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18 DECEMBER 2016. - Act on various health provisions

PHILIPPE, King of the Belgians,
To all, present and to come, Hi.
The House of Representatives adopted and sanctioned the following:
PART 1^er. - Introductory provision
Article 1^er. This Act regulates a matter referred to in Article 74 of the Constitution.
PART 2. - INAMI
CHAPTER 1^er. - Amendments to the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994
Section 1^re. - Bachelor of Science
Art. 2. Section 2 of the Compulsory Health Care and Compensation Insurance Act, coordinated on July 14, 1994, last amended by the Act of July 17, 2015 is supplemented by (t) and (u) as follows:
"(t) by "Licence in Science", the Licensee in Science and the Master's degree in Science;
u) by "Licensee in Dental Sciences", the Licensee in Dental Sciences and the Master's degree in Dental Sciences. ".
Art. 3. Section 2 produces its effects on 1^er July 2009.
Section 2. - Medical Refund Commission
Art. 4. In section 29bis, paragraph 3, of the Act, inserted by the Act of 27 December 2004 and replaced by the Act of 27 December 2005, the following amendments are made:
1° the words ", designated for a period of up to 6 years renewable by the Minister who has the Social Affairs in his responsibilities among the experts working in a university institution" are replaced by the words "who works in a university institution, designated for a period of up to 6 years renewable by the King";
2° the paragraph is supplemented by the following sentence:
"The president has the right to vote."
Art. 5. Section 4 comes into force on December 31, 2017.
The King may fix an effective date prior to that referred to in paragraph 1^er.
Section 3. - Conventions
Art. 6. In section 35bis, § 7, of the same law, inserted by the law of 10 August 2001 and last amended by the law of 22 June 2016, the following amendments are made:
1° a sub-paragraph is inserted between paragraphs 1 and 2:
"If the Drug Refund Commission has made a proposal for a negatively motivated reimbursement, and the Minister wishes to depart from this proposal, but considers that the repayment base proposed by the applicant is not proportional to the assessment of the criteria referred to in § 2, or if the Minister considers that the registration of the speciality on the repayable specialties list contains budgetary uncertainty, the Minister may propose to the applicant to enter into a convention with the health insurance institute, ";
2° in paragraphs 5 and 6, which become paragraphs 6 and 7, the words "paragraph 4" are replaced by the words "paragraph 5".
Section 4. - Reference reimbursement
Art. 7. In section 35ter of the Act, replaced by the Act of 27 December 2005 and last amended by the Act of 22 June 2016, the following amendments are made:
1° in paragraph 1^erParagraph 3, the words "and 2" are replaced by the words ", 2 and 5";
2° in paragraph 1^er, paragraph 4, the words "This new refund base" are replaced by the words "The new refund base referred to in paragraph 1^er and 2";
3° paragraph 1^er is supplemented by three subparagraphs as follows:
"A new refund base is also set in full right respectively to 1^er January 1^er April 1^er July and 1^er October of each year for specialties referred to in article 34, paragraph 1^er, 5°, c), 1), having more than one active principle, of which at least one active principle is the same active principle of a specialty, referred to in article 34, paragraph 1^er, 5°, c), (1) for which the provisions of paragraph 1^erParagraph 1^er or 2, are applied.
The new reimbursement base referred to in paragraph 5 shall be calculated in accordance with the provisions of Article 35 bis, § 2bis, and in accordance with the rules laid down by the King.
The manner in which it is indicated that the reductions referred to in paragraphs 5 and 6 have been applied are determined by the King."
4° the article is supplemented by a paragraph 13, as follows:
§ 13. 1^er March 2017, the basis for reimbursement of specialties referred to in article 34, paragraph 1^er, 5°, c), 1), having more than one active principle, of which at least one active principle is the same active principle of a specialty, referred to in article 34, paragraph 1^er§ 1^erParagraph 1^er or 2, were applied before 1^er March 2017, is diminished in full law in accordance with the provisions of § 1^erParagraph 6.
Section 5. - Electronic medical record
Art. 8. Section 36s of the Act, inserted by the Act of 22 August 2002, is supplemented by the following sentence:
"This honorary is only due if the recognized general practitioner uses an electronic medical record for the beneficiary concerned, which is managed by a software registered by the eHealth platform in accordance with the law of August 21, 2008 on the institution and organization of the eHealth platform and carrying various provisions. ".
Art. 9. Section 8 comes into force on 1^er January 2017.
For general practitioners who are recognized as general practitioners before 1^er January 2017, however, section 8 comes into force on 1^er January 2021.
Section 6. - Maximum charge
Art. 10. In section 37duodecies, § 3, of the same law, inserted by the law of 5 June 2002, the following amendments are made:
1° the words "When specific criteria, fixed by the King, appear" are replaced by the words "When it appears";
2° the words "increasing a significant decrease in household income" are replaced by the words "that have the consequence that household income has become less than one of the amounts determined by the King";
3° the words "according to these elements" are repealed.
Section 7. - Social status of nursing practitioners
Art. 11. In title III, chapter V, section IV, of the same law, the words ", practitioners of nursing art "are inserted between the words "logpeds" and the words "and physiotherapists".
Art. 12. In Article 54, § 1^erParagraph 1^erin the same Act, replaced by the Act of 22 December 2003 and amended by the Acts of 14 April 2014 and 17 July 2015, the following amendments are made:
1° the words ", of the Convention Commission responsible for negotiating and concluding the national convention between nursing practitioners and insurance organizations," are inserted between the words "of the Convention Commission responsible for negotiating and concluding the national agreement between the logopeds and insurance organizations" and the words "or the Convention Commission responsible for negotiating and concluding the national convention between physiotherapists and insurance organisations"
2° the words ", the practitioners of nursing art" are inserted between the words "the logopeds" and the words "or the physiotherapists who adhere".
Art. 13. In Article 54, § 1^er, paragraph 3, of the same law, replaced by the law of December 22, 2003 and amended by the laws of December 19, 2008 and April 10, 2014, the words ", practitioners of nursing art" are inserted between the words "the logopeds" and the words "and the physiotherapists".
Section 8. - Transaction
Art. 14. Section 167 of the Act is supplemented by three subparagraphs as follows:
"The deputy head may transfer and compromise in cases where the interests of the Institute are engaged.
The transaction or compromise shall be subject to the approval of the relevant service management committee when its object exceeds an amount of 250,000 euros.
An inventory of transactions and compromise is communicated to the General Management Committee every semester.".
Section 9. - Termination of prescription
Art. 15. In section 174, paragraph 4, of the Act, the following sentence is inserted between the first and the second sentence:
"In addition, the requirements referred to in 3°, 4°, and 6° may be interrupted by an electronic message specifying the health benefits referred to in the practical terms set by the Insurance Committee by a regulation referred to in article 22, 11°. ".
Section 10. - Contributions
Art. 16. Article 191, paragraph 1^er, 15°, paragraph 4, 1°, of the same law, inserted by the law of 10 June 2006 and amended by the laws of 24 July 2008 and 26 December 2013, the last two sentences are replaced as follows:
"The King determines the procedures and sets the conditions under which a pharmaceutical specialty, which lost this status after the end of the 10-year commercial exclusivity, is granted an extension of this exclusion. The extension is subject to the absence of a refundable pharmaceutical alternative. The extension is limited to a maximum of 5 years.".
Art. 17. In section 191, paragraph 1^er, 15°, paragraph 6, of the same law, last amended by the law of 23 December 2009, the words "and 16° bis" are replaced by the words ", 15° quaterdecies and 16° bis".
Art. 18. In section 191, paragraph 1^er, 15°, paragraph 7, of the same law, last amended by the law of 22 June 2012, the words "and 15° terdecies" are replaced by the words ", 15° terdecies and 15° quaterdecies. ".
Art. 19. Article 191, 15° undecies, of the same law, inserted by the law of 22 December 2008 and amended by the law of 23 December 2009, is supplemented by the following sentence:
"For the year t, starting in 2017, this subsidiary contribution is no longer applicable.".
Art. 20. Article 191, paragraph 1^er, of the same law, last amended by the law of 18 March 2016, is supplemented by the 15° quaterdecies, as follows:
"15° quaterdecies. For the year t, it is established, beginning in 2017, under the conditions and terms set out in 15°, an indemnity contribution on the turnover made in t, provided that an overexpenditure of the overall budget established pursuant to section 69, § 5, is recognized and established for this year t by the General Health Care Insurance Council, as defined below.
The amount of the exceedance referred to in paragraph 1^er may be adapted by the General Council, after the opinion of the Budget Control Board, to take into account the impact of the elements of the annual budget, determined by the King, which have not or have not produced their full effects.
If in November of year t, it is established, on the basis of the expenditures of the first seven months of year t recorded by the insurers, that there is an overrun, the contribution referred to in paragraph 1^er is due to the amount of the budgetary overrun established by the General Council.
If in November of year t, it is determined, on the basis of these expenditures recorded by insurers, that there is no overrun, the contribution referred to in paragraph 1^er Not due.
The amount of the contribution referred to in paragraph 1^er is capped. For the year 2016, the ceiling is set at 100 million euros. From 2017 onwards, the ceiling is set at 2.5 p.c. of the overall budget established in accordance with Article 69, § 5.
Pharmaceutical specialties, refunded in accordance with Article 37, § 3, are exempt from this contribution to a maximum of 75 p.c.. The correction factor applied on reported turnover is the result of a 75 per cent increase in the ratio between the expenses in the package and the Institute's total expenditures for the particular specialty. This report is prepared by the Institute on the basis of the latest known data, at the time of the overtaking, which are communicated pursuant to Article 206, § 1^er. For specialties for which the last data are not known, there is no possible exemption.
This contribution is paid through an advance deposit, based on the turnover of the year t-1, and a deposit, based on the turnover of the year t, the percentages of which are fixed by the General Council, by a majority of the votes of the members having a deliberative vote, including the votes of all members referred to in Article 15, paragraph 1^er(a).
If the majority is not reached by 1^er Monday of December, year t with respect to the percentage of the deposit, and year t+1 with respect to the percentage of the deposit, the officer of the Health Care Service shall inform the Minister of the deposit. The Minister sets the percentage(s).
