Adverse effects of drugs and vaccines The Netherlands

1.1 Which are the main kinds of responsibility (contractual, in tort, criminal) of the following subjects with respect to adverse drugs reactions?

A. Manufacturers

Manufacturers generally do not have a contractual relationship with the patient. If the patients suffer from adverse reactions, the grounds to hold the manufacturer liable should be sought in the legal regime for product liability and/or in tort.

B. Healthcare professionals

The healthcare professional has a contractual relationship with the patient. Therefore, the healthcare professional's main responsibility will be regarding the good performance of his obligations as a good healthcare professional. The healthcare professional is responsible for any objects or products it uses while performing his obligations. The use of drugs and vaccines in the context of a medical treatment agreement falls within the responsibility of the healthcare professional and under certain circumstances, he can be liable for the use of them. 

C. State

Generally, the state (The Netherlands) is not a relevant party with regards to claims related to adverse reactions of drugs. It is imaginable that the state might bear some form of liability for the vaccinations it includes in the state vaccination programme. A few years ago, a group of patients who claimed to have suffered damage from a vaccination against the Mexican flue – which vaccine was included in the state vaccination programme – started a procedure against the Dutch government. However, the patients and the government came to a (financial) settlement agreement, so the question whether the government could be hold liable has never been answered in the Netherlands. 

With respect to the COVID-19 vaccine; exceptional agreements have been concluded about the allocation of liability between manufacturer and the EU/member states, but this is not the "normal" legal regime in the Netherlands. 

Generally speaking – and assuming that there is no intent – there will not be a criminal liability for adverse reactions of drugs and medicines. 

Which are the conditions for claiming compensation (including the burden of proof)?

2.1 In order to be able to claim compensation under the Civil liability regime, the following conditions must be met:

Generally, the three main legal grounds for claiming compensation in case of adverse drug reactions would be 1) non-performance of a contractual obligation, 2) product liability and 3) in tort. 

In case someone wants to claim compensation for the damage caused adverse drugs reactions there are several conditions that must be met before damages can be claimed. In case of:

1. Performance of a contractual obligation: 
   1. There must be a breach/failure in the performance of the contract; and
   2. The breach of contract/failure is attributable to the debtor, and;
   3. The existence of a damage caused by the non-performance is eligible for reimbursement under the Dutch legal system (causal link between the damage and the non-conformity).
2. Product liability:
   1. There must be a (safety) defect in the product. A defective product is one that does not provide the safety that one would expect under the given circumstances; and
   2. The existence of damage that is eligible for reimbursement under the Dutch legal system; being damages in te form of personal injury or death, or damage to a private item and the damages exceeds the threshold of EUR 500; and
   3. The existence of a causal relationship between the damages and the unsafe, defective product.
3. In a tortious act 
   1. The existence of damage that is eligible for reimbursement under the Dutch legal system; and
   2. Liability of the person/legal entity committing the tortious act; and
   3. Causal relationship between the damages and the tortious act; and
   4. Accountability of the person/legal entity committing the tortious act; and
   5. The violated norm must intent to offer protection against damage as suffered by the injured person.

Generally, the burden of proof for all legal grounds above lies with the person invoking the legal effect, which is the person claiming the damages. Deviations from this rule of evidence have been developed in case law for specific situations. It will have to be determined on a case-by-case basis whether a specific rule of evidence applies. 

2.2 Which are the grounds for exclusion of liability?

A. Manufacturers

Dutch law lists different grounds for exclusion. There is no liability for the manufacturer in case:

• he has not put the product into circulation;
• when it's plausible that the defect that caused the damage did not exist at the time when he put the product into circulation, or that this defect arose later; 
• the product has not been manufactured for sale or for any other form of distribution with an economic purpose on the part of the producer, 
• nor has it been manufactured or distributed in the exercise of his profession or business;
• the defect is a consequence of the fact that the product conforms to mandatory government regulations; 
• the state of scientific and technical knowledge at the time when he put the product into circulation did not allow the existence of the defect to be discovered; 
• in the case of a producer of a raw material or manufacturer of a component part, if the defect is attributable to the design of the product of which the raw material or component is a part, or to the instructions given by the manufacturer of the product. 

