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7 MAY 2017. - Human Use Clinical Trials Act (1)

PHILIPPE, King of the Belgians,
To all, present and to come, Hi.
The Chambers adopted and We sanction the following:
CHAPTER 1^er. - Object, definitions and scope
Article 1^er. This Act regulates a matter referred to in Article 74 of the Constitution.
Art. 2. This Act applies to clinical trials within the meaning of Regulation No. 536/2014 of the European Parliament and the Council of 16 April 2014 on clinical trials of human-use drugs and repealing Directive 2001/20/EC. It completes the application procedures.
Art. 3. For the purposes of this Act and its enforcement orders, it shall be understood by:
1° the "regulation": Regulation (EU) No 536/2014 of the European Parliament and the Council of 16 April 2014 on clinical trials of drugs for human use and repealing Directive 2001/20/EC;
2° the "Minister": the Minister with Public Health in his duties;
3° the "AFMPS": the Federal Agency for Drugs and Health Products, as established by the Act of 20 July 2006 on the establishment and operation of the Federal Agency for Drugs and Health Products;
4° the "SPF Public Health": the Federal Public Service Public Health, Food and Environment Safety;
5° the "Collège": an independent body that coordinates the functioning of the Ethics Committees and ensures its quality. It also acts as a single point of contact between the Ethics Committees and the AFMPS;
6° the "Committee of Ethics": the Ethics Committee within the meaning of Article 2, § 2, 11), of the Regulation;
7° the "Commission for Human Drugs": the Commission referred to in Article 6, § 1^erParagraph 12 of the Act of 25 March 1964 on Drugs;
8° a Phase I trial: a clinical trial with non-therapeutic objectives, conducted on healthy volunteers or certain types of patients and covering one or more of the following aspects:
(a) the initial safety assessment and tolerability;
(b) pharmacokinetics;
(c) pharmacodynamics;
(d) initial activity measures to prove the concept.
9° a "phase center I": a physically delimited research site where phase I tests are carried out.
CHAPTER 2. - Competent authorities
Section 1^re- AFMPS
Art. 4. The PSMPS is designated as the national contact point within the meaning of section 83 of the regulations.
The AFMPS provides communications through the Union Portal.
Art. 5. For the purposes of this Act, the deputy head of the PSMPS is designated as the Minister's delegate.
The Minister may also designate as delegate other members of the PSMPS staff, while indicating the limit of their delegated competencies.
Section 2. - Ethics Committees
Art. 6. § 1^er. The Ethics Committee shall, in an independent manner and in accordance with the provisions of this Act, conduct an ethical review referred to in section 4, paragraph 2, of the Regulations.
§ 2. The Ethics Committee shall contain at least:
1° an expert in pharmacology, pharmacotherapy and pharmacokinetics;
2° a member with expertise in clinical research methodology;
3° a general practitioner;
4° a doctor carrying the special professional title of doctor specialized in paediatrics;
5° a psychologist;
6° two nurses;
7° a hospital pharmacist;
8° a philosopher or representative of the human sciences, initiated or trained in medical ethics;
9° a jurist;
10° a patient representative.
The King may specify the rules concerning the composition of the Ethics Committee.
The Ethics Committee is composed of a majority of doctors in medicine.
The membership of an Ethics Committee is incompatible with the following functions:
1° hospital director;
2° doctor-chef ;
3° President of the Medical Council of a hospital;
4th head of the nursing department of a hospital;
5° manager, member of management, managing director or member of the board of directors of a holder of an authorization to put on the market of a drug, within the meaning of Article 6, § 1^er, the Act of March 25, 1964 on drugs, an authorization to manufacture, within the meaning of section 12bis of the same Act or a wholesale distribution authorization, within the meaning of section 12ter of the same Act.
§ 3. The Committee of Ethics meets the standards of accreditation established by the King.
In particular, these standards concern:
1° the implementation of a quality system;
2° the implementation of a registration and management system for member conflicts of interest. This system provides that, at a minimum, members of the Ethics Committee are independent of the proponent(s) involved, the clinical trial site(s) involved, the investigator(s) involved, the person(s) funding the clinical trial, and are free from any other unjustified influence;
3° members' skills and expertise.
The King may issue additional accreditation standards for the evaluation of phase I tests.
§ 4. Accreditation is granted by the Minister for a maximum period of four years.
The Minister shall refuse the approval, suspend the approval or withdraw it if the Ethics Committee fails to comply with its obligations under this Act or its enforcement orders.
§ 5. The King sets the application, suspension and withdrawal procedure.
The King may impose additional approval for the evaluation of phase I tests.
Art. 7. The King determines the criteria on which the College designates the Ethics Committee authorized to render its opinion on the application for authorization, subsequent expansion or substantial modification of a clinical trial, or as part of a graceful appeal.