The Health Care Service shall inform the applicants concerned of the percentages set.
The deduction of the contribution must be paid before December 31st of the year t on the account of the National Institute of Disability Insurance by indicating the statement "Compensation Payment Year t". The balance of the contribution must be paid before December 31 of the year t+1 on the account of the National Institute of Disability Health Insurance by indicating the "Sold Year-T" compensation contribution. In the event of a determination of the percentage of the deposit and/or count by the Minister, the corresponding maturity is posted for 3 months.
Revenues resulting from this compensation contribution are included in the accounts of the mandatory health care insurance for the year t.".
Art. 21. In section 191bis, paragraph 1^er, of the same law, last amended by the law of June 28, 2013, the words "at 15° terdecies" are replaced by the words "at 15° quaterdecies".
Art. 22. In section 191ter, paragraph 1^er, of the same law, last amended by the law of June 28, 2013, the words "at 15° terdecies" are replaced by the words "at 15° quaterdecies".
Art. 23. In section 191quater, paragraph 1^er, of the same law, last amended by the law of June 28, 2013, the words "at 15° terdecies" are replaced by the words "at 15° quaterdecies".
Section 11. - Advertising.
Art. 24. In Article 218, § 2, paragraph 1^er, from the same law, replaced by the law of 7 February 2014, the words ", address(s) of work" are inserted between the words "INAMI number" and the words "and status of accession to agreements and conventions".
Section 12. - Medical check
Art. 25. In section 73bis of the Act, inserted by the Act of 13 December 2006 and amended by the Acts of 29 March 2012 and 10 April 2014, the following amendments are made:
1° 7° is replaced as follows:
"7° not to issue regulatory documents when their issuance is mandatory or to prepare, prepare, issue or issue regulatory documents that are irregular without the conditions for reimbursement of health benefits being questioned; ";
2° Article 73bis is supplemented by the 9° and 10° written as follows:
"9° to accept deposits outside the limits referred to in Article 53, § 1^er/1;"
"10° not to comply with the obligation to apply the pay third party regime as provided for in Article 53, § 1^erParagraph 14. ";
3° Article 73bis is supplemented by a paragraph written as follows:
"The above-mentioned regulatory documents cover both paper and electronic documents in accordance with section 9bis.".
Art. 26. Article 25, 3°, comes into force on 1^er January 2017.
Art. 27. In section 142 of the Act, reinstated by the Act of 13 December 2006 and amended by the Acts of 27 December 2006, 29 March 2012, 19 March 2013 and 10 April 2014, the following amendments are made:
1° in paragraph 1^erParagraph 1^er, 7°, the words "9° and 10°" are inserted after the word "7°";
2° in paragraph 2, paragraph 2, the word "two" is replaced by the word "three";
3° in paragraph 3, paragraph 1^er, 2°, the words "1°, 2°, 3° and 7°" are replaced by the words "1°, 2°, 3°, 7°, 9° and 10°".
Art. 28. In section 143 of the Act, restored by the Act of 13 December 2006 and amended by the Acts of 19 December 2008, 29 March 2012 and 19 March 2013, the following amendments are made:
1° in paragraph 1^erParagraph 1^er2°, the words "7° and 8°" are replaced by the words "7°, 8°, 9° and 10°";
2° in paragraph 3, the words "1°, 2°, 3°, 7° and 8°" are replaced by the words "1°, 2°, 3°, 7°, 8°, 9° and 10°".
Art. 29. In Article 156 § 1^er paragraph 3, of the same Act, reinstated by the Act of December 21, 2006 and amended by the Acts of April 10, 2014 and July 17, 2015, the words "property documentation" are replaced by the words "perception and recovery".
Art. 30. In section 206bis, § 2, of the same law, inserted by the law of January 14, 2002 and amended by the laws of April 10, 2014 and July 17, 2015, the words "healing documentation" are replaced by the words "perception and recovery".
Section 13. - New SECM search method
Art. 31. In section 146 of the Act, last amended by the Act of 10 April 2014, a paragraph 2/1 is inserted as follows:
§ 2/1. To determine the offences referred to in Article 73bis and to calculate the value of unduly refunded benefits by compulsory health care insurance, inspection personnel referred to in § 1^er may, among other things, use the sampling and extrapolation verification method.
This method consists of:
1° establish the survey base by identifying and defining a set of independent cases that will be examined;
2° conduct a random draw in this survey base to form a sample and document the drawing method;
3° analyze cases in this sample and calculate in the sample the percentage of amounts unduly refunded by compulsory health care insurance;
4° calculate the value below which the percentage of the population sought to be estimated is less than 2.5 per cent likely to be present;
5° use this value to calculate the amount to be recovered for all benefits of the survey base. ".
Section 14. - Health care budget
Art. 32. In section 18 of the Act, replaced by the Act of 25 January 1999 and amended by the Acts of 24 December 1999 and 10 August 2001, the Royal Decree of 17 September 2005 and the Act of 27 December 2012, the following amendments are made:
1° in paragraph 1^er the words "not later than September 15 of the year before the fiscal year," are replaced by the words "not later than the eighth working day after September 15 of the year preceding the fiscal year,"
2° between subparagraphs 1^er and 2, a new paragraph is inserted as follows: "The Budget Control Board shall analyze the overall proposal of the Insurance Committee referred to in section 39 with respect to the compliance with the budgetary framework and the multi-year journey decided by the Council of Ministers and issue a notice to the General Council no later than the third Monday of October. "
Art. 33. In section 38 of the Act, amended by the Acts of 12 December 1997, 25 January 1999 and 24 December 1999, and by the Royal Decree of 17 September 2005, the following amendments are made:
1° in paragraphs 1^er and 2, the words "for financing" are replaced by the words "for financing priority adaptations";
2° in paragraph 2 the words "means" are replaced by "financial means";
3rd paragraph 1^er is supplemented by the following sentence: "These priority adaptations take into account the budgetary framework, the multi-year journey and strategic priorities for new policy and the adaptations of the existing policy as communicated by the Insurance Committee and the General Council."
4° in paragraph 2, the following sentence is inserted between the first and the second sentence: "These priority adaptations also take into account the budgetary framework, the multi-year journey and strategic priorities for new policy and the adaptations of existing policy as communicated by the Insurance Committee and the General Council."
5° in paragraph 3, the words "for priority adaptations" are inserted between the words "the necessary financial means" and the words "from the level of expenditure";
6° two paragraphs are inserted between paragraphs 3 and 4, which read as follows:
"The Conventions and Agreements Commissions shall communicate no later than 1^er September of the year before the fiscal year, the financial means for funding priority adaptations.
Convention and Agreement Commissions shall communicate no later than 1^er September of the year prior to the fiscal year, proposals for compensatory measures on the one hand, if based on technical estimates, as determined by the Service no later than May 31 of the year prior to the fiscal year, a surge in the partial budget objective for which the Conventions and Agreements Commission is competent and on the other hand to eventually finance a new policy is assumed. "
7° in paragraph 4, which becomes paragraph 6, the words "June 30" are replaced by the words "May 31" and the words "at the latest fifteen days before the first Monday of the month of October" are replaced by the words "until September 15 of the year before the fiscal year. "
Art. 34. Article 40, § 1^erParagraph 1^er, of the same Act, last amended by the Royal Decree of 17 September 2005, the first sentence is replaced by the sentence: "In light of the overall proposal of the Insurance Committee referred to in section 39, the proposals for savings measures of the Budget Control Board referred to in section 18 and the opinion of the Budget Control Board on the overall proposal of the Insurance Committee referred to in section 18, "
Art. 35. In section 40 of the Act, last amended by the Act of 10 August 2015, subsection 2 is replaced by the following:
"§2. In the event of non-approval of the budget and budget objective, the General Council shall notify the Minister of the budget. In this case, on the proposal of the Minister, the Council of Ministers sets the budget and the amount of the overall annual budget objective of health care insurance, and the partial objectives and overall budgets of the financial means for benefits or benefit groups to which this system is applicable. "
Art. 36. In article 51, § 4, paragraph 2, of the same law, last replaced by the law of 19 December 2008, the words "May 15" are replaced by the words "June 30".
Art. 37. In section 39 of the Act, last amended by the Royal Decree of 17 September 2005, paragraph 3 is replaced by the following:
"The Insurance Committee shall forward to the General Council and to the Budget Control Board, no later than the first Monday of October of the year preceding the fiscal year, a comprehensive proposal that meets the growth standard, the increase in the health index referred to in section 40, § 1^erparagraph 3, the budgetary framework, multi-year travel and policy priorities for new policy and policy adjustments. "
CHAPTER 2. - Amendment of the Act of March 31, 2010 on compensation for damages resulting from health care (FAM)
Single section. - Access to the patient's file
Art. 38. In Article 16, paragraphs 1^er and 2, of the Act of March 31, 2010 on compensation for damages resulting from health care, the words "access to the patient file" are replaced by the words "right to consultation and copy of the patient file".
Art. 39. Section 38 produces its effects on 1^er September 2012.
CHAPTER 3. - Amendment of the Act of 27 April 2005 on the Control of the Health Care Budget and on various health provisions
Art. 40. In article 69, paragraph 21, of the Act of 27 April 2005 on the Control of the Health Care Budget and on various health provisions, inserted by the Act of 26 December 2015, the words " § 1^er, paragraph 5" are inserted between the words "for which Article 35ter" and the words " § 2 or § 2bis".
PART 3. - Federal Agency for Drugs and Health Products (AFMPS)
CHAPTER 1^er. - Sunshine act
Art. 41. § 1^er. For the purposes of this chapter, the following means:
1° "Company subject to notification": any entity that carries on an economic activity, regardless of its legal form and how it is financed, within the meaning of Title VII of the Treaty concerning the operation of the European Union, including holders of authorization to market drugs for human or veterinary use, importers, manufacturers and distributors of medicines for human or veterinary use, persons engaged in brokering of medicines for human or veterinary use,
2° "organization of the health sector": any association or organization active in the field of health care, medical or scientific, regardless of its legal or organizational form, as well as any legal entity by which one or more health professionals provide services;
3° "beneficiary": any person listed in Article 10, § 1^er, of the Act of 25 March 1964 on medicines, having a practice or a seat of exploitation or social in Belgium as well as the organizations of the health sector referred to in 2°, or any organization of patients with a fixed seat or place in Belgium.
