, which reads as follows:
§ 8. The Institute provides annual lump-sum financial intervention starting in 2014 with a maximum of EUR 150,000 to the Federal Public Service for Programming Social Integration, Poverty Reduction, Social Economy and Policy of the Great Cities to cover the benefits referred to in section 34 and which have been taken over by this Federal Public Service while they come into account for an intervention of health care insurance.
Compensation is paid on the production of an estimate that is transmitted by the Federal Public Service to the General Council no later than the first week of December of the year concerned.
The General Council decides the amount, which is paid by the end of the year concerned.
Compensation is fully charged to the health care budget. ".
Section 11. - Medical imaging
Art. 19. Article 69ter of the same law §§ 1^er 10, 13 and 14, of the same Act, inserted by the Act of 21 December 1994, is repealed.
Art. 20. Sections 69quater, 69quinquies, 69sexies and 69ssepties, of the same Act, inserted by the Act of 21 December 1994, are repealed.
Section 12. - Health Care Insurance Conditions for Certain Benefits
Art. 21. In Article 64, § 1^erParagraph 1^er, of the same law, last amended by the Act of 10 December 2009, the first is replaced by the following:
"1° have been installed and operated in accordance with the provisions for the programming and approval of the Hospitals Act and its enforcement orders. From a date fixed by the King, only the services carried out by means of apparatus whose list is established by the King and which are provided within the time frames fixed by the King of an identification number and a counter may be refunded. Under the conditions to be determined by the King, the particular care certificate or the document to be issued refers to the identification number assigned by the Institute to the service or place in which the services are performed, as well as the identification number of the device by which the service is performed and the order number of the service, as noted by the meter;"
Section 13. - College of Physicians and Director Advisory Board of Functional Rehabilitation
Art. 22. Title III, chapter I^erSection VI of the Act is replaced by the following:
"Section VI. - College of Physicians and Directors"
Art. 23. In section 23, paragraph 2, paragraph 2, of the Act, as amended by the Acts of 22 August 2002 and 23 December 2009, the sentence "For this purpose, the College of Physicians and Directors shall receive the advice of the Advisory Board of Functional Rehabilitation." is repealed.
Art. 24. In section 23, § 4, paragraph 2, of the same Act, the words ", after having communicated it to the Advisory Council for Functional Rehabilitation," and the sentence "If no comments were made by the Council within thirty days of the receipt of the notice, it is deemed to approve the notice" are repealed.
Art. 25. Section 24 of the Act is repealed.
Section 14. - Functional rehabilitation benefits
Art. 26. In section 71 of the Act, paragraph 2 is replaced by the following:
"The annual budgetary objective for the functional rehabilitation services referred to in Article 34, 7°, 7° ter, 7° quater and 7° quinquies is set out in the procedure provided for in Articles 38, 39 and 40, the College of Physicians and Directors referred to in Article 23 ensuring, for these functional rehabilitation services, the role of the convention committee provided for in Article 38. "
Section 15. - Reference amounts
Art. 27. In Article 56ter, § 1^er, from the same law, replaced by the law of 19 December 2008, the words "version 15.0" are replaced by the words "version 28.0".
Art. 28. In article 56ter, § 4, first sentence, of the same law, replaced by the law of 19 December 2008, the words "and paragraph 11" are inserted between the words "in paragraph 3" and the word "concerning".
Art. 29. In section 56ter, § 5, 1°, b., of the same law, replaced by the law of 19 December 2008, the first dash is replaced by the following:
"- for RTAs, degree of clinical severity 1 or 2 and group of benefits for which the result calculated in point a, first dash, is positive; calculation by hospital of the differences in the amount between, on the one hand, the actual expenses for admissions referred to in § 1^er, taking into account the limitations referred to in § 2, and, on the other hand, the corresponding median national expenditure, by APR-DRG, by clinical degree 1 or 2 and by benefit group. "
Art. 30. Section 56ter §9 of the Act, replaced by the Act of 19 December 2008, is replaced by the following:
" § 9 Diagnostic groups are formed on the basis of "All Patients Refined Diagnosis related groups, Definitions Manual, Version 28.0" :
1° APR-DRG 024 - APR-DRG
2° APR-DRG 045 - Cerebral vascular injury and pre-cerebral occlusion with infarction, APR-DRG 046 - Non-specific vascular injury and pre-cerebrain occlusion without infarction, APR-DRG 047 - Transient Brain Ischemia (TIA), APR-DRG 134 - Pulmonary Emboli "
Art. 31. In section 56ter, § 11, of the same law, replaced by the law of 19 December 2008 and amended by the law of 19 March 2013, the 1st is replaced by the following:
"1° In the benefit group defined in § 8, 3°, the benefits of Article 22 (physiotherapy) are excluded from the calculation of the reference amounts for the following five diagnostic groups: APR-DRG 045 - Brain vascular accident and pre-cerebraal occlusion with infarctus, APR-DRG 046 - Non-specific stroke and pre-cerebral occlusion 139
Art. 32. In section 56ter, § 12, of the same law, replaced by the law of 19 March 2013, the 1st is replaced by the following:
"1° the diagnostic group APR-DRG 190 is divided into diagnostic groups APR-DRG 190 - Acute myocardial infarction if admission takes place in a hospital that does not have during the year of application of a B or B1 care program, either alone or in association and APR-DRG 190 - Acute myocardial infarctus if admission takes place in a hospital that has, during the year of application concerned, a B or B1 care program alone or in association;
Art. 33. In section 56ter, § 12, of the same law, replaced by the law of 19 March 2013, the second is replaced by the following:
"2° diagnostic groups APR-DRG 45, APR-DRG 46, APR-DRG 139, APR-DRG 301 and APR-DRG 302 are divided into diagnostic groups APR-DRG 45 - Brain vascular accident and pre-cerebrale occlusion with infarctus, if admission takes place in a hospital that, during the year of application, has concluded with the Insurance Committee a convention for the revalidation of disorders (neuro)locoprops (7.71 or 9.50), APR-DRG 46 - Non-specific vascular stroke and pre-cerebrale occlusion without infarction if admission takes place in a hospital which, during the year of application, has concluded with the Insurance Committee a convention for the revalidation of disorders (neuro)locomotors (7.71 or 9.50), APR-DRG 139 - Other pneumonia, if the admission takes place in a hospital that, during the year of application, has entered into an agreement with the Insurance Committee for the revalidation of disorders (neuro)locomotors (7.71 or 9.50), APR-DRG 301 - Replacement of hip joints, if the admission takes place in a hospital that, during the year of application, has entered into an agreement with the Insurance Committee Brain vascular accident and pre-cerebrale occlusion with infarctus, if admission takes place in a hospital that, during the year of application, has not entered into a revalidation agreement with the Insurance Committee (neuro)locoprops (7.71 or 9.50), APR-DRG 46 - Non-specific vascular stroke and pre-cerebrale occlusion without infarction if admission takes place in a hospital that, during the year of application, has not entered into a revalidation agreement with the Insurance Committee (neuro)locoprops (7.71 or 9.50), APR-DRG 139 - Other pneumonia, if the admission takes place in a hospital that, during the year of application, has not entered into with the Insurance Committee any agreement to revalidate the disorders (neuro)locoprops (7.71 or 9.50), APR-DRG 301 - Replacement of hip joint, if the admission takes place in a hospital that, during the year of application, has not entered into insurance ".
Art. 34. In section 156bis of the Act of 29 April 1996 on social provisions, inserted by the Act of 24 December 2002 and amended by the Act of 24 July 2008, paragraph 1^er is replaced by the following:
"The technical unit has, for the data and in the manner to be determined by the King by order deliberately in the Council of Ministers and after the advice of the Commission on the Protection of Privacy, the competence to couple data other than the data defined in section 156, in relation to the missions defined in sections 263 and 264 of the Programme Law of 24 December 2002 and for the institutions defined in section 278, paragraph 5, of the same Act. The King shall determine in accordance with the same procedure the date of entry into force of this competence of the Technical Cell, which for coupling for the benefit of the Intermutualist Agency is limited to couplings with the representative sample referred to in section 278, paragraph 5, of the same Act. The competence of the technical cell to couple other data than those of the representative sample referred to above with the data referred to in section 156 in favor of the Intermutualist Agency is determined by the King following the same procedure, after the advice of the Multiparty Hospital Policy Structure. "
Art. 35. Sections 27 to 33 apply to admissions that end after December 31, 2013.
Section 16. - Biological medicine
Art. 36. In section 73, § 2, of the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994, replaced by the Act of 24 December 2002 and amended by the Royal Decree of 17 September 2005 and the Acts of 27 December 2005, 13 December 2006, 8 June 2008, 19 December 2008, 22 December 2008, 23 December 2009, 29 December 2010 and 22 June 2012, the following amendments are made:
1° paragraph 3, 4°, and paragraph 9, 3°, are each time supplemented by the words "and whose reimbursement base is not greater than the reimbursement base calculated on the basis of the theoretical ex-factory price of the biological reference drug referred to in (a) of the following point, at the time of the refund of the first repayable pharmaceutical specialty authorized in accordance with Article 6bis, § 1^er, paragraph 8, of the Act of 25 March 1964 on medicines which essentially contains the same biological substance, reduced by 15% and increased according to the rules laid down in section 35ter, § 1^er4";
2° Paragraph 3 is supplemented by the 5° written as follows:
"5° of refundable pharmaceutical specialties that:
(a) are the biological reference drug for repayable pharmaceutical specialties authorized in accordance with Article 6bis, § 1^er, paragraph 8, of the Act of 25 March 1964 on medicines or biological medicines that essentially contain the same biological substances as the biological reference drugs but were not authorized in accordance with Article 6bis, § 1^erParagraph 8 of the Act of 25 March 1964 on Drugs;
(b) and whose base of reimbursement is not greater than the base of reimbursement calculated on the basis of the theoretical ex-factory price of the biological reference drug concerned referred to in (a), at the time of reimbursement of the first repayable pharmaceutical specialty authorized in accordance with Article 6bis, § 1^er, paragraph 8, of the Act of 25 March 1964 on medicines which essentially contains the same biological substance, reduced by 15% and increased according to the rules laid down in section 35ter, § 1^er4."
3° Paragraph 9 is supplemented by the 4° written as follows:
"4° of refundable pharmaceutical specialties that:
(a) are the biological reference drug for repayable pharmaceutical specialties authorized in accordance with Article 6bis, § 1^er, paragraph 8, of the Act of 25 March 1964 on medicines or biological medicines that essentially contain the same biological substances as the biological reference drugs but were not authorized in accordance with Article 6bis, § 1^erParagraph 8 of the Act of 25 March 1964 on Drugs
(b) and whose base of reimbursement is not greater than the base of reimbursement calculated on the basis of the theoretical ex-factory price of the biological reference drug concerned referred to in (a), at the time of reimbursement of the first repayable pharmaceutical specialty authorized in accordance with Article 6bis, § 1^er, paragraph 8, of the Act of 25 March 1964 on medicines which essentially contains the same biological substance, reduced by 15% and increased according to the rules laid down in section 35ter, § 1^erParagraph 4."
Section 17. - Drugs
Art. 37. Article 72bis, § 1^erof the same law, inserted by the Act of 20 December 1995 and last amended by the Act of 22 June 2012, the following amendments are made:
1° 5° is replaced by the following:
"5° according to conditions to be defined by the King, to provide of a single barcode the packagings allowed, from the date of entry into force of the refund, as well as the packagings "in bulk" and the hospital packagings containing specialties of "oral-solid" pharmaceutical forms intended to be used in the preparation of individual medication referred to in article 12bis, § 3, of the law of 25 March 1964
2° the 7° is replaced by the following:
"7° communicate to the Federal Agency for Drugs and Health Products, hereafter referred to as AFMPS, spontaneously and in accordance with Article 6, § 1^erSexies, from the law on medicines of March 25, 1964, any lack of 2° ;".
Art. 38. Article 72bis, § 1^erbis of the same law, inserted by the Act of 22 December 2008, the following amendments are made:
1° in paragraph 1^er, the phrases "The applicant who is not in a position to satisfy the obligation referred to in paragraph 1^erParagraph 1^er1°, informs the health care service of the Institute in accordance with paragraph 1^er7°, no later than the day before the repayment comes into force, specifying the presumed date at which the specialty will be available and the reason for the unavailability. This non-availability is mentioned by the service on the Institute's website." are replaced by the following sentence:
"If the applicant is not in a position to meet the requirement under subsection 1^erParagraph 1^er, 1°, this non-availability is mentioned by the Institute's health care service on the Institute's website. ";
2° in paragraph 2, the words "the health care service of the Institute" are replaced by the words "AFMPS";
3° in the Dutch text of paragraph 2, the word "paragraef" is replaced by the word "paragraaf";
Paragraph 3 is replaced by the following:
"If the Institute's health care service is informed of the non-availability of a pharmaceutical specialty other than by the applicant or where applicable the AFMPS, the service immediately informs the AFMPS and requests confirmation to the applicant that the pharmaceutical specialty is actually unavailable. The applicant has 14 days from the receipt of this application to confirm or invalidate the unavailability. If the applicant confirms the unavailability, the applicant shall inform the health care department of the Institute by registered mail with acknowledgement of receipt and shall attach to its consignment the evidence that the pharmaceutical specialty is available. If the applicant confirms the unavailability, the applicant shall inform the PSMPS in accordance with § 1^er, 7°, and it specifies the start date, the presumed end date and the reason for the unavailability. This non-availability is mentioned by the service on the Institute's website. The mention of the unavailability on the Institute's website is without impact on the reimbursement of the speciality concerned, which remains on the list. However, if the unavailability is maintained, the specificity concerned is deleted from the list on the first day of the twelfth month following the date of the beginning of the unavailability. On the other hand, if the applicant does not respond within the specified time limit, or if the elements it provides do not allow for certainty to establish the availability of the pharmaceutical specialty, the specialty is deleted as quickly as possible from the list, in full law and without taking into account the procedures provided for in section 35bis. ";
5° in paragraph 4, the words "at the earliest the Institute" are replaced by the words "at the earliest the AFMPS".
