Preclinical and Clinical Trial Requirements
Heuking Kühn Lüer Wojtek / Germany
A brief overview of the situation regarding preclinical and clinical trial requirements in Germany. Prepared in association with Heuking Kühn Lüer Wojtek, a leading global law firm, this is an extract from The Pharma Legal Handbook: Germany, available to purchase here for USD 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
1. In principle, pre-clinical and clinical studies and trials can be obtained from regulated and approved providers in Germany or abroad. Conditions apply. Pursuant § 40 of the German Medicinal Products Act, 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 that is a party to the Agreement on the European Economic Area, must be available. See also the summary of the Federal Agency for Medicinal Products and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) at https://www.bfarm.de/EN/MedicalDevices/ClinicalTrials-MD/Authorisation/_node.html
2. The sixth chapter of the German Medicinal Products Act sets some of the relevant rules for clinical trials and the protection of human subjects in clinical trials (§ 40: General conditions for clinical trials (acceptable risks, informed consent of subjects following comprehensive disclosure and risk information, risk insurance purchased for the benefit of subjects, protection of minors, completion of prior toxicological and animal testing, minimum of two years professional experience of supervising physician (principal investigator), independent ethics committee evaluation with consent), § 41: Other special pre-conditions for clinical trials, § 42: Ethics committee procedures, procedure for authorisation by the German federal authority, § 42a: Withdrawal, revocation and suspension of the authorisation or of the favourable opinion, and § 42b: Publication of the results of clinical trials.
2. How are clinical trials funded?
Funding is generally provided by the medicinal product developer or manufacturer (sponsor and co-sponsors).
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
1. The protocol describing all details of the study terms is prepared by the study sponsor and submitted, with supporting documentation (active ingredient dossier, proof of insurance, consent forms, sponsor/investigator/institution details, study subject inclusion scheme etc.) to the relevant ethics committee (§ 42 (1), (2) of the Medicinal Products Act) and the relevant approval authority (Federal Institute for Drugs and Medical Devices (BfArM) or the Federal Institute for Vaccines and Biomedicines (PEI), as applicable). Thereafter, the competent local supervising authority is notified of the intended clinical trial (§ 67 (1), (1), (5) of the Medicinal Products Act).
2. A changed approval procedure is expected in 2019 under EU Regulation on Clinical Trials (536/2014, CTR) and pertinent German law, providing for a single application to the EU-Portal. That will be accessible via the EU-Database from all EU member states in which an applicant plans a clinical trial.
4. What are the requirements for consent by participants in clinical trials?
Pursuant § 40 of the German Medicinal Products Act, the study subject must be of age and capable of understanding the nature, significance and implications of the clinical trial and able to form a rational intention in the light of the facts. It must have been fully informed and given written consent which consent must also refer specifically to the collection and processing of health-related data.
5. May participants in clinical trials be compensated?
Yes, compensation is permitted and customary.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
Pursuant § 40 of the German Medicinal Products Act, an insurance policy covering risks of death and body or health injury must be in place which provides benefits to the study subject even when no one else is liable for the damage. The insurance must be taken out in favour of the study subject 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 study subject, at least 500,000 € will be available. In so far as benefits are paid by the insurance, all claims to damages shall be extinguished.