§ 2. Companies subject to notification notify the Federal Agency for Drugs and Health Products (hereinafter referred to as "AFMPS") of all premiums and monetary or in-kind benefits, directly or indirectly, from Belgium or elsewhere to beneficiaries.
§ 3. The obligation described in subsection 2 does not apply to the following premiums and benefits:
1° the premiums and benefits referred to in Article 10, § 2, paragraph 1^er1°, of the Act of 25 March 1964 on Drugs;
2° the meals and drinks offered in the context of scientific events referred to in Article 10, § 2, paragraph 1^er2° of the Act of 25 March 1964 on Drugs;
3° the economic and discount margins that are part of the usual purchase and sale of medicines or medical devices by a notified company or between the notification company and a beneficiary;
4° the samples within the meaning of section 12 of the Act of 25 March 1964 on drugs.
§ 4. Paragraphs 2 and 3 do not prejudice the provisions of section 10 of the Act of 25 March 1964 on drugs.
§ 5. The notification may result in the payment of a royalty whose amount is fixed by the King.
Art. 42. § 1^er. The notification referred to in Article 41 shall contain at least:
1 the name and number of the company subject to notification referred to in Article 41, § 2;
2° the name and company number or the INAMI number of beneficiaries, or any other unique means of identification that allows the AFMPS to identify beneficiaries with certainty;
3° the total amount of premiums and benefits awarded during the full reference year concerned.
The King may specify the terms and conditions of the notification referred to in paragraph 1^er. The King may for publication referred to in Article 43, § 1^erdetermine the categories of premiums and benefits, without prejudice to the provisions of section 10 of the Act of March 25, 1964 on drugs.
Derogation from paragraph 1^er, 2°, the bonuses and benefits, awarded in the context of the experiments referred to in section 2, 11°, of the Act of May 7, 2004 on human person experiments in the context of non-clinical studies as defined in the OECD Principles on Good Laboratory Practice and in the context of clinical trials within the meaning of section 6quinquies of the Individual Drug Law of March 25, 1964, will be notified on an unaccredited basis
§ 2. The notification by the reporting company shall take place annually no later than 31 May of the year following the end of the calendar year in which the premiums and benefits were awarded (hereinafter referred to as the "reference year"), and in accordance with the model and practical and technical terms determined by the AFMPS.
The King may define the minimum requirements on the practical and technical terms referred to in paragraph 1^er.
§ 3. Recipients shall communicate to enterprises subject to notification the data necessary for the purposes of the execution of this Article.
Art. 43. § 1^er. AFMPS publishes the information referred to in Article 42, § 1^er, with the exception of unique identifiers that are exclusively used for internal audit purposes at the PSMPS, and § 2, on a single website accessible to the public. The publication is in French, Dutch and German.
Premiums and benefits are published on a nominal individual basis.
By derogation from paragraph 2, the premiums and benefits, granted in the context of the experiments referred to in section 2, 11°, of the Human Person Experiments Act of 7 May 2004 in the context of non-clinical studies as defined in the OECD Principles on Good Laboratory Practice and in the framework of clinical trials within the meaning of section 6quinquies of the Individual Drugs Act of 25 March 1964, will be published on an unpublished basis
The publication takes place no later than June 30 of the year following the end of the reference year.
The King may specify the terms of the publication.
§ 2. FAMPS and notification companies retain the information referred to in paragraph 1^er for 10 years from publication in accordance with the provisions of paragraph 1^er. Notification companies also retain relevant supporting documents during the same 10-year period.
Art. 44. § 1^er. The King may approve an organization to carry out the AFMPS' duties under sections 41 to 43, on behalf of and on behalf of the AFMPS, under the following conditions:
§ 1^er. The King may approve an organization to carry out the AFMPS' duties under sections 41 to 43, on behalf of and on behalf of the AFMPS, under the following conditions:
2° the majority of members are composed of members involved in health care, such as representatives of health professionals, patient organizations, the pharmaceutical industry and the medical device industry;
3° the organization has a procedure ensuring strict application of the provisions of this chapter, including the technical and practical terms of notification and publication;
4° the organization has a quality system and a management body that monitors compliance with conditions of accreditation. Each sector of the pharmaceutical industry and medical devices is represented in this body;
5° the presence of a delegate of the Minister who has the Public Health in his or her duties is guaranteed by statute. The delegate designated within the PSMPS attends meetings of the organization's management body.
§ 2. The organization referred to in paragraph 1^er gives access to the PSMPS to all the documents and information that are necessary in the exercise of its control skills.
§ 3. FAMPS may conduct audits and inspections in the organization referred to in paragraph 1^er.
The organization submits an annual evaluation by the AFMPS to ensure that the organization meets the conditions of accreditation. The organization also communicates a full and detailed activity report to the PSMPS each year, as well as any other information that the PSMPS requests.
If, during the annual assessment or an audit or inspection, irregularities are found, the PSMPS may impose corrective measures to address these deficiencies. Compliance with these corrective actions is monitored through additional inspections or audits.
The audit report and activity report are communicated to the Minister and the PSMPS.
§ 4. The organization referred to in paragraph 1^er may be financed by the royalty determined under section 41, § 5.
Art. 45. § 1^er. The application for approval pursuant to section 44 is addressed to the Minister by recommended.
Under penalty of inadmissibility, the application shall be accompanied by a record relating to the conditions of registration referred to in Article 44, § 1^erincluding coordinated statutes, internal procedures and the membership list.
The Minister's reasoned decision is communicated within 30 days to the applicant by registered mail.
§ 2. Any changes to the statutes of the organization or members are immediately communicated to the Minister.
§ 3. The King may withdraw the approval on the basis of the following reasons:
1° for serious reasons if the organization no longer meets the conditions of approval or if the mission referred to in section 42 is not insured;
1° for serious reasons if the organization no longer meets the conditions of approval or if the mission referred to in section 42 is not insured.
Art. 46. Sections 14, 14bis and 17 of the Act of March 25, 1964 on Drugs apply to this chapter.
Art. 47. A fine of 200 to 15,000 euros is punished, the person who contravenes the provisions of articles 41 or 42.
Art. 48. § 1^er. This chapter comes into force on a date to be determined by the King.
§ 2. The King may, as a transitional measure, exempt companies subject to notification of obligations under articles 41 and 42.
This exemption applies to premiums and benefits granted by veterinary drug marketing authorization holders, importers, manufacturers and distributors of veterinary drugs and persons engaged in veterinary drug brokering activities.
The exemption is only applicable to the veterinary activities of the notified companies.
The exemption expires on a date to be determined by the King, no later than one year after the coming into force of this chapter.
CHAPTER 2. - Amendments to the Act of 25 March 1964 on Drugs
Section 1^re. - Specific Regulations of Issue
Art. 49. Article 6, § 1^erbis of the Act of 25 March 1964 on Drugs, inserted by the Law of 1^er May 2006 and amended by the Act of 3 August 2012, the following amendments are made:
1° in paragraph 3, fourth dash, the words "reserved to certain groups of specialists and/or whose delivery is reserved for hospital pharmacists" are replaced by the words "reserved to certain specialized media";
2° paragraph 1^erbis is supplemented by three subparagraphs, as follows:
"For the purposes of paragraph 3, fourth dash, "medicines reserved for certain specialized media" means:
(1) drugs whose prescription and/or administration is reserved for medical art practitioners referred to in Article 3, § 1^er, of the Coordinated Act of 10 May 2015 on the Exercise of Health Care Professions, which bear certain special professional titles within the meaning of section 85 of the Act, commonly referred to as "special physicians"; and/or
(2) drugs whose first prescription must be established by a practitioner referred to in paragraph (1) but whose subsequent requirements may be established by a medical practitioner referred to in Article 3, § 1^er, of the co-ordinated Act of 10 May 2015 on the Exercise of Health Care Professions, which is not bearing certain particular professional titles within the meaning of section 85 of the Act, commonly referred to as "general practitioner"; and/or
3) drugs whose prescription and/or administration is reserved for dental practitioners referred to in section 4 of the Coordinated Act of May 10, 2015 on the exercise of health care professions; and/or
(4) drugs for which the delivery is restricted to hospital pharmacists; and/or
(5) large packagings of medicines intended to be used by hospital pharmacists for the delivery of the quantity of this medicine to patients for their treatment; and/or
(6) large packagings of medicines intended to be used by persons authorized to issue drugs in the preparation of individual medications as referred to in Article 12bis, § 3.
When a drug is subject to one or more subcategories referred to in paragraph 3, the Minister or his or her delegate shall specify the subcategories in the MMA or the registration of the drug, and, where applicable, the classification on the basis of the division of paragraph 9. In the cases referred to in paragraph 9, (1) and (2), the Minister or his or her delegate shall also specify the category or categories of specialists authorized to prescribe or administer this medication.
Large packagings of medicines referred to in 9, points 5) and 6) cannot be delivered directly to patients. ".
Section 2. - Exception to the rules for the issuance of medications for human use on the basis of reimbursement conditions
Art. 50. In Article 6, § 2 of the Act, inserted by the Royal Decree of 8 August 1997 and last amended by the Act of 10 April 2014, the following amendments are made:
1° Paragraph 3 is replaced by the following:
"The hospital pharmacist may, in the same way as pharmacists in a public-opened pharmacist, issue medicines for human use and medical devices to outpatients in the course of treatment begun at the hospital or in the outpatient, under the conditions and conditions determined by the King by order deliberately in the Council of Ministers;
2° Article 6, § 2, is supplemented by two sub-paragraphs, as follows:
"The hospital pharmacist can also deliver the following medications to outpatients under the conditions and conditions determined by the King by decree deliberately issued in the Council of Ministers:
1° Orphan drugs;
2° drugs for human use that are subject to a limited medical prescription whose delivery is reserved for hospital pharmacist. ".
The hospital pharmacist may issue medicines for human use to outpatients whose exclusive delivery by a hospital informal was laid as a condition of reimbursement, in accordance with the provisions of article 35bis, § 1^erParagraph 1^er, the Compulsory Health Care and Compensation Insurance Act, coordinated on July 14, 1994. ".