Art. 39. to section 77quinquies of the Act, inserted by the Act of 27 December 2012, the following amendments are made:
1° in § 1^er, paragraph 2, the words "at the Technical Council of Radioisotopes" are replaced by the words "at the AFMPS";
2° in § 2, paragraph 1^er is replaced by the following:
"If the Institute's Health Care Service is informed of the unavailability of a radiopharmaceutical product other than by the firm or where applicable by the AFMPS, the Service shall immediately inform the PSMPS and request confirmation to the firm that the product is actually unavailable. The firm has 14 days from receipt of this request to confirm or invalidate the unavailability by registered mail with acknowledgement of receipt. If she infirms her, she joins the evidence that the product is available. If the firm confirms the unavailability, it specifies the start date, the presumed end date and the reason for the unavailability to the PSMPS. ";
3° in § 3, the words "at the AFMPS" are inserted between the words "If the firm communicates" and the word "que".
Art. 40. to article 77quater, of the same law, inserted by the law of May 19, 2010, the words "as well as for each unit actually issued of the repayable specialties having a "oral - solid" pharmaceutical form issued to the public offering to a beneficiary staying in a home of rest and care or nursing home for the elderly, not having a non-ficin or a deposit of medicines in accordance with the provisions of
Art. 41. Section 69 of the Act of 27 April 2005 on the Control of the Health Care Budget and on various health provisions, as amended by the Acts of 19 December 2008, 23 December 2009, 29 December 2010, 17 February 2012 and 27 December 2012, is supplemented by a paragraph that reads as follows:
"An exception to the application of paragraphs 10, 11 and 13 is also granted to pharmaceutical specialties whose basis for reimbursement of a specialty consists of a fixed amount by indication, treatment or examination, for the drug or all of the drugs that are dispensed for this indication, treatment or examination."
Section 18. - Duties of caregivers
Art. 42. In the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994, an article 73quater is inserted as follows:
"Art. 73quater. § 1^er. Is required to register at the Banque-Carrefour des Entreprises in order to obtain a business number:
1° any legal person of Belgian law and any legal person of foreign and international law who has a seat in Belgium, which brings together caregivers within the meaning of Article 2, n), carrying out their economic and professional activities as a principal or as a complementary measure in this Act;
2° any association without a legal personality that brings together caregivers within the meaning of Article 2, n), carrying out their economic and professional activities as principal or as complementary within the framework of this Act;
3° any natural person, care provider within the meaning of section 2, n), who, as an autonomous entity, is engaged in an economic and professional activity, either as a principal or as a supplementary measure under this Act.
The Minister who has the Social Affairs in his or her responsibilities determines the terms and conditions under which the Institute is being conducted, the communication of the business number, the identity of the person in charge, the identity of the dispensants composing the entities in question, and the permanent update of the data.
§ 2. Caregivers within the meaning of section 2, (n), or their groupings carrying out their economic and professional activities as a principal or as a supplement under this Act, shall notify the Health Care Service of any changes in their registration or accreditation records to the Institute.
The Minister who has the Social Affairs in his or her responsibilities determines the elements of the record subject to this obligation and the administrative procedures for the communication of these elements, the closing of a record and the reopening of a closed record."
Art. 43. Section 76 of the Act is repealed.
Art. 44. Section 42 comes into force on 1^er January 2015.
Art. 45. Section 43 comes into force on 1^er January 2015.
Section 19. - Benefits in clinical scientific research
Art. 46. In section 34 of the Act, paragraph 2, inserted by the Act of 22 February 1998, is replaced by the following paragraphs:
"Health care insurance does not intervene in the benefits performed for an aesthetic purpose, except under the conditions fixed by the King, after the advice of the Insurance Committee.
For benefits performed in the context of scientific research or clinical trials, health care insurance only occurs in the cost of treatment benefits if they meet generally accepted clinical recommendations or scientific consensus. They are documented and justified in the medical file of the insured by the investigator referred to in section 2, 17°, of the Human Person Experiments Act of May 7, 2004.
Health care insurance does not intervene in benefits whose performance is a specific requirement of the protocol referred to in section 2, 22°, of the above-mentioned Act and which exceed the benefits provided in paragraph 3. The investigator holds a list of scientific research and clinical trials in which patients are included. The King may determine the terms and conditions for the application of this paragraph."
Section 20. - Funding for general physicians custody
Art. 47. Section 56 of the Act, last amended by the Act of 26 December 2013, is supplemented by a § 10, which reads as follows:
§ 10. The General Council sets out the maximum budget allocated to the Inland FPS to finance the cost of the attendants to the unified appeal system referred to in Article 9bis, § 1^er, Royal Decree No. 78 concerning the exercise of health care professions.
These expenses are fully charged to the health care budget and are defined annually as part of the overall budget objective."
Section 21. - Dependants
Art. 48. Section 126 of the Act, replaced by the Act of 19 December 2008, is replaced by the following:
"The King sets the conditions for the registration of the dependant, on the proposal of the insurable working group as referred to in section 31bis.
It also determines on the proposal of the insurable working group, to which licensee is by priority registered a person who, pursuant to section 32, paragraph 1^er, 17°, 18°, 19°, can be registered as a dependant with different holders.
The King shall, on the proposal of the insurable working group, establish the conditions under which it may be derogated from that principle when the circumstances of the cause justify it.
If a child is a child, the registration shall be made in accordance with the choice of parents in respect of whom filiation is established, except in the case of a child referred to in section 123, 3, (f) of the Royal Decree of July 3, 1996 enforcing the Compulsory Health Care and Allowance Insurance Act, coordinated on July 14, 1994.
A first registration of a dependent child referred to in section 123, 3, (a) of the above-mentioned Royal Decree may be carried out on an ex officio basis without the licensee designated under the rules of priority having to apply.
Art. 49. The King sets the effective date of this section.
Section 22. - Transaction
Art. 50. Article 16, § 1^er, of the same law is inserted a new point 16° written as follows:
"16° may enter into transactions within the meaning of Article 2044 of the Civil Code, with a view to ending the disputes arising from the application of Articles 64, 73bis, 2°, and 142, § 1^er, read in conjunction with Article 18, § 2, B, d) quater of the schedule as attached to the Royal Order of September 14, 1984 establishing the nomenclature of health benefits in respect of compulsory health care and allowances and/or Chapter VI of the list attached to the Royal Order of December 21, 2001 setting out the procedures, deadlines and conditions for the intervention of the compulsory health care
As part of each of these transactions, it may waive 35% of the amount of benefits referred to in paragraph 1^er. Each transaction is subject to the prior written commitment of the competent person of the hospital, to a refund within 3 months of at least 65% of the contentious benefits referred to in paragraph 1^er"
Art. 51. Article 50 comes into force on the first day of the month following the publication of this Act to the Belgian Monitor and will cease to be applied on the first day of the fourth month following the publication.
CHAPTER 2. - eHealth
Section 1^re. - User Consultation Committee
Art. 52. In section 5, 8°, of the Act of August 21, 2008 relating to the institution and organization of the eHealth platform and bearing various provisions, the words ", of the non-profit association referred to in section 37," are repealed.
Art. 53. Article 15, § 1^erParagraph 1^er, 3°, of the same law, is supplemented by an e) written as follows:
"e) the chair of the User Consultation Committee referred to in Article 22."
Art. 54. Section 22 of the Act is replaced by the following:
"Art. 22. It is created with the eHealth platform a User Consultation Committee. The Committee for Consultation assists the Management Committee of the eHealth platform in carrying out its tasks.
The Coordinating Committee is responsible for promoting, in the patient's interest, the exchange of electronic information and the sharing of secure data between health actors authorized by the Sectoral Committee on Social Security and Health for the purpose of:
- to increase the quality and continuity of health care by ensuring permanent availability of patient health data;
- to optimize collaboration and communication between care providers to improve patient monitoring.
To this end, the Coordinating Committee is responsible for formulating proposals or advice to the eHealth Platform Management Committee on its own initiative or upon request, including:
1° organization of future electronic data streams for the collection, processing and provision of clinical data and the organization of records related to different clinical areas to the extent that this organization concerns care providers;
2° of designation of the intermediate body, as defined under the Act of 8 December 1992 on the protection of privacy with respect to personal data processing, responsible for the operational organization of the fluxes and registers, referred to in 1°, provided that the eHealth platform cannot carry out this mission under section 5, 8°;
3° the definition of therapeutic relations, procedure for informed consent of patients and the right of patients to look at the use of data that affect them unless the rules in this regard have already been established by the Management Committee or the Sectoral Committee for Social Security and Health either before the coming into force of this Act or after the advice of the Consultation Committee.
Consultation with the Consultation Committee is mandatory in the matters referred to in paragraph 3. In such cases, the Consultation Committee shall make a notice within three months by a two-thirds majority of the members of the Consultation Committee. If this majority is not reached, the considerations of the majority and the minority are, if any, referred to in the notice.
The eHealth platform and the Coordinating Committee regularly organize a round table involving the various actors in the health sector to assess progress in the implementation of eHealth and to identify needs in this area.
The Committee for Consultation may establish working groups within the framework of specific missions.
It establishes its rules of procedure and submits it to the approval of ministers. "
Art. 55. Section 23 of the Act is replaced by the following:
"Art. 23. The Coordinating Committee is chaired by a doctor and comprises 32 members, including:
1. the following members who have a deliberate vote:
a. eleven members, including seven doctors, representing care providers and care facilities, as referred to in Article 3, 2 and 3, as well as representative organizations of care providers;
b. seven members proposed by insurers;
c. four members proposed by the representative organizations of patients serving on the Federal Commission "Patient Laws";
2. the following members who have an advisory vote:
a. six members representing federated entities;
b. four members representing the federal authority, including:
- a member representing the eHealth platform;
- a member representing INAMI;
- a member representing the Federal Public Service Public Health, Food Chain Safety and Environment.
The King appoints the chair and members of the Committee of Consultation. He specifies, if applicable, his skills, and sets out his operating procedures.
The King also determines the amount and conditions for the granting of presence chips to be allocated to the president.
Apart from the cases referred to in Article 22, the King may determine the cases in which consultation of the Committee of Consultation is mandatory. In such cases, the Consultation Committee shall make a notice within three months.
The eHealth platform is responsible for the operational costs of the Consultation Committee and the working groups established within it and provides the secretariat."
Art. 56. Chapter 11 of the Act, comprising sections 37 to 40, is repealed.
Art. 57. In Article 17bis, § 1^erParagraph 1^er, 3° bis, of the law of January 15, 1990 on the institution and organization of a Banque-Carrefour de la Sécurité sociale, inserted by the law of August 21, 2008, the words "and the association referred to in section 37 of the law of August 21, 2008 on the institution and organization of the eHealth platform" are repealed.
Section 2. - Miscellaneous provisions
Art. 58. In Article 32, § 2, of the Law of August 21, 2008 on the institution and organization of the eHealth platform and bearing various provisions, the words "entertainment" are replaced by the words "publication to the Belgian Monitor".
Art. 59. In section 21 of Royal Decree No. 78 of 10 November 1967 concerning the exercise of health care professions, last amended by the Act of 9 July 2004, the following amendments are made:
(a) paragraph 1^er is replaced by the following paragraphs:
"All orders:
1° indicates as much as possible the method of use of the drug;
2° is dated by the doctor, by the dental practitioner or by any other person who may prescribe medication by or under this Royal Decree, on paper or electronically using a procedure established by the eHealth Platform Management Committee and approved by the Sectoral Committee for Social Security and Health;
3° is signed by the doctor, the dental practitioner or any other person who may prescribe medication by or under this Royal Order, or the identity of the doctor, dental practitioner or any other person who may prescribe Health drugs by or under this Royal Order is authenticated using a procedure approved by the Management Committee of the E-Base
The King may extend the application of the procedures referred to in paragraph 1^er, 2° and 3° of the first paragraph to categories of prescriptions other than prescription drugs. ";
(b) in paragraph 2, becoming paragraph 3, the phrase "the King may possibly determine the terms and conditions of application, as well as provide for possible derogations from these requirements for the use of electronic signature in hospitals and determine the date of entry into force of this provision." is repealed.
Art. 60. The Royal Decree of July 19, 2013 on various provisions of probative force is confirmed with effect to 1^er January 2012.
CHAPTER 3. - Amendment of the Programme Law of 20 July 2006
Single section. - Second pillar of pensions
Art. 61. In section 55 of the Program Act of 20 July 2006, as amended by the Acts of 27 December 2006, 22 December 2008, 29 December 2010 and 19 March 2013, paragraphs 6, 7 and 8 are replaced by the following:
"From 2012, an amount of 904,653 euros is transferred from the National Institute of Disability Insurance to the National Board of Pensions in favour of employees bound by a contract of employment with an employer of the public sector. An amount of 8.083.660 euros is transferred from the Federal Sector Savings Fund for Employees under a contract of employment with a private sector employer. These transfers take place annually in June. Starting in 2013, these amounts are adjusted annually to the evolution of the arithmetic mean of the June Health Index and the index figures for the previous three months between June 30 of the last year and June 30 of the year preceding. The ratio expressed by this evolution is rounded up to four decimals, upwards if the fifth digit is at least one and down for the other cases. The amounts are charged by the Institute in charge of the Health Care Insurance budget. The amounts paid in 2013 and for the year 2012 are charged by the Dependant Institute of the 2012 Health Care Insurance Budget.
