Miscellaneous Provisions Act Health

Original Language Title: Loi portant des dispositions diverses en matière de santé

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Published the: 2016-12-27 Numac: 2016024298 SERVICE PUBLIC FEDERAL public health, food chain security and environment 18 December 2016. -Law on miscellaneous provisions health PHILIPPE, King of the Belgians, all, present and future, A salvation.
The House of representatives has adopted and we sanction the following: title 1. -Available introductory Article 1. This Act regulates a matter referred to in article 74 of the Constitution.
TITLE 2. -INAMI Chapter 1. -Changes to the law on compulsory health care and benefits, insurance co-ordinated on 14 July 1994, Section 1. -Graduates in science article (2. article 2 of the law on compulsory health care and insurance benefits, co-ordinated on 14 July 1994, amended last place by the law of 17 July 2015 is complemented by the t) and u) drafted as follows: "(t) by"Bachelor of science", the master in sciences and the owner of the master's degree in science;"
(u) by "degree in dental science", the Bachelor of dental sciences and holder of the diploma of master in dental sciences. "."
Art.
3. article 2 takes effect July 1, 2009.
Section 2. -Commission of reimbursement of medicines art. 4. at article 29bis, paragraph 3, of the Act, inserted by the law of 27 December 2004 and replaced by the Act of 27 December 2005, the following changes are made: (1) the words ", designated for a maximum period of 6 years renewable by the Minister who has social affairs responsibilities among experts working in an academic institution" are replaced by the words "who works in a University ", designated for a maximum period of 6 years renewable by the King";
(2) paragraph is completed with the following sentence: "the president has the right to vote.".
Art. 5 section 4 comes into force on December 31, 2017.
The King may set a date of entry into force earlier than referred to in clause 1.
Section 3. -Agreements art. 6a article 35bis, § 7, of the same Act, inserted by the law of August 10, 2001 and amended lastly by the law of June 22, 2016, the following changes are made: (1) a written paragraph as follows is inserted between paragraphs 1 and 2: "If the drug Commission has made a proposal for motivated refund negative , and that the Minister wishes to deviate from this proposal, but believes that the basis of reimbursement proposed by the applicant is not proportional to the assessment of the criteria referred to in paragraph 2, or if the Minister considers that registration of the specialty on the list of reimbursable specialties includes uncertainties on the budget plan, the Minister may propose to the applicant to enter into an agreement with the Institute , which provides compensation for the compulsory health care and compensation arrangements. ";
each time, (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. -Refund of reference art. 7A section 35ter of the Act, replaced by the Act of 27 December 2005 and amended lastly by the law of June 22, 2016, the following changes are made: (1) in paragraph 1, paragraph 3, the words "and 2" are replaced by the words "2 and 5";
(2) in paragraph 1, paragraph 4, the words "This new basis of repayment" are replaced by the words "the new basis of reimbursement referred to in paragraphs 1 and 2";
(3) paragraph 1 is supplemented by three paragraphs written as follows: 1), with more than one active ingredient, including at least one active ingredient is the same active a specialty " (referred to in article 34, paragraph 1, 5 °, c), 1) for which the provisions of subsection 1, paragraph 1 or 2, are applied.
The new basis of reimbursement referred to in paragraph 5 is calculated in accordance with the provisions of article 35bis, § 2bis, and according to the rules laid down by the King.
Procedures which stated that the reductions referred to in paragraphs 5 and 6 have been applied, are laid down by the King. ";
(4) article is supplemented by a paragraph 13, as follows: "§ § 13 13" March 1, 2017, the basis for reimbursement from specialties referred to in article 34, paragraph 1, 5 °, c), (1), having more than one active ingredient, including at least one active ingredient is the same active ingredient specialty, referred to in article 34, paragraph 1, 5 °, c), 1) for which the provisions of § 1, paragraph 1 or 2, have been applied before March 1, 2017 , is diminished in its own right in accordance with the provisions of § 1, paragraph 6. "."
Section 5. -Record medical electronic art. 8. article 36septies of the same Act, inserted by the law of August 22, 2002, is supplemented by the following sentence: "this fee 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 platform eHealth in accordance with the law of August 21, 2008 relating to the institution and the Organization of the eHealth platform and wearing various provisions.".
Art. 9 section 8 comes into force January 1, 2017.
For practitioners who are recognized as general practitioners before January 1, 2017, article 8 however comes into force January 1, 2021.
Section 6. -Maximum charging art. 10. in article 37duodecies, § 3, of the same Act, inserted by the law of June 5, 2002, the following changes are made: (1) the words "when specific criteria, set by the King, showed" are replaced by the words "when it appears".
(2) the words "resulting in a significant decrease in the income of the household" are replaced by the words "who have for consequence that the household income became less than the amount determined by the King";
(3) the words "based on these elements" are repealed.
Section 7. -Social status of practitioners of the art of nursing art. 11. in the heading of title III, chapter V, section IV, of the same Act, the words ", practitioners of the art of nursing"are inserted between the words "of the speech therapists" and the words "and physiotherapists".
Art. 12. in article 54, § 1, paragraph 1, of the same law, replaced by the Act of 22 December 2003 and amended by the law of 14 April 2014 and 17 July 2015, the following changes are made: (1) the words ", the convention Committee responsible for negotiating and concluding the national convention between practitioners of the art of nursing and insurers "shall be inserted between the words"of the convention Committee to negotiate and conclude the national convention between the speech therapists and insurers"and the words"or of the convention Committee to negotiate and conclude the national convention between physiotherapists and insurers".
(2) the words ", the art of nursing practitioners" are inserted between the words "speech therapists" and the words "or physiotherapists who Member".
Art. 13. in article 54, § 1, paragraph 3, of the same Act, replaced by the Act of 22 December 2003 and amended by the law of December 19, 2008 and April 10, 2014, the words ", the art of nursing practitioners" are inserted between the words "speech therapists" and the words "and physiotherapists".
Section 8. -Transaction art. 14. article 167 of the Act is completed by three paragraphs written as follows: "the general administrator can compromise and compromise in cases where the interests of the Institute are engaged.
Compromise or the transaction is subject to the approval of the competent Management Committee when its object exceeds an amount of € 250,000.
An inventory of transactions and compromise is communicated every six months to the general management committee. "."
Section 9. -Interruption of the prescription of art.
15. in article 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 e-mail message specifying health benefits covered under the practical terms set by the Committee of insurance by a regulation referred to in article 22 (11). ".
Section 10. -Contributions art.
16A article 191, paragraph 1, 15 °, paragraph 4, 1 °, of the same Act, inserted by the Act of June 10, 2006 and amended by laws on July 24, 2008 and December 26, 2013, the last two sentences are replaced as follows: "the King determines procedures and conditions according to which a pharmaceutical speciality, which has lost that status after the end of 10 years market exclusivity" has an extension of this exclusion. The extension is conditional on the absence of reimbursable pharmaceutical alternative. The extension is limited to a maximum of 5 years. "."
Art. 17. in article 191, paragraph 1, (15), paragraph 6, of the same Act, amended lastly by the law of December 23, 2009, the words "and (16)" bis shall be replaced by the words ", 15 m and 16 bis".
Art. 18. in article 191, paragraph 1.

15 °, paragraph 7, of the same Act, amended lastly by the law of 22 June 2012, the words "and 15 ° l" shall be replaced by the words ", 15 l and 15 m.".
Art. 19. article 191, 15 ° undecies of the same Act, inserted by the law of December 22, 2008 and amended by the law of December 23, 2009, is supplemented by the following sentence: "For the year t, from the year 2017, this alternative assessment is more application.".
Art. 20. article 191, paragraph 1, of the Act, amended lastly by the law of March 18, 2016, is complemented by the 15 ° m, written as follows: "15 ° m. For the year t, shall be introduced, beginning in 2017, according to the terms and conditions set to 15 °, an assessment of damages on the turnover achieved in t, as long as the overall budget exceed fixed pursuant to article 69, § 5, be found and established this year t by the general Council of the health care insurance According to the terms set out below.
The amount of the excess referred to in paragraph 1 may be adapted by the general Council, after opinion of the Committee on budgetary control, in order to take account of the impact of the elements of the annual budget, determined by the King, who did not or not entirely produced their effects.
If in November of year t, it is established, on the basis of expenditures of seven first months of the year accounted for by insurers, that there is an overrun, the contribution referred to in paragraph 1 is due to the amount of the cost overrun identified by the general Council.
If in November of year t, it is established, on the basis of these expenses accounted for by insurers, that there are not exceeded, the contribution referred to in paragraph 1 is not due.
The amount of the fee referred to in paragraph 1 is capped. For the year 2016, the ceiling is set at EUR 100 million. Beginning in 2017, the ceiling is set at 2.5% of the overall budget fixed pursuant to article 69, § 5.
Pharmaceutical specialties, reimbursed in accordance with article 37, paragraph 3, are exempt from this fee up to a maximum of 75 sq.f.. The correction factor applied on turnover stated is the result of the multiplication of 75 per cent by the report between expenditures in the plan and total expenditures of the Institute for the specialty concerned. This report is prepared by the Institute on the basis of the latest data known at the time of the passing, which are communicated in accordance with article 206, § 1. For specialties for which the latest data are not known, there is no possible exemption.
This contribution is made through a deposit, established on the basis of the turnover achieved during the year t-1, and with a statement, established on the basis of the turnover achieved during the year t, the percentages fixed by the general Council, by a majority of the votes of the members with voting rights, including the voices of all of the members referred to in article 15 (, paragraph 1, a).
If the majority is not reached at the 1st Monday of the month of December, year t with respect to the percentage of the deposit, and the year t + 1 in what concerns the percentage of the count, the officer official of the health care Service shall inform the Minister. The Minister sets the percentages.
Health care Service inform applicants concerned of the fixed percentages.
