Adverse effects of drugs and vaccines in Austria

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 

Manufacturers are liable to their contract partners under the general civil liability regime of the Austrian Civil Code if a breach of contractual duties has occurred. Liability is limited to damages that are adequately caused by a negligent breach of contractual duties. The manufacturer is also liable for any negligent breach of contractual duties by any person that the manufacturer has used to fulfil the contract.

Apart from contractual relationships, manufacturers of drugs and vaccines are primarily liable under the Austrian Product Liability Act (Produkthaftungsgesetz), which provides for liability of the manufacturer irrespective of any negligence. Liability is triggered if a person or a product different from the defective product in question has been damaged, as the defective product did not fulfil the safety standards that may be reasonably expected. Such expectation can result from the presentation of the product (e.g., packaging). The defect of the product may be due to faulty design, production, or instructions. Under certain conditions, the ineffectiveness of a product may constitute a defect.

Moreover, manufacturers may be liable according to general tort law under the Austrian Civil Code for damages caused by unlawful and negligent conduct of the manufacturer. The unlawfulness of conduct results either from the breach of duties imposed upon manufacturers by law or generally protected legal rights such as property, health, and life.

In addition, manufacturers may be subject to administrative and criminal penalties: 

Placing unsafe medicinal products on the market is subject to an administrative penalty under the Medicinal Products Act and the Product Safety Act (up to EUR 25.000,00). 

Where manufacturers have caused the death of a person or damaged a person’s health culpably, they can be subject to criminal law sanctions. Criminal liability may also arise if a larger number of people’s lives are endangered.

B. Healthcare professionals 

A healthcare professional (HCP) may be liable for breach of contractual obligations and under general tort law. The same principles as outlined above under A. apply. 

Liability mainly results from malpractice or breach of the obligation to inform the patient. The HCP must act according to the state of the art (lege artis), otherwise there is a risk of liability. It is considered malpractice if an HCP does not check the label of the drug before using it on a patient.  Incorrect use of a medicinal product can also constitute malpractice. Liability is also possible in case of off-label use (see below under 4.). Especially when new therapeutic methods are being used, it is essential that the patient is fully informed  about the conditions, risks and consequences of the treatment to reduce the risk of liability.

If pharmacists manufacture drugs which cause harm (e.g., magistral preparations), they can be liable according to general civil law. Claims can also be based on the Product Liability Act.

Criminal sanctions are possible if an HCP, negligently or intentionally, caused an injury, damage to health or death of a patient. 

C. State

The State may be liable for damages incurred by negligent administrative conduct of its public officials according to the Governmental Liability Act (Amtshaftungsgesetz). Hence, liability can arise where officials of the competent authorities for medicinal products acted unlawfully by breaching their statutory obligations and thereby culpably caused damage. However, the state will generally not be liable in case of malpractice by physicians working in public hospitals. Although, malpractice can lead to liability of the state in the case of an officially institutionalised patient.

In addition, the State may be required to pay compensation for vaccine damages according to the Vaccine Damage Act (Bundesgesetz vom 3. Juli 1973 über die Entschädigung für Impfschäden or Impfschadengesetz) (see in more detail below).

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:

1. Contractual / Tort law

A claim of contractual liability must show a contract between claimant and defendant as well as damage incurred and the adequate causation of this damage by the defendant through negligent conduct that is in violation of contractual obligations.

The burden of proof lies on the claimant for the damage incurred as well as the causation and the conduct violating contractual obligations. However, if the claim is based on ordinary negligence of the defendant, the defendant must prove that he did not act with ordinary negligence (reversal of the burden of proof according to Sec 1298 Civil Code). This reversal of the burden of proof is not applicable in cases where the claim is based on gross negligence.

Regarding tort liability, the claimant must show all four elements mentioned above (damage, causation, unlawful behaviour, negligence), but no reversal of the burden of proof takes place.

Healthcare professionals and drug manufacturers are typically considered experts who are held to a higher standard of care (Sec 1299 Civil Code). They are expected to possess the relevant skills required by their activities and will therefore be acting negligently if they lack the average skills of an expert in the field.

2. Product liability

For a claim based on the Product Liability Act (Produkthaftungsgesetz) the claimant must show the damage incurred, the causation of this damage by the manufacturer’s product and the defectiveness of said product. Negligence is not required.