Section 3. - Hospital exemption for innovative therapy drugs
Art. 51. Article 6quater, § 3, of the same law, restored by the law of 1^er May 2006 and amended by the Acts of 29 March 2012, 3 August 2012, 19 March 2013 and 17 July 2015, is supplemented by two paragraphs as follows:
"For drugs referred to in paragraph 1^er at 6/1), absolute traceability is guaranteed and patients are followed. In order to ensure the traceability of the medication and to ensure the monitoring of suspected and actual adverse effects in patients, the personal data of treated patients are processed and stored. These personal data are provided in a form coded by the hospital or health professional concerned to the person who, pursuant to the rules to be established by the King, has an authorization for the preparation of the drug or to the AFMPS.
The person referred to in paragraph 4, in fine, shall keep the data coded for at least one period to be determined by the King. The King sets out the conditions and modalities for this processing and data transmission. ".
Section 4. - Regulatory advice
Art. 52. Article 6sexies of the same law, inserted by the law of 1^er May 2006 and amended by the laws of 3 August 2012 and 22 June 2016, the existing text will form paragraph 1^er, is supplemented by paragraph 2, as follows:
"§2. The King may set the conditions and rules under which the AFMPS provides an interpretation of the legislation in response to concrete and individual questions.
"Interpretation" means the legal act in which the PSMPS sets out, in accordance with the provisions in force, how the law is applied to a particular situation or operation.
An interpretation cannot be given when:
1° the issue concerns situations or transactions that are identical to those already subject to an administrative remedy or judicial action between the AFMPS or the Belgian State and the applicant;
2° an interpretation is not indicated or is without effect under the legal or regulatory provisions invoked in the application;
3° the question concerns the application of a measure imposed by or under this Act or the exercise of public action.
The AFMPS provides, as an administrative authority, interpretation. This one engages the AFMPS for the future, except:
1 if the conditions to which the interpretation is submitted are not fulfilled;
2° if it turns out that the situation or operations are described by the applicant in an incomplete or incorrect manner, or if essential elements of the operations were not made in the manner described by the applicant;
3° in the event of amendments to the provisions of treaties, community law or domestic law that apply to the situation or operation referred to in the interpretation;
4° if it turns out that interpretation is not consistent with the provisions of treaties, community law or internal law.
In addition, the interpretation no longer binds the PSMPS when the main consequences of the situation or operations were modified by one or more related or subsequent elements that are directly or indirectly attributable to the applicant. In this case, the withdrawal of the interpretation results from the day of the facts charged to the applicant.
The interpretations are published on the AFMPS website after deletion of confidential business information. ".
Section 5. - Council of Europe Convention on counterfeiting of medical products and similar offences threatening public health, made in Moscow on 28 October 2011
Art. 53. In article 16bis, § 2, of the same law, inserted by the law of 15 December 2013, the 6th is inserted as follows:
"6° manufactures, imports, puts on the market, puts in service, lets circulate or uses in any capacity a medical device or a medical device for diagnosis in vitro counterfeit. ".
Art. 54. In the same law, an article 16ter is inserted as follows:
"Art. 16ter. The penalties for offences provided for in articles 16, § 1^er, 2°, and § 3, 3° and 4°, and 16bis, § 2, 6°, will be doubled if these offences:
1° caused the death or affected the physical or mental health of the participant;
2° were committed by a person who abuses the confidence that he or she is a health professional, manufacturer or supplier;
3° with respect to supply or supply offences, were committed using large-scale dissemination processes, such as computerized systems, including the Internet;
4° were committed in a criminal organization;
5° were committed by an author already convicted of similar offences. The provisions of Article 18, § 2, apply to the convictions referred to in this point.".
Art. 55. In section 18 of the Act, the current text of which will form paragraph 1^era paragraph 2 is inserted as follows:
"§2. Without prejudice to articles 57bis and 99bis of the Criminal Code, the previous final convictions imposed by the criminal courts of another State party to the Council of Europe Convention on counterfeiting medical products and similar offences threatening public health, made in Moscow on 28 October 2011, are taken into account in the same conditions as the convictions of Belgian criminal courts for offences referred to in articles 16, 1 §^er, 2° and § 3, 3° and 4° and 16bis, § 2, 6°, and they will produce the same legal effects as these convictions. ".
Section 6. - Offence under 6 of the Medical Devices Act of 15 December 2013
Art. 56. Article 16bis, § 1^er, 2°, of the Act of 25 March 1964 on drugs, is supplemented by the d) written as follows:
"(d) contravenes section 62 of the Act of 15 December 2013 on medical devices and the orders made pursuant to this section. ".
Section 7. - Administrative disclosure
Art. 57. In section 17 of the Act, replaced by the Act of 20 October 1998 and amended by the Acts of 15 December 2013 and 17 July 2015, the following amendments are made:
1° paragraph 1^er is replaced by the following:
§ 1^er. In the event of a breach of the provisions of this Act or of its enforcement orders, the grievor-lawyer, holder of the doctorate degree, licence or master's degree in law, designated for that purpose by the Administrator General of the AFMPS, may propose to the alleged offender a transaction whose payment extinguishes public action.
The transaction is sent to the offender within three months from the date of the minutes.
In case of payment of the transaction in the month of its shipment, the grievor-law informs the King's attorney and transmits the original of the minutes and a copy of the proposal of the transaction.
The payment of the transaction extinguishes the public action, unless the King's Attorney notifies the perpetrator of the offence, in the month of the date on which the payment information was sent, that he intends to exercise that action.
If the public action is introduced after payment of the transaction and results in the conviction of the interested party, the amount of the transaction is then charged to the legal costs due to the State and the fine imposed. The potential surplus is returned. In case of acquittal, the amount of the transaction is returned.
In the event of a conditional conviction, the amount of the transaction shall be returned after deduction of court fees.
In the event of non-payment of the transaction in the month of its shipment, the grievor-law informs the King's prosecutor and transmits the original of the minutes and a copy of the proposal of the transaction.
If the grievor-law does not make a transaction proposal, he shall forward the original of the minutes to the King's Attorney within three months from the date of the minutes. The Crown Prosecutor may return the original of the minutes to the grievor-law so that he may propose a transaction to the alleged perpetrator of the offence. This transaction is sent to the offender within three months of the referral.
The rules of procedure and payment procedures referred to in this paragraph may be determined by the King."
2° in paragraph 2, the following modifications are made:
a. Paragraph 3 is replaced by the following:
"When the transaction relates to breaches of the provisions for which, in respect of the person concerned, offences by record had already been found or had already been notified within three years of the date of the finding, the maximum amount of the transaction is doubled. ";
b. Paragraph 5 is replaced by the following:
"A transaction can be proposed both to a legal person and to a natural person. The amount of the fine is determined on the basis of the fine set for the offence without taking into account the possible prison sentence. ";
3° in paragraph 3, the words "worker referred to in § 1^er"are replaced by the words "worker-legal";
4° in paragraph 5, the words "seen to § 1^er"are repealed;
5° Paragraph 6 is repealed;
6° in paragraph 8, the words "provided by § 1^er"are replaced by the words "to propose to the offender a transaction whose payment extinguishes public action,"
Paragraph 9 is repealed.
Section 8. - Criminal sanctions
Art. 58. Article 16bis, § 1^er, 2°, of the same law, inserted by the law of 15 December 2013, is supplemented by the d) written as follows:
"(d) contravenes sections 59 and 60 of the Act of 15 December 2013 on medical devices, as well as its enforcement orders.".
CHAPTER 3. - Amendments to the Act of 7 May 2004 on experiments on the human person
Art. 59. In section 33 of the Human Person Experiments Act of 7 May 2004, as amended by the Acts of 24 July 2008 and 5 February 2016, the following amendments are made:
1° paragraph 1^er is replaced by the following:
§ 1^er. Without prejudice to the application of the penalties provided for by other laws and, if applicable, the application of disciplinary sanctions, is punishable by imprisonment from one month to two years and a fine from 500 euros to 250,000 euros, or only one of these penalties:
1° he who contravenes articles 5 to 10, 12, 17, 19 to 21, 22, § 2, 24, 25, 27, 28, §§ 1^er and 2, 29, § 2, 32, § 1^er;
2° he who buys, possesses, sells, offers for sale, delivers, delivers, delivers, distributes, supplies, imports or exports of experimental drugs that are varied, altered, perished, falsified or imitation or not in accordance with the provisions of this Act;
3° he who has falsified or imity or has made falsify or imitate experimental drugs that are intended to be sold, offered for sale, delivered, delivered, distributed, supplied, supplied, imported or exported;
4° the one in whom have been found experimental drugs that are intended to be sold, offered for sale, delivered, delivered, delivered, distributed, supplied, supplied, imported or exported, and that sells them, offers for sale, delivers, delivers, distributes, supplies, imports or exports knowing that they are damaged, altered, perished, falsified, imitated or not in conformity with the provisions of the law
If the violation of the articles referred to in paragraph 1^er, 1°, caused either a seemingly incurable disease, or a personal incapacity of work more than four months, or the complete loss of the use of an organ, the penalty will be three months to three years and the fine of 1000 euros to 500,000 euros.
Section 16ter of the Drugs Act of March 25, 1964 applies to offences referred to in subsection 1^er2."
2° Paragraph 2 is supplemented by two subparagraphs as follows:
"Without prejudice to articles 57bis and 99bis of the Criminal Code, the previous final convictions imposed by the criminal courts of another State party to the Council of Europe Convention on the Counterfeit of Medical Products and similar offences threatening public health, made in Moscow on 28 October 2011, are taken into account in the same conditions as the convictions imposed by Belgian criminal courts for the offences set out in paragraph 1^erparagraph 2, and they will produce the same legal effects as those convictions.
The attempt to commit an offence under this Act is punishable by the same penalty as that applicable to the offence itself. ";
3° Article 33 is supplemented by paragraph 6 as follows:
§ 6. If there are public health grounds, the judge shall declare the confiscation of falsified, counterfeit, corrupt, altered or non-compliant experimental drugs. ".