Prepayment of dues to be paid by 31 December of year t on account of the sickness-disability insurance national Institute indicating the reference "installment fee indemnitaire year t". The balance of the contribution must be paid by 31 December of year t + 1 on account of the sickness-disability insurance national Institute indicating the reference "balance assessment indemnitaire year t". In the case of fixing of the percentage of the deposit and/or the count by the Minister, the corresponding deadline is postponed 3 months.
Revenues resulting from this indemnity fee entered in the accounts of the insurance mandatory healthcare for the accounting year t. "."
Art. 21. in article 191bis, paragraph 1, of the Act, amended lastly by the law of June 28, 2013, the words "at 15 ° l" are replaced by the words "15 ° m".
Art. 22. in article 191ter, paragraph 1, of the Act, amended lastly by the law of June 28, 2013, the words "at 15 ° l" are replaced by the words "15 ° m".
Art. 23. in article 191quater, paragraph 1, of the Act, amended lastly by the law of June 28, 2013, the words "at 15 ° l" are replaced by the words "15 ° m".
Section 11.
-Of advertising art. 24. in article 218, § 2, paragraph 1, of the same law, replaced by the Act of 7 February 2014, the words ", address (s) of work" are inserted between the words "INAMI number" and the words "and situation of accession to the conventions and agreements".
Section 12. -Control medical art. 25A article 73bis of the same Act, inserted by the law of 13 December 2006 and amended by laws of March 29, 2012 and April 10, 2014, the following changes are made: (1) the 7th is replaced as follows: "(7) to not issue regulatory documents when their issue is mandatory or to write, prepare, deliver or make issue regulatory documents that are irregular without the repayment terms of the health benefits are respondent ";
(2) article 73bis is complemented by the 9 ° and 10 ° drafted as follows: "(9) to accept payments outside the limits referred to in article 53, § 1 1;"
"(10) for not respecting the obligation of the scheme of the third paying such as provided for in article 53, § 1, paragraph 14".
(3) article 73bis is supplemented by a paragraph to read: "these regulatory documents as well are paper documents that documents in electronic form in accordance with article 9bis.".
Art. 26. article 25 (3), comes into force January 1, 2017.
Art.
27. in article 142 of the Act, restored by the law of 13 December 2006 and amended by the law of 27 December 2006, 29 March 2012, 19 March 2013 and April 10, 2014, the following changes are made: (1) in paragraph 1, sub-paragraph 1, (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, (2), the words "(1), (2), (3) and (7)" are replaced by the words "(1), (2), (3), (7), (9) and (10)".
Art.
28. in article 143 of the same Act, restored by the law of 13 December 2006 and amended by the law of December 19, 2008, 29 March 2012 and March 19, 2013, the following changes are made: (1) in paragraph 1, paragraph 1, (2), 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 paragraph 3 of the same law, restored by the law of 21 December 2006 and amended by the law of April 10, 2014 and July 17, 2015, the words "patrimonial documentation" are replaced by the words "collection and recovery".
Art. 30. in article 206bis, § 2, of the same Act, inserted by the Act of January 14, 2002 and amended by the law of April 10, 2014 and July 17, 2015, the words "patrimonial documentation" are replaced by the words "collection and recovery".
Section 13. -New search method SECM art. 31. in article 146 of the Act, amended lastly by the Act of April 10, 2014, it is inserted a paragraph 2/1 as follows: "§ 2/1. To see the offences referred to in article 73bis and calculate the value of benefits improperly reimbursed by insurance compulsory health care, inspection staff referred to the § 1 can, among other things, use the method of checking by sampling and extrapolation.
This method involves: (1) establish the basis of survey by identifying and defining a set of unrelated cases that will be considered.
(2) conduct a random draw on this frame for a sample and document the method of pulling;
(3) analyze the case in this sample and calculate the percentage of the amounts unduly paid by mandatory health care insurance in the sample;
(4) calculate the value below which the percentage of the population sought to estimate, has a probability of less than 2.5% to find;
(5) use this value to calculate the amount to be recovered for all benefits from the frame. "."
Section 14. -Budget healthcare art. 32. in article 18 of the same Act, replaced by the law of January 25, 1999 and amended by the law of 24 December 1999 and August 10, 2001, the royal decree of 17 September 2005 and the Act of December 27, 2012, the following changes are made: (1) in paragraph 1 the words "no later than 15 September of the year preceding the budget year "are replaced by the words" no later than the eighth business day following September 15 of the year

prior to the fiscal year ";
(2) between paragraphs 1 and 2, a new subparagraph is inserted drafted as follows: "The Committee on budgetary control analysis the overall proposal of the Insurance Committee referred to in article 39 concerning compliance with the fiscal framework and the multi-year trip decided by the Council of Ministers and shall issue an opinion to the general Council no later than the third Monday in October."
Art. 33. in article 38 of the same Act, amended by laws of December 12, 1997, 25 January 1999 and 24 December 1999 and by the Decree royal September 17, 2005, the following changes are made: (1) in paragraphs 1 and 2, the words "for funding" are replaced by the words "for the financing of priority adaptations";
(2) in paragraph 2 the words "means" are replaced by "financial resources";
(3) paragraph 1 is supplemented by the following sentence: "these priority adjustments take into account the budgetary framework, multi-year journey and strategic adaptations of existing policy and new policy priorities such as was provided 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 changes also take account of the budgetary framework, multi-year journey and the strategic priorities for new policy and adaptations of existing policy as was provided by the Insurance Committee and the general Council."
(5) in paragraph 3, the words "for priority adjustments" are inserted between the words "necessary financial resources"and the words", from the level expenditure";
(6) two subparagraphs shall be inserted between paragraphs 3 and 4, read: "fees of conventions and agreements shall communicate to no later than 1 September of the year preceding the budget year, financial resources for the financing of priority adaptations.
"Commissions of conventions and agreements provide no later than 1 September of the year preceding fiscal year, proposals for compensatory measures on the one hand, if based on engineering estimates, as established by the Department no later than May 31 of the year preceding the budget year, presumably an overrun of the partial budget objective for which the Committee on conventions and agreements is competent and secondly to possibly finance a new policy."
(7) in paragraph 4, which becomes paragraph 6, the words "30 June" is replaced by "31 May" and the words "no later than 15 days before the first Monday in October" are replaced by the words "no later than 15 September of the year preceding the budget year."
Art. 34. in article 40, § 1, paragraph 1, of the Act, as last amended by the royal decree of September 17, 2005, the first sentence is replaced by the phrase: "insurance in light of the overall proposal of the Insurance Committee referred to in article 39, proposals for cost-saving measures to the Committee on budgetary control referred to in article 18 and the opinion of the Committee on budgetary control on the proposal of the Committee referred to in article 18" the general Council approves insurance health care budget, the overall annual budget goal of health care insurance and partial annual budgetary objectives of the Commissions of conventions or agreements no later than the third Monday in October of the year preceding the budget year."
Art. 35. in article 40 of the same Act, amended lastly by the law of August 10, 2015, paragraph 2 is replaced by the following: "§ § 2 2." In the event of failure to approve the budget and the fiscal target, the general Council shall notify the Minister. In this case, upon proposal by the Minister, the Council of Ministers fixed budget and the amount of the overall annual budget goal of health care insurance, and the partial goals and global budgets of the financial means for the benefits or groups of services to which this system is applicable."
Art.
36. in article 51, § 4, paragraph 2, of the same law, replaced finally by the law of December 19, 2008, the words "15 may" are replaced by the words "30 June".
Art. 37. in article 39 of the Act, amended lastly by the royal decree of September 17, 2005, paragraph 3 is replaced by the following: "the Insurance Committee shall forward to the general Council and the Committee on budgetary control, no later than the first Monday in October of the year preceding the budget year, a comprehensive proposal which meets the standard of growth ", the increase in the index of health referred to in article 40, § 1, paragraph 3, the budget framework, the multi-year journey and the political priorities on the new policy and adjustments of existing policy."
CHAPTER 2. -Modification of the Act of March 31, 2010 on compensation of damage resulting from healthcare (FAM) single Section. -The art patient record access 38. in article 16, paragraphs 1 and 2, of the Act of March 31, 2010 on compensation of damage resulting from health care, the words "access to patient records" are each time replaced by the words "right to consultation and the copy of patient record".
Art. 39. article 38 is effective September 1, 2012.
CHAPTER 3. -Amendment of the law of 27 April 2005 relating to the control of the health care budget and wearing various provisions health art. 40. in article 69, paragraph 21, of the law of 27 April 2005 relating to the control of the health care budget and with various health provisions, inserted by the law of December 26, 2015, the words "§ 1, paragraph 5" shall be inserted between the words "for which article 35ter," and the words "§ 2 or § 2bis".
TITLE 3. -The Federal Agency of medicines and health (FAMHP) Chapter 1 product. -Sunshine act art. 41 § 1. For the purposes of this chapter, means: (1) "business subject to notification": any entity that exercises an economic activity, regardless of its legal form and the way in which it is financed, within the meaning of title VII of the Treaty on the functioning of the European Union, including holders of authorisation for placing on the market of medicines for human or veterinary use , importers, manufacturers and distributors of medicines for use in human or veterinary, persons performing brokering activities of medicinal products for human or veterinary use, as well as distributors, retailers and manufacturers of medical devices.
(2) "Organization of the health sector": any association or organization active on the health care plan, medical or scientific, regardless of its form, legal or organizational, as well as any legal entity by which one or more of the health sector professionals provide services;
(3) "beneficiary": any person enumerated in article 10, § 1, of the law of 25 March 1964 on medicines, a practice or a seat of exploitation or social in Belgium as well as organizations in the sector of health referred to in the 2nd, or any organization of patients having a seat or place fixed in Belgium.
§
2. Companies subject to notification shall notify the Federal Agency of medicines and health products (hereinafter referred to as "the FAMHP") all premiums and all benefits in kind, granted directly or indirectly, from the Belgium or to beneficiaries.
