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Informed Consent: When Is It Legally Valid?

Before a doctor carries out medical treatment, the patient must be well informed about what is going to happen, what risks are associated with it and what alternatives exist. That's called informed consent. Without good information, a patient cannot give informed consent. In this blog we explain what informed consent means, when consent is valid and when it is not, and what you can do if you are not sufficiently informed.

What is informed consent?

The basic principle in the medical world is that a patient decides for himself or herself about his or her treatment. It is essential for this that the patient understands what the treatment entails, what risks are involved and what alternatives are available.
Informed consent therefore means: consent based on complete and understandable information.

What does 'treatment' include?

In this context, 'treatment' actually means everything that a doctor does for you around your care process. This goes beyond just the actual procedure or operation. Also consider, for example, physical examination, diagnostic tests, making a diagnosis and the follow-up care that follows. In short: every medical procedure that is part of your treatment is included.

The doctor must explain:

The nature and purpose of the treatment;
The possible risks and complications;
The chance of success or recovery;
Alternatives, including waiting or not treating;
The consequences of refusing treatment.

Information about effectiveness and waiting times

In addition to basic information about the treatment, the doctor is also obliged to be honest about the proven effectiveness of the proposed care. This means that you can expect the doctor to indicate whether a treatment is scientifically substantiated or whether it has not (yet) been sufficiently proven. Especially with new treatment methods, alternative therapies or experimental care, it is important that you get clarity about this. You should also be informed about any waiting times for the treatment. This way you know what to expect and you can take this into account in your decision whether or not to agree to the treatment proposal. Summary:

Does a treatment have a proven effect? The doctor must mention this explicitly.
How long will it take to get help? You should also get clarity about this.

All this ensures that you as a patient receive an honest and complete picture, so that your consent is actually informed.

Only once this information has been provided and understood can consent be legally valid.

Implied and explicit consent: when does what apply?

Consent for medical treatment can be given in different ways. In many cases, verbal or even tacit (implicit) consent is sufficient. For example: if you extend your arm for a vaccination, the doctor may assume that you agree to the injection. Even for simple or urgent actions, such as suturing a wound after an accident, implicit consent is often considered sufficient. However, if it concerns drastic, riskier or non-urgent (elective) treatment, you as a patient must give explicit consent. In that case, the doctor will not only provide all relevant information, but also record in the medical file that you have agreed. In short:

Implied consent: for simple, routine or necessary emergency treatments.
Explicit consent: for serious, risky or planned medical procedures, always confirmed in writing or verbally and recorded by the doctor.

When is a doctor allowed to treat without explicit permission? A doctor may only start treatment if the patient has given permission. However, this consent does not always have to be expressly expressed. In practice, it often happens that a patient gives implicit consent for simple, routine actions or in emergency situations—for example, by extending an arm for an injection or taking a seat on the treatment table. The situation is different with major treatments, risky interventions or planned operations. Then it is required that the patient clearly, i.e. explicitly, agrees to the proposed plan. This explicit consent is carefully recorded by the doctor in the medical file. This ensures that the patient remains fully in control of important decisions and that the right to self-determination is central.

Why good communication and informed consent are so important

Good communication between doctor and patient goes beyond a legal obligation; it forms the basis for a strong relationship of trust. By talking clearly and openly about the treatment, risk factors and options, the patient feels taken seriously and involved in what is happening to him or her. This trust not only ensures that patients are more likely to share their concerns or doubts, but also promotes treatment compliance: people are more likely to follow advice when they understand why certain choices are made. Clear explanations and sincere attention not only ensure compliance with the rules, but also create mutual respect—a foundation for good care.

From classical model to shared decision-making

With the arrival of additional rules regarding informed consent, the emphasis is increasingly shifting to so-calledshared decision making, or 'joint decision-making'. Where in the past the doctor often determined what seemed best—and the patient followed that advice—nowadays the patient's preference is central. With shared decision-making, the doctor and patient discuss the treatment together. You indicate what is important to you, for example work, family or quality of life, and the doctor explains the medical options, including the pros and cons. This way you make a decision together that suits your personal situation and values, instead of just following the doctor's advice. This approach ensures that medical choices are not only medically responsible, but also meet the wishes and expectations of the patient.

Legal basis of informed consent

The right to information and consent is laid down in Article 7:448 of the Civil Code. This states that the care provider must inform the patient “in a clear manner” about the intended treatment and the expected consequences or risks.

