Adverse effects of drugs and vaccines in Hungary

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

Should the responsibility of manufacturers, healthcare professionals (“HCPs”) or the state with respect to adverse drug reactions arise, such responsibility is primarily rooted in civil law provisions (mainly in tort liability, depending on the particularities of the situation).

Civil law liability

A. Manufacturers

In the case of the patient’s death, permanent harm to bodily integrity or health arising in connection with the use of a medicinal product, the compensation for non-monetary damages as well as monetary damages connected thereto should be, in principle, regulated in accordance with the provisions of Act V of 2013 on the Civil Code (the “Hungarian Civil Code”) pertaining to (i) restitution and (ii) product liability. 

Restitution: The violation of a patient’s life, bodily integrity or health should be regarded as a violation of personality rights. Non-monetary damages arising from such violation should be compensated by virtue of restitution. 

Product liability: Under product liability provisions, the producer (manufacturer) shall be liable for damage caused by a defect in its product. In the context of this provision, damage means, among others, any damage incurred by the death, bodily injury or any impairment in the health of a person caused by a defective product. A product shall be considered defective if it fails to provide a level of safety generally expected, with special regard to, among others, (i) the purpose of the product, (ii) the way in which it can be reasonably expected to be used, (iii) the information provided in connection with the product, and (iv) the date of the sale of the product.

B. Healthcare professionals (HCPs)

All patients should be treated (i) with such care that could be expected from persons involved in the treatment and (ii) in accordance with professional and ethical rules and guidelines. If such principle is violated as a result of which an adverse reaction occurs, HCPs may be held liable in accordance with restitution and tort liability provisions specified in the Hungarian Civil Code. Although, it should be highlighted , that, depending on the particular situation, it may not be the HCP but the healthcare institution employing such HCP that is to be held liable.

C. State

In regards to the responsibility of the state, where a medicinal product was used in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation in possession of authorization by the government body for pharmaceuticals, the state shall compensate such injured party or the person who suffered loss, or in the case of death, his/her dependent relative.

Criminal law liability

A. Manufacturers and HCPs

In respect of criminal law liability, the same may be established, if the adverse reactions cause imminent danger to someone’s health, life or results in death, and they go beyond the scope of ordinary side effects predictable on the basis of the pharmacology of the drug, i.e. they occur as a result of a negligent breach of professional rules/policies of manufacturing or use of drugs by manufacturers or HCPs accordingly. The extent of the punishment is subject to the severity of the adverse implications arising out of the professional misconduct.

Criminal liability may also be established for negligently placing a faulty and harmful medicinal product on the market even if it does not cause imminent danger to someone’s health, life, or results in death.

It is to be noted that only natural persons may be held liable for negligent criminal conducts i.e., corporations may not be subject to prosecution in this respect (the Corporate Criminal Code does not apply in terms of negligent crimes).

B. State

The state does not have criminal liability for any 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:

Restitution

As regards the conditions of payment of restitution - such as the definition of the person liable for the restitution and the cases of exemptions, the rules of tort liability (detailed below) should be applied, with the proviso that apart from the fact of the infringement no other harm has to be verified for entitlement to restitution.

Product liability

The elements of claiming compensation under product liability provisions are: (i) defect in the product, (ii) damages and (iii) causal link between the defect in the product and the damages.

The burden of proof lies with the injured party.

In tort liability

Any person who unlawfully causes damage to another person shall be liable for such damage. The tortfeasor shall be relieved of liability if he is able to prove that his conduct was not attributable to him.

The conditions of claiming compensation are (i) unlawful conduct, (ii) damages and (iii) causal link between the conduct and the damages. Pursuant to the Civil Code, all torts shall be considered unlawful, as a general rule. If the injured party is able to prove that there is a causal link between the damage and the conduct of the tortfeasor, the unlawfulness of the conduct is assumed, i.e. it is the tortfeasor who should demonstrate that its conduct was actually not unlawful. However, no causal link should be deemed to exist in respect of any damage that the tortfeasor could not and should not have foreseen.

2.2 Which are the grounds for exclusion of liability?

A. Manufacturers – Product liability and restitution

Manufacturers shall be relieved of product liability if they are able to prove that:

1. it did not place the product on the market;
2. the product was not produced for retail purposes, or it was not produced or distributed within the framework of regular business activities;
3. the product was in perfect condition at the time it was placed on the market, and the cause of the defect developed subsequently; or
4. the defect in the product was caused by the application of a statutory or regulatory provision.

The Hungarian Civil Code explicitly states that, with regard to damages resulting from the proper administration of a medicinal product, the manufacturer shall not be exempted from product liability relying on the reasoning that, at the time the product was placed on the market, the defect could not have been discovered, according to the current state of scientific and technological achievements.

