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22 JUNE 2016. - Act on various health provisions

PHILIPPE, King of the Belgians,
To all, present and to come, Hi.
The House of Representatives adopted and sanctioned the following:
Introductory provision
Article 1^er. This Act regulates a matter referred to in Article 74 of the Constitution.
PART 1^er. - INAMI
CHAPTER 1^er. - Amendments to the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994
Section 1^re. - Notification of decisions of the College of Physicians and Directors
Art. 2. In section 25 of the Compulsory Health Care Insurance Act, coordinated on July 14, 1994, inserted by the Act of April 27, 2005, renumbered and amended by the Act of February 7, 2014, the following amendments are made:
1° Paragraph 4 is replaced by the following:
"The decision of the College of Physicians and Directors is notified by the Institute at the same time to the recipient and the insurer within 15 working days of the approval by the College of Physicians and Directors of the minutes of the meeting where the decision was adopted. ";
2° Paragraph 5 is repealed.
Section 2. - Administrative simplification of pharmaceutical benefits procedures
Art. 3. In section 18, paragraph 4, of the Act, replaced by the Act of 25 January 1999 and amended by the Acts of 24 December 1999, 10 August 2001 and 27 December 2012, the last two sentences are replaced by the following:
"In particular, it ensures compliance with the expenditure standard and the partial annual budget target for medicines and other pharmaceutical services. To this end, the Health Care Service shall prepare three summaries every three months, the first of which shall include the amendments to the list referred to in Article 35, § 2ter, the second shall be the amendments to the list referred to in Article 35 bis and the third shall be the amendments to the list referred to in Article 35, § 2quater."
Art. 4. In section 35 of the Act, last amended by the Act of 19 December 2014, the following amendments are made:
1° in paragraph 1^erParagraph 1 is replaced by the following:
"The King shall establish the nomenclature of health benefits, with the exception of the benefits referred to in article 34, paragraph 1^er4° bis, 5°, 19°, 20° and 20° bis."
2° in paragraph 1^er, paragraph 2, fourth sentence, the words "and 5°, a), 19° and 20° are repealed;
3° in paragraph 1^er, paragraph 2, fifth sentence, the words "19° and 20°, " are repealed;
4° in paragraph 1^er, paragraph 2, the sentences "These admission criteria with respect to the benefits referred to in article 34, paragraph 1^er, 5°, a), concern prices, volume estimates, the cost of processing pharmaceutical supplies, whether patented or not of the main active ingredient, medical, epidemiological, therapeutic and social elements. Admission of benefits under section 34, paragraph 1^er, 5°, a), is reviewed at least every five years. For benefits under section 34, paragraph 1^er, 5°, a), for which there is already a refund, the Pharmaceutical Technical Council is authorized to review the admission criteria and their application. This revision can be done for a therapeutic class or a group of master preparations, following the Anatomical Therapeutical Chemical Classification, established under the responsibility of the World Health Organisation Collaborating Center for Drug Statistics Methodology, or for a separate masterful preparation." are repealed;
5° in paragraph 1^er, paragraph 9, the words "5°, (a) and (d), and 15°, 19°, 20° and 20° bis, are each replaced by the words "5°, (d), and 15°";
6° in paragraph 1^erParagraph 10 is repealed;
7° in paragraph 2, 6° is repealed;
8° a paragraph 2quater is inserted as follows:
§ 2quater. The King confirms the list of refundable pharmaceutical services referred to in article 34, paragraph 1^er, 5°, a), 19°, 20° and 20° bis.
Upon a proposal by the Technical Pharmaceutical Council or after notice by the Minister, the Minister amends the list of repayable pharmaceutical benefits referred to in section 34, paragraph 1^er, 5°, a), 19°, 20° and 20° bis, as well as the terms and conditions relating thereto.
On the proposal of the Pharmaceutical Technical Council, the King determines the procedure that must be followed by those who request the admission, modification or removal of a pharmaceutical benefit from the list referred to in paragraph 1^er.
It also defines deadlines and obligations for applications for admission, modification or removal.
The list of pharmaceutical benefits referred to in section 34, paragraph 1^er, 5°, a), 19°, 20° and 20° bis, is fixed on the basis of the admission criteria defined by the King and according to which these benefits can be divided into different categories.
With respect to pharmaceutical benefits referred to in article 34, paragraph 1^er, 5°, a), these admission criteria relate to prices, volume estimates, cost of treatment of pharmaceutical benefits, whether patented or not of the main active principle, medical, epidemiological, therapeutic and social elements.