In addition, the law stipulates that the doctor is obliged to keep a good medical file in which this information is recorded.
Read more about this in our blog Medical file: inspection, copy and correction.

Other legal information obligations In addition to the Civil Code, there are also other laws that contain information obligations for the doctor, such as the Health Care Quality, Complaints and Disputes Act (Wkkgz). According to this law, the healthcare provider (often the treating physician) must inform the patient about the care offered if he or she so requests. This not only concerns the nature of the care, but also the rates, the quality and the experiences of other patients with that care. In addition, the doctor is obliged to inform the patient about the existence or otherwise of scientifically proven effectiveness of the care and the possible waiting time. This way the patient gets a complete picture and he or she can make an informed decision.

Latest additions to the information obligation since 2020

Since January 1, 2020, the information obligation for healthcare providers has been further expanded. Not only must doctors and other care providers inform patients in a timely manner about the treatment and the risks, it is now also legally required to consult with the patient about the proposed treatment. The patient must be actively invited to ask questions. The healthcare provider must also provide additional information, such as:

The option to opt out of the treatment.
Alternative examinations or treatments that can be performed by other healthcare providers.
The expected duration and when the treatment can start.

These changes are intended to give the patient more influence and control, or in other words, to make joint decisions about care. In other words, the focus shifts from the traditional 'the doctor advises' to 'joint decisions', where the wishes and preferences of the patient are central.

When is consent not legally valid?

Consent is not legally valid if the patient has not been informed, or has been incorrectly informed. This can occur in different ways, for example:

The doctor did not explain what risks are associated with the treatment;
There was no discussion of alternative treatments;
The risk of complications has been downplayed;
The patient has been pressured to agree;
Consent was given without the information being understandable.

If a doctor has violated his obligation to provide information, the treatment can be considered unlawful. If the patient suffers damage as a result, there may be medical liability. You can read more about this in our blog Medical liability in the Netherlands: patients' rights and route to compensation.

The importance of evidence: what is in your file?

In a liability case, the medical file is crucial. This must state what information was given, whether an informed consent form was signed and whether there are notes of conversations with the doctor.

Capturing consent: explicit and implicit A doctor may only start treatment after the patient has given permission. This consent can be given in various ways. Sometimes there is implicit or tacit consent—for example for less drastic actions or if immediate action is required in an emergency situation. However, if it concerns drastic, risky or planned (elective) treatment, you as a patient must explicitly consent. In such a case, this permission is also recorded in the file by the doctor.

If this information is missing, the burden of proof often lies more heavily with the healthcare provider.
You can request the file from the hospital or practitioner. You can read how to do this step by step in our blog Medical file: inspection, copy and correction.

Consequences of violation of informed consent

If it turns out that you were not properly informed, the doctor or hospital may be liable for the resulting damage. This may be, for example, because you would not have agreed to the treatment if you had received correct information, or because you would have opted for an alternative with less risk.

In such a case, damages can be claimed, consisting of:

Material damage – medical costs, loss of income, travel expenses, domestic help;
Intangible damage (punishment) – compensation for pain, sorrow and loss of enjoyment of life.

Read in our blog How can you calculate damages? how the amount of the damages is determined.

Common misunderstandings

A signature on a consent form does not automatically mean that informed consent has been given.
Oral explanation is also mandatory — written information alone is not enough.
The fact that a risk is mentioned in a leaflet does not absolve the doctor from the obligation to discuss it personally.
Not every complication is a mistake; there must be a violation of the obligation to provide information and demonstrable damage.

Practical example

A patient only received a standard leaflet with general risks prior to surgery. During the procedure a complication arose that was not mentioned in the brochure and which had not been discussed. The patient stated that if he had received correct information he would not have consented to the operation. The judge ruled that the hospital had violated its obligation to provide information and awarded damages.

What can you do if you think you have not been properly informed?

Request your medical file.
Note what was said during conversations with doctors.
Contact a specialized personal injury lawyer.
Have it assessed whether there has been a violation of the obligation to provide information.

Our lawyers will help you safeguard your rights and take the right steps towards compensation.

Why Arslan Lawyers?

At Arslan Lawyers we regularly handle cases in which the obligation to provide information has been violated. We work together with independent medical advisors and ensure that your file is fully compiled. Our services are free of charge for victims, because we recover the costs from the liable party.

This way you can be sure that you will get what you are entitled to — without financial risk.

Informed Consent: When Is Consent Legally Valid and When Is It Not?