The damages must be caused by a defect of a product. The defect of the product may be due to faulty design, production, or instruction. Under certain conditions, the ineffectiveness of a product may also constitute a defect. Product liability is triggered if the product fails to comply with the level of safety that is reasonably expected, and damages have resulted as a consequence of that failure.

Furthermore, the defect must have already existed at the time the product was placed on the market.

The manufacturer is not liable if, at the time the product was placed on the market, a defect could not be detected, according to the state of the scientific and technical knowledge.

3. Administrative/Criminal penalties

For administrative liability, the prosecuting authorities must show that the administrative criminal offence was factually committed and that the offender acted negligently. However, if the administrative fine for committing the respective administrative offence does not exceed EUR 50,000, the law assumes that the offender did act negligently (Sec 5 para 1 and 2 Administrative Penal Act, Verwaltungsstrafgesetz).

For criminal law liability, the prosecuting authorities must show that the criminal law offence was factually committed and that the offender acted negligently.

Legal entities are liable for criminal law offences according to the Corporate Criminal Liability Act (Verbandsverantwortlichkeitsgesetz).  Criminal law liability for legal entities requires that the criminal offence was either committed for the benefit of the legal entity or in violation of the legal entity’s legal duties. In addition, the offence must have been culpably committed by a decision maker or if committed by another employee (culpability not required), a violation of the organisation’s management, coordination, supervision, or control duties must have taken place.

4. State-liability

For a claim based on the Governmental Liability Act (Amtshaftungsgesetz) the main prerequisite is to show that the damage was caused by a public official in relation to the enforcement of laws rather than the adoption of laws. Other prerequisites are identical to a claim under general civil tort law.

2.2 Which are the grounds for exclusion of liability?

1. Manufacturers

It is admissible to exclude contractual liability for damages to property.  However, it is not permissible to exclude liability for personal injuries. 

Under the Product Liability Act, liability is excluded if:

• the product defect was caused by compliance of the manufacturer with mandatory regulatory provisions; or
• the product was manufactured according to the state of the art when it was put onto the market.

2. Healthcare professionals

Healthcare professionals may exclude contractual liability for property damages, however, exclusion of liability for personal injuries is not permitted.

3. State

State liability cannot not be excluded

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

Compensation claims for contractual liability, according to tort law as well as the Governmental Liability Act, must be submitted within three years after actual knowledge of the damage and the liable party. 

Claims under the Product Liability Act must be submitted within ten years after the defective product has been put on the market. 

2.4 Which damages can be compensated?

Contractual liability compensation includes compensation for property damages, loss of profit (regardless of the level of negligence), compensation for pain and suffering, costs of treatment and, in case of death, a pension for surviving dependants.

This is also applicable to tort law liability and state liability according to the Governmental Liability Act, the only difference being that loss of profits is only compensated if the liable party’s conduct was grossly negligent (or intentional). 

Compensation under the Product Liability Act includes compensation for damage to property, other than the defective product, and compensation for personal injuries (compensation for pain and suffering, costs of treatment and in case of death pension for surviving dependants). 

Compensation pursuant to the Vaccine Damage Act includes costs of treatment and rehabilitation in case of long-term effects, and a pension for the victim or, in case of death, for surviving dependants. If the damage has not caused permanent consequences, compensation is only due if the vaccination has caused serious bodily injury - it will then be paid in a one-time-sum.  

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

Direct compensation claims against insurance companies are only possible if a liability insurance is compulsory and such direct compensation claims are stipulated by law.

This, for instance, is the case for healthcare professionals such as doctors and pharmacies (Sec 52d Physician’s Act and Sec 4a Pharmacy’s Act). In addition, private hospitals are required to conclude a liability insurance agreement (Sec 5c para 3 Krankenanstalten- und Kuranstaltengesetz).

In these cases, the law stipulates that damaged parties may claim compensation directly against the respective insurance company. 

Please note that, in Austria, drug manufacturers as well as public hospitals are not required to enter into a liability insurance agreement. Thus, compensation claims cannot be directed against the insurance company.

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

Compassionate use programmes do not impact the liability of manufacturers and healthcare professionals.

