ࡱ> #` Lbjbjmm .V E""" , 888LBBB8HBLBL]hDC(lClClClCGDD<E L]N]N]N]N]N]N]$U_haRr]8nJGDGDnJnJr]88lClC]* Q Q QnJf8lC8lCL] QnJL] Q Qr[T88\lC8C "zBN,\\T]<]:\bvPb\b8\ %EF QGH%E%E%Er]r] Q%E%E%E]nJnJnJnJLLLL:LLLLLLL888888  Annex No. 1: Law of May 7, 2004 concerning experiments on the human person Unofficial consolidated version - May 2007  TC "Annex No. 1: Law of May 7, 2004 concerning experiments on the human person" \f C \l "2"  CHAPTER I. General provision Art.1. This law regulates a matter as referred to in Article 78 of the Constitution. CHAPTER II. Definitions and scope Art. 2. For the application of this law, the terms are defined as follows: 1 European Agency: the European Medicines Agency, established by Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency; 2 "the minister": the minister whose competency covers the area of public health, or his representative; 3 "investigator's brochure": a compilation of the clinical and non-clinical data on the investigational medicinal product or products which are relevant to the study of the product or products; 4 ethics committee: the independent body which is: either referred to in Article 70ter of the law pertaining to hospitals, coordinated on August 7, 1987; or linked to a faculty of medicine or to the Scientific Association of General Practitioners (WVVH) or the "Socit scientifique de mdecine gnrale (SSMG)", composed of a minimum of 8 and a maximum of 15 members, representing the two sexes, a majority of which are medical doctors, and at least one lawyer, and which are accredited by the minister, upon the request of a medical faculty or a scientific association of general practitioners. Each medical faculty or a Scientific Association of General Practitioners can submit a request for accreditation for only one ethics committee. In addition, in order to be qualified to exercise its assignments, as referred to in this law, with the exception of that of submitting an opinion on points 4, 6 and 7 of 4 of Article 11, the ethics committee shall demonstrate to the minister, in the report referred to in Article 30, 5, that it analysed, during the previous year, either at least 5 new protocols for multicentre experiments in its capacity as the body competent to submit a single opinion or at least 20 new protocols for multicentre experiments, in its capacity as committee competent to submit an opinion, whether single or otherwise. At the time of their appointment, the members of the committee provide the minister with a declaration, which states any direct or indirect connections with the sponsors of the study, with the exception of the sponsors of non-commercial experiments. That declaration is made public and is updated on their initiative as soon as a modification of those connections occurs or as soon as new connections arise. Individuals, who are not independent of the sponsor of the concerned study, given the above-mentioned declaration, cannot participate in a valid manner in a deliberation; 5 "adverse reaction": all untoward and unintended responses to an investigational medicinal product or to an experiment and, when an investigational product is concerned, related to any dose administered; 6 "unexpected adverse reaction": an adverse reaction, the nature or severity of which is not consistent with the information on the experiment, and, when a clinical trial is concerned, with the applicable product information (e.g. investigator's brochure for an unauthorised investigational product or the patient leaflet joined to the summary of product characteristics for an authorised product); 7 "clinical trial" hereinafter to be called trial: any investigation in human persons intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy; 8 non-interventional trial": a study where the medicinal products are prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of collected data; 9 "adverse event": any untoward medical occurrence in a patient or subject of the treated group during an experiment, and which does not necessarily have a causal relationship with this treatment; 10 "serious adverse event or serious adverse reaction": any untoward medical occurrence or effect that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect, and this, when it is a clinical trial, at any dose; 11 "experiment": trial, study or investigation carried out on the human person with the aim of developing knowledge particular to the exercise of the health care professions as referred to in Royal Decree No. 78 of 10 November 1967 concerning the health care professions; 12 phase I trial: study performed on healthy volunteers or on certain types of patients without therapeutic objectives which covers one or more of the following aspects: estimation of initial safety and tolerability, pharmacokinetics, pharmacodynamics, early measurement of drug activity; 13 "monocentre experiment": an experiment conducted according to a single protocol and at a single site; 14 "multicentre experiment": an experiment conducted according to a single protocol but at more than one site, and therefore by more than one investigator, in which the sites may be located in a single Member State of the European Union, in a number of Member States and/or in Member States and third countries; 15 non commercial experiment: an experiment for which: a) the sponsor is either a university or a hospital referred to in Article 4, part two, of the law on the hospitals coordinated on 7 August 1987, or a hospital referred to in Article 7, 2, g), 1 of the Royal Decree of 25 April 2002 concerning the setting and liquidation of the budget for the financial resources of hospitals, or a hospital referred to in Article 7, 2, g), 2 of the same decree where both surgical and medical services are carried out exclusively for children or in connection with tumours, or the "Fonds National de la Recherche Scientifique", either the Fonds voor Wetenschappelijk Onderzoek or a research fund that depends on either of those two Funds, or a hospital department accredited for that purpose according to rules further to be determined by the King, if that department is a centre of expertise in its activity domain, or another body accredited for that purpose in application of the provisions of Article 31 of this law; b) the patent holder of a medicinal product or of a deposited trademark of a medical device to which the experiment relates, is neither directly, nor indirectly the sponsor of the experiment; c) the sponsor asserts the intellectual property rights to the concept of an experiment, the realisation of the experiment and the scientific data resulting from the experiment; 16 "inspection": the act by the minister in application of Article 26 of conducting an official review of documents, facilities, records, quality assurance arrangements, and any other resources that are deemed by the minister to be related to the experiment and that may be located at the site of the experiment, at the sponsor's and/or contract research organisation's facilities, or at other establishments which the minister sees fit to inspect; 17 "investigator": a medical doctor or any other person exercising a profession referred to in the Royal Decree No. 78 of November 10, 1967 concerning the health care professions and who is qualified for conducting an experiment. The investigator is responsible for the conduct of the experiment at a certain site. If the experiment is conducted by a team of individuals at a certain site, the investigator is the leader responsible for the team and may be called the principal investigator; 18 "medicinal product": the medicinal product in the sense of Article 1 of the law of 25 March 1964 on medicinal products; 19 "investigational medicinal product": a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form; 20 "subject": an individual who participates in an experiment irrespective of whether he belongs to the experimental group or the control group; 21 "sponsor": an individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of an experiment; 22 "protocol": a document that describes the objective(s), design, methodology, statistical considerations and organisation of an experiment. The term protocol refers to the protocol, successive versions of the protocol and protocol amendments; 23 "human person": a born, living and viable person. Experiments on embryos in vitro, on human biological