Adverse effects of drugs and vaccines in Slovenia

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

1. Manufacturers

1. Tort liability

The drug manufacturer is liable for damages resulting from inadequate quality 1 Pursuant to Article 27(3) of the Medicinal Products Act (Zakon o zdravilih, Official Gazette of the Republic of Slovenia no. 17/14 as amended) the drug manufacturer, who places the medicinal product on the market, is responsible for manufacturing, quality control and labelling of the drug, regardless of if the drug is manufactured by it or by a third party on his behalf. Pursuant to Article 2 of the Rules on recall of medicines (Official Gazette of the Republic of Slovenia no. 105/08 as amended) “inadequate quality” of the drug shall mean any deviation from the quality of the drug as well as any falsification or subsequently identified deviation affecting (or suspected of affecting) the safety or efficiency of the drug with marketing authorisation. Deviation from the quality of the drug shall mean any difference in appearance, physiochemical, microbiological and pharmaco-technological properties between the actual state of the drug and the data provided in the marketing authorisation. Deviation from the quality shall also mean any non-compliance of the instructions for use, immediate or outer packaging with the market authorisat of the drug, even if he proves that the state of scientific and technical progress in the world, at the time when the drug was placed on the market, was not such that the defect could have been detected. 2 Article 27(4) of the Medicinal Products Act.

The manufacturer is also liable for damages when its defective product (drug) causes death, personal injury or damage to human health. 3 Article 4 of the Consumer Protection Act (Zakon o varstvu potrošnikov, Official Gazette of the Republic of Slovenia no. 98/04 as amended) and Article 155 of the Obligations Act. The product is defective when its safety is not what the consumer can reasonably expect, taking into account the presentation of the product in relation to its intended use, the foreseeable use of the product in a reasonable manner, the time at which the product was placed on the market. 4 Article 5 of the Consumer Protection Act.

2. Criminal liability

The manufacturer may be criminally liable (imprisonment up to 5 years) for manufacturing and marketing of harmful drugs and other medical substances, if done so with negligence. 5 Article 183 of the Criminal Code (Kazenski zakonik, Official Gazette of the Republic of Slovenia no. 50/12 as amended).

2. Healthcare professionals

1. Contractual liability

The healthcare professional (“HCP”) is generally not directly liable for damages as its employer is responsible for its actions. 6 Article 147 of the Obligations Code (Obligacijski zakonik, Official Gazette of the Republic of Slovenia no. 97/07 as amended).  The healthcare organisation (and the insurance company that insures its liability) is liable for the damages caused by the HCP, if the HCP did not act with the professional diligence (contra legem artis). 7 The healthcare organisation has a right to a recourse claim against the HCP, if it caused the error intentionally or with gross negligence (Article 147/3 of the Obligations Code).  The HCP did not act with the professional diligence if the worsening of the patient’s health is the result of its professional misconduct (a medical or professional error 8 Article 45 of the Health Services Act (Zakon o zdravstveni dejavnosti, Official Gazette of the Republic of Slovenia no. 23/05 as amended) stipulates that the HCP must carry out its healthcare activities in accordance with the accepted medical doctrine and the code of medical deontology or other professional and ethical codes. The HCP must treat all people on equal basis and in the same way and respect their constitutional and legal rights. The only criterion for priority is the urgency of the medical intervention. due to non-compliance with the requirements of the medical doctrine) or if the HCP did not fulfil or has incorrectly fulfilled its duty to disclose 9 Article 20 of the Patients’ Rights Act (Zakon o pacientovih pravicah, Official Gazette of the Republic of Slovenia no. 15/08 as amended).  (inter alia) the drug, its function and the possible risks, side effects, adverse consequences and other inconveniences of the drug.

Professional misconduct must be differentiated from a complication that sometimes occurs during an otherwise lege artis treatment with professional due diligence. A complication is not a medical error and the liability for damages due to medical error is excluded in such case, however, liability for damages due to complication is not excluded in the event of violation of the HCP’s duty to disclose.

2. Tort liability

The HCP’s liability is non-contractual only in case of emergency medical assistance where the patient is unable to express his will due to its medical condition. 10 Article 28 of the Patient’s Rights Act.

3. Criminal liability

The HCP may be criminally liable for negligent treatment if it acts in breach of the code of conduct of the profession and causes the worsening of health of an individual. The penalty is imprisonment up to three years, if a person dies from one to eight years. 11 Article 179 of the Criminal Code.