As of 2013, an amount of € 1.427.000 is transferred from the National Disability Insurance Institute to the National Pension Board for Employees under a contract of employment with an employer in the public sector. This transfer takes place every year in June. From 2014, this amount will be adjusted annually to the evolution of the arithmetic mean of the June Health Index and the indexes of the previous three months between June 30 of the last year and June 30 of the previous year. The ratio expressed by this evolution is rounded up to four decimals, upwards if the fifth digit is at least one and down for the other cases. This amount is charged by the Institute in charge of the Health Care Insurance budget. The amount paid in 2014 and for 2013 was charged by the Institute in charge of the 2013 budget for health care insurance. ".
CHAPTER 4 . - Amendment of the Programme Law (I) of 27 December 2006
Art. 62. In Article 245, § 1^erParagraph 1^erof the Programme Law (I) of 27 December 2006, replaced by the Law of 19 March 2013, the words "12, 6°" are replaced by the words "16, § 1^er3°.
CHAPTER 5. - Amendment of the Act of 25 January 1999
of social provisions
Art. 63. Sections 130 and 131 of the Act of 25 January 1999 on social provisions are repealed.
CHAPTER 6. - Experiment on the human person
Art. 64. In article 31, paragraph 2, paragraph 2, of the Act of 7 May 2004 on experiments on the human person, the second sentence is repealed.
Art. 65. In section 191, paragraph 1^erof the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994, last amended by the Act of 15 December 2013, the 22nd is repealed.
CHAPTER 7. - Blood and derived from human blood
Art. 66. In chapter II of the Act of 5 July 1994 on blood and blood derivatives of human origin, an article 4/1 is inserted, as follows:
"Art. 4/1. The establishments referred to in Article 4 are responsible for the following public service:
1° Organize the collection of total blood from voluntary donors and volunteers to ensure the supply of labile blood derivatives;
2° ensure the regular supply of total blood and labile blood derivatives;
3° provide the amount of residual plasma, if necessary supplemented by aesthetic plasma, required for self-sufficiency, to the mission officer referred to in section 20/1, on the basis of a price fixed by the King."
Art. 67. In the same law, a chapter III/1 entitled "Chapter III/1". Provisions concerning the self-sufficiency of plasma derivatives".
Art. 68. In chapter III/1, inserted by article 67, an article 20/1 is inserted as follows:
"Art. 20/1. A mission officer, designated in accordance with the Act of 15 June 2006 on public procurement and certain contracts of work, supplies and services, is responsible for a period of five years for the treatment of the plasma issued by the institutions that are approved by the Minister who has the Public Health in his or her powers under section 4 of this Act, for the quarantine of the plasma and for its maintenance, pending acceptance, distribution or maintenance
Are considered stable plasma derivatives normal human immunoglobulins for intravenous administration (ATC: J06BA02), albumin solutions:
- Albumine 20% solution for intravenous infusion;
- Stable solution of Plasmatic proteins 4% (ATC BO5AA01).
The King may amend the definitions of human immunoglobulins and albumin solutions, as referred to in paragraph 2.
This mission officer has a certificate of compliance with Community legislation for the permanent record of plasma, referred to in 1.1, c), Part III of Schedule 1 to the Royal Decree of 14 December 2006 on human and veterinary drugs, and a marketing authorization referred to in Article 6, § 1^erParagraph 1^er, of the Act of 25 March 1964 on drugs, on the basis of which authorized activities are carried out. The mission manager has a traceability system that ensures that the treatment is carried out exclusively on the basis of the plasma delivered by the registered establishments.
Hospitals provide at least 50% of the immunoglobulins and 100% of the albumin solutions they need from the mission manager in accordance with the King's prices, terms and conditions
The King is empowered to take all measures to enforce this provision. In particular, it determines:
1° the duration of the market failure period during which self-sufficiency is to be ensured;
2° the hierarchy of indications for which stable plasma derivatives are then prescribed;
3° the volume of plasma required for self-sufficiency;
4° how market dysfunction is recognized by the Federal Agency for Drugs and Health Products.
Pending the appointment of the mission officer, the contractual commitments made by the registered establishments prior to the entry into force of this chapter with the Scrutiny Central Department of Fraction of the Red Cross shall be maintained by 31 December 2015. The relevant firm is responsible until that date for the missions referred to in paragraph 1. Stable plasma derivatives from the plasma issued by registered establishments are delivered to hospitals according to the reimbursement base established under section 35bis of the Compulsory Health Care Insurance Act, coordinated on July 14, 1994. By December 31, 2015, half of the overall use of immunoglobulins and 100% of the overall use of albumin solutions for the year 2012 is considered as a self-sufficiency reserve as recognized by the National Institute of Disability Insurance.
Hospitals provide stable plasma derivatives produced within the framework of self-sufficiency, in accordance with the prices and conditions fixed by the King.
For the years 2014 and 2015, the SCRL Central Department of Fractionnement de la Croix-Rouge is responsible for a contribution to the National Institute of Disability Insurance per litre of plasma whose derivatives were provided to Belgian hospitals against the reimbursement base established under the Compulsory Health Care Insurance Act. This contribution is €49.40 per litre of plasma. The total amount of the contribution is limited in 2014 and 2015 to the amount calculated on the basis of the amount of plasma provided in 2012. A 75% advance based on the amount of plasma provided in 2012 is paid to INAMI respectively before December 31, 2014 and December 31, 2015. The balance is paid before June 30, 2015 and June 30, 2016. When it is found that the amount of plasma provided is less than that of 2012, the contribution is reduced prorated."
Art. 69. Article 191, paragraph 1^er, the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994, last amended by the Act of 15 December 2013, is supplemented by a 33° written as follows:
"33° the proceeds of the contribution referred to in section 20/1, paragraph 9, of the Act of 5 July 1994 on blood and blood derivatives of human origin".
Art. 70. In section 192, paragraph 4, 1°, (j), paragraph 1^er, of the same law, replaced by the law programme of 22 December 2003 and amended by the laws of 19 December 2008, 17 June 2009 and 27 December 2012, the words "to 32°" were replaced by the words "to 33°".
CHAPTER 8. - Support for undue amounts not recovered by insurers
Section 1^re. - Administration fees
Art. 71. In section 194 of the Act, as amended by the Royal Decree of 17 March 1997, a paragraph 3 is inserted as follows:
§ 3. It is also considered administrative costs, the portion of unduly paid expenses that cannot be recovered under section 17, paragraph 2, of the Act of 11 April 1995 to establish the Charter of the social insured, as determined in accordance with the provisions of this paragraph.
These amounts are calculated annually by sector based on the percentage of the indus referred to in paragraph 1^er compared to the overall amount of expenses incurred by the insurer in this sector.
These amounts are fixed by levels as follows:
(a) in the compensation sector:
- 0 per cent of unrecoverable indus that represent a percentage of the overall expenditure of less than 0.05%;
- 10% of unrecoverable indus that represent a percentage of the overall expenditure amount greater than or equal to 0.05 and less than 0.1%;
- 25 per cent of unrecoverable indus that represent a percentage of the total expenditure amount greater than or equal to 0.1 per cent and less than 0.2 per cent;
- 50% of the unrecoverable indus that represent a percentage of the total expenditure of 0.2% or less than 0.35%;
- 75 per cent of unrecoverable indus that represent a percentage of the total amount of expenditure greater than or equal to 0.35 per cent and less than 0.5 per cent;
- 100 per cent of unrecoverable indus that represent a percentage of the total expenditure amount greater than or equal to 0.5 per cent.
(b) in the health care sector:
- 0 per cent of unrecoverable indus that represent a percentage of the overall expenditure of less than 0.0069 per cent;
- 10 per cent of unrecoverable indus who represent a percentage of the total amount of expenditures greater than or equal to 0.0069 and less than 0.0083 per cent;
- 20% of the unrecoverable indus that represent a percentage of the total expenditure of 0.0083 per cent and less than 0.0097 per cent;
- 30% of the unrecoverable indus that represent a percentage of the total expenditure of 0.0097 per cent and less than 0.0111 per cent;
- 40% of the unrecoverable indus that represent a percentage of the total amount of expenditures greater than or equal to 0.0111 per cent and less than 0.0125 per cent;
- 50% of the unrecoverable indus that represent a percentage of the total amount of expenditures greater than or equal to 0.0125 per cent and less than 0.0139 per cent;
- 60 per cent of unrecoverable indus that represent a percentage of total expenditures greater than or equal to 0.0139 per cent and less than 0.0153 per cent;
- 70 per cent of unrecoverable indus that represent a percentage of the total expenditure amount greater than or equal to 0.0153 per cent and less than 0.0167 per cent;
- 80 per cent of unrecoverable indus who represent a percentage of the total amount of expenditures greater than or equal to 0.0167 per cent and less than 0.0181 per cent;
- 90% of unrecoverable indus who represent a percentage of the total expenditure amount greater than or equal to 0.0181 per cent and less than 0.0195 per cent;
- 100 per cent of unrecoverable indus that represent a percentage of the total expenditure amount greater than or equal to 0.0195 per cent.
Unduly paid expenses that cannot be recovered pursuant to section 17, paragraph 2 of the Act of 11 April 1995 to establish the Charter of the social insured are communicated to the Institute in accordance with the terms and conditions set out in section 164 quater for the insurance sector and in the health care insurance expenditure documents for the health care sector.
If the insurer determines that the error within the meaning of section 17, paragraph 2 of the above-mentioned Act is attributable to another social security institution, the amounts concerned shall be deducted from the amounts taken into account in calculating the percentage provided for in paragraph 3, paragraph 2. "
Art. 72. Section 71 comes into force on 1^er January 2014 and the calculation provided for in section 194, § 3, paragraph 2, of the Compulsory Health Care and Compensation Insurance Act, coordinated on July 14, 1994 will be carried out for the first time in April 2015.
Section 2. - Electronic message of unduly paid compensation
Art. 73. Section 164quater of the Act, inserted the Program Act of 29 March 2012, is withdrawn on the date of 1^er January 2014.
Art. 74. In the same Act, an article 164quater is inserted as follows:
"Insurer organizations are required to communicate to the Institute, by mutuality or regional office, by the licensee and by the nature of the risk, the amount of compensation paid unduly, the cause of the undue payment and if it results from an error, fault or negligence of the insurer.
The insurer shall also communicate, in accordance with the terms and conditions referred to in paragraph 1^er, the amounts of compensation recovered, the amounts not recovered and the reasons for which these amounts were not recovered. It also discloses the unrecovered amounts that are dependant on its administrative costs and the unrecovered amounts that are considered to be plan expenditures; such data shall be reported separately, with respect to amounts not recoverable under section 17, paragraph 2 of the Act of 11 April 1995 to establish the Charter of the Social Insured.
Data referred to in paragraph 1^er and 2 are communicated through an electronic process approved by the Institute, no later than the last day of the month following each calendar quarter to which they relate.".
Art. 75. Section 74 comes into force on 1^er January 2015.
Section 3. - Limitation period applicable to the recovery of unduly paid benefits
Art. 76. Section 174, paragraph 3, of the Act, inserted by the Act of 19 December 2008, is repealed.
CHAPTER 9. - Provisions to combat social fraud
Section 1^re. - Anti Fraude Commission
Art. 77. In Title II of the Act, an article 13/1 is inserted as follows:
"Art. 13/1. § 1^er. Within the Institute, it is set up a special commission, called Anti Fraude Commission, with a coordinating and advisory role. This commission is chaired by the Director General of the Institute or by the employee designated by him.
This commission is composed by members of the Health Care Service, the Medical Evaluation and Control Service and the Administrative Control Service, and representatives of the insurers. The members of the Institute's services are appointed by the Executive Officer of these Services, the members who represent the insurers are appointed to the National Intermutualist College.
§ 2. In the area of the fight against fraud in compulsory health and disability insurance, this commission is responsible for:
1° the conduct of studies missions for the simplification and coordination of the activities of the Institute and the National Intermutualist College in the field of the execution of the legal missions of the Institute and the medical consultants;
2° the harmonization and coordination of sources of information between the Institute and the National Intermutualist College for common actions, or to avoid different actions over time, in respect of the same target group or individual, in accordance with the secrecy of the investigation to which the control services of the Institute are held;
3° the harmonization of the activities of the Intermutualist National College and the services of the Institute in the detection and prosecution of fraud, in the respect of and without interference in the legal competence of the services of the Institute and the medical consultants;
4° the proposal and development of working methods within the existing legal framework to achieve a uniformity of action;
5° the common proposal for regulatory adaptation recommendations, when necessary after analysis of the actions of the Intermutualist National College and the services of the Institute.
6° the development of the guidelines in order to trace the contours of the notion of "serious, precise and concordant indices" referred to in Article 77sexies.
The commission reports semi-annually to the General Management Committee on the progress of collaboration between the Institute's services and the National Intermutualist College in the field of combating fraud in compulsory health and disability insurance.
§ 3. The King may establish complementary rules in relation to the composition and operation of the Anti Fraude Commission."
Art. 78. In title III, chapter V, of the same law, a section XXII, entitled "Dispositions concerning the fight against fraud. "
Art. 79. In section XXII, inserted by article 74, an article 77sexies is inserted, as follows:
"Art. 77sexies. If there are serious, accurate and consistent fraud indices in the head of a care provider within the meaning of section 2, n, payments by insurers under the paid third party plan may be suspended, in whole or in part, for a maximum period of 12 months.
Each social insurance organization may communicate these indices to the Medical Evaluation and Control Service, which may also act on its own initiative. If an insurer communicates clues to the Medical Evaluation and Control Service, it simultaneously communicates them to other insurers.
The Medical Evaluation and Control Service Officer, or the employee designated by him, shall notify the facts on which the indexes are based to the registered letter health care provider, which is expected to be received on the third business day after delivery to the post office. He invites the care provider to transmit his defences by registered letter within fifteen days.
Following the examination of defences, or in the absence of defences received within the time limit, the Senior Official or the designated official shall make a decision. If it decides to suspend payments, it determines the duration of the suspension period. It also determines whether the suspension is total or partial.