material or on corpses do not fall within the scope of this law. Art. 3. This law applies to the conduct of experiments on the human person, in particular of trials, including multicentres, in particular concerning the application of good clinical practices as referred to in Article 4. The Articles of this law which are specific to trials are not applicable to non-interventional trials. CHAPTER III. General provisions concerning the protection of subjects of experiments Art. 4. All experiments, including bioavailability and bioequivalence studies, shall be designed, conducted and reported in accordance with the principles of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting experiments and in particular trials. The King may, after being advised by the Advisory Committee for Bio-ethics, determine all or part of these requirements which constitute good clinical practices. Art. 5. An experiment may be undertaken or pursued only if the following conditions are met: 1 the experiment is scientifically justified and is based upon the latest scientific knowledge and upon an adequate preclinical experiment; 2 the objective of the experiment is to educate the individual or to improve his condition; 3 there is no alternative method with comparable effectiveness and which makes it possible to attain the same results; 4 the foreseeable risks and inconveniences, in particular those of a physical, psychological, social and economic nature, have been weighed against the anticipated benefit for the individual subject and other persons, including respect for the physical and mental integrity and the right to respect for private life and the protection of personal data; 5 the evaluation leads to the conclusion that the anticipated therapeutic and public health benefits justify the risks. The experiment may be continued only if compliance with this requirement is permanently monitored; the interests of the subject always prevail over those of science and society; 6 the protocol has been the object of a favourable opinion of an ethics committee and, when the present law requires it, of an authorisation by the minister in accordance with the provisions of Article 12; 7 without prejudice to the application of Articles 6 to 9, the individual who participates in an experiment, or his representative, has given consent and he shall be provided with a contact point where he may obtain further information; 8 the medical care given to, and medical decisions made on behalf of, subjects shall be the responsibility of an appropriately qualified professional in accordance with Royal Decree No. 78 of November 10, 1967 concerning the health care professions; 9 provision has been made for insurance and indemnity to cover the liability of the investigator and sponsor in accordance with the provisions of Article 29. Art. 6. 1. With the exception of the individuals referred to in Articles 7, 8 and 9, an individual may only participate in an experiment, if he has given his free and informed consent, after being advised of the information referred to in 2. This consent must be given in writing. If the individual is unable to write, oral consent in the presence of at least one witness of legal age who is independent of the sponsor and the investigator, may be given. 2. The information referred to in 1 concerns at least the nature, significance, objectives, implications, anticipated benefits, and risks of the experiment, the circumstances under which it is conducted, and the identification and opinion of the competent ethics committee in accordance with the provisions of Article 11. The subject or his representative in the cases referred to in Articles 7 and 8, has also been informed of his right to withdraw himself or the subject from the experiment at any time, without any repercussions for the subject. This information is given prior and is written, in a clear and comprehensible manner, to the subject or to his representative in the cases referred to in Articles 7 and 8. These individuals have also had the opportunity to discuss this information in an interview with the investigator or a member of the investigating team. 3. The subject or his representative in the cases referred to in Articles 7 and 8, may without repercussions withdraw from the experiment at any time by revoking the consent referred to in 1. CHAPTER IV. Specific provision for the protection of minors participating in experiments Art. 7. Without prejudice to the compliance pertaining to the conditions referred to in Articles 5 and 6, an experiment on minors is permitted only under the following conditions: 1 the informed consent of the parents who exercise legal authority over the minor, or, if there are no parents, of the guardian of the minor, must be obtained; the minor must be involved in the exercise of this right, according to his age and his degree of maturity. In order to achieve this result, the minor must receive, prior to the experiment, information from pedagogically trained staff specifically geared to the minors capacity of understanding. The explicit wish of a minor who is capable of forming an opinion and assessing this information with regard to his participation in an experiment, to refuse participation or to be withdrawn from the experiment at any time is also considered and respected by the investigator. This consent must represent the minor's presumed will and may be revoked at any time, without repercussions to the minor; 2 such experiment should either relate directly to a clinical condition from which the minor concerned suffers, or be of such a nature that it can only be carried out on minors; 3 the experiment is essential to validate data obtained in experiments on individuals able to give consent, or by other research methods, and additionally, some direct benefit for the group of patients should be obtained from the experiment; 4 the risk taken by the subject and the foreseeable risks in the current state of scientific knowledge are not disproportionate to the expected benefit for that individual; 5 the experiment has been designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and developmental stage; both the risk threshold and the degree of distress have to be specially defined and constantly monitored; 6 the ethics committee, which includes at least two doctors-specialists in paediatrics or which has taken advice from two doctors-specialists in paediatrics on clinical, ethical and psychosocial aspects of the protocol in the field of paediatrics, has given a favourable opinion on the protocol; 7 the minor, or his representative, do not receive incentives or financial inducements except compensation; 8 for trials, the corresponding scientific guidelines of the European Agency have been followed. CHAPTER V. Specific provisions for the protection of adults incapable of giving consent to an experiment Art. 8. Without prejudice to the conditions referred to in Articles 5 and 6, an experiment on an adult who is incapable of giving consent, is permitted only if the following conditions are met: 1 the informed consent of the legal representative has been obtained. This consent must represent the subject's presumed will. This consent may be revoked at any time, without repercussions to the adult incapable of giving consent. If an adult who is incapable of giving informed consent himself to participate in an experiment, has disclosed in writing his consent or refusal to participate in an experiment before the onset of his incapacity, this element should be considered and respected by the legal representative. The adult incapable of giving consent is involved as much as possible with the decision and according to his/her capacity of understanding. He/she receives in particular information regarding the experiment, the risks and the benefits. The explicit wish of a subject, who is capable of forming an opinion and assessing this information, to refuse participation in, or to be withdrawn from the experiment at any time, is considered and respected by the investigator. For an adult falling under the statute of extended minority, or for an adult who is legally declared incapable, the right of giving consent to participate in an experiment is exercised by his parents or guardian. For the adult incapable of giving consent who does not fall under the provisions of the previous paragraph, the right to consent to participate in an experiment is exercised by a representative who was appointed in advance by the participating subject through a specific written power of attorney dated and signed by both parties. Without a power of attorney, the right to consent to participate in an experiment is exercised by the cohabiting spouse, the legally cohabiting partner or the de facto cohabiting partner. If those parties are not present, the right to consent to participate in an experiment is exercised in descending order by a child of legal age of the subject, a parent, or a sibling of legal age. In the event of a disagreement between siblings of legal age, the consent is considered not given. 