Last Updated on May 29, 2021 by LawEuro
Medicinal Products Act (Laws / Regulations of Germany)
CHAPTER SIX
Protection of human subjects in clinical trials
Section 40
General conditions for clinical trials
(1) The sponsor, the investigator and all of the other persons involved in the clinical trial shall, in the conduct of the clinical trial of a medicinal product on human beings, fulfil the requirements of good clinical practice laid down in Article 1 paragraph 3 of Directive 2001/20/EG. The clinical trial of a medicinal product on human beings may only be commenced by the sponsor if the competent ethics committee has issued a favourable opinion on it pursuant to Section 42 sub-section 1 and the competent higher federal authority has given its approval pursuant to Section 42 sub-section 2. The clinical trial of a medicinal product may only be conducted on human beings if and as long as:
1. a sponsor or a representative of the sponsor whose registered place of business is situated in a Member State of the European Union or in another State Party to the Agreement on the European Economic Area, is available,
2. the foreseeable risks and inconveniences are medically justifiable, compared with the benefit for the person on whom the clinical trial is to be conducted (person concerned), and the anticipated significance of the medicinal product for medical science,
2a. according to the state of scientific knowledge in relation to the purpose of the clinical trial of a medicinal product consisting of a genetically modified organism or a combination of genetically modified organisms or containing such organisms, unjustifiable harmful effects on:
a) the health of third persons and
b) the environment
are not to be expected,
3. the person concerned:
a) is of age and is capable of understanding the nature, significance and implications of the clinical trial and to form a rational intention in the light of the facts,
b) has been informed pursuant to sub-section 2 sentence 1 and has given written consent, in so far as no deviating provisions are specified in sub-section 4 or Section 41, and
c) has been informed pursuant to sub-section 2a sentences 1 and 2 and has given written consent; consent must refer specifically to the collection and processing of health-related data,
4. the person concerned has not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities,
5. it is conducted in an appropriate facility by a suitably qualified investigator in a responsible manner and the trial is managed by an investigator who can provide evidence of at least two years’ experience in the clinical trial of medicinal products,
6. a pharmacological-toxicological test of the medicinal product in accordance with the prevailing state of scientific knowledge has been carried out,
7. each investigator has been informed, by a scientist responsible for the pharmacological-toxicological test, about the findings of the test and the foreseeable risks involved in the clinical trial,
8. in the event that a person is killed or a person’s body or health is injured during the course of the clinical trial, an insurance policy which provides benefits, even when no one else is liable for the damage, exists in accordance with the provisions contained in sub-section 3, and
9. a physician is responsible for the medical care of the person concerned or in the case of dental treatment, a dentist.
If the person affected is unable to write, in exceptional cases, instead of the written consent required in sentence 3 number 3 letters b and c, oral consent in the presence of at least one witness who was also included when the affected person was being informed may be given. The witness may not be anyone working at the trial site nor a member of the investigating team. The orally given consent shall be documented in writing, dated and signed by the witness.
(1a) The investigator shall designate suitably qualified members for the investigating team. He/she shall instruct and supervise them as well as providing them with the information necessary to perform their activities in conducting the clinical trial in particular the protocol and the investigator’s brochure. The investigator shall designate at least one deputy with comparable qualifications.
(1b) An insurance pursuant to sub-section 1 sentence 3 number 8 is not necessary for clinical trials with authorised medicinal products if they are used in accordance with the particulars specified in the marketing authorisation and risks and burdens owing to additional tests or the treatment comparison are minor and if the investigator and the sponsor are otherwise insured.
(2) The person concerned shall be informed by an investigator who is a physician, or in the case of a dental trial, a dentist, or by a member of the investigating team who is a physician, or in the case of a dental trial, a dentist about the nature, significance, risks and implications of the clinical trial as well as about his/her right to withdraw from the clinical trial at any time; a generally comprehensible information sheet is to be handed out to him. Furthermore, the person concerned is to be given the opportunity to have a counselling session with an investigator or a member of the investigating team who is a physician, or in the case of a dental trial, a dentist about the other conditions surrounding the conduct of the clinical trial. A declaration of consent pursuant to sub-section 1 sentence 3 number 3 letter b to participate in a clinical trial, can be revoked at any time before the investigator or a member of the investigating team, orally or in writing, without disadvantage to the person concerned.