It may set out the conditions and conditions under which the College shall take into account, at the time of designation, the implementation and monitoring of the quality control system under Article 8 and the compliance by the Ethics Committees of the recommendations issued under Article 9, § 3, paragraph 1^erThree.
The Ethics Committee authorized to render its opinion may in no case be that of the site(s) of the clinical trial.
Art. 8. The Ethics Committees ensure high quality. They implement a quality control system.
Quality control is based on an independent, objective, systematic and methodological approach under the supervision of the College.
In particular, the Ethics Committees ensure, through this system of quality control, independence and avoiding conflicts of interest, in accordance with Article 6, § 3, paragraph 2, 2°, of this Act.
The King can set the terms of quality control.
Section 3. - College
Art. 9. § 1^er. An independent college is established within the Public Health SPF.
The College is composed of:
1° an expert in quality control systems;
2° two experienced doctors in the conduct or evaluation of clinical trials;
3° a jurist.
Members are appointed by the Minister, taking into account their experience and expertise in accordance with sections 2 and 2bis of the Act of 20 July 1990 to promote the balanced presence of men and women in bodies with a competence of opinion. Similarly, the Minister designates a chair and vice-chair among the members. The Minister shall designate at least two members based on their experience with phase I tests.
The mandates of the College members are five years and are renewable.
There are as many alternate members as there are actual members. Alternate members are appointed under the same conditions as actual members.
The King sets out the terms and conditions for the application of this article. In particular, it determines the required experience of members either in terms of quality management or clinical study.
§ 2. The College membership is not compatible with the following functions:
1° hospital director;
2° doctor-chef ;
3° President of the Medical Council of a hospital;
4th head of the nursing department of a hospital;
5° member of an Ethics Committee;
6° AFMPS personnel;
7° Principal Investigator and member of the management of sites where clinical trials are conducted;
8° manager, management member, managing director or member of the board of directors of the holder of an authorization to put on the market of a drug, within the meaning of Article 6, § 1^er, the Act of March 25, 1964 on drugs, an authorization to manufacture, within the meaning of section 12bis of the same Act or a wholesale distribution authorization, within the meaning of section 12ter of the same Act.
§ 3. The College's mission is:
1° communication with the Ethics Committees as a single point of contact of the AFMPS. All communications between the Ethics Committees and the PSMPS pass through the College;
2° to designate, in accordance with Article 7, the Ethical Committee authorized for each application for authorization, subsequent expansion and substantial modification of a clinical trial, as well as in the course of a graceful appeal;
3° to ensure the consistent application of this Act by the Ethics Committees. The College may make recommendations to the Ethics Committees for this purpose;
4° to formulate, on initiative or at the request of the Minister, notices relating to the application of the regulations, this Act and its enforcement orders;
5° to coordinate, harmonize, support, evaluate and monitor the quality control carried out by the Ethics Committees. The College may adopt recommendations for this purpose;
6° the administrative support of the Ethics Committees for the follow-up of requests under Article 7.
The College annually sends a report of activities of the Ethics Committees and the College to the Minister and Parliament.
The King may, by Royal Decree deliberated in the Council of Ministers, charge the College of Additional Missions.
§ 4. The College guarantees the independence of its members at any time. In this context, it ensures, at a minimum, that College members are independent of the proponent(s) involved, the clinical trial site(s) involved, the investigator(s) involved, the person(s) funding the clinical trial, and that they are free from any other unjustified influence.
Members of the College do not participate in the activities of the College under § 3, paragraph 1^er5°, to the extent that they have an interest in the Ethics Committee or the site where the Ethics Committee is established that could compromise their impartiality.
§ 5. The College establishes its rules of procedure within three months of its creation. This is approved by the King.
The rules of procedure set out the rules for the organization and operation of the College. The rules of procedure include a registration and management system for member conflicts of interest as referred to in paragraph 4.
§ 6. The College is assisted by a coordinator, who is designated for this purpose by the Minister among public health officials.
The Public Health SPF is responsible for the logistical and administrative support of the College so that it can perform its tasks in a comprehensive and effective manner. The King may set the terms of this support.
CHAPTER 3. - General protection provisions for participants in a clinical trial
Section 1^re. - Enlightened consent during cluster testing
Art. 10. Simplified means of obtaining informed consent, as provided in Article 30 of the Regulation, are excluded in accordance with Article 30, § 3, (a), of the Regulation.
Section 2. - Special provisions for the protection of minor and incapable participants
Art. 11. Without prejudice to the application of the regulation, the "legally designated representative" within the meaning of section 2, § 2, 20, of the regulation is designated, for the purpose of exercising the rights of the minor and incapable participant, in accordance with articles 12 and 14 of the Act of 22 August 2002 on the rights of the patient.
