10 AOUT 2001. - Health Care Measures Act (1)

ALBERT II, King of the Belgians,
To all, present and to come, Hi.
The Chambers adopted and We sanction the following:
PART I^er. - General provision
Article 1^er. This Act regulates a matter referred to in Article 78 of the Constitution.
PART II. - Social Affairs and Pensions
CHAPTER 1^er. - Amendments to the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994
Section 1^er. - Changes in the renovated drug policy
Art. 2. In section 18, paragraph 5, of the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994, as amended by the laws of 25 January 1999 and 24 December 1999, the words "list attached to the Royal Order setting out the conditions under which an intervention is granted for the health benefits referred to in section 34, paragraph 1, 5°, (b) and (c)" of the last sentence are replaced by the words "list referred to".
Art. 3. In section 22, 4°, of the Act, replaced by the Act of 24 December 1999, the following amendments are made:
1° to paragraph 1^er, the words "and when it is a proposal made in accordance with section 35, § 3" are deleted and the words "in which case the proposals must always be forwarded to the Minister", are replaced by the words "in which case the proposal must always be forwarded to the Minister";
2° Paragraph 3 is deleted.
Art. 4. In article 22, 4°bis, of the same law, inserted by the law of 24 December 1999, the words "and article 29bis, 3°" are inserted between the words "article 27, paragraph 3" and "and sets the date of entry into force".
Art. 5. In article 25, § 2, paragraph 4, of the same law, replaced by the law of 25 January 1999, the words "of the Technical Council of Pharmaceutical Specialties" are replaced by the words "of the Drug Refund Commission" and the words "in article 27" are replaced by the words "in articles 27 and 29bis".
Art. 6. In section 27 of the Act, the following amendments are made:
1° to paragraph 1^er, the words "a Technical Council of Pharmaceutical Specialties, a Technical Council of Relations with the Pharmaceutical Industry" are replaced by the words "a Technical Council of Diagnostic Means and Care Materials" and the words "or Drug Commission" are deleted;
2° to paragraph 2, as amended by the law of 25 January 1999, the reference "and § 3" is deleted;
3° in paragraph 4, replaced by the Act of 24 December 1999, the words "proposals or opinions of the Technical Council of Pharmaceutical Specialties and" are deleted.
Art. 7. In article 28, § 3, of the same law, replaced by the law of 24 December 1999, the last sentence is deleted.
Art. 8. In title III, chapter I^er, of the same law, is inserted a section IXbis, as follows:
"Section IXbis. Drug Refund Commission
Art. 29bis. It is created within the Institute a Drug Refund Commission.
The Commission is composed of experts working in a university institution, representatives of insurance organizations, professional organizations of physicians and pharmacists, representative representatives of the drug industry and representatives of the Minister, the Minister with Public Health in his or her duties, the Minister who has the Economic Affairs in his or her duties and the Medical Control Service, who are represented in the conditions to be determined by the King. Representatives of the drug industry, the Minister, the Minister with Public Health in his or her duties, the Minister who has Economic Affairs in his or her duties and the Medical Control Service have a consultative voice.
The Drug Refund Commission is responsible for:
1° to formulate proposals and carry out the tasks referred to in section 35 bis;
2° to provide advice, at the request of the Minister, on aspects of the policy on the reimbursement of pharmaceutical specialties;
3° to formulate to the Insurance Committee proposals for interpretative rules concerning the reimbursement of pharmaceutical specialties.
The King shall determine, on the proposal of the Minister, the detailed composition and operating rules of the Commission. The members of the Commission are appointed by the King."
Art. 9. In section 35 of the Act, the following amendments are made:
1° § 1^erParagraph 1^er, is supplemented as follows: ", except for benefits referred to in section 34, paragraph 1^er5°, b) and c). »;
2° § 1 and paragraph 2, as amended by the Act of 24 December 1999, is replaced by the following provision:
"This nomenclature lists the said benefits, sets the relative and precise value of the benefits, including its rules of application, and the required qualification of the person authorized to perform each of them. Where applicable, different rates may be applied for the same benefit, depending on whether or not the care provider meets additional conditions, other than the qualification requirements, as provided in the nomenclature. Name of benefits under section 34, paragraph 1^er, 4°, as long as it is implants, and 5°, a), and 20°, is fixed on the basis of the admission criteria defined by the King and according to which these benefits can be divided into different categories. With respect to benefits under Article 34, paragraph 1^er, 4°, as long as it is implants, and 20°, these admission criteria concern prices, the cost for insurance and medical, therapeutic and social elements. These admission criteria for benefits under section 34, paragraph 1^er, 5°, a), concern prices, volume estimates, the cost of processing pharmaceutical supplies, whether patented or not of the main active ingredient, medical, epidemiological, therapeutic and social elements. Admission of benefits under section 34, paragraph 1^er, 5°, a), is reviewed at least every five years. For benefits under section 34, paragraph 1^er, 5°, a), for which there is already a refund, the Pharmaceutical Technical Council is authorized to review the admission criteria and their application. This revision can be done for a therapeutic class or a group of master preparations, following the Anatomical Therapeutical Chemical Classification, established under the responsibility of the World Health Organisation Collaborating Center for Drug Statistics Methodology, or for a separate masterful preparation. »;
3° in § 1^er, last paragraph, inserted by the law of 24 December 1999, the mention "5°" is each time replaced by the mention "5°, a),";
4° § 2, last paragraph, inserted by the law of 25 January 1999, is repealed;
5° § 3, inserted by the Royal Decree of 23 December 1996 and replaced by the law of 25 January 1999, is repealed.
Art. 10. In the same law is inserted, instead of section 35bis which becomes section 35ter, a new section 35bis, as follows:
"Art. 35bis. § 1^er. The King confirms the list of refundable pharmaceutical specialties at 1^er January 2002, referred to in section 34, paragraph 1^er5°, b) and c). The list is in principle classified according to the Anatomical Therapeutical Chemical Classification. From 1^er January 2002, this list may be amended by the Minister on the proposal of the Drug Refund Commission. Companies that put pharmaceutical specialties on the Belgian market, below referred to as applicants, or the Minister, may ask the Commission to make a proposal, or the Commission may make a proposal on its own initiative. The changes in the list may consist of the registration and removal of pharmaceutical specialties as well as the modification of the terms and conditions of the listing.
