Adverse effects of drugs and vaccines in Slovakia

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

A. Drug manufactures can be liable under following legal regimes: 

1. General civil liability regime
   The manufacturers are subject to general civil liability under the Act No. 40/1964 Coll. Civil Code (the “Civil Code”). According to the general civil liability regime, anyone is liable for damage caused by a breach of a legal obligation. This liability regime is applicable to damage caused both by natural or legal person when it was caused in the course of their activities or by those whom they used for those activities.
2. Product liability
   Under the Act No. 294/1999 Coll. on liability for damage caused by defective products, the manufacturer could be liable for damage caused by a defective product to the health or life of the injured person. 
3. Commercial liability
   If the manufacturer breaches the obligation under the contractual relationship, then the manufacturer is obliged to compensate the damage caused to the other party, unless the manufacturer proves that the breach of the obligation was caused by circumstances precluding liability.
4. Criminal liability regime
   The manufacturer can be held liable for the criminal offence of threat to health, under the Slovak Criminal Code, if his actions would fall under all legal characteristics of the aforementioned crime. 

B. Healthcare professionals can be liable under following legal regimes:

1. The General Civil liability
   Under the Civil Code, the health care professionals have a general preventive duty to act in such a way as to prevent damage to health (doctors shall not act non lege artis, e.g. using unsterilised vaccine injections).  
   Please note that health care professionals are not directly liable for vaccine side effects or its medical characteristics. 
2. Administrative liability
   Health care professionals could hold administrative liability and could, subsequently, be fined for the damage caused to the patient.

Under the Act No. 581/2004 Coll. on Health Insurance Companies and Health Care Supervision,  the Healthcare Supervisory Authority may fine both healthcare professionals (but again not the individual health care professional) and insurance companies if it finds that the health care has not been provided correctly.  

C. State can be liable under following legal regime: 

The state responsibility is regulated by the Act 514/2003 Coll. on Liability for Damage Caused in the Exercise of Public Power. The State could be held liable under the conditions laid down in this Act for damage caused by public authorities in the exercise of public authority (for example unlawful decision and maladministration).

Additionally, based on most recent amendments to the Act no. 362/2011 Coll. on medicines and medical devices, the liability for use of unregistered vaccines used in Slovakia (e.g. Sputnik V), the State assumed, under specific conditions included therein, part of the liability for any damage to health and life, if this damage is caused solely by circumstances originating in the unregistered vaccine used. The State's obligation should only apply until the vaccine has been officially registered by theEuropean Medicines Agency. 

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

1. Breach of a legal obligation, i.e. an unlawful act or omission;
2. the occurrence of damage;
3. causal link between the damage suffered and the breach of the legal obligation;
4. fault on the part of the person who caused the damage (intent or negligence).

The compensation claim shall be directed not at the healthcare professional but at the healthcare provider (i.e. hospital, clinique). 

The burden of proof, in respect to the actual damage caused to patient, lies with the injured party. The injured party has to establish that the damage was caused by the unlawful act of the alleged injurer (based on expert medical opinion). In the case of proving the causal nexus between the damage caused and the actual health injury, the patient has to prove that the vaccine they were given caused harm to their health. 

2.2 Which are the grounds for exclusion of liability?

A. Manufacturers

Under the Civil Code regime, the liability can be excluded if the manufacturer proves that the damage was not caused by their unlawful actions. 

Additionally, courts are entitled to reduce the damages considering the manner in which the damage was caused and the personal and financial circumstances of the manufacturer as a natural person. Such reduction is applicable only in negligence cases.

B. Healthcare professionals

The civil liability regime is applicable to healthcare professionals as described above. 

The possibility to exclude the civil liability of the healthcare professional can be achieved by proving that the healthcare professional acted lege artis, i.e. in accordance with the most current medical knowledge and that all necessary steps were taken at appropriate time. 

C. State

It is not possible to exclude state responsibility regulated by the Act 514/2003 Coll. on Liability for Damage Caused in the Exercise of Public Power.

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

A. Civil liability regime 

Time limit for submitting a claim for damages is two years from the date when the damaged person became aware of the damage and the liable party.

B. Product liability regime

The time limit for submitting a claim for compensation for damage caused by a defective product is three years from the date on which the damaged party knew or could have known of the damage caused by the defective product and of the identity of the manufacturer (i.e. subjective time limit).

The objective time limit for the claim for compensation for damage caused by a defective product is ten years from the date on which the manufacturer put the defective product into market. 

2.4 Which damages can be compensated?

Under the Civil Code, damages that could be compensated are following:

1. pain of the injured party;
2. difficulty in subsequent socialization;
3. loss of earnings during incapacity for work; and
4. reasonable costs of treatment.

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

The damages claim for adverse drug reactions is usually directed against the hospital or another medical institution, not the individual healthcare professional nor the insurance company. 

However, the insurance company of the healthcare provider can be introduced to the court proceedings as a party affected by the dispute. Effectively, it is the insurance company which will be liable to pay the compensation to the injured party. The insurance company can subsequently recover the damages paid to the injured party from the manufacturer and the registrant of the drug or vaccine which caused the damage to the injured party.

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

N/A

However, the answer here is likely to change in near future as the Ministry of Health brought forward a draft act, which deals, inter alia, with the issues of off-label use and compassionate use program in more detail. The changes included therein might include the liability regime of damage caused by the off-label and compassionate use of the drug.

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

N/A

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

N/A

The civil liability regime as described above is also applicable to vaccines. 

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

Currently, there is no public indemnity/compensation scheme available in case of side effects in connection to either compulsory or non-compulsory vaccination. 

However, the Ministry of Health stated that the vaccination compensation fund is currently subject of an ongoing expert discussion. 

The compulsory nature of particular vaccination is regulated by the Decree No. 585/2008 Coll. of the Ministry of Health of the Slovak Republic, however it does not provide any particular liability regime. 

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

Under Act No. 578/2004 Coll. on health care providers, health care workers, professional organizations in health care, every health care provider shall be covered by mandatory insurance for damages caused in pursuit of healthcare provision. Moreover, each provider of healthcare needs to be insured throughout the entire duration of healthcare provision. The insurance can cover both pecuniary and non-pecuniary damage.

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

No major procedural issues particular to litigation of ADR claims are included in the relevant Slovak acts. 

However, in the case of proving the causal nexus between the damage caused by the vaccine and the actual health injury, the patient has to prove that the vaccine they were given caused harm to their health. However, in practice, the causal nexus is extremely difficult to prove. This means that the claimant (the patient) will have to submit and expert opinion on the matter. 

Considering the complexness of such proceedings, it is recommended to the patient to introduce the insurance company into the proceedings.