CHAPTER 4. - Amendment of the Act of 20 July 2006 on the establishment and operation of the Federal Agency for Drugs and Health Products
Single section. - Perception of retributions
Art. 60. In the Act of 20 July 2006 on the establishment and operation of the Federal Agency for Drugs and Health Products, an article 13/1 is inserted, as follows:
"Art. 13/1. § 1^er. Unless the retribution has been imposed under penalty of inadmissibility, the debtor may file a reasoned administrative appeal within 30 days of receipt of the notice of payment, under penalty of infeiture. If there is no administrative remedy, retribution becomes final.
Under penalty of nullity, the notice of appeal shall be sent to the deputy head of the Agency and shall contain:
1° the signature of the debtor or, in the case of a legal person, the signatures of persons who represent the legal person;
2° the indication if the debtor wishes to be heard;
and
3° a copy of the payment notice.
The deputy head or his or her representative shall determine the amount of the retribution in a decision after the debtor, if requested, has been heard or duly summoned. This decision is notified to the debtor within three months of the introduction of the appeal.
If a decision is not notified within three months as referred to in paragraph 3, the debtor may appeal to the competent court.
§ 2. If an administrative remedy has been introduced in accordance with the provisions of paragraph 1^er, retribution becomes final:
1° at the end of a three-month period, if the debtor has not filed an appeal with the competent court after he has been aware of the decision referred to in paragraph 1^erParagraph 3; or
2° if retribution has been found by means of a judgment or a judgment with force of judgment.
§ 3. The collection and recovery of retributions that have become final in accordance with paragraph 2 is at the request of the Agency by the General Administration of the Perception and Recovery of the Federal Public Service Finance through any legal process, in accordance with Article 3 of the State Law of 22 December 1949. ".
CHAPTER 5. - Amendments to the Act of 6 July 2007 relating to medically assisted procreation and the destination of supernumerary embryos and gametes
Art. 61. In Article 4, paragraphs 1^er and 2, of the Act of 6 July 2007 on medically assisted procreation and the destination of supernumerary embryos and gametes, the words ", aged 45 years maximum" are each replaced by the words "until the day before their 46^Third birthday.
Art. 62. In article 4, paragraph 3, of the same law, the words "can not be carried out in the case of a major woman over the age of 47" are replaced by the words "may be carried out in the case of major women until the day before their 48^Third birthday.
CHAPTER 6. - Amendments to the Act of 15 December 2013 on medical devices
Section 1^re. - Management of the installation, maintenance and withdrawal of medical devices as part of their home use
Art. 63. In the Act of 15 December 2013 on medical devices, a title 5 is inserted, entitled:
"Title 5. Management of the installation, maintenance and withdrawal of medical devices as part of their home use."
Art. 64. In heading 5 inserted by section 63, an article 59 is inserted, which reads as follows:
"Art. 59. Companies that, as part of a patient's medical treatment outside a hospital, install and/or maintain medical devices, must establish, apply and maintain a system of self-control to:
1° ensuring product safety;
2° to ensure the quality of related services;
3° to give the necessary instructions to the patient and health care professionals regarding the correct and safe use of the material;
4° to inform health professionals dealing with incidents or risks of incidents that are known to people who perform the installation or maintenance.
Companies referred to in paragraph 1^er inform responsible health professionals, essential characteristics and risks of devices installed or maintained.
The King may set the principles on which the system referred to in paragraph 1 must be based.^er".
Art. 65. In the same heading 5, an article 60 is inserted, which reads as follows:
"Art. 60. § 1^er. To respond to section 59, the company may use guides approved by the Federal Agency for Drugs and Health Products.
The King shall determine the procedure and procedure for approval referred to in paragraph 1^er.
§ 2. Without prejudice to the provisions laid down by and under Article 6ter, § 3, of the Act of 25 March 1964 on medicines, the King may designate medical devices which, as part of a medical treatment of a patient outside a hospital, must be installed and/or maintained by companies that use a guide that He has designated, which has been approved in accordance with paragraph 1^er.
If the King makes use of the authorization referred to in paragraph 1^er. It also sets out the conditions and conditions under which foreign companies applying an equivalent self-control system under the legislation applicable to them are exempt from the use of the guides referred to in paragraph 1^er.
Companies that install and/or maintain medical devices in accordance with the provisions of paragraph 1^erinform the Federal Agency for Drugs and Health Products. The King may determine the terms of this notification.
Without prejudice to the physician's responsibility for information to the patient, the companies referred to in paragraph 1^er also ensure the necessary instructions given to patients by their staff for the correct use of the material as well as for safe use.".
Section 2. - Amendments to Title 3 of the Act of 15 December 2013 on medical devices
Art. 66. Article 33, § 1^erof the Medical Devices Act of 15 December 2013, the following amendments are made:
(a) the 3° is replaced by the following:
"3° "distributor": any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a product available on the European Union market. ";
(b) in the 4th, the words "any physical or moral person" are replaced by the word "distributor".
(c) the 7° is replaced by the following:
"7° "dispositives" :
- a medical device or an accessory of a medical device;
or
- an active implantable medical device or an active implantable medical device accessory;
or
- a medical device for in vitro diagnosis or an accessory of a medical device for in vitro diagnosis."
(d) paragraph 1^er is completed by the 16th to 18th written as follows:
"16° "manufacturer": the natural or legal person responsible for the design, manufacture, packaging and labelling of a device for the purpose of placing it on the market in his or her own name, whether these operations are carried out by the same person or on behalf of a third person. It is also considered to be a manufacturer, the natural or legal person who assembles, conditiones, treats, refurbishes and/or labels one or more prefabricated products and/or assigns them the destination of a device for placing it on the market in its own name. This rule does not apply to a person who, without being a manufacturer within the meaning of the first sentence, assembles or adapts according to their destination devices already put on the market for an individual patient.
17° "importer": any natural or legal person established in the European Union that puts a device from a third country on the European Union market.
18° "operator": manufacturer, importer or distributor. ".
Art. 67. In Title 3, Chapter 2, of the Act, an article 33/1 is inserted as follows:
"Art. 33/1. This chapter applies to operators, with the exception of the retailer, established in the European Union, who make devices available to retailers or end-users established in Belgium.
This chapter does not apply to retailers referred to in sections 33, § 1^er, 4°, and § 2.
Art. 68. Section 34 of the Act, as amended by the Act of 26 December 2015, is replaced by the following:
"Art. 34. Operators are responsible for an annual contribution of up to 0.426092% on their turnover of medical devices realized the previous calendar year on the Belgian market.
The annual contribution referred to in paragraph 1^er is, for the contribution year concerned, multiplied by the quotient of the deficit to be financed to the budget execution account as referred to in Article 6, § 2, of the Act of 16 March 1954 relating to the control of certain bodies of public interest, the Federal Agency for Drugs and Health Products for the contribution year concerned and the denominator.
The denominator referred to in paragraph 2 is the sum of:
- the maximum annual contribution, not less than 500 euros per distributor;
- the total number of authorizations that are subject to the lump sum contribution referred to in Article 225, § 1^erthe Act of 12 August 2000 on social, budgetary and other provisions multiplied by the maximum amount of the Act.
For the purposes of this section, the deficit to be financed from the performance account is the difference between expenses and revenues for that year before the imputation of this annual contribution and the lump sum contribution referred to in Article 225, § 1^erthe Act of 12 August 2000 on social, budgetary and other provisions.
The quotient is positive and is maximum 1. The Federal Agency for Drugs and Health Products publishes the amount of the quotient on its website before May 31 of the year following the year of contribution.
The annual contribution referred to in paragraph 2 shall be paid by the payment of an advance before December 31 of the relevant contribution year and a balance. The advance is calculated on the basis of the maximum contribution, with a minimum of 500 euros. The balance is refunded.
By derogation from paragraph 6, the PSMPS calculates the advance for the following year of contribution, including the balance if the debtor remains the same.
The amount of 500 euros in this chapter is adjusted annually, according to the September index, to the evolution of the Consumer Price Index. The starting index is that of September prior to the publication of this Act to the Belgian Monitor. The indexed amounts are published in the Belgian Monitor and are due from 1^er January of the year following that during which the adaptation was made.".
Art. 69. In section 35 of the Act, the following amendments are made:
(a) in paragraph 1^er, the words "Distributors" are replaced by the words "Operators";
(b) in paragraph 2, the words "of the distributor" are replaced by the words "of the operator";
(c) in paragraphs 2, 3 and 4, the words "distributor" are replaced by the words "operator".
Art. 70. In section 36 of the Act, the following amendments are made:
(a) paragraph 1^er is supplemented by the following sentence:
"The quotient used to fix the annual contribution is 1."
(b) in paragraphs 2 and 3, the words "distributor" are replaced by the words "operator".
Art. 71. In section 37, paragraph 2, of the same law, the words "to the distributor" are replaced by the words "to the operator".
Art. 72. In Article 38, § 1^erand § 2, paragraph 1^er, from the same law, the words "distributor" are each time replaced by the words "operator".
Art. 73. In section 39, paragraph 1^er, from the same law, the words "to the distributor" are replaced by words to "the operator".
Art. 74. In Article 40, § 1^er, of the same law, the words "is paid" are replaced by the words "as well as that of the advance, are paid".
Art. 75. In section 42, paragraph 1^er, from the same law, the words "the distributor" are replaced by the words "the operator".
Art. 76. In section 45 of the Act, paragraph 1 is replaced by the following:
"If there is no declaration referred to in Article 35, § 3, the contribution may be fixed in accordance with this chapter for a maximum of five years of contribution during which the operator has subtracted from the contribution and before the year of the attachment. ".
Art. 77. In section 50 of the Act, the following amendments are made:
(a) paragraph 1^er is replaced by the following:
"Distributors established in Belgium and distributors established in the European Union who make devices available in Belgium are subject to a prior registration with the AFMPS. ";
(b) in paragraph 2, the words "that it provides to the end user or retailer in Belgium" are replaced by the words "that it makes available";
(c) the article shall be supplemented by two paragraphs as follows:
"The King may set out the terms and conditions under which health professionals referred to in the Coordinated Act of May 10, 2015 on the exercise of health care professions are exempted from the requirement of pre-registration with the PSMPs, or provide for certain adjustments to this obligation for health care professionals covered by the Coordinated Act of May 10, 2015 on the exercise of health care professions.