(2a) The person concerned shall be informed of the purpose and scope of the collection and use of personal data, especially medical data. The person concerned shall be informed especially of the fact that:
1. where necessary, the recorded data:
a) will be kept available for inspection by the supervisory authority or the sponsor’s representative in order to verify the proper conduct of the clinical trial,
b) will be passed on in a pseudonymised form to the sponsor or to an agency commissioned by the latter for the purpose of scientific evaluation,
c) will be passed on, in a pseudonymised form, to the applicant and the competent authority for the marketing authorisation if an application for a marketing authorisation is filed,
d) will be passed on, in a pseudonymised form, to the sponsor and the competent authority and subsequently by the latter to the European database in the event of undesirable events in connection with the investigational medicinal product,
2. the consent pursuant to sub-section 1 sentence 3 number 3 letter c is irrevocable,
3. in the case of a revocation of a declaration of consent pursuant to sub-section 1 sentence 3 number 3 letter b, the stored data may continue to be used where necessary, in order to:
a) determine the effects of the investigational medicinal product,
b) to ensure that those interests of the person concerned which are worthy of special protection are not prejudiced,
c) satisfy the obligation to provide complete marketing authorisation documents,
4. the data will be stored with the specified bodies for the specified period pursuant to Section 42 sub-section 3.
In the case of a revocation of a declaration of consent made pursuant to sub-section 1 sentence 3 number 3 letter b, the competent bodies shall determine immediately whether the data stored for the purposes provided for in sentence 2 number 3 might still be needed. Data which are no longer needed are to be deleted immediately. Furthermore, the collected personal data shall be deleted after the period specified on the basis of Section 42 sub-section 3 has elapsed as long as no legal statutory or contractual retention periods exist to the contrary.
(3) The insurance pursuant to sub-section 1 sentence 3 number 8 must be taken out in favour of the person concerned in a clinical trial with an insurance carrier authorised to conduct business in a Member State of the European Union or another State Party to the Agreement on the European Economic Area. Its scope must be reasonably commensurate with the risks involved in the clinical trial and determined on the basis of the risk assessment in such a way as to ensure that for every case of the death or permanent occupational disability of a person concerned by clinical trial, at least 500,000 euros will be available. In so far as benefits are paid by the insurance, all claims to damages shall be extinguished.
(4) In respect of a clinical trial on minors, sub-sections 1 to 3 shall apply with the following proviso:
1. the medicinal product must be intended to diagnose or prevent diseases in minors and the use of the medicinal product must be indicated in accordance with medical knowledge for the purpose of diagnosing or preventing diseases in the minor. The medicinal product is indicated if its administration to minors is medically indicated.
2. clinical trials performed on adults or other research methods cannot be expected to produce satisfactory test results according to medical knowledge,
3. the consent is granted by the legal representative after being informed pursuant to sub-section 2. It must correspond to the minor’s presumed will where such a will can be ascertained. Before the start of the clinical trial, the minor shall be informed, by an investigator who is experienced in dealing with minors who is a physician or, in the case of a dental trial, a dentist or an adequately experienced member of the investigating team who is a physician or, in the case of a dental trial, a dentist, about the trial, the risks and benefits, in so far as this is possible taking into account the minor’s age and mental maturity; should the minor declare or express in any other way that he/she does not wish to take part in the clinical trial, this must be respected. If the minor is in a position to comprehend the nature, significance and implications of the clinical trial and to form a rational intention in the light of these facts, then his/her consent shall also be required. An opportunity for a counselling session pursuant to sub-section 2 sentence 2 shall be offered, not only to the legal representative but also to the minor,
4. the clinical trial may only be conducted if it subjects the person concerned to as little burden and other foreseeable risks as possible; both the degree of burden and the risk threshold must be defined specifically in the trial protocol and monitored constantly by the investigator,
5. with the exception of adequate compensation, no advantages may be granted.
