Adverse effects of drugs and vaccines in Czech Republic

1. Drug adverse effects: kinds of responsibility

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

In regard to the responsibility of a manufacturer (i.e. a marketing authorisation holder “MAH”), it needs to be distinguished whether the damage to health was caused by an adverse effect which is listed in the SPC of the pharmaceutical.

MAH is always liable for an adverse effect which is not listed in the SPC and the MAH cannot be released from such liability (i.e. it is not necessary for the claimant to prove that the MAH caused the damage).

For an adverse effect which is included in the SPC, the MAH will be held liable only if it is proved, among other things, that the MAH caused the damage.

In extreme cases, criminal liability of the MAH is also possible.

B. Healthcare professionals

It needs to be distinguished whether a healthcare professional (“HCP”) works as an employee of a healthcare institution (hospital, “HCI”) or whether the HCP provides healthcare services individually.

In case an HCP is an employee of an HCI, the HCI would be, in most cases, primarily liable (and the HCI would then have a right of recourse against the HCP). If the HCP provides the services individually, the HCP would be primarily liable.

In both cases, it will need to be assessed if an HCP acted lege artis (i.e. according to the law, state of scientific knowledge, norms and processes etc.).

In extreme cases, criminal liability of an HCP and / or HCI is also possible.

Specific rules may apply in case the damage to the health is caused as a result of use of an unregistered pharmaceutical or an off-label use of a pharmaceutical.

In regard to the responsibility of a MAH and HCP / HCI, specific rules on liability would also apply in case the drug was defective or in cases in which public health could be endangered.

C. State

With the exception for vaccination (please see our response below), the Czech Republic is not liable for adverse reactions of drugs.

2. Claiming compensation for damages caused by adverse drugs reactions

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:

In general, claimants bear the burden of proof and, within their claim, they need to prove: 

  • existence of adverse effects,
  • damage,
  • direct causality between the adverse effect and the damage.

Further conditions for claiming compensation depends on the specific circumstances of the damage and who the defendant is (MAH or HCP). If the compensation is claimed from the MAH on the basis of an adverse effect which is included in the SPC, the claimant needs to prove that the MAH caused the damage. On the other hand, if the adverse effect is not included in the SPC, the claimant does not need to prove that the MAH caused the damage in order for the MAH to be held liable. 

If a compensation is claimed from HCP / HCI, it will be necessary to prove, among other things, that the HCP caused the damage (most likely by not acting “lege artis”). 

Specific rules apply in criminal law proceedings.

2.2 Which are the grounds for exclusion of liability?

A. Manufacturers

In the event that the adverse effect is not included in the drug’s SPC, the MAH’s liability cannot be excluded. If the adverse effect is included in the drug’s SPC, the MAH will not be held liable unless the claimant proves, among other things, that the MAH caused the damage. 

B. Healthcare professionals

For an HCP / HCI to be held liable for an adverse reaction of a drug, the claimant would need to prove, among other things, that the HCP / HCI did not act “lege artis”.

In regard to the responsibility of the MAH and HCP / HCI, specific rules on liability would apply in case the drug was defective or in cases in which public health could be endangered.

C. State

With the exception for vaccination (please see our response below), the Czech Republic is not liable for adverse reactions of drugs.

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

The length of a limitation period is three years from the moment the claimant becomes aware about the damage and the person who is obliged to compensate it. 

2.4 Which damages can be compensated?

In case of damage to health, it is necessary to monetarily compensate the claimant (patient), to fully cover pain and other non-pecuniary harm suffered. If the damage to health resulted in an impediment to a better future, the deteriorated social position also needs to be compensated. Usually, the following aspects are being compensated: loss of earnings, medical expense, loss of pension, emotional distress and pain suffering are compensated. In addition, if a third person takes care of person whose health was damage, it is necessary to compensate costs that such third person reasonably incurred when taking care of the patient. 

In case of death or particularly serious damage to health, the spouse, parent, child or other close person shall be compensated for mental suffering. Funeral costs shall be also compensated. 

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

In general, no. It is necessary to claim compensation from the damaging party (however, the insurance contract between the damaging party and the insurance company may stipulate otherwise).

3. Compassionate use programmes

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

HCI is liable if a damage to health occurs as a consequence of use of an unregistered product (provided that the unregistered products was used in line with the rules set out in the Pharmaceuticals Act).

4. Off-label use

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

HCI is liable if a damage to health occurs as a consequence of an off-label use of a drug (provided that the off-label use was used in accordance with the rules set out in the Pharmaceuticals Act).

5. Vaccines

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

Czech law sets out specific rules in case of adverse effect of vaccines which are compulsory. 

If a patient suffers “particularly serious” damage to health as a result of compulsory vaccination, the Czech Republic shall compensate the patient for suffered pain, loss of earning and their deteriorated social position. The state shall also compensate the reasonably incurred costs associated with the care of the patient. 

In case of death or particularly serious damage to health, the spouse, parent, child or other close person shall be compensated for mental suffering. Funeral costs shall be also compensated. 

The claim for the compensation shall be filed with the Ministry of Health (i.e. it is not a court proceeding).

General rules will apply in case of non-compulsory vaccination.

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

Please see our response above.

6. Insurance issues

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

Healthcare providers (i.e. either HCI or HCP if they provide healthcare services individually) are required by law to conclude an insurance contract to cover their liability for damage. 

There are also special rules for compulsory liability insurance for sponsors and investigators of clinical trials to cover all kinds of damages that subjects of clinical trials may incur.

7. Procedural issues (litigation)

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

With some exceptions (adverse effect not included in the SPC, use of a defective drug, compulsory vaccination), liability for the damage to health caused by a drug’s adverse effect is a fault liability. Claimants bear the burden of proof, i.e. claimants need to prove (i) existence of adverse effects (damage), (ii) breach of law, (iii) direct causality between the breach of law and the damage, and (iv) fault of the damaging party.

Portrait ofTomáš Matĕjovský
Tomáš Matĕjovský
Partner
Prague
Portrait ofPavel Dřimal
Pavel Dřímal
Senior Associate
Prague