The King may also determine the conditions and conditions under which distributors who make available or put in service certain medical devices (including certain medical devices for in vitro diagnosis) are exempt from the requirement to register before the AFMPS. These are medical devices and in vitro medical devices whose limited risk does not justify a pre-registration obligation or whose multiple and easy access is of particular importance to public health and could be prevented by this requirement of registration. The King may fix the types of medical devices and/or types of in vitro diagnostic medical devices for which the distributor may be exempted from the pre-registration requirement with the AFMPS. "
Art. 78. This section comes into force on a date determined by the King.
The King provides transitional measures for the registration of distributors that began their activities prior to the coming into force of this section.
Section 3. - Market surveillance of medical devices
Art. 79. In the Act of 15 December 2013 on medical devices, a title 6 entitled:
"Title 6. Market surveillance of medical devices. ".
Art. 80. In Title 6, inserted by Article 79, an article 61 is inserted as follows:
"Art. 61. Distributors referred to in Article 33, § 1^er3°, established in Belgium, may use guides approved by the AFMPS to ensure the quality of the medical devices they distribute.
The King shall determine the procedure for approval referred to in paragraph 1^er".
Art. 81. In the same title, 6, an article 62 is inserted as follows:
"Art. 62. Distributors referred to in section 61 are validly completing a form transmitted by the AFMPS.
The form referred to in paragraph 1^er contains questions relating to the activities of the distributor, the products it distributes, its quality assurance system, and the follow-up to the guides referred to in section 61.
The King specifies the contents of the form referred to in paragraph 1^er and 2, and determine the procedure and procedure for responding to the form".
CHAPTER 7. - Autosufficiency of plasma derivatives
Art. 82. Article 1^er, § 2, of the Act of 5 July 1994 on blood and blood derivatives of human origin is supplemented by the 6th written as follows:
"6° hospital: a hospital as described in Article 2 of the Coordinated Act of 10 July 2008 on hospitals and other care facilities, including university hospitals and hospitals operated by the Ministry of National Defence. ".
Art. 83. In article 4/1, 3° of the same law, inserted by the law of 10 April 2014, the word "of a fixed price" is replaced by the word "of fixed remuneration".
Art. 84. Section 20/1 of the Act, inserted by the Act of 10 April 2014, partially annulled by the Constitutional Court Decision No. 160/2015 and amended by the Act of 26 December 2015, is replaced by the following:
"Art. 20/1. § 1^er. An adjudicator, designated by the Federal Public Service Public Health, Food Chain and Environment Safety in accordance with the Public Procurement Act of 15 June 2006 and certain labour, supplies and services contracts, is responsible for a four-year period:
1° of the treatment of plasma issued by institutions that are approved by the Minister who has Public Health in his or her powers under section 4;
2° the quarantine of the plasma and its maintenance, pending its acceptance, distribution or rejection;
3° assurance, in hospitals, of a sufficient supply of stable plasma derivatives, produced from this plasma in order to meet their obligations on the basis of paragraph 2, and of the establishment and maintenance of a strategic reserve of the products concerned manufactured from this plasma.
For the purposes of this article, are considered to be stable plasma derivatives:
1° normal human immunoglobulins for intravenous administration;
2° albumin solutions:
- albumin 20% solution for intravenous administration;
- albumin 4 and/or 5% solution for intravenous administration.
The King may amend the definitions of immunoglobulins and albumin solutions referred to in paragraph 2.
The court has:
1° of a Certificate of Compliance with Community Legislation for the Permanent Folder of Plasma for Plasma issued by establishments that are approved by the Minister who has Public Health in his or her powers under Article 4 of this Act, referred to in 1.1, Part III of Schedule I to the Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001;
2° of marketing authorizations referred to in Article 6, § 1^erParagraph 1^erthe Act of 25 March 1964 on medicines for stable plasma derivatives;
3° of a traceability system that ensures that the treatment is carried out exclusively on the basis of the plasma issued by registered establishments.
The award-winner guarantees at least:
1° a quarantine reserve corresponding to the volume required for the production of immunoglobulins referred to in paragraph 2 for two months;
2° a strategic reserve in Belgium of stable plasma derivatives corresponding to a sale, by the buyer, of three months.
The King may change the time limits referred to in the preceding paragraph. This amendment does not affect the current market.
In the expectation of the appointment of the Adjudicator, the contractual commitments made by registered establishments prior to the entry into force of this chapter with the SCRL Central Department of Fractionnement of the Red Cross are maintained until 1^er December 2017 at the latest. Stable plasma derivatives produced by the SCRL Central Department of Fractionnement of the Red Cross from this plasma are intended for the market referred to in paragraph 1^er and to ensure the adequate supply of stable plasma derivatives of hospitals.
§ 2. Hospitals provide at least the following stable plasma derivatives to the contractor in accordance with the price and market conditions assigned in accordance with paragraph 1^er :
1° 50% of the immunoglobulins needed for them; and
2° 100% of the albumin solutions they need.
The King is empowered to take all measures for the execution of this article. For this purpose, it shall determine, inter alia, the conditions and modalities for:
1° the hierarchy of indications for which stable plasma derivatives are prescribed in case of a shortage of stable plasma derivatives on the market in order to meet the demand of hospitals (hereinafter: "market dysfunction");
2° the volume of plasma required for self-sufficiency;
3° how market dysfunction is recognized by the Federal Agency for Drugs and Health Products and how the quarantine reserve and strategic reserve referred to in paragraph 1^er, paragraph 6, may be used in the event of market failure."
CHAPTER 8. - Amendment of the Act of 19 December 2008 on the obtaining and use of human body equipment for human medical applications or for scientific research
Art. 85. This chapter partially transposes:
1° Commission Directive 2015/565/EU of 8 April 2015 amending Directive 2006/86/EC with respect to certain technical requirements for the codification of tissues and cells of human origin;
2° Commission Directive 2015/566/EU of 8 April 2015 implementing Directive 2004/23/EC with regard to procedures for verification of equivalent standards of quality and safety of imported tissues and cells.
Art. 86. In section 2 of the Act of 19 December 2008 relating to the obtaining and use of human body equipment for human medical applications or for scientific research purposes, last amended by the Act of 22 June 2016, the following amendments are made:
1° 17° is replaced by the following:
"17° "distribution"; any transportation and supply of human bodily material for special use, including the export of it;"
2° in 18°, the words "or distribution, including import and export" are replaced by the words, ", distribution, or import";
3° the 24° is replaced by the following:
"24° "human bodily material bank": the organized structure that obtains, controls, treats, preserves, stores, distributes and if necessary, human bodily material intended for human medical application. This structure is, without prejudice to Article 8, § 2, only competent to decide on the allocation of human bodily material;"
4° the 26° is replaced by the following:
"26° "Production establishment": the organized structure that can carry out the obtaining, controlling and, where appropriate, import of human body equipment, for the industrial manufacture of innovative therapy drugs as referred to in the Act of 25 March 1964 on drugs, for the purpose of a therapeutic and predetermined use that is exclusively autologous; ";
5° in the 34°, the words "European Union" are replaced by the words "European Economic Area";
6° the article is supplemented by the 38° to 50° written as follows:
38° "unique European code" or "SEC" ("Single European Code"): the unique identifier, composed of a sequence of identification of the gift and a sequence of identification of the product, which is applied to the human body material distributed in the European Union and intended for human medical applications.
39° "donation identification sequence": the first part of the unique European code, composed of the Union's tissue establishment code and the unique number of donations;
40° " Union Tissue Establishment Code": the unique identifier for accredited, designated, authorized or licensed tissue establishments in the European Union. For Belgium, it is the banks of human body equipment and approved intermediate structures and approved production facilities. The Union Tissue Establishment Code is composed of the country's ISO code and the tissue establishment number in the Union's tissue establishment register;
41° "one number of donations": the unique number assigned to a gift of human body material by the human body equipment bank or production facility;
42° "Product identification sequence": the second part of the single European code, consisting of the product code, the sub-lot number and the expiration date;
43° "Product code": the code identifying the specific type of human body material involved. This product code is made up of the product coding system identifier, which indicates the coding system used by the tissue establishment ("E" for EUTC, "A" for ISBT128, "B" for Eurocode), and the number of the tissue or cellular product specified in the corresponding coding system for the product type;
44° "sublot number": the number that uniquely distinguishes and identifies human body material having the same unique gift number and product code and originating from the same human body equipment bank or the same production facility;
45° "expiry date": the date until which human body material can be used;
46° "Registration of tissue establishments of the Union": the register of all tissue establishments referred to in Directive 2004/23/EC of the European Parliament and the Council of 31 March 2004 which are authorized, licensed, designated or authorized by the competent authorities of the Member States and which contains information concerning these establishments and information on the authorization, approval, approval, designation or licence of the establishment;
47° "Save of Union tissue and cellular products": the register of all types of tissues and cells circulating in the European Union and corresponding product codes in the three authorized codification systems (EUTC, ISBT128 and Eurocode);
48° "EUTC": the system for the codification of products for tissues and cells established by the European Union consisting of a register of all types of tissues and cells circulating in the Union and their corresponding product codes;
49° "liberation for circulation": distribution for human application or transfer to another human body equipment bank, intermediate structure, production establishment or a third party, for example for further transformation with or without return;
50° "third country": a country outside the European Economic Area.".
Art. 87. Article 3, § 1^erthe following amendments are made to the Act:
1st paragraph 1^er is replaced as follows:
"This Act applies to the gift, collection, inspection, processing, storage, distribution, import and use of human body equipment and manufactured products derived from human body material for human applications or for scientific research purposes. ";
2° a paragraph written as follows is inserted between subparagraphs 1^er and 2:
"By derogation from paragraph 1^er, this Act applies only to the gift, collection, inspection and importation of human bodily material intended to be used exclusively in manufactured products that are governed by another legislation. ".
Art. 88. In Article 4, § 1^erParagraph 1^er, from the same law, the words "Hospital Law, coordinated on 7 August 1987" are replaced by the words "Coordinated Law of 10 July 2008 on Hospitals and Other Care Institutions".
Art. 89. In article 7, § 4, paragraph 2, of the same law the words "and obtaining" are replaced by the words ", obtaining and importing".