(5) The person concerned, his/her legal representative or authorised representative, shall have access to a competent contact point from which information about all of the facts which are likely to be of significance for the conduct of a clinical trial can be obtained. The contact point shall be set up at the higher federal authority competent in the specific case.
Section 41
Special conditions for clinical trials
(1) In the case of a clinical trial on a person of legal age who is suffering from a disease which is to be treated by the investigational medicinal product, Section 40 sub-sections 1 to 3 shall apply with the following provisos:
1. the use of the investigational medicinal product is indicated according to the findings of medical science in order to save the person’s life, to restore health, alleviate suffering, or
2. it must be of direct benefit to the group of patients who are suffering from the same disease as this person.
If, in an emergency situation, consent cannot be obtained, treatment which is necessary without delay to save the life of the person concerned, restore good health or alleviate suffering can be started immediately. Consent for continued participation must be obtained as soon as it is possible and reasonable.
(2) In the case of a clinical trial on a person of legal age who is suffering from a disease which is to be treated by the investigational medicinal product, Section 40 sub-sections 1 to 4 shall apply with the following provisos:
1. the use of the investigational medicinal product must be indicated according to the findings of medical science in order to save the life of the person concerned, to restore him or her to health, to alleviate suffering, or:
2.
a) the clinical trial must be of direct benefit to the group of patients suffering from the same disease as the person concerned,
b) the research must be absolutely necessary in order to confirm data obtained in clinical trials on other persons or by means of other research methods,
c) research must relate to a clinical condition from which the minor concerned is suffering, and
d) the research may cause only minimal risk and minimal burden to the person concerned; research bears a minimal risk only when it is to be expected, owing to the nature and scope of the intervention, that it will result, at the most, in a very slight and temporary impairment of the health of the person concerned; it causes a minimal burden only when it is to be expected that the discomfort will be, at the most, temporary and very slight for the person concerned.
Sentence 1 number 2 shall not apply to minors to whom sub-section 3 would apply when they are of legal age.
(3) Section 40 sub-sections 1 to 3 shall apply under the following provisos to the conduct of a clinical trial on a person of legal age who is incapable of comprehending the nature, significance and implications of the clinical trial and of determining his/her will in the light of these facts and who is suffering from a disease in the treatment of which the investigational medicinal product is to be used:
1. the use of the investigational medicinal product must be indicated, according to the findings of medical science, in order to save the life of the person concerned, to restore him or her to health or to alleviate suffering; furthermore, such research must relate directly to a life-threatening or highly debilitating clinical condition suffered by the person concerned and the clinical trial may involve as little burden and other foreseeable risks as possible for the person concerned; both the degree of burden and the risk threshold must be defined specifically in the trial protocol and monitored constantly by the investigator. The clinical trial may only be conducted if there is a justified expectation that the benefits of using the investigational medicinal product for the person concerned outweigh the risks or that the use does not entail any risks,
2. consent shall be given by the legal representative or authorised representative after he/she has been duly informed pursuant to Section 40 sub-section 2. Section 40 sub-section 4 number 3 sentences 2, 3 and 5 shall apply mutatis mutandis,
3. the research must be absolutely necessary for the confirmation of data obtained from clinical trials conducted on persons capable of granting informed consent or by means of other research methods. Section 40 sub-section 4 number 2 shall apply mutatis mutandis,
4. with the exception of adequate compensation, no advantages may be granted.
Section 41a
Registration process for ethics committees
(1) Only the public sector ethics committees of the Laender that are responsible, pursuant to Land law, for evaluating and assessing clinical trials in human beings and are registered pursuant to sub-sections 2 to 5 may participate in the procedure to assess an application for the approval of a clinical trial pursuant to Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158 of 27.5.2014, p. 1).