With respect to pharmaceutical benefits referred to in article 34, paragraph 1^er, 19°, 20° and 20° bis, these admission criteria concern prices, costs for insurance and medical, therapeutic and social elements.
Admission of pharmaceutical benefits under section 34, paragraph 1^er, 5°, a), is reviewed at least every five years.
The King shall determine, with respect to the pharmaceutical services referred to in article 34, paragraph 1^er, 5°, a), the procedure setting the basis for reimbursement, by which the Technical Pharmaceutical Council formulates a proposal, taking into account the elements that it must develop and which relate, inter alia, to the packagings available in the trade, to the selling price at the pharmacist and to the data on the quantities sold. It sets out the conditions and fees according to which mandatory insurance is involved in the cost of these benefits, as well as the maximum amounts, if applicable.
Reimbursement of pharmaceutical benefits under section 34, paragraph 1^er, 5°, a), 19°, 20° and 20° bis, may be subject to the authorization of the medical consultant.
The King may also determine the conditions under which the consulting physician may verify whether the pharmaceutical benefits provided under section 34, paragraph 1^er, 5°, a), 19°, 20° and 20° bis, which have given rise to reimbursement have been prescribed by the dispensator in accordance with the conditions of reimbursement fixed.
The King sets out the appeal procedure introduced by the caregiver against the decisions of the consulting physician.
The King may determine the cases in which the Institute's Health Care Service may propose to the Minister amendments to the list of pharmaceutical benefits referred to in section 34, paragraph 1^er, 5°, a), 19°, 20° and 20° bis, without intervention of the Technical Pharmaceutical Council in case of technical corrections of different types of errors.
The King may determine the cases in which the Institute's Health Care Service may submit to the Minister amendments to the list of pharmaceutical benefits referred to in section 34, paragraph 1^er, 5°, a), 19°, 20° and 20° bis, after the advice of the Technical Pharmaceutical Council, with a view to ensuring greater coherence between the terms and conditions of reimbursement of the various reimbursable benefits or for administrative simplifications, and provided that these changes have no effect on the target group and if applicable the indications already refundable. ".
Art. 5. In title III, chapter V, of the same law, a section XXIII entitled:
"Section XXIII. Obligations of firms that put pharmaceutical benefits under Article 34, paragraph 1^er, 5°, a), 19°, 20° and 20° bis, on the Belgian market and ask for their admission to the refund".
Art. 6. In section XXIII, inserted by article 5, an article 77octies is inserted as follows:
Art. 7octies. § 1^er. The firm that puts pharmaceutical benefits under section 34, paragraph 1^er, 5°, a), 19°, 20° and 20° bis, on the Belgian market and which has requested the refund is required, from the introduction of a refund request, to ensure that the pharmaceutical benefit concerned will be effectively available at the latest on the date of entry into force of the refund and to guarantee the continuity of the availability of the pharmaceutical benefit.
When the firm that puts pharmaceutical benefits under section 34, paragraph 1^er, 5°, a), 19°, 20° and 20° bis in the Belgian market and who has asked for the refund is unable to supply the market for a conditioning, this packaging is considered unavailable. The firm notifies the start date, the alleged end date and the reason for the unavailability of the Institute's Health Care Service.
§ 2. If the Institute's Health Care Service is informed of the unavailability of a drug benefit referred to in section 34, paragraph 1^er, 5°, a), 19°, 20° and 20° bis, other than by the firm or if applicable by the AFMPS, the Service requests confirmation to the firm that the pharmaceutical service is actually unavailable. The firm has 14 days from receipt of this request to confirm or invalidate the unavailability by registered mail with acknowledgement of receipt. If she infirms her, she joins her consignment the evidence that the drug benefit is available. If the firm confirms the unavailability, it specifies the start date, the expected end date and the reason for the unavailability.
If the firm fails to respond within the specified time limit, or if the elements that the firm provides do not allow for certainty to establish the availability of the pharmaceutical benefit, the pharmaceutical benefit is deleted as soon as possible from the list, in full right and without taking into account the procedures determined under section 35, § 2quater.
§ 3. If the firm communicates that the packaging will be unavailable for more than twelve months, or if the unavailability lasts more than twelve months, the packaging concerned shall be removed in full right from the list, without taking into account the procedures determined under section 35, § 2quater, respectively on the first day of the month following the discharge of a period of 10 days from the receipt of the notification or the first day of the thirteenth month of unavailability.
§ 4. If the unavailability is the result of a proven case of force majeure, the packaging is re-registered on the list on the first day of the month following the end of the unavailability, without taking into account the procedures determined under section 35, § 2quater.".