The executive decision of the Senior Official or designated official is motivated. It is notified by registered letter to the care provider and takes effect, notwithstanding appeal, on the third working day following the day on which the fold was handed over to the Post Office. Copy of the decision is simultaneously notified to insurers.
A non- suspensive appeal may be filed before the Labour Tribunal which is competent in accordance with section 167.
The suspension shall end in full right if, within one year of the decision, no record of finding is established."
Art. 80. In the same section XXII, an article 77septies is inserted, as follows:
"Article 77s. The benefits that it determines are contrary to the rules set out in article 73bis, 1° to 6° of the law, cannot be introduced again for payment to the insurer.
Art. 81. In section 153 of the Act, replaced by the Act of 19 December 2008, a paragraph 2/1 is inserted, as follows:
§ 2/1. The factual and medical findings that physicians counsel have made during the exercise of their control tasks are probative to the contrary. These findings may, with their probative value, be used by the inspectors and controllers referred to in sections 146 and 162 for the purpose of finding offences. "
Art. 82. In Article 156, § 1^er of the Act, reinstated by the Act of 13 December 2006 and amended by the Act of 29 March 2012, the third paragraph shall be replaced as follows:
"In the case where the debtor remains in default, the insurers under section 206bis, § 1^er, or the Administration of the value added tax, registration and domains under section 206bis, § 2, may be responsible for the recovery of the amounts due".
Art. 83. In section 164 of the Act, last amended by the Act of 10 December 2009, paragraph 5 is replaced by the following:
"The recovery of unduly paid benefits may be carried out in accordance with the provisions of Article 206bis, § 1^er, or in accordance with Article 206 bis, § 2, with respect to benefits whose non-recovery may be admitted as justified as referred to in Article 194, § 1^er(b). ".
Art. 84. In section 206bis of the Act, inserted by the Act of 14 January 2002, the current text of which will form paragraph 2, are amended as follows:
1° it is inserted a paragraph 1^er as follows:
§ 1^er. In the framework of health care insurance, any amount that must be paid by the insurers to a health care provider, may be used in full right by these insurers for the payment by compensation of the unduly collected amounts by the care provider or for the settlement of any other receivable that originates in this Act, in its enforcement orders and regulations, in the conventions and agreements made under this Act."
2° the article is supplemented by a paragraph 3 written as follows:
§ 3. The amounts recovered are a recipe for health care insurance as referred to in section 191 and are paid on the Institute's account."
Section 2. - Medical control and sanctions
Art. 85. In the Dutch text of Article 2, n), of the Compulsory Health Care and Compensation Insurance Act, coordinated on July 14, 1994, amended by the laws of December 24, 1999 and December 13, 2006, the sign of punctuation ", is inserted between the word "tewerkstellen" and the word "die".
Art. 86. Section 73bis, 1°, of the same Act, inserted by the Act of 13 December 2006 and amended by the Act of 29 March 2012, is supplemented by the words "or when they were made or provided during a period of temporary or final ban on the exercise of the profession".
Art. 87. In Article 141, § 1^erParagraph 1^erthe same Act, as amended by the Royal Decree of 25 April 1997 and by the Acts of 24 December 1999, 24 December 2002, 22 December 2003, 27 April 2005, 13 December 2006, 19 December 2008, 17 June 2009 and 29 March 2012, is repealed.
Art. 88. Article 142, § 1^erthe same Act, reinstated by the Act of 13 December 2006 and amended by the Act of 27 December 2006, the following amendments are made:
1° in paragraph 1^er, 2°, the words "of the value of the same benefits" are replaced by the words "of refund";
2° the § is supplemented by a paragraph, which reads as follows:
"When a health care provider is prosecuted in a criminal proceeding following a public prosecutor's communication of the facts to the Public Prosecutor's Office by the Medical Evaluation and Control Service, the Institute may form a civil party for the recovery of unduly refunded benefits by health care insurance. The amounts recovered are paid to the Institute's account and recorded as health insurance revenues. "
Art. 89. Section 154 of the Act, as amended by the Acts of 24 December 2002 and 19 December 2008, paragraphs 7 and 8 are repealed.
Art. 90. In section 175, paragraph 2, of the Act, replaced by the Act of 22 December 2008, the words "Physicians-Inspectors, Pharmacists-Inspectors, Nurses-Controllers and Social Comptrollers" are replaced by the words "Micists-Inspectors, Pharmacists-Inspectors and Nurses-Controllers".
Art. 91. In section 168quinquies of the Act, inserted by the Act of 19 May 2010 and amended by the Act of 29 March 2012, the following amendments are made:
1° in § 2, 3°, (a) is replaced by the following:
"(a) resumed an activity without the authorization referred to in Article 100, § 2, or without respecting the conditions of the authorization;"
2° in the Dutch text of § 3, paragraph 5, the words "het werk" are replaced by the words "werkzaamheid";
3° In the Dutch text of § 8, paragraphs 5 and 7, the word "word" is each time replaced by the word "wordt".
CHAPTER 10
Financial Transparency in Health Care
Art. 92. This chapter partially transposes Directive 2011/24/EU of the European Parliament and Council 9 March 2011 on the application of patient rights in cross-border health care.
Art. 93. In section 2, (n), of the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994, as amended by the Acts of 24 December 1999 and 13 December 2006, the second sentence beginning with the words "Sont assimilated" and ending with the words "health care" is replaced by the following sentence:
"Similar to caregivers for the application of articles 53, § 1^er§ 1^erbis and § 1^erter, 73bis and 142, the natural or legal persons who employ them, who organize the dispensation of care or the perception of the sums due to health care insurance;".
Art. 94. In Article 50, § 3, paragraph 8, of the Act, the following amendments are made:
1° the word "titular" is replaced by the word "beneficiaries";
2° in the French version of the text, the words "when it" are replaced by the words "when they". "
Art. 95. In section 52 of the Act amended by the Acts of 14 January 2002 and 13 December 2005, a paragraph 2bis is inserted, as follows:
"Conventions and agreements contain clauses on how to monitor compliance with commitments by health care providers who have acceded to them. Without prejudice to the legal oversight missions of insurers, the relevant commissions transmit to the Insurance Committee a report on compliance with the conventions and agreements, including requests for information from beneficiaries. "
Art. 96. In section 53 of the Act, the following amendments are made:
(a) paragraph 1^er § 1^eramended by the laws of 25 January 1999 and 27 December 2005, is supplemented by the two sentences as follows:
"That the care provider performs the benefits on his or her own behalf or on behalf of others, the amount paid by the recipient to the care provider for the benefits performed is mentioned on the portion received from the particular care certificate or supplies or on the equivalent document. As soon as a convention or agreement has established electronic billing rules by caregivers, the King shall, on the proposal of the Insurance Committee and after the advice of the Conventions or relevant agreements, establish the additional data to be transmitted by caregivers to insurers. "
(b) Paragraph 1^er/1, as follows:
§ 1^er /1. Payments may be collected for health benefits to be performed or to be provided within the limits set by the conventions and agreements. "
Caregivers are required to provide the recipient with a receipt in the event of a deposit perception. ";
(c) a paragraph 1 is inserted^er/2, written as follows:
§ 1^er/2. Caregivers are required to provide the recipient with a supporting document of the benefits that result in the intervention of compulsory insurance and benefits that do not result in the delivery of the benefits with benefits that result:
1° when the third party pay is applied;
2° where the care provider pays the beneficiary in addition to the amounts for benefits that result in the intervention of the mandatory insurance of the amounts for benefits that do not result in an intervention of compulsory insurance;
3° where the care provider receives the amounts from the recipient after issuing the certificate of care or supplies or the equivalent document referred to in § 1^er;
4° where the certificate of care or supplies or the equivalent document referred to in § 1^erParagraph 1^er, is replaced by an electronic data transmission by the care provider to the recipient's insurer.
The total amount of benefits referred to in paragraph 1^er to the beneficiary and the total amount paid by the beneficiary for the benefit, including the deposits paid, are included in the supporting document.
In respect of each of the benefits carried out, in the form referred to in § 1^erParagraph 1^er for benefits resulting in an intervention of compulsory insurance and by a language for benefits that do not result in it, is the amount.
Derogation from paragraph 1^er, 1° and 3°, a supporting document shall not be issued by the general practitioner or specialist physician when conducting a consultation or visit referred to in section 34, paragraph 1^er, 1°, a), as well as in the case of manual opening or extension of the overall medical file. In this case, the care provider shall issue to the recipient a receipt of the amount collected.
at the request of the recipient, the supporting document contains, for the health benefits and the devices referred to in section 33, § 1, 11° of the Act of 15 December 2013 concerning medical devices determined by the Conventions or competent agreements, the amount of purchase of the devices provided by the provider when the medical devices are subject to compulsory insurance intervention or are part of a health benefit giving rise to such intervention.
The agreements and agreements entered into by the commissions referred to in Article 26 shall set out the other references on the supporting document and the manner in which the supporting document is delivered to the recipient. Conventions and agreements also stop the model to be used by caregivers.
The documents reproduced in annexes 37, 38, 43, 49 and 52 of the Regulations of 28 July 2003 implementing section 22, 11°, of the Compulsory Health Care and Allowance Insurance Act, coordinated on 14 July 1994, remain in effect until they are replaced in accordance with paragraph 6. ";
(d) a paragraph 1 is inserted^er/3, as follows:
§ 1^er/3. Decisions taken pursuant to § 1^er /1 and § 1^er/2, paragraphs 5 and 6 are gathered in the conventions and agreements in the form of a device. They remain in application as long as they have not been adapted by another convention or other agreement.
They may be made obligatory by the King, after notice of the Conventions or relevant agreements and the Insurance Committee.
The device of the convention or of the binding agreement is published in the Belgian Monitor, annexed to the royal decree which makes it mandatory.
The mandatory device is binding on all care providers who fall under the category concerned, whether or not they have acceded to the agreement or agreement.
The royal decree making the device obligatory has effect from the date fixed by the King.
The King may, after the advice of the Committee of Conventions or competent agreements, completely or partially repeal the decree having made the device mandatory, to the extent that it no longer meets the situation and conditions that justified the extension of the compulsory force. The notice is considered to have been given if it was not filed within two months of the Minister's request for notice. "
(e) Paragraph 1^er/4, written as follows:
§ 1^er/4. For persons who, without being a caregivers, perform benefits that give rise to the intervention of compulsory insurance, or perform benefits that do not result in the intervention of compulsory insurance when they are carried out with benefits that take place therein, as well as for caregivers who perform such benefits and for which there is no commission referred to in section 26, the King may take measures to ensure transparency of the cost of health care in respect of the health care."
"Art. 96/1. In section 73 of the Act, replaced by the Act of 24 December 2002 and amended by the Royal Decree of 17 September 2005 and the Acts of 27 December 2005, 13 December 2006, 8 June 2008, 19 December 2008, 22 December 2008, 10 December 2009, 23 December 2009, 29 December 2010, 29 March 2012 and 22 June 2012, the following amendments are made:
1° to § 1^er, paragraph 7, the words "last paragraph" are replaced by the words "paragraph 8";
2° in § 1^er, paragraph 7, in the Dutch version of the text, the word "mededeling" is replaced by the word "posting";
3° it is inserted a paragraph 1^er/1, as follows:
§ 1^er/1. Subject to the application of section 152, § 5, of the Hospitals and Other Care Institutions Act, coordinated on July 10, 2008, the King may determine the conditions under which supplements may be applied for clinical biology, anatomy and genetic services.
The King sets these conditions on the basis of the proposal of the National Medico-mutualist Commission.
For the purposes of this subsection, a surcharge means the difference between the fees and the rates of the agreement in the event that an agreement referred to in section 50 is in force or the difference between the fees and the rates that serve as the basis for calculating the intervention of the insurance in the event that such an agreement is not in force.
Art. 97. This chapter comes into force on 1^er January 2015.
CHAPTER 11
Medical Evaluation and Control Service
Art. 98. In section 139 of the Act, last amended by the Act of 29 March 2012, the following amendments are made:
1° to paragraph 1^er, the words "composed of a central service, ten provincial services and a bilingual service for the Brussels-Capital Region. The ten provincial services and bilingual service for the Brussels-Capital Region are regional services within the meaning of section 32 of the Acts of 18 July 1966 on the employment of languages in administrative matters are replaced by the words "composed of a central service and regional services within the meaning of section 32 of the Acts of 18 July 1966 on the employment of languages in administrative matters";
2° a paragraph 2 is inserted, as follows:
"The King determines, by royal decree deliberated in Council of Ministers, for regional services
1° their number;
2° their spring;
3° their seat."
Art. 99. Article 146, § 1^erParagraph 1^er, of the same Act, last amended by the Act of 19 March 2013, is amended as follows:
"To carry out the mission referred to in section 139, paragraph 2, 1 to 5°, the Medical Evaluation and Control Service has an inspection staff as well as administrative staff with different grades.
Inspection personnel include: inspectors, pharmacists, inspectors, nurses, and inspectors with another professional qualification.
Inspection staff is a social inspector within the meaning of Article 16, 1°, of the Social Criminal Code. They are sworn in pursuance of section 175.
Inspection personnel are competent for all Belgian territory, notwithstanding their administrative residence. ".
Art. 100. In section 146bis of the Act, last amended by the Act of 19 December 2008, the following amendments are made:
1° in paragraph 1^er, paragraph 2, the words "inspectors" are replaced by the words "inspective personnel";
2° in paragraph 1^er, paragraph 11, the words "physicists-inspections" are replaced by the words "inspection personnel";
3° in paragraph 2, paragraph 1^er, the words "physicists-inspectors, pharmacists-inspectors and nurses-controllers" are replaced by the words "inspection personnel".