(2) The application for registration is to be submitted, by the specific body responsible for the Land ethics committees, to the Federal Institute for Drugs and Medical Devices.
(3) In agreement with the Paul-Ehrlich Institut, the Federal Institute for Drugs and Medical Devices shall authorise the application for registration if the following prerequisites are fulfilled through the submission of suitable documents:
1. the requisite up-to-date scientific expertise of the Member States, as well as that of external experts,
2. the interdisciplinary composition of the ethics committee, with the participation of at least one jurist, one person with scientific or professional experience in the field of ethics in medicine, one person with experience in the field of experimental design and statistics, three physicians who possess experience in clinical medicine, including one specialist in clinical pharmacology or in pharmacology and toxicology, as well as one layperson,
3. the ethics committee shall comprise female and male members and, with the aim of equal participation, women and men will be given equal consideration when members and external experts are selected,
4. rules of procedure that, in particular, draw up binding regulations on the ethics committee’s methods of working; this includes, in particular, regulations on management, the chair, the preparation of decisions, the adoption of decisions as well as on honorary activities and the confidentiality obligations of members and external experts,
5. a managing office with the necessary qualified personnel to organise the tasks incumbent on the ethics committee,
6. material resources, that make it possible to conduct voting procedures on short notice and to draw up statements and assessment reports on time,
7. for each application, the ethics committee shall obtains declarations of independence from the participating members and external experts stating that they have no financial or personal interests that could affect their impartiality.
(4) Registered ethics committees shall notify the Federal Institute for Drugs and Medical Devices of changes that affect the registration prerequisites, without delay.
(5) The Federal Institute for Drugs and Medical Devices can, in agreement with the Paul-Ehrlich-Institut, order the registration to be suspended, or rescind the registration if it becomes known that the prerequisites for the registration do not or no longer exist, or in the presence of a violation of the rules of procedure stipulated in Section 41b sub-section 1.
(6) The Federal Institute for Drugs and Medical Devices shall publish a list of the registered ethics committees in the Federal Gazette. Personal data may be published only with the consent of the specific individual. The list is to be updated regularly.
Section 41b
Rules of procedure and schedule of responsibilities
(1) The Federal Ministry shall create, by ordinance subject to the approval of the Bundesrat, rules of procedure governing cooperation among the higher federal authorities and the registered ethics committees when processing applications for the authorisation of clinical trials pursuant to Regulation (EU) No. 536/2014. The rules of procedure shall stipulate in particular the details of the registration procedure, the deadlines for opinions by the registered ethics committees, the fixed fee scales or guideline rates, depending in each case on the number of personnel and amount of material required for the opinions and assessment reports by the registered ethics committees, the criteria for a schedule of responsibilities, including the factors that are decisive for the distribution of the applications to be processed, as well as who bears responsibility for requesting additional information from the sponsor pursuant to Regulation (EU) No. 536/2014.
(2) The ethics committees that were registered by 30 September 2017, or a body notified by them, shall issue a joint schedule of responsibilities for all registered ethics committees, by 1 January 2018. This schedule of responsibilities is to be updated annually by 1 January of each year. In special cases, the schedule of responsibilities can be updated and modified by way of derogation from sentence 2. The Federal Institute for Drugs and Medical Devices shall publish each new updated schedule of responsibilities. Personal data may be published only with the consent of the specific individual.
Section 41c
Power to issue ordinances
The Federal Ministry is hereby empowered to set up, by ordinance not subject to the approval of the Bundesrat, a Federal Ethics Committee at the Federal Institute for Drugs and Medical Devices and the Paul-Ehrlich Institut, where this is necessary to ensure the conduct of the procedures provided for in Regulation (EU) No. 536/2014. The provisions contained in this Chapter shall apply mutatis mutandis to the Federal Ethics Committee, subject to the proviso that the Federal Ethics Committee is deemed to be registered.