Art. 90. Article 8, § 1^erParagraph 1^er, 7°, of the same Act, as amended by the Act of 19 March 2013, the following amendments are made:
1° the words "or an authorized production establishment" are inserted between the words "who has procured tangible material" and ", or";
2° the words "import by another person other than a registered human body material bank or a notified biobank" are replaced by the words "import by another person other than a registered human body material bank for importation, an authorized production facility for import, or a notified biobank".
Art. 91. Section 14 of the Act is replaced by the following:
§ 1^er. The human bodily material manager within the human bodily material bank, within the intermediate structure or within the production facility ensures the traceability of the human body material contained in the human bodily material bank, the intermediate structure and the production facility respectively.
In the event that human body material is intended for the preparation of innovative therapy medications, traceability is ensured under this Act at least until it is transferred to the drug manufacturer or, if the preparation of the drug takes place in an establishment that has an approval as a production facility, until the preparation begins.
In the event that human bodily material is entrusted to a third party who is neither a bank nor an intermediate structure of human bodily material, the manager ensures that traceability is maintained and that this Act and its enforcement orders are respected.
In the event of the transfer of human bodily equipment between human bodily banks, intermediate structures and production facilities, the various managers of human bodily equipment ensure the continuity of traceability.
All persons who perform sampling or operations with human body equipment shall communicate to the relevant human body equipment managers all the information necessary to ensure traceability.
Any person responsible for the use of human bodily material or the preparation of products by means of human bodily material shall take the necessary measures and shall transmit all information to ensure traceability.
§ 2. Traceability assurance for human bodily equipment intended for human applications is done through the documentation and encoding of human bodily material upon obtaining it.
Encoding is done through the donor identification sequence and, no later than before the distribution of human body material for the human application, the unique European code.
Paragraph 2 is not an application to gametes during a donation between partners. The King sets out the conditions to which encoding must be met in that case.
The King sets out the terms of encoding and documentation referred to in this paragraph. These rules relate in particular to the obligations of human bodily equipment banks, intermediate structures, production facilities and hospitals referred to in Article 4, § 1^er, with respect to encoding and documentation. It also determines the federal Agency's obligations regarding the application and control of encoding and documentation. ".
Art. 92. In section 23 of the Act, as amended by the Act of 17 July 2015, the following amendments are made:
1° in paragraph 1^er a paragraph written as follows is inserted between paragraph 1^er and paragraph 2:
"The control referred to in paragraph 1^er also includes inspections and other supplier control measures established in third countries that export human body equipment to Belgium. ";
2° a paragraph 4/1 is inserted as follows:
§ 4/1. At the duly justified request of another Member State in which human body equipment imported into Belgium is then distributed, the Federal Agency is considering inspecting human body equipment banks and production facilities that import human material, and the activities of any supplier established in a third country or submitting them to other control measures. The Federal Agency decides on appropriate measures to be taken after consulting the Member State that has made the application.
When an inspection is carried out on site following an application under paragraph 1^er, the Federal Agency and the competent authorities of the Member State that has made the application agree on whether and how the Member State that has made the application participates in the inspection. The final decision on this participation belongs to the Federal Agency. The reasons for a decision to refuse such participation are explained to the Member State which has made the application. ";
3° Paragraph 5 is supplemented by a paragraph which reads as follows:
"At the duly justified request of another Member State or the European Commission, the Federal Agency also provides information on the results of inspections and other control measures relating to the banks of human body equipment and production facilities that import human body equipment and human body equipment suppliers in third countries that provide human body equipment to these banks or production facilities."
Art. 93. In the same Act, an article 45/2 is inserted as follows:
"Art. 45/2. Encoding by means of the identification sequence of the gift and the unique European code provided for in Article 14, § 2, does not apply to human body equipment already in stock as of 29 October 2016, provided that the material is released for circulation in the European Union no later than five years after that date and that complete traceability is guaranteed by other means, in particular by the application of the univocal system of identification of the donor King.
"Art. 45/2. Encoding by means of the identification sequence of the gift and the unique European code provided for in Article 14, § 2, does not apply to human body equipment already in stock as of 29 October 2016, provided that the material is released for circulation in the European Union no later than five years after that date and that complete traceability is guaranteed by other means, in particular by the application of the univocal system of identification of the donor King.
Art. 94. The provisions of this chapter come into force on a date determined by the King.
PART 4. - SPF Public Health, Food Chain Safety and Environment
CHAPTER 1^er. - Amendments to the Coordinated Act of May 10, 2015 on the Exercise of Health Care Professions
Section 1^re. - Licensee/master
Art. 95. § 1^er. In the Coordinated Act of 10 May 2015 on the Exercise of Health Care Professions, last amended by the Act of 10 July 2016, the following amendments are made:
1° the word "lightened" is each time replaced by the words "lightened/master";
2° the word "lightened" is each time replaced by the words "lightened/masters".
§ 2. Paragraph 1^er produces its effects from the day the first master's degrees were conferred.
Section 2. - Testing demedicalized
Art. 96. Section 124, 1°, of the Act is supplemented by a paragraph written as follows:
"This provision is also not applicable to persons who pass diagnostic orientation tests to third parties, following a training delivered by a doctor or nurse and after they have been authorized to perform one or more technical services referred to in Article 46, § 1^er, 2°, necessary to pass the aforementioned orientation tests. The document issued by the physician or nurse indicates the identity of the person receiving the authorization necessary to perform the authorized technical services and the duration of the authorization and any additional conditions imposed by the doctor or nurse to perform the technical services or services. The King sets out the list of the relevant diagnostic orientation tests and the purpose of these tests, the conditions for carrying out these tests, as well as the conditions to which the training and authorization granted at its end must respond.".
CHAPTER 2. - Amendments to the Coordinated Law of 10 July 2008 on Hospitals and Other Care Institutions
Section 1^re. - Modernization of terminology
Art. 97. In section 8 of the Coordinated Act of 10 July 2008 on hospitals and other care facilities, the following amendments are made:
1° the 3° is replaced by the following:
"3° must be heard by doctor: the medical art practitioner referred to in Article 3, § 1^erthe Coordinated Act of May 10, 2015 on the Exercise of Health Care Professions";
2° 5° is replaced by the following:
"5° we must hear by nurse: the practitioner of the nursing art referred to in Article 45, § 1^erthe coordinated law of 10 May 2015 referred to above";
3° 7° is replaced by the following:
"7° is to be heard by caregiver: the caregiver referred to in section 59 of the aforementioned coordinated law of 10 May 2015 and attached to the hospital";
4° 9° is replaced by the following:
"9° is to be heard by support staff: all staff members who do not fall within one of the categories of professional practitioners referred to in the coordinated law of 10 May 2015 mentioned above, and who assist nursing staff in their administrative and logistical tasks."
Art. 98. Section 9 of the Act, replaced by the Act of 10 December 2009, is replaced by the following:
"Art. 9. For the provisions of sections 18 to 22, with the exception of section 18, paragraph 2, 1 and Part IV, dental practitioners referred to in section 4, paragraph 1^er, of the co-ordinated Act of 10 May 2015 on the Exercise of Health Care Professions, as well as pharmacists or licensed/masters in the chemical sciences working in the hospital environment who are authorized, in accordance with Article 23, § 2, of the same law to conduct clinical biology analyses, are considered to the hospital physician. ".
Art. 99. Section 13 of the Act is replaced by the following:
"Art. 13. The provisions of sections 23 to 27 applicable to practitioners of nursing art are also applicable to birth attendants attached to the hospital, referred to in article 3, paragraph 2, of the coordinated law of 10 May 2015 on the exercise of health care professions. ".
Art. 100. In section 18 of the Act, as amended by the Acts of March 19, 2013 and April 10, 2014, paragraph 5 is replaced by the following:
"By derogation from paragraph 2, 2°, pharmacists or licensed/masters in the chemical sciences who, in accordance with section 23, § 2, of the coordinated law of May 10, 2015 on the exercise of health care professions, are authorized to perform clinical biology analyses, may be appointed or designated as the head of service of a clinical biology laboratory. ".
Art. 101. In section 30/1 of the Act, inserted by the Act of 27 December 2012 and amended by the Act of 17 July 2015, paragraph 2 is replaced by the following:
"Concerning the imputation of supplements, the King may, by order deliberately in the Council of Ministers, extend the provisions referred to in Article 152, § 2, paragraphs 1^er and 2, and in section 152, § 4, to other categories of health professionals covered by the coordinated law of 10 May 2015 on the exercise of health care professions, exercising in the hospital.".
Art. 102. In section 66, paragraph 2, of the Act, the 3rd is replaced by the following:
"the organization of the dispensation of urgent medical care in collaboration with the medical body, without prejudice to the provisions of section 28 of the coordinated law of May 10, 2015 on the exercise of health care professions. ".
Art. 103. In section 102 of the same law, as amended by the law of 15 December 2013, in the provision at 3°, the word "lightened" is replaced by the words "lightened/masters".
Art. 104. In the same Act, last amended by the Act of 17 July 2015, the following amendments are made in the Dutch text:
1° the word "geneesheer" is each time replaced by the word "arts";
2* the word "geneesheren" is replaced each time by the word "artsen";
3° the word "ziekenhuisgeneesheer" is each time replaced by the word "ziekenhuisarts";
4° the word "ziekenhuisgeneesheren" is each time replaced by the word "ziekenhuisartsen";
5° the word "hoofdgeneesheer" is each time replaced by the word "hoofdarts";
6° the word "geneesheer-diensthoofd" is each time replaced by the word "arts-diensthoofd";
7° the word "geneesheren-diensthoofd" is each time replaced by the word "artsen-diensthoofd";
8° the word "geneesheren-specialisten" is each time replaced by the word "artsen-specialisten";
9° the word "geneesheren-adviseurs" is each time replaced by the word "arten-adviseurs".
Section 2. - Federal Hospitals Council
Art. 105. In the same Act, last amended by the Act of 17 July 2015, the words "National Hospitals Council", the words "National Hospitals Council, Programming and Approval" and the words "National Hospitals Council, Funding Section" are replaced by the words "Federal Hospitals Council".
Art. 106. In Title II of the Act, the title of Chapter II is replaced by the following:
"Chapter II. Mission.