Also, If the manufacturer of a medicine includes in the package leaflet a mention of the side-effects that may occur under normal use of the medicinal product and explicitly and correctly warns the user in the package leaflet about its use, this may reduce or exclude the producer's liability.

B. Healthcare professionals

If a healthcare professional uses a unfit product (drugs) in the performance of his obligations, he can be hold liable for the use of that unfit product. Liability of the healthcare professional can be reduced in case liability would be unreasonable given the circumstances. Healthcare professionals may not exclude their liability (beforehand). 

C. State

As mentioned before, the state generally is not a relevant party with regards to claims related to adverse reactions of drugs. A tortious act-claim could be issued against the central government but since such proceedings have rarely occurred in the Netherlands, it is not yet clear how successful such an action will be.  Because the state is normally not a party in these situations and rarely liable, exclusion of liability by the State is also highly unlikely.

2.3 Which are the time limits for submitting a claim for compensation?

There are different time limits for the various legal grounds for claiming compensation:

1. Non-performance of a contractual obligation

A claim for compensation or to pay a penalty must be made within five years of the day following the day the claimant becomes aware of:

• The damage (or of the fact that the claimant could demand a penalty); and
• The identity of the person responsible.

The claim expires in any case when twenty years pass from the event causing the damage. In case the damage exists of personal injury or death, the time limit of five years with respect to the right to claim damages starts from the moment the injured party claiming the damages becomes aware of both the damage and the identity of the person responsible. If the injured person was a minor on the day on which he became aware of the damage and identity of the responsible party, the right of action shall expire five years from the day following the one on which he reached the age of legal majority.   

2. Product liability 

The time limit for claims based on defective products is three years, starting from the day the injured party becomes aware of both the damage, the defect and the identity of the manufacturer. Those claims are furthermore subject to a ten-year statute of response. This means that ten years after the manufacturer has placed the product on the market, claims regarding defective products will expire. 

3. In tort

The time limits in tort are the same as mentioned for the non-performance of a contractual obligation: a claim for compensation or to pay a penalty must be made within five years of the day following the day the claimant becomes aware of:

• The damage (or of the fact that the claimant could demand a penalty); and
• The identity of the person responsible. 

The claim expires in any case when twenty years pass from the event causing the damage. 

In case the damage exists of personal injury or death, the time limit of five years with respect to the right to claim damages starts from the moment the injured party claiming the damages becomes aware of both the damage and the identity of the person responsible. If the injured person was a minor on the day on which he became aware of the damage and identity of the responsible party, the right of action shall expire five years from the day following the one on which he reached the age of legal majority.   

2.4 Which damages can be compensated?

The damages that can be compensated consist of material damage and/or other damages. The latter can be compensated insofar as the law implies that there is an addition entitlement to a compensation for such damages.  
Material loss includes any financial loss and other disadvantages. Financial damages include both financial loss and lost and/or missed profits. Furthermore, the reasonable cost (i) to prevent or limit the damages, (ii) to determine the nature and scope of the damage and (iii) for attempts to get satisfied based on a settlement out of court, also qualify for compensation as material loss.  Therefor many different damages are eligible for compensation (such as medical expenses; housekeeping; transportation).

With "other damages than material loss", the Dutch legal system has created a legal ground for compensation of damages if a person has sustained physical or mental injuries as a result of an event for which another person is liable. Under certain circumstances these immaterial damages can also be compensated. The damages that could be eligible for compensation are death, injury, disability, (scientifically acknowledged) mental illnesses and even in some cases the loss of enjoyment of life or the mental suffering of an affected party – however the latter two are very restricted grounds for compensation.