Art. 101. In Part VII, Chapter II of the Act, the title of Section II is replaced by the following:
"Section II. - Inspection staff of the Medical Evaluation and Control Service."
Art. 102. In Article 150, paragraph 1^er, in the same Act, last amended by the Act of March 29, 2012, the words "to inspectors, pharmacists-inspections, nurse controllers and social controllers" are replaced by the words "to inspection staff of the Medical Evaluation and Control Service".
Art. 103. Section 151 of the Act, last amended by the Act of 19 May 2010, is replaced by the following:
"The regional director and inspection staff of each regional service are placed under the direction of two general inspectors, who are placed under the direction of the doctor-director-general, officer-in-chief. The administrative staff of each regional service is placed under the direction of an administrative officer."
Art. 104. In section 152 of the Act, last amended by the Act of 24 December 2002, the words "master's doctor" are replaced by the words "regional director".
Art. 105. In section 175, paragraph 2, of the Act, last amended by the Act of 19 May 2010, the words "Physicians-Inspectors, Pharmacists-Inspectors, Nurses-Inspectors and Social Comptrollers" are replaced by the words "Inspective staff".
Art. 106. Section 98 comes into force on 1^er January 2015.
The King may fix an effective date prior to that referred to in paragraph 1^er.
PART 3. - AFMPS
CHAPTER 1^er. - Amendments to the Act of 25 March 1964 on Drugs
Section 1^re. - Objects and apparatus
Art. 107. Article 1^erbis of the Act of 25 March 1964 on Drugs, inserted by the Act of 21 June 1983 and last amended by Act of 20 June 2013, the following amendments are made:
1° § 2 is supplemented by a paragraph written as follows:
"These provisions are stopped after the advice of the Superior Health Council. ";
2° § 4 is repealed.
Section 2 . - Drug availability
Art. 108. Article 6, § 1sexies, of the same law, inserted by the law of 1^er May 2006 and amended by the Act of 3 August 2012, the following amendments are made:
1° paragraph 2 is replaced by the following:
"In the event of a temporary or final cessation of the marketing of this drug or in the event that the licensee has requested the withdrawal of an AMM or a registration, or has not filed an application for an extension of an AMM or a registration, the licensee shall also notify the Minister or his or her delegate of that information. In the event of a final stop, this notification shall take place, except in exceptional circumstances, no later than two months before the cessation of the drug market. ";
2° a paragraph, as follows, is inserted between paragraphs 2 and 3:
"By derogation from paragraph 2, the notification of a final stop to a repayable pharmaceutical specialty in health care insurance takes place no later than six months prior to the cessation of the drug market. ";
3° the current paragraph 4, becoming paragraph 5, is supplemented by the words "in particular with regard to how to notify the temporary or final cessation of the marketing, the information to be notified obligatoryly and the time limits in which the temporary unavailability must be notified. ".
Section 3. - Delivering medicines to the public by hospital pharmacists
Art. 109. In Article 6, § 2, of the same law, inserted by the Royal Decree of 8 August 1997 and amended by the laws of 12 August 2000, 30 December 2001 and 22 December 2003, the following amendments are made:
1° in paragraph 1^er, the words "human use" are inserted between the word "medicals" and the words "to the people hosted";
2° in paragraph 2, the words "human use" are inserted between the word "medicals" and the words "for the benefit of people";
3° the § is supplemented by a paragraph, which reads as follows:
"The hospital pharmacist may, in the same way as other pharmacists of an offence, issue medicines for human use to ambulatory patients as part of a treatment begun at the hospital or polyclinic and medical devices in the circumstances and conditions determined by the King by deliberate order in the Council of Ministers. The hospital pharmacist may also issue orphan drugs and human-use drugs to outpatient patients who are subject to a limited medical prescription and whose delivery is reserved to the hospital pharmacist in the circumstances and conditions determined by the King by order deliberately in the Council of Ministers. ".
Section 4. - Whole distribution for humanitarian purposes
Art. 110. Article 12ter of the same law, inserted by the law of 1^er May 2006 and last amended by the Act of 20 June 2013, is supplemented by a paragraph 3, which reads as follows:
§ 3. Without prejudice to § 1^er, an organization approved on the basis of Article 26 of the Act of 19 March 2013 on the Belgian Development Cooperation can operate a wholesale distribution of human-for-human-human-for-human drugs owned by it.
The wholesale distribution for humanitarian purposes can only provide medicines to organizations, institutions or associations with a similar non-profit and humanitarian personality, in order to distribute and deliver non-profits in Belgium, in a Member State of the European Union or another State that is a member of the European Economic Area, or export drugs to a State that is not a member of the European Union or of the European Economic Area, with a view to distributing a non-profit
By derogation from paragraph 2, wholesale distribution for humanitarian purposes may issue to companies, as part of a humanitarian objective market that is awarded to them. For the purposes of this paragraph, the holder of the wholesale humanitarian distribution authorization is subject to the Public Procurement Act of 15 June 2006 and to certain contracts of work, supplies and services.
Without prejudice to the other conditions set out in this §, the activities referred to in paragraphs 2 and 3 may only be carried out with other wholesale distributors or with pharmacists and other persons authorized to deliver human-use drugs to the public in accordance with Article 4 of Royal Decree No. 78 of 10 November 1967 concerning the exercise of health care professions. When the wholesale distribution for humanitarian purposes provides medicines to persons in third countries, it ensures that they are issued only to persons who, according to the legal and administrative provisions in force of the third country concerned, are authorized or authorized to receive medicines for wholesale distribution or deliverance to the public.
The pharmacist responsible for the wholesale distribution facility for humanitarian purposes participates in the administration of the organization which is the owner of the wholesale distribution.
Wholesale humanitarian distribution and organization referred to in paragraph 1^er are not subject to contributions and retributions that are perceived to obtain and maintain wholesale distribution licences and to control by the PSMPS on the basis of this Act and 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 narcotic substances.
The King may set additional rules to control activities in the context of the fulfilment of the humanitarian purpose of the organization referred to in paragraph 1^er".
Section 5. - Pharmacovigilance
Art. 111. Article 6, § 1^erParagraph 9 of the Act, as amended by the Act of 3 August 2012, is supplemented by a sentence that reads as follows:
"In the cases referred to in the second sentence, with respect to drugs for human use, where an emergency action is necessary to protect public health, at any stage of the procedure, the Minister or his delegate may suspend the MMA and prohibit the use of the drug concerned until a final decision is adopted; it informs the European Commission, the EMA and other Member States of the reasons for its action by the next working day.".
Art. 112. Article 6, § 1^erquater, paragraph 2, of the Act, inserted by the Act of 1 May 2006 and amended by the Act of 3 August 2012, is supplemented by a sentence written as follows:
"The King sets the conditions and procedures for amending WMAs or registrations. ".
Art. 113. Article 6, § 1^erwhich, in paragraph 5, of the Act,^er May 2006, the following amendments are made:
1° the first sentence is replaced by the following:
"The leaflet that accompanies a drug for human use is written and designed to be clear and understandable, allowing users to act appropriately, if necessary with the help of health professionals. ";
2° the paragraph is supplemented by the following sentence:
"The notice that accompanies a veterinary drug is intelligible for the general public."
Art. 114. Article 6s., § 1^erthe same Act, as amended by the Act of 3 August 2012 and renumbered by the Act of 20 June 2013, the following amendments are made:
1° in paragraph 7, the first sentence is replaced by the following:
"When a drug for human use is not intended to be delivered directly to the patient, or where there are serious problems with the availability of the drug, the Minister or his delegate may, subject to the measures that he considers necessary to protect human health, exempt from the requirement to include certain labelling and notice. ";
2° the § is supplemented by a paragraph, which reads as follows:
"When a veterinary drug is only intended to be administered by the veterinary, the Minister or his or her delegate may exempt from the requirement to include certain labelling and the relevant drug record. It may also exempt from the requirement to write the notice in the three official languages. The King may set the terms and conditions for the application of this paragraph.".
CHAPTER 2. - Amendments to Royal Decree No. 78
of 10 November 1967 on the Exercise of Health Care Professions
Art. 115. In Article 4, § 2bis, of Royal Decree No. 78 of 10 November 1967 concerning the exercise of the professions of health care, inserted by the law of 1 May 2006 and amended by the law of 22 December 2008, two paragraphs, as follows, are inserted between paragraphs 2 and 3:
"The exercise of the pharmacist function in open-ended pharmaceuticals is subject to ongoing training to ensure the quality of pharmaceutical care.
The King may set the minimum conditions for continuous training, referred to in paragraph 3, and establish terms and conditions for the control of compliance with that provision. "
Art. 116. in section 21 of the same Royal Decree, as amended by the Acts of 22 February 1994, 10 August 2001, 22 December 2003 and 9 July 2004, the current paragraph 3, becoming paragraph 4, is supplemented by the following sentence:
"The King may also determine the content and terms of the prescription for the recognition in Belgium of the requirements of prescriptors established in another Member State and for the recognition in another Member State of the requirements of prescriptors established in Belgium. ".
CHAPTER 3. - Amendments to the Act of 7 May 2004
on experiments on the human person
Art. 117. In section 10 of the Human Person Experiments Act of 7 May 2004, as amended by the Act of 19 March 2013, a paragraph as follows is inserted between paragraphs 1^er and 2:
"By derogation from paragraph 1^er, the favourable opinion of a committee of ethics with partial approval is sufficient, if this notice takes into account Article 11, § 4, paragraph 1^er1° to 11°, and provided:
1° that it is a non-interventional monocentric experiment as referred to in section 2, 8°, and performed as part of the work required to obtain the grade of bachelor;
2° that the ethics committee with partial approval that issues the notice is linked to the site where the experiment is performed. ".
Art. 118. Article 11, § 1^erthe Human Person Experiments Act of 7 May 2004 replaced by the Act of 19 March 2013, is supplemented by the following sentences:
"Unreceivable application, in the case of a trial concomitant to the application referred to in Article 12, § 1^er, this application must be filed with the Minister. If the investigator does not introduce the file himself, the file contains, under penalty of inadmissibility, a written proxy. "
Art. 119. Article 11, § 4, paragraph 1^er, of the same law, is supplemented by the 12°, written as follows:
"12° the objectives and activities of the biobank related to experimentation as referred to in Article 18/1, 2°";
Art. 120. In Article 11, § 7, paragraph 1^er, from the same law, replaced by the law of March 19, 2013, the words ", under penalty of irreceivability," are inserted between the words "the request for notice is introduced" and "considerately with the ethics committee".
Art. 121. Article 11 of the Act, as amended by the Act of 19 March 2013, is supplemented by § 14 as follows:
§ 14. Following the issuance of the notice by the Ethics Committee, no new research site may be added for three months in accordance with the procedure for amendments in conducting an experiment referred to in Chapter X."
Art. 122. Article 11/2, § 3, paragraph 3, inserted by the Act of 19 March 2013, is replaced as follows:
"The Minister refuses approval or extension if, during the last four years preceding the application, the Ethics Committee:
1° or did not analyze on average more than 25 new multicenter experiments per year as a competent committee for issuing the single notice;
2° or has not analyzed on average at least 40 new multicenter experiments per year as a competent committee for issuing the single notice or non-unique notice. ".
Art. 123. Article 12, § 1^erthe same law shall be replaced by the following:
§ 1^er. The proponent who wishes to conduct a trial in Belgium shall apply to the Minister by registered mail.
Under penalty of inadmissibility of the application, the proponent shall ensure that the application is filed with the Minister in accordance with section 11, § 1^erwith the ethics committee and in consultation with the investigator. Dispatch conveniently means remission on the same day to the post. ".
Art. 124. § 1^er. In the same Act, a chapter IX/1, containing articles 18/1, 18/2 and 18/3, is inserted as follows:
"CHAPITRE IX/1. - Special provisions for experiments in which human bodily material is obtained and, where appropriate, treated, preserved and made available
Art. 18/1. For the biobank that is created in the course of a clinical trial and that obtains exclusively human body material and, where applicable, treats, stores and makes available in the objectives and purpose of the clinical trial as referred to in the protocol, the authorization as a clinical trial in accordance with Article 10 is valid for the duration of this test as a notification referred to in Article 22, § 1^erParagraph 1^erthe Act of 19 December 2008 relating to the obtaining and use of human bodily equipment for human medical applications or for scientific research purposes under the following conditions:
1° the application to the ethics committee with full approval, as referred to in Article 11, § 1^erand the application to the Minister as referred to in Article 12, § 1^er, accompanied by the completed form having the title "notification of a biobank as referred to in Article 22, § 1^erParagraph 1^erthe Act of 19 December 2008 relating to the obtaining and use of human bodily material for human medical applications or for scientific research purposes, as well as section 18/1 of the Human Person Experiments Act of 7 May 2004 as published by the Federal Agency for Drugs and Health Products. This form contains at least the following data:
On biobanking:
- site of the deposit(s) of human bodily material;
- name, first name and company number/national register number of the person who operates the biobank;
- operator contact data (name, name, telephone number and e-mail address);
- types of human body equipment retained and made available;
Concerning the human bodily material manager in the biobank:
- name and name;
- copy of diplomas;
- address;
- telephone number and e-mail address;
2° the objectives and activities of the biobank are the subject of the favourable opinion as referred to in Article 10, paragraph 1^er.
Art. 18/2. If the Minister authorizes the trial in accordance with Article 10, paragraph 2, then immediately communicates to the person who introduces the form referred to in Article 18/1, 1°, that the biobank has been notified validly, indicating the notification number if the application meets the conditions laid down in Article 18/1, 1°, and if he is aware of the positive opinion as referred to in Article 11, § 13.
Art. 18/3. The biobank human bodily material manager as referred to in section 2, 28°, of the Act of 19 December 2008 on the obtaining and use of human bodily equipment for human medical applications or for scientific research purposes, shall forthwith communicate all changes to the form as referred to in section 18/1, 1°, to the Federal Agency for Drugs and Health Products. ".