§ 2. The amendment of the list includes a decision regarding the reimbursement base, refundable indications, refund terms and the reimbursement category and is made after an assessment of one or more of the following criteria:
1° the therapeutic value of the pharmaceutical specialty: this therapeutic value is expressed in one of the following three surplus-value classes:
- Class 1: Pharmaceutical specialties with demonstrated therapeutic surplus-value compared to existing therapeutic alternatives;
- Class 2: Pharmaceutical specialties having no proven therapeutic surplus-value compared to existing therapeutic alternatives, which do not belong to Class 3;
- Class 3: Specialties registered in accordance with Article 2, 8°, 2 and 3, of the Royal Decree of 3 July 1969 concerning the registration of drugs;
2° the price of the pharmaceutical specialty and the refund base proposed by the applicant;
3° the interest of pharmaceutical specialty in medical practice based on therapeutic and social needs;
4° the budgetary impact for compulsory health care insurance;
5° the relationship between the cost for compulsory health care insurance and the therapeutic value.
The King may define the criteria in a more detailed manner and determine how the class of surplus-value of a pharmaceutical specialty is fixed as well as the criteria of those listed in 2° to 5°, which must be at least evaluated, depending on the class of surplus-value which was mentioned by the applicant of the pharmaceutical specialty concerned.
The decision shall be communicated by notification to the applicant, either by the Minister or by officials mandated by the Minister. The amendment of the list comes into force on the first day of the month following the expiration of the 10-day period that takes place the day after the publication in the Belgian Monitor.
§ 3. In the event of the introduction of an application for registration in the list of refundable pharmaceutical specialties, the Drug Reimbursement Commission shall make a proposal based upon the assessment of the file by independent experts and after receiving the applicant's communication of the maximum selling price, authorized by the Minister with Economic Affairs in his or her responsibilities.
The overall timeframe for the evaluation of the file, the determination of the price and the proposal of the Drug Refund Commission may not exceed 160 days, from the date, communicated by the secretariat of the Drug Refund Commission, to which the file was received, on the understanding that it contains the application for approval of the price with the Department of Economic Affairs. If the information provided in support of the application is insufficient, the deadline is suspended and the secretariat shall immediately notify the applicant of the detailed additional information required.
The King shall, on the proposal of the Minister and the Minister who has the Economic Affairs in his or her powers, determine the allocation of this period between the authorities referred to in the preceding paragraph.
In the absence of a proposal within the time limit referred to in paragraph 2, the Minister shall make a reasoned decision on the application within 20 days of the expiry of that period.
The King, by a deliberate order in the Council of Ministers, sets out the terms and conditions under which the Minister may deviate from the proposal of the Drug Refund Commission within 20 days, as specified in the preceding paragraph.
In the absence of a decision within 180 days, from the date provided by the secretariat of the Drug Refund Commission, to which the file was received, the decision is considered to be positive as to the reimbursement base, the reimbursement terms and conditions and the reimbursement category proposed by the applicant. The King determines in which cases the 180-day period may be extended for a period of 60 days.
The King specifies how the decision referred to in the preceding paragraph is communicated to the applicant.
§ 4. The Drug Refund Commission may propose an individual review of the refund of pharmaceutical specialties for a period of 18 months to 3 years after the first registration on the list, in accordance with the terms fixed by the King. This individual revision is applicable for specialties admitted for the first time on the list after 1^er January 2002. An individual revision may result in an amendment to the refund base, refund terms and/or the refund category or a deletion of the list, after reassessment of the criteria mentioned in § 2 which are taken into consideration for the decision to register on the list.
The King determines the pharmaceutical specialties that come into account for an individual revision depending on the surplus-value class in which a pharmaceutical specialty is classified.
For pharmaceutical specialties used for an identical or similar indication, the Drug Refund Commission may propose a revision of the group rebate independently of the fact that the specialties concerned are taking into account for an individual review. A group revision may result in a group or individual modification of the refund base, the refund conditions and/or the refund category or, after assessment on the basis of one or more of the criteria referred to in § 2. The Drug Refund Commission shall, on its own initiative or at the request of the Minister, decide when these revisions are taken by groups.
§ 5. The King determines the procedure whereby the list is amended in the event of a price change set by the Minister who has the Economic Affairs in his or her powers and in the event of a change in the bases of reimbursement of qualified specialties.
§ 6. The King specifies, on the proposal of the Minister and the Minister who has the Economic Affairs in his powers, the procedure described in §§ 3 and 4, including the procedure for the introduction of an application and the conditions under which and how the time limit can be suspended and elaborates a simplified procedure for pharmaceutical specialties for which the classes of surplus-value 2 or 3 have been requested.
In addition to the information to be provided by the applicant, the King may, on the proposal of the Minister, the Minister of Public Health and the Minister who has the Economic Affairs in his or her powers, determine the information that the Minister with the Public Health in his or her duties and the Minister who has the Economic Affairs in his or her duties is required to communicate to the Drug Refund Commission.
The King shall prepare, on the proposal of the Minister and the Minister who has the Economic Affairs in his or her terms and conditions, the reports that relate to the assessment of pharmaceutical specialties and which have been prepared under the control of the Drug Refund Commission shall be forwarded to the Department of Economic Affairs.
It sets out the conditions to be met by the experts who prepare the evaluation reports, particularly with regard to the independence of applicants, and determines the terms and conditions of their remuneration.
§ 7. If the Drug Refund Commission considers that the refund base proposed by the applicant is not proportional to the assessment of the criteria referred to in § 2, it may, on its own initiative or at the request of the applicant, propose to enter into an agreement with the Institute, according to which, for a certain period of time, a certain percentage of the turnover realized through the relevant pharmaceutical specialty is refunded to health care insurance.
The King sets out the conditions and rules that such a convention may be concluded between the applicant and the institute.
When the agreement referred to in the preceding paragraph is concluded, the Drug Refund Commission may make a proposal to amend the list referred to in § 1^erwith regard to the specialties concerned.
§ 8. The King sets out the procedure that must be followed in the event of changes in the registration or deletion of a pharmaceutical specialty at the request of the applicant. It further defines the deadlines to be met in these cases.
§ 9. The King determines, on the proposal of the Minister and the Minister who has the Economic Affairs in his responsibilities, the specific rules of procedure and the deadlines for generic drugs, orphan drugs, that is, the drugs that, in accordance with the conditions set out in Regulation EC No. 141/2000 of the European Parliament and the Council of 16 December 1999 concerning orphan drugs, are referred to as orphan drugs and pharmaceutical specialties imported in parallel, i.e.
§ 10. The King may define the rules that the reimbursement of pharmaceutical specialties may be subject to prior authorization from the consulting physician and/or to an assessment of a college of doctors.