Art. 7. Section 213, § 2, of the Act, replaced by the Act of 22 February 1998 and amended by the Act of 19 March 2013, is supplemented by a paragraph written as follows:
"By derogation from paragraph 2, the opinion of the Insurance Committee and the General Council is not necessary for the modification of the lists of reimbursable benefits referred to in Articles 35, § 2ter, 35, § 2quater, 35bis and 35septies/2."
Art. 8. This section comes into force on 1^er January 2018.
The King may determine a effective date prior to the date referred to in the first paragraph.
Article 7 comes into force on the day after its publication to the Belgian Monitor for the amendments to the lists of refundable benefits, referred to in Articles 35, § 2ter, 35bis and 35s.
Section 3. - Procedure for changing the nomenclature
Art. 9. In section 27 of the Act, last amended by the Act of 15 December 2013, the following amendments are made:
1° in paragraph 2, the words "and Article 35, § 2ter" are replaced by the words ", Article 35, § 2ter and Article 35, § 2quater";
2° in paragraph 4, the words "In case of an exceptional reasoned circumstance, this notice" are replaced by the words "If the notice has not been formulated in session, it";
3° in paragraph 4, the words "in session or in writing" are inserted between the words "formulated" and "in the five-day period referred to above."
Section 4. - Paediatric conditions
Art. 10. In article 35bis, § 8, of the same law, inserted by the law of 10 August 2001 and amended by the law of 22 December 2003 and 19 December 2008, a paragraph written as follows is inserted between paragraphs 1^er and 2:
"The King may set the conditions for a particular procedure by which the reimbursement of a speciality listed in the list may be amended, with a view to the reimbursement of this speciality for beneficiaries under the age of 18, provided that this speciality is already refunded for beneficiaries over the age of 18 in the same indication. ".
Section 5. - Drugs
Art. 11. In section 35bis of the Act, inserted by the Act of 10 August 2001 and last amended by the Act of 22 June 2012, the following amendments are made:
1° in paragraph 2, paragraph 3, the last sentence is repealed;
2° Paragraph 2 is supplemented by two subparagraphs as follows:
"The amendment of the list comes into force on the day after the decision to amend the list was published on the Institute's website.
If the change in the list reduces the patient's access to drug therapy, the amendment comes into force only on the first day of the month following the expiration of the 10-day period that takes place the day after its publication in the Belgian Monitor. ";
3° in paragraph 4, paragraph 8, the words "paragraph 3" are replaced by the words "paragraph 4";
4° in the Dutch text of paragraph 4, paragraph 9, the words "artikel 5" are replaced by the words "het vijfde lid";
5° in paragraph 5, paragraph 2, the words "are in force the modification of the list on the first day of the month following the expiration of a period of ten days that takes place the day after the publication in the Belgian Monitor. The King may define in which cases it may be derogated from that date of entry into force." are replaced by the words "the modification of the list comes into force on the day after the change of the list was published on the Institute's website.".
Art. 12. In article 35bis, § 7, of the same law, inserted by the law of 10 August 2001 and last amended by the law of 10 December 2009, five paragraphs are inserted between paragraphs 1^er and 2:
"The information described as confidential by the parties during negotiations or the conclusion of a convention with the Institute will be referred to in the Annex to the Convention and will be strictly confidential.
The Institute, its employees and agents, preserve and guarantee this confidentiality.
It may only be derogated from the above-mentioned confidentiality:
1° if ordered in a disciplinary, administrative, criminal or civil proceeding or investigation;
2° in case the applicant enters on its own initiative in a collective reimbursement procedure with one or more partner countries.
In the cases referred to in paragraph 4, 1°, the Institute may share information described as confidential by the parties with the competent authorities.
In the cases referred to in paragraph 4, 2°, the Institute may share the information described as confidential by the parties with the relevant foreign authorities, provided that they are held by this confidentiality. ".
Art. 13. In section 35ter of the Act, replaced by the Act of 27 December 2005 and last amended by the Act of 19 December 2014, the following amendments are made:
1° in paragraph 2, paragraph 3, the words "monthly and" are repealed;
2° in paragraph 2bis, paragraph 3, the words "monthly and" are repealed;
3° in paragraph 3, paragraph 3, the words "monthly and" are repealed.
Art. 14. Sections 17 to 19 of the Act of 7 February 2014 on various accessibility provisions for health care are repealed.
Art. 15. This section comes into force on 1^er September 2016.
The King may determine a effective date prior to the date referred to in paragraph 1^er.