§ 2. § 1^er comes into force on a date to be fixed by the King by order deliberately in the Council of Ministers.
Art. 125. In the same Act, a chapter X/1 containing section 20/1 is inserted, as follows:
"CHAPITRE X/1. - Notice of the Commission for Human Drugs in the event of a trial and related to the application of this Act
Art. 20/1. § 1^er. The Commission for Human Drugs, as provided for in Article 6, § 1^er, the Act of March 25, 1964 on medicines, referred to as the "Commission", may render a notice to the Minister concerning a specific test. The notice procedure is initiated at the request of the ethics committee which makes the notice unique for the specific test in question.
The request for notice is motivated and accurately indicates the subject matter of the additional analysis. The notice may only concern the application and execution of the trial in question.
For specific tests, the notice may only be requested if it is a test:
- in which an experimental drug with a new mechanism of action is first administered to man;
- on children as described in chapter IV and on pregnant women;
- in therapeutic indications for which no alternative treatment exists.
§ 2. The Board's advice is limited to the assessment of the risk-benefit ratio of the application of the experimental drug, the safety of participants in the trial, including the application of good clinical practices as referred to in section 4. The Commission relies on making its opinion on scientific information on quality and preclinical and clinical aspects that are made available by the sponsor or are available in scientific publications. In its opinion, the Commission refers to specific references to available relevant publications.
The promoter of the study concerned is informed of the notice procedure.
The proponent may be heard by the Commission at the request of the Commission or at its own request.
The Commission makes a reasoned opinion that is made available to the Minister or the applicant ethics committee, as well as to the sponsor.
§ 3. The Commission may, at the request of the Minister or an ethics committee with full approval, issue a notice on generic aspects of clinical studies with drugs as referred to in this Act. These generic aspects relate to the safety of the participant and to the principles of good clinical practices as referred to in section 4.
The Commission shall render an opinion on this matter within sixty days.
§ 4. For the application of §§ 1^er and 2, the King may set out the terms and conditions for the operation of the Commission and concerning the course of the notice procedure, the schedule and the terms and conditions of the sponsor's hearing, and the notification of the notice.".
CHAPTER 4. - Amendments to the Act of 20 July 2006 relating to the creation and operation of the Federal Agency for Drugs and Health Products
Art. 126. Article 4, § 1^er, the Act of 20 July 2006 on the establishment and operation of the Federal Agency for Drugs and Health Products, last amended by the Act of 19 March 2013, the following amendments are made:
1° paragraph 3, 4°, is supplemented by k. and l., as follows:
"k. controlling the quality of pharmaceutical care in open-ended pharmaceuticals;
l. inspecting veterinary prescription behaviour and the provision of drugs to animal officials;"
2° in paragraph 3, 6°, e), the words "and the prescription" are inserted between the words "the supply" and the words "medications";
3° paragraph 3, 6°, is supplemented by (k), as follows:
"(k) Royal Decree No. 80 of 10 November 1967 concerning the Order of Pharmaceuticals in the matter of ongoing training. "
CHAPTER 5. - Amendments to the Act of 6 July 2007 relating to medically assisted procreation and the destination of supernumerary embryos and gametes
Art. 127. Section 26 of the Act of 6 July 2007 on medically assisted procreation and the destination of supernumerary embryos and gametes is supplemented by a paragraph, which reads as follows:
"For the purposes of paragraph 1^erthe two authors of the female parent project who declare that they have a common parental project are considered to be a single woman."
Art. 128. Section 55 of the Act is supplemented by a paragraph, which reads as follows:
"For the purposes of paragraph 1^er, the authors of the female parental project, who declare to have a common parental project, are considered to be a single woman."
CHAPTER 6. - Amendments to the Act of 19 December 2008 relating to the obtaining and use of human body equipment for human medical applications or for scientific research
Art. 129. In article 2, 28°, of the law of 19 December 2008 relating to the obtaining and use of human bodily material for human medical applications or for scientific research purposes, the words "physician, holder of the diploma of doctor in medicine, surgery and delivery" are replaced by the words "physicist who gathers the conditions set out in article 7 of the Royal Decree 78 of 10 November 1967 concerning the occupation "
Art. 130. In section 7 of the Act, the following amendments are made:
1° § 1^er, paragraph 2, is supplemented by the words "and which simultaneously operates the hospital referred to in paragraph 1^er or university referred to in paragraph 1^er"
2° Paragraph 2 is supplemented by a paragraph, which reads as follows:
"The Federal Agency for Drugs and Health Products publishes on its website a list of human body equipment banks, human body equipment intermediate structures and approved production facilities, indicating the type or types of human body equipment to which the licence relates, and, where applicable, the operation or operations for which the establishment is registered."
Art. 131. In Article 9 of the same Law, the words "of Article 10, §§ 1^er at 6, and articles 11 to 15" are inserted between the word "dispositions" and the word "du".
Art. 132. Article 10 of the same Act is supplemented by § 7 as follows:
"§ 7. Without prejudice to §§ 1^er 6, and without prejudice to the Act of 8 December 1992 on the protection of privacy in respect of personal data processing, the donor or persons referred to in §§ 3 and 4 expressly give their written consent to the possible processing of personal data resulting from the application of this Act or its enforcement orders."
Art. 133. In article 13, paragraph 2, of the same law, the words "or biobank" are inserted between the words "human body material" and the words "to which".
Art. 134. In article 18 of the same law, the words "which is taken or applied in Belgium" are inserted between the words "human body material" and the words ", taking into account".
Art. 135. Article 22, § 1^erin the same Act, replaced by the Act of 19 March 2013, the following amendments are made:
1° a paragraph, as follows, is inserted between subparagraphs 1^er and 2:
"For the biobank that is created as part of a clinical trial as referred to in the Human Person Experiments Act of 7 May 2004 and that obtains exclusively human bodily material, and where applicable treats, stores and makes available in the objectives and purpose of the clinical trial as referred to in the protocol, the authorization as a clinical trial shall be valid for the duration of this trial as a notification referred to in paragraph 1^er under conditions as set out in the Act of 7 May 2004. ";
2° in paragraph 2, becoming paragraph 3, the words "The Fixed King" are replaced by the words "Without prejudice to paragraph 2, the Fixed King";
3° a paragraph, as follows, is inserted between paragraph 2, becoming paragraph 3, and paragraph 3, becoming paragraph 4:
"The Federal Agency for Drugs and Health Products publishes on its website the list of biobanks notified pursuant to paragraphs 1^er and 2. The King may set terms for this publication. ";
4° a paragraph, as follows, is inserted between paragraph 3, becoming paragraph 5, and paragraph 4, becoming paragraph 6:
"In the case referred to in paragraph 2, the favourable opinion of the Ethics Committee as referred to in Article 11, § 1^er, of the Human Person Experiments Act of May 7, 2004, applies, with respect to clinical trial as a favourable opinion as referred to in paragraph 5, under the conditions as set out in the Act of May 7, 2004. ".
5° in paragraph 4, becoming paragraph 7, paragraph 5, becoming paragraph 8, and paragraph 7, becoming paragraph 10, the words "favourable notice referred to in paragraph 3" are each replaced by the words "favourable notice referred to in paragraph 5";
Art. 136. Article 22, § 2, paragraph 1^er, of the same law, replaced by the law of 19 March 2013, is supplemented by the words "unless, in the case referred to in article 22, § 1^er, paragraph 2, these data are already recorded as part of the clinical trial".
Art. 137. In Article 22, § 3, paragraphs 1^er and 2, of the same law, replaced by the law of 19 March 2013, the word "physician" is each time replaced by the words "physician who gathers the conditions set out in article 7 of Royal Decree No. 78 of 10 November 1967 concerning the exercise of the professions of health care or a citizen of one of the Member States of the European Union who is authorized to practise medicine in another Member State than Belgium".
Art. 138. Section 45/1 of the Act, inserted by the Act of 19 March 2013, is replaced by the following:
"Art. 45/1. The provisions amended by the Act of March 19, 2013 relating to various health provisions (I) and the Act of [....] relating to various health provisions that relate to section 22, paragraphs 3 to 9, of this Act apply exclusively to human bodily material that is taken from the date of entry into force of these amended provisions. "
Art. 139. Articles 129 to 138 come into force on a date to be determined by the King by order deliberately in the Council of Ministers.
PART 4. - SPF Public Health, Food Chain Safety and Environment
CHAPTER 1^er. - Exercise of health care professions
Section 1^re. - Dental art
Art. 140. Article 3bis of Royal Decree No. 78 of 10 November 1967 on the Exercise of Health Care Professions, inserted by the Act of 10 August 2001 and replaced by the Act of 24 November 2004, is supplemented by a paragraph written as follows:
"Paragraph 1^er also applies, for the duration of their internship, to candidates for special professional titles for dental practitioners, whose internship plan is admissible, up to two months no later than the date of completion of their internship. "
Section 2. - Continuity of care
Art. 141. Section 8 of the same order, last amended by the Act of 19 December 2008, is replaced by the following:
"Art. 8. For the purposes of articles 8bis, 9 and 9bis, it is understood by:
1st deep night: the period of twenty-three hours to eight hours;
2° normal practice time: the period, from Monday to Friday, from eight hours to eighteen hours, except holidays;
3rd period of permanence: the period outside the normal hours of practice;
4° continuity of care: follow-up of patient treatments by the treating health care professional or another health care professional when the treating health care professional interrupts its practice;
5° medical permanence: regular and normal dispensation of health care to the population during the period of permanence;
6° Daily closure: closing the practice of a health professional outside the normal practice schedule. ".
Art. 142. In the same Royal Decree, an article 8bis is inserted as follows:
"Art. 8bis. § 1^er. The practitioners referred to in articles 2, § 1^er, 3, 21bis, 21quater and 21noviesdecies cannot knowingly and without legitimate reason in their leader, interrupt the treatment of a patient in progress without having previously made any provisions to ensure continuity of care.
The competent medical board shall ensure compliance with paragraph 1^er by the practitioners referred to in articles 2, § 1^er, 3, 21bis, 21quater and 21noviesdecies.
By a deliberate decree in the Council of Ministers, the King may extend or supplement the list of occupations referred to in this article.
§ 2. The continuity of care is ensured by another practitioner with the same special professional title.
With respect to the practitioners referred to in Article 2, § 1^er, continuity of care during the deep night, with the exception of palliative care and treatment of pain, may, under conditions fixed by the King, be entrusted to the bearer of another special professional title reserved for holders of a doctor's degree in medicine.
§ 3. The pharmacist can knowingly and without legitimate reason in his/her leader, temporarily or permanently close his/her offspring without having previously made any provisions to ensure the continuity of dispensation of the medications prescribed in an ongoing order.
The competent medical board shall ensure compliance with paragraph 1^er.
§ 4. In the event of a patient's ongoing treatment interruption due to a daily closure, the continuity of care may be ensured within the framework of the medical permanence, provided that the health care professional participates in the medical permanence in accordance with the terms set out in section 9.".
Art. 143. Section 9 of the same Royal Decree, last amended by the Act of 24 July 2008, is replaced by the following:
"Art. 9. § 1^er. The King defines the conditions under which medical permanence is guaranteed.
The King may entrust the missions set by Him, relating to the local organization of the medical permanence to the representation of the professionals concerned and to collaboration with other health care professionals, to professional organizations representative of the practitioners referred to in Articles 2, § 1^er, 3, 4, 21bis, 21quater and 21noviesdecies, groupings formed for this purpose or employers of practitioners referred to in articles 2, § 1^er, 3, 4, 21bis, 21quater and 21noviesdecies, provided they are approved for this purpose.
The conditions and procedure for obtaining approval are set by the Minister who has Public Health in his or her powers.
None of the practitioners referred to in articles 2, § 1^er, 3, 4, 21bis, 21quater and 21noviesdecies and meeting the conditions required cannot be excluded from this medical permanence, provided that the person concerned subscribes to the rules of procedure and observes the ethical rules.
When a permanence has been established for open-ended informals, all of the open-ended informals on the custodial role will participate in it in accordance with the terms determined by the King.
The organizations, groupings or employers referred to in paragraph 2 shall communicate to the competent medical board the custodial role established by their care, as well as any amendments made thereto and a rules of procedure.
The King sets out the terms for recording calls during the period of permanence.
§ 2. The medical commission defines the local organization needs of the medical permanence. It monitors the operation of the local medical permanence organized by the organizations, groups or employers referred to in § 1^er and is authorized to approve the internal regulations referred to in § 1^er and to determine the local organisational challenges of the medical permanence.
When rules on medical permanence are set out in a code of ethics applicable to health care professionals concerned, the commission refers to it in the execution of the missions referred to in paragraph 1^er.
In the event of a deficiency or insufficiency, the medical commission appeals, on initiative or at the request of the provincial governor, to the collaboration of the organizations, groups or employers referred to in § 1^er or practitioners interested in establishing or completing the local organization of the medical permanence.
§ 3. If at the expiry of the time limit set out in the application referred to in paragraph 2, paragraph 3, the local organization of the medical permanence does not function satisfactorily, the hygiene inspector or, if purchased, the pharmacy inspector shall take all measures to organize or complete the local organization of the medical permanence according to the needs that may have been defined by the medical commission presided in this case by the governor of the province. In this context, the health inspector or, if purchased, the official of the Federal Agency for Drugs and Control Products may require the participation of the organizations, groups or employers referred to in § 1^er or interested practitioners, which they designate, in order to organize or complete the local organization of the medical permanence. ".
Art. 144. In the same Royal Decree, an article 9bis is inserted as follows:
"Art. 9bis. § 1^er. It is created within the Federal Public Service Public Health, Food Chain Safety and Environment a unified call system for medical permanence enabling the population to reach the medical permanence services referred to in Article 9. The King sets out the operation of this call system, as well as minimum quality standards, call terms and number for telephone calls.
