belgiquelex.be - Carrefour Bank of Legislation

17 JULY 2015. - Act respecting various health provisions (1)

Introductory provision
Article 1^er. This Act regulates a matter referred to in Article 74 of the Constitution.
PART 1^er. - INAMI
CHAPTER 1^er. - Amendment of the Program Law of 19 December 2014
Art. 2. Section 137 of the Program Act of 19 December 2014 is repealed.
Art. 3. This chapter produces its effects on June 30, 2015.
CHAPTER 2. - Amendment of the Act of 10 April 2014
various health provisions
Art. 4. In Article 96 of the Act of 10 April 2014 on various health provisions, (c) and (d), in that they insert § 1^er/2 and § 1^er/3 in Article 53, § 1^er, the Compulsory Health Care and Compensation Insurance Act, coordinated on July 14, 1994, is repealed.
Art. 5. This chapter produces its effects on June 30, 2015.
CHAPTER 3. - Amendments to the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994
Section 1^re. - Recipients of compulsory health care insurance
Art. 6. Article 32, paragraph 1^er, of the Compulsory Health Care and Compensation Insurance Act, coordinated on July 14, 1994, last amended by the Act of December 26, 2013, the following amendments are made:
1° 6° ter is replaced by the following:
"6° ter self-employed persons benefiting from social insurance in the event of bankruptcy, situations associated with it or forced cessation, referred to in Article 2 of the Royal Decree of 18 November 1996 establishing social insurance for self-employed persons in the event of bankruptcy, situations assimilated or forced cessation, for up to four quarters.
This four-quarters period takes place, with respect to the independent workers referred to in section 2, of the aforementioned Royal Decree, on the first day of the quarter following that of termination within the meaning of article 1bis of the aforementioned Royal Decree;"
2° in 22°, paragraph 1^er, the words "Article 5" are replaced by the words "Articles 5 and 5/1";
3° in the 22°, paragraph 2, the words ", or which may assert a quality of holder or dependant under an order, taken in execution of Article 33, § 1^erParagraph 1^er", are repealed.
Section 2. - Conclusion of conventions
with the Scientific Institute of Public Health
Art. 7. Article 22, 20°, of the same law, inserted by the law of 10 April 2014, is supplemented by a c) written as follows:
"(c) in the context of reference laboratories in clinical biology, to ensure the diagnosis and monitoring of rare diseases. ".
Section 3. - Anthropogenetics
Art. 8. In the same Act, Title III, Chapter V, section VIII, comprising section 59, last amended by the Act of 10 April 2014, is replaced by the following:
"Section VIII. - Clinical biology, anatomopathology and human genetic services provided to hospitalized and non-hospital beneficiaries.
Art. 59. The General Council shall, no later than 31 December of the year preceding the year of application, after the advice of the National Medico-mutualist Commission and the Insurance Committee, set out the overall financial resources budgets for the entire Kingdom:
1° for clinical biology services as determined by the General Council;
2° for anatomopathology services as fixed by the General Council;
3° for human genetic services as determined by the General Council.
The General Council also sets out the distribution of these budgets, as the above-mentioned benefits are provided to hospitalized and non-hospitable beneficiaries.
The lump-sum fees payable by day hospitalization are part of the benefit budget provided to hospitalized beneficiaries. ".
Section 4. - Availability fees
Art. 9. In article 36quinquies, paragraph 1^er, of the same law, inserted by the law of August 22, 2002, the words "and to pharmacists and graduates in science approved by the Minister of Public Health to perform clinical biology services" are inserted between the word "medical doctors" and the words "who participate".
Section 5. - Online Accession to Agreements
Art. 10. In section 50 of the Act, last amended by the Act of 10 April 2014, subsection 5 is repealed.
Section 6. - Experimental character of special models
prescription, dispensation or payment of health care
Art. 11. In Article 56, § 2, paragraph 1^er, of the same law, the 1°, last amended by the law of 7 February 2014, is replaced by the following:
"1° to give an intervention for special models of an experimental nature of prescription, dispensation or payment of health care;".
Section 7. - Caregivers
Art. 12. In section 2, n), of the same law, as amended by the Acts of December 24, 1999 and April 10, 2014, the words "caregivers," are inserted between the words "paramedical auxiliaries," and the words "hospital institutions".
Art. 13. In section 56 of the Act, last amended by the Act of 10 April 2014, subsection 5 is repealed.
Section 8. - Pricing Offices
Art. 14. In the same Act, an article 165/1 is inserted as follows:
"Art. 165/1. Where the intervention of insurance organizations in the cost of health benefits except those referred to in section 165 is not directly paid by these organizations to the recipients, all pricing operations and all payments by the insurers for these benefits may be made by means of fees approved by the Minister.
The King determines the criteria for the approval of these pricing offices.
These offices are authorized to apply to care providers, under the conditions to be determined by the King, an intervention in their fees.
Care providers can join the pricing office of their choice.
The King may set rules relating to:
1° this accession, among other things concerning the denunciation of membership by the pricing office and the withdrawal of membership by the applicant;
2° the outsourcing of the pricing.
The King defines the security measures that all interested parties must take in the collection, transmission and processing of data in accordance with the above-mentioned objectives. ".
Section 9. - Maximum charge
Art. 15. In section 37news of the Act, inserted by the Act of 5 June 2002, replaced by the Royal Decree of 3 June 2007 and amended by the Acts of 22 December 2008 and 29 March 2012, the words "on the basis of the physical or mental incapacity of at least 66 p.c. of a child, or", are repealed.
Art. 16. Section 15 produces its effects on 1^er January 2014.
Section 10. - Readmission to clinical biology or medical imaging
Art. 17. In article 56quinquies, paragraph 1^er, of the same law, inserted by the law of December 26, 2013, the sentence "However, the percentage referred to in the first sentence is increased from 82 to 67 p.c. for flat-rate interventions calculated by admission to clinical biology or medical imaging." is inserted between the words "previous admission." and the words "These flat-rate interventions diminished".