Section 6. - Unavailability of drugs
Art. 16. In Article 72bis, § 1^erbis, the Compulsory Health Care and Compensation Insurance Act, coordinated on 14 July 1994, inserted by the Act of 22 December 2008 and amended by the Act of 10 April 2014, the following amendments are made:
1st paragraph 1^er is supplemented by the following sentences:
"If the speciality concerned is primarily intended for hospital use and if the responsible applicant does not establish a public market with a hospital in a period of twelve months following the effective date of the refund, the applicant may obtain an exception to the deletion of the full right. The applicant shall notify the Institute no later than seven days after the first day of the eleventh month following the effective date of the refund. If the unavailability continues, the speciality concerned will be deleted from the list on the first day of the 60^e months after the effective date of the refund. ";
2° paragraph 2 is supplemented by the following:
"If the speciality concerned is primarily intended for use in hospitals and if the responsible applicant does not establish a public market with a hospital in a period of twelve months following the commencement of unavailability, the applicant may obtain an exception to the removal of full rights. The applicant shall communicate it to the Institute no later than seven days after a period of eleven months following the commencement of unavailability. If the unavailability continues, the speciality concerned will be deleted from the list on the first day of the 60^e months after the beginning of unavailability. ";
3° in paragraph 3, the last sentence is replaced by the following:
"If the speciality concerned is primarily intended for use in hospitals and if the responsible applicant does not establish a public market with a hospital in a period of twelve months following the commencement of unavailability, the applicant may obtain an exception to the removal of full rights. The applicant shall communicate to the Institute no later than seven days after a period of eleven months following the commencement of unavailability. If the unavailability continues, the speciality concerned will be deleted from the list on the first day of the 60^e months after the beginning of unavailability. On the other hand, if the applicant does not respond within the specified time limit, or if the elements it provides do not allow for certainty to establish the availability of the pharmaceutical specialty, the specialty is deleted as quickly as possible from the list, in full law and without taking into account the procedures provided for in section 35bis. ".
Art. 17. The following amendments are made to section 77quinquies of the Act, inserted by the Act of 27 December 2012 and amended by the Act of 10 April 2014:
1° it is inserted a paragraph 1^er/1, as follows:
§ 1^er/1. If the unavailability is maintained, the packaging concerned shall be removed from the list on the first day of the twelfth month following the effective date of the refund. If the responsible applicant does not establish a public contract with a hospital in a twelve-month period following the effective date of the refund, the applicant may obtain an exception to the deletion of full rights. The applicant shall notify the Institute no later than seven days after the first day of the eleventh month following the effective date of the refund. If the unavailability is maintained, the packaging will be removed from the list on the first day of the 60^e months after the effective date of the refund. ";
2° in paragraph 3, the words "three months" are replaced each time by the words "two months" and the words "of the fourth month of unavailability" are replaced by the words "of the thirteenth month of unavailability";
3° paragraph 3 is supplemented by the following:
"If the responsible applicant does not establish a public market with a hospital in a period of twelve months following the commencement of the unavailability, the applicant may obtain an exception to the removal of full law. The applicant shall communicate it to the Institute no later than seven days after a period of eleven months following the commencement of unavailability. If the unavailability is maintained, the packaging will be removed from the list on the first day of the 60^e months after the beginning of unavailability. ".
Section 7. - Cheap specifications
Art. 18. In article 73, § 2, paragraph 3, 1°, of the same law, inserted by the law of 19 December 2008 and replaced by the law of 19 December 2014, the following amendments are made:
1° the words "that is not unavailable within the meaning of Article 72bis, § 1^erbis, are inserted between the words "formed of specialty" and the words "whose basis of reimbursement";
2° the words "the lowest or" are repealed.
Art. 19. Article 18 comes into force on the first day of the second month following the publication of this Act to the Belgian Monitor.
Section 8. - Adaptation of the ceiling of personal quotas for dental care
Art. 20. In Article 37, § 1^er, paragraph 3, of the same law, as amended by the Act of 20 December 1995, by the Royal Decree of 16 April 1997 and by the laws of 22 August 2002, 27 December 2006 and 29 March 2012, the words "dentery" are inserted between the words "podology" and the words "and dietetic".
Art. 21. Article 20 comes into force on the day of the publication of this Act to the Belgian Monitor.
Section 9. - Role of Convention Commissions and Agreements in Budget Development
Art. 22. Section 51 of the Act, last amended by the Act of 23 December 2009, is supplemented by a paragraph written as follows:
§ 8. §§ 1^er to 7 does not apply to conventions with implant suppliers. ".
Section 10. - Funding of Legal Psychiatric Centres
Art. 23. In section 56, § 3ter, of the same law, inserted by the law of 26 December 2013, the following amendments are made:
1st paragraph 1^er is supplemented by the words "and related fees."