Section 3. - Insurance and liability
Art. 12. § 1^er. The proponent assumes, even without fault, the liability for damage to the participant or, in the event of death, his or her rights holders, whether directly or indirectly related to the clinical trial. Any contractual stipulation to restrict this liability is deemed null.
When a clinical trial has more than one promoter, all promoters are jointly responsible.
§ 2. The proponent, prior to the clinical trial, undertakes insurance covering this responsibility and that of any clinical trial practitioner, regardless of the nature of the existing links between the intervener, the promoter and the participant.
Pursuant to Article 74, § 1^er, of the regulation, the promoter or a legal representative of the promoter is established in the European Union.
When a clinical trial has more than one promoter, one of them is designated as responsible for contracting the insurance referred to in paragraph 1^er.
§ 3. For the purposes of this article, the participant or his or her rightful persons may quote directly the insurer in Belgium, either before the judge of the place where the act of the damage occurred, or before the judge of the participant's domicile, or before the judge of the insurer's seat.
Without prejudice to the possibility of setting in the contract between the proponent and the insurer the maximum amounts in order to indemnify the damages of the participant or, in the event of death, his or her eligible beneficiaries, as well as the possibility of setting a maximum amount of coverage of the risk, no invalidity, no exception or termination of the law or insurance contract may not be opposed by the insurer to the participant or his or his or his or her legal persons
CHAPTER 4. - Procedure for authorizing a clinical trial
Section 1^re. - Validation of application
Art. 13. § 1^er. The Minister or his delegate may propose Belgium as a rapporteur member state pursuant to Article 5, § 1^erparagraphs 3 to 5 of the regulations.
§ 2. When Belgium acts as a rapporteur member State, the procedure for validation of the application, as referred to in Article 5, §§ 3 to 6, of the regulation, is within the competence of the AFMPS.
Art. 14. When Belgium acts as a member State concerned, the AFMPS may communicate to the rapporteur member State, any observations concerning the validation of the application, in accordance with Article 5, § 3, paragraph 2, of the Regulation.
Art. 15. The King may specify the procedure and procedures for the validation of the application for authorization for a clinical trial.
Section 2. - Evaluation and consolidation
Sub-section 1^re. - General principles
Art. 16. The PSMPS and the Ethics Committee are jointly responsible for the evaluation of the aspects of Parts I and II of the evaluation report, as defined in Articles 6 and 7 of the Regulations.
The King determines the respective missions of the AFMPS and the Committee of Ethics in this context, which Belgium acts as a rapporteur member state or member state concerned.
Art. 17. The King may determine the procedure to be followed with respect to the assessment of aspects under Parts I and II of the evaluation report.
Without prejudice to section 22, the King may, in this context, set time limits for assessment shorter than the maximum time limits set out in the regulations.
Art. 18. § 1^er. The PSMPS is responsible for the consolidation of the evaluations of the PSMPS and the Ethics Committee in a report. The College informs the AFMPS of the position of the Ethics Committee.
§ 2. AFMPS may, after consultation with the College, establish the respective reporting templates that are used by the AFMPS and the Ethics Committees.
§ 3. In the hypotheses where Belgium acts as a rapporteur member State for the assessment of aspects under Part I and as a member State concerned for the assessment of aspects under Part II, the report referred to in § 1^er constitutes the assessment report within the meaning of the regulations.
Sub-section 2. - Belgium acts as a rapporteur member state
Art. 19. The King determines, with regard to clinical trials for which Belgium acts as a member State rapporteur:
1° how the AFMPS, the Ethics Committee and the College coordinate and consolidate the respective assessments of the Member States concerned, pursuant to Article 6, § 5, of the Regulation;
2° the way in which the PSMPS, the Ethics Committee and the College implement the faculty of Article 6, § 7, of the Regulation;
3° the way in which the AFMPS, the Ethics Committee and the College implement the faculty of Article 6, § 8, paragraphs 1^er and 2 of the Regulation and coordinate the consolidation referred to in Article 6, § 8, paragraph 4, of the Regulation.
Subsection 3. - Belgium acts as a member state concerned
Art. 20. The King determines, with respect to clinical trials for which Belgium acts as a member State concerned, the way in which AFMPS, the Ethics Committee and the College implement the faculty offered by Article 7, § 2, paragraph 2, and § 3, of the Regulation.
Section 3. - Clinical Trial Decision
Art. 21. The Minister or his or her delegate makes a decision on the clinical trial pursuant to section 8 of the regulations.
The clinical trial can only be authorized if both the PSMPS and the Ethics Committee issued a favourable opinion in this regard.