2 the experiment relates directly to a life-threatening or debilitating clinical condition from which the participating adult incapable of giving consent suffers; the experiment is essential to validate data obtained in experiments on individuals capable of giving informed consent or by other research methods. 3 the experiment has been designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and developmental stage; both the risk threshold and the degree of distress shall be specially defined and constantly monitored; 4 the risks taken by the subject, which are foreseeable in the current state of scientific knowledge are not disproportionate in relation to the benefit expected for that individual; 5 the positive opinion on the protocol is given by an ethics committee of which one member has expertise in the relevant disease and the patient population concerned or after being advised by experts in clinical, ethical and psychosocial questions in the field of the relevant disease and patient population concerned; 6 no incentives or financial inducements are given with the exception of compensation; 7 if the subject regains the capacity to consent, the investigator shall immediately respect the requirements referred to in Article 6 with regard to the subject. CHAPTER VI. Specific provisions for the protection of persons whose consent cannot be obtained due to emergency Art. 9. If the consent cannot be obtained due to emergency, the experiment can only be conducted if the following conditions are met: 1 the experiment relates directly to a clinical condition from which the subject, whose consent cannot be obtained due to emergency, suffers and which is life-threatening or which can lead to serious and permanent injuries; the experiment is essential to validate data obtained in experiments on individuals capable of giving informed consent or by other research methods; 2 the experiment has been designed to minimise pain, discomfort, fear and any other foreseeable risk in relation to the disease and developmental stage; both the risk threshold and the degree of distress shall be specifically defined and constantly monitored; 3 the risks taken by the subject which are foreseeable in the current state of scientific knowledge are not disproportionate in relation to the benefit expected for that individual; 4 the positive opinion on the protocol is given by an ethics committee of which one member has expertise in the relevant disease and the patient population concerned or after being advised by experts in clinical, ethical and psychosocial questions in the field of the relevant disease and patient population concerned; the ethics committee declares itself openly in favour of the exception to the principle of informed consent prior to the experiment; 5 no incentives or financial inducements are given with the exception of compensation; 6 the investigator shall respect the requirements referred to in Article 6 with regard to the subject as soon the individual regains the capacity to consent, or with regard to his representative, as referred to in Articles 7, 1 and 8, 1, as soon as it is possible to contact him. CHAPTER VII. Commencement of an experiment Art. 10. The experiment can start only when the sponsor and the investigator have obtained a favourable opinion of an ethics committee according to the provisions of Chapter VIII. If a trial is concerned, the trial can begin only when the minister has not announced grounds for non-acceptance in accordance with the provisions of Chapter IX. If the experiment involves medical devices, it can only begin when the minister has not announced grounds for non-acceptance, after the completion of a procedure of which the King has established the conditions. CHAPTER VIII. Ethics committee Art. 11. 1. The investigator who wants to organise an experiment in Belgium, must address his request to an ethics committee. 2. In the case of a monocentre experiment, the opinion referred to in Article 10, paragraph 1, is issued by an ethics committee which meets the condition referred to in Article 2, 4, second paragraph, and which is related to the site or the structure where the experiment is conducted. If this site or structure does not have an ethics committee which meets the condition referred to in Article 2, 4, second line, second paragraph, the opinion is issued by an ethics committee appointed by the sponsor from among the ethics committees: either of a hospital referred to in Article 7, 2, g), 1 of the Royal Decree of 25 April 2002 concerning the setting and liquidation of the budget for the financial resources of hospitals; or of a hospital referred to in Article 7, 2, g), 2 of the same decree where both surgical and medical services are carried out exclusively for children or in connection with tumours; or referred to in Article 2, 4, second indent. In that case, the ethics committee which is related to the site or the structure where the experiment is conducted, only gives its opinion on the capacity of the site to meet the criteria referred to in 4, 4, 6 and 7. 3. In the case of a multicentre experiment, the opinion is issued by a single ethics committee, regardless of the number of sites where the experiment is planned. If just one of the sites is either a university hospital referred to in Article 4, paragraph 2, of the consolidated law on hospitals of 7 August 1987, or a hospital referred to in Article 7, 2, g), 1 of the Royal Decree of 25 April 2002 concerning the setting and liquidation of the budget for the financial resources of hospitals, or referred to in Article 7, 2, g), 2 of the same decree where both surgical and medical activities are carried out exclusively on children or in connection with tumours, or a hospital where a service has been approved as a centre of excellence in accordance with the provisions of Article 2, 15, a), when the experiment in question concerns the field for which the service was approved as a centre of excellence, the single opinion is issued by the ethics committee of this hospital. If several sites are hospitals as described in the previous paragraph, the single opinion is issued by one of the ethics committees of these hospitals, which is appointed by the sponsor among the different ethics committees. If none of the sites meet the criteria of the two previous paragraphs, but if one of the sites is a hospital, the single opinion is issued by the ethics committee of that hospital. If several sites are hospitals as described in the previous paragraph, the single opinion is issued by one of the ethics committees of these hospitals, which is appointed by the sponsor. If no site is the place of establishment of a hospital, the single opinion is issued either by the ethics committee of the hospital referred to in paragraph 2, or by an ethics committee referred to in Article 2, 4, paragraph 1, second indent. 4. In preparing its opinion, the ethics committee which is competent to issue an opinion shall consider the following elements: 1 the relevance of the experiment and its design; 2 whether the evaluation of the anticipated benefits and risks as required is satisfactory and whether the conclusions are justified, in particular on a therapeutic and public health level; 3 the protocol; 4 the suitability of the investigator and supporting staff; 5 the investigator's brochure; 6 the quality of the facilities; 7 the adequacy and completeness of the written information to be given and the procedure to be followed for the purpose of obtaining informed consent and the justification for the research on persons incapable of giving informed consent or whose consent cannot be obtained due to emergency concerning their participation in an experiment; 8 provision for indemnity and/or compensation in the event of injury or death attributable to an experiment; 9 any insurance or indemnity to cover the liability of the investigator and sponsor; these have to meet the criteria referred to in Article 29; 10 the amounts and, where appropriate, the arrangements for rewarding or compensating investigators and subjects and the relevant aspects of any agreement between the sponsor and the site; 11 the arrangements for the recruitment of subjects. 