Art. 18. Article 17 comes into force on the first day of the month following the expiration of a ten-day period beginning on the day after the publication of this Act to the Belgian Monitor.
Section 11. - Living organ donors
Art. 19. In section 37 of the Act, last amended by the Act of 7 February 2014, a paragraph 16quater is inserted as follows:
§ 16quater. The King may, by order deliberately in the Council of Ministers, in the conditions it determines, completely or partially remove the personal intervention relating to the health benefits granted to live organ donors. "
Section 12. - Third party pay plan
Art. 20. Article 53, § 1^erin the same Act, as amended last by the Act of 10 April 2014, the following amendments are made:
(a) Five subparagraphs as follows are inserted between subparagraphs 1^er and 2:
"In the context of the paid third party plan, and without prejudice to the obligations established under section 320 of the Income Tax Code 1992, the documents referred to in paragraph 1^er are replaced by a data transmission by the care provider to the insurers via an electronic network, in accordance with the administrative terms determined by the Insurance Committee.
The King sets out the date on which, for a category of caregivers, transmission to data insurers under the third-party payment regime using an electronic network is applicable.
From the date established under paragraph 3, the caregiver shall have a period of two years to meet the obligation referred to in paragraph 2.
Paragraph 1^er remains of application under the pay third party plan:
1° before the date fixed under paragraph 3;
2° during the period referred to in paragraph 4 until the caregiver has complied with the obligation referred to in paragraph 2.
By derogation from paragraphs 3 and 4, the obligation referred to in paragraph 2 is born on 1^er July 2015 for nurse art practitioners. ";
(b) paragraph 2, becoming paragraph 7, is replaced by the following:
"Insurer organizations may not grant reimbursement if the certificate of care or supplies, the document taking place or the data referred to in paragraph 2 are not transmitted to them."
(c) in paragraph 3, becoming paragraph 8, the words "or transmit" are inserted between the word "remit" and the words "the documents", and the words "or data" are inserted between the words "the documents" and the words "from whom";
(d) in paragraph 8, to paragraph 13, the following amendments are made:
1° the sentence "In the context of the third-party pay plan, the Insurance Committee sets out the administrative procedures for the transmission of the documents referred to in paragraph 1^er to insurers." is inserted between the phrase "Nothing is, any agreement that derogates from the regulations enacted by the King pursuant to this provision." and the phrase "The King may, subject to situations for which the application of the pay third party regime is mandatory, also specify the conditions and conditions under which a prohibition of the application of the pay third party regime is pronounced with respect to individual dispensers. ";
2° the words "fixes the terms of this verification and" are repealed;
(e) Paragraph 9, to be paragraph 14, is replaced by the following:
"From 1^er July 2015, the obligation to apply the paid third party plan is introduced to the beneficiaries of the increased intervention of the insurance referred to in section 37, § 19, for health benefits issued by the general practitioner, as determined by the King, namely:
1° on the basis of a proposal by the National Medico-mutualist Commission that decides on its transmission to the Insurance Committee;
2° on the basis of the proposal made by the National Medico-mutualist Commission at the request of the Minister; these proposals are communicated to the Insurance Committee;
3° on the basis of the Minister's proposal. ";
(f) in paragraph 10, becoming paragraph 15, the number "9" is each time replaced by the number "14";
(g) Paragraph 11, as paragraph 16, is replaced by two subparagraphs as follows:
"The King may, by order deliberately in the Council of Ministers, extend the obligation referred to in paragraph 14 to other categories of beneficiaries.
The Institute's Health Care Service analyses the elements that are communicated by insurers regarding the mandatory application of the third-party pay plan referred to in paragraph 14 after one year of the application. The Service specifies the data to be reported and the terms and conditions of their communication. ";
(h) in paragraph 14, becoming paragraph 20, the number "13" is replaced by the number "19".
Art. 21. This section comes into force on 1^er July 2015.
Section 13. - Financial Transparency of Health Care
Art. 22. In section 53 of the Act, last amended by the Act of 10 April 2014, the following amendments are made:
(a) Paragraph 1^er/1, paragraph 1^er, is supplemented by the words "or by separate decision adopted by convention and agreement commissions";
(b) in paragraph 1^er/1, a preambular paragraph is inserted between subparagraphs 1^er and 2:
"The effective date of the decisions referred to in paragraph 1^er is determined by the commission concerned. These decisions are published in the form of a notice to the Belgian Monitor and remain in application until a decision has been adopted. ";
(c) a paragraph 1 is inserted^er/2 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° in the case 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;
2° 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 payable by the recipient for benefits referred to in paragraph 1^er, including deposits paid, are on the supporting document.
Where a certificate of care or supplies or equivalent document referred to in § 1^erParagraph 1^er detailing all refundable benefits to the recipient, the supporting document includes:
- for all reimbursable benefits, the total to be paid, including any surcharges;
- in respect of each non-refundable benefit, in the form of a wording, its amount.
Where a certificate of care or supplies or equivalent document referred to in § 1^erParagraph 1^er detailing all refundable benefits is not provided to the recipient, the supporting document includes:
- in a separate manner, in respect of each repayable benefit in the form referred to in § 1^erParagraph 1^er, unless the benefits are grouped in accordance with the decisions made under paragraph 6, 4°, the amount paid by the beneficiary under the rates, the amount paid by the beneficiary as a surcharge and, where applicable, the intervention charged directly to the insurer;
- in respect of each non-refundable benefit, in the form of a wording, its amount.
At the request of the beneficiary, the supporting document contains, for health benefits and the devices referred to in Article 33, § 1^erParagraph 1^er, 11°, of the Act of 15 December 2013 on medical devices determined by the Committee of Conventions or relevant agreements, the amount of purchase of the devices provided by the dispensator when they are subject to compulsory insurance intervention or are part of a health benefit giving rise to such intervention.