The King may, after the advice of the National Medico-mutualist Commission, establish the conditions under which it is possible to verify and note that the pharmaceutical specialties issued, which resulted in a refund, have been prescribed by the care provider in accordance with the conditions of reimbursement established. "
Art. 11. In section 35bis of the Act, inserted by the Act of 2 January 2001 and amended by the Royal Decree of 22 March 2001, which becomes section 35ter:
1° the words "From 1^er April 2001 and thereafter every 6 months is set up a new reimbursement base for pharmaceutical specialties referred to in article 34, paragraph 1^er, 5°, c), 1)" are replaced by the words "A new refund base is fixed for the specialties mentioned in article 34, paragraph 1^er, 5°, c), 1),
2° paragraphs 3 and 4 are replaced by the following:
"To this end, the Minister amends 1^er June 2001 and 1^er October 2001, the list annexed to the Royal Decree setting out the conditions under which an intervention is granted for the health benefits referred to in section 34, paragraph 1^er, 5°, (b) and (c), without taking into account the procedural rules referred to in Article 35, § 3.
1^er January 2002, and thereafter every six months, the new reimbursement base is applied in accordance with paragraphs 1^er and 2, without taking into account the procedural rules referred to in this Act. The amended lists are published by ministerial order to the Belgian Monitor in the second month preceding the application date.
Without prejudice to the provisions of paragraphs 3 and 4, the Minister may, from 1^er June 2001, and without taking into account the procedural rules referred to in this Act, adjust the list monthly to take into account the voluntary reductions in the maximum price of pharmaceutical specialties referred to in paragraph 1^er.
The King may, by order deliberately in the Council of Ministers, consider the portion of the cost of pharmaceutical specialties which may be borne under this provision by the beneficiary, for the categories of pharmaceutical specialties which He indicates and under the conditions set by him, as a personal intervention for the application of Article 43 of the Programme Law of 24 December 1993, as well as for the application of the measures taken pursuant to Article 37, § 18.
The King may amend the percentages referred to in paragraph 1^er and 2, in the circumstances and according to the conditions and rules that He sets and for the specialties and/or conditioning that He determines. It can also specify the concept of the identical form of administration. "
Art. 12. In section 37, § 2 of the Act, inserted by the Act of 24 December 1999, paragraph 2 is repealed.
Art. 13. Article 69, § 5 of the Act, amended by the Acts of 24 December 1999 and 2 January 2001, paragraph 1^er is supplemented by the following provision:
"The overall budget for the above benefits is set after consultation with representative representatives of the drug industry referred to in section 191, 15°quater. "
Art. 14. In section 72 of the Act, replaced by the Act of 25 January 1999, the words "Technical Council for Pharmaceutical Specialties" are replaced each time by the words "Medicinal Refunding Commission".
Art. 15. Section 72bis of the Act, inserted by the Act of 20 December 1995 and amended by the Acts of 22 February 1998 and 12 August 2000, is replaced by the following provision:
« § 1^er. In the context of health care insurance and subject to other legal provisions, the applicant is required to meet the following obligations from the entry into force of the refundability of pharmaceutical specialties or packaging for which the applicant has applied:
1° to ensure that the pharmaceutical specialty is actually available in the trade in all packagings allowed no later than the first day of the third month following the effective date of the refundability;
2° ensure the continuity of the marketing of pharmaceutical specialty in all forms and repayable packagings;
3° communicate before 31 January of each year to the health care service of the Institute the number of packagings or the number of pharmaceutical units that were sold on the Belgian market the previous year;
4° immediately communicate to the health care department of the Institute any changes to one of the elements of the refundability request;
5° according to the conditions to be defined by the King, a unique barcode and a distinctive vignette, the packagings allowed, from the date of entry into force of the refundability, and not to oppose such a thumbnail on a condition not allowed;
6° mention on public conditioning, according to the conditions to be defined by the King, the respective amounts of the share of the beneficiary, next to the distinctive thumbnail.
§ 2. When a firm that markets a pharmaceutical specialty on the Belgian market wishes to permanently cancel the refundability of this pharmaceutical specialty or one or more of its packagings, and continues to market the pharmaceutical specialty or the (the) packaging(s), it must apply for deletion. The deletion of the list then comes into force one year after receipt of the application. The Minister may, after the advice of the Drug Refund Commission, and taking into account economic, social and therapeutic criteria, set a date of early entry into force, on the basis of a more short-term reasoned deletion request, sent simultaneously to the Minister and the Drug Refund Commission. The applicant is required to offer the pharmaceutical specialty in existing repayable packagings up to the effective date of withdrawal of the pharmaceutical specialty from the list.
Where the firm referred to in paragraph 1^er definitively withdraws from the market a pharmaceutical specialty or one or more of its packagings, for which registration is also withdrawn, it must inform the Institute's health care service six months before the withdrawal of the market. Refundability remains maintained for a period of six months after the deletion of the registration, after which the pharmaceutical specialty or conditioning(s) are removed from the list in full right, without taking into account the procedures provided for in section 35bis.
Where the firm referred to in paragraph 1^er permanently withdraws from the market a pharmaceutical specialty or one or more of its packaging, without the registration being withdrawn, it must inform the health care service of the institute six months before the withdrawal of the market. Refundability remains maintained for a period of six months after the contract withdrawal decision, after which the pharmaceutical specialty or conditioning(s) are removed from the list in full right, without taking into account the procedures provided for in section 35bis.
Where the firm referred to in paragraph 1^er, temporarily withdraws from the market a pharmaceutical specialty or one or more of its packagings, it must inform the health care service of the institute three months in advance, except in the case of justified reasons, by communicating the date of commencement and the expected end date, and the reasons for the temporary withdrawal of the market. If the pharmaceutical specialty or conditioning(s) are removed from the market for more than three months, the pharmaceutical specialty or the packaging(s) are removed from the market, without taking into account the procedures provided for in section 35bis. If the temporary withdrawal of the market is the result of the suspension of the registration or of a proven case of force majeure, the pharmaceutical specialty or the conditioning(s) are immediately and in full right again entered on the list, without taking into account the procedures provided for in section 35bis, if the suspension of the registration is lifted and if the specialty has in the meantime been removed from the list, or if the marketing is restored.
The temporary suspension of the refundability of a pharmaceutical specialty or one or more of its packagings and continued marketing is not permitted.
The King may set specific rules for orphan drugs to ensure continuity of availability and reimbursement of these specialties.
§ 3. In the event of the transfer of the registration of a pharmaceutical specialty on the list or of one or more of its packagings, all the rights and obligations related to it under compulsory health care insurance are also transferred to the new applicant referred to in section 35bis, § 1^er.