The manufacturer shall not be exempt from product liability alleging that a third party contributed to the occurrence of the damage. However, this shall not affect the legitimate claims of the manufacturer against a third party.

As regards restitution, the manufacturer shall be relieved of liability if it is able to prove that its conduct was not attributable to it.

B. HCPs – In tort liability

The HCP shall be relieved of liability if he is able to prove that his conduct was not attributable to him.

C. State

There are no grounds for exclusion of the compensation obligation of the State detailed above in question 1.1.

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

Product liability

The injured party may claim his right to compensation within a 3-year limitation period.

The manufacturer shall remain subject to liability for a period of 10 years effective from the date of placing the given product on the market. This is a statutory time limit.

The period of limitation commences when the injured party became, or could have become aware of the damage, the defect in the product and the identity of the manufacturer.

Tort liability

The general limitation period is 5 years, unless otherwise provided by law. The limitation period may be suspended if the obligee is unable to enforce a claim for an excusable reason.

In respect of damages caused by the commission of a crime, the period of limitation for a claim shall not expire even after five years as long as the criminal offense remains punishable under the statute of limitations.

The period of limitation on annuity claims shall commence uniformly for the whole claim when the damage serving as a basis of the annuity claim emerges for the first time.

2.4 Which damages can be compensated?

Product liability

In case of product liability, the total loss of the injured party should be compensated.

Tort liability

The tortfeasor shall compensate the injured party for all his losses in full, in the framework of which the tortfeasor shall cover:

1. any depreciation in value of the property of the aggrieved party;
2. any pecuniary advantage lost; and
3. the costs necessary for the mitigation or elimination of the financial losses sustained by the aggrieved party.

In exceptional circumstances, the court may award compensation in an amount lower than the amount of the total loss.

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

As a general rule, it is not possible to claim compensation directly from the insurance company of the damaging party.

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

In respect of investigational medicinal products, Act XCV of 2005 (“Medicines Act”) determines the responsible person/entity depending on what the actual circumstances of the adverse reaction are, if, during the clinical trial of an investigational medicinal product, or as a consequence thereof, a natural person suffers health impairment. For instance, the sponsor of the trial should be liable if the death, disability or severe health impairment occurred in consequence of the sponsor withholding any information of knowledge from the authority which has authorized the clinical trials. While in other cases, the liability of the authority or the healthcare institution conducting the trial could also be established.  

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

If the adverse drugs reactions occur as part of an off-label use of an authorized medicinal product, the liability of the treating physician and/or its employer could be established considering that it is the treating physician who proposes the off-label application of the respective medicinal product and provides information on the risk-benefit ratio thereof to the patient based on which the patient consents to the treatment.

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

Not compulsory vaccination

A. Manufacturers

In the case of a defectively manufactured vaccine, the product liability of the manufacturer (as a form of strict liability) could arise.

B. HCPs and healthcare providers

The liability of HCPs and/or healthcare providers for damages may be investigated in relation to vaccination carried out incorrectly by the HCPs (e.g.  despite contra-indication, breach of professional protocol, etc.).

Compulsory vaccination

C. State

There are some compulsory vaccines in Hungary, in which case the state bears a compensation obligation towards the patients (as detailed in 5.2).

In case of compulsory vaccination, the state compensation covers instances such as the possible failure of the information provided by the healthcare provider or the lack thereof who administers the vaccine, since the vaccination could not have been refused.

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

Not compulsory vaccination

State compensation is not applicable in case of optional vaccinations.

Compulsory vaccination

If the person subject to the compulsory vaccination suffers serious damage to his or her health, disability or death as a result of the vaccination, the state will compensate him or her, or his or her dependent relative.

According to the text of the Healthcare Act (Act CLIV of 1997), the state compensation linked to compulsory vaccinations is only available in the case of a minimum serious health impairment, but not in the case of a mild/temporary impairment.  However, we note that under other compensation regimes provided for in the Healthcare Act, minimum serious health impairment is not specified as the prerequisite for claiming compensation.

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

Almost every type of liability can be insured but eventually it is up to the insurance company. There are compulsory insurance requirements in Hungary e.g. in relation to (i) manufacturers of medicinal products in Hungary; (ii) healthcare providers providing healthcare services; (iii) healthcare providers conducting researches, (iv) sponsors of clinical trials. 

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

Compulsory vaccination

If a minor is harmed, the non-dependent parent cannot receive compensation pursuant to the text-positive interpretation of the legislation, which also means that if the minor dies as a result of the vaccination, no one can receive compensation. However, the parent may represent the minor in the proceedings initiated while the minor was still alive, and claim compensation on behalf of the minor as the minor’s legal successor after the minor’s death.

In case of state compensation, the damaged person is not obliged to initiate proceedings against all tortfeasors, and the liability of other potential tortfeasors cannot be examined in the proceedings for compensation.