The Insurance Committee, on a proposal by the Committee of Conventions or relevant agreements or, if the Commission has not responded in the month to a request for a proposal by the Insurance Committee, after notice by that Commission, deemed to be favourable if it has not been issued in the month, may, by regulation referred to in section 22, 11°, fix for each category of caregivers:
1° any other mentions on the supporting document;
2° the manner in which the supporting document is given to the beneficiary;
3° when the supporting document is given to the recipient if it is not the time when the benefit is made;
4° of the modalities for the consolidation of similar benefits on the supporting document;
5° a supporting document template and the cases in which this model is to be used.
The obligation to issue a supporting document is waived when an invoice is issued in accordance with paragraphs 2 to 6, 1 to 4°.
(d) paragraph 1^er/4 is renumbered in paragraph 1^er/3.
Art. 23. This section comes into force on 1^er July 2015.
Section 14. - Administrative oversight
Art. 24. In section 166 of the Act, replaced by the Act of 19 May 2010, subsection 1^er is completed by (j) and (k), as follows:
"j) A fine of EUR 250, by request of the Medical Evaluation and Control Service, that is, where the data on the lists referred to in section 138 do not correspond with the authentic source or do not contain the information necessary for the complete identification of the benefits, the caregivers who prescribed them, carried out or delivered them, and the beneficiaries, as well as the order number of the prescriptions of medicines, either in the event of an authentication by a registered agent
(k) A fine of EUR 125, by insured person or care provider, where, by mistake, negligence or negligence, the insurance agency failed to pay a benefit under this Act or the orders and regulations made pursuant to this Act, or pays less than the amount actually due."
Section 15. - Medical check
Art. 25. In Article 145, § 2, paragraph 1^er, from the same law, repealed by the law of 24 December 2002 and restored by the law of 21 December 2006, the word "three" is replaced by the word "four".
Art. 26. Article 156, § 1^erthe Act, repealed by the Act of 13 December 2002, reinstated by the Act of 21 December 2006 and amended by the Acts of 29 March 2012 and 10 April 2014, the following amendments are made:
1° paragraph 2 is replaced by the following:
"Amounts due shall be paid within thirty days of notification of decisions referred to in paragraph 1^er. In the absence of payment within this period, the remaining amounts due shall, in full law, produce interest at the rate of legal interest in social matters, as provided for in Article 2, § 3, of the law of May 5, 1865 relating to the interest loan, from the expiry of that period.";
2° in paragraph 3, the words "Management of the value added tax, registration and domains" are replaced by the words "General Administration of Heritage Documentation".
Art. 27. In section 206bis, § 2, of the same law, inserted by the law of January 14, 2002 and amended by the law of April 10, 2014, the words "Administration of the tax on value added, registration and domains" are replaced by the words "General Administration of Heritage Documentation".
Art. 28. In section 139 of the Act, last amended by the Act of 10 April 2014, a paragraph is inserted between paragraphs 2 and 3:
"By derogation from paragraph 1^er, and pending the execution by the King of the jurisdiction granted to him by paragraph 2, the Medical Evaluation and Control Service is composed as follows: a central service, to a maximum of ten regional services whose jurisdiction corresponds to the provincial constituencies of which they bear the name (Anvers, Limburg, Namur, Luxembourg, Liege, Eastern Flanders, West Flanders, Hainaut, Flemish Brabant and Brabant)
Section 16. - Medical Accidents Fund
Art. 29. In section 137quinquies of the same Act, inserted by the Act of March 19, 2013, the words "Director General" are replaced by the words "Council General".
Art. 30. In section 177, paragraph 2, of the Act, replaced by the Act of 29 April 1996 and amended by the Acts of 24 December 2002 and 19 March 2013, the words "a Director General of the Medical Accidents Fund" are replaced by the words "a General Counsel of the Medical Accidents Fund".
Art. 31. In section 182 of the Act, replaced by the Act of 29 April 1996 and amended by the Acts of 14 January 2002 and 19 March 2013, the following amendments are made:
1° in paragraph 3, the words "the Director General of the Medical Accidents Fund" are replaced by the words "the General Counsel of the Medical Accidents Fund";
2° in paragraph 4, paragraph 1^er, the words "The Director General" are replaced by the words "The General Counsel";
3° Paragraph 4 is supplemented by a paragraph which reads as follows:
"In the event that the above-mentioned general advisor of the Medical Accidents Fund is prevented, his or her skills are exercised by an official designated by the General Committee."
Section 17. - The social status of doctors, dental practitioners, pharmacists, logopeds and physiotherapists and other benefits that may be granted to certain doctors
Art. 32. Article 54, § 1^erParagraph 1^erthe same law, replaced by the Act of 22 December 2003 and amended by the Act of 10 April 2014, is supplemented by the following sentence:
"In any case, they are excluded from the benefit of these social benefits, medical consultants, doctors and directors from insurers, doctors in charge of supervisory missions or exercising their functions for a public institution that is a national of the federal state or a federated entity, other than care institutions."
CHAPTER 4. - Amendment of the Programme Law (I) of 27 December 2006
Art. 33. In section 245 of the Program Law (I) of 27 December 2006, replaced by the Act of 19 March 2013 and amended by the Act of 10 April 2014, the following amendments are made:
(a) in paragraph 1^er, paragraph 2, the number "138 412.35" is replaced by the number "513 412.35";
(b) in paragraph 4, the words "and rare diseases" are replaced by the words ", rare diseases and patient associations and mutual aid groups, to encourage knowledge of health, to provide accessible information, as well as to support their representation missions,"
(c) Paragraph 8 is replaced by the following:
§ 8. The amounts referred to in paragraphs 1^er and 3 of which will benefit the associations referred to in Article 245, § 1^er, 1° and 2°, fixed for the year 2015 are suitable for 1^er January of each year according to the evolution of the health index value, as referred to in section 1^er of the Royal Decree of 8 December 1997 establishing the terms and conditions of application for the indexing of benefits in the compulsory health care insurance plan, between 30 June of the penultimate year and 30 June of the previous year.