§
3. The obligation set out in paragraph 2 does not apply to premiums and benefits include: (1) the premiums and benefits referred to in article 10, § 2, paragraph 1, 1 °, of the law of 25 March 1964 on medicines;
(2) food and drinks offered as part of scientific events referred to in article 10, § 2, paragraph 1, 2 °, of the law of 25 March 1964 on medicines;
(3) the economic margins and discounts that are part of the usual transactions of purchase and sale of drugs or medical devices by a company subject to notification or between the latter and a beneficiary;
(4) the samples within the meaning of article 12 of the law of 25 March 1964 on medicines.
§ 4. Paragraphs 2 and 3 do not prejudice the provisions of article 10 of the law of 25 March 1964 on medicines.
§
5. The notification may give rise to the payment of a fee whose amount is set by the King.
Art.
42 § 1. The notification referred to in article 41 contains at least: (1) the name and business number of the business subject to notification referred to in article 41, § 2;
(2) the name and business number or number INAMI of beneficiaries, or any other means of unique identification which allows the FAMHP to identify beneficiaries with certainty;
(3) the total amount of premiums and benefits granted during the year concerned complete reference.
The King may lay down rules for the notification referred to in paragraph 1. The King may for the publication referred to in article 43, § 1, determine the categories of premiums and benefits, without prejudice to the provisions of article 10 of the law of 25 March 1964 on medicines.

By way of derogation to paragraph 1, 2 °, premiums and benefits under the experiments referred to in article 2, 11 °, of the law of 7 May 2004 on experiments on the human person in non-clinical studies such as defined in the OECD Principles on Good Laboratory Practice and in clinical trials within the meaning of article 6quinquies of the law of 25 March 1964 on medicines will be reported on an aggregate, not individual basis unless the identity of the beneficiary is notified.
§ 2. Notification by the company subject to notification takes place annually at the latest on 31 May of the year following the end of the year calendar during which premiums and benefits have been granted (hereinafter referred to as the "base year"), and in accordance with the model and to the practical and technical terms determined by the FAMHP.
The King can define minimum requirements on the practical and technical terms referred to in paragraph 1.
§
3. The beneficiaries shall communicate to companies subject to notification the data necessary for the purposes of execution of this article.
Art. 43 § 1. The FAMHP annually publishes the information referred to in article 42 § 1, with the exception of the unique identifiers that are used exclusively for purposes of internal audit at the FAMHP, and § 2, on a single internet site accessible to the public. The publication is in french, Dutch and German.
The premiums and benefits are published on a personal basis.
By way of derogation to paragraph 2, premiums and benefits under the experiments referred to in article 2, 11 °, of the law of 7 May 2004 on experiments on the human person in non-clinical studies such as defined in the OECD Principles on Good Laboratory Practice and in clinical trials within the meaning of article 6quinquies of the law of 25 March 1964 on medicines will be published on an aggregate, not individual basis unless the identity of the beneficiary will not be published.
The publication takes place no later than 30 June of the year following the end of the reference year.
The King may lay down rules for the publication.
§
2. The FAMHP and businesses held in notification shall keep the information referred to in paragraph 1 for ten years from the date of publication in accordance with the provisions of paragraph 1. Businesses held in notification also retain the relevant supporting documents for the same 10-year period.
Art. 44 § 1.
The King can accept an organization to accomplish the missions of the FAMHP under sections 41 to 43, in the name and for account of the FAMHP, to the following: § 1.
The King can accept an organization to accomplish the missions of the FAMHP under sections 41 to 43, in the name and for account of the FAMHP, to the following: (2) a majority of the members is composed of actors in the field of health care, as members representatives of healthcare professionals, organisations of patients, the pharmaceutical industry and medical devices industry;
(3) the Organization has a procedure ensuring strict application of the provisions of this chapter, including technical and practical modalities of the notification and publication;
(4) the Organization has a system of quality and a management body which monitors compliance with the approval conditions. Each sector of the pharmaceutical industry and medical devices is represented on that body;
(5) the presence of a representative of the Minister who has the public health responsibilities is provided by statute. The delegate who is appointed within the FAMHP attends meetings of the Board of management of the organization.
§ 2. The organization referred to in paragraph 1 provides access to the FAMHP in all documents and information which are necessary for the exercise of its powers of control.
§ 3.
The FAMHP may conduct audits and inspections in the organization referred to in paragraph 1.
The Organization submits annually an assessment by the FAMHP to verify that the organization meets the conditions for approval. The Organization shall communicate each year to the FAMHP a complete and detailed report of activities, as well as any other information that the FAMHP asks.
If evaluation annual or an audit or inspection, irregularities are noted, the FAMHP can impose corrective measures to remedy those irregularities. The respect of these corrective measures is controlled through inspections or to additional audits.
The audit report and the annual report are provided to the Minister and to the FAMHP.
§ 4. The organization referred to in paragraph 1 may be funded through the fee determined under section 41, § 5.
Art.
45 § 1. The request for approval under section 44, is addressed to the Minister by registered mail.
Under penalty of inadmissibility, the request is accompanied by a dossier on the conditions for approval referred to in article 44, § 1, and including the statutes coordinated procedures internal and a list of members.
The reasoned decision of the Minister is communicated within 30 days to the applicant by registered mail.
§ 2. Any changes to the statutes of the organization or members is 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 for approval or if the mission referred to in article 42 is not assured;
(1) for serious reasons if the organization no longer meets the conditions for approval or if the mission referred to in article 42 is not assured.
Art. 46. articles 14, 17 of the law of 25 March 1964 on medicines and 14bis apply to this chapter.
Art. 47 is punished with a fine of 200 to 15,000 euros, one who violates the provisions of articles 41 or 42.
Art. 48 § 1. 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 the obligations provided for in articles 41 and 42.
This exemption applies to premiums and benefits granted by holders of authorisation for placing on the market of medicines for veterinary use, importers, manufacturers and distributors of veterinary drugs and persons engaged in brokerage of drugs for veterinary use.
The exemption applies only to veterinary activities of the companies subject to notification.
The exemption expires at a date to be determined by the King, at the latest one year after the entry into force of this chapter.
CHAPTER 2. -Amendments to the law of 25 March 1964 on medicines Section 1.
-Specific licensing statutes art. 49. in article 6, § 1erbis of the law of 25 March 1964 on medicines, inserted by the law of 1 May 2006 and amended by the law of August 3, 2012, the following changes are made: (1) in paragraph 3, fourth indent, the words "reserved for some groups of specialists and/or the issue is reserved for hospital pharmacists" are replaced by the words "reserved for certain specialist circles";
(2) paragraph 1erbis is complemented by three subparagraphs, written as follows: "for the purposes of paragraph 3, fourth indent, means 'medicines for some specialized circles' (: 1) medicines including prescription and administration is reserved for practitioners of the medical art referred to in article 3, § 1, of the coordinated Act of 10 may 2015 on the exercise of the professions of health care" which are carriers of some professional individual securities within the meaning of section 85 of this Act, commonly referred to as "specialists"; (and/or (2) the medication the first requirement must be established by a practitioner referred to in point 1) but whose subsequent requirements may be established by a practitioner of the medical art referred to in article 3, § 1, of the coordinated Act of 10 may 2015 on the exercise of the professions of health care, who is not a holder of some professional individual securities within the meaning of section 85 of this Act commonly called "GP";
and/or (3) drugs with the prescription and administration is reserved for practitioners of dentistry covered by article 4 of the coordinated Act of 10 may 2015 on the exercise of the professions of health care; and/or (4) the drugs issue is reserved for hospital pharmacists; and/or (5) the large packaging of drugs intended to be used by hospital pharmacists for the issuance to the patients of the amount necessary for their treatment. and/or (6) the large packaging of drugs intended to be used by persons authorized to deliver drugs in preparation for individual medication as referred to in article 12bis, paragraph 3.
When a drug is submitted to one or more subcategories referred to in paragraph 3, the Minister or his delegate says this or these subcategories in the WMA or record of the drug, as well as, where applicable,

the classification on the basis of the division of clause 9. In the cases referred to in paragraph 9, 1 and 2), the Minister or his delegate precise also the class or classes of medical specialists allowed to prescribe, or to administer this medication.
(The large packaging of drugs referred to in clause 9, 5 points) and 6), cannot be supplied directly to the patients. "."
Section 2. -Exception to the rules of issue of medicines for human use based on repayment terms art.
50. in article 6, § 2 of the same Act, inserted by the order royal on 8 August 1997 and amended lastly by the Act of April 10, 2014, the following changes are made: (1) paragraph 3 is replaced by the following: "can the hospital pharmacist, in the same way that pharmacists in a pharmaceutical dispensary open to the public, deliver drugs for human use and medical devices to outpatients as part of treatment at the hospital or on an outpatient basis, under the terms and conditions determined by the King by Decree deliberated in the Council of Ministers;
(2) article 6, § 2, is completed by two paragraphs, written as follows: "the hospital pharmacist may also issue the following drugs in ambulatory patients under the terms and conditions determined by the King by Decree deliberated in the Council of Ministers: (1) orphan drugs;"
(2) the human drugs which are subject to a limited prescription delivery is reserved for the hospital pharmacist. "."
The hospital pharmacist can deliver drugs for human use in ambulatory patients whose exclusive issuance by a hospital pharmacy been asked as a condition of reimbursement, in accordance with the provisions of article 35bis, § 1, paragraph 1, of the law on compulsory health care and benefits, insurance co-ordinated on 14 July 1994. "."
Section 3. -Hospital exemption for the therapy medicinal products art. 51. article 6, paragraph 3, of the same law, restored by the law of 1 May 2006 and amended by the laws of the March 29, 2012, August 3, 2012, 19 March 2013 and 17 July 2015, is completed by two paragraphs written as follows: "(Pour les médicaments visés à l'alinéa 1er àle point 6/1), absolute traceability is guaranteed and the patients are followed." In order to ensure the traceability of the drug and to keep track of real and suspected adverse reactions in patients, personal data of patients treated are processed and stored. These personal data are provided in coded form by the hospital or the health professional concerned to the person who, pursuant to the rules established by the King, has permission to preparation of the drug, or the FAMHP.