2° paragraph 2 is supplemented by the following sentence:
"It also covers non-refundable medicines, as well as all care-related fees, fees for the registration of health care data and taxes of any kind. ";
3° a paragraph is inserted between paragraphs 2 and 3:
"No room or fees supplement may be considered to persons referred to in paragraph 1^er".
Section 11. - Clinical biology laboratories
Art. 24. Article 63, paragraph 1^er, 3°, of the same law, is repealed.
Art. 25. In section 63, paragraph 2, of the Act, the words "and 3°" are repealed.
Section 12. - Dialysis
Art. 26. In Title III, Chapter V, of the same Act, section XIVbis, which contains section 71bis, inserted by the Act of 22 August 2002, is repealed.
Art. 27. Section 26 comes into force on 1^er October 2016.
The King may determine a effective date prior to the date referred to in paragraph 1^er.
Section 13. - Distribution key for the financial responsibility of insurers and advances
Art. 28. Article 196, § 1^erParagraph 5 of the Act, last amended by the Act of 24 July 2008, is supplemented by the following:
"For the closing of accounts from the 2012 accounting year, this distribution key will be adapted to the evolution of the number of members per insurer organization between the year of calculation of the distribution key and the year of closing of accounts. The distribution key is multiplied by two quotients:
1) the quotient of the number of members of the closing year and the number of members of the calculation year;
2) the quotient of the sum of the normative expenditures of the calculation year and the sum of the normative expenditures obtained by weighting the average normative expenditures of the calculation year by the number of members of the closing year. ".
Art. 29. In Article 196, § 2, paragraph 1^er, of the same law, the words "or in the course of the next exercise" are inserted after the words "in the course of the given exercise".
Art. 30. In Article 202, § 1^er, of the same law, as amended by the Royal Decree of 12 August 1994 and by the Acts of 20 December 1995, 30 December 2001 and 27 December 2006, a sub-paragraph is inserted between paragraphs 2 and 3:
"For the purposes of the preceding paragraph, the second distribution key is adapted to the evolution of the number of members per insurer organization between the year of calculation of the distribution key and the year of the current fiscal year. The distribution key is multiplied by two quotients:
1) the quotient of the number of members of the current year and the number of members of the year of calculation of the distribution key;
(2) the quotient of the sum of the normative expenditures of the year of calculation of the distribution key and the sum of the normative expenditures obtained by weighting the average normative expenditures of the year of calculation of the distribution key by the number of members of the year of the current fiscal year. "
CHAPTER 2. - Amendment of the Act of 30 July 2013 on various provisions
Single section. - Insulins
Art. 31. In article 30, paragraph 1^er, from the Act of July 30, 2013 on various provisions, the word "V.8.7," is inserted between the words "V.8.1," and the words "VII.9".
PART 2. - AFMPS
CHAPTER 1^er. - Amendments to the Act of 25 March 1964 on Drugs
Section 1^re. - Temporary Stop Notification Time
Art. 32. Article 6, § 1^ersexies, of the Act of 25 March 1964 on medicines, inserted by the law of 1^er May 2006 and amended by the Acts of 3 August 2012 and 10 April 2014, the following amendments are made:
1° in paragraph 2, second sentence, the words "In the event of a final stop, this notification takes place" are replaced by the words "This notification takes place";
2° in paragraph 5, the word "and" is inserted between the words "marked" and "information", and the words "as well as the deadlines in which temporary unavailability must be notified" are repealed;
3° the paragraph shall be supplemented by paragraph 6, which reads as follows:
"This paragraph also applies to wholesale distributors referred to in Article 12ter, § 1^erParagraph 3.
Section 2. - Scientific or technical advice
Art. 33. In article 6sexies of the same law, inserted by the law of 1^er May 2006 and amended by the Act of August 3, 2012, the words "Federal Public Service Health, Food and Environment Safety" are replaced by the word "AFMPS".