A professional organization, grouping or employer referred to in Article 9, § 1^er, paragraph 2, may be associated with the unified system of medical permanence.
§ 2. Professional organizations, groups or employers referred to in Article 9, § 1^er, paragraph 2, which are associated with the unified medical permanence call system, delegates to this call system the choice of response that is provided by the call system attendants to the requests of patients who use this call system.
The unified call system staff assess the requests of patients who use this unified call system and provide the most appropriate medical responses in accordance with the medical permanence protocols validated by the Minister of Public Health.
The King may establish an existing body or designate an existing body to propose the protocols referred to in paragraph 2.
§ 3. The King, in accordance with the Act of 8 December 1992 on the protection of privacy with respect to personal data processing and after the advice of the Privacy Commission, sets out the terms for the registration of appeals.
These terms are particularly relevant to the nature of the call data to be recorded and their structuring, and allow for the evaluation of the operation of the call system, both with respect to the minimum quality standards and the organization of quality internal monitoring.
§ 4. The King shall determine by profession the date of entry into force of this article. ".
Art. 145. In section 38 of the same Royal Decree, last amended by the Act of 19 December 2008, the following amendments are made:
1° in § 1^er, the 3° is replaced by the following:
"3° Is punishable under 2°:
(a) a person who, being required to participate in the local organization of the medical permanence pursuant to the measures imposed pursuant to Article 9, § 3, fails to fulfil his or her obligations without being able to justify an impediment resulting from the fulfilment of a more urgent professional duty or other serious cause;
(b) any practitioner referred to in section 8bis who, knowingly and without legitimate reason in his or her leader, interrupts the treatment of an ongoing patient without having previously made any provisions to ensure continuity of care;
(c) any pharmacist who, knowingly and without legitimate reason in his or her leader, temporarily or permanently closes his or her offspring without having previously made any provisions to ensure the continuity of the dispensation of the drugs prescribed in an order in progress. ";
2° in § 3, (a) and (b) are repealed.
Section 3. - Kinesitherapy
Art. 146. In article 21ter, inserted by the law of 6 April 1995 and last amended by the law of 10 August 2001, article 45, last amended by the law of 19 December 2008 and article 47, inserted by the law of 6 April 1995, of the same royal decree, the words "National Council of Kinesitherapy" are each replaced by the words "Federal Council of Kinesitherapy".
Art. 147. In section 21bis of the same Royal Decree, inserted by the Act of 6 April 1995 and amended by the Act of 24 November 2004, the following amendments are made:
(a) in § 4, 1°, the words "one of the following forms of therapy" are replaced by the words "one or more of the following forms of therapy";
(b) in § 4, 4°, the words "prenatal and postnatal gymnastics" are replaced by the words "perinatal physiotherapy and abdomino-pelvic rehabilitation";
(c) § 6 is replaced by the following:
§ 6. Persons authorized under § 1^er may exercise physiotherapy only in respect of patients who are sent on the basis of a prescription made by a person authorized to practise medical art under section 2, § 1^erParagraph 1^er, or, with respect to physiotherapy in the event of temporal andibular dysfunction, which is sent by a person authorized to exercise dental art under section 3.
This requirement is written, possibly electronically or by telefax. It indicates the diagnosis or diagnostic elements established by the doctor, or if applicable by the dental practitioner, the maximum number of treatment sessions to be performed by the physiotherapist and possible contraindications for certain treatments. It may also indicate the benefit(s) requested by the physician, or if applicable by the dental practitioner.
With the consent of the prescribing physician, or if applicable of the dental practitioner, the physiotherapist may perform other benefits than those prescribed or refrain from performing the prescribed services.
At the request of the prescribing physician, or if applicable of the dental practitioner, the physiotherapist shall provide a report on the completion of the treatment and the results obtained.
The King may set a list of reasons and situations in which persons authorized under § 1^er may derogate from the condition referred to in paragraph 1^er"
Art. 148. In Article 21ter of the same Royal Decree, § 7, inserted by the laws of 6 April 1995 and amended by the laws of 25 January 1999 and 10 August 2011, is replaced by the following:
"§ 7. The King regulates the organization and operation of the Federal Council of physiotherapy.
This may only be valid if at least half of its effective members are present or represented by their alternate members. If the members of the Federal Council of physiotherapy are not present in sufficient numbers, the President shall convene a second meeting with the same agenda. The Council may then deliberate validly whatever the number of members present.
The Council shall take action by a majority of the members present. In the event of a parity of votes, the item that was submitted to the vote is not adopted.
The decisions of the board are, with respect to the notices referred to in Article 47, § 1^ertaken by a two-thirds majority of the members referred to in § 4, paragraph 1^er1° and 2°, provided that the majority includes at least one member referred to in § 4, paragraph 1^er Two. "
Section 4. - Women
Art. 149. In Article 21quater of the same Royal Decree, amended and renumbered by the Act of 6 April 1995, § 2 is replaced by the following:
"§2. The holder of the professional title of midwife, who graduated before 1^er October 2018, may exercise nursing art in the same conditions as the holders of the graduated nursing professional title.
The holder of the professional title of midwife who graduated after 1^er October 2018, can fully perform the technical nursing services as well as the medical acts entrusted to nursing art, in the field of obstetric art, the treatment of fertility, gynaecology and neonatology. ".
Art. 150. In chapter 1^erquater of the same royal decree, an article 21noviesdecies/1 is inserted as follows:
"Art. 21noviesdecies/1. § 1^er. A Midwives Accreditation Commission is established with the Federal Public Service Public Health, Food Chain Safety and Environment.
§ 2. The purpose of the Midwives Accreditation Commission is to render an opinion on applications for accreditation authorizing midwives to carry the professional title, as well as to render an opinion on the registration of permanent training courses. Its mission is also to monitor compliance with the conditions established by the Minister who has the Public Health in his or her duties, to maintain the title concerned, and to propose to the Minister sanctions when, in the event of control, it is established that these conditions are not met.
§ 3. The King regulates the composition, organization and operation of the accreditation committee for midwives. ".
Section 5. - Paramedical Professions
Art. 151. In the Dutch text of article 22bis of the same royal decree, inserted by the law of 19 December 1990, the words "stelt stelt" are replaced by the word "stelt".
Art. 152. In article 28 of the same Royal Decree, the words "Ministry of Public Health and the Family" are replaced by the words "Federal Public Service Public Health, Food and Environment Safety".
Art. 153. In Article 30, § 1^erParagraph 1^er, of the same royal decree, last amended by the law of 10 August 2001, 6°, is replaced by the following:
"6° and two officials who will serve as secretary and assistant secretary;".
Art. 154. Section 35bis of the same Royal Decree, inserted by the Act of 19 December 1990, is replaced by the following:
"Art. 35bis. § 1^er. It is established with the Federal Public Service Public Health, Food Chain Safety and Environment a Technical Commission for Paramedical Professions.
The purpose of this commission is to give the opinions referred to in Article 46bis, § 2.
§ 2. The commission is composed by representatives of paramedical professions and representatives of the art of healing, appointed by the King. The King also appoints an alternate for each of these representatives.
§ 3. The King appoints a Chairman and a Vice-Chair on the proposal of the Technical Commission. The chair of the meeting sits without a deliberate vote. If the president is a member of a paramedical profession, he may be represented by his alternate member who then vote in full right. If the Vice-President is a member of a paramedical profession and is to serve as chair of the meeting, he or she may be represented by his or her alternate member, who then vote in full right.
The secretariat shall be provided by an official designated by the Minister who has Public Health in his or her functions.
§ 4. Subject to paragraphs 2 and 3 and 2, the King shall rule the composition, organization and operation of the Technical Commission of Paramedical Professions.
The commission deliberates validly when half of the representatives of the paramedical professions and half of the representatives of the professions of the art of cure are present. It shall make its decisions by a two-thirds majority of the votes of the members present and at least by a majority of the votes of each group.
When at a meeting of the Commission, half of the members of each group are not present, the Commission may deliberate on the same agenda items at the next session, regardless of the number of members present. In this case she makes her decisions by a three-quarters majority vote.".
Section 6. - Planning
Art. 155. In the same Royal Decree, the title of Chapter IIbis, replaced by the Act of 29 January 2003, is replaced by the following:
"Chapter IIbis. - Specific professional qualifications, specific professional titles, supply control, end of career, assessment, structure and organization of practice, permanent federal data bodies and bank for healthcare professionals"
Art. 156. The opening sentence of Article 35octies, § 2bis, paragraph 3, of the same Royal Decree, inserted by the law of 29 January 2003, is supplemented by the words "permanently".
Art. 157. In Article 35quaterdecies, §§ 1^er, 4, 5 and 6, of the same Royal Decree, last amended by the Act of 29 March 2012, the word "permanent" is inserted between the words "federal data bank" and the words "health care professionals".
Section 7. - Medical commissions
Art. 158. In section 36 of the same Royal Decree, last amended by the Act of 19 December 2008, the following amendments are made:
1° § 2 is replaced by the following:
"§2. Each medical commission consists of:
1° a president, doctor;
2° a vice president, doctor;
3° two members per profession referred to in articles 2, § 1^er3, 4, § 1^er21 bis, 21quater and 21octiesdecies;
4° two veterinary doctors;
5° a member by profession referred to in this Order, other than the professions referred to in Articles 2, § 1^er3, 4, § 1^er21 bis, 21quater and 21octiesdecies;
6° a registered non-conventional practice member as referred to in the Act of 29 April 1999 on non-conventional practices in the fields of medical art, pharmaceutical art, physiotherapy, nursing art and paramedical professions;
7° a health inspector from the Federal Public Service Public Health, Food Chain and Environment Safety. This hygiene inspector is the secretary of the commission;
8° an inspection officer of the Federal Agency for Drugs and Health Products. ";
2° in § 3, the words "sub 3° to 8° of § 2 of this article" are replaced by the words "vised in § 2, 3° to 6°, ";
3° in § 4, the words "staffs and substitutes referred to under 3° to 8°" are replaced by the words "staffs and substitutes referred to in § 2, 3° to 6°" and the words "The members referred to under 9° and 10° of the same §" are replaced by the words "The members referred to in § 2, 7° and 8°".
Art. 159. In section 37 of the same Royal Decree, last amended by the Act of 19 December 2008, the following amendments are made:
1° in § 1^er, 2°, b), paragraph 1^erthe words "that a health care professional referred to in this Order or a veterinary physician" are replaced by the words "that a health care professional referred to in this Order, a veterinary physician or a member of an unregistered practice referred to in the Act of 29 April 1999 referred to above";
2° in § 1^er, 2°, c), 1., the words "medical art and pharmaceutical art, veterinary art physiotherapy, nursing art and paramedical professions" are replaced by the words "the professions of health care covered by this decree, veterinary art, and the unconventional practices registered and subject to the law of 29 April 1999 referred to above";
3° in § 1^er, 2°, c), 2., the words "of medical art, pharmaceutical art, veterinary art, kinesitherapy of nursing art or a paramedical profession" are replaced by the words "of the professions of health care covered by this decree, of veterinary art, and of non-conventional practices registered and referred to in the law of 29 April 1999 referred to above";
4° in § 1^er, 2°, e), the words "by a practitioner of medical art, pharmaceutical art, veterinary art, nursing art or a member of a paramedical profession or a physiotherapist" are replaced by the words "by a health care professional referred to in this Order, a veterinary doctor or a member of a non-conventional practice registered and referred to in the law of April 29, 1999;
5° in § 1^er, 2°, h), the words "for health care professionals covered by this Order or a veterinary physician" are replaced by the words "for health care professionals covered by this Order, a veterinary physician or a member of a non-conventional practice registered and referred to in the Act of 29 April 1999 referred to above,"
6° § 2 is replaced by the following:
"§2. For the fulfilment of its general mission, the medical commission consists of the members referred to in Article 36, § 1^er1° to 8°.
For the purpose of its special mission, the medical commission shall be composed only of the President, the Vice-President, the Secretary, the member or members representing the profession of the person or persons concerned or of the member representing the non-conventional registered practice referred to in the Act of 29 April 1999 referred to above by the person or persons concerned. ".
Section 8. - Care by the entourage
Art. 160. In section 38ter of the same Royal Decree, last amended by the Act of 19 March 2013, the 1st is supplemented by a paragraph written as follows:
"It is also not an application for a person who is part of the patient's entourage and who, outside the exercise of a profession, after a training delivered by a physician or nurse, according to a procedure or plan of care established by the patient, receives the authorization of the patient to perform with the patient determined one or more technical services referred to in Article 21 (b)). A document issued by the doctor or nurse indicates the identity of the patient and the person who received the authorization. This document also indicates the authorized technical benefit(s), the duration of the authorization, and any additional conditions imposed by the doctor or nurse to perform the technical benefit(s). ".
Section 9. - Accreditation
Art. 161. Article 49bis, § 2, of the same Royal Decree, inserted by the law of 22 February 1998, is supplemented by two paragraphs written as follows:
"When the application relates to the exercise of a profession related to the possession of a diploma in nursing art, the application is submitted in advance to the advice of the Accreditation Commission for nursing practitioners.
When the application concerns the exercise of a profession related to the possession of a midwife's degree, the application is subject to the advice of the Midwives Accreditation Board. ".
CHAPTER 2. - Emergency medical assistance
Art. 162. Section 3ter of the Act of 8 July 1964 on urgent medical assistance, inserted by the Act of 24 July 2008, is replaced by the following:
"Art. 3ter. Within the limits of the budgetary appropriations, a subsidy is allocated to the ambulance services referred to in Article 5 for the organization of a permanence and whose terms and conditions of granting are fixed by the King.".