The person referred to in paragraph 4, in the end, retains these coded data for at least a period to be fixed by the King. The King sets the terms and conditions of this treatment and transmission of data. "."
Section 4. -Notice regulation art. 52. article 6sexies of the same Act, inserted by the law of 1 May 2006 and amended by the law of August 3, 2012 and 22 June 2016, which the text existing form paragraph 1, is supplemented by a paragraph 2, to read: "§ § 2 2." The King can establish the conditions and rules under which the FAMHP gives an interpretation of the legislation in response to concrete and individual issues.
"Interpretation", refers to the legal act in which the FAMHP fixed, in accordance with the provisions in force, the way in which the law is applied to a particular transaction or situation.
An interpretation can be given when: (1) the issue concerns situations or operations that are identical to those already subject to an administrative review or a writ between the FAMHP or the Belgian State and the applicant;
(2) an interpretation is not specified or has no effect under the legal or regulatory provisions referred to in the application;
(3) the issue concerns the application of a measure imposed by or under this Act or the exercise of public action.
The FAMHP provides, as an administrative authority, interpreting. It committed the FAMHP for the future, except: (1) if the conditions to which the interpretation is subject are not met;
(2) if it turns out that the situation or operations are described by the applicant of incompletely or incorrectly, or if essential parts of the operations have not been realized as described by the applicant;
(3) in the case of modification of the provisions of the treaties, Community law or the law internal that apply to the situation or operation covered by the interpretation;
(4) if it turns out that the interpretation is not consistent with the provisions of the treaties, Community law or the law internal.
In addition, the interpretation is more binding the FAMHP when the main consequences of the situation or operations have been modified by one or several elements related or subsequent which are directly or indirectly attributable to the applicant. In this case, the withdrawal of interpreting an effect from the day of the facts imputed to the applicant.
The interpretations are published on the website of the FAMHP after deletion of confidential commercial information. "."
Section 5.
-Convention of the Council of Europe on counterfeiting of medical products and similar crimes threatening public health, made in Moscow on 28 October 2011 art. 53. in article 16bis, § 2, of the same Act, inserted by the law of December 15, 2013, it is inserted the 6 ° to read: "(6) manufactures, matter, puts on the market, put into service, let flow or uses in any capacity, whether a medical device or a medical device of diagnosis in vitro counterfeit.".
Art. 54. in the same Act, it is inserted a 16ter article as follows: "art.
16ter. the punishment of the offences provided for in articles 16, § 1, 2 °, and § 3, 3 ° and 4 °, and 16bis, § 2, (6), will be doubled if these offences: (1) caused death or have infringed the physical or mental health of the participant;
(2) have been committed by a person abusing the trust conferred on him by his quality of professional health, manufacturer or supplier;
(3) with regard to the offences of supply or offer to supply, have been committed using methods for wide dissemination, such as computer systems, including the internet;
(4) have been committed as part of a criminal organization;
(5) have been committed by an author already sentenced for offences of the same nature.
The provisions of article 18, § 2, apply to the convictions referred to in this point. "."
Art.
55. in article 18 of the same law, the current text will form the 1st paragraph, inserted a paragraph 2 as follows: "§ § 2 2." Without prejudice to sections 57A and 99bis of the penal Code, the previous final convictions pronounced by the criminal courts of another State party to the Convention of the Council of Europe on counterfeiting of medical products and similar crimes threatening public health, made in Moscow on 28 October 2011, are taken into account under the same conditions as the convictions handed down by Belgian criminal courts for the offences referred to in articles 16 , § 1, 2 °, and § 3, (3) and (4) and 16bis, § 2, (6), and they will produce the same legal effects as these convictions. "."
Section 6. -Violation of title 6 of the Act of 15 December 2013 for medical devices art.
(56. article 16bis, § 1, 2 °, of the law of 25 March 1964 on medicines, is complemented by the d) to read: "(d) violates article 62 of the law of 15 December 2013 for medical devices and orders made pursuant to this article.".
Section 7. -Transaction administrative art. 57. in article 17 of the same Act, replaced by the law of October 20, 1998 and amended by law of December 15, 2013 and 17 July 2015, the following changes are made: (1) paragraph 1 is replaced by the following: "§ 1." Breaches of the provisions of this Act or orders of execution, official-lawyer, holder of doctorate degree, license or master in law, designated for this purpose by the general administrator of the FAMHP, may propose to the alleged perpetrator of the offence a transaction whose payment off public action.
The transaction is sent to the author of the offence within three months from the date of the report.
In case of payment of the transaction within one month of its shipment, the official lawyer informs the public prosecutor and passes on the original of the minutes and a copy of the transaction proposal.
Payment for the transaction turn off public action, unless the public prosecutor shall notify the author of the offence, within one month of the date on which the payment information was addressed to it, he intends to bring this action.
If public action is introduced after payment of the transaction and involves the conviction of the person concerned, the amount of the transaction is then charged fees

of justice due to the State and the pronounced fine. Any surplus is returned. In case of acquittal, the amount of the transaction is returned.
In case of a conditional sentence, the amount of the transaction is returned after deduction of the costs of justice.
In the event of non-payment of the transaction within one month of its transmission, the official lawyer informs the public prosecutor and passes on the original of the minutes and a copy of the proposal of the transaction.
If the official jurist does not transaction proposal, it shall forward the original of the minutes to the King's Prosecutor within a period of three months from the date of the report. The King's Prosecutor may return the original of the minutes to the official lawyer so that he proposed a transaction that the alleged perpetrator of the offence. This transaction is sent to the author of the offence within three months of the referral.
The rules of procedure and the terms of payment referred to in this paragraph may be laid down by the King. ";
(2) in paragraph 2, the following changes are made: a. paragraph 3 is replaced by the following: "When the transaction involves violations of the provisions for which, with respect to the person concerned, offenses by minutes had already been found or had been the subject of a warning within three years from the date of the finding, the maximum amount of the transaction is doubled.";
(b) paragraph 5 is replaced by the following: "a transaction may be offered as well to a legal person to a natural person. The amount of the fine is determined on the basis of the fine for the offence without taking account of any imprisonment. ";
(3) in paragraph 3, the words "official concerned in the § 1" are replaced by the words "official-lawyer";
(4) in paragraph 5, the words "referred to the § 1" are repealed;
(5) paragraph 6 is repealed;
(6) in paragraph 8, the words "provided by the § 1" are replaced by the words "to suggest to the author of the offence a transaction whose payment off public action,";
(7) paragraph 9 is repealed.
Section 8. -Penalty criminal art. (58. article 16bis, § 1, 2 °, of the same Act, inserted by the law of December 15, 2013, is complemented by the d) to read: "(d) contrary to articles 59 and 60 of the Act of 15 December 2013 for medical devices, as well as its implementation orders.".
CHAPTER 3. -Changes in the law of 7 May 2004 on experiments on human art. 59. in article 33 of the law of 7 May 2004 on experiments on the human person, modified by the law of 24 July 2008 and February 5, 2016, the following changes are made: (1) paragraph 1 is replaced by the following: "§ 1." Without prejudice to the penalties provided for by other laws and, if the application of disciplinary sanctions, is punished with imprisonment of one month to two years and a fine of 500 euros to 250,000 euros, or one of those penalties only: (1) who contravenes sections 5 to 10, 12, 17, 19-21, 22 , § 2, 24, 25, 27, 28, §§ 1 and 2, 29, § 2, and 32, § 1;
(2) one who buys, possesses, sells, offers for sale, delivers, book, distributes, provides, matter or exports damaged, altered, obsolete, altered or imitated experimental drugs or not comply with the provisions of this Act;
(3) who has forged or imitated or did falsify or imitate experimental drugs that are to be sold, offered for sale, delivered, delivered, distributed, provided, imported, or exported;
(4) those who have found experimental drugs that are to be sold, offered for sale, delivered, delivered, distributed, supplied, imported or exported, and who sells, offers for sale, delivers, book, distributes, provides, matter or exports knowing they are damaged, altered, outdated, falsified, imitated or not comply with the provisions of this Act.
If the violation of the items covered in the paragraph 1, 1 °, caused either a disease appearing incurable, or an incapacity to work of more than four months, or loss of use of a body, punishment will be of three months to three years and fine of 1,000 euros to EUR 500 000.
Article 16ter of the law of 25 March 1964 on medicines shall apply to the offences referred to in paragraph 1, paragraph 2. ';
(2) paragraph 2 is supplemented by two paragraphs written as follows: "without prejudice to sections 57A and 99bis of the penal Code, the previous final convictions pronounced by the criminal courts of another State party to the Convention of the Council of Europe on counterfeiting of medical products and similar crimes threatening public health, made in Moscow on 28 October 2011 , are taken into account in the same conditions as the convictions handed down by Belgian criminal courts for offences provided for in paragraph 1, paragraph 2, and they will produce the same legal effects as these convictions.
The attempt to commit an offence under this Act is punished by the same penalty as that applicable to the offence itself. ";
(3) article 33 is complemented by paragraph 6 to read: "§ § 6 6" If there are reasons of public health, the judge pronounces the confiscation of forged, counterfeit, corrupted, altered, or noncompliant experimental drugs. "."
CHAPTER 4. -Modification of the law of July 20, 2006 on the creation and the functioning of the Federal Agency for medicines and health products unique Section. -Perception of payments art. 60. in the law of July 20, 2006 on the creation and the functioning of the Federal Agency for medicines and health products, it is inserted an article 13/1, to read: "art. 13/1. § 1. Unless the compensation has been set under penalty of inadmissibility, the taxpayer may appeal administrative motivated within 30 days of receipt of the notice of payment, under pain of nullity. If there is no administrative appeal, compensation becomes final.