5. The ethics committee shall have a maximum of 15 days, in case of a monocentre trial of phase I, and a maximum of 28 days for all other experiments, to give its reasoned opinion to the investigator. The term will commence at the time a valid application is received, on condition that the contributions referred to in Article 30 have been paid in full. 6. Within the period of examination of the application requesting an opinion, the ethics committee which is competent to issue the single opinion, may issue a single request for information supplementary to the information already supplied by the applicant. The term established in 5 shall be suspended until the supplementary information is received. The terms established in 5 cannot be extended, with the exception of cases referred to in 10 and 11 of the present Article. 7. In the case of a multicentre experiment, the request is directed simultaneously to the ethics committee competent to issue the single opinion and to the ethics committees related to the sites where the experiment would be conducted if it proceeds. The ethics committee competent to issue the single opinion has 20 days to communicate its opinion to the other ethics committees involved, and to inquire these ethics committees concerning the conditions referred to in 4, 4, 6 en 7. The committees which do not issue the single opinion within this period, can send their remarks to the committee which is competent to give the single opinion. After that term of 20 days the committees which do not issue the single opinion, have a term of 5 days to send an answer to the ethics committee which issues the single opinion. The committee may either accept or refuse, without the right to submit a proposal for modification, other than 4, 7. If the answer does not reach the committee competent to issue the single opinion within the period, the site to which the ethics committee is related, cannot receive the trial. 8. The ethics committee which issues the single opinion has a term of 3 days from the end of the period which was accorded to the ethics committees which are not competent to issue the single opinion, to inform the investigator about the single opinion with a copy to the committees related to the sites where the experiment is conducted. 9. The King determines the rules in relation to an accelerated procedure according to which the opinion on an experiment which is not a phase I clinical trial, is made known to the applicant within a term of 15 days. 10. The terms referred to in 5 can be extended by 30 days in the case of trials involving medicinal products for gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms. For these products, this term may be extended by a further 90 days in the event of consultation of the Advisory Council for Biosecurity, referred to in Article 2 of the Royal Decree of December 18, 1998 concerning the regulation of deliberate release into the environment and on the putting on the market of genetically modified organisms or products which contain them. 11. In the case of xenogenic cell therapy, there shall be no time limit. 12. The member of an ethics committee, who participates in any capacity in a protocol, cannot sit as a member during the examination of that protocol by the ethics committee concerned. He can however be heard in his capacity as an investigator if the ethics committee considers this necessary. 13. The ethics committee sends a copy of its opinion to the minister. CHAPTER IX. Authorisation of the minister in the case of a trial Art. 12. 1. The sponsor who wishes to organise a trial in Belgium, addresses his request to the minister by registered mail. 2. The sponsor must include the following information in his request: 1) the complete qualitative and quantitative composition of the investigational medicinal product, indicating the active substances, in usual wordings, and if such a name exists, the international non-proprietary name which is recommended by the World Health Organisation; 2) a chemico-pharmaceutical dossier (IMPD) the contents of which is determined by the King. If the medicinal product however does not have a marketing authorisation in Belgium, but if a marketing authorisation for a medicinal product with the same qualitative and quantitative composition concerning the active substances is granted in another Member State of the European Union, in a Member State of the European Economic Area or in a State with which the European Union has concluded appropriate conventions which assure that the manufacturer of the medicinal product respects good manufacturing practices at least equivalent to those established in the European Union, the chemico-pharmaceutical dossier may be replaced by an official declaration of the competent authorities of that State; 3) a certificate assuring that during the manufacturing of the medicinal product concerned, the good manufacturing practices for medicinal products which are included in Annex 2 of the Royal Decree of June 6, 1960 concerning the manufacturing, preparation and wholesale distribution and delivery of medicinal products, are respected; 4) the protocol; 5) the investigators brochure. Art. 13. 1. The minister has a maximum of 15 days to notify the sponsor of reasoned grounds for non-acceptance of the commencement of the trial in the case of a monocentre phase I trial, and a maximum of 28 days for other trials. The term will commence at the time a valid application is received, on the condition that the contribution referred to in Article 30 has been paid in full. 2. The King determines the rules in relation to an accelerated procedure according to which the minister notifies the sponsor within a term of 15 days, for an experiment which is not a phase I clinical trial, that there are no grounds for non-acceptance of the commencement of the trial. 3. The terms as referred to in 1 can be extended by 30 days in the case of trials involving medicinal products for gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms. For these products, this term may be extended by a further 90 days in the event of consultation of the Advisory Council for Biosecurity, referred to in Article 2 of the Royal Decree of December 18, 1998 concerning the regulation of deliberate release into the environment and on the putting on the market of genetically modified organisms or products which contain them. 4. In the case of xenogenic cell therapy, there shall be no time limit. Art. 14. On the occasion of the evaluation of the protocol and of the investigators brochure, the minister gives his opinion only on the points related to the quality of the medicinal product. The other points are subject to the opinion of the ethics committee. However, the minister shall examine, if applicable, the preclinical data on the investigational medicinal product. Art. 15. During the evaluation of the file, the minister takes into consideration the fact that authorisation has already been accorded for the same trial by the competent authority of another Member State or of a Member State which is part of the European Economic Area. Art. 16. In the event that the minister notifies the sponsor of reasoned grounds for non-acceptance, the sponsor may, on one occasion only, amend the content of the request in order to take due account of the grounds given. The term in which the minister gives his opinion is suspended from the moment he has notified the reasoned grounds for non-acceptance to the sponsor. If the sponsor fails to amend his request within a term of one month, the request shall be considered rejected. Art. 17. Written authorisation is required before the commencement of trials for such trials on medicinal products which do not have marketing authorization within the meaning of Article 1, 1 of the Royal Decree of July 3, 1969 concerning