LIFE SCIENCES LAW - Ralph Schäfer – Lawyer - Your expert for legal issues in the life sciences sector

New standard contract template for clinical trials in Germany

Specialist article in pharmaceutical law

Clinical trials in Germany on the brink of change

A binding standard contract template will now be available for conducting clinical trials in Germany. Several key organizations from the pharmaceutical industry, clinical research, university medicine, and contract research sectors have developed a joint contractual framework for this purpose. The aim is to significantly simplify the often lengthy and complex contract negotiations between companies and medical institutions.

The background to this is the declining proportion of clinical trials in Germany over the past few years. A joint analysis by EFPIA, IQVIA, and Vaccines Europe from 2024 shows that the number of commercial clinical trials in phases I to IV fell from 618 to 417 between 2018 and 2023. The proportion of clinical trials also declined across Europe. In many cases, the complex and non-standardized contract negotiations with hospitals and medical practices were identified as a major contributing factor.

Approval by the Federal Council paves the way

A crucial step has now been achieved with the approval of the Federal Council of the corresponding regulation. This establishes the legal basis for binding standard contractual clauses between sponsors and medical institutions in industry-initiated clinical trials. The Federal Ministry of Health can now implement the regulation promptly.

The participating associations see this as an important step forward for Germany as a location for clinical trials. Standardized contract clauses should make it possible to conclude contracts more quickly and efficiently, and to make Germany more attractive again in the international competition for clinical trials.

A uniform contractual basis for greater speed and legal certainty

Clinical trials require close collaboration between companies and medical institutions. In hospitals and clinics, patient consultations, examinations, treatments, and the documentation of study progress all take place. Often, multiple institutions in different federal states are involved, which further complicates contract negotiations.

Until now, individually negotiated contracts often led to significant delays. Other European countries, however, were able to conduct studies more quickly because they already use binding standard clauses. With the Medical Research Act passed in October 2024, the possibility of introducing such binding contractual clauses was created in Germany for the first time.

The draft regulation, now adopted, was approved by the Federal Cabinet at the end of May 2025 and subsequently submitted to the Federal Council for approval. Once the regulation enters into force, the standard contractual clauses for industry-initiated studies will become binding. Deviations will only be permitted in justified exceptional cases and by mutual agreement.

Balanced compromise of interests

The new standard contract template is intended to serve as a guideline for specific contract drafting and to ensure a fair balance between the interests of sponsors and the implementing medical institutions. Representatives from university hospitals, the KKS network, research-based pharmaceutical companies, the pharmaceutical industry, medical device manufacturers, and medical contract research organizations were among those involved in its development.

Previously existing model contracts were merely advisory and failed to significantly expedite contract negotiations. The new, government-mandated standard clauses now establish binding frameworks for the first time.

Regardless, supplementary recommendations regarding the remuneration of services provided by trial centers remain applicable. This is because, in addition to legal issues, economic aspects, particularly the remuneration for complex patient care, play a central role. These should continue to be negotiated individually and are not subject to a uniform fee schedule.

Strengthening Germany as a study location

The introduction of binding standard contractual clauses is intended to significantly speed up the setup of clinical trials in the future. At the same time, transparency will be increased and legal certainty improved for all parties involved. This will allow pricing for study services to be more closely aligned with market conditions, without being bogged down by lengthy contract negotiations.

Overall, the new standard contracts are expected to make an important contribution to making Germany more attractive for clinical trials again and accelerating patients' access to innovative therapies.

Submit your inquiry now

We will gladly advise you comprehensively and personally on your request.

Submit your inquiry now

We will gladly advise you comprehensively and personally on your request.

FAQs – Frequently Asked Questions about Standard Contract Templates for Clinical Trials

What is the new standard contract template for clinical trials?

The standard contract template is a binding contractual framework for agreements between industrial companies and medical institutions for conducting clinical trials. It is intended to simplify and expedite contract negotiations.

Why was a new standard contract template introduced?

In Germany, contract negotiations for clinical trials have often been lengthy and inconsistent. This has led to an increasing number of trials being relocated to other countries. The new model is intended to make Germany a more competitive location for clinical trials.

From what date do the binding standard contractual clauses apply?

Following approval by the Federal Council, the Federal Ministry of Health can enact the corresponding regulation. From this point on, the standard contractual clauses for industry-initiated studies are mandatory.

For which studies does the standard contract template apply?

The contract template applies to industry-initiated clinical trials of pharmaceuticals and medical devices conducted in collaboration with clinics or medical practices.

Can contracting parties deviate from the standard clauses?

Deviations are only permissible in justified exceptional cases and exclusively with the mutual agreement of the contracting parties. The standard clauses should be applied as the norm.

What advantages does the standard contract template offer companies?

Companies benefit from shorter contract negotiations, greater planning certainty, clear responsibilities and an accelerated start to studies.

What is the significance of the standard contract for clinics and testing centers?

For medical institutions, the contract template creates transparency, legal certainty and a reliable basis for cooperation with sponsors in clinical trials.

Are remuneration issues regulated by the standard contract template?

No. The standard clauses primarily concern legal frameworks. Remuneration for academic services remains subject to individual negotiations between the parties.

What role does the Medical Research Act play?

The Medical Research Act of 2024 created for the first time the legal basis for introducing binding standard contractual clauses for clinical trials.

When is legal advice advisable in connection with standard contractual clauses?

Specialized consulting is particularly useful when reviewing and applying standard clauses, regarding permissible deviations, complex study configurations, or international projects. Life Sciences Law supports pharmaceutical and biotech companies in implementing study contracts in a legally sound, efficient, and strategic manner.