CHAPTER 2. - Amendments to the Act of 20 July 2006 relating to the creation and operation of the Federal Agency for Drugs and Health Products
Single section. - Self-control
Art. 34. In the Act of 20 July 2006 on the creation and operation of the Federal Agency for Drugs and Health Products, Article 4, § 1^er, paragraph 3, 6°, last amended by the Act of 10 April 2014, is replaced by the following:
"6° in the field of legislation:
a. to propose to the Minister the regulations for matters within the Agency's jurisdiction and to ensure the monitoring, application, control of the following regulations related to its missions and their enforcement orders:
- the Act of 24 February 1921 concerning the trafficking of poisonous, soporific, narcotic, psychotropic, disinfectant or antiseptic substances and substances that can be used for the illicit manufacture of narcotic and psychotropic substances;
- Act of 25 March 1964 on medicines;
- the Act of July 15, 1985 on the use of hormone-effect substances, anti-hormonal effect, beta-adrenergic effect or stimulator effect of production in animals;
- the Act of 19 December 2008 on the obtaining and use of human bodily material for human medical applications or for scientific research purposes;
- the Act of 28 August 1991 on the Exercise of Veterinary Medicine with regard to the supply and prescription of drugs to animal officials;
- the Act on the Exercise of Health Care Professions, coordinated on May 10, 2015 with regard to the issue of medicines;
- the Blood and Blood Derivatives Act of 5 July 1994;
- the Human Person Experiments Act of 7 May 2004;
- the Act of 24 January 1977 on the Protection of Consumer Health with regard to food and other products;
- the Act of 6 July 2007 on medically assisted procreation and the destination of supernumerary embryos and gamets, with the exception of articles 4, 3, 5, 6, 31, 32, 33, paragraph 2, 66, 67, 68, 71 and 72;
- Royal Decree No. 80 of 10 November 1967 concerning the Order of Pharmaceuticals in the matter of continuous training;
- the Medical Devices Act of 15 December 2013;
b. to propose to the Minister the regulations for the establishment of a self-control system in the areas under its jurisdiction under this Act.".
CHAPTER 3. - Amendments to the Act of 19 December 2008 relating to the obtaining and use of human body equipment for human medical applications or for scientific research
Single section. - Biobanks
Art. 35. In section 2 of the Act of 19 December 2008 relating to the obtaining and use of human body equipment for human medical applications or for scientific research purposes, last amended by the Act of 10 April 2014, the following amendments are made:
1° in 32°, the words "at Royal Decree No. 78 of 10 November 1967 concerning the exercise of health care professions" are replaced by the words "in the law on the exercise of health care professions, coordinated on 10 May 2015";
2° the article is completed by the 37° written as follows:
"37° "transformation": every manipulation that substantially alters the genetic code of all cells composing human body material so that the material no longer has a link with the donor and can no longer generate significant information on the donor's health condition. ".
Art. 36. In Article 3, § 3, of the Act, amended by the Acts of 23 December 2009 and 19 March 2013, the following amendments are made:
1st paragraph 1^er is completed by the e) as follows:
"e) hair and hair (with the exception of follicles), nails, urine, breast milk, stools, tears and sweats, unless they are intended for scientific research without human application. ";
2° Paragraph 2 is repealed.
Art. 37. In Article 7, § 1^er, paragraph 3, of the same law, the words "see Article 11, § 3, paragraph 2, of" are replaced by the words "with complete approval referred to in".
Art. 38. In Article 8, § 1^erParagraph 1^er, 2°, from the same law the words "with full approval" are inserted between the words "ethics" in "tel".
Art. 39. In Article 10, § 5, of the Act, a paragraph written as follows is inserted between paragraph 2 and paragraph 3:
"In the case where human bodily material is taken for scientific research without human application, the information referred to in § 5, paragraph 2 also refers, if any, to the possible transformation that human bodily material may undergo, as well as the possible consequences of this transformation referred to in Articles 15, § 1^erParagraph 3 and 22 (1)^erTwo. ".
Art. 40. Article 15, § 1^erin the same Act, as amended by the Act of 19 December 2013, the following amendments are made:
1° in paragraph 1^erthe words "or the manager of human bodily material within the biobank" are repealed;
2° paragraph 1^er is completed by the words "or 20, § 1^eror against which no opposition has been expressed pursuant to section 10 of the Act of 13 June 1986 on organ removal and transplantation";
3° two paragraphs written as follows are inserted between paragraph 1^er and paragraph 2:
"The manager of human bodily material within the biobank ensures that he puts the human body material at disposal for use:
1° that conforms to the objectives and activities of the biobank; and
2° for which the authorization was given under Article 10 or 20, § 1^er, for which no refusal has been communicated in accordance with Article 20, § 2, or against which no opposition has been expressed under Article 10 of the Act of 13 June 1986 on organ removal and transplantation.
By derogation from paragraph 2, 2°, the human body material that has undergone a transformation and whose traceability has been lifted may be made available for use other than that for which the authorization has been given under Article 10 or 20, § 1^er, no refusal was communicated in accordance with Article 20, § 2, or against which no opposition was expressed pursuant to Article 10 of the Act of 13 June 1986 on organ removal and transplantation. ".
