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).
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