A. Manufacturers

The guidelines for compassionate use of the Austrian Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen – BASG) explicitly refer to Art 83 Regulation (EU) 726/2004. Accordingly, any opinions on the conditions for the compassionate use programmes, shall not affect the civil or criminal liability of the manufacturers.

B. Healthcare professionals

Compassionate use programmes only concern the regulatory aspect of medicines, i.e., allow the use of a medicine before it has received marketing authorization. Therefore, a healthcare professional may be fully liable for treatment errors, even if the medicine in question is part of a compassionate use programme. 

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

Off-label use is when medicine is used for an unapproved indication. This may affect liability of manufacturers and healthcare professionals.

A. Manufacturers

Off-label use may limit liability of manufacturers according to the Product Liability Act. 

In principle, the manufacturer may also be liable for damages incurred while using the product in a foreseeable manner, however, not in a way originally intended by the manufacturer. Therefore, manufacturers of medicines may be liable, according to the Product Liability Act, if off-label use of a specific medicine corresponds to the reasonable medical practice.

However, if off-label use of a specific medicine does not correspond to the reasonable medical practice, the manufacturers will not be liable. 

In case the manufacturer becomes aware of off-label use of his medicines, he may be required to object to such off-label use to avoid being liable according to the Product Liability Act. However, the manufacturer cannot not impose a general prohibition of off-label use of his medicine. Therefore, any objections made by the manufacturer must be precise, dealing with specific health risks related to off-label use. 

B. Healthcare professionals

Off-label use may trigger liability of healthcare professionals resulting from medical malpractice and failure to provide sufficient information to the patients.

Healthcare professionals are liable for off-label use if such off-label use does not correspond to the state-of-the-art medical treatment (taking into account the specific patient and the patient’s medical history).

However, not using a medicine off-label may also trigger liability of healthcare professionals. This may be the case if off-label use corresponds to the state-of-the-art medical treatment in a specific situation, but the healthcare professional has not informed the patient on the possibility of such off-label use. Thus, in certain circumstances, healthcare professionals may be liable for not using a medicine off-label.

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

Austrian law provides for a public-law system for the payment of compensation by the state under the Vaccine Damage Act (Bundesgesetz vom 3. Juli 1973 über die Entschädigung für Impfschäden or Impfschadengesetz).

In addition, general civil law claims or claims according to the Product Liability Act (as set out above) could be directed against manufacturers, for damages that were not compensated for by the state (e.g. non-monetary damages).

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

The state will pay compensation in the event of damage to a person’s health resulting from the administration of certain vaccines. The responsible body is primarily the Ministry of Social Affairs. The compensation will be provided on the basis of a social-security claim against the state, pursuant to the Vaccine Damage Act. The claim will be assessed in an administrative proceeding.

Any person who has suffered an impairment of health by one of the following vaccinations is eligible for compensation:

• the smallpox vaccination prescribed until 1980; or
• a vaccination administered based on an administrative order for persons engaged in medical occupations; or
• a vaccination for border guards; or
• a vaccination mentioned in the 'mother-child' passport; or
• a vaccination recommended by Regulation of the Ministry of Health.

COVID-19 vaccinations have been included into the above-mentioned Regulation on Recommended Vaccinations. Vaccinations that are in the phase of a clinical trial are not included.

The vaccine must have caused severe bodily harm or resulted in permanent consequences and it must be probable that the vaccination caused the severe injury. 

The vaccination must have been administered in Austria, but non-Austrian citizens are also entitled to compensation. Generally, damages for death, injury or disability will be paid. Damages can include recurring cash benefits (e.g. in case of disability) or payments to orphans or widow/ers.

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

Insurances may only cover civil law liability. Insurance agreements covering criminal law sanctions or administrative penalties are considered agreements contrary to public policy and are thus null and void.

Compulsory insurance exists for:

• healthcare professionals, such as doctors and pharmacies (Sec 52d Physician’s Act and Sec 4a Pharmacy’s Act);
• private hospitals (Sec 5c para 3 Krankenanstalten- und Kuranstaltengesetz)

Please note that there is no compulsory insurance for drug manufacturers as well as public hospitals.

However, the Product Liability Act obligates manufacturers to ensure that there are sufficient funds available to satisfy compensation claims, which may involve taking out adequate insurance.

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

N/A