§ 4. The King sets out the conditions under which applicants, whether they are producers, importers or conditioners of pharmaceutical specialties, must, in order to manage the annual expenses of health care insurance for such specialties and to be able to assess the possible protection of the principal active principle by granting a patent or a complementary certificate of protection of the patent, provide the Commission for the Repayment of Drugs and at the request of the patent, with information concerning the active costs "
Art. 16. In the same law it is inserted, instead of section 77bis, inserted by the law of 1^er December 1997, which becomes article 77ter, a new article 77bis in chapter V, section XVIII, of title III, as follows:
"Art. 77bis. Without prejudice to the provisions of Article 139, the King, after the advice of the National Medico-mutualist Commission, sets out the conditions and procedure whereby, in respect of physicians for whom, pursuant to Article 35bis, § 10, paragraph 2, it is found that they prescribe or have prescribed drugs outside the prescribed conditions of reimbursement, without mentioning the non-refundability on the prescription of drugs:
1° Accreditation benefits may be reduced or withdrawn for a specified period;
2° for a specified period, the prior authorization of the consulting physician may be imposed with respect to the prescription of certain medications. "
Art. 17. In section 165 of the Act, as amended by the Acts of 22 February 1998, 15 January 1999 and 25 January 1999, the following amendments are made:
1° in paragraph 8, the terms "anonymous with respect to the identity of the beneficiary" are replaced by the terms "coded with respect to the identity of the beneficiary in a manner that does not permit the reidentification by the beneficiary";
2° Paragraph 9 is replaced by the following provision:
"The purpose of the communication is to allow the reimbursement of prescribed medications and on the one hand, to organize the monitoring of prescribed and invoiced supplies, and on the other hand, to provide the competent authority with information on the policy to be followed, in particular in order to allow the evaluation of medical practice in the field of medicines. By assessing medical practice, it is necessary to hear, among other things: the establishment of profiles of prescriptive doctors, if any in relation to their patients, the study of the consumption of drugs in the form of prevalence data, the extent of the behaviour, the analysis of the interaction between general practitioners and specialist physicians when prescriptions are issued by different doctors, the detection of confidence-building effects in the therapy and "
Art. 18. In the same Act, section 168bis is inserted, as follows:
"Art. 168bis. In the event of an infringement of the provisions of section 72bis, an administrative fine is imposed by the administrative control department to the company that puts on the market the pharmaceutical specialty or the (the) packaging(s) concerned and to which the offence was found.
The King determines the amount of fines whose maximum can not exceed 100% of the turnover made on the Belgian market for the pharmaceutical specialty or the condition(s) concerned in the year prior to the year in which the offence was found. It also sets out the specific procedures for the application of this sanction.
In the event of a failure of the debtor, the final decisions, which have been made pursuant to the preceding paragraph, may be entrusted to the Administration of the value added tax, registration and domains for the recovery of the administrative fine, in accordance with the provisions of Article 94 of the Acts on State Accounting, coordinated on 17 July 1991. "
Art. 19. In section 191, paragraph 1, 15°, of the Act, replaced by the Act of 22 February 1998 and amended by the Act of 2 January 2001, the following amendments are made:
1° Paragraph 3 is replaced by the following provision:
"For 1995, 1996, 1998, 1999, 2000, 2001 and 2002, the amounts of these contributions are set at 2%, 3%, 4%, 4%, 4%, 4% and 3%, respectively, in 1994, 1995, 1997, 1998, 2000, and 2001. »;
2° in paragraph 5, the last sentence is replaced by the following sentence:
"For the years 1995, 1996, 1998, 1999, 2000, 2001 and 2002, they shall be introduced respectively before 1^er February 1996, 1^er November 1996, 1^er March 1999, 1^er April 1999, 1^er May 2000, 1^er May 2001 and 1^er May 2002. »;
Paragraph 6 is replaced by the following provision:
"For the years 1995, 1996, 1998, 1999, 2000, 2001 and 2002, the contribution must be paid respectively before 1^er March 1996, 1^er December 1996, 1^er April 1999, 1^er May 1999, 1^er June 2000, 1^er June 2001 and 1^er June 2002 on account No. 001-1950023-11 of the National Disability Insurance Act, indicating, according to the year concerned, the mention: "Business Tax 1994", "Business Number 1995", "Business Number 1997", "Business Number 1998", "Business Number 1999", "Business Number 2000" or "Business Number 2001"
4° the last paragraph is replaced by the following provision:
"The revenues resulting from the above-mentioned contribution will be charged in the accounts of the mandatory health care insurance, respectively, for the year 1995 for the turnover, 1994, 1996 for the turnover, 1995, 1998 for the turnover, 1997 contribution, 2000 for the turnover, 1999, 2001 for the turnover 2000 and 2002 contribution for the turnover 2001. "
Art. 20. In section 191, paragraph 1 of the Act, replaced by the Royal Decree of 12 August 1994 and amended by the Acts of 20 December 1995, 26 July 1996, 22 February 1998, 15 January 1999, 25 January 1999, 4 May 1999, 24 December 1999, 12 August 2000 and 2 January 2001 and by the Royal Decree of 25 April 1997, is inserted a 15°quater, as follows:
"15°quater. § 1^er. From 2002 onwards, a supplementary dependant contribution from pharmaceutical firms is established annually on the turnover that was made in the year preceding that for which the contribution is due in accordance with the terms and conditions set out in this provision.
This assessment is payable if, for the previous year, expenditures recorded by insurers exceed the overall budget established under section 69, § 5.
The exceedance referred to in the preceding paragraph may, after the opinion of the Budget Control Board, be adapted by the General Council, to take into account the elements fixed by the King who did not produce their effects or produced them only partially. In addition, the overrun thus corrected is reduced to 25% of the possible underutilization of the overall annual budget objective referred to in section 40.
The total amount of the contribution is 65% of this exceedance, subject to the application of paragraph 3.
§ 2. Pending the establishment of the supplementary contribution referred to in § 1, paragraph 1^er, with respect to the possible overrun of 2002 expenditures, the pharmaceutical companies concerned were in 2002 liable to an advance of 1% of the turnover of 2001. This advance is paid to the National Disability Insurance Number 001-1950023-11 before 1^er July 2002, indicating the "additional contribution year 2002".
The King shall fix increases and late interest in the event of non-payment of the advance on the fixed date. This contribution increase may not exceed 10% of the due contribution.
If at 1^er October 2003, the supplementary contribution referred to in § 1^erParagraph 1^er, has not been established for 2002 or is less than 1%, the lnstitut reimburses the advance or balance to the pharmaceutical companies concerned for the 1st^er December 2003.