When it comes to the amount that will benefit from the "Rare Diseases Organisation Belgium", the amounts set out in paragraphs 2 and 3 for the year 2013 are adjusted to 1^er January of each year according to the evolution of the health index value, as referred to in section 1^er of the Royal Decree of 8 December 1997 establishing the terms and conditions of application for the indexing of benefits in the compulsory health care insurance plan, between 30 June of the penultimate year and 30 June of the previous year. "
Art. 34. Section 33 produces its effects on 1^er January 2015.
PART 2. - CMO
CHAPTER 1^er. - Amendments to the Act of 6 August 1990
on mutuality and national mutuality unions
Section 1^re. - Affiliation with retroactive effect
Art. 35. In section 3bis, paragraph 2, of the Act of 6 August 1990 on mutuality and national mutuality unions, inserted by the Act of 22 December 2003 and replaced by the Act of 26 March 2007, the following amendments are made:
1° in the 1°, the words "request for affiliation" are replaced by the words "request for registration";
2° between 1° and 2°, a point 1° /1 is inserted as follows:
"1° /1. for a person who was affiliated, for the service referred to in section 3, paragraph 1^er, a), with a mutuality as a licensee and registered as a dependant with another mutuality, on the first day of the month following the signature of the application for registration;".
Art. 36. In article 3ter, 1°, of the same law, inserted by the law of 22 December 2003 and replaced by the law of 26 March 2007, the words "in the case referred to in article 3bis, paragraph 2, 1°, " are replaced by the words "in the cases referred to in article 3bis, paragraph 2, 1° and 1° /1,".
Section 2. - Approval by the board of directors of the national union of new benefits envisaged by the affiliates
Art. 37. Section 4bis of the Act, inserted by the Act of 12 August 2000, is replaced by the following:
"A mutuality cannot provide for a new benefit in a service referred to in Article 3, paragraph 1^er, (b) and (c), of this Act, after having previously obtained the approval of the board of directors of the national union to which it is affiliated.
The King shall determine, on the proposal of the Supervisory Board, what shall be heard by a new advantage referred to in paragraph 1^er".
Section 3. - Statutes
Art. 38. In section 11, of the Act, last amended by the Act of 29 March 2012, the following amendments are made:
1° in § 1^er, paragraph 3, the words "forty-five calendar days from the date on which these statutes or the amendments thereof were transmitted to it" are replaced by the words "seventy-five calendar days from the date on which these statutes or amendments thereof were transmitted to it in accordance with paragraph 2";
2° in § 1^er, paragraph 6, the words "in the previous paragraph" are replaced by the words "in paragraphs 3 and 4";
3° in paragraph 3, the words "at § 1^er, paragraph 4, are replaced by the words "at § 1^erParagraph 6."
Art. 39. Article 12, § 2, of the same law, as amended by the law of 12 August 2000, is supplemented by a paragraph 2 which reads as follows:
"Each mutuality and national union shall publish on its website its statutes as approved by the Board of the Supervisory Board, as defined by the King, on the proposal of the Supervisory Board. ".
Section 4. - Annual accounts
Art. 40. In Article 29, § 1^er, of the same law, last amended by the Act of 26 April 2010, the words "the Act of 17 July 1975 relating to the accounting of enterprises", the words "the law of 17 July 1975 referred to above" and the words "the aforementioned law of 17 July 1975" are replaced by the words "the Code of Economic Law".
Art. 41. In the same law, an article 30bis is inserted, as follows:
"Art. 30bis. Within thirty days of their approval by the General Assembly, the annual accounts of the mutualities and national mutuality unions are deposited by the administrators at the National Bank of Belgium.
Are filed at the same time and in accordance with paragraph 1^er :
1° a document containing the names and names of the administrators and the revisor(s) in office;
2° the report of the reviser(s).
The King shall determine the terms, forms and conditions for the filing of the documents referred to in paragraph 1^er and 2, on the Board's proposal. It also determines the amount and mode of payment of the relevant advertising fees. The deposit shall be accepted only if the provisions of this paragraph are complied with.
Within fifteen working days following the acceptance of the deposit, the deposit is referred to in a collection prepared by the National Bank of Belgium on a medium and in the manner determined by the King. The text of this mention is sent by the National Bank of Belgium to the Office of Control.
The National Bank of Belgium shall issue a copy, in the form determined by the King, to those who make the request, even by correspondence, of all the documents transmitted to it pursuant to paragraphs 1^er and 2, or documents referred to in subparagraphs 1^er and 2 relating to national pools or unions of mutualities named and to specific years transmitted to it. The King shall determine the amount of the costs to be paid to the National Bank of Belgium for obtaining the copies referred to in this paragraph.
The National Bank of Belgium is empowered to prepare and publish, as determined by the King, comprehensive and anonymous statistics relating to all or part of the elements contained in the documents transmitted to it pursuant to paragraphs 1^er and 2. "
Section 5. - Financing and missions of the Office of Oversight
Art. 42. In Article 50, § 2, of the same law, amended by the laws of 12 August 2000 and 26 April 2010, the words "and mutualist societies referred to in Article 43bis, § 5, and Article 70, § 6, 7 and 8," are replaced by the words ", mutualist societies referred to in Article 43bis, § 5, and Article 70, § 6, and paragraphs 1 and 8,^erof the Act of 26 April 2010 referred to above,".
Art. 43. Article 52, paragraph 1^erin the same Act, as amended last by the Act of 26 April 2010, the following amendments are made:
1° in 11°, the words "June 25, 1992 on the land insurance contract and March 27, 1995 on the intermediation in insurance and reinsurance and the distribution of insurance" are replaced by the words "April 4, 2014 on insurance and August 2, 2002 on the supervision of the financial sector and financial services";
2° in the 12°, the words "27 March 1995 relating to the intermediation in insurance and reinsurance and the distribution of insurance" are replaced by the words "4 April 2014 relating to insurance".
