Interim legal and compliance in pharma and life sciences

Short answer: Pharma and life sciences companies mainly need legal support for licensing and collaboration deals, clinical trials, supply and distribution agreements, product launches and compliance around interactions with healthcare professionals. A good interim legal counsel for life sciences combines contract skills with sector knowledge: in Switzerland, of integrity and transparency under Art. 55 and 56 of the Therapeutic Products Act (HMG); in Germany, of the healthcare bribery offences in Sections 299a and 299b of the Criminal Code (StGB) and the industry codes. For peaks and projects, interim legal counsel or interim compliance professionals can be brought in, part-time or full-time.

This guide is for general counsel, heads of legal and heads of compliance in pharma, biotech, medtech and diagnostics in Switzerland and Germany. It covers typical triggers, the key contract types and compliance topics, and which profile suits which task.

Typical triggers: when life sciences companies need extra lawyers

In life sciences, extra legal workload usually comes from projects with fixed milestones. The most common triggers:

• Licensing and collaboration deals: in- and out-licensing, co-development, co-promotion, option deals.
• Clinical trials: many clinical trial and site agreements in parallel, often across several countries and languages.
• Distribution and supply chain: new distributors, contract manufacturers (CMOs), quality agreements, supply agreements.
• Product launch: review of promotional and information material, agreements with healthcare professionals, patient programmes.
• Vacancy or absence: parental or maternity leave, illness or a resignation in the legal or compliance team.
• Transactions and integration: acquisition of a product portfolio, carve-out, harmonising contracts after an acquisition.

The table maps triggers to tasks and the matching profile.

Which contracts are typical in pharma and life sciences?

Typical life sciences contracts are licence, collaboration, clinical trial, supply, contract manufacturing, quality and distribution agreements. They differ from general commercial contracts mainly because regulatory duties have to be passed through to the counterparty.

Licence and collaboration agreements

The focus is on rights to patents, know-how and data, development obligations, milestone payments, royalties and responsibility for marketing authorisation.

Clinical trial agreements

They govern the site's services, payment, publication rights, data protection, insurance and the roles of sponsor and investigator. Multi-country trials add different templates and languages.

Supply, contract manufacturing and quality agreements

They pass Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) duties to counterparties. Quality agreements are usually aligned with quality assurance.

Distribution agreements

Besides territory, exclusivity and pricing, they include duties on pharmacovigilance, recalls and storage. Competition law limits on price and territory clauses apply; see the guide on competition law compliance.

The guide on clearing a contract review backlog shows how to review a large contract base in a planned way.

Compliance: interactions with healthcare professionals, transparency and anti-bribery

Pharma compliance centres on whether benefits to healthcare professionals could influence the prescribing or dispensing of medicines. The rules differ between Switzerland and Germany.

Typical compliance tasks in an interim assignment include:

• Updating the policy on gifts, hospitality, fees and sponsorship.
• Reviewing and documenting agreements with healthcare professionals (consulting, speaking, advisory boards).
• Recording discounts and rebates and preparing them for information requests.
• Third-party due diligence on distributors and agencies.
• Training sales and medical affairs and documenting attendance.

Profiles for interim compliance roles are described under interim compliance.

Data protection for health data

Health data is specially protected in both countries. In Switzerland it counts as sensitive personal data (Art. 5(c) of the Federal Act on Data Protection, FADP/DSG); in the EU it is a special category of personal data (Art. 9 GDPR). Where processing is likely to result in a high risk, for example in a clinical trial, both regimes require a data protection impact assessment (Art. 22 DSG; Art. 35 GDPR).

• Clinical trials: set out consent, pseudonymisation and the roles of sponsor, site and service providers clearly.
• Patient programmes and digital services: check the legal basis, processor agreements and transfers abroad.
• Pharmacovigilance: adverse event reports contain health data and need clear processes.

The guide on legal support in data protection projects shows how such work is organised.

