Standardisation for Clinical Trial Agreements: Germany’s New Standard Contractual Clauses

In recent years, the number of industry‑sponsored medicinal product and medical device trials involving German medical institutions has declined. A key reason has been the deterrent effect of how long it typically takes to negotiate contracts between companies and hospitals or practices in Germany. By contrast, some other EU countries have been able to conduct more clinical trials, as contracts there are concluded more quickly on the basis of binding standard clauses.

For industry‑sponsored clinical trials, the SCC will, from now on, be mandatory in Germany. Deviation from these clauses will only be possible by mutual agreement of the contracting parties.

This insight summarises and assesses the key points of the SCC and highlights practical implications for sponsors.

Practical impact for sponsors

For sponsors, the main benefit of the SCC is faster, more consistent contracting across sites in Germany, with fewer bespoke positions. Where the SCC include placeholders or alternatives, the parties must (i) complete the placeholders and (ii) select one of the listed alternatives in the contract.

We recommend:

• integrating the SCC into sponsor contract templates and playbooks; and
• pre-defining preferred selections for the available alternatives.

Publication Rights

The sponsor is granted the right of first publication of the clinical trial results. Trial sites retain publication rights for non-commercial scientific purposes. If the sponsor remains inactive, the trial site may publish after 12 months.

Legal transparency obligations (e.g., registry postings, reporting duties) remain unaffected. In multicentre trials, the first publication should be centrally coordinated by the sponsor and should reflect the overall results.

Sponsors should:

• set a publication plan at an early stage;
• define internal review workflows; and
• track the 12-month period to avoid loss of control over publication timing.

Inventions

Inventions arising from protocol-compliant performance of the trial and falling under the German Act on Employee Inventions (Gesetz über Arbeitnehmererfindungen – “ArbnErfG”) must be offered to the sponsor by the trial site. The sponsor has two months to accept the offer and claim the invention. If the sponsor does not exercise this option in time, the trial site may exploit the invention in accordance with the ArbnErfG. Where employees of the trial site make an additional inventive contribution, the sponsor owes the trial site appropriate remuneration.

Sponsors should:

• align their patent filing and IP strategy with the option timeline; and
• ensure internal processes allow for timely evaluation and acceptance of offered inventions.

Remuneration Options for Employee Inventions

The SCC provide two alternatives for compensating the trial site for employee inventions:

Market-based remuneration: A reasonable, market-based payment calculated using established criteria, taking into account, in particular, the parties’ interests, any agreed compensation framework, the trial site’s cost model, and the share payable to employee inventors under applicable rules.

Lump sum remuneration: A fixed payment, subject to adjustment in the event of a gross imbalance.

The market-based option offers flexibility and closer linkage to the actual value of the invention, while the lump sum option provides greater predictability of costs (subject to subsequent adjustment in exceptional cases).

Results that Are Not Inventions

Results that do not qualify as inventions are assigned to the sponsor upon contract signature. Where an assignment is not legally possible (for example, certain copyright-protected works), the trial site grants an extensive, exclusive licence to the sponsor. The trial site receives a licence back for non-commercial research, teaching and patient care.

This structure aims to ensure that the sponsor can fully exploit the trial results while trial sites retain rights for academic and clinical purposes, in line with the EU Research and Development Block Exemption Regulation ((EU) 2023/1066).

Confidentiality, Names and Trademarks

The SCC contain industry standard clauses on confidentiality and the use of names and trademarks:

• Use of the other party’s name or trademarks requires prior approval.
• Standard carve-outs to confidentiality apply, and use of confidential information is limited to contractual purposes.
• Confidentiality obligations generally survive for ten years beyond the end of the trial.

Sponsors may wish to establish pre-approved uses for names and logos (e.g., trial conduct, submissions to authorities, registries, customary author credit) to reduce the need for individual approvals.

Devices and Materials

The SCC also address devices and materials entrusted by the sponsor to the trial site:

• The sponsor remains owner of devices and materials provided.
• The sponsor bears the costs for delivery, installation, maintenance, accessories and consumables.
• Sponsors should maintain an asset register, clarify insurance arrangements and risk of loss, and provide clear instructions on the return or disposal of devices and materials at the end of the trial.

Liability

• The site gives no warranty for achieving a specific result of work or for freedom from third-party rights.
• The site must inform the sponsor without undue delay of any known conflicting third-party rights.
• The limitation of liability for slight negligence reflects the practical risks and constraints in the clinical trial environment.

Sponsors may consider adding trial-specific IP clearance warranties or indemnities and confirming that insurance coverage (for both sponsor and sites) aligns with the agreed risk allocation.

Term and Termination

Under the SCC, the contract ends in the following scenarios:

• all contractual obligations have been fulfilled;
• termination by a party; or
• refusal of approval by the competent ethics committee or authority.

Termination rights are structured as follows:

• both parties may terminate for good cause; and
• in addition, the sponsor may terminate without cause within a 14-day notice period.

Sponsors should ensure that internal planning and site communication take account of the sponsor’s unilateral termination right and any resulting compensation or wind-down obligations.

Conclusion

The SCC provide a pragmatic, balanced baseline for clinical trial agreements in Germany. They are largely aligned with current industry practice but introduce a standardised framework that should:

• shorten contract negotiations;
• improve consistency across sites; and
• still permit protocol and site-specific tailoring where needed.

We expect adoption to increase as sponsors and sites embed the SCC into their templates and playbooks. The overall benefit will depend on uptake by major university hospitals and the continued flexibility of the SCC for complex or innovative trial designs.

Our experts support sponsors and sites in:

• integrating the SCC into existing templates and processes;
• selecting and documenting the most suitable options; and
• negotiating site-specific deviations, including for high complexity or high value studies.