Section 42
Ethics committee procedure, procedure for authorisation by the higher federal authority
(1) An application for the favourable opinion from the ethics committee required pursuant to Section 40 sub-section 1 sentence 2 shall be submitted by the sponsor to the independent, interdisciplinary ethics committee responsible under Land law for the investigator. If the clinical trial is to be conducted by several investigators, the application shall be submitted to the independent ethics committee responsible for the chief investigator. The detailed provisions regarding the setting up, composition and financing of the ethics committee shall be stipulated by Land law. The sponsor shall submit to the ethics committee all of the information and documents required by the ethics committee for its opinion. In assessing the documents, the ethics committee can use its own scientific findings, consult experts or request expert opinions. It shall call in experts or ask for expert reports in the case of clinical trials conducted on minors if it is not in possession of expert knowledge of its own in the field of paediatrics, including the ethical and psychosocial aspects of paediatrics, or in the case of xenogeneic medicinal products or gene therapy medicinal products. A favourable opinion may only be refused if:
1. the documents submitted are incomplete even after expiry of an appropriate deadline given to the sponsor for their supplementation,
2. the documents submitted, including the trial protocol, the investigator’s brochure, and the modalities for selecting trial subjects, do not correspond to the current state of scientific knowledge, and especially, the clinical trial is unsuitable for providing proof of the safety or efficacy of a medicinal product, including a difference in the mode of action in women and men, or
3. the requirements specified in Section 40 sub-section 1 sentence 3 numbers 2 to 9 sub-section 4 and Section 41 are not fulfilled.
The detailed provisions shall be laid down in the ordinance pursuant to sub-section 3. The ethics committee shall have at the latest 60 days from the date of receipt of the required documents to give its opinion on the application referred to in sentence 1, which period can be extended or shortened in compliance with the ordinance pursuant to sub-section 3; no time limit with respect to the authorisation period shall apply in the testing of xenogeneic medicinal products.
(2) An application for the authorisation by the competent higher federal authority required pursuant to Section 40 sub-section 1 sentence 2 shall be made by the sponsor to the competent higher federal authority. In this regard, the sponsor shall submit all the information and documents necessary for the assessment especially the results of the analytical and pharmacological-toxicological tests as well as the trial protocol and the clinical data on the medicinal product including the investigator’s brochure. The authorisation may only be refused if:
1. the documents submitted are incomplete even after expiry of an appropriate deadline given to the sponsor for their supplementation,
2. the documents submitted, especially the data on the medicinal product and the trial protocol including the investigator’s brochure, do not comply with the current state of scientific knowledge, and especially, the clinical trial is unsuitable for providing proof of the safety or efficacy of a medicinal product, including a difference in the mode of action in women and men, or
3. the requirements stipulated in Section 40 sub-section 1 sentence 3 numbers 1, 2, 2a and 6, in the case of xenogeneic medicinal products also in number 8, in particular regarding the insurance of third-party risks, are not fulfilled,
4. the competent higher federal authority is in possession of findings which indicate that the testing facility is not suitable to conduct the clinical trial or is not capable of meeting the requirements for the clinical trial stipulated in number 2, or
5. the requirements provided for in Section 40 sub-section 4 or Section 41 are not fulfilled.
The authorisation shall be considered granted if the competent higher federal authority does not inform the sponsor of any reasoned objections within a maximum of 30 days after receipt of the application documents. If the sponsor fails to modify the application correspondingly, within a maximum of 90 days following the reasoned objections, the application shall be deemed to be rejected. The detailed provisions shall be laid down in in the ordinance pursuant to sub-section 3. By way of derogation from sentence 4, the clinical trial of medicinal products:
1. that fall under Number 1 of the Annex to Regulation (EC) No. 726/2004,
2. that are advanced therapy medicinal products, xenogeneic medicinal products,
3. that contain genetically modified organisms, or
4. the active substance of which is a biological product of human or animal origin, contains biological components of human or animal origin or requires such components in its manufacture,
can only be commenced if the competent higher federal authority has issued the sponsor with a written authorisation. The competent higher federal authority shall take a decision on the application for the authorisation of a medicinal product pursuant to sentence 7 numbers 2 to 4, within a maximum of 60 days, after receipt of the required documents stipulated in sentence 2, which period can be extended or shortened in compliance with an ordinance pursuant to sub-section 3; no time limit with respect to the authorisation period shall apply in the testing of xenogeneic medicinal products.