Art. 41. Article 20, § 1^erin the same Act, as amended by the Act of 23 December 2009, the following amendments are made:
1° in paragraph 2, the number "4" is replaced by the number "5";
2° Paragraph 2 is supplemented by a sentence, as follows:
"Article 10, § 7, is applied with respect to consent to the possible processing of personal data in the context of secondary use. ";
3° in paragraph 3, the words "see Article 11, § 3, paragraph 2, of" are replaced by the words "with complete approval referred to in".
Art. 42. In article 21, paragraph 1^er, of the same law, amended by the law of March 19, 2013, the words ", which meets the provisions of section 2, 4°, and 11ter, of" are replaced by the words "with complete approval referred to in".
Art. 43. In section 22 of the Act, last amended by the Act of 10 April 2014, the following amendments are made:
1° in paragraph 1^er, paragraph 2, the words "during the duration of this test" are replaced by the words "until the publication of the final report of the study";
2° in paragraph 1^er, paragraph 6, the words "as referred to in Article 11, § 1^er, of" are replaced by the words "with complete approval referred to in";
3° in paragraph 2, paragraph 3, the words "the manager of human body material within" are replaced by the words "the operator of";
Paragraph 7 is replaced as follows:
"§ 7. Without prejudice to the provisions of the Human Person Experiments Act of May 7, 2004, the human bodily material manager in the biobank may at any time lift the traceability of human bodily material:
(1) if the donor or the person authorized to grant consent for the collection and use has previously given consent to that effect;
2° if the human body material has undergone a transformation.
In the case referred to in paragraph 1^er, 2°, the human bodily material manager within the biobank only lifts traceability after the researcher has declared on the honour that the material has undergone a transformation.
Where it is found that section 11, traceability may only be waived once the procedure under this section has been fully complied with. ".
Art. 44. In articles 2, 28° and 22, § 3, paragraphs 1^er and 2, of the same Act, as amended by the Act of April 10, 2014, the words "Article 7 of Royal Decree No. 78 of November 10, 1967 on the Exercise of Health Care Professions" are each replaced by the words "Article 25 of the Act respecting the Exercise of Health Care Professions, coordinated on May 10, 2015".
Art. 45. Articles 35 to 44 come into force on a date determined by the King.
CHAPTER 4. - Amendment of the Human Person Experiments Act of 7 May 2004
Single section. - Biobanks
Art. 46. In the introductory sentence of Article 18/1, of the Law of 7 May 2004 on Human Person Experiments, inserted by the Law of 10 April 2014, the words "during the duration of this trial" are replaced by the words "until the publication of the final report of the study".
CHAPTER 5. - Amendment - of the Medical Devices Act of 15 December 2013
Single section. - Scientific and technical advice
Art. 47. The Medical Devices Act of 15 December 2013 is supplemented by a title 4 which reads as follows:
"Title 4. - Scientific and technical advice on medical devices
Art. 58. The King may set out the conditions and conditions under which the Federal Agency for Drugs and Health Products provides a scientific or technical opinion regarding the research and development of a medical device for its possible marketing or for its possible modification after it is placed on the market. It determines the conditions, deadlines and terms of the procedure for the processing of requests for such notices and the conditions for obtaining such notices.".
CHAPTER 6. - Amendments to the Act of 28 August 1991 on the Exercise of Veterinary Medicine
Art. 48. Section 9, § 2, of the Act of 28 August 1991 on the Exercise of Veterinary Medicine, the following amendments are made:
1° the words ", of the administration" are inserted between the word "prescription" and the words "and the supply";
2° the paragraph shall be supplemented by three paragraphs, as follows:
"The King may submit to a registration by the veterinarian, in a central data file, the prescription, supply and administration of drugs for the reporting of the use of drugs and the execution of measures taken for the purposeful and prudent use of drugs.
The King sets out the terms of the registration referred to in paragraph 2, and the use of the central data file. It may prescribe the conditions and conditions under which the central file may be used for the control of the supply and prescription of medications to animal officials.
In particular, the King sets out the conditions under which operator identification data can be processed for univocal and correct registration in the data file referred to in paragraph 2.".
Art. 49. Article 10, § 1^er, paragraph 2, of the same law, amended by the law of May 19, 2010, the words "and administration" are inserted between the words "providing" and "medications.
Art. 50. In Article 11, § 3, of the same law, the words ", their acquisition and administration" are inserted between the words "detention" and "by the person responsible".
Art. 51. In article 22, 2°, of the same law, the words ", to the administration" are inserted between the words "prescription" and "and to the supply".