The clinical trial may only be allowed under conditions if the PSMPS and the Ethics Committee have issued one or more conditions. In the case that the conditions issued respectively, at the end of their examination, by the AFMPS and the Ethics Committee are incompatible with each other, the AFMPS shall notify the Minister in the report referred to in Article 18, § 1^er. In this case, the test cannot be allowed.
The Minister may not derogate from the joint conclusions of the PSMPS and the Ethics Committee, issued through the report referred to in Article 18, § 1^er.
Art. 22. For a phase I mononational clinical trial authorization application, the PSMPS shall notify the decision on the clinical trial to the proponent through the Union Portal within twenty days of the filing of the application file.
This twenty-day period is suspended when the powers referred to in Articles 5, § 5, and § 6, § 7 and 8, of the Regulation are used.
Art. 23. The King determines the procedure in which Belgium contests the conclusion of the member State rapporteur with respect to Part I of the assessment report, pursuant to Article 8, paragraph 2, of the Regulation.
CHAPTER 5. - Procedure for further expansion of a clinical trial
Section 1^re. - Evaluation and consolidation
Art. 24. The PSMPS and the Ethics Committee are jointly responsible for assessing the proponent's request to extend a clinical trial within the meaning of section 14 of the regulations.
The King determines the respective missions of the AFMPS and the Committee of Ethics in this framework and what Belgium acts as a rapporteur member state or member state concerned.
Art. 25. The King may determine the procedure to be followed, relating to the execution of section 14 of the Regulation.
Without prejudice to section 34, the King may, in this context, set time limits for assessment shorter than the maximum time limits set out in the regulations.
Art. 26. The PSMPS is responsible for the consolidation of the evaluations of the PSMPS and the Ethics Committee in a report. The College informs the AFMPS of the position of the Ethics Committee.
AFMPS can, after consultation with the College, determine the respective reporting models that are used by the AFMPS and the Ethics Committees.
In the assumptions where Belgium acts as a rapporteur member State for the assessment of aspects under Part I and as a member State concerned for the assessment of aspects under Part II, the report referred to in paragraph 1^er, constitutes the assessment report within the meaning of the regulations.
Section 2. - Decision on the application for further expansion
Art. 27. The Minister or his or her delegate makes a decision on the application for further expansion of the clinical trial referred to in section 14 of the regulations.
Subsequent enlargement can only be authorized if both the PSMPS and the Ethics Committee have issued a favourable opinion in this regard.
The Minister may not derogate from the joint conclusions of the PSMPS and the Ethics Committee, issued through the report referred to in section 26, paragraph 1^er.
The clinical trial may only be allowed under conditions if the PSMPS and the Ethics Committee have issued one or more conditions. In the case that the conditions issued respectively, following their examination, by the PSMPS and by the Ethics Committee are incompatible with each other, the PSMPS shall notify the Minister in the report referred to in section 26, paragraph 1^er. In this case, the test cannot be allowed.
Art. 28. The King determines the procedure in which Belgium contests the conclusion of the member State rapporteur with respect to Part I of the assessment report, pursuant to Article 14, § 4, paragraph 2, of the Regulation.
CHAPTER 6. - Authorization procedure for a substantial modification of a clinical trial
Section 1^re. - Validation
Art. 29. The AFMPS is responsible for the validation of applications for a substantial modification of a clinical trial pursuant to articles 17, 20, §§ 1^er to 3, and 21 § 1^errules.
The King may specify the procedure and procedures for the validation of the application for a substantial modification of a test.
Section 2. - Evaluation and consolidation
Art. 30. The FAMPS and the Ethics Committee are jointly responsible for assessing the application for a substantial modification of a clinical trial within the meaning of articles 18, 20, § 5, 21, § 2, and 22, of the regulations.
The King determines the respective missions of the AFMPS, the Committee of Ethics and the College in this context, which Belgium acts as a rapporteur member state or member state concerned.
Art. 31. The King may determine the procedure to be followed by the AFMPS, the Committee of Ethics and the College respectively, relating to the execution of Articles 18, 20, §§ 5 and 6, 21, § 2, and 22, of the Regulation.
The King may, within this framework, set time limits for evaluation shorter than the maximum time limits set out in the regulations.
Art. 32. The PSMPS is responsible for the consolidation of the evaluations of the PSMPS and the Ethics Committee in a report. The College informs the AFMPS of the position of the Ethics Committee.
AFMPS can, after consultation with the College, determine the respective reporting models that are used by the AFMPS and the Ethics Committees.
In the assumptions where Belgium acts as a rapporteur member State for the assessment of aspects under Part I and as a member State concerned for the assessment of aspects under Part II, the report referred to in paragraph 1^er constitutes the assessment report within the meaning of the regulations.