3. State

1. Tort liability

The state is not liable for any damages due to drug adverse effects. Regarding the state’s liability for damages due to adverse effects of the vaccines see the answer below under point 5.1.

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:

The injured party must prove the following prerequisites for liability of the HCP or the medical organisation:

1. unlawful act or omission of the HCP,
2. existence of the legally recognised damage,
3. causal relationship between the damage and the unlawful act or omission.

The fault of the HCP causing the damage is presumed, meaning that regarding the contractual and tort liability the burden of proof in reversed – the fault for damages is presumed and the HCP or the healthcare organisation may exonerate from its liability (see below). The presumption applies only to ordinary negligence and not also to gross negligence and intent.

Regarding the tort liability of manufacturers, the injured party must prove the defect, the damage and the causal relationship between them. 12 Article 7 of the Consumer Protection Act.

Regarding the liability of the manufacturer, the determination of causal relationship, that is whether a defect caused the damage, is usually a complex (scientific) technical issue where it is not possible to prove with certainty the (non-)existence of the causal relationship. Usually there are various possible causes, therefore according to case law, 13 Judgement of the Celje Higher Court Cp 270/2020 dated 15.10.2020, Decision of the Ljubljana Higher Court VSL I Cp 1397/2016 dated 19.10.2016.   the burden of proof for establishing the causal relationship regarding product liability would be too heavy for the injured party, if it would also have to prove that there was no other cause (although less probable) for the damage besides the main cause that proves the existence of the causal relationship. Therefore, the manufacturer is liable for the damage if the injured party proves, with sufficient probability (i.e. 50 per cent), that the defect was the cause for the damage. With that, the burden of proof is shifted to the manufacturer who must prove, with sufficient probability, that the causal relationship does not exist – that the defect of the product is not the cause of the damage. For the manufacturer to not be liable for the damage, it must prove another specific cause of the damage with sufficient probability, merely stating other hypothetical possible causes is insufficient.

2.2 Which are the grounds for exclusion of liability?

A. Manufacturers

1. Tort liability

The manufacturer is only liable for damages that have occurred in 10 years from the day that the drug was placed on the market. 14 Article 9 of the Consumer Protection Act.

The manufacturer is also not liable for damages if it proves that:

• the circumstances show that the defect causing the damage did not exist at the time the product was put on the market, 
• the defect is a result of the product’s compliance with mandatory regulations.

B. Healthcare professionals

1. Contractual liability

The HCP (and the healthcare institution) may be exonerated from its contractual liability only if it proves that it was not able to fulfil its obligations or was not able to fulfil its obligations in time, due to the circumstances that occurred after the conclusion of the contract which could not have been prevented, eliminated or avoided. 15 Article 240 of the Obligations Act.

2. Tort liability

The HCP (and the healthcare organisation) may be exonerated from its non-contractual liability if it proves that the damage was caused without the HCP’s fault (because the above stated four prerequisites for liability must be given cumulatively). 16 Article 131/1 of the Obligations Act.

The HCP (and the healthcare organisation) may be exonerated from its contractual or non-contractual liability if it proves that the HCP has not conducted a professional misconduct or that the duty to disclose was correctly fulfilled and that the causal relationship between the unlawful act or omission and damage does not exist. The HCP (and the healthcare organisation) may therefore exonerate from its liability for a medical error by proving that the HCP acted as it ought to in the given circumstances, 17 Article 147/1 of the Obligations Act.  i.e. that the HCP exercised sufficient diligence and acted in accordance with the standards and rules of the medical profession. The HCP may only be directly liable for damages if it intentionally caused the damage. 18 Article 147/2 of the Obligations Act.

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

The limitation period for submitting a claim regarding the contractual liability is the period prescribed for the limitation of that obligation. 19 Article 352 of the Obligations Act.  Since there is no specific time limit prescribed for the limitation of contracts for medical services, the limitation period for these liability claims is a general limitation period of five years.

The limitation period for submitting a claim regarding the non-contractual liability is three years from when the injured party became aware of the damage and of the person responsible. The general limitation period is five years. 20 Article 352 of the Obligations Act.

The limitation period for submitting a claim regarding the liability of the manufacturer is three years from when the injured party became aware or should have become aware of the damage, the defect and the identity of the manufacturer. 21 Article 352 of the Obligations Act in accordance with Article 10 of the Directive 85/374/EEC on liability for defective products (Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products, Official Journal of the European Union no. L 210, 7.8.1985, as amended).