the registration of medicinal products and which are stated in a list dictated by the King. The King can also impose this obligation for other medicinal products with special characteristics, such as medicinal products the active ingredient(s) of which is or are (a) biological product(s) of human or animal origin, or contain(s) biological components of human or animal origin, or the manufacturing of which requires such components. Written authorisation shall be required before commencing trials involving medicinal products for gene therapy, somatic cell therapy including xenogenic cell therapy and all medicinal products containing genetically modified organisms. No gene therapy trials may be carried out which result in modifications to the subject's genetic identity; in other words, the experiment may not be directed at the selection or the improvement of non-pathological genetic characteristics of the human species. Art. 18. The authorisation to conduct a trial is granted, as the situation arises, without prejudice to the application of the Royal Decree of December 18, 1998 on the regulation of deliberate release into the environment and on the putting on the market of genetically modified organisms or products which contain them. CHAPTER X. Amendments in the conduct of an experiment Art. 19. 1. In the event, after the commencement of the experiment, that the sponsor wishes to make substantial amendments to the protocol which are likely to have an impact on the safety of the subjects or to change the interpretation of the scientific documents in support of the conduct of the experiment, or if these amendments are otherwise significant, the investigator must notify the ethics committee(s) concerned of the reasons for, and content of, these amendments and the sponsor must notify them to the minister by registered mail in the case of a trial. The King can dictate a list of amendments which are considered substantial. 2. In the case of a monocentre experiment, the ethics committee concerned analyses the request for amendment in accordance with the provisions of Article 11; in the case of a multicentre experiment this is the ethics committee which is competent to issue the single opinion. 3. In the case of a trial, the minister examines the proposed amendment according to the provisions of Article 12 and Article 13. 4. In the case of an experiment which is not a trial, the protocol cannot be amended when the ethics committee as referred to in 2 has issued an unfavourable opinion. In the case of a trial, if the opinion of the ethics committee is favourable and the minister has raised no grounds for non-acceptance of the above-mentioned substantial amendments, the sponsor shall proceed to conduct the trial following the amended protocol. Should this not be the case, the sponsor shall either take account of the grounds for non-acceptance and adapt the proposed amendment to the protocol accordingly or withdraw the proposed amendment. Art. 20. 1. Without prejudice to the application of the provisions of Article 19, in the light of the circumstances, notably the occurrence of any new event relating to the conduct of the experiment where that new event is likely to affect the safety of the subjects, the sponsor and the investigator shall take appropriate urgent safety measures to protect the subjects against any immediate hazard. 2. The sponsor shall forthwith inform the ethics committee or the ethics committees and in the case of a trial, the minister of those new events and the measures taken in application of 1. CHAPTER XI. End of experiment Art. 21. 1. Within 90 days of the end of an experiment, the sponsor shall notify the competent ethics committee in the case of a monocentre experiment and the ethics committee competent to issue the single opinion in the case of a multicentre experiment that the experiment has ended. If the experiment involves a trial, the sponsor must also notify the minister within the same term. 2. If the experiment must be terminated early, this term shall be reduced to 15 days. The notification shall clearly explain the reasons for the early termination. 3. The King can determine further rules concerning the communication of the end of the experiment. CHAPTER XII. Suspension or prohibition of the experiment and infringements Art. 22. 1. In the event the ethics committee has objective grounds for considering that the conditions in the request for a favourable opinion in relation to the conduct of an experiment are no longer met, or when the committee has information raising doubts about the safety or scientific validity of the experiment, the committee shall notify the sponsor and the investigator thereof, which have one week to deliver their opinion. Where there is imminent risk, the term of one week can be shortened. 2. In the event that the ethics committee, after receiving of the opinion referred to in 1 or in the absence of such an opinion within the fixed term still considers that the conditions for a favourable opinion in relation to the conduct of an experiment are no longer met, or when there is doubt about the safety or scientific validity of the experiment, the committee notifies the minister which can suspend or prohibit the experiment. This suspension or prohibition is effective as soon as the sponsor is notified. In the event that the minister has objective grounds for considering that the conditions of the valid request for authorisation to conduct an experiment as referred to in Article 11 are no longer met or when he has information raising doubts about the safety or scientific validity of the experiment, he must follow the same procedure. In this case, the minister shall forthwith inform the competent authorities of the Member States, the ethics committee concerned, the European Agency and the European Commission of its decision to suspend or prohibit the experiment and of the reasons for the decision. Art. 23. 1. In the event that there are objective grounds for considering that the sponsor or the investigator or any other person involved in the conduct of the experiment no longer meets the obligations established, the minister shall, on his own initiative or at the suggestion of the ethics committee, forthwith inform the sponsor or investigator thereof, indicating the course of action which he must take to remedy this situation. 2. The minister shall forthwith inform the competent authorities of the other Member States and the Commission of this course of action. CHAPTER XIII. Manufacture, import and distribution of investigational medicinal products Art. 24. 1. For the manufacture and import of investigational medicinal products, authorisation from the minister is required. Authorisation is also required if the investigational medicinal product is manufactured with a view to export. The King shall set the procedures concerning cases in which this authorisation is required, the conditions and procedures that must be satisfied to obtain it and the obligations and procedures that the authorisation holder must satisfy. He also sets the principles and guidelines concerning good manufacturing practices for investigational medicinal products that must be respected. 2. The authorisation holder referred to in 1 has permanently and continuously at his disposal the services of at least one qualified person who is responsible in particular for executing the duties specified in 3 and which meets the conditions established by the King. 3. The qualified person referred to in the second paragraph is responsible - without prejudice to his relationship with the manufacturer or importer - for ensuring: a) in the case of investigational medicinal products manufactured in Belgium, that each batch of medicinal products has been manufactured and checked in accordance with the principles and guidelines for good manufacturing practices referred to in 1, in compliance with the product specification file and the information notified pursuant to Article 12; b) in the case of investigational medicinal products manufactured in a third country, that each production batch has been manufactured and checked in accordance with standards of good manufacturing practice at least equivalent to the principles and guidelines referred to in 1, in accordance with the product specification file, and that each production batch has been checked in accordance with the information notified pursuant to Article 12; c) in the case of an investigational medicinal product which is a comparator product from a third country, and which has a marketing authorisation, where the documentation certifying that each production batch has been manufactured in conditions at least equivalent to the standards of good manufacturing practice referred to above cannot be obtained, that each production batch has undergone all relevant analyses, tests or checks necessary to confirm its quality in accordance with the information notified pursuant to Article 12. The King can dictate detailed guidance on the elements to be taken into account when evaluating products with the object of releasing batches within the Community and the manner they are elaborated upon. Insofar as the provisions established in a), b) or c) are complied with, investigational medicinal products shall not have to undergo any further checks if they are imported together with batch release certification signed by the qualified person. 