2.5 Is it possible to claim compensation directly to the insurance company of the damaging party?

If someone suffers damage, the party causing the damage, can be held liable for this damage. However, in practice, the insurance company of the party that caused the accident will handle the case for the insured party. The insurer will compensate the damage caused to you by the insured party. 

3.1 How would the answers above change if adverse drugs reactions occur within a compassionate use program?

There is no different regime for the liability when an adverse drug reaction occurs within a compassionate use program. The assessment of the producer's liability remains the same as already explained above. The fact that the drugs are used in this specific programme, while it's not yet registered, does not legally increase or decrease the manufacturer's liability. However, in such situations, it is conceivable that in the case of adverse drug reactions, the risk of use falls more on the patient. The rationale behind this is that in such cases the patient themselves will agree with the use of the unregistered medications. 

4.1 How would the answers above change if the adverse drugs reactions occur as part of an off-label use?

If a healthcare professional prescribes medication for other purposes as mentioned in the package leaflet, this is entirely within the doctor's own sphere of risk/at the healthcare professional's risk. In this case, the liability for adverse drug reactions cannot be passed on to the manufacturer – since the drug is used 'off-label'. The healthcare professional will be liable for the caused damage because there is a non-performance of his contractual obligation, caused by the use of an "unsuitable" drug. This could be different in case it is an "unsafe" medicine, in that case the manufacturer could be liable on product liability grounds. 

5.1 How would the answers above change if the adverse drugs reactions concern a vaccine?

The Netherlands does not have a different regime for vaccines. A tortious act-claim could be issued against the central government, for example for including the COVID-19 vaccine in the national vaccine program, or it could be issued against the manufacturer of the vaccine. Such proceedings have rarely, if ever, occurred in the Netherlands, so it is not yet clear how successful they will be. 

A product liability-claim could be issued against the manufacturer of the vaccine, in this case the pharmaceutical company/market authorisation holder. 

However, in case of the COVID-19 vaccine, the manufacturers and the EU/decentral governments have made special agreements with regard to the allocation of the liability for any adverse reactions or other risks regarding the COVID-19 vaccines. 

5.2 Is any public indemnity/compensation provided in the case of both compulsory and not compulsory vaccination?

First of all, the Netherlands does not (yet) have any compulsory vaccinations. 

But, as mentioned above special agreements has been made regarding the liability in the event of adverse reactions. Also, the member states of the European Union have made special agreements with the pharmaceutical companies concerning damage claims. 

The member states, including the Dutch government, will offer a financial compensation for claims that, for example, have tot do with a hidden defect of a vaccine that was unknown at the time of authorization. This includes side effects of the COVID-19 vaccine that did not surface during the testing phase of the vaccine. 

6.1 Which liabilities can be insured? Is there any compulsory insurance?

Manufacturers

Most manufacturers have a business liability insurance. With this insurance the manufacturers are insured against liability claims for damage caused by the drugs they manufacture. 

Healthcare professionals

Healthcare professionals have a professional liability insurance. This insures them for any liability claims for damages resulting from their performances including the use of medical supplies (drugs).

State

The state never insures itself for any liability or damage claims. 

7.1 Are there particular procedural issues to be highlighted in relation to ADR claims?

Due to the legal requirements for a liability claim, it is considered difficult to obtain compensation for damages resulting from adverse drugs reactions. 

First, as mentioned above under 2.1, there are a lot of requirements that must be met before the other party can be hold liable and damage can be claimed. 

An issue with ADR-claims against the manufacturers can be found in the many legal grounds for the exclusion of liability. Also, when the manufacturer mentions the side-effects that may occur under normal use of the medicinal product and explicitly and correctly warns the user in the package leaflet about the side effect and its use, this, and the other grounds of exclusion, will make it very difficult to establish liability. 

In addition to the grounds of exclusion in some cases it will be difficult to prove causality of the use of drugs and the experienced side effect, since it will be hard to determine whether they are caused by the drugs or for example a person's illness.