Section 3. - Decision on Authorization for Substantial Change
Art. 33. The Minister or his or her delegate shall make a decision on applications for authorization to make a substantial amendment in accordance with sections 19, § 1^er20 § 5 and 23 § 1^errules.
Substantial amendment can only be authorized if both the PSMPS and the Ethics Committee have issued a favourable opinion in this regard.
The Minister may not derogate from the joint conclusions of the PSMPS and the Ethics Committee issued through the report referred to in section 32, paragraph 1^er.
Art. 34. For a phase I mononational clinical trial authorization application, the PSMPS notifies the decision on a substantial amendment to the proponent, via the Union Portal, within twenty days of filing the application file.
This twenty-day period is suspended when it is made use of the powers referred to in Articles 17, § 4, 18, §§ 5 and 6, and 20, § 3 and § 6, of the Regulation.
Art. 35. The King shall determine the procedure in which Belgium contests the conclusion of the member State, referred to in Articles 19, § 2, paragraphs 2 and 3, and § 2, paragraphs 2 and 3, of the Regulation.
CHAPTER 7. - Conduct of a clinical trial
Section 1^re. - Adequacy of persons involved in the conduct of the clinical trial
Art. 36. Pursuant to section 49 of the regulations, the investigator must be a physician within the meaning of the Health Care Professions Act, coordinated on May 10, 2015.
Section 2. - Adequacy of clinical trial sites
Art. 37. Without prejudice to section 50 of the regulations, Phase I centres may be accredited by the AFMPS.
The King sets the accreditation system and specifies the standards for the application of paragraph 1^er. It determines the date on which the accreditation system is applied.
CHAPTER 8. - Manufacturing and import of experimental and auxiliary medicines
Art. 38. § 1^er. Authorization is required for manufacturing and import:
1° of unauthorised experimental drugs, in accordance with Article 61, § 1^erthe regulations;
2° of authorized experimental drugs if they are subject to an amendment not subject to a marketing authorization referred to in section 64 of the regulations;
3° of non-authorized auxiliary drugs and authorized auxiliary drugs subject to an amendment that do not fall within a marketing authorization referred to in section 65 of the regulations;
Authorization for the manufacture and importation of drugs is issued by the Minister or his delegate.
§ 2. The holder of the authorization shall, in accordance with Article 61, § 4, of the regulation, be required to allow the qualified person referred to in Article 61, § 2, (b), of the regulation to carry out his or her mission, inter alia, by making available to him all the necessary means.
§ 3. The King sets out the conditions, deadlines and terms of the procedure for reviewing applications for authorization. It also takes the necessary measures to protect public health regarding the manufacture, import and export of drugs. It sets the content of the application and may determine the form in which the application must be filed. The King may also set rules on the admissibility of an application.
The Minister or his or her delegate only authorizes an investigation that the information provided is accurate. In accordance with Article 61, § 4, of the Regulations, the authorization is valid only for the premises specified in the authorization as well as for the drugs and pharmaceutical forms for which the authorization was requested and granted. Authorization may be accompanied, in order to ensure compliance with all conditions, with certain obligations imposed either on the occasion of granting or after granting. The King may fix the contents of the authorization.
Art. 39. The King sets the appropriate and proportionate requirements, pursuant to Article 61, § 6, of the Regulation, to ensure the safety of participants and the reliability and robustness of the data obtained during the clinical trial that applies to the operations referred to in Article 61, § 5, of the Regulation.
CHAPTER 9. - Labelling
Art. 40. The information that should be included on the outer packaging and on the primary packaging of drugs is written in the three national languages. This does not exclude that this information is also written in other languages, provided that the same information is included in all the languages used.
Derogation from paragraph 1^er, information may be written in a single national or English language when experimental or auxiliary drugs are administered on the site of the clinical trial and participants do not handle the drug.
Derogation from paragraph 1^erand in accordance with Article 67, § 1^er, b), of the regulation, authorized experimental drugs and authorized auxiliary drugs may be labelled in accordance with Article 6, § 1^erquinquies, paragraphs 6 to 9, and 6s., § 1^erof the Act of 25 March 1964 on drugs and their enforcement orders.
CHAPTER 10. - Inspection, control and sanction
Art. 41. Pursuant to Rule 77, the Minister or his delegate may take corrective action on Belgian territory. The King determines the terms and conditions.
The consultation of one or more other Member States in connection with the taking of such a measure, within the meaning of Article 77, § 4, of the regulation, shall be carried out through the Minister or his delegate.
Art. 42. § 1^er. Without prejudice to the competence of judicial police officers, the members of the statutory personnel designated by the King for this purpose, or in the absence of the staff members engaged in the ties of an indeterminate employment contract, the AFMPS, monitor the application of the regulations, enforcement acts and delegated acts of the European Commission, this Act and its enforcement orders.