§ 3. The perception of this additional contribution cannot go hand in hand with the recovery referred to in Article 69, § 5. "
Art. 21. Section 56 of the Act, as amended by the Act of 24 December 1999, is replaced by the following:
« § 1^er. The Insurance Committee may conclude agreements for surveys and comparative studies of certain models of health care dispensation and funding. The related expenses are charged to the administration costs of the institute and are fully borne by the health care sector.
§ 2. In the conditions to be determined by the King and by derogation from the general provisions of this co-ordinated law and its enforcement orders, the Insurance Committee may conclude agreements that are limited in time and/or in their scope and that are intended to:
1° to provide a refund for special models of dispensation and payment of experimental health care;
2° to provide an intervention to specialized centres for the financing of pharmaceutical treatments that are not repayable under the list referred to in section 35bis, but which are innovative in nature, which meet a social necessity and which have clinical value and effectiveness. This intervention is related to a report and a scientific assessment;
3° to provide intervention to care providers who develop care coordination projects for early detection, avoid or delay complication and treat chronic conditions that require a multidisciplinary approach;
4° to provide an intervention for the payment of vaccines through national prevention programs.
Expenditures related to the conventions concerned are financed by the resources of the insurance referred to in section 191 and are dependant, starting in fiscal year 2002, of the budgetary objective under section 40. "
Art. 22. § 1^er. Applications filed before 1^er January 2002 in order to obtain a notice from the Transparency Commission and to renew the opinion of the same Commission, pursuant to section 6quater of the Act of 25 March 1964 on drugs, or in order to obtain an intervention under section 35, § 3, of the law coordinated on 14 July 1994, as it was announced before its repeal by this Act, and whose file 1 is not found,^er January 2002 to the Drug Refund Commission. The King specifies the rules concerning this transmission and the procedure to be followed.
§ 2. Requests to obtain an opinion from the Transparency Commission and to renew the opinion of the Commission, which were submitted validly before 1^er January 2002, and whose file has already been deemed complete, continue to be processed according to the rules in force before 1^er January 2002.
§ 3. Applications to obtain an intervention, which were filed validly before 1^er January 2002, and whose file has already been deemed complete, continue to be processed according to the rules in force before 1^er January 2002, on the understanding that these applications must be considered within 90 days, as of the date of the delivery of the award, as determined by the Minister who has the Economic Affairs in his or her responsibilities, or as of the date of the communication of the Transparency Commission's notice, if subsequently made.
For applications for which the applicant has already communicated 1^er January 2002 the price fixed by the Minister who has the Economic Affairs in his or her powers, as well as the opinion of the Transparency Commission, the 90-day time limit is calculated from 1^er January 2002.
In the absence of a decision within the 90-day deadline referred to in paragraph 1^er and 2, the file is forwarded to the Drug Refund Commission.
The King specifies the procedure for this transmission and the procedure to be followed.
§ 4. For pharmaceutical specialties for which an application was filed before 1^er January 2002 in order to obtain a notice from the Transparency Commission and to renew the opinion of the same Commission, but for which no request has yet been filed for reimbursement, the King may set the conditions under which the Drug Refund Commission shall take into account the final opinion of the Transparency Commission when it is available under § 2 of this article.
Art. 23. The Technical Council of Pharmaceutical Specialties may propose to the Insurance Committee to conclude, under the conditions and in the rules fixed by the King, agreements with firms that put pharmaceutical specialties on the Belgian market, in order to repay, for a certain period, to health care insurance, a specified percentage of the turnover realized through a pharmaceutical specialty.
Where the agreement referred to in the preceding paragraph is concluded, the Technical Council of Pharmaceutical Specialties may propose to amend the nomenclature referred to in section 35, § 1^er.
Section 2. - Organization of home care
Art. 24. In section 34 of the Compulsory Health Care Insurance Act, coordinated on 14 July 1994, amended by the Acts of 21 December 1994, 20 December 1995, 12 February 1998, 25 January 1999, 12 August 2000 and 2 January 2001, the following amendments are made:
1st paragraph 1^er, 1°, b, is replaced by the following provision:
"(b) care provided by nursing practitioners, associations, group firms and home nursing services.
Without prejudice to the application of the rules laid down in article 35 of the Royal Decree No. 78 of 10 November 1967 relating to the exercise of the art of healing, of nursing art, of paramedical professions and of medical commissions, it is meant by home nursing services, nursing organizations that rely exclusively on employee or statutory personnel. »;
2° paragraph 1^er, 13°, is replaced by the following provision:
"13° benefits that are performed by integrated home care services; the integrated home care services referred to above must meet the conditions to be fixed by the King in accordance with Article 5, § 1^erParagraph 1 of the Act of 27 June 1978 amending the Hospitals Act and dealing with certain other forms of care. "
Art. 25. Article 37, § 13, of the same law, as amended by the law of 25 January 1999, is replaced by the following provision:
“§ 13. The King may, on the proposal or after notice of the convention commission and after the advice of the Insurance Committee and the Budgetary Control Board, establish a lump-sum intervention of insurance for the benefits it determines and which are referred to in article 34, paragraph 1^er, 1°, b), as well as for the specific costs of home nursing services mentioned in this article, and set the conditions for granting these interventions.
The King may, however, provide that the benefits to which the package is applicable shall only be refunded by the package for a part specified by him. "
CHAPTER 2. - Amendments to the Act of 25 March 1964 on Drugs
Art. 26. Section 6quater of the Medicines Act of March 25, 1964 is repealed.
PART III. - Public health. - Amendments to Royal Decree No. 78 of 10 November 1967 relating to the exercise of the art of healing, nursing art, paramedical professions and medical commissions
Art. 27. The title of Royal Decree No. 78 of 10 November 1967 concerning the exercise of the art of healing, nursing art, paramedical professions and medical commissions is replaced as follows:
"Royal Decree No. 78 on the Exercise of Health Care Professions. "
Art. 28. In Article 2, § 2, of the same Royal Decree, the following amendments are made:
1° in paragraph 1^er, the words "the holders of the birth certificate, issued in accordance with the provisions of the King" are replaced by the words "people who are registered as holders of the professional birth title, by the Minister who has the Public Health in his or her duties or by an official delegated by him";
2° after paragraph 1^erthe following paragraphs shall be inserted:
"Accreditation is granted in accordance with the procedure established by the King and provided that it is satisfied with the approval criteria established by the King, after the advice of the National Board of Birthlers.