Under penalty of nullity, the notice of appeal is addressed to the Deputy Head of the Agency and contains: (1) the signature of the person liable or, in the case of a legal person, the signatures of the people representing law the legal person;
(2) the indication if the taxpayer wishes to be heard;
and (3) a copy of the notice of payment.
The Chief Executive or his representative the amount of compensation in a decision once the person liable, if he asked, has been heard or duly summoned. This decision is notified to the person liable within three months after the introduction of the remedy.
If notification of decision within the three months referred to in paragraph 3, the person liable may before the competent court.
§ 2. If an administrative appeal was introduced in accordance with the provisions of paragraph 1, compensation becomes final: (1) at the end of a period of three months, if the person liable has not introduced to appeal to the competent court once he had knowledge of the decision referred to in paragraph 1, paragraph 3; or (2) if compensation were found by means of a judgment or a stop with force of res judicata.
§ 3. The perception and the recovery of payments become final in accordance with paragraph 2 is done at the request of the Agency by the General Administration of Perception and the recovery of Service federal public finance by any law, in accordance with article 3 of the national law of December 22, 1949. "."
CHAPTER 5. -Amendments to the law of 6 July 2007 on medically assisted procreation and the destination of supernumerary embryos and gametes art. 61. in article 4, paragraphs 1 and 2, of the law of 6 July 2007 on maximum reproductive medically assisted and the destination of the supernumerary embryos and gametes, the words ", 45 years old" are replaced by the words "up to the day preceding their 46ieme birthday" every time.
Art. 62. in article 4, paragraph 3, of the Act, the words "can only be performed in women over the age of 47 years, major" are replaced by the words "can be performed in major women until the day preceding their 48th birthday".
CHAPTER 6. -Amendments to the law of December 15, 2013 for medical devices Section 1. -Management of installation, maintenance and the withdrawal of medical devices in their use to home art. 63. in the law of 15 December 2013 for medical devices, it is inserted a title 5, entitled: "title 5. Management of installation, maintenance and removal of medical devices as part of their home use."
Art. 64. in title 5 inserted by article 63, it is inserted a section 59, written as follows: "art. 59. the companies which, in the context of medical treatment of a patient outside of a hospital, install and/or maintain medical devices, must establish, implement and maintain a self-assessment system to: (1) to ensure the safety of the products;
(2) to guarantee the quality of services;
(3) to give

the necessary instructions to the patient and treating health professionals with regard to the correct and safe use of the equipment;
(4) inform the health professionals treating incidents or risks of incidents which have knowledge people who carry out installation or maintenance.
The undertakings referred to in paragraph 1 shall inform the health professionals responsible, of the essential characteristics and risks of the devices installed or maintained.
The King can establish the principles on which must rest the system referred to in paragraph 1. "."
Art. 65. in the same title 5, inserted a section 60, written as follows: "art. 60 § 1. In response to article 59, the company can use guides approved by the Federal Agency for medicines and health products.
The King determines the procedure and the terms of the approval referred to in paragraph 1.
§
2. Without prejudice to the provisions set by and under article 6ter, paragraph 3, of the law of 25 March 1964 on medicines, the King may appoint medical devices which, in the context of medical treatment of a patient outside of a hospital, must be installed and/or maintained by companies who use a guide whom he has appointed which has been approved in accordance with paragraph 1.
If the King made use of the authorisation referred to in paragraph 1.
He also established the terms and conditions according to which foreign companies which apply a system of self-checking equivalent under the legislation that applies to them, are exempt from the use of the guides referred to in paragraph 1.
Companies that install or maintain medical devices in accordance with the provisions of paragraph 1, shall inform the Federal Agency for medicines and health products. The King may lay down the details of this notification.
Without prejudice to the responsibility of the physician with respect to information to the patient, the undertakings referred to in paragraph 1 shall also instructions given to patients by their staff for the correct use of the equipment as well as regarding the safe use. "."
Section 2. -Changes of title 3 of the Act of 15 December 2013 for medical devices art. 66. in article 33, § 1, of the law of 15 December 2013 for medical devices, the following changes are made: has) 3 is replaced by the following: "(3) 'distributor': any physical or legal person forming part of the supply chain, other than the manufacturer or the importer, who makes a product available on the market of the European Union.";
(b) in the 4th, the words "any physical or moral person" shall be replaced by the word "distributor".
(c) (7) is replaced by the following: "(7)"devices":-a medical device or accessory of a medical device;"
or - an active implantable medical device or active implantable medical device accessory;
or - a medical diagnostic device in-vitro or accessory of a medical diagnostic device in vitro. ";
(d) paragraph 1 is supplemented by the 16 ° to 18 ° drafted as follows: "(16)"manufacturer": the natural or legal person responsible for the design, manufacturing, packaging and labelling of a device with a view to its placing on the market on his own behalf, that these operations are performed by that person or on his behalf by a third party." Is also considered as a manufacturer, the physical or legal person who assembles, conditions, deals, refurbishes and/or labels one or more prefabricated products and/or assigns the destination of a device with a view to its placing on the market under his own name. This rule does not apply to the person who, without being a manufacturer within the meaning of the first sentence, assembles or adapts according to their destination of devices already placed 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 market of the European Union.
18 ° "operator": manufacturer, importer or Distributor. "."
Art.
67. in title 3, Chapter 2, of the Act, it is inserted an article 33/1 to read: "art.
33/1. This chapter applies to operators, with the exception of the retailer, established in the Union European, which make devices available to retailers or end users established in Belgium.
This chapter does not apply to dealers referred to in sections 33, § 1, 4 °, and § § 2 2 "."
Art. 68. article 34 of the same Act, amended by the law of December 26, 2015, is replaced by the following: "art. 34. operators are liable to an annual contribution of a maximum of 0,4026092% on their sales of medical devices the previous calendar year on the Belgian market.
The annual contribution referred to in paragraph 1 is, for the year of contribution concerned, multiplied by the quotient of the deficit to fund to the account of the budget as referred to in article 6, § 2, of the Act of 16 March 1954 on the control of some public interest organizations, of the Federal Agency of medicines and health products for the year of contribution concerned and the denominator.
The denominator referred to in paragraph 2 is the sum of:-the maximum annual contribution, which may be less than 500 euros per Distributor.
-the total number of authorizations that are subject to the flat-rate contribution referred to in article 225, § 1, of the law of 12 August 2000 of the social, budgetary and diverse provisions and multiplied by the maximum amount thereof.
For the purposes of this article, the deficit to finance the execution account is the difference between expenditures and revenues for this year before the posting of this annual contribution and the flat-rate contribution referred to in article 225, § 1, of the law of 12 August 2000 of the social, budgetary and diverse provisions.
The quotient is positive and is maximum 1. The Federal Agency for medicines and health products publishes the amount of the quotient on its website by May 31 of the year following the year of contribution.
The annual contribution referred to in paragraph 2 is set by an advance payment before 31 December of the year concerned contribution and a balance. The advance is calculated based on the maximum contribution, with a minimum of 500 euros. The balance is repaid.
Notwithstanding paragraph 6, the FAMHP calculates the advance, for the contribution next year, including the balance if the debt remains the same.
The amount of 500 euros of this chapter is adapted annually, depending on the index for the month of September, to the evolution of the consumer price index. The starting index is that of September preceding the publication of this law in the Official Gazette. The indexed amounts are published in the Official Gazette and are due January 1 of the year following that during which the adaptation was made. "."
Art. 69. the provisions of article 35 of the same Act, the following changes are made: has) in the paragraph 1, the words "Distributors" are replaced by the words "Operators";
(b) in paragraph 2, the words "the Distributor" are replaced by the words "the operator";
(c) in paragraphs 2, 3 and 4, the words "the Distributor" are each time replaced by the words "the operator".
Art.
70. section 36 of the Act, the following changes are made: has) 1st paragraph is completed with the following sentence: "the quotient used for fixing of the annual contribution is 1.";
(b) in paragraphs 2 and 3, the words 'distributor' are each time replaced by the words "the operator".
Art. 71. in article 37, paragraph 2, of the Act, the words "the Distributor" are replaced by the words "the operator".
Art.
72. in article 38, § 1, and § 2, paragraph 1, of the same law, the words "the Distributor" are each time replaced by "operator".
Art.
73. in article 39, paragraph 1, of the Act, the words "the Distributor" are replaced by the words "the operator".
Art. 74. in article 40, § 1, of the Act, the words "gets paid" are replaced by the words "as well as that of the advance are paid".
Art.
75. in article 42, paragraph 1, of the Act, the words "the Distributor" are replaced by the words "the operator".
Art. 76. in article 45 of the same Act, the first paragraph is replaced by the following: "in the absence of declaration referred to in article 35, § 3, the contribution can be set under this chapter for a maximum of five years of contribution, during which the operator is exempted from the contribution and prior to the year of the fixation.".
Art.
77. A section 50 of the Act, the following changes are made: a) paragraph 1 is replaced by the following: "distributors established in Belgium and distributors based in the European Union which make devices available in Belgium are subject to prior registration with the FAMHP.";
(b) in paragraph 2, the words "that it provides to the end user or the retailer in Belgium", are replaced by the words "that it offers".

(c) the article is completed by two paragraphs written as follows: "the King may fix the terms and conditions according to which the health professionals referred to in the Act coordinated 10 may 2015 relative to the exercise of the professions of health care are exempt from the obligation of registration with the FAMHP or predict certain adaptations to this obligation for professionals of health referred to in the Act coordinated 10 may 2015 relative to the exercise of professions" health care.
The King may also fix the terms and conditions according to which distributors who service or make available certain medical devices (including some medical devices vitro) are exempt from the obligation of prior registration with the FAMHP. It is medical devices and medical devices in vitro which limited risk does not justify an obligation of prior registration or multiple and easy access is of particular importance for public health and could be prevented by this registration requirement. The King may determine the types of medical devices and/or types of medical devices for diagnosis in vitro for which the Distributor may be exempt from the requirement of prior registration with the FAMHP."