Section 6. - Sanctions
Art. 44. In section 62quater of the Act, inserted by the Act of 26 April 2010, the following amendments are made:
1° the words "the provisions of the Act of 27 March 1995 relating to the intermediation of insurance and reinsurance and the distribution of insurance or its enforcement measures" are replaced by the words "the provisions of the Act of 4 April 2014 on insurance or its enforcement measures, the provisions of the Act of 2 August 2002 on the supervision of the financial sector and financial services or its enforcement measures, which are applicable to it"
2° the words "administrative and the measures" are inserted between the words "the sanctions" and the words "predicted by the said laws".
Art. 45. In section 62 of the Act, inserted by the Act of 26 April 2010, the following amendments are made:
1° the words "the provisions of the Act of 27 March 1995 relating to the intermediation of insurance and reinsurance and the distribution of insurance or its enforcement measures" are replaced by the words "the provisions of the Act of 4 April 2014 relating to insurance or its enforcement measures applicable to that intermediary";
2° the words "administrative and measures" are inserted between the words " sanctions" and the words "foreseeed by the said law".
Section 7. - Rectification
Art. 46. In article 62decies of the same law, inserted by the law of 26 April 2010, the words "art. 62nonies" are replaced by the words "art. 62novies".
Section 8. - Unpaid mandate
Art. 47. In article 70, § 9, of the same law, inserted by the law of 26 April 2010, the words "with the exception of the independent administrators who are elected pursuant to article 19, paragraphs 3 and 4, of this Law" are inserted between the number "22" and the number "23".
Section 9. - Changes following the integration, in compulsory health insurance, of "small risks" for self-employed workers
Art. 48. In section 60bis of the Act, last amended by the Act of 26 April 2010, the following amendments are made:
1° in paragraph 5, 9° is repealed;
2° in paragraph 6, the 2° is repealed.
Art. 49. Section 71 of the Act, reinstated by the Act of March 26, 2007, is repealed.
Art. 50. Sections 71bis, 71ter, 71sexies and 71ssepties of the Act, inserted by the Act of 26 March 2007, are repealed.
Art. 51. Sections 71quater and 71quinquies of the Act, last amended by the Act of 24 July 2008, are repealed.
CHAPTER 2. - Amendments to the Act of 26 April 2010 relating to the organization of supplementary health insurance (I)
Art. 52. In section 68 of the Act of 26 April 2010 on various provisions concerning the organization of supplementary health insurance (I), the following amendments are made:
1° in paragraph 1^er, words "in the sense of Article 1^er, 3°, of the Act of 27 March 1995 relating to the intermediation in insurance and reinsurance and the distribution of insurances, hereafter referred to as "the law of 27 March 1995" are replaced by the words "in the sense of Article 5, 20°, of the Act of 4 April 2014 on insurances, hereafter referred to as "the law of 4 April 2014";
2° paragraph 1^er, 1°, is replaced by the following:
"1° the mutualities, the national mutuality unions and the mutualist societies other than those referred to in sections 43bis, § 5, and 70, § 6, 7 and 8, of the law of 6 August 1990 relating to the mutualities and the national mutuality unions which carry out activities of intermediation in insurance within the meaning of Article 5, 46°, of the law of 4 April 2014 referred to above ";
3° in paragraph 1^er2°, the words "27 March 1995" are replaced by the words "4 April 2014" and the words "art. 70, § 6, 7 or 8, of the law of 6 August 1990" are replaced by the words "art. 70, § 6 or 7, of the law of 6 August 1990";
4° in paragraph 2, the words "Article 70, § 6, 7 or 8, of the Law of 6 August 1990" are replaced by the words "Article 70, § 6 or 7, of the Law of 6 August 1990".
Art. 53. In Article 69, paragraph 2, of the same Law, the words "Law of 27 March 1995 and which are exercised by mutualities and mutual societies referred to in Article 43bis, § 5, and Article 70, § 6, 7 and 8, of the Law of 6 August 1990" are replaced by the words "Law of 4 April 2014 and which are exercised by the mutualities, the national unions referred to in Article 70
CHAPTER 3. - Final provisions
Art. 54. The King shall determine, on the proposal of the Supervisory Board, the effective date of section 37.
Art. 55. Section 38, 1° and 2° shall apply to the statutes and their amendments, the entry into force of which the general assembly or board of directors of the entity concerned shall be after 1^er January 2015 and which are transmitted to the Supervisory Office, in accordance with Article 11, § 1^erParagraph 2 of the above-mentioned Act of 6 August 1990, from the date of the publication of this Act to the Belgian Monitor.
Article 38, 3°, comes into force on the day of the publication of this Act to the Belgian Monitor.
Art. 56. The King shall determine, on the proposal of the Supervisory Board, the effective date of sections 39 and 41 and, for section 41, the first accounting period to which that provision applies.
PART 3. - AFMPS
CHAPTER 1^er. - Amendments to the law
25 March 1964 on Drugs
Section 1^re. - Distribution chain
Art. 57. Article 1, § 1^erof the Act of 25 March 1964 on Drugs, last amended by the Act of 20 June 2013, the following amendments are made:
1° in 18), second dash, the words "Veterinary doctors" are replaced by the words "persons authorized to provide drugs to animal officials";
2° 25) is supplemented by the words "and persons authorized under Article 3, § 3, paragraph 2;".
Art. 58. In section 3 of the Act, last amended by the Act of 20 June 2013, the following amendments are made:
1° in paragraph 3, paragraph 1^er, the words "veterinary doctors" are replaced by the word "people";
2° in paragraph 4, a paragraph as follows is inserted between subparagraphs 1^er and 2:
"The King can empower other people to issue veterinary medicines that are not subject to prescription and for which, because of their characteristics, the exclusive follow-up of the classical distribution system is not suitable. The King sets the conditions and terms of this authorization.".