(2a) The competent higher federal authority responsible for authorising a clinical trial pursuant to sub-section 2 shall inform the competent ethics committee pursuant to sub-section 1, if it is in possession of information bearing on other clinical trials which is of significance to the ethics committee’s assessment of the clinical trial on which it is to issue an expert opinion; this applies especially to information on aborted or otherwise prematurely discontinued investigations. In such instances, no transmission of personal data shall take place; furthermore, business and company secrets shall remain confidential.
(3) The Federal Ministry is hereby empowered to issue, by ordinance subject to the approval of the Bundesrat, regulations to ensure the proper conduct of the clinical trial and the obtention of documents which correspond to the state of scientific knowledge. The ordinance may contain in particular regulations concerning:
1. the tasks and responsibilities of the sponsor, the investigator or other persons conducting or monitoring the clinical trial including notification, documentation and reporting obligations, especially with respect to adverse reactions or other adverse events occurring in the course of the study and which could endanger the safety of the trial subjects or the conduct of the study,
2. the tasks of the ethics committee and the procedure it follows including the documents to be submitted, also with information on the adequate participation of women and men as trial subjects, the interruption, extension or curtailment of the processing period and the special requirements placed on the ethics committee in the case of clinical trials pursuant to Section 40 sub-section 4 and Section 41 sub-sections 2 and 3,
3. the tasks of the competent authorities and the official authorisation procedure including the documents to be submitted, also with information on the adequate participation of women and men as trial subjects, the interruption, extension or shortening of the processing period, the procedure for inspecting documents in enterprises and facilities as well as the prerequisites and the procedure for the withdrawal, revocation and suspension of the authorisation or prohibition of a clinical trial,
4. the requirements for the testing facility regarding the furnishing and preservation of evidence,
5. the transmission of the name and the registered place of business of the sponsor and of the investigator responsible and non-personal data pertaining to the clinical trial, as well as results of the clinical trial, to a European database by the competent authority,
6. the powers to collect and utilise personal data, if so required for the conduct and supervision of the clinical trial; this also applies to the processing of data that are not processed or used in files,
7. in the case of medicinal products consisting of a genetically modified organism or a combination of genetically modified organisms or containing such organisms,
a) the collection and use of personal data where such data are necessary for protection against risks to the health of third persons or to the environment as an interactive structure,
b) the tasks and powers of the authorities to protect against risks to the health of third persons and to the environment as an interactive structure,
c) the transmission of data in a publicly accessible European database, and
d) the exchange of information with the European Commission;
furthermore, the transmission of documents and copies of the decisions to the competent authorities and to the ethics committees responsible for the investigators can be regulated and it can be stipulated that documents be submitted on electronic storage media. The ordinance shall provide for exceptions for authorised medicinal products pursuant to Directive 2001/20/EC.
Section 42a
Withdrawal, revocation and suspension of the authorisation or of the favourable opinion
(1) The authorisation shall be withdrawn if it becomes known that one of the grounds for refusal as referred to in Section 42 sub-section 2 sentence 3 numbers 1, 2 or 3 existed at the time of issuance; it shall be revoked, if facts subsequently arise which would justify refusal pursuant to Section 42 sub-section 2 sentence 3 numbers 2, 3, 4 or 5. In the cases referred to in sentence 1, the suspension of the authorisation may also be ordered for a limited period of time.
(2) The competent higher federal authority may withdraw the authorisation if the conditions surrounding the clinical trial do not correspond to the information contained in the authorisation application or if facts give reason to doubt the safety or the scientific basis of the clinical trial. In such a case, the suspension of the authorisation can also be ordered for a limited period of time. The competent authority shall immediately inform the other competent supervision authorities and ethics committees, as well as the European Commission and the European Medicines Agency, stating the grounds for its action.