Staff members referred to in paragraph 1^er sworn, before the performance of their duties, in the hands of the Minister or his delegate.
§ 2. Without prejudice to the competence of the European Commission, referred to in Article 78, § 7, of the Regulation, the King may determine the qualifications and training required of inspectors.
Art. 43. Without prejudice to the competence of the European Commission referred to in Article 78, § 7, of the Regulation, the inspections shall take place in accordance with the terms defined in Articles 14, §§ 2 to 4, 14bis and 15, § 4, of the Act of 25 March 1964 on drugs.
Staff members referred to in Article 40, § 1^erhave the inspection skills referred to in articles 14, paragraphs 2 to 4, 14 bis and 15, § 4, of the Act of 25 March 1964 on medicines.
Inspections are compiled in the inspection report referred to in Article 78, § 6, of the Regulations.
Without prejudice to Article 78, § 7, of the Regulation, the King may determine the terms and procedures that are followed when conducting the inspections.
Art. 44. Without prejudice to the application of the penalties provided for by other laws and, if applicable, the application of disciplinary sanctions, is punishable by imprisonment from one month to two years and a fine from 500 euros to 250,000 euros, or one of these penalties only:
1° the person who contravenes articles 3, 4, paragraph 1^er15, 28, § 1^er29, §§ 1^er at 6, 31, §§ 1^er and 2, 32, 33, 35, 36, 37, 38, § 1^er41, 42, 43, § 1^er, 47, §§ 1^er and 2, 49, 51, § 1^er52, § 1^er, 53, 54, §§ 1^er and 2, 55, 56, 57, 58, 59, § 1^er, 61, § 1^er62, § 1^er, 63, §§ 1^er and 3, 65, 66, 67, 68, 72, § 2, 74, 76, § 2, and 90, paragraph 2, of the Regulation;
(2) the person who contravenes articles 12, § 2, 36, 38 and 40 of this Law;
3° he who buys, owns, sells, offers for sale, delivers, delivers, delivers, distributes, supplies, imports or exports of damaged, altered, perished, falsified, imitation or non-compliant experimental drugs;
4° he who has falsified or imity or has made falsify or imitate experimental drugs that are intended to be sold, offered for sale, delivered, delivered, distributed, supplied, supplied, imported or exported;
5° that in which are found experimental drugs that are intended to be sold, offered for sale, delivered, delivered, delivered, distributed, supplied, supplied, imported or exported, and that sells them, offers for sale, delivers, delivers, delivers, distributes, supplies, imports or exports knowing that they are damaged, altered, perished, falsified, imitated or not in conformity with the provisions of the law present.
The penalty referred to in paragraph 1^er, 3°, does not apply to the possession of quarantine experimental drugs for their destruction.
Art. 45. § 1^er. The prison sentence will be three months to three years and the fine will be 1,000 euros to 500,000 euros if the offences provided for in article 44:
1° caused the death or affected the physical or mental health of the participant;
2° were committed by a person abusing the confidence that he or she is a professional in health care, as referred to in the Act respecting the exercise of health care professions coordinated on May 10, 2015, as a manufacturer or supplier;
3° for supply and supply offences, were committed using large-scale dissemination processes, such as computerized systems, including the Internet;
4° were committed within the framework of a criminal organization, as referred to in Article 324bis of the Criminal Code;
5° were committed by a person already convicted of similar offences.
§ 2. The provisions of Book I^er, including those of chapter VII and section 85 of the Penal Code are applicable to the offences provided for in this Act.
The attempt to commit an offence under this Act is punishable by the same penalty as that applicable to the offence itself.
§ 3. Individuals and legal entities are civilly liable for fines and fees resulting from the convictions imposed under this Act against their organs or agents.
§ 4. If there are public health grounds, the judge shall declare the confiscation of falsified, counterfeit, corrupt, altered or non-compliant experimental drugs.
§ 5. Without prejudice to articles 57bis and 99bis of the Criminal Code, the final convictions of the criminal courts of another State party to the Council of Europe Convention on counterfeiting medical products and similar offences threatening public health, agreed in Moscow on 28 October 2011, are taken into account in the same conditions as the convictions of Belgian criminal courts for the offences set out in paragraph 1^er and will produce the same legal effects as these convictions.
§ 6. The judge may order that any judgment or judgment of conviction under this Act be posted in the places that he or she determines and may be published by extract in the manner that he or she fixes at the expense of the convicted person.
§ 7. The judge may prohibit, by a reasoned decision, any person convicted under this Act from participating in a clinical trial as a promoter, investigator or in any other way, even under the direction of an investigator for a period that the judge determines which may not be less than three years or more than ten years. The person who violates this prohibition shall be punished by the penalties provided for in paragraph 2.
