About law & regulation

The pharmaceutical and biotech industry is well regulated, for obvious reasons. But well regulated can be complicated. In this section you will find an overview of several aspects of law and regulations regarding the Dutch industry.

Intellectual property

To ensure future ownership of your innovations it is vital to protect them properly. The holder of a patent holds the right to prevent third parties from commercially exploiting an invention without authorization. In this industry patents are vital and patent law is a high-stakes game. Even when your invention is indeed unique and commercially interesting, you should anticipate lawsuits as others will most probably test your patent to see if they can profit from your invention. A well written - ironclad - patent and some financial backing is what you are looking for.

Biological patents and chemical patents

When your invention is based on biological elements or chemical structures, the patent procedure might not be as straightforward. As a rule, existing living organisms cannot be patented unless their genomic makeup is artificially engineered and thus man-made.

For chemical structures goes that complete groups of structures (that are considered 'functionally equivalent') can be patented to prevent competitors from producing a generic drug.

Do the research

The patent application process is a highly specialized one, and you will need professional help. But before you hire an agent to research the viability of your patent and draft an application, there are a few things you should do first:

1. Browse existing patents
Ensure that your invention does not infringe existing patterns. The European Patent Office gives you free access to Espacenet, a database with more than 70 million patent documents worldwide, containing information about inventions and technical developments from 1836 to today. You can use Espacenet to check if your invention has been described already. Also you might discover new technologies or come across solutions for your technical challenges.

2. Find an investor
Most patents will be tested in court. Finding a well funded partner increases the chance to fight and win your battles in court if necessary. Most investors (Angel Investors and VC’s) will have both the funds and the expertise to protect your invention.

3. Do not pay for advice just yet
Explore the possibilities to get free or subsidized help. Talk to governmental agencies and publicly funded organizations (university program, innovation network, patent office) before hiring a patent agency. Knowing your options will lead to better decisions and saves unnecessary specialist fees.

Patent application procedure

The European Patent Office (EPO) provides a uniform application procedure for individual inventors and companies seeking patent protection in up to 40 European countries.

In contrast to the procedure for granting European patents, the PCT (Patent Cooperation Treaty) procedure does not directly result in a patent being granted. That is why a worldwide patent does not exist. By means of a single application procedure the PCT allows you to obtain a world-wide valid patent. The World Intellectual Property Organization (WIPO) is responsible for implementing this treaty.

If you require further information on IP, the NL Patent office is your first stop.

Animal testing

Animal testing is often needed to develop new medicines, vaccines and treatments. Animal testing increases our knowledge of biological systems and is used for educational purposes. The Dutch Law on Animal Experiments governs the responsible use of laboratory animals and reduction of the number of animal experiments.

DECs

In the Netherlands experiments on vertebrates are prohibited unless a local evaluation through an 'Animal Experiment Committee', or DEC in Dutch, has been carried out. These DECs are united in the NVDEC (in Dutch).

When a license for an experiment with animals has been granted, the applicant is required to house the animal properly and ensure that the animals do not suffer unnecessarily. Only experts are allowed to design and implement experiments on animals.

Alternative options

The Dutch government supports the Assuring Safety without Animal Testing (ASAT) Initiative to find new ways to reduce, refine and replace the use of animal tests. This initiative resulted in the ASAT Foundation in 2008 and offers an alternative for animal testing in chemical safety.

Clinical trials

The Netherlands adheres to the European regulatory framework for clinical trials. An overview of EU legislation governing the pharmaceutical sector including clinical trials can be found at the Public Health website by the European Union. The Dutch Clinical Trial Foundation (nl) is an initiative of multiple parties within the sector that want to further improve the infrastructure for clinical research in the Netherlands.

Clinical Trial Directive

One of the most important European Directives is the Clinical Trial Directive (Directive 2001/20/EC of 4 April 2001). This directive has been implemented through the 'Law on medical-scientific research involving human subjects'. Based on this law, the Central Committee on Research Involving Human Subjects (CCMO) reviews research involving humans on the basis of the statutory provisions, taking into account the interest of medical progress.

For an overview of the reviewsystem in The Netherlands, visit the CCMO website.

Medical Devices

Clinical trials for medical devices & diagnostics are governed by EU and national rules; the applicable laws vary according to the type of device. The Dutch Health Care Inspectorate can provide you with more information.

Clinical Trials Register EU

In march 2011 the European Medicines Agency (EMA) launched the EU Clinical Trials Register. This online register gives public access to information on interventional clinical trials for medicines authorised in the 27 EU Member States and Iceland, Liechtenstein and Norway. The database allows the public to search for information on clinical trials in:

European Union (EU) member states,
the European Economic Area (EEA) and
outside the EU/EEA if they form part of a paediatric investigation plan (PIP).

Visit the EU Clinical Trials Register

Market authorization

Authorization for pharmaceutcals in the Netherlands

Market authorization for the Netherlands can be attained in two ways.

A European trajectory through the European Medicines Agency (EMA)
A national trajectory through the Dutch Medicines Evaluation Board.

Depending on your product you can choose either between these two options or only have one option available.

An overview of EU legislation governing the pharmaceutical sector including market authorization can be found on the website on public health by the European Union

Devices & Diagnostics

The market for medical devices in the Netherlands is supervised by the Dutch Health Care Inspectorate. Based on EU regulations, medical devices are divided classes, from low till high risk. For an overview of the European regulatory framework visit ECeuropa.eu.

Notified Bodies

Depending on product classification, the procedure for entering the market will differ. For some devices in class I a registration with CIBG, an agency of the Dutch Ministry of Health is sufficient. Other devices have to be registered with a 'notified body'. These organizations will guide you through a conformity procedure. At the website http://www.team-nb.org/ you will find a list of Europan notified bodies. A leading notified body for the Netherlands is Dekra.

In-vitro diagnostic devices

According to the European directive for medical devices for in-vitro diagnostics (Directive 98/79/EC) a producer of medical devices has to register with the authorities in the Member State in which it is located. In The Netherlands, new in-vitro diagnostics and their producers have to register with the CIBG.