Art. 59. Article 12ter, § 1^erof the same law, inserted by the law of 1^er May 2006 and last amended by the Act of 20 June 2013, the following amendments are made:
1° in paragraph 2, a sentence written as follows is inserted between the first and the second sentence:
"In the case of the wholesale distribution of drugs for human use to another Member State, this condition does not apply but the drugs concerned must be subject to a marketing authorization granted in accordance with Community law. ";
2° in paragraph 2, second sentence, becoming the third sentence, the words "in paragraph 9" are replaced by the words "in paragraph 10";
3° in paragraph 10, second sentence, the words "to persons who are authorized to deliver drugs to the public or to provide medication to those responsible for animals," are inserted between the words "big distribution authorization" and the words "or, in the case of pre-mixed drugs,"
4° a paragraph to read is inserted between paragraphs 10 and 11:
"By derogation from paragraph 10, licensees for the wholesale distribution of medicines may deliver medicines to persons in order to fulfil a legal obligation on their part, as referred to in Article 6, § 2, 9°, of the Health Care Professions Act, coordinated on May 10, 2015. The King may set the terms and conditions of the King. It may also empower other persons to issue these drugs to persons in order to fulfil a legal obligation on their part. ".
Section 2. - Rectification
Art. 60. Article 6, § 1^erin the same Act, as amended last by the Act of 10 April 2014, the following amendments are made:
1° in paragraph 9, the last sentence is repealed;
2° Paragraph 10 is supplemented by the following sentence:
"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.".
Section 3. - Optional opinion
Art. 61. Article 7, § 1^er, in the same Act, last amended by the Act of 3 August 2012, the following amendments are made:
1° in paragraph 1^er, the words "on notice of the commission concerned referred to in Article 6, § 1^erParagraph 11 is repealed;
2° in paragraph 2, the words "in the opinion of the concerned commission referred to in paragraph 6, § 1^erParagraph 11 is repealed;
3° a paragraph is inserted between paragraphs 2 and 3:
"In accordance with paragraph 1^er or paragraph 2, the King may collect the opinion of the Commission concerned, referred to in Article 6, § 1^erParagraph 12.
Section 4. - Importing a drug for a group of patients
Art. 62. Article 6quater, § 1^erParagraph 1^er4° of the same law, inserted by the law of 1^er May 2006 and amended by the Acts of 29 March 2012 and 3 August 2012, the following amendments are made:
1° the first sentence is replaced by the following sentence:
"The person authorized to issue medications to the public may import a drug for human use that is authorized or registered in the country of origin, on the basis of a prescription and a statement by the prescriber in which the prescriber declares that the patient cannot be treated adequately by means of a drug currently placed on the Belgian market, in the following cases:"
2° a paragraph written as follows is inserted between subparagraphs 1^er and 2:
"The person authorized to deliver drugs to the public in a hospital informal, commonly referred to as "hospital hospitals" or "hospital hospitals", may also, in the cases referred to in paragraph 1^erimport a human-use drug that is authorized or registered in the country of origin, for a specific group of patients. In this case, the prescriptor's statement is established for this group of patients based on the individual requirements of these patients. These requirements are attached to this declaration.".
Section 5. - Right to be heard
Art. 63. Article 8bis of the same law, inserted by the law of 1^er May 2006 and amended by the laws of 3 August 2012 and 20 June 2013, is supplemented by a paragraph, which reads as follows:
"In the event that the procedure referred to in section 107 of Directive 2001/83 applies, paragraph 3 is not applicable. ".
Section 6. - Delegation of master preparations
Art. 64. Article 12bis of the same law, inserted by the law of 1^er May 2006 and last amended by the Act of 26 December 2013, the following amendments are made:
1° in paragraph 1^er, paragraph 3, the second sentence which begins with the words "These persons" and ends with the words "see this article.", is supplemented by the words ", either to persons in another Member State who are legally authorized to carry out such operations in that Member State. ";
2° in paragraph 1^er/1, paragraph 2, the words "By derogation from paragraph 1^er," are inserted at the beginning of the first sentence.
Section 7. - Right of importation
for personal use
Art. 65. Article 12quater of the same law, inserted by the law of 1^er May 2006, is replaced by the following:
"Every person has the right to take with her, from another Member State, a reasonable amount of human-use medication for her personal use and obtained lawfully in that Member State.
Every person has the right to be sent, from another Member State, a reasonable amount of medication for his or her personal use and obtained lawfully in that Member State.
Sections 12bis and 12ter do not apply in the cases referred to in paragraphs 1^er and 2.
The King may set more precise terms and conditions for the application of this article. ".
Section 8. - Administrative disclosure
Art. 66. In Article 17, § 1^erParagraph 1^er of the same Act, replaced by the Act of 15 December 2013, the words "to the provisions of this Act or its enforcement orders and" are inserted between the word "offence" and the words "under title 3, chapter 3, of the Act of 15 December 2013 in respect of medical devices or the orders made pursuant to this chapter".
Art. 67. Section 31 of the Act of 15 December 2013 on medical devices comes into force ten days after the publication of this Act to the Belgian Monitor.
Section 9. - Attempted crime
Art. 68. Section 19 of the Act, replaced by the Act of 21 June 1983 and amended by the Act of 22 December 2003, the current text of which will form paragraph 1^er, is supplemented by paragraph 2 as follows:
"§2. The attempt to commit an offence under this Act is punishable by the same penalty as that applicable to the offence itself."
CHAPTER 2. - Amendment of the Act of 5 July 1994
relative to blood and blood derivatives of human origin
Art. 69. In Article 21, § 1^er, paragraph 4, of the Act of 5 July 1994 on blood and blood derivatives of human origin, as amended by the Act of 13 December 2006, the words "transmitted to the offender within three days of the finding of the wrongful act" are replaced by the words "to the knowledge of the offender within twenty days, which takes place the day after the day of the finding of the offence".
CHAPTER 3. - Amendments to the Act of 6 July 2007 relating to medically assisted procreation and the destination of supernumerary embryos and gametes
Art. 70. In section 35 of the Act of 6 July 2007 on medically assisted procreation and the destination of supernumerary embryos and gametes, the following amendments are made:
1° the current text of paragraph 1^er form paragraph 1^er;
2° paragraph 2, which will form paragraph 2, is supplemented by the words ", including information necessary for the application of Article 26.".
