Pharma & Life Sciences

As a life sciences lawyer, Law & More drafts and negotiates the contracts that pharma, medtech and biotech companies depend on: clinical trial agreements, licence agreements, R&D collaborations and supply agreements. We work for start-ups, scale-ups, research sites and international companies with activities in the Netherlands, in Dutch and English. The first step is a free introductory meeting in which we look at the draft contract or the project you are planning.

Clients rate Law & More 9.6 out of 10 on Klantenvertellen, the Dutch review platform (81 reviews, as of October 2026).

What can we help you with?

• Reviewing or negotiating a clinical trial agreement between sponsor, site and investigator.
• Drafting an in-licence or out-licence for a compound, technology or patent.
• Structuring an R&D collaboration with a university, hospital or industry partner.
• Negotiating supply, manufacturing and quality agreements with a contract manufacturer.
• Drafting confidentiality agreements and material transfer agreements.
• Setting up data protection arrangements for health data under the GDPR.
• Resolving a dispute with a partner, licensee or supplier.

What should a clinical trial agreement in the Netherlands cover?

A clinical trial agreement (CTA) records the obligations of the sponsor, the trial site and the investigator. It must fit the EU Clinical Trials Regulation (EU) No 536/2014 and the Dutch Medical Research Involving Human Subjects Act (WMO).

The Clinical Trials Regulation has applied since 31 January 2022. Since 31 January 2025, trials of medicinal products running in the EU must be conducted under this Regulation, with applications submitted through the EU Clinical Trials Information System (CTIS). In the Netherlands, the Central Committee on Research Involving Human Subjects (CCMO) and accredited medical research ethics committees review research with human subjects. Under the WMO, the sponsor must in principle take out insurance covering damage to trial subjects.

Points we check in every CTA:

• the budget, payment milestones and what happens on early termination;
• ownership of results and inventions, and the site's right to use data for research;
• publication rights and the review period for the sponsor;
• allocation of roles under the GDPR, since health data are a special category of personal data under Article 9;
• indemnities, liability caps and insurance;
• applicable law and the competent court, especially when the sponsor is based outside the Netherlands.

Many Dutch sites prefer to work with standard model agreements. Deviating from such a model is possible, but it usually takes longer to get approval from the site's legal department.

How do you structure a licence or R&D collaboration?

A licence or collaboration agreement must clearly state who owns which intellectual property, who may use it for what, and what each party receives in return. Disputes in this field usually arise from vague definitions of the licensed rights or of the results.

Licence agreements

Key terms are the scope of the licence (exclusive or non-exclusive, field of use, territory), upfront payments, milestones and royalties, and the right to grant sublicences. Diligence obligations matter as well: they oblige the licensee to make real efforts to develop the product, so that rights do not sit unused. EU competition law limits certain restrictions in licence agreements, such as some territorial and non-compete clauses, which we check for each deal. See also our intellectual property lawyer page.

R&D collaborations

In a collaboration, distinguish between background IP that each party brings in and foreground IP created during the project. Agree in advance who may file patent applications, who bears the costs and how jointly owned results may be exploited. Good confidentiality arrangements are essential, because publication or disclosure before filing can destroy the novelty of an invention. Our page on cooperation agreements covers the general framework.

What belongs in a pharma supply agreement?

A supply agreement sets out volumes, forecasts, prices and delivery terms; a separate quality agreement allocates responsibilities under good manufacturing practice (GMP). Both documents must be consistent, because a quality failure usually becomes a contractual claim.

Pay attention to forecasting and minimum purchase obligations, the procedure for rejected batches, recall costs and the limitation of liability. Under Dutch law, a limitation of liability clause can be set aside in case of intent or deliberate recklessness, so it never offers absolute protection. Also arrange what happens if the manufacturer loses a required licence or approval. Our article on supply agreements discusses the general clauses.

Which regulatory questions should you consider?

Medicines may only be placed on the Dutch market with a marketing authorisation. It is granted by the Medicines Evaluation Board (CBG) or, in the central procedure, by the European Commission on the advice of the European Medicines Agency (EMA). Medical devices must meet the Medical Devices Regulation (EU) 2017/745 or, for in vitro diagnostics, Regulation (EU) 2017/746.