4. In all cases, the qualified person must certify in a register or equivalent document that each production batch satisfies the provisions of this Article. The said register or equivalent document shall be kept up to date as operations are carried out and shall remain at the disposal of the minister for a term of ten years. 5. The distribution of investigational medicinal products is subject to the authorisation referred to in Article 12ter of the Medicines Law. 6. Without prejudice to the application of the provisions of Article 23, the sponsor and the investigator shall take appropriate urgent safety measures to protect the subjects against any imminent hazard, notably the occurrence of any new event relating to the development of the investigational medicinal product where that new event is likely to affect the safety of the subjects. 7. For a trial, the investigational medicinal products and, as the case may be, the devices used for their administration shall be made available free of charge by the sponsor. CHAPTER XIIIbis. Labelling of investigational medicinal products Art. 25. The King determines the particulars to appear in at least the three official languages on the outer packaging of investigational medicinal products or, where there is no outer packaging, on the immediate packaging. In addition, he shall establish appropriate provisions relating to labelling for investigational medicinal products intended for trials with the following characteristics: 1 the planning of the trial does not require particular manufacturing or packaging processes; 2 the trial is conducted with medicinal products with, in the Member States concerned by the study, a marketing authorization, manufactured or imported in accordance with the provisions of the said Royal Decree of June 6, 1960; 3 the patients participating in the trial have the same characteristics as those covered by the indication specified in the above-mentioned authorisation. CHAPTER XIV. - Verification of compliance of investigational medicinal products with good clinical and manufacturing practice Art. 26. 1. The King shall appoint inspectors to verify compliance with the provisions concerning this law and the good clinical practices and good manufacturing practices established by the King. To that end, these inspectors are specifically charged with the inspection of the sites concerned by any trial conducted, particularly the trial site or sites, the manufacturing site of the investigational medicinal product, any laboratory used for analyses in the trial and/or the sponsor's premises. The minister shall guard the realisation of the inspections and shall inform the European Agency; they shall be carried out on behalf of the Community and the results shall be recognised by all the other Member States. These inspections shall be coordinated by the European Agency, within the framework of its powers as provided for in Regulation (EC) No. 726/2004. A Member State may request assistance from another Member State in this matter. 2. Following inspection, an inspection report shall be prepared. It must be made available to the sponsor while at the same time safeguarding confidential aspects. It may be made available to the other Member States, to the ethics committee concerned and to the European Agency, at their reasoned request. 3. At the request of the European Agency, within the framework of its powers as provided for in Regulation (EC) No. 726/2004, or of one of the Member States concerned, and following consultation with the Member States concerned, the Commission may request a new inspection should verification of compliance with this law reveal differences between Member States. 4. Subject to any arrangements which may have been concluded between the Community and third countries, the Commission, upon receipt of a reasoned request from a Member State or on its own initiative, or a Member State may propose that the trial site and/or the sponsor's premises and/or the manufacturer established in a third country undergo an inspection. The inspection shall be carried out by duly qualified Community inspectors. 5. The detailed guidelines on the documentation relating to the trial, which shall constitute the master file on the trial, archiving, qualifications of inspectors and inspection procedures to verify compliance of the trial in question with this law shall be adopted by the King. CHAPTER XV. Notification of adverse events Art. 27. 1. The investigator shall report all serious adverse events immediately to the sponsor except for those that the protocol or investigator's brochure identifies as not requiring immediate reporting. The immediate report shall be followed by detailed, written reports. The immediate and follow-up reports shall identify subjects by code numbers. 2. Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations shall be reported to the sponsor according to the reporting requirements and within the terms specified in the protocol. 3. For reported deaths of a subject, the investigator shall supply the sponsor and the accredited ethics committee with any additional information requested. 4. The sponsor shall keep detailed records of all adverse events which are reported to him by the investigator or investigators. These records shall be submitted to the minister if the experiment is being conducted in Belgium, if he so requests. CHAPTER XVI. - Notification of serious adverse reactions Art. 28. 1. The sponsor shall ensure that all relevant information about suspected unexpected serious adverse reactions that are fatal or life-threatening is recorded and reported as soon as possible to the minister, to the competent authorities in all the Member States concerned in the case of a trial, and to the competent ethics committee, and in any case no later than seven days after knowledge by the sponsor of such a case, and that relevant follow-up information is subsequently communicated within an additional eight days. All other suspected unexpected serious adverse reactions shall be reported to the minister, to the competent authorities of all Member States concerned in the case of a clinical trial and to the ethics committee concerned as soon as possible but within a maximum of fifteen days of first knowledge by the sponsor. The minister shall ensure that all suspected unexpected serious adverse reactions to an investigational medicinal product which are brought to its attention are recorded. The sponsor shall also inform the other investigators. 2. Once a year throughout the experiment, the sponsor shall provide the minister and the ethics committee in Belgium and those of the member States in whose territory the trial is conducted in the case of a multicentre trial, with a listing of all suspected serious adverse reactions which have occurred over this period and a report of the subjects' safety. 3. The minister shall see to it that all suspected unexpected serious adverse reactions to an investigational medicinal product which are brought to its attention are immediately entered in a European database to which only the competent authorities of the Member States, the European Agency and the Commission shall have access. The European Agency shall make the information notified by the sponsor available to the competent authorities of the Member States. Chapter XVII. Liability and insurance Art. 29. 