Before a doctor carries out a medical treatment, the patient must be properly informed about what is going to happen, what risks are involved and what alternatives exist. That is called informed consent. Without proper information a patient cannot give considered consent. This article explains what informed consent involves, when consent is valid and when it is not, and what you can do if you were insufficiently informed.
What is informed consent?
The starting point in medicine is that the patient decides about their own treatment. For that it is essential that the patient understands what the treatment involves, what risks attach to it and what the alternatives are.
Informed consent therefore means: consent on the basis of complete and comprehensible information.
What counts as ‘treatment’?
In this context ‘treatment’ means essentially everything a doctor does for you around your care. That goes further than the procedure or operation itself. Think of physical examination, diagnostic tests, making a diagnosis and the aftercare that follows. In short: every medical act forming part of your treatment falls under it.
The doctor must explain:
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the nature and purpose of the treatment;
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the possible risks and complications;
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the chance of success or recovery;
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alternatives, including waiting or not treating;
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the consequences of refusing the treatment.
Information about effectiveness and waiting times
Besides the basic information about the treatment, the doctor must also be candid about the proven effectiveness of the proposed care. You may expect the doctor to say whether a treatment is scientifically supported, or not (yet) sufficiently proven. With new treatment methods, alternative therapies or experimental care in particular, it is important that you are given clarity on this.
You should also be informed about any waiting times for the treatment. That way you know what to expect and can factor it into your decision whether or not to agree to the proposal.
In summary:
- Does a treatment have proven efficacy? The doctor must say so explicitly.
- How long before you are treated? You should be given clarity about that too.
All of this ensures that you, as a patient, get an honest and complete picture, so that your consent really is ‘informed’.
Only once this information has been given and understood can consent be legally valid.
Implied and express consent: which applies when?
Consent to medical treatment can be given in various ways. In many cases oral or even tacit (implied) consent is enough. For example: if you hold out your arm for a vaccination, the doctor may assume you agree to the injection. For simple or urgent acts, such as stitching a wound after an accident, implied consent is also often regarded as sufficient.
Where the treatment is far-reaching, riskier or non-urgent (elective), however, you as the patient must give express consent. The doctor will then not only provide all the relevant information but also record in the medical file that you agreed.
In brief:
- Implied consent: for simple, routine or necessary emergency treatment.
- Express consent: for major, risky or planned medical procedures, always confirmed in writing or orally and recorded by the doctor.
When may a doctor treat without express consent?
A doctor may only start treatment once the patient has consented. That consent does not always have to be expressly stated, however. In practice it often happens that for simple, routine acts or in emergencies a patient consents implicitly — by holding out an arm for an injection, say, or getting onto the treatment table.
With far-reaching treatment, risky procedures or planned operations the position is different. The patient must then clearly, that is expressly, agree to the proposed plan. The doctor records that express consent carefully in the medical file.
That ensures the patient retains full control over important decisions and that the right to self-determination remains central.
Why good communication and informed consent matter so much
Good communication between doctor and patient goes further than a legal duty; it is the basis of a strong relationship of trust. By speaking clearly and openly about the treatment, risk factors and options, the patient feels taken seriously and involved in what is happening to them. That trust not only makes patients more likely to share their concerns or doubts, it also improves adherence: people are more inclined to follow advice when they understand why certain choices are made.
Clear explanation and genuine attention not only satisfy the rules but also create mutual respect — a foundation for good care.
From the classic model to shared decision-making
With the arrival of additional rules on informed consent the emphasis is shifting more and more towards so-called shared decision-making. Where the doctor used to determine what seemed best — and the patient followed that advice — today the patient’s preference is central.
In shared decision-making, doctor and patient discuss the treatment together. You say what matters to you — work, family or quality of life, for instance — and the doctor sets out the medical options, including their advantages and disadvantages. Together you then reach a decision that fits your personal situation and values, rather than simply following the doctor’s advice.
This approach ensures that medical choices are not only medically sound but also match the patient’s wishes and expectations.
The statutory basis of informed consent
The right to information and consent is set out in Article 7:448 of the Dutch Civil Code. It provides that the care provider must inform the patient “in a clear manner” about the proposed treatment and the expected consequences or risks.
The law also requires the doctor to keep a proper medical file in which this information is recorded.
Read more about this in our article The medical file: access, copies and correction.
Other statutory duties to inform
Besides the Dutch Civil Code there are other statutes containing duties to inform, such as the Care Quality, Complaints and Disputes Act (Wkkgz). Under that Act the care provider (often the treating doctor) must, on request, inform the patient about the care offered. That covers not only the nature of the care but also the rates, the quality and other patients’ experiences with it.
The doctor must also inform the patient whether the care has scientifically proven efficacy, and about any waiting time. That gives the patient a complete picture and allows a considered decision.