Art. 46. Article 17, §§ 1^er 5 and 8, of the Act of 25 March 1964 on drugs is applicable in the event of a breach of the provisions of this Act and the orders made pursuant to it.
CHAPTER 11. - Financial arrangements
Art. 47. § 1^er. The following activities make the promoter of the clinical trial liable to a retribution:
1° the introduction of a request for authorization of the clinical trial;
2° the introduction of a request for further expansion of the clinical trial to another Member State concerned;
3° the introduction of a request for a substantial modification of a clinical trial;
§ 2. The introduction of an application for accreditation as provided in section 37 is subject to the payment to the PSMPS of a fee of 16,996 euros.
§ 3. The King shall determine the amount and terms of payment of the remuneration referred to in paragraph 1^er and the payment of royalties and remuneration referred to in this article.
The amount of retributions may be reduced for non-commercial promoters, as defined by the King and in accordance with the terms defined by Him.
§ 4. Retributions referred to in paragraph 1^er are distributed, according to a distribution key fixed by the King and according to the terms fixed by the King, between the AFMPS, the Ethics Committees and the Public Health SPF.
§ 5. Retributions and royalties referred to in this section are adjusted annually to the evolution of the UK Consumer Price Index (base 2013), based on the September index.
The starting index is that of September prior to the publication to the Belgian Monitor of the Royal Decree setting the amount of the contribution or retribution.
The indexed amounts are published in the Belgian Monitor and are applicable to the refunds due from 1^er January of the year following that during which the adaptation was made.
CHAPTER 12. - Gracious remedies
Art. 48. § 1^er. In the case that a refusal is expressed in Belgium within the meaning of Articles 8, § 4, 14, § 10, 19, § 2, paragraph 4, 20, § 7 or 23, § 4, of the Regulation, the promoter may make a gratis appeal to the Minister.
The appeal shall be filed, with a copy of the contested decision, within thirty days of the publication of the refusal of the authorization concerned on the Union Portal.
§ 2. In case of appeal referred to in paragraph 1^er, the Minister or his delegate requests, within two business days, a reasoned opinion, on the one hand, to the Commission for Human Drugs, and on the other hand, of another Ethics Committee that the person who has rendered his opinion in the context of the quarrelled decision, designated by the College.
These notices are forwarded to the Minister within one month of receipt of the notice request.
§ 3. The Minister or his or her delegate shall, on the basis of the notices referred to in paragraph 2 and after hearing the applicant in his or her comments, within three months of receiving the appeal referred to in paragraph 1^er. The decision is served by registered mail against receipt.
§ 4. The King may determine the procedure for the due diligence of the graceful appeal referred to in paragraph 1^er.
Art. 49. § 1^er. Pursuant to section 26 of the Regulations, applications for clinical trial authorization, subsequent expansion and substantial modification of a clinical trial are submitted in one of the three national or English languages.
§ 2. Derogation from paragraph 1^er, documents for participants referred to in items K.60 and L of Schedule I to the Regulations are written in the language(s) of the participants.
Derogation from paragraph 1^erthe synopsis of the protocol referred to in point D.24. of Schedule I to the Regulations is in the three national languages.
Art. 50. By derogation from section 41 of the Laws on the Use of Languages in Administrative Matters, coordinated on July 18, 1966, the PSMPS may respond in English to promoters established abroad, where they have introduced their application file referred to in section 49 in English, or use English in their communications.
CHAPTER 13. - General provisions
Art. 51. The deadlines mentioned in this Act and its enforcement orders are calculated in accordance with Council Regulation (EEC) No 1182/71 of 3 June 1971 establishing the rules applicable to deadlines, dates and terms.
CHAPTER 14. - Amendments
Art. 52. In Article 6quater, § 3, paragraph 1^er, 3° ), of the Act of 25 March 1964 on medicines, inserted by the law of 1^er May 2006, the words "May 7, 2004 on human person experiments" are replaced by the words "May 7, 2017 on clinical trials of human-use drugs".
Art. 53. In Article 10, § 2, paragraph 1^er, 3°, of the same law, replaced by the law of 16 December 2004, the words "seen to article 2, 7°, of the law of 7 May 2004 on experiments on the human person" are replaced by the words "regulated by the law of 7 May 2017 on clinical trials of drugs for human use".
Art. 54. In Article 25quater/1, § 2, paragraph 1^er, b), of the Compulsory Health Care and Compensation Insurance Act, co-ordinated on July 14, 1994, inserted by the Act of February 7, 2014, the words "May 7, 2004 on Human Person Experiments" are replaced by the words "May 7, 2017 on clinical trials of drugs for human use".