This approval as a holder of the professional title can only be granted to the holder of a higher education degree, a diploma that must be issued by a school recognized by the competent authority.
Accreditation as a holder of the professional title is a document signed by the Minister who has Public Health in his or her duties or by a delegated official. "
Art. 29. It is inserted in the same royal decree an article 3bis, written as follows:
"Art. 3bis. As soon as the criteria for obtaining specific professional titles from dental practitioners, referred to in sections 35ter and 35sexies, will come into force, the independent and autonomous exercise of dental art will be reserved for holders of these particular professional titles or dental practitioners who are also holders of the legal degree of doctor in medicine, surgery and delivery or the academic degree of doctor, taking into account the provisions relating to acquired rights. "
Art. 30. In Article 4 of the same Royal Decree, the following amendments are made:
1° in § 3, 1°, paragraph 10, 2°, are inserted between the words "to proceed" and "to the temporary or definitive closure of the offence" the words "through coercive measures";
2° in the Dutch text of § 3quater, 6°, inserted by the law of 13 May 1999, are inserted between the words "van 17 december 1973", and "de vergunning werd geschorst, vernietigd, ingetrokken of is vervallen" the words "de vergunning nooit werd verleend of waarvan".
Art. 31. Article 9, § 1^er, of the same Royal Decree, amended by the laws of 6 April 1995 and 25 January 1999, a third paragraph was added, as follows:
"The King may entrust the missions set by him, relating to the local organization and representation of the professionals concerned and relating to collaboration with other health care professionals, to the organizations or groups referred to in paragraph 1^erprovided 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. "
Art. 32. In section 21, of the same Royal Decree, as amended by the Act of 22 February 1994, a paragraph is inserted between paragraphs 1^er and 2, as follows:
"The King may specify the content and terms of the prescription. It also sets out the complementary conditions to which the outpatient and extra-hospital orders must be met. The signature of an order cannot be delegated. "
Art. 33. In the Dutch text of article 21ter, § 7, of the same royal decree, inserted by the law of 6 April 1995 and amended by the law of 25 January 1999, the words "geldig beslissen" are replaced by the words "geldig beraadslagen".
Art. 34. Section 21 quater, of the same Royal Decree, inserted by the Act of 20 December 1974 and amended by the Act of 6 April 1995, is replaced as follows:
"Art. 21 quater.§ 1^er. No one may exercise the infirmary art, as referred to in section 21quinquies, if he is not registered as a bearer, either as a professional nurse practitioner, or as a professional graduated nurse practitioner, and if in addition he meets the conditions set out in section 21sexies.
§ 2. The approval referred to in § 1^er is granted in accordance with the procedure established by the King and provided that it is met with the approval criteria established by the King, after the advice of the National Council of Nursing Art.
Accreditation as a holder of the professional title of graduated nurse can only be granted to the holder of a higher education degree in nursing.
Accreditation as a holder of the professional title of nurse practitioner can only be granted to the holder of a patent or diploma of the 4^e degree of secondary education in nursing or a secondary vocational secondary education, nursing section.
The relevant diplomas or patents must have been granted after training in full-year education with at least 3 years of study or its equivalent in social promotion education, organized in a school recognized by the competent authority.
The approval referred to in § 1^er A document signed by the Minister who has Public Health in his or her duties or by a delegated official.
§ 3. Persons who, on the date of entry into force of the Act of 10 August 2001 relating to health care, are in possession of the patent or the title of hospital or hospital, the patent or the title of assistant or assistant in hospital care, the patent or the title of nurse, the diploma or the title "in de verplek
§ 4. The holder of the professional birth certificate, who graduated before 1^er October of the fourth year after the entry into force of section 34 of the same Act of 10 August 2001 on health care measures, may exercise in full right the nursing art under the same conditions as the holders of the professional title of graduated nurse practitioner.
The holder of the professional birth certificate may exercise nursing art in the field of obstetric art, the treatment of fertility and neonatology. "
Art. 35. Section 21quinquies, of the same Royal Decree, inserted by the Act of 20 December 1974 and amended by the Act of 6 April 1995, is replaced by the following provision:
"Art. 21quinquies. § 1^er The following activities are carried out by the exercise of nursing art:
(a) - observe, identify and establish a mental, physical and social state of health;
- defining the problems of nursing;
- collaborate in the establishment of the medical diagnosis by the doctor and the execution of the prescribed treatment;
- inform and advise the patient and his family;
- to provide continuous assistance, to carry out acts or to assist in their implementation for the maintenance, improvement and recovery of the health of people and groups that they are healthy or sick;
- ensuring the accompanying of the dying and accompanying them during the mourning process;
(b) the technical benefits of nursing art that do not require a medical prescription and those for which it is necessary.
These benefits may be related to the establishment of a doctor's diagnosis, the execution of a doctor's prescribed treatment or preventive medicine.
(c) acts that may be entrusted by a physician in accordance with Article 5, § 1^erparagraphs 2 and 3.
§ 2. Nursing benefits, as referred to in § 1^er(a), (b) and (c) are recorded in a nurse ' s file.
§ 3. The King may, in accordance with the provisions of Article 46bis, set the list of benefits referred to in § 1^er, as well as their terms and conditions of performance and qualification required. "
Art. 36. Article 21sexies, of the same Royal Decree, inserted by the Act of 20 December 1974 and amended by the Acts of 6 August 1993 and 6 April 1995, is replaced by the following provision:
"Art. 21sexies. § 1^er. Certificates, patents or diplomas of persons referred to in Article 21quater shall be referred to in advance by the medical commission provided for in Article 36, and which is competent because of the place where they intend to settle.
Prior to the granting of the visa, the Accreditation Commission of the National Council of Nursing Art shall verify whether the approval criteria are met as the holder of the professional title referred to in Article 21quater, in accordance with the terms and conditions established by the King, after the advice of the National Council of Nursing Art.
The visa is granted against payment of a fee. The King sets the amounts and terms of payment.
§ 2. At the request of the interested person, the medical board may refer to the document by which the direction of the educational institution or the competent examination board certifies that the applicant has passed the final examination giving the right to the diploma or patent.
The effects of this visa cease upon the expiration of the month following that of the registration of the diploma or patent and, at the latest, at the expiry of the twelfth month following that of the granting of the visa. "
Art. 37. Section 21s of the same Royal Decree, inserted by the Act of 20 December 1974 and amended by the Act of 6 April 1995, is replaced by the following provision:
"Art. 21septies. § 1^er. No one may wear any of the professional titles referred to in Article 21quater, § 1^erif it does not meet the conditions laid down by Article 21quater, § 1^er.