Art. 107. In the same Act, section 32 is replaced by the following:
"Art. 32. The Commission's mission is, in addition to the notices provided in sections 5, 6, 36, 38, 40, 41, 52, 53, 54, 57, 61, 63, 85, 96, 100, 105, 108, 109, 113 and 124, to issue a notice of any hospital programming problem and any problems with the application of the hospital programming for which the federal authority has the power to make a decision, as well as to provide an opinion on any issue The Commission provides an opinion on the cost of care programs.".
Art. 108. In section 33 of the Act, as amended by the Act of 19 March 2013, the following amendments are made:
1° in the first paragraph, first sentence, the words "and sections" are repealed;
2° in the first paragraph, second sentence, the words "The Council and the sections will be composed in such a way as to appoint members who are either particularly familiar with the tasks of the sections" are replaced by the words "The Council will be composed in such a way as to appoint members who are either particularly familiar with the missions of the Council";
Paragraph 3 is repealed.
Art. 109. Section 34 of the Act is replaced by the following:
"Art. 34. The King sets the composition of the Council's office.
The King can create working groups within the Council.
The Council and the Bureau are chaired by the President of the Council appointed by the King.
The office organizes the activities of the Council.
The office shall review and transmit the requests for notice to the relevant working group as appropriate.
The office coordinates, where appropriate, the opinions of the working groups and transmits them to the Minister who has Public Health in his or her duties.
The secretariat of the Council and the Bureau shall be provided by a general official designated by the Minister who has Public Health in his or her functions.
The King sets out the other rules of operation of the Council and determines the time limits in which the notices requested must be provided."
Art. 110. In Part II of the Act, Chapter V, comprising section 35, is repealed.
Art. 111. For the provisions of the same law under the material jurisdiction of the authorities referred to in sections 128, 130 or 135 of the Constitution and in which a notice of the National Hospital Establishments Council is provided, the Council, in its earlier composition of the amendments to this section, continues to exercise its role until the aforementioned authorities establish a proper procedural regulation.
Section 3. - Accuracy on the right to free choice of room in case of hospitalization
Art. 112. In title I^er, chapter V, of the same law, an article 29/1 is inserted as follows:
"Art. 29/1. Regardless of the choice of admission to a single room, a two-bed room or a common room, the patient is entitled to the same quality health care offer.
The offer referred to in paragraph 1^er concerns both the benefits provided to the hospital, the time limit for these benefits, and the doctors who are active in the hospital."
Art. 113. Section 128 of the Act is supplemented by the 13°, which reads as follows:
"13° the person who, in violation of section 29/1, treats patients unevenly. ".
CHAPTER 3. - Amendment of the Programme Law of 27 April 2007
Art. 114. Section 36, 2. of the Program Act of 27 April 2007 is repealed.
CHAPTER 4. - Amendments to the Consumer Health Protection Act of 24 January 1977 concerning food and other products
Single section. - Clarifications and technical adaptations
Art. 115. In section 6 of the Act of 24 January 1977 on the Protection of Consumer Health in respect of food and other products, as amended lastly by the Act of 10 December 2009, the following amendments are made:
1° in paragraph 4, the words " tobacco products" and " tobacco products" are replaced by the words " tobacco products";
2° Paragraph 6 is replaced by the following:
§ 6. It is prohibited to sell, serve or offer any beverage or product with an alcoometric title acquired greater than 0.5% vol to young people under the age of 16.
The person responsible for which this beverage or product has been sold, served or offered may also be held liable in the event of non-compliance.
Any person who intends to buy or consume drinks or other alcohol-based products may be required to prove that they have reached the age of sixteen years.
It is prohibited to sell, serve or offer spirituous beverages as defined in section 16 of the law of 7 January 1998 concerning the structure and rates of excise duty on alcohol and alcoholic beverages, to young people under the age of 18.
The person responsible for which this beverage has been sold, served or offered may also be held liable in the event of non-compliance.
It may be required of any person who intends to buy or consume spirituous beverages to prove that they have reached the age of eighteen.".
Art. 116. In article 7, § 2bis, 2°, third dash, of the same law, inserted by the law of 10 December 1997 and amended by the law of 19 July 2004, the words "the display of the mark of a tobacco product" are replaced by the words "the affixing of the mark of a tobacco product on posters".
Art. 117. Section 11, § 2, paragraph 5, of the Act, last amended by the Act of 10 April 2014, is supplemented by the following sentence: "The conditions for this purpose are elaborated by the Minister. ".
Art. 118. Section 14 of the Act, replaced by the Act of 27 December 2012 and amended by the Act of 10 April 2014, is replaced by the following:
"Art. 14. shall be punished by imprisonment of eight days to six months and a fine of fifty to three thousand euros or of any of these penalties only, that which manufactures or imports and that which, without being the manufacturer or importer, knowingly introduced into the trade of foodstuffs or other products covered by this Act in contravention of Article 6, §§ 4 and 6, and Article 8 and the decrees taken in execution of Articles 2, paragraph 2,^er and 2, 3, 1°, a), 2° to 5°, 4, § 4, 6 and 10. ".
Art. 119. In Article 15, § 3, paragraph 1^er, of the same law, inserted by the law of 10 December 1997, the words ", or enforcement orders of Article 7, § 2, concerning tobacco products" are repealed.
Art. 120. In section 18 of the Act, amended by the Act of 22 March 1989, by the Royal Decree of 22 February 2001 and by the Act of 22 December 2003, a paragraph 4/1 is inserted as follows:
§ 4/1. Persons referred to in Article 11 may seize beverages or other alcohol-based products that have been obtained by unawareness of Article 6, § 6. These people can destroy seized drinks on site. In no case is compensation payable."
PART 5. - Horizontal arrangements
UNIC CHAPTER. - Amendment of the Act of 21 December 2013 to enhance the transparency, independence and credibility of decisions taken and advice rendered in the field of public health, health insurance, food chain security and the environment
Art. 121. Section 2 of the Act of 21 December 2013 to enhance the transparency, independence and credibility of decisions taken and opinions rendered in the field of public health, health insurance, food chain security and the environment is supplemented by the 5th, which reads as follows:
"5° "instances": advisory colleges, committees, commissions and other relevant bodies in the field of public health, health insurance, food chain security and the environment, whose mission is to issue objective opinions and which are composed of members serving in their personal capacity and because of their expertise; proceedings composed of members who represent groups of interest and whose mission is to synthesize and communicate the vision of groups of interest, are excluded from the application of this Act."
Art. 122. In section 3 of the Act, the following amendments are made:
1° the words "by deliberate decree in the Council of Ministers" are repealed.
2° Article 3 is supplemented by a paragraph written as follows:
"The list referred to in paragraph 1 includes only the instances that:
- make decisions that may have an impact on the rights and duties of individual citizens, groups or organizations;
- issuing binding notices to the competent minister or government;
- whether or not political opinions or recommendations form the scientific basis on which the decision-making process is based."
Art. 123. In section 4 of the Act, the following amendments are made:
1° in the second paragraph, the sentence: "The Committee referred to in Article 5, paragraph 1^er, on the basis of the information contained in this general statement of interest, decides on participation in the work, deliberation and votes of the person concerned." is replaced by the sentence: "The proceedings referred to in Article 3 may decide to publish the general statements of interest of their members or experts on a website or to make them public via another channel of communication";
2° in paragraph 3, the words "and to recall, on a regular basis, their obligations in this matter." are repealed;
Paragraph 4 is repealed.
Art. 124. Section 5 of the Act is replaced as follows:
"Art. 5. All instances covered by this Act establish their own conflict of interest management system. A Ethics Committee is established with the Public Health SPF, Food Chain Safety and Environment, which is responsible for analyzing conflict of interest management systems and proposing adjustments.
The Ethics Committee can investigate potential conflicts of interest. This may be, in this case, both conflict of interest mentioned and conflict of interest not mentioned in general statements of interest of persons referred to in Article 4. The Committee may initiate this investigation on its own initiative or as a result of a complaint. If the investigation reveals that a provision of Article 6, § 1^er, was transgressed, the Committee informs the Public Prosecutor ' s Office.
The proceedings referred to in this Act shall communicate their conflict of interest management system and shall transmit the declarations of interest referred to in section 4 to the Ethics Committee which shall register the declarations in a register.
The King specifies the rules of application of this article, including the rules relating to the composition and mode of operation of the above-mentioned Ethics Committee, including a common model for all instances of general declaration of interest. ".
Art. 125. In Article 6, § 2, of the Act, the following amendments are made:
1° in paragraph 1^er, the words "statute, in view of the importance of this conflict of interest, on validity" are replaced by the words "transmit to the competent minister and, if applicable, to the administrative officer to whom the proceeding concerned is instituted, a report on the impact of this conflict of interest on legitimacy";
2° the first paragraph is supplemented by the following:
"On the basis of this report, the competent minister may decide to request a new opinion, a new proposal, recommendation or decision in the proceeding, which then decides without the person involved in the conflict of interest participating in the work. To promote transparency, reports are made public by the Ethics Committee. ".
PART 6. - Mutualities
UNIC CHAPTER. - Amendment of the Act of 6 August 1990 on mutuality and national mutuality unions
Art. 126. Article 44bis, § 1^er, from the law on mutuality and national mutuality unions, inserted by the law of 26 April 2010, paragraph 3 is supplemented as follows:
"3° with a mutualist society referred to in Article 70, § 1^erParagraph 1^er, b), and in Article 70, § 6, which is affiliated with a mutuality which constitutes a section of the mutualist society referred to in Article 70, § 1^erParagraph 1^er, a), 3°, and article 70, § 6."
Art. 127. Section 126 produces its effects on November 30, 2016.
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 18 December 2016.
PHILIPPE
By the King:
The Minister of Social Affairs and Public Health,
Mr. DE BLOCK
Seal of the state seal:
Minister of Justice,
K. GEENS
____
Note
(1)Documents of the House of Representatives:
54-2154/2016/2017
Number 1: Bill.
No. 2: Amendments.
No. 3: Amendment.
N^bones 4 in 5: Reports.
No. 6: Text adopted.
No. 7: Amendments.
No. 8: Supplementary report.
No. 9: Text adopted.
No. 10: Amendments.
No. 11: Text adopted.