Art. 71. In the introductory sentence of section 36 of the Act, the words "paragraph 1^er" are replaced by the words " § 1^er".
Art. 72. The following amendments are made to section 64 of the Act:
1° the existing text of paragraph 1^er form paragraph 1^er;
2° paragraph 2, which shall form paragraph 2, shall be supplemented by the words ", including the information necessary for the application of the requirement of section 55".
Art. 73. In the introductory sentence of section 65 of the Act, the words "paragraph 1^er" are replaced by the words " § 1^er".
CHAPTER 4. - Amendment of the Act of 20 July 2006 on the establishment and operation of the Federal Agency for Drugs and Health Products
Art. 74. In 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 10 April 2014, an article 7ter is inserted as follows:
"Art. 7ter. Without prejudice to any contrary provisions that provide authority, the Minister may authorize officials of the Agency to sign individual administrative acts taken by the Minister under the legislation referred to in Article 4, § 1^eraccording to the conditions it determines.".
CHAPTER 5. - 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. 75. In the Act of 19 December 2008 on obtaining and using human bodily material for human medical applications or for scientific research purposes, last amended by the Act of 25 April 2014, an article 1/1 is inserted as follows:
"Art. 1/1. This Act partially transposes:
1° Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on the establishment of quality and safety standards for the donation, obtaining, controlling, processing, conservation, storage and distribution of human tissues and cells;
2° Directive 2006/17/EC of the Commission of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and the Council on certain technical requirements relating to the donation, obtaining and controlling of tissues and cells of human origin;
3° Directive 2006/86/EC of the Commission of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and the Council with regard to traceability requirements, notification of serious adverse reactions and incidents, as well as certain technical requirements for the codification, transformation, conservation, storage and distribution of tissues and cells of human origin. ".
Art. 76. In section 23 of the Act, the following amendments are made:
1° in paragraph 2, paragraph 1^erthe words "their mission referred to in § 1^er"are replaced by the words "their missions referred to in § 1^er and 4";
2° the article is supplemented by paragraphs 4 and 5, as follows:
§ 4. Staff and staff referred to in paragraph 1^erParagraph 1^er, organize as much as necessary, inspections and implement, control measures in the event of notification to the Federal Agency of a serious adverse incident or serious adverse reaction.
In addition, inspections and control measures referred to in paragraph 1^er are organized and implemented at the duly motivated request of the competent authority or competent authorities of another Member State of the European Union.
§ 5. At the request of another Member State or the European Commission, the Federal Agency provides information on the results of inspections and control measures relating to the prescriptions of this Act.".
PART 4. - SPF Public Health
CHAPTER 1^er. - Amendments to the law on the exercise of health care professions, coordinated on May 10, 2015
Section 1^re. - Technologist in medical imaging
and medical laboratory technologist
Art. 77. In Article 153, § 3, of the Law on the Exercise of Health Care Professions, coordinated on May 10, 2015, a paragraph written as follows is inserted between paragraphs 2 and 3:
"By derogation from paragraph 1^er and by derogation from Article 72, § 1^er, persons who do not meet the qualification requirements set out in Article 72, § 2, paragraph 2, for the professions of medical imaging technologist or medical laboratory technologist, but who, as of 2 December 2013, carried out acts of the profession of medical imaging technologist or medical laboratory technologist for at least three years, may continue to perform the same acts in the same conditions as technologists performing medical imaging or ".
Section 2. - Distribution chain
Art. 78. Article 6, § 2, of the same law is supplemented by the 9°, as follows:
"9° dispensation of medicines to fulfil a particular legal obligation. "
Art. 79. Article 11, paragraph 1^erthe same law shall be replaced by the following:
"The Minister who has the Public Health in his or her powers decides to grant the authorization, on the reasoned opinion of a settlement commission. "
CHAPTER 2. - Order of doctors
Art. 80. In the Dutch text of the title of the version of Royal Decree No. 79 of 10 November 1967 concerning the Order of Physicians, the words "Orde der geneesheren" are replaced by the words "Orde der artsen".
In the Dutch text of the same Royal Decree No. 79, the following amendments are made:
1° the words "Orde der geneesheren" are each time replaced by the words "Orde der artsen";
2° the word "geneesheer" is each time replaced by the word "arts";
3° the word "geneesheren", is each time replaced by the word "artsen".
Art. 81. In Article 2 of the same Royal Decree No. 79, as amended by the Royal Decree of 26 December 1985, the following amendments are made:
1st paragraph 1^er is replaced by the following:
"The College of Physicians includes all physicians domiciled in Belgium and listed in the Order's Table. Physicians are listed on the College of the Province in which their domicile is located. Physicians whose domicile is located in the Brussels-Capital Region choose to be registered either in the table of the Flemish Brabant Provincial Council and Brussels, or in the table of the Brussels Provincial Council and Walloon Brabant. For the purposes of this Order, it is necessary to hear by domicile the place where the doctor exercises his principal activities. ";
2° in paragraph 2, the words "the provisions of section 44septics" are replaced by the words "article 44terdecies".
Art. 82. Article 7, § 1^erthe following amendments are made to the same Royal Decree No. 79:
1° to 1°, the following modifications are made:
(a) in paragraph 4, the words "judicial borough of" are repealed;
(b) in paragraph 5, the words "and the representation of doctors having their domicile in the Brussels-Capital Region, respectively to the Flemish Brabant and Brussels Provincial Council or to the Brussels and Walloon Brabant Provincial Council" are inserted after the words "from Liège";
2° 2°, paragraph 3, is supplemented by the following sentence:
"As for the Flemish Brabant and Brussels Provincial Council and the Walloon Brabant Provincial Council, assessors may also be domiciled in the Brussels-Capital Region".
Art. 83. In Article 8, § 1^er, of the same Royal Decree No. 79, the words "of their domicile" are repealed.
Art. 84. In article 9, paragraph 1^er, of the same Royal Decree No. 79, the words "for borough" are repealed.