The Health and Youth Care Inspectorate (IGJ) supervises compliance in the Netherlands, including the rules on advertising. The Dutch Medicines Act (Geneesmiddelenwet) prohibits advertising prescription-only medicines to the general public. We advise on how these rules affect your contracts and commercial plans. For detailed regulatory submissions, we work together with regulatory affairs consultants where needed.

How does working with Law & More work?

1. Introductory meeting: we discuss your company, the project and the contract, free of charge.
2. Advice and cost estimate: we review the draft or term sheet, list the main risks and give you a cost estimate.
3. Approach and negotiation: we propose changes, prepare a mark-up and negotiate with the counterparty.
4. Proceedings or completion: the contract is signed, or, in a dispute, we negotiate a settlement or conduct proceedings.

What does a life sciences lawyer cost?

We work at an hourly rate of 250 to 350 euros excluding VAT for a lawyer and 300 to 400 euros excluding VAT for a partner. We discuss the rate and the expected time with you in advance. For a contract review, we can usually give an estimate of the number of hours. The introductory meeting is free of charge. A one-off advice meeting without further assistance costs 300 euros including VAT.

We do not work on the basis of legal aid. Subsidised legal aid exists through the Legal Aid Board (Raad voor Rechtsbijstand), but we do not accept cases on that basis. External costs, such as court fees (griffierecht) or translation costs, are charged separately.

Who handles your case?

Your case is handled by one of our lawyers; in the introductory meeting you will hear who. You can read more about our lawyers on our team page.

Frequently asked questions

What does a life sciences lawyer do?

A life sciences lawyer advises pharma, medtech and biotech companies and research institutions on contracts and legal risks. At Law & More the focus is on clinical trial agreements, licence and collaboration agreements, supply agreements and disputes. We also advise on how regulatory rules, such as the Clinical Trials Regulation and the Medicines Act, affect those contracts and your commercial plans.

Which rules apply to a clinical trial in the Netherlands?

Trials with medicinal products fall under the EU Clinical Trials Regulation (EU) No 536/2014, which has governed all such trials in the EU since 31 January 2025. The Dutch WMO applies alongside it, for example to the insurance obligation and to research outside the scope of the Regulation. The CCMO and accredited medical research ethics committees review the research with human subjects.

Who owns the results of a clinical trial?

That depends on the clinical trial agreement. Usually the sponsor owns the results and inventions arising from the protocol, while the site keeps its background IP and may use data for non-commercial research or teaching under conditions. Publication rights for the investigator are common, often after a review period for the sponsor. Clear definitions prevent disputes later.

Is a confidentiality agreement enough before talks with a partner?

A confidentiality agreement is a good start, but not always enough. It should define what is confidential, for what purpose information may be used and for how long. If you share materials, a material transfer agreement is also advisable. For inventions, consider filing a patent application before disclosing details, because an NDA does not prevent every risk to novelty.

Can we limit our liability in a supply or licence agreement?

Yes, Dutch law allows parties to limit or exclude liability in a business contract. However, a court may disregard such a clause in case of intent or deliberate recklessness, or if relying on it is unacceptable by standards of reasonableness and fairness. Product liability towards consumers cannot be excluded by contract. We help you draft a cap that is balanced and holds up.

Do you work with foreign life sciences companies?

Yes. We regularly review English-language contracts for companies based outside the Netherlands that run trials, license technology or source products here. Where a contract is governed by foreign law, we advise on the Dutch aspects, such as the WMO, the GDPR and Dutch court procedures, and work together with a lawyer in the other country.

In doubt about your position? Tell us about your situation via our contact page or call +31 40 369 06 80, or e-mail info@lawandmore.nl. We will let you know within one working day what your options are.

Law & More, Marconilaan 13, 5612 HM Eindhoven (+31 40 369 06 80) and visiting location Pietersbergweg 291, 1105 BM Amsterdam (+31 20 369 71 21). Available Monday to Friday 08:00-22:00, Saturday and Sunday 09:00-17:00.

This page provides general information and does not replace advice on your specific situation.