Art. 78. This section comes into force on a date determined by the King.
The King provides for transitional measures for the registration of dealers who started their activities before the entry into force of this section.
Section 3. -Monitoring of the market of medical devices art.
79. in the law of 15 December 2013 for medical devices, it is inserted a title 6 title: 'title 6. The market of medical devices surveillance. "."
Art. 80. in the title, 6, inserted by section 79, it is inserted a section 61 to read: "art. 61. the distributors referred to in article 33, § 1, 3 °, established in Belgium, can use guides approved by the FAMHP, to ensure the quality of the medical devices they distribute.
The King determines the procedure for the approval referred to in paragraph 1. "."
Art.
81. in the same title 6, inserted a section 62 drafted as follows: "art. 62. the distributors referred to in article 61 validly complete a form provided by the FAMHP.
The form referred to in paragraph 1 contains questions related to the activities of the Distributor, to the products it distributes to its quality assurance system, as well as the follow-up of the guides referred to in article 61.
The King says the content of the form referred to in paragraphs 1 and 2, and determines the procedure and modalities of response to the form".
CHAPTER 7. -The self-sufficiency of the plasma derivatives art. 82. the article 1, § 2, of the law of July 5, 1994 on blood and derivatives of blood of human origin is completed by the 6th drafted as follows: "(6) Hospital: a hospital such as described in article 2 of the coordinated Act of 10 July 2008 on hospitals and other care facilities, including hospitals and hospitals operated by the Department of national defence.".
Art. 83. in article 4/1 (3) of the Act, which was inserted by the Act of April 10, 2014, the word "fixed price" is replaced by the word "fixed compensation".
Art. 84. article 20/1 of the same Act, inserted by the Act of April 10, 2014, partially annulled by the judgment of the Court constitutional No. 160/2015 and amended by the law of December 26, 2015, is replaced by the following: "art. 20/1. § 1.
A successful tenderer, designated by the federal public Service health, food chain security and environment in accordance with the law of 15 June 2006 on public procurement and some contracts for works, supplies and services, is responsible for a period of four years: (1) to the treatment of the plasma issued by institutions that are approved by the Minister who has the public health responsibilities under section 4;
(2) to the quarantine of plasma and its maintenance, pending its acceptance, its distribution or its rejection;
(3) insurance, hospitals, a sufficient offer of stable plasma derivatives produced from plasma in order to fulfil their obligations on the basis of paragraph 2, and the constitution and maintenance of a strategic reserve of the concerned products manufactured from plasma.
For the purposes of this article, are considered to be stable plasma derivatives: (1) the immuno-globulins human normal for intravenous administration.
(2) the albumin solutions:-albumin 20% solution for intravenous administration.
-albumin 4 or 5% solution for intravenous administration.
The King may change the definitions of immunoglobulins and albumin solutions referred to in clause 2.
The successful tenderer has: (1) a certificate of compliance with Community legislation for the permanent of the plasma for plasma record issued by institutions that are approved by the Minister having health in its attributions under section 4 of this Act, referred to in 1.1, of part III of annex I to Directive 2001/83 / EC of the European Parliament and of the Council of 6 November 2001;
(2) to permissions on the market, referred to in article 6, § 1, paragraph 1, of the law of 25 March 1964 on medicines, for the stable plasma derivatives;
(3) a traceability system that ensures that the treatment is carried out exclusively on the basis of plasma issued by approved establishments.
The contractor guarantees at least: (1) a reserve of 40 corresponding to the volume required for production, for two months, immunoglobulins referred to in clause 2;
(2) a strategic reserve, in Belgium, of stable plasma derivatives corresponding to a sale by the purchaser, of three months.
The King can change the periods referred to in the preceding paragraph. This change has no impact on the current market.
Pending the appointment of the preferred bidder, the contractual commitments made by institutions registered prior to the entry into force of this chapter with the Central SCRL Department of fractionation of the Red Cross are maintained until December 1, 2017 at the latest. The stable plasma derivatives produced by SCRL Central Department of the Red Cross from this plasma fractionation, are intended for the market referred to in paragraph 1 and to ensure the adequate supply of stable plasma derivatives of hospitals.
§ 2. Hospitals procure at least following with the successful bidder and this stable plasma derivatives, in accordance with the price and conditions of contract pursuant to paragraph 1: (1) 50% of immunoglobulins which are necessary; and (2) 100% albumin solutions they need.
The King is empowered to take all measures for the enforcement of this section. For this purpose it determines conditions and modalities: (1) the hierarchy of the indications for which stable plasma derivatives are prescribed in case of shortage of stable plasma derivatives on the market to meet demand from hospitals (hereinafter: "market failure");
(2) the volume of plasma required for self-sufficiency;
(3) the way in which the market failure is found by the Federal Agency of drugs and products of health and how the reserve of quarantine and the strategic reserve referred to in paragraph 1, subparagraph 6, can be used in the event of market failure. "."
CHAPTER 8. -Modification of the law of 19 December 2008 on obtaining and use of human body material intended for human medical applications or for scientific research purposes art.
85. the present chapter partially transposes: (1) the 2015-565-EU Commission directive of 8 April 2015 amending directive 2006/86/EC regarding certain technical requirements for the codification of the tissues and cells of human origin;
(2) the 2015-566-EU Commission directive of 8 April 2015, which implements directive 2004/23/EC with regard to the procedures for verifying the equivalent standards of quality and safety of tissues and cells imported.
Art.
86 A, article 2 of the law of 19 December 2008 on the use of human body material intended for human or for purposes of scientific research, medical applications and obtaining amended lastly by the law of June 22, 2016, the following changes are made: 17 ° (1) is replaced by the following: "17 ° 'distribution'; all transport and any supply of human body material for special use, including export; ";
(2) in the 18th, the words "or distribution, including import and export" are replaced by the words, ", distribution, or import";
the 24 ° (3) is replaced by the following: "24 °"human body material bank": the organized structure that gets, control, treats, keeps, stores, distributes and if any matter, human body material intended to"

human medical application. This structure is, without prejudice to article 8, § 2, only competent to decide on the allocation of the human body material ";
26 ° (4) is replaced by the following: "26 °"production facility": the organized structure that can make obtaining, control and where applicable the importation of body material human, for the manufacturing of therapy medicinal products as referred to in the law of 25 March 1964 on medicines, and for therapeutic and predetermined use which is exclusively autologous;";
(5) in the 34 °, the words 'the European Union' shall be replaced by the words 'European economic area';
(6) article is complemented by the 38 ° to 50 ° written as follows: 38 ° "single European code" or "SEC" ("Single European Code"): ID unique, consisting of a sequence of identification of the gift and a sequence for the identification of the product, which is applied to the human body material distributed in the European Union and intended for human medical applications.
(39) "sequence for the identification of the gift": the first part of the single European code, composed of code Te of the Union and the unique number of donation;
40 ° "Te of the Union code": ID unique for institutions of tissue accredited, designated, authorised or licensed in the Union European. For Belgium, it's the banks of human body material and approved intermediary structures and approved production facilities. The Te of the Union code consists of the ISO code of the country and the number of the establishment of tissue in the register of tissue of the Union institutions;
(41) "unique number": the unique number assigned to a gift of human body material by the Bank of human body material or production facility.
42 ° "product identification sequence": the second part of the unique European code composed of code of product, number of sublot with the expiration date;
43 ° "product code": the code that identifies the specific type of body material concerned human. This product code consists of the identifier of the codification system of the product, which indicates the coding system used by the facility of tissue ("E" for EUTC, "A" for ISBT128, 'B' to Eurocode), and tissue product number or cell under the system of coding corresponding to the type of product;
(44) "number of sublot": the number that distinguishes and identifies uniquely human body material with the same unique number and the same product code and from the same bank of human body material or of the same production facility;
45 ° "expiration date": the date until which the human body material can be used.
46 ° "register of tissue of the Union institutions": the registry of all tissue establishments referred to in directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 who are authorized licensees licensed, appointed or approved by the competent authorities of Member States and which contains information regarding such institutions as well as information on the authorization accreditation, designation or the license of the facility;
47 ° "register products tissue and cell of the Union": the register of all types of tissues and cells circulating in the European Union and corresponding product codes in three coding systems allowed (EUTC, ISBT128 and Eurocode);
48 ° "EUTC": the codification system of products for tissues and cells set up by the European Union consisting of a registry of all types of tissues and cells circulating in the Union and their corresponding product codes.
49 ° "release for circulation": distribution for human application or transfer to another bank of human body material, intermediate structure, production facility or a third party, for example for further processing with or without return.
(50) "third country": a European country outside the economic area. "."
Art. 87. in article 3, § 1, of the Act, the following changes are made: (1) paragraph 1 is replaced by the following: "this Act applies to the gift, to the taking, obtaining, control, processing, preservation, storage, distribution, import and use of human body material and of manufactured products derived from human body material" intended for human applications or for scientific research purposes. ';
(2) a written paragraph as follows is inserted between paragraphs 1 and 2: "by way of derogation to paragraph 1, this Act applies only to the gift, collection, obtaining, control and importation of human body material intended to be used exclusively in manufactured products that are governed by other legislation.".
Art. 88. in article 4, § 1, paragraph 1, of the same law the 'law on hospitals, coordinated on 7 August 1987' is replaced by the words "Act coordinated 10 July 2008 on hospitals and other care facilities".
Art. 89. in article 7, § 4, paragraph 2, of the Act the words "and getting" are replaced by the words ", obtaining and importing".
Art.