§ 2. A person who meets the qualification requirements required by the legislation of a foreign country may only carry one of the professional titles referred to in section 21quater, subject to the authorization given by the Minister who has the Public Health in his or her powers and is responsible for the execution of the orders establishing the qualifications required, or by a delegated official. "
Art. 38. Section 21novies, of the same Royal Decree, inserted by the Act of 20 December 1974 and amended by the Act of 6 April 1995, is replaced by the following provision:
"Art. 21novies. No one may assign to persons who he occupies, even voluntary, one of the professional titles referred to in Article 21quater, § 1^erif these persons do not meet the conditions laid down in Article 21quater, § 1^er. "
Art. 39. In article 21undecies, § 2 of the same Royal Decree, inserted by the law of 20 December 1974 and amended by the law of 6 April 1995, the words "to ministers who have public health and national education, respectively, in their powers", are replaced by the words "to the Minister who has public health in his powers and the authorities of the communities, competent in the field of education".
Art. 40. Article 21duodecies, § 1^er, 3°, of the same royal decree, amended by the laws of 22 February 1994 and 6 April 1995, the words "Articles 59bis, § 2, paragraph 1^er2°, 59ter, § 2, paragraph 1^er3° of the Constitution are replaced by the words "Articles 127 and 130, § 1^erParagraph 1^erthe coordinated Constitution. "
Art. 41. In Article 21quaterdecies, § 5, paragraph 2, of the same Royal Decree, as amended by the Act of 6 April 1995, the following amendments are made:
1° the first sentence is replaced as follows: "The commission can only deliberate validly if half of the members referred to in § 2, 1°, and half of the members referred to in § 2, 2°, are present. »;
2° the paragraph referred to is supplemented by the following provision: "When at a meeting of the Commission, half of the members of each group are not present, the commission may deliberately at a next session regardless of the number of members present. "
Art. 42. In the same royal decree, an article 21quinquiesdecies is inserted as follows:
"Art. 21quinquiesdecies. No one can practise the profession of care without being registered in government services, in accordance with the terms set by the King. "
Art. 43. It is inserted in the same royal decree, an article 21sexiesdecies, written as follows:
« Art. 21sexiesdecies.§ 1^er. Care, education and logistics assistance is defined as a person specifically trained to assist the nurse, under their control, in the context of care, education and logistics activities coordinated by the nurse or nurse in a structured team.
§ 2. The King shall determine, after the advice of the National Council of Nursing Art and the Technical Commission of Nursing Art, the activities referred to in Article 21quinquies § 1^er, (a) and (b), that the caregiver may carry out, and sets out the modalities for carrying out these activities related to the caregiver function, in accordance with § 1^er. "
Art. 44. It is inserted in the same royal decree, an article 21septiesdecies, written as follows:
"Art. 21septiesdecies. § 1^er. Certificates, patents or diplomas of persons referred to in Article 21quindecies shall be pre-appeared by the medical commission provided for in Article 36, and which is competent because of the place where they intend to settle.
Before the grant of the visa, the Accreditation Commission of the National Council of Nursing Art shall verify whether it is in accordance with the registration procedure as a caregiver referred to in Article 21quinquiesdecies, in accordance with the terms fixed by the King, after the advice of the National Council of Nursing Art.
The visa is granted against payment of a fee. The King sets the amounts and terms of payment.
§ 2. At the request of the interested person, the medical board may refer to the document by which the direction of the educational institution or the competent examination board certifies that the applicant has passed the final examination giving the right to the diploma or patent.
The effects of this visa cease upon the expiration of the month following that of the registration of the diploma or patent and, at the latest, at the expiry of the twelfth month following that of the granting of the visa. "
Art. 45. Article 30 of the same Royal Decree, as amended by the Acts of 20 December 1974, 22 February 1994, 6 April 1995, 22 February 1998 and 25 January 1999, are amended as follows:
1° in § 1^er, 1°, the words "of a president occupying or occupying a charge in paramedic education" are replaced by the words "of a president, occupying or having occupied a paramedical profession";
2° in § 1^er, 3°, paragraph 1^er, the words "an official of the Ministry of Public Health and the Family who will serve as secretary, and" are deleted;
3° in § 1^er, 3°, paragraph 2, the words "of the official and", are deleted;
4° in § 1^er, 4°, the words "of two dental art practitioners" are replaced by the words "of a dental art practitioner";
5° in § 1^er5°, the words "of two pharmacists" are replaced by the words "of a pharmacist";
6° § 1^er, 6°, is replaced by the following provision: "6° and an official who will serve as secretary. »;
7° § 3, paragraph 3, is repealed.
Art. 46. The title of Chapter IIbis of the same Royal Decree, inserted by the Act of 10 December 1997, is replaced as follows:
"Chapter IIbis - Specific professional qualifications, specific professional titles, supply control, end of career, evaluation, structure and organization of practice, organs".
Art. 47. In article 35ter of the same royal decree, inserted by the law of 19 December 1990 and amended by the laws of 6 April 1995 and 17 March 1997, it is necessary to replace, in the Dutch text, the word "beroepsbekwamingen", with the word "beroepsbekwaamheden'.
Art. 48. In section 35quater of the same Royal Decree, inserted by the Act of 19 December 1990, the following amendments are made:
1° it is necessary to replace, in the Dutch text, the word "beroepsbekwaming" with the word "beroepsbekwaamheid";
2° the words "or by the official delegated by him" are added after the words "Public Health in its powers".
Art. 49. In article 35quinquies of the same royal decree, inserted by the law of 19 December 1990, it is necessary to replace, in the Dutch text, the word "bekwamingen" with the word "bekwaamheden".
Art. 50. In article 35s of the same royal decree, inserted by the law of 19 December 1990, it is necessary to replace, in the Dutch text, the word "beroepsbekwaming", with the word "beroepsbekwaamheid".
Art. 51. Article 35octies of the same royal decree, inserted by the law of 29 April 1996, and amended by the law of 22 February 1998, is supplemented by § 2bis, as follows:
Ҥ 2bis. In order to ensure its legal duties, the Planning Commission may process personal data relating to health care professionals.