1. The sponsor is, even if faultless, liable for the damage which the subject or, in the case of death, his rightful claimants sustained and which shows either a direct or an indirect connection with the experiments; every contractual provision aiming at limiting this liability is considered null. 2. Before commencing the experiment, the sponsor shall enter into an insurance contract which covers this liability, and the liability of every individual intervening in the experiment, irrespective of the nature of the affiliation between the intervening individual, the sponsor and the subject. To that end, the sponsor or a legal representative of the sponsor shall be established in the European Union. 3. For the application of this Article, the subject or his rightful claimants can sue the insurer directly in Belgium before the judge of the jurisdiction where the event from which the damage has arisen has taken place, before the judge of the place of residence of the subject, or before the judge of the jurisdiction where the seat of the insurer is located. Notwithstanding the possibility of laying down in the contract between the sponsor and the insurer maximum amounts to compensate for the damage suffered by the participant or, in the case of death, his rightful claimants, as well as the possibility of setting a maximum duration for coverage of the risk, the insurer can oppose no nullity, no defence or no dissolution which result from the law or the insurance contract, to the subject or to his rightful claimants, with the exception of the cases established by the King. CHAPTER XVIII. Financial provisions Art. 30. 1. Without prejudice to the application of Article 31, 5, the request for a favourable opinion to the ethics committee and the request for authorisation to the minister, are admissible only insofar as the proof of payment of the contributions, as established by the King, is joined thereto. 2. The introduction of a dossier to the minister, within the meaning of the Articles 12 or 19 of this law, obliges the sponsor to pay a contribution to that authority. The contribution is deposited to the Federal Agency for Medicines and Health products. 3. 25 % of the contributions referred to in paragraph 2 is transferred to the Federal Agency for Medicines and Health products for the financing of the tasks assigned by this law. 75 % of these contributions is designated for the ethics committees for the financing of the assignments referred to in this law, in accordance with the rules established by the King. The King may annually review the distributive code referred to above. 4. Every year, following the opinion of the bioethics consultative committee, the minister may allocate a maximum of 10 % of the sum referred to in 3 and destined for the ethics committees for the payment of projects aimed at lending administrative or computing support in carrying out the missions of the ethics committees as a whole in the framework of this law. The remaining sum shall be awarded by the Federal Agency for Medicines and Health Products by means of a subsidy to the ethics committees as follows: 1 point awarded for the examination of a new protocol for multicentre experiments to the committee competent to submit the single opinion; 1 point awarded for the examination of a new protocol for a phase 1 trial to the committee competent to submit the single opinion; 0.25 points awarded for the examination of a new protocol to the committee that is not competent to submit a single opinion; 0.25 points awarded for the examination of a new protocol for a monocentre experiment, with the exception of the case in which this experiment is a phase 1 trial and the case when it is carried out in the framework of activities required for the obtaining of a higher education diploma; 0.1 points awarded for the examination of a new protocol for an experiment in the case when this is carried out in the framework of activities required for obtaining a higher education diploma. The value of one point shall be determined annually by dividing the said remaining sum by the total number of points awarded to all the ethics committees in accordance with the provisions of the previous paragraph. As a transitional measure, all the sums referred to in this Article shall be the subject of global regulation for the years 2004 and 2005 and they will be paid in 2007. 5. The sponsor of a monocentre experiment within the meaning of Article 11, 2 shall pay a fee directly to the ethics committee concerned. The sponsor of a multicentre experiment within the meaning of Article 11, 7, shall pay a fee directly to the ethics committees concerned. The introduction of a dossier by an investigator, in accordance with Article 19, 2, obliges the sponsor, depending on whether a monocentre or a multicentre experiment is concerned, to the payment of a fee directly payable to the ethics committee, the ethics committee competent to issue the single opinion, and of a fee directly payable to each ethics committee which is not competent to issue the single opinion, but on which an appeal is made in relation to Article 11, 4, 4, 6 and 7. 6. The King fixes the amount and the rules of payment of the contributions and fees established in the present Article. 7. Each ethics committee is obligated to send an annual report to the minister. This report contains a list of the requests for opinions which were submitted to the ethics committee in the application of this law, and a list of the reasoned answers given to the requests for opinions. The King can establish the form of this report. 8. The King may introduce, to be payable by the sponsor or the applicants of an authorisation to conduct an experiment or the holders of an authorisation to conduct an experiment as referred to in this law and for the benefit of the competent authority, other contributions than those referred to in 2, for the execution of the missions of the Federal Agency for Medicines and Health Products provided for by this law, the amounts and procedures of which the King shall determine. 9. The King may, by decree deliberated at the Council of Ministers, impose for investigational medicinal products a contribution payable by the sponsor of a clinical trial for the benefit of the Federal Agency for Medicines and Health Products. On this occasion, the King shall set the procedures for its collection. The amount of this contribution shall be set according to the risks to public health linked to these investigational medicinal products and the related activities. The royal decrees passed pursuant to paragraph 1 shall be automatically repealed if they are not confirmed by the legislator at the latest 18 months after they enter into force. 10. The contributions and fees referred to in this Article shall be adapted annually, according to the index of the month of September, to the consumer price index of the Kingdom. The starting index is that of the month of September preceding publication in the Moniteur belge of the royal decree setting the amount of the contribution or the fee. The index-linked amounts shall be published in the Moniteur belge and are applicable to the contributions and fees payable from 1 January of the year following that during which the adaptation is made. CHAPTER XIX. Specific provisions for non-commercial experiments Art. 31. 1. The King can, after being advised by the Advisory Committee for Bio-ethics, certify non-profit institutions which have introduced a request to that end, and whose company objectives are primarily focussed on research, in order for all or part of the experiments they conduct to be recognised as non-commercial experiments insofar as they meet the conditions referred to in Article 2, 15, b) en c). 2. For a trial which is not a commercial trial and which relates to a medicinal product with a marketing authorisation, the sponsor is not subject to the application of Article 12, 2, 2. Moreover, in this case the sponsor benefits from an exception to Article 24, 7, when he can prove at any moment, with regard to a trial with a marketing authorized medicinal product, that the medicinal product would have been prescribed in any case by the treating physician if the patient were not subject to the trial. The sponsor, who uses this possibility, notifies this to the INAMI. 