The most recent additions to the duty to inform since 2020
Since 1 January 2020 the duty to inform has been extended further. Doctors and other care providers must not only inform patients in good time about the treatment and its risks; they are now also legally required to consult with the patient about the proposed treatment. The patient must be actively invited to ask questions.
The care provider must also give additional information, such as:
- the option of forgoing the treatment;
- alternative examinations or treatments that other care providers could carry out;
- the expected duration and when the treatment can start.
These changes are intended to give the patient more influence and say — in other words, to decide about care together. The emphasis shifts from the traditional ‘the doctor advises’ to ‘deciding jointly’, with the patient’s wishes and preferences at the centre.
When is consent not legally valid?
Consent is not legally valid if the patient was not informed, or was misinformed. That can happen in various ways, for example:
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the doctor did not say what risks attach to the treatment;
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alternative treatments were not discussed;
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the chance of complications was played down;
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the patient was pressured into agreeing;
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consent was given without the information being comprehensible.
Where a doctor has breached the duty to inform, the treatment can be regarded as unlawful. If the patient suffers loss as a result, there may be medical liability. Read more about this in our article Medical liability in the Netherlands: patients’ rights and the route to compensation.
The importance of evidence: what is in your file?
In a liability case the medical file is crucial. It must show what information was given, whether an informed consent form was signed, and whether there are notes of conversations with the doctor.
Recording consent: express and implied
A doctor may only start treatment once the patient has consented. That consent can be given in various ways. Sometimes it is implied or tacit — for less far-reaching acts, or where immediate action is needed in an emergency. Where the treatment is far-reaching, risky or planned (elective), however, you as the patient must expressly agree. The doctor then also records that consent in the file.
If those records are missing, the burden of proof often weighs more heavily on the care provider.
You can request the file from the hospital or the practitioner. Our article sets out step by step how to do that: The medical file: access, copies and correction.
Consequences of a breach of informed consent
If it turns out you were not properly informed, the doctor or the hospital can be liable for the resulting loss — because with correct information you would not have agreed to the treatment, for instance, or because you would have chosen a lower-risk alternative.
In such a case compensation can be claimed, consisting of:
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Material loss – medical costs, loss of income, travel costs, household help;
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Non-material loss (compensation for pain and suffering) – compensation for pain, grief and loss of enjoyment of life.
Read in our article How is compensation for pain and suffering calculated? how the level of that compensation is determined.
Common misconceptions
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A signature on a consent form does not automatically mean informed consent was given.
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Oral explanation is required too — written information alone is not enough.
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The fact that a risk appears in a leaflet does not release the doctor from the duty to discuss it in person.
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Not every complication is an error; there must be a breach of the duty to inform and demonstrable loss.
A practical example
Before an operation a patient was given only a standard leaflet setting out general risks. During the procedure a complication arose that was not in the leaflet and had not been discussed. The patient argued that with correct information he would not have agreed to the operation. The court held that the hospital had breached its duty to inform and awarded compensation.
What can you do if you think you were not properly informed?
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Request your medical file.
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Note what was said during conversations with doctors.
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Contact a specialist personal injury lawyer.
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Have it assessed whether the duty to inform was breached.
Our lawyers help you secure your rights and take the right steps towards compensation.
Why Arslan Advocaten?
At Arslan Advocaten we regularly handle cases in which the duty to inform was breached. We work with independent medical advisers and make sure your file is built up in full. Our service is free of charge for victims, because we recover our costs from the liable party.
That way you can be sure you get what you are entitled to — without financial risk.
Related legal services
Read also
- Personal injury as a passenger
- Personal injury caused by an electric bicycle: your rights and options
- Head-on collision: who is liable and what personal injury can you claim?
Frequently asked questions
What is informed consent and why does it matter in healthcare?
Informed consent means that a patient agrees to a treatment after being fully and comprehensibly informed about its nature, risks and alternatives. It is essential to a considered decision and to the legal validity of the consent.
When is consent to medical treatment not legally valid?
Consent is not legally valid if the patient was insufficiently informed or does not understand what the treatment involves. Consent given under pressure or coercion is likewise invalid.
What information must a doctor give before I consent?
The doctor must explain the nature and purpose of the treatment, the possible risks, the alternatives, and the consequences of refusing. They should also inform you about effectiveness and waiting times.
Can I give oral consent to a medical procedure?
Yes, in many cases oral or implied consent is sufficient — holding out your arm for an injection, for instance. For far-reaching treatment, however, written consent is usually required for legal validity.
🏥 Independent medical advice in your personal injury case
In medical personal injury cases Arslan Advocatuur works with MEDICA Medisch Advies — an independent medical advisory firm working exclusively for personal injury victims. Their registered doctors assess your medical file, map out your complaints and limitations, and support your claim medically.
➡️ Read more about the role of a medical adviser in personal injury cases