Art. 52. In article 27bis of the same law, inserted by the law of 1^er May 2006 and amended by the Act of 27 December 2006, the following amendments are made:
1° in paragraph 1^erParagraph 1^er, the words "punished within the meaning of articles 20 to 22" are inserted between the words "or the decrees taken in execution of it," and the words "the official-lawist, designated for that purpose by the King";
2° in paragraph 1^erParagraph 3 is replaced as follows:
"For offences defined in sections 20 and 21, the amount of the administrative fine may not be less than half of the minimum or greater than the maximum fine set for the offence. ";
3° in paragraph 1^era paragraph, as follows, is inserted between paragraphs 3 and 4:
"For offences defined in Article 22, the amount of the administrative fine cannot be less than 25 euros, nor more than 5000 euros. ";
4° in paragraph 1^erParagraph 5, to be paragraph 6, is replaced by the following:
"In case of application of section 25, the sum may be doubled."
Art. 53. In Article 34, § 1^er, paragraph 2, of the same law, as amended by the law of 27 December 2004, the word "eight" is replaced by the word "twenty".
PART 3. - SPF - Public Health, Food Chain Safety and Environment
CHAPTER 1^er. - Amendments to the Health Care Professions Act, coordinated on May 10, 2015
Section 1^re. - Compliance notice
Art. 54. In section 141 of the Health Care Professions Act, coordinated on May 10, 2015, the word "conform" is repealed each time.
Section 2. - Federal Council of Paramedical Professions
Art. 55. In articles 23, § 1^erParagraph 4, 71, § 2, 72, § 2, paragraph 1^er76, 119, § 1^er, 2°, e), paragraph 2, 133, paragraph 1^er, 176, paragraph 1^er, 2°, and 180 of the same law, the words "National Council of Paramedical Professions" are each replaced by the words "Federal Council of Paramedical Professions".
Section 3. - Assistant pharmaceutico-technical
Art. 56. In Article 153, § 3, of the same Act, as amended by the Act of 17 July 2015, a paragraph written as follows is inserted between paragraphs 3 and 4:
"By derogation from paragraph 1^er and by derogation from Article 72, § 1^er, persons who do not meet the qualification conditions provided for in Article 72, § 2, paragraph 2, for the occupation of pharmaceutico-technical assistant, but who, at 1^er September 2010, performed acts of the pharmaceutico-technical assistant profession for at least three years, may continue to perform the same acts under the same conditions as the pharmaceutico-technical assistants performing these acts. ".
CHAPTER 2. - Amendments to the law of May 23, 2013 regulating the qualifications required for non-surgical cosmetic medicine and cosmetic surgery and regulating the advertising and information relating to these acts
Single section. - Authorization
Art. 57. In section 24 of the Act of 23 May 2013 regulating the qualifications required for non-surgical cosmetic medicine and cosmetic surgery and regulating the advertising and information relating to these acts, as amended by the Act of 10 April 2014, the following amendments are made: 1° in § 2, paragraph 2 is replaced by the following: "The application for authorization must be filed within a period of two years after entry into force." 2° in § 3, the sentence "The application for authorization must be filed within two years after the entry into force of this article." is replaced by the following: "The application for authorization must be filed within two years after the entry into force of Article 10.".
Art. 58. In section 25 of the same law, the words "and no later than 1^er September 2015" are repealed.
Art. 59. Section 58 comes into force on August 31, 2015.
CHAPTER 3. - Amendments to the Consumer Health Protection Act of 24 January 1977 concerning food and other products
Section 1^re. - Definition of tobacco products
Art. 60. Article 1^er, 2°, d), of the Act of 24 January 1977 on the Protection of Consumer Health in respect of foodstuffs and other products is supplemented by the words ", below referred to as tobacco products".
Section 2. - Labeling tobacco products
Art. 61. Section 8 of the Act, amended by the Act of 22 March 1989, the current text of which will form paragraph 1^er, is supplemented by paragraph 2 as follows:
"§2. Derogation from paragraph 1^er, the statements on the label of tobacco products that are made mandatory in accordance with this Act are in Dutch, French and German, regardless of the linguistic region where the products are marketed. ".
Promulgate this law, order that it be clothed with the seal of the State and published by the Belgian Monitor.
Given in Brussels on 22 June 2016.
PHILIPPE
By the King:
The Minister of Social Affairs and Public Health,
Mr. De Block
Seal of the state seal:
Minister of Justice
K. Geens
____
Note
(1) Documents of the House of Representatives:
54-1838 - 2015/2016
No. 1: Bill
No. 2: Annex
No. 3: Amendment
Number 4 and 5: Reports
N° 6: Text adopted
No. 7: Amendment
N° 8: Text adopted