(3) Before a decision pursuant to sub-sections 1 and 2 is taken, the sponsor shall be allowed a deadline of one week to submit a statement. Section 28 sub-section 2 number 1 of the Administrative Procedures Act shall apply mutatis mutandis. In the event that the competent higher federal authority orders the immediate interruption of the clinical trial, it shall inform the sponsor immediately of this order. The lodging of an objection and action to rescind the revocation, the withdrawal or the order to suspend the authorisation as well as against orders pursuant to sub-section 5, shall have no suspensive effect.
(4) If the authorisation to conduct a clinical trial is withdrawn, revoked or suspended, the clinical trial may not be continued.
(4a) The favourable opinion by the competent ethics committee shall be withdrawn if the ethics committee subsequently becomes aware that grounds for a refusal pursuant to Section 42 sub-section 1 sentence 7 existed at the time; it shall be withdrawn if the ethics committee becomes aware of the fact that subsequently:
1. the requirements regarding the suitability of the investigator, his or her deputy or the trial site are no longer fulfilled,
2. the clinical trial participants are no longer properly insured or the prerequisites for an exception to the insurance obligation no longer exist,
3. the modalities for selecting trial subjects no longer correspond to the current state of medical knowledge and, especially, the clinical trial is unsuitable for providing proof of the safety or the efficacy of a medicinal product including a difference in the mode of action in women and men, or
4. the prerequisites for the inclusion of persons pursuant to Section 40 sub-section 4 or Section 41 are no longer fulfilled.
Sub-sections 3 and 4 shall apply mutatis mutandis. The competent ethics committee shall inform the competent higher federal authority and the other authorities responsible for surveillance immediately, stating the grounds.
(5) If the competent higher federal authority, in the context of its activities, becomes aware of facts which justify the assumption that the sponsor, one of the investigators or another participant no longer fulfils his/her obligations with regard to the proper conduct of the clinical trial, the competent higher federal authority shall immediately inform said person thereof and shall order remedial measures to be taken by this person; should the measures not relate to the sponsor, he/she shall be informed of the order. This shall be without prejudice to measures taken by the competent supervision authority pursuant to Section 69.
Section 42b
Publication of the results of clinical trials
(1) Pharmaceutical entrepreneurs who place a medicinal product that requires a marketing authorisation or an authorisation and is intended for use on human beings on the market, within the purview of this Act, shall place reports on all the results of confirmatory clinical trials substantiating the efficacy and safety of the medicinal product at the disposal of the competent higher federal authority for entry into the database referred to in Section 67a sub-section 2. These reports shall be made available within six months subsequent to the granting or modification of the marketing authorisation or authorisation, if the modification is based on confirmatory clinical trials.
(2) If a clinical trial is conducted with a medicinal product which has already been granted a marketing authorisation and if this medicinal product is not being used as the comparator medicinal product, the sponsor shall make the results of the clinical trial available within one year after its completion pursuant to sub-section 1.
(3) The reports pursuant to sub-sections 1 and 2 must contain all of the results of the clinical trials, whether they are favourable or not. In addition, information regarding subsequent essential modifications to the trial protocol, as well as interruptions and early termination of the clinical trial, shall be included in report. Furthermore, the report of findings shall be drawn up according to the requirements of good clinical practice. With the exception of the name and address of the pharmaceutical entrepreneur or the sponsor, as well as the name and the address of the consenting investigators pursuant to Section 4a of the Federal Data Protection Act, the reports pursuant to sentence 1 may not contain personal nor especially patient-related data. The report may be written in German or English. Section 63b sub-section 3 sentence 1 shall not apply. This shall be without prejudice to the provisions protecting intellectual property and those protecting operating and trade secrets, as well as Sections 24a and 24b.
Leave a Reply