CHAPTER 3
Amendment of the Health Act of 1^er September 1945
Art. 163. In the Health Act of 1^er September 1945, an article 4/1 was inserted as follows:
"Art. 4/1. The King determines the amount of retributions that may be required for the execution of inspection and control activities carried out in the context of the sanitary inspection of vessels and aircraft, as well as the deadlines and modalities of their perception.".
CHAPTER 4. - Hospitals
Section 1^re. - Retention of records
Art. 164. In Article 20, § 1^er, from the coordinated law of 10 July 2008 on hospitals and other care facilities, the words "at the hospital" are replaced by the words "by the hospital".
Art. 165. In Article 25, § 1^er, from the same law, renumbered by the Royal Decree of 19 June 2009, the words "at the hospital" are replaced each time by the words "by the hospital".
Section 2. - Medical management and structure
Art. 166. Section 18 of the Act, as amended by the Act of 19 March 2013, is supplemented by two sub-items as follows:
"The chief physician is invited and may attend, with an advisory voice, meetings of the organ that, under the legal status of the hospital, is responsible for the management of the operation of the hospital.
Paragraph 6 does not apply where the discussions relate to matters for which the chief physician is personally and directly concerned.".
Art. 167. the following amendments are made to section 22 of the Act:
1° in paragraph 2 the words "The Chief Medical Officer and the Chief Medical Officer are appointed or designated" are replaced by the words "The Chief Medical Officer is appointed or designated";
2° the article is supplemented by a paragraph written as follows:
"Unless otherwise provided in the regulation referred to in section 137, 2°, the head physician shall be appointed or designated for a renewable period of six years."
Section 3. - Heavy machinery
Art. 168. Section 56 of the Act is replaced by the following:
"The professional practitioner who operates a device or equipment for medical imaging or treatment communicates to the Minister who has the Public Health in his duties, the data set by the King by order deliberately in the Council of Ministers. The King determines the devices for which data are to be communicated and the time limit for such communication."
Section 4. - Financing operating costs
Art. 169. In section 95 of the Act, paragraphs 2 and 3 are repealed.
Art. 170. Section 121 of the Act is repealed.
Section 5. - State aids
Art. 171. Article 105, § 1^erParagraph 1^er, of the same law, (a) is supplemented by the words "that cannot last more than ten years, except for the components of the budget of the financial means that cover important investment costs of the hospital requiring, in accordance with generally accepted accounting principles, a depreciation over a longer period".
Art. 172. Section 108 of the Act is supplemented by a paragraph, which reads as follows:
"Notice to the manager of the draft decision and final decision, as referred to in paragraph 1^er, contain a reference to the Commission's Decision of 20 December 2011 on the application of Article 106, paragraph 2, of the Treaty on the Functioning of the European Union to State Aids in the form of public service compensation awarded to certain companies responsible for the management of services of general economic interest."
Section 6. - Conflict resolution
Art. 173. In article 139, § 2, paragraph 4, of the same law, the words "chosen on a list of mediators drawn up by him, on the proposal of the National Joint Medical Hospital Commission" are replaced by "chosen on a list proposed by the National Joint Medical Hospital Commission".
CHAPTER 5. - Patient rights
Art. 174. In the Act of 22 August 2002 on the Rights of the Patient, as amended by the Acts of 24 November 2004, 13 December 2006, 17 March 2013 and 23 May 2013, an article 8/1 is inserted, as follows:
"Art. 8/1. The professional practitioner informs the patient whether he or she has insurance coverage or any other individual or collective form of protection regarding professional liability. ".
Art. 175. "In the same law, an article 8/2 is inserted, as follows:
"Art. 8/2. The professional practitioner informs the patient of his or her status of authorization to exercise or register."
Art. 176. In article 16, § 2, of the Act of 22 August 2002 on patient rights, the following amendments are made:
1° 4° is supplemented by the words "and make recommendations in this regard;"
2° 5° is repealed.
CHAPTER 6. - Advertising
Art. 177. The title of the law of May 23, 2013 regulating the qualifications required to perform non-surgical cosmetic medicine and cosmetic surgery is supplemented by the words: "and regulating advertising and information relating to these acts. ".
Art. 178. In section 2, 1°, of the same law, the words "Understand in devices using any form of energy devices using Class 4 or higher laser or intense pulsed light" are repealed.
Art. 179. Article 2 of the same law is supplemented by the 6th to 9th written as follows:
"6° advertising: any form of communication or action intended for the public, directly or indirectly, to promote the performance of the acts referred to in Article 3, regardless of the location, support or techniques used, including tele-reality programming;
7° professional information: any form of communication that aims, directly and specifically, regardless of the location, support or techniques used, to make a practitioner known or to give information on the nature of his professional practice;
8° misleading information: any form of communication or action that, in any way, including its presentation, misleads the persons to whom it addresses or touches and who, because of its misleading character, may affect their behaviour or which, for these reasons, may damage or may damage a patient;
9° comparative information: any form of communication or action that explicitly or implicitly identifies another practitioner or service offered by another practitioner."
Art. 180. Section 3 of the Act is supplemented by a paragraph 2 which reads as follows:
"Do not fall under the application of this Act tattoos, piercings and hair removal techniques.".
Art. 181. Section 15 of the Act is repealed.
Art. 182. In the same Act, a chapter 6/1 is inserted as follows:
"Chapter 6/1. - Advertising and information."
Art. 183. In chapter 6/1 of the same Act, inserted by section 172, an article 20/1 is inserted, as follows:
"Art. 20/1, It is prohibited for any natural or legal person to broadcast advertising relating to the acts referred to in Article 3.
The professional information relating to these acts is authorized in accordance with the following conditions.
Professional information must be consistent with reality, objective, relevant, verifiable, discreet and clear.
This information cannot be misleading, comparative and cannot use financial arguments.
Professional information always mentions specific professional titles within the meaning of Article 35ter of Royal Decree No. 78 of 10 November 1967 concerning the exercise of the professions of health care available to the practitioner.
When professional information is disseminated by an institution that uses the services of practitioners, the names of practitioners as well as special professional titles within the meaning of article 35ter of Royal Decree No. 78 of 10 November 1967 relating to the exercise of the professions of health care of each of them are always mentioned.
The provisions of this Act in respect of advertising and professional information shall not prejudice the application of the Act of 22 August 2002 on the rights of the patient to the extent that it applies information relating to acts referred to in this Act.".
Art. 184. In chapter 7 of the Act, an article 22/1 is inserted as follows:
"Art. 22/1. A person who commits an offence under section 20/1 shall be punished by imprisonment from eight days to six months and a fine of two hundred and fifty euros to five thousand euros or only one of these penalties.
In addition, the court may order the publication of the judgment or its summary at the offender's expense through three newspapers and in any other way. ".
Art. 185. the following amendments are made to section 24 of the Act:
1° in § 2, paragraph 1^er, the words "of a minimum theoretical formation in non-surgical aesthetic medicine and" are inserted after the words "can justify";
2° in § 2, paragraph 2, the words "one year" are replaced by the words "two years";
3° in § 3, the words "one year" are replaced by the words "two years".
Art. 186. In section 24 of the Act, § 5 is repealed.
Art. 187. In section 25 of the Act, the number "2014" is replaced by the number "2015".
CHAPTER 7. - Animals, Plants and Food
Section 1^re. - Amendments to the Consumer Health Protection Act of 24 January 1977 concerning food and other products
Art. 188. In section 10 of the Act of 24 January 1977 on the Protection of Consumer Health in respect of food and other products, as amended by the Act of 9 February 1994 and by the Royal Decree of 22 February 2001, the following amendments are made:
1° Paragraph 3 is replaced by the following:
"The amount of these fees is paid, either on behalf of the Federal Agency for the Safety of the Food Chain or on the Budget Fund for raw materials and products";
2° the article is supplemented by a paragraph written as follows:
"The King is authorized to amend, replace or repeal the provisions of the Royal Decree of 13 November 2011 setting out the remuneration and contributions due to the Budget Fund for raw materials and products. ".
Art. 189. In section 11 of the Act, last amended by the Act of 27 December 2011, the following amendments are made:
1° § 1^er is replaced by the following:
"Art.11. § 1^er. Without prejudice to the powers of judicial police officers, the members of the statutory or contractual staff of the Federal Public Service Public Health, Food Chain Security and Environment designated for this purpose by the King shall monitor the execution of the provisions of this Act and its enforcement orders as well as the regulations of the European Union and which fall within the competence of the Federal Public Service Public Health, Safety of the Food Chain and Environment by conducting unwarranted inspections, equipped with
Staff members shall be sworn in, prior to the performance of their duties, in the hands of the Minister or his delegate.
Members of the statutory or contractual staff of the Federal Public Service Public Health, Safety of the Food Chain and the Environment designated by the King for the monitoring of the application of this Act and the orders made pursuant to this Act may, within the limits of the performance of their jurisdiction, enter, without prior warning, in any place assigned to the trade in food or other products covered by this Act and in the deposits adjacent to these places and other places They can search them, even if they are not accessible to the public.
They may enter without prior warning at any time in places that are used for the manufacture of food or other products covered by this Act and intended for trade, as well as in places where they are stored.
The visit of the exclusively housed places is permitted only between 5 a.m. and 9 a.m. and can only be done with the permission of the judge.
They may require the production of all writings and trade documents relating to foodstuffs and other products covered by this Act and any documents imposed by the Orders made pursuant to this Act.
They can control transport, public transport and transport. ";
2° in § 2, paragraph 3, the words "ten days" are replaced by the words "trent days";
3° § 2 is supplemented by paragraphs 5 and 6 as follows:
"They can seal automatic distribution devices that do not comply with Article 6, §§ 4 and 6.
They may conduct any review, review and hearing and collect any information they consider necessary to ensure that the provisions of the legislation they exercise surveillance are effectively observed and, in particular, take the identity of any person they consider necessary for the exercise of surveillance. ".
Art. 190. In the opening sentence of Article 13 of the same Law the words "twenty-six to three hundred francs" are replaced by the words "twenty-six euros to thousand euros".
Art. 191. In article 14 of the same law, replaced by the law of December 27, 2012, the words "fifty to thousand euros" are replaced by the words "fifty euros to three thousand euros".
Art. 192. Section 16 of the Act amended by the Act of 22 December 2003, is replaced by the following:
"Art. 16. Without prejudice to the application of the penalties provided for in sections 269 to 274 of the Criminal Code, is punishable by imprisonment of fifteen days to three months and a fine of one hundred to two thousand euros or of one of these penalties only, the person who opposes visits, inspections, investigations, checks, hearings, consultations of documents, taken of samples, gatherings of evidence or seizure or other decisions by the persons authorized to
Art. 193. In section 19 of the Act, last amended by the Act of 27 December 2012, the following amendments are made:
1° in paragraph 1^erthe words "Ministry of Public Health and the Environment" are replaced by the words "Federal Public Service Public Health, Food Chain Safety and Environment";
2° Paragraph 2 is replaced by the following:
"The amount to be paid cannot be less than half of the minimum nor exceed the maximum amount set for the offence. ";
Paragraph 6 is replaced by the following:
"The sum is paid to the Raw Materials and Products Budget Fund. ".
Section 2. - Amendment to the Act of 28 July 1981 approving the Convention on International Trade in Endangered Species of Wild Fauna and Flora, and the Annexes, made in Washington on 3 March 1973, as well as the Amendment to the Convention, adopted in Bonn on 22 June 1979
Art. 194. Article 4bis, § 1^er, the Act of 28 July 1981 approving the Convention on International Trade in Endangered Species of Wild Fauna and Flora, and the Annexes, made in Washington on 3 March 1973, as well as the Amendment to the Convention, adopted in Bonn on 22 June 1979, inserted by the Act of 24 December 2002, is supplemented by a paragraph that reads as follows:
"The King is authorized to amend, replace or repeal the provisions of the Royal Decree of 13 November 2011 setting out the remuneration and contributions due to the Budget Fund for raw materials and products. ".
Section 3. - Amendment of the Act of 20 July 1991 on social and other provisions
Art. 195. Section 132 of the Act of 20 July 1991 on social and other provisions, replaced by the Act of 1^er March 2007 and amended by the Act of 8 June 2008, is supplemented by a paragraph written as follows:
"The King is authorized to amend, replace or repeal the provisions of the Royal Decree of 13 November 2011 setting out the remuneration and contributions due to the Budget Fund for raw materials and products. ".
Section 4. - Amendment of the Act of 22 December 2009 establishing general regulations on the prohibition of smoking in closed places accessible to the public and the protection of workers against tobacco smoke
Art. 196. In section 2 of the Act of 22 December 2009 establishing a general regulation relating to the prohibition of smoking in closed places accessible to the public and to the protection of workers against tobacco smoke, partially annulled by Constitutional Court decision No. 37/2011 of 15 March 2011, the 11th and 12th are repealed.
Art. 197. In the same Act, an article 9/1 is inserted as follows:
"Art. 9/1. In addition to the penalties provided for in section 9, the court may order the closure, for a period of one month to six months, of the closed place accessible to the public where the offences were committed. ".
Promulgate this Act, order that it be put on the State Seal and published by the Belgian Monitor.
Given in Brussels on 10 April 2014.
PHILIPPE
By the King:
Minister of Social Affairs and Public Health,
Ms. L. ONKELINX
The Secretary of State for Social Affairs, Families and Persons with Disabilities, responsible for Occupational Risks, Deputy Minister of Social Affairs and Public Health, and Secretary of State for Scientific Policy, Deputy Minister of Social Affairs and Public Health,
Ph. COURARD
Seal of the state seal:
The Minister of Justice,
Ms. A. TURTELBOOM
____
Note
(1) House of Representatives (www.lachambre.be):
Documents: 2013/2014-0 - 53-3349
Full report: 13 March 2014
Senate (www.senate.be):
Documents: 2013-2014 - 53-2740
Annales du Senate : April 3, 2014