Art. 55. In section 34 of the Act, last amended by the Act of 10 April 2014, the following amendments are made:
1° Paragraph 3 is supplemented by the words "or Article 2, § 2, 15), Regulation (EU) No 536/2014 of the European Parliament and Council of 16 April 2014 on clinical trials of drugs for human use and repealing Directive 2001/20/EC."
2° in paragraph 4, the words "or article 2, § 2, 22), of the above-mentioned regulation" are inserted between the words "of the protocol referred to in article 2, 22°, of the above-mentioned law" and the words "and which exceed the benefits made referred to in paragraph 3".
Art. 56. Article 3, § 1^erthe Human Person Experiments Act of 7 May 2004 is supplemented by a paragraph written as follows:
"This Act does not apply to clinical trials referred to in Article 2, § 2, (2), and (3), Regulation (EU) No 536/2014 of the European Parliament and Council of 16 April 2014 concerning clinical trials with drugs intended for human use and repealing Directive 2001/20/EC, with the exception of the cases provided for in Article 98 of the Regulations. ".
Art. 57. In the same law, articles 26/1 and 30, § 9/1, are repealed.
Art. 58. In the same Act, an article 34/1 is inserted, which reads as follows:
"Art. 34/1. Article 11, § 1^er to 3 and 7, is not applicable for pilot projects organized by the AFMPS prior to the coming into force of the Act of May 7, 2017 concerning clinical trials with drugs for human use.
In cases provided for in paragraph 1^er, the proponent shall, as provided for in section 10 of this Act, apply for a favourable opinion to the Public Health SPF, Food Chain and Environment Safety, together with the application to the Minister under section 12. The SPF Public Health, Food Chain Safety and Environment attributes this application to an ethics committee with full approval within the meaning of section 11/2, which is independent of the site or structure where the clinical trial is conducted.
In cases provided for in paragraph 1^er, the promoter of a clinical trial shall, by derogation from Article 30, § 5, pay to the designated ethics committee in accordance with § 2. The amount of the retribution referred to in this paragraph is equal to the amount defined by the King in accordance with Article 30, § 6, paragraph 5, for the sole opinion in the context of a monocentric experience.
The King may set out the modalities for these pilot projects. ".
Art. 59. Article 4, § 1^er, paragraph 3, 6°, a., of the Act of 20 July 2006 on the Establishment and Operation of the Federal Agency for Drugs and Health Products, replaced by the Act of 22 June 2016, is supplemented by two dashes as follows:
"- Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials of drugs for human use and repealing Directive 2001/20/EC;
- the Law of May 7, 2017 on Clinical Trials of Medicines for Human Use.".
Art. 60. In section 70 of the Coordinated Act of 10 July 2008 on Hospitals and Other Care Institutions, as amended by the Royal Decree of 19 June 2009, a sub-item is inserted between paragraphs 4 and 5:
"In addition, the Hospital Ethics Committee is systematically notified by the Director of the Medical Experiments Hospital within the meaning of the Human Experiments Act of 7 May 2004, and clinical trials within the meaning of Regulation No. 536/2014 of the European Parliament and the Council of 16 April 2014 on clinical trials of human-use drugs and repealing Directive 2001/20/EC, organized on the hospital's website. To this end, as long as the College established under section 9 of the Act of 7 May 2017 on clinical trials of human-use drugs is notified of the filing of a clinical trial assessment application, which is planned on a hospital site in Belgium, it shall inform the director of the hospital without delay.".
Art. 61. In section 3 of the Act of March 31, 2010 on compensation for damages resulting from health care, paragraph 2, 1°, is supplemented by the words:
"and a clinical trial within the meaning of the Law of May 7, 2017 on clinical trials of human-use drugs".
CHAPTER 15. - Entry into force
Art. 62. § 1^er. This Act comes into force on the day on which the regulation is applicable in accordance with section 99, second paragraph, of the Regulations.
The King may set for articles of the law a date of entry into force prior to that referred to in paragraph 1^er.
§ 2. Derogation from paragraph 1^erArticle 58 comes into force on the date of publication of this Act to the Belgian Monitor.
Promulgate this law, order that it be clothed with the seal of the State and published by the Belgian Monitor.
Given in Brussels on 7 May 2017.
PHILIPPE
By the King:
The Minister of Public Health,
Mr. DE BLOCK
Seal of the state seal:
Minister of Justice,
K. GEENS
____
Note
(1) Session 2016-2017
House of Representatives
Documents. - 54-2296:
n°: Bill
n^bones 2 and 5: Amendments
#3: Report
No. 4: Text adopted by the Commission
No. 6: Text adopted in plenary session
Full report: 20 April 2017.