Profiles and languages: what an interim lawyer for pharma should bring

The right interim lawyer for a regulated industry combines solid contract or compliance skills with sector knowledge and the necessary languages. These criteria help with selection:

• Sector experience: familiarity with licence, clinical trial or quality agreements and with the logic of authorisation and pharmacovigilance.
• Regulatory grounding: HMG and VITH in Switzerland; medicines law, pharma advertising law and industry codes in Germany.
• Languages: English almost always; plus the languages of the sites, authorities and counterparties, often more for clinical trials.
• Way of working: close cooperation with medical affairs, quality assurance, regulatory affairs and business development.
• Seniority: senior for deals and leadership, experienced for ongoing contracts, junior for data capture within a team.

Alpinum Solutions provides legal and compliance professionals for pharma and life sciences through staff leasing or freelancing, part-time or full-time, as individuals or teams. Pharma and life sciences is one of the sectors in which Alpinum has completed assignments over the last 24 months. Under staff leasing the company holds the right to give professional instructions; under freelancing the professional works independently within the agreed mandate. The page interim legal for companies and law firms gives an overview of all practice areas.

Typical assignment scenario

An international life sciences company reinforces its legal department at short notice with experienced interim legal and compliance specialists. They cover regulatory questions, commercial contract negotiations and ongoing compliance processes during a period of staff transition.

Limits and risks

• No legal advice from Alpinum: Alpinum is not a law firm. Legal responsibility, contact with authorities and representation stay with the company or an instructed law firm.
• Formal functions: statutory functions, for example in quality or pharmacovigilance, are not typical legal roles. Whether an interim professional can take on a formal function is for the company to clarify before the start.
• Confidentiality: trial data, deal information and pricing data are sensitive. Access, a confidentiality agreement and filing rules belong in onboarding.
• Boundary with regulatory affairs: regulatory affairs, not the legal team, prepares authorisation dossiers. The assignment should describe this interface clearly.

Frequently asked questions about interim legal and compliance in pharma

Do interim lawyers need pharma sector experience?

For licensing deals, clinical trial agreements and compliance topics, sector experience is a clear advantage because regulatory duties from authorisation, pharmacovigilance and therapeutic products law feed into the contracts. For general commercial contracts or a contract backlog, solid contract skills are often enough, supported by a briefing and an experienced contact person inside the company.

Which contracts are typical in life sciences?

Typical contracts are licence and collaboration agreements, clinical trial and site agreements, supply and contract manufacturing agreements, quality agreements and distribution agreements. Added to these are agreements with healthcare professionals for consulting or speaking, non-disclosure agreements and data processing agreements. Many follow templates that can be reviewed efficiently against a clear grid.

What does the Swiss integrity rule require?

Art. 55 HMG requires that benefits of any kind must not influence the choice of treatment or the prescribing and dispensing of prescription-only medicines. The details are set out in the Ordinance on Integrity and Transparency in the Therapeutic Products Sector (VITH), which has applied since 1 January 2020. Exceptions exist, for example, for gifts of modest value and, subject to conditions, for support of research and training.

How quickly can an interim lawyer for a pharma project be found?

At Alpinum, selected profiles are usually available within 48 hours; the company and Alpinum agree the start date together. It is faster when the role profile already states contract types, languages, workload and reporting line. Very specific profiles, for example for multi-country clinical trial agreements, can take longer to select.

Can interim professionals build a pharma compliance programme?

Yes, experienced interim compliance officers can build or revise policies, approval processes, training and transparency reporting. Responsibility for the programme stays with management and the in-house compliance function. A clear project brief with milestones and a handover ensures the programme keeps running after the assignment.

Next step

Tell us about the project, contract types, languages and timeline. We will show you suitable legal or compliance profiles for pharma and life sciences.

• Interim legal for companies and law firms
• Interim compliance
• Legal support in data protection projects
• Discuss your requirements

Last updated: 30 October 2026.