90. in article 8, § 1, paragraph 1, 7 °, of the law, amended by the law of March 19, 2013, the following changes are made: (1) the words "be an approved production establishment" are inserted between the words "who gave the body material" and "either";
(2) the words "import by another person that a Bank of human body material accredited or notified BioBank" are replaced by the words "the importation by a person other than a Bank of human body material approved for import, a facility approved for import, or a notified BioBank".
Art. 91. article 14 of the Act is replaced by the following: "§ 1." Human human within the Bank of body material body material Manager, within the structure of the intermediary or in the establishment of production ensures traceability of human body material content in respectively the Bank of human body material, the intermediate structure and the production facility.
Where human body material is intended for the preparation of the therapy medicinal products, traceability is ensured in respect of this Act at least until his transfer to the drug's manufacturer or, if the preparation of the drug takes place within an institution that has an approval as a production facility, up to the moment where preparation begins.
In the case of human body material is entrusted, for an operation to a third party who is not a Bank, or an intermediate structure of human body material, the manager ensures that traceability is maintained and that the Act and its implementation orders are respected.
Assignment of human body material between banks of human body material, intermediate structures and production facilities, different human body material managers ensure continuity of traceability.
All individuals conducting tests or operations with human body material, communicate to managers of human body material necessary to guarantee traceability information.
Any person responsible for the use of human body material or preparation of products through human body material, takes the necessary measures and transmits information to ensure traceability.
§
2. Insurance of traceability for the human body material intended for human applications is done by the documentation and encoding of the human body material upon obtaining it.
The encoding is done through the sequence of identifying the gift and, at the latest prior to the distribution of the unique human body material for human application of the European code.
Paragraph 2 is not applicable to the gametes during gift between partners. The King sets the conditions to address in this case where the encoding.
The King sets the terms encoding and the documentation referred to in this paragraph. These rules cover in particular the obligations of banks of human body material, intermediate structures, production establishments and hospitals referred to in article 4, § 1, with respect to the encoding and the documentation. It also determines the obligations of the Federal Agency regarding the application and the documentation and encoding control. "."
Art. 92. A section 23 of the Act, amended by the law of 17 July 2015, the following changes are made: (1) in paragraph 1 a written paragraph as follows is inserted between paragraph 1 and paragraph 2: "the control referred to in paragraph 1 also includes inspections and other measures of control of suppliers established in third countries exporting human body material to the Belgium.";

(2) there is inserted a paragraph 4/1 as follows: "§ 4/1.
Request duly justified another State member in which the material body human imported in Belgium is then distributed, the Federal agency plans to inspect the banks of human body material and production facilities that import human body material, and the activities of any provider established in a third country or submit them to other control measures. The Federal Agency decides the adequate measures to be taken after consultation with the Member State making the request.
When an inspection is conducted on as a result of a request referred to in paragraph 1, the Federal Agency and the competent authorities of the Member State making the request agree on the question of whether and how the Member State making the request participates in the inspection.
The final decision on this participation belongs to the Federal Agency. The reasons for a decision of refusal of this participation are explained to the Member State making the request. ";
(3) paragraph 5 is supplemented by a paragraph to read: "request duly justified the Commission or another Member State European, the Federal Agency provides also information on the results of inspections and other control measures related to human body material banks and institutions of production that matter human body material and suppliers of human body material established in third countries that provide human body material to these" banks or production plants. "."
Art. 93. in the same Act, it is inserted a section 45/2 to read: "art. 45/2. Encoding using the sequence of the gift and the single European code identification provided for in article 14, § 2, does not apply to the human body material already in stock at October 29, 2016, provided that the material is released for circulation in the European Union at the latest within five years of that date and that full traceability is guaranteed by other means in particular through the application of the unequivocal identification of the donor system described by the King.
"Art. 45/2. Encoding using the sequence of the gift and the single European code identification provided for in article 14, § 2, does not apply to the human body material already in stock at October 29, 2016, provided that the material is released for circulation in the European Union at the latest within five years of that date and that full traceability is guaranteed by other means in particular through the application of the unequivocal identification of the donor system described by the King.
Art. 94. the provisions of this chapter enter into force at a date to determined by the King.
TITLE 4. -FPS health, food chain security and environment Chapter 1. -Changes in the coordinated Act of 10 may 2015 on the exercise of Section 1 health care professions.
-Bachelor/master art. 95. § 1. In the coordinated Act of 10 may 2015 on the exercise of the professions of health care, amended lastly by the law of July 10, 2016, the following changes are made: (1) the word "licensed" is every time replaced by the words "Bachelor/master".
(2) the word "dismissed" is every time replaced by the words ' licensees/masters'.
§ 2. Paragraph 1 has effect from the day where the first master's degrees were conferred.
Section 2. -Demedicalized Testing art. 96. article 124, 1 °, of the same law is supplemented by a paragraph to read: "this is not either application to people who put others to tests of diagnostic and orientation at the end of training issued by a doctor or a nurse, and after receiving approval from the latter to perform from third parties one or more technical benefits referred to in article 46 '' , § 1, 2 °, necessary to make the above orientation test. The document issued by the doctor or nurse indicates the identity of the person receiving the necessary permission to perform technical services authorized and the duration of this authorization and any additional conditions posed by the doctor or nurse to perform the technical services. The King fixed the list of diagnostic orientation tests involved and the purposes of these tests, the conditions of these tests, as well as the conditions under which training and an authorisation granted to an end must meet. "."
CHAPTER 2. -Amendments to the Act coordinated on July 10, 2008, on hospitals and other healthcare Section 1. -Modernization of the terminology of art. 97. in article 8 of the Act coordinated 10 July 2008 on hospitals and other healthcare facilities, the following changes are made: 3 ° (1) is replaced by the following;
"(3) should be understood by the doctor: medical art practitioner referred to in article 3, § 1, of the coordinated Act of 10 may 2015 on the exercise of the professions of health care";
5 ° (2) is replaced by the following;
"(5) means by nurse: nursing practitioner referred to in article 45, § 1, of the coordinated Act of 10 may 2015";
7 ° (3) is replaced by the following;
"(7) means an orderly: the care worker referred to in article 59 of the coordinated Act of 10 may 2015 above and attached to the hospital";
9 ° (4) is replaced by the following;
"(9) is meant by support staff: all staff members are not one of the categories of professional practitioners in the coordinated Act of May 10, 2015, and that help the nursing staff for their administrative and logistical tasks;".
Art.
98. article 9 of the same law, replaced by the law of December 10, 2009, is replaced by the following: "art. 9. for the provisions of articles 18 to 22, with the exception of article 18, paragraph 2, 1 °, and title IV, practitioners of dentistry referred to in article 4, paragraph 1, Act coordinated 10 may 2015 relative to the exercise of the professions of health care, as well as pharmacists or licensees/masters in chemical sciences working in the hospital who are authorized in accordance with article 23, § 2, of the Act to conduct analyses of clinical biology, are assimilated to the hospital doctor. "."
Art. 99. article 13 of the Act is replaced by the following: "art. 13. the provisions of sections 23 to 27 apply to practitioners of the art of nursing, are also apply to the midwives attached to hospital, referred to in article 3, § 2, of the Act on 10 may 2015 relative to the exercise of the professions of health care coordinated. "."
Art. 100. in article 18 of the same Act, amended by laws of March 19, 2013 and April 10, 2014, paragraph 5 is replaced by the following: "by way of derogation to paragraph 2, 2 °, pharmacists or licensees/masters in chemistry who, in accordance with article 23, § 2, of the coordinated Act of 10 may 2015 on the exercise of the professions of health care" , are authorized to carry out analyses of clinical biology, can be named or appointed head of a laboratory of clinical biology. "."
Art. 101. in article 30/1 of the same Act, inserted by the Act of 27 December 2012 and amended by the law of 17 July 2015, paragraph 2 is replaced by the following: "regarding settlement of supplements, the King may, by Decree deliberated in the Council of Ministers, extend the provisions referred to in article 152, § 2, paragraphs 1 and 2, and article 152 , § 4, to other categories of health professionals covered by the coordinated Act of 10 may 2015 on the exercise of the professions of health care, working in the hospital. "."
Art.
102. in article 66, paragraph 2, of the same law, the 3rd is replaced by the following: "the Organization of the dispensation of any urgent medical care in collaboration with the medical body, without prejudice to the provisions of article 28 of the coordinated Act of 10 may 2015 relative to the exercise of the professions of health care.".
Art. 103. A section 102 of the Act, amended by the law of December 15, 2013, in the provision on the 3rd, the word "redundant" is replaced by the words ' licensees/masters'.
Art.
104. in the same Act, amended lastly by the law of 17 July 2015, the following changes were made in the Dutch text: (1) the word "geneesheer" is replaced each time by the word "arts";
2 * each time, the word "geneesheren" is replaced by the word "artsen";
each time, (3) the word "ziekenhuisgeneesheer" is replaced by the word "ziekenhuisarts";
(4) the word "ziekenhuisgeneesheren" is replaced each time by the word "ziekenhuisartsen";
each time, (5) the word "hoofdgeneesheer" is replaced by the word "hoofdarts";
(6) the word "geneesheer-diensthoofd" is replaced each time by the word "arts-diensthoofd";
(7) the word "geneesheren-diensthoofd" is each time be replaced by the word "artsen-diensthoofd";
(8) the word "geneesheren-specialisten" is replaced each time by the word "artsen-specialisten";
(9) the word "geneesheren-advisers" is each time be replaced by the word "artsen-advisers".

Section 2. -Federal Council of hospital facilities art. 105. in the same Act, amended last by Act of 17 July 2015, the words "National Council of hospitals", the words "National Council of hospital facilities, programming and approval section" and the words "National Council of hospital facilities, financing section" are each time replaced by "Federal Council of hospitals".
Art.
106. in title II of the same law, the title of chapter II is replaced by the following: "chapter II. Mission".
Art. 107. in the same Act, article 32 is replaced by the following: "art.