Art. 85. In Article 12, § 7, of the same Royal Decree No. 79, the words "Brusselsian agglomeration" are replaced by the words "the Brussels-Capital Region".
Art. 86. In article 13, paragraph 3, of the same Royal Decree No. 79, the words "or place of inscription" are inserted between the words "at home" and the words "of one".
Art. 87. In article 14, § 7, of the same Royal Decree No. 79, the words "Brusselsian agglomeration" are replaced by the words "the Brussels-Capital Region".
Art. 88. In Article 25, § 1^erParagraph 1^erof the same Royal Decree No. 79, as amended by the Law of 1^er March 2007, the words ", within fifteen frank days from the notification of the decision," are repealed and the words "from this notification" are replaced by the words "from the notification of the decision".
Art. 89. Article 27, § 1^erParagraph 1^er of the same Royal Decree No. 79, amended by the Law of 1^er March 2007, supplemented by the following sentence:
"If the decision has been taken as a last resort, the execution shall take place on the expiry of the period of sixty frank days."
Art. 90. Article 29 of the same Royal Decree No. 79 whose current text will form paragraph 1^er, is supplemented by paragraph 2 as follows:
§ 2. The effective and alternate members of the provincial councils, appeal councils and the National Council whose term ends remain on an interim basis until the renewal of the term following elections is completed. ".
Art. 91. Section 3, paragraph 4, of the Act of 25 July 1938 creating the College of Physicians is repealed.
Art. 92. On the date of entry into force of this Act, the doctors registered on that date on the Dutch-speaking council referred to in section 3, paragraph 4, of the Act of 25 July 1938 creating the College of Physicians are registered in full right on the list of the Flemish Brabant and Brussels Provincial Council. On the date of entry into force of this Act, physicians registered on that date on the French-speaking council referred to in section 3, paragraph 4, of the Act of 25 July 1938 establishing the College of Physicians are registered in full right on the list of the Brussels Provincial Council and the Walloon Brabant.
Art. 93. Section 90 produces its effects on May 13, 2015.
CHAPTER 3. - Hospitals
Section 1^re. - Funding
in the event of an epidemic or pandemic
Art. 94. In section 101 of the Coordinated Act of 10 July 2008 on hospitals and other care facilities, paragraph 1^er is replaced by the following:
"The financial resources budget may cover, on a lump-sum basis, costs associated with services following:
1° of disasters or calamities, for which phase three or phase four of the disaster plan was triggered, respectively by the provincial governor or by the minister who has the Interior in his office;
2° an epidemic or pandemic that is determined by the King by order deliberately in the Council of Ministers, after the advice of the Superior Council of Health. ".
Section 2. - Financial accessibility
Art. 95. In article 30/1 of the same law, coordinated by the law of 27 December 2012, the words "for the benefits defined by the King" are repealed.
Art. 96. In section 98 of the same coordinated law, as amended by the Acts of 10 December 2009 and 27 December 2012, paragraph 2 is repealed.
Art. 97. Article 152, § 1^erof the same coordinated law, replaced by the Act of 27 December 2012, the following amendments are made:
1° in paragraph 1^er, the words "for the benefits defined by the King after the advice of the National Medical Commission" are repealed;
2° Paragraph 2 is repealed.
Art. 98. Royal Decree 10 April 2014 enforcing Article 152, § 1^erthe Coordinated Act of 10 July 2008 on Hospitals and Other Care Institutions is repealed.
Section 3. - Cadaster heavy machinery
Art. 99. In section 56 of the Coordinated Act of July 10, 2008 on hospitals and other care facilities, replaced by the Act of April 10, 2014, the words "The professional practitioner who operates a medical imaging or treatment equipment" are replaced by the words "The manager or professional practitioner who installs and operates a heavy medical device".
CHAPTER 4. - Organ transplant
Section 1^re. - Registration of the declaration of will
Art. 100. In Article 10, § 3, paragraph 2, (a), of the Act of 13 June 1986 on organ removal and transplantation, the words "through the services of the National Registry" are repealed.
Section 2. - Status of the candidate-receiver
Art. 101. In article 13ter of the same law, inserted by the law of 25 February 2007 and amended by the law of 3 July 2012, the words "to be domiciled in Belgium for at least 6 months" are replaced by the words "to be registered in the register of the population or for at least 6 months in the register of foreigners".
PART 5. - Federal Centre for Health Care Expertise
Art. 102. Article 270, § 1^er, of the Programme Law (I) of 24 December 2002, last amended by the Act of 23 December 2009, the following amendments are made:
1° in the introductory sentence of paragraph 1^erthe words "twenty and one member" are replaced by the words "twenty-four members";
2° paragraph 1^er is completed by the 13th grade, as follows:
"13° two members representing patients and users of health services. ";
Paragraph 4 is replaced by the following:
"The president and the members referred to in 6°, 7°, 8°, 9°, 10°, 12° and 13° are, on presentation of the ministers, appointed and revoked by the King. The president and the members referred to in 6°, 8°, 9°, 10°, 12° and 13° are appointed for a renewable period of six years."
4° in paragraph 5, the words "members referred to in 6°, 7°, 8°, 9°, 10° and 12°" are replaced by the words "members referred to in 6°, 7°, 8°, 9°, 10°, 12° and 13°";
5° in paragraph 8, the words "members referred to in 6°, 7°, 8°, 9° and 12°" are replaced by the words "members referred to in 6°, 7°, 8°, 9°, 12° and 13°".
Promulgation of this law, let us order that it be clothed with the seal of the State and published by the Belgian Monitor.
Given in Brussels on 17 July 2015.
PHILIPPE
By the King:
Seal of the state seal:
Minister of Justice,
K. GEENS
Minister of Social Affairs and Public Health,
Mr. DE BLOCK
____
Note
(1) Documents of the House of Representatives:
54-1161/2014/2015
Number 1: Bill. - No. 2: Annex. - No. 3: Amendments. n^bones 4 in 5: Reports. - No. 6: Text adopted. - No. 7: Amendments. No. 8: Text adopted.