3. By a decree established after deliberation in the Council of ministers, for a clinical trial which is not a commercial trial, the King can exempt the trial completely or partially of the requirements referred to in Article 25. 4. In the context of clinical non-commercial research, the hospital pharmacist may, contrary to the provisions of the Royal Decree of 19 October 1978 establishing rules concerning the pharmacies and the depots of medicinal products in nursing homes, prepare medicinal products according to prescription and deliver them to another hospital pharmacist, on condition that an agreement is contracted between the different hospitals which establishes the respective rights and duties. 5. If the experiment concerns a non-commercial experiment, the sponsor is exempted from the contribution and fee referred to in Article 30. CHAPTER XX. General provisions Art. 32. 1. No one individual can lend himself simultaneously to several phase I biomedical investigations. For each trial of phase I, the protocol submitted to the ethics committee determines an exclusion period in which the individual, who lends himself to the trial, cannot participate in another phase I trial. The length of this period differs according to the nature of the research. For other experiments than those of phase I, the involvement of the same subject in more than one protocol, is possible only after a specific opinion of the ethics committee competent for the second protocol. 2. In order to guarantee respect for 1, a databank shall be used to create a register of healthy volunteers willing to participate in experiments on the human person. The King determines the further rules of application of the previous paragraph. 3. Prior to commencing an experiment, the investigator is obligated to consult the database referred to in 2. 4. The minister must install a database at the European Agency, the European Commission and other Member States disposal, which contains the data on all requests for authorisation submitted to him, including requests for amendments, opinions of the ethics committee, the declaration of the end of the clinical trial and the reference to the inspections carried out in the application of Article 26. At the substantiated request of any Member State, the European Agency or the European Commission, the minister shall supply all further information other than the data already supplied in the application of the previous paragraph. Art. 33. 1. Without prejudice to the application of the penalties provided for in other laws and, as the case arises, the application of disciplinary sanctions, for whomever commits an infringement of Articles 5 to 9 will be punished with a prison sentence of a minimum of one month to a maximum of two years and with a fine of 500 EUR to 250 000 EUR or with only one of these two penalties alone. If an infringement of the above-mentioned Articles leads either to a disease which seams incurable, either to a permanent physical or mental incapacity, or the complete loss of an organ, the prison sentence will be for a minimum of three months to a maximum of three years and the fine will be 1 000 EUR to 500 000 EUR. 2. The provisions of Book I, including Chapter VII and Article 85 of the Penal Code, are applicable to the infringements regulated by this law. 3. Natural persons and legal persons are civilly liable for the fines and costs arising from the convictions pronounced by virtue of this law against their organs or agents. 4. The judge can decide that every judgment or arret containing a conviction by virtue of 1, is posted at the locations indicated by him and that possibly an excerpt of said judgment or arret is published in a manner to be determined by the judge and at a cost to the convicted individual. 5. By a reasoned decision, the judge can prohibit any individual convicted by virtue of 1 to participate during a period to be fixed by said judge which cannot be less than three years and not more than ten years, in the capacity of sponsor, investigator or in any other manner to conduct experiments on a human person, even under the authority of an investigator. Whomever infringes this prohibition shall be punished with the penalties provided for in 1, second paragraph.  HYPERLINK "http://www.juridat.be/cgi_loi/loi_a1.pl?DETAIL=2004050732%2FF&caller=list&row_id=1&numero=3&rech=3&cn=2004050732&la=F&chercher=t&language=fr&trier=promulgation&choix1=ET&choix2=ET&ddda=2004&ddfa=2004&tri=dd+AS+RANK+&text1=experimentations&dddj=01&fr=f&dt=LOI+-&ddfj=31&dddm=01&ddfm=12&set1=SET+TERM_GENERATOR+%27word%21ftelp%2Flang%3Dfrench%2Fbase%2Froot%2Fderive%2Finflect%27&set3=set+character_variant+%27french.ftl%27&fromtab=loi&sql=dt+contains++%27LOI%27+and+dd+between+date%272004-01-01%27+and+date%272004-12-31%27++and+%28+text+contains++%28+%27experimentations%27%29+++%29&imgcn.x=50&imgcn.y=9" \l "Art.33#Art.33" Art.  HYPERLINK "http://www.juridat.be/cgi_loi/loi_a1.pl?DETAIL=2004050732%2FF&caller=list&row_id=1&numero=3&rech=3&cn=2004050732&la=F&chercher=t&language=fr&trier=promulgation&choix1=ET&choix2=ET&ddda=2004&ddfa=2004&tri=dd+AS+RANK+&text1=experimentations&dddj=01&fr=f&dt=LOI+-&ddfj=31&dddm=01&ddfm=12&set1=SET+TERM_GENERATOR+%27word%21ftelp%2Flang%3Dfrench%2Fbase%2Froot%2Fderive%2Finflect%27&set3=set+character_variant+%27french.ftl%27&fromtab=loi&sql=dt+contains++%27LOI%27+and+dd+between+date%272004-01-01%27+and+date%272004-12-31%27++and+%28+text+contains++%28+%27experimentations%27%29+++%29&imgcn.x=50&imgcn.y=9" \l "LNK0022#LNK0022" 33bis. The deadlines mentioned in this law are counted in calendar days. When, pursuant to Articles 11, 13 and 19, a period of validation for the dossier submitted to the ethics committee or the minister is created, this is included in the deadlines mentioned in this law. CHAPTER XXI. Amending provisions and provisions of abolition Art. 34. 1. () 2. Article 6bis of the law of March 25,1964 on medicinal products, inserted by the law of June 21, 1983 and modified by the law of December 24, 2002, is abolished. 3. Article 191, first paragraph, 22, of the law on the mandatory insurance for health care and payments, coordinated on July 14, 1994, abolished by Royal Decree of April 25, 1997, is restored in the following version: 22: the amounts referred to in Article 30, 2, of the law of May 7, 2004 concerning experiments on the human person. 25 % of the amounts received from this retribution are paid on the order account of the treasury as referred to in Article 30, 2, last paragraph of the law of May 7, 2004 concerning experiments on the human person. The other 75 % are, by virtue by modalities established by the King, designated for the financing of the ethics committees for the assignments referred to in the same law. 4. In Article 1 of the Royal Decree No. 78 of November 10, 1967 concerning the health care professions, modified by the law of June 14, 2002, the word "preventive" is replaced by the words "preventive or experimental". CHAPTER XXII. Transitory measures and entry into force Art. 35. The provisions of the present law are not applicable to experiments which on the date of entry into force of the law have already obtained the opinion of an ethics committee. Art. 36. 1. This law enters into force on May 1, 2004. 2. The condition referred to in Article 2, 4 second paragraph is applicable as of September 1, 2006. Prior to this date, the ethics committees who meet the conditions referred to in Article 2, 4, first and third paragraph, are qualified to issue the opinion in accordance with the present law and in accordance with the conditions determined by the present law.  Consolidated version of the Law of May 7, 2004 concerning experiments on the human person modified by the programme law of December 27, 2004 (MB/BS 31/12/2004), by the law bringing various provisions of July 20, 2005 (MB/BS 29/7/2005), by the law bringing various provisions of December 27, 2005 (MB/BS 30/12/2005), by the law bringing various provisions on the subject of health of December 13, 2006 (MB/BS 22/12/2006), by the law bringing various provisions of December 27, 2006 (MB/BS 28/12/2006) and by the programme law of April 27, 2007 (MB/BS 08/05/2007, third edition).     These documents are for information purposes only. pharma.be is not responsible for the content of these documents. 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