If the damage has been caused by a criminal offence and a longer limitation period is provided for criminal prosecution, this limitation period also applies to the claim for damages. 22 Article 353 of the Obligations Act.

2.4 Which damages can be compensated?

In case of contractual and non-contractual liability, the material and non-material damages that are legally recognised can be compensated. Material damages include actual losses (damnum emergens) and loss of profit (lucrum cessans). 23 Article 132 of the Obligations Act. The circle of non-material damages is closed, and monetary compensation is only possible for:

• the physical pain suffered,
• the psychological pain suffered (as a result of the impairment of the life activity, malformation, defamation of reputation or honour or impairment of liberty or personal right) and
• fear. 24 Article 132 and Article 179/1 of the Obligations Act.

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

Yes, the injured party may claim compensation directly from the insurance company up to the maximum of the insured amount. 25 Article 965/1 of the Obligations Act.

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

The manufacturer and the HCP shall not be liable for the adverse drug reactions resulting from the use within a compassionate use program, approved by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (“JAZMP”). 26 Article 27/6 of the Medicinal Product Act

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

The manufacturer and the HCP shall not be liable for the adverse drug reactions resulting from off-label use, if such use has been recommended or requested by the JAZMP, the Ministry of Health or the ministry responsible for veterinary medicine. 27 Article 27/ of the Medicinal Product Act.

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

Regarding the adverse reactions of vaccines, the state (Republic of Slovenia) has a reimbursement scheme for its objective liability for damages due to mandatory vaccinations. Legally recognised damages are:

• damage to health, manifesting in serious and permanent impairment of vital functions and
• death. 28 Article 53.a of the Communicable Diseases Act (Zakon o nalezljivih boleznih, Official Gazette of the Republic of Slovenia no. 33/06 as amended).

This does not include damages resulting from professional misconduct in administering the vaccine or resulting from inadequate quality of the vaccine – for liability of the HCP or the manufacturer, the civil law rules described under point 1 and 2 apply.

The procedure for obtaining the right to the above state compensation shall be initiated with an application to the Ministry of Health. The application must be submitted no later that six years from the date of vaccination of the injured party on the territory of the Republic of Slovenia. 29 Article 53.č of the Communicable Diseases Act.  The Minister of Health decides on the entitlement to compensation in a one-time amount of EUR 60.000 30 In the event of death, the spouse or partner of the injured party or in case of a minor, its parents shall be entitled to compensation in a one-time amount of EUR 10.000. In the event of death, the children of the injured party up to the age of 18 years shall be entitled to compensation in a one-time amount of EUR 20.000 (Article 53.b of the Communicable Diseases Act).  based on the expert opinion of the Commission for establishing a causal relationship between compulsory vaccination and occurred damage 31 The Commission for causal relationship gives an assessment of whether the damage to health of the injured party was caused by compulsory vaccination or whether there is a causal relationship between the damage to health or death of the injured party. and the opinion of the Disability Commission of the Pension and Disability Insurance Institute. 32 The Disability Commission gives an opinion if the injured party has a serious impairment of vital functions. Their opinion is not needed in the event of death (Article 53.d of the Communicable Diseases Act).

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

Please see the answer under point 5.1 regarding the reimbursement scheme of the state in case of compulsory vaccination. No public indemnity/compensation is provided in case of non-compulsory vaccination. 

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

There is compulsory insurance for the HCP who works directly with patients for liability for damages that may arise in the course of its work. An employed HCP is insured by his employer. 33 Article 61 of the Medical Services Act.

Insurance companies may exclude insurance coverage of certain damages, such as damages due to violation of duty to disclose, damages due to intended action in breach of the applicable provisions, damages caused by criminal offence etc.

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

There is a difficulty of proving liability due to the problem of proving the causal relationship because it often requires special expertise that the injured party generally does not possess and the evidence that proves the causal relationship is in most cases in the possession of the HCP or healthcare organisation. For this reason, where the burden of proof is too heavy for the injured party, case law introduced a standard of proof of preponderance of the evidence regarding the facts that prove the causal relationship between the action of the HCP and the damage. That means that the injured party must prove said facts with probability of more than 50% and not with certainty. 34 Judgement of the Supreme Court of the Republic of Slovenia II Ips 671/2008 dated 20.11.2008.

The court generally decides whether the HCP in particular case has acted with sufficient diligence and in accordance with the standards of the medical profession based on the court-appointed expert opinion which affects the procedural costs