The results of this treatment may be the subject of communication, dissemination or publication only if the identification of persons is impossible. "
Art. 52. In section 35novations of the same Royal Decree, inserted by the Act of 29 April 1996 and amended by the Act of 22 February 1998, the following amendments are made:
1° § 1^er is replaced by the following provision:
« § 1^er. On the joint proposal of Ministers who have Public Health and Social Affairs respectively in their responsibilities, by a deliberate decree in the Council of Ministers:
1° the King may determine, after the opinion of the Planning Commission, the total number of candidates, divided by Community, who, after graduation referred to in Articles 2, § 1^er, and 3, have annual access to the allocation of specific professional titles, subject to the approval referred to in section 35quater and the overall number of candidates, distributed by Community, who have annual access to the award of the approval referred to in Article 21bis, § 3;
2° the King may determine, after the opinion of the Planning Commission, the overall number of candidates who have annual access to obtaining an approval for the exercise of a profession for which an approval exists;
3° the King may set the criteria and the terms for the selection of candidates referred to in 1° and 2°. »;
2° the article is supplemented by a § 5, which reads as follows:
“§ 5. The King may, by order deliberately in the Council of Ministers, on the proposal of Ministers who have Public Health and Social Affairs respectively in their responsibilities, set the list of specific professional titles that may be acquired by the holders of the basic diplomas referred to in articles 2, § 1^er, 3 and 5, § 2 for which the limitation of the number of candidates is not of application. »;
3° the article is supplemented by a § 6, which reads as follows:
“§ 6. When a candidate is to be part of two groups of health care professionals whose number is regulatoryly limited in accordance with § 1^er, it must be taken back only in one group. "
Art. 53. It is inserted in the same royal decree, after Article 37, a chapter IIIbis written as follows:
"Chapter IIIbis - Health Care Care Cell
Art. 37bis.§ 1^er. The King creates a health care cell within the government's services.
§ 2. The cell has a mission:
1° to propose to the authority any measures to preserve public health;
2° to ensure the effective collaboration of practitioners of medical art, pharmaceutical art and nursing art, as well as practitioners of paramedical professions in the implementation of the measures enacted by the authority to manage health crises and the coordination of measures taken at the level of provincial medical commissions. "
Art. 54. Article 38, § 1^er, 5°, of the same Royal Decree, as amended by the Act of 22 February 1994, is replaced as follows:
"5° is punished by a fine of twenty-six francs to five hundred francs, the practitioner of medical art or pharmaceutical art who contravenes the provisions of Articles 18, § 2, 20 and 21; "
Art. 55. In section 38ter of the same Royal Decree, inserted by the Act of 20 December 1974 and amended by the Acts of 19 December 1990 and 6 April 1995, the following amendments are made:
1° point 1° is replaced as follows:
"1° the person who does not have the necessary approval or does not meet the conditions laid down in Article 21quater, § 1^er, performs one or more activities related to nursing art as provided for in Article 21quinquies, § 1, a), with the intention of drawing a financial benefit or usually carries out one or more activities referred to in Article 21quinquies, § 1^er(b) and (c).
This provision is not applicable to persons authorized to practise medicine, birth attendants, caregivers and practitioners of physiotherapy or a paramedical profession with respect to the regulatory exercise of their profession.
It is not more applicable to the medical student, the physiotherapy student, the birth student and the person following a paramedical training carrying out the above-mentioned activities as part of his or her training, or to the student carrying out the above-mentioned activities as part of a recognized training to obtain the accreditation referred to in Article 21quater, § 1^eror article 21quinquiesdecies;";
2° point 4° is replaced by the following provision:
"4° the person who usually charges the exercise of the nursing art or usually authorizes for that purpose a person who is not in possession of the licence referred to in section 21quater or the registration referred to in section 21quinquiesdecies and a qualification title referred to or who does not have the quality of a student referred to in 1° of this section; »;
3° the article is supplemented by a point 7°, which reads as follows:
« 7° The person who usually charges one of the persons referred to in Article 21quinquiesdecies of the performance of an act that is considered to be relevant to medical art. "
Art. 56. Article 46bis, § 1^er, of the same royal decree, inserted by the law of 19 December 1990 and amended by the law of 6 April 1995, the words "21quinquies, § 2" are replaced by the words "21quinquies, § 3".
Art. 57. In section 54ter of the same Royal Decree, replaced by the Act of 25 January 1999, the following amendments are made:
1° in the Dutch text of § 3, paragraph 1^er, the word "bekwaamheidseisen" is replaced by the word "kwalificatievoorwaarden";
2° in the Dutch text of § 3, paragraph 1^er, the word "wanneer" is replaced by "op het moment waarop";
3° in the Dutch text of § 3, paragraph 1^er, the words "voor hun beroep" are replaced by "in verband met het paramedisch beroep waartoe zij behoren";
4° in the Dutch text of § 3, paragraph 1^er, the word "prestatie" is replaced by "prestaties";
5° in the Dutch text of § 3, paragraph 2, the word "bekwaamheidseisen", is each time replaced by the word "kwalificatievoorwaarden";
6° in the Dutch text of § 3, paragraph 2, the word "prestatie" is replaced by the word "prestaties";
7° in the Dutch text of § 3, paragraph 2, the words "op het einde van het jaar waarin", are replaced by the words "op het moment waarop";
8° in § 3, paragraph 3, the words "at the end of a procedure" are replaced by the words "on a procedure".
Art. 58. It is inserted in the same royal decree, a new article 55bis written as follows
"Art. 55bis. The King may coordinate the provisions of this Royal Decree with the provisions that have expressly or implicitly amended them until the time of coordination.
To this end, He may:
1° reorganize the arrangements for coordination, including reordering and renumbering;
2° renumber references in the provisions to be coordinated in a manner that is consistent;
3° rewrite the provisions to be co-ordinated in order to ensure their consistency and to unify the terminology, without touching the principles contained therein;
4° adapt the references to the coordinate provisions in the provisions that are not inserted in the coordination.
Coordination will include the following title: "Coordinated laws related to the exercise of health care professions. "
PART IV. - Entry into force
Art. 59. § 1^er. This Act comes into force on the day of its publication to the Belgian Monitor, with the exception of:
- articles 11 and 12 that produce their effects on 1^er April 2001;
- articles 2 to 10 included and articles 14, 16, 20, 22 which come into force on 1^er January 2002;
- of Article 26 which comes into force on 1^er January 2002, without prejudice to the application of Article 22.
§ 2. Section 23 ceases to be in force on March 31, 2002.
Promulgate this law, order that it be clothed with the seal of the State and published by the Belgian Monitor.
Given in Nice on 10 August 2001
ALBERT
By the King:
Minister of Public Health,
Ms. M. AELVOET
Minister of Social Affairs,
F. VANDENBROUCKE
For the Minister of the Interior, absent,
Minister of Justice,
Mr. VERWILGHEN
Minister of Economy,
Ch. PICQUE
Seal of the state seal:
Minister of Justice,
Mr. VERWILGHEN