32. the Council, in addition to the notice provided for in articles 5, 6, 36, 38, 40, 41, 52, 53, 54, 57, 61, 63, 85, 96, 100, 105, 108, 109, 113 and 124, issue an opinion on any issue of Hospital program and on any application problem of programming to hospitals for which the Federal Authority has decision-making power as well as an opinion on any problem which, under this Act coordinated, with regard to the financing of hospitals. The Council will formulate an opinion on the elements of the cost of care programs. "."
Art. 108. in article 33 of the same Act, amended by the law of March 19, 2013, the following changes are made: (1) in the first paragraph, first sentence, the words "and sections" are repealed;
(2) in the first paragraph, second sentence, the words "Council and sections will be compound to nominate individuals who are either particularly familiar with the missions of the sections" are replaced by the words "The Council will be composed so as to nominate individuals who are either particularly familiar with the missions of the Council";
(3) section 3 is repealed.
Art. 109. article 34 of the Act is replaced by the following: "art. 34. the King determines the composition of the bureau of the Council.
The King can create groups of work within the Council.
The Board and the Board are chaired by the president of the Council appointed by the King.
The office organizes the activities of the Council.
The office reviews requests for advice and passes it, as appropriate, to the relevant working group.
The office coordinates, as appropriate, the views of the working groups and transmits these to the Minister who has the public health responsibilities.
The secretariat of the Council and of the bureau is provided by a general officer designated by the Minister who has the public health responsibilities.
The King the other rules of functioning of the Board and determines deadlines in which requested reviews should be provided. "."
Art. 110. in title II of the same law, chapter V, with section 35, is repealed.
Art. 111. for the provisions of the Act under the jurisdiction of the authorities referred to in articles 128, 130 or 135 of the Constitution and in which a notice of the national Council for hospital establishments is planned, this Council, in its composition prior to this section changes, continued to exercise its role until the moment where the abovementioned authorities put in place a procedural regulation.
Section 3. -Precision on the right to the free choice of the room in case of hospitalization art. 112. in title I, chapter V, of the same Act, it is inserted an article 29/1 to read: "art. 29/1. Whatever the choice of an admission in a single room, double room and common room, the patient is entitled to the same offer of quality health care.
The offer referred to in paragraph 1 concerns both the services provided at the hospital, the period in which these benefits are available, only physicians who are active in the hospital. "."
Art. 113. article 128 of the Act is completed by ° 13, to read: "(13) those who, in violation of section 29/1, treats patients of unevenly.".
CHAPTER 3. -Modification of the programme law of 27 April 2007 art.
114. article 36, 2., of the programme law of 27 April 2007 is repealed.
CHAPTER 4. -Changes to the law of 24 January 1977 on the health protection of consumers with respect to food and other products unique Section. -Clarifications and technical adaptations art. 115 A article 6 of the law of 24 January 1977 on the protection of the health of consumers in what concerns food and other products, amended lastly by the law of December 10, 2009, the following changes are made: (1) in paragraph 4, the words "tobacco products" and "tobacco products" shall be replaced by the words "tobacco products";
(2) paragraph 6, is replaced by the following: "§ § 6 6" It is forbidden to sell, serve or deliver any drink or product having an acquired alcoholic strength higher than 0.5% vol at the age of sixteen.
The person in charge on behalf of which this drink this product has been sold, served or offered can also be held responsible for any breach of this prohibition.
It may be required of any person who intends to purchase or consume beverages or other products with alcohol to prove that she has reached the age of sixteen.
It is forbidden to sell, serve or offer some spirit drinks as defined in article 16 of the law of 7 January 1998 on the structure and rates of excise duty on alcohol and alcoholic, beverages to children under the age of eighteen years.
The person in charge on behalf of which this drink has been sold, served or offered can also be held responsible for any breach of this prohibition.
It may be required of any person who intends to purchase or consume spirituous beverages to prove that she has reached the age of eighteen years. "."
Art. 116. in article 7, § 2bis, (2), third indent, of the Act, inserted by the law of 10 December 1997 and amended by the law of July 19, 2004, the words "display of the brand of a tobacco product" are replaced by the words "the application of the mark to a product of tobacco on posters".
Art. 117 article 11, § 2, paragraph 5, of the Act, as last amended by the Act of April 10, 2014, is supplemented by the following sentence: "the conditions therefor are developed by the Minister.".
Art. 118 article 14 of the same Act, replaced by the law of 27 December 2012 and amended by the Act of April 10, 2014, is replaced by the following: "art.
14 is punished with imprisonment from eight days to six months and a fine of fifty to three thousand euros or one of these penalties, who makes or imports and that, without being the manufacturer or the importer, knowingly enters the trade of foodstuffs or other products covered by this law in breach of article 6 (, §§ 4 and 6, and article 8 and to the orders taken in implementation of articles 2, paragraphs 1 and 2, 3, 1 °, a), and 2 ° to 5 °, 4, § 4, 6 and 10. "."
Art. 119. in article 15, § 3, paragraph 1, of the Act, inserted by the law of 10 December 1997, the words ", or the implementation orders of article 7, § 2, relating to tobacco products" are repealed.
Art. 120. in article 18 of the same Act, amended by the law of March 22, 1989, by the royal decree of 22 February 2001 and the Act of 22 December 2003, it is inserted a paragraph 4/1 as follows: "§ 4/1. The persons referred to in article 11 may proceed with the seizure of drinks or other products with alcohol that has been obtained through lack of article 6, § 6. These people can destroy seized drinks on the spot. Any compensation is due. "."
TITLE 5. -Horizontal provisions chapter one. -Amendment of the law of December 21, 2013, to enhance transparency, the independence and the credibility of the decisions and opinions in the field of public health, the health, the safety of the food chain and environmental art. 121. article 2 of the law of December 21, 2013, to enhance transparency, the independence and the credibility of the decisions and opinions in the field of public health, Medicare, safety of the food chain and the environment is completed by 5, to read: "5 °"bodies": the Advisory colleges, committees, commissions and other bodies in the field of health public" Medicare, safety of the food chain and the environment, whose mission is to provide objective advice and which are composed of members serving in a personal capacity and because of their expertise; bodies composed of members that represent interest groups and who have a mission to synthesize and communicate the vision of interest groups, are excluded from the application of this Act. "."
Art. 122 A article 3 of the Act, the following changes are made: (1) the words "by Decree deliberated in the Council of Ministers" are repealed.
(2) article 3 is supplemented by a paragraph to read: "the list referred to in paragraph 1 includes only bodies which:- either take decisions which may have an impact on the rights and duties of individual citizens, groups or organizations;"
-either to emit opinions to binding on the Minister or the competent Government.

-either to emit opinions or policy recommendations forming the scientific basis for decision-making. "."
Art. 123 A article 4 of the Act, the following changes are made: (1) in the second paragraph, the sentence: "The Committee referred to in article 5, paragraph 1, on the basis of the information contained in this general declaration of interest, statue on the participation in the work, deliberation and the vote of the person concerned" shall be replaced by the sentence: "the bodies referred to in article 3 may decide to publish the general declarations of interests of their members or experts on a website or make them public through another channel of communication";
(2) in paragraph 3, the words "and recalling, at regular intervals, their obligations in the matter." are repealed;
(3) section 4 is repealed.
Art.
124. article 5 of the same Act is replaced as follows: "art. 5. all proceedings under this Act establish their own conflicts of interest management system. An Ethics Committee is set up with the FPS health, food chain safety and environment, who is responsible to analyze conflicts of interest management systems and propose adjustments.
The Ethics Committee can open an investigation into the potential conflicts of interest. It may be, in this case, both of mentioned conflict of interest conflicts not mentioned in the general declarations of interests of persons referred to in article 4. The Committee may launch this investigation on its own initiative or following a complaint. If the investigation reveals that a provision in article 6, § 1, has been infringed, the Committee shall inform the public prosecutor.
Proceedings under this Act communicate their conflicts of interest management system and transmit the declarations of interest referred to in article 4 to the Ethics Committee that records them in a register.
The King says the rules of application of this article, including the rules relating to the composition and mode of operation of the Ethics Committee and including a common template to all instances of general statement of interest. "."
Art.
125. in article 6, § 2, of the Act, the following changes are made: (1) in paragraph 1, the words "decide, in the light of the importance of this conflict of interest, on the validity" are replaced by the words "send to the competent Minister and, where appropriate, the official leader of the administration with which the body concerned is established, a report on the impact of the conflict on the legitimacy";
(2) the first paragraph is completed by the following sentences: "on the basis of this report, the competent Minister may decide to request a review, a new proposal, recommendation or decision to the instance, who shall then decide without the person involved in the conflict of interest is involved in the work.
To promote transparency, the reports are made public by the Ethics Committee. "."
TITLE 6. -Mutual single chapter. -Modification of the law of 6 August 1990 on mutual societies and the national unions of mutual societies art. 126. in article 44A, § 1, of the law on mutual societies and the national unions of mutual societies, inserted by the Act of April 26, 2010, paragraph 3 is completed as follows: "(3° avec une société mutualiste visée à l'article 70, § 1er, alinéa 1er, b), and article 70, § 6, which is affiliated with a health insurance fund, which is a section of the mutual company referred to in article 70" (, § 1er, alinéa 1er, a), (3), and article 70, § 6. "
Art.
127. article 126 effect November 30, 2016.
Enact this Act, order that it self clothed with the seal of State and published in the Moniteur belge.
Given in Brussels, December 18, 2016.
PHILIPPE by the King: the Minister of Social Affairs and the health public, Mr. BLOCK sealed with the seal of the State: the Minister of Justice, K. GEENS _ Note (1) Documents of the House of representatives: 54 - 2154/2016/2017 No. 1: Bill.
No. 2: amendments.
No. 3: amendment.
Our 4 5: reports.
No. 6: Text adopted.
No. 7: amendments.
No. 8: Supplementary report.
No. 9: Adopted text.
No. 10: amendments.
No. 11: The adopted text.