GCP violations: pharmaceutical law studies prohibited even in case of abstract risk

Even purely formal GCP violations without concrete health damage or falsified study results justify incisive regulatory measures.

Pharmaceutical law background: preventive health protection and Good Clinical Practice

German and European pharmaceutical law is consistently oriented towards prevention. The objective of the Arzneimittelgesetz (AMG) according to § 1 AMG is to comprehensively protect human health and to minimise risks at an early stage that may arise from the development, testing and use of pharmaceutical products. Clinical trials involving humans occupy a particularly sensitive position as they directly interfere with high-ranking legal interests such as life, bodily integrity and self-determination of study participants.

Against this background, clinical trials are subject to strict legal requirements. Central importance is placed on the rules of Good Clinical Practice (GCP), which are mandatorily provided for in § 40 AMG and the GCP Regulation. They are intended to ensure that clinical trials are conducted in a scientifically valid manner, that the data collected are reliable, and that the rights, safety and well-being of the persons concerned are preserved at all times.

To enforce these requirements, § 69 Abs. 1 Satz 1 AMG establishes a broadly formulated pharmaceutical law intervention authority of the supervisory authorities. Accordingly, the authorities may issue necessary orders to prevent violations of pharmaceutical law provisions that have been established or are expected to occur in the future. The Higher Regional Court (OVG) Niedersachsen clarified with Beschluss vom 17. Dezember 2025 -13 ME 184/25 – the extent of this authority and what intervention threshold applies in a manner that merits attention.

What this case was about: repeated GCP violations by a trial investigator

The subject matter of the proceedings was the pharmaceutical law prohibition of commencing new GCP studies and further patient recruitment for already ongoing studies. The addressee of the order was an authorised physician who was active as a trial investigator in clinical pharmaceutical studies.

In the course of several inspections over an extended period, the competent authority had identified substantial breaches of duty through GCP violations. In particular, serious documentation deficiencies were noted, faulty and incomplete entries in electronic case report forms as well as inadequate recording of adverse events. In addition, there were deviations from the approved trial protocol, namely with regard to the dosage of a cytostatic agent, without the prescribed notification obligations, coordination obligations and reporting obligations to the sponsor, authority and ethics committee having been complied with.

The authority then prohibited the further conduct and commencement of new clinical trials and ordered immediate enforcement. Against this, the trial investigator took action seeking preliminary legal protection. In essence, he contended that the violations identified had led neither to a concrete risk to study participants nor to a demonstrable impairment of the study results. Such an incisive measure was therefore disproportionate.

The legal assessment of the OVG Niedersachsen: abstract risk from GCP violations is sufficient

The Higher Regional Court (OVG) rejected this argument in clear terms and fully upheld the prohibition order. The central statement of the decision is that § 69 Abs. 1 Satz 1 AMG does not require a concrete danger or damage already incurred. Neither the wording nor the systematic structure of the Arzneimittelgesetz permits the inference of such an unwritten element of the legal definition.

Rather, the provision is based solely on violations that have been established or are expected to occur in the future against pharmaceutical law obligations, including GCP violations. The court expressly emphasises that the AMG is configured as a security and precaution law. The protection of human health does not first come into play when concrete health impairment is demonstrable, but rather when such impairment appears possible. This preventive conception justifies taking measures already in the case of an abstract risk to the protected legal interests.

The court attaches particular importance to the documentation obligations of the trial investigator. Proper, complete and timely documentation is not a mere formal requirement, but rather a central quality characteristic of clinical research. Only comprehensive documentation ensures the traceability, verifiability and scientific utility of the study results. GCP violations in this area directly undermine the credibility of the entire studyand were therefore of considerable weight.

The OVG furthermore makes clear that the investigator cannot rely on the fact that any deficiencies could be remedied by the sponsor's data management or plausibility controls. Responsibility for the correctness and completeness of the data collected rests originally with the investigator. Investigator and sponsor do not form a unit of responsibility; a "delegation" of statutory obligations is excluded.

The court likewise did not accept the unauthorised deviation from the investigation plan on the grounds of patient welfare. Even if medical concerns were to exist, the investigator is strictly bound by the regulatory procedures. Deviations from the investigation plan may only be made within the framework of the provided amendment and notification procedures. Whoever deliberately deviates from approved investigation plans reveals a fundamental misunderstanding of the legal and scientific requirements of clinical trials.

Freedom of profession and proportionality: No professional ban

From a constitutional law perspective, the OVG does not qualify the prohibition as a professional ban, but rather as a permissible regulation of professional practice. The activity as an investigator does not constitute a separate profession, but merely a particular manifestation of medical practice. The person affected retains the unrestricted ability to practise the medical profession.

In view of the repeated and substantial GCP breaches as well as the high public interest in patient protection, study integrity and confidence in clinical research the interference with freedom of profession is proportionate. The ordering of immediate enforcement was also justified, as otherwise there would have been a risk of further GCP breaches and the devaluation of ongoing studies.

Conclusion and practical recommendation

The decision of the OVG Niedersachsen is of considerable practical significance. It makes unmistakably clear that GCP breaches already at the formal level can justify drastic administrative measures. Proof of concrete health damage or falsified study results is not required. For investigators, this represents a significant tightening of the liability and risk profile.

Our clear recommendation is therefore: GCP compliance must be secured structurally, organisationally and legally. Trial centres and investigators should regularly review their processes, professionally prepare for inspections and respond promptly to any criticisms in order to avoid GCP breaches from the outset. Particularly in dealing with documentation, adherence to investigation plans and notification obligations, there is no room for informal solutions or "medical discretion".

As a specialised law firm in pharmaceutical law the experts at AVANTCORE Rechtsanwälte in Stuttgart have been advising for many years on administrative measures, inspections and court proceedings. We help to identify risks at an early stage, to avoid prohibitions or – if necessary – to take effective action against them. Contact us before formal GCP deficiencies lead to existential legal and economic consequences..