Adverse effects of drugs and vaccines in Poland

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

Manufacturers of drugs and vaccines are primarily liable towards patients based on strict liability for hazardous (defective) products (under civil law provisions implementing Directive 85/374/EEC). However, this does not exclude a manufacturer’s general fault based on liability in tort, as well as the criminal liability (e.g. for endangering the life or health of patients as a result of a breach of the manufacturer’s obligations). 

In most cases, contractual liability will be the liability towards wholesalers or other entities purchasing drugs.

2. Healthcare professionals

Healthcare professionals (which include health care services providers, both private and public) are liable towards patients primarily in tort (fault-based liability). This liability may arise e.g. if the wrong medicine was prescribed for the patient, if the wrong dose or method of administration was used or the drug was applied despite the existence of contraindications. The liability is usually related to a failure to exercise due diligence. In this context it is important to note the doctor’s obligations related to the duty of information towards the patient, in particular with regard to the possible adverse effects of a drug.

Healthcare professionals can also be subject to criminal liability for wrongful death or bodily harm, including liability for criminal negligence. There are discussions concerning introducing a no-fault based liability and eliminating criminal liability for ordinary negligence. However, no law has been passed in that respect yet.

Contractual liability is also possible, in particular in the case of private healthcare services.

3. State

The State Treasury can also be held liable for adverse reactions of drugs if their administration was compulsory. This may concern liability in connection with the use of immunisations as well as compulsory treatment. In this case, it is possible to claim compensation based on the equity principle (no fault liability for lawful actions). 

The State Treasury can potentially also bear liability in case of unlawful actions of its officials which resulted in an injury. In practice, in most cases it may be difficult to demonstrate causality between the action of the state official and an adverse reaction of the drug. 

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, the injured party has to demonstrate the existence of the event (adverse reaction), the damage, as well as causality (normal causal link) between the damage and the event.

In the case of claims based on strict liability of the manufacturers for hazardous products, the injured party has to demonstrate the defect of the product (e.g. contamination of the drug, inherently dangerous qualities or defective instructions in the patient leaflet).

In the case of claims based on general liability in tort, the injured party has to demonstrate fault, which includes both a breach of the obligations under the law or the general rules of society and negligence or wilfulness. For civil claims it is not usually necessary to prove the fault of a particular individual, an organisational fault is sufficient. A breach of obligations includes the obligation of a given doctor to practice his/her profession in accordance with the current medical knowledge, available methods and means of prevention, diagnosis and treatment of diseases, in accordance with the principles of professional ethics and with due diligence.

In the case of the liability of the State based on the equity principle, the injured party has to demonstrate, in addition to the event, the damage and causality, also the circumstances that justify full or partial compensation for the consequence of lawful actions of the State. In particular, the injured party can demonstrate the inability to work or his or her severe material situation. 

In the case of liability for unlawful actions of State officials, it is necessary to prove the existence of such action and that it resulted in damage (causality). No fault needs to be demonstrated.

As to the standard of proof, the courts in proceedings concerning claims related to the process of medical treatment recognise the difficulty of proving causality. Therefore, it is usually sufficient for the injured party to prima facie demonstrate the causality, i.e. by showing that a causal connection between the harmful event and the damage is probable to a sufficiently high degree. Once the causality is shown prima facie, the burden of proof is shifted to the respondent.

2.2 Which are the grounds for exclusion of liability?

A. Manufacturers 

In the case of strict liability for a hazardous product, the manufacturer will not be held liable if:

1. it did not place the product on the market or if placing the product on the market was outside the scope of its business activity;  
2. dangerous properties of the product appeared after the product was placed on the market (e.g. as a result of improper storage of the drug by the healthcare professionals), unless their cause was inherent in the product;
3. the product's dangerous properties were undetectable given the state of scientific knowledge at the time of placing it on the market; or
4. the dangerous properties of the product are the result of the product complying with mandatory legal regulations issued by a public authority.

The manufacturers of drugs are also generally not liable for the properly disclosed adverse effects of the drugs which are inherent for the drug and cannot be avoided.

B. Healthcare professionals  

Healthcare professionals are not liable for the adverse effects of drugs if they could not have foreseen the occurrence of the undesirable effect. In case of known adverse effects of which the patient was informed, healthcare professionals will not be liable if they exercised due diligence and are otherwise not at fault. 

Moreover, healthcare professionals employed based on an employment contract are not liable for damages towards persons other than their employers (unless the damage results from wilful behaviour). In this case the healthcare provider is liable for the negligence of the healthcare professionals it employs.

C. State 

The State cannot be held liable if the injured party fails to prove the existence of the prerequisites for liability indicated in para. 2.1

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

Damages claimed under strict liability for hazardous products are time-barred with the lapse of three years from the day on which the injured party learned or, exercising due diligence, could have learned of the damage and the person obliged to compensate for it. However, in any case, the claims are time-barred ten years after the product was placed on the market.

Claims based on general tort liability against manufacturers or healthcare professionals as well as claims based on the liability of the State are time-barred with the lapse of three years from the day on which the injured party learned or, exercising due diligence, could have learned about the damage and the person obliged to compensate for it. In addition, the claims become time barred regardless of the above after ten years from the day on which the event giving rise to the damage occurred.

However, this additional rule does not apply to cases of personal injury (bodily harm). Finally, personal injury claims of a minor cannot become time-barred earlier than two years after the minor becomes an adult.

In case of tort claims where the damage resulted from a crime (including criminal negligence), the claims become time-barred after 20 years from the time of the crime regardless of when the injured party learned about the damage and the person obliged to compensate for it.  

2.4 Which damages can be compensated?

The injured person is entitled to full compensation which includes:

• reimbursement of all costs incurred in connection with the person’s treatment (costs connected with the injured person's stay in hospital, specialist appointments, costs of drugs or additional nursing or rehabilitation care). It is argued that such costs may also include travel expenses for relatives visiting the injured party, especially if the injured party is a minor; 
• costs of training for another occupation if the injured worker has become disabled; 
• disability benefit for a partial or total loss of ability to work or to compensate for increased needs or loss of future prospects;
• compensation to the injured party for the harm suffered; and
• compensation for the closest family in case of the death of the injured person or bodily harm resulting in loss of connection with the family.

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

In general, only an insured person under a policy has a right to raise a claim resulting from an insurance contract directly against an insurance company. However, in the case of third-party liability insurance, a prospective third-party claimant who has suffered a loss as a result of the actions and / or omissions of the insured has a right to raise a claim directly against the insurance company (so-called actio directa). 

In practice, to successfully raise a claim against an insurer, the prospective third-party claimant must possess the data of the given insurer and the insurance policy itself. This can be burdensome - as a rule, an insured party does not have to reveal such information (except for inter alia healthcare professionals who are obliged to provide information about their compulsory third-party civil liability insurance upon request of a patient). 

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

Poland has not implemented local provisions on compassionate use programmes – in practice, these are not conducted in Poland.

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

Off-label use of drugs is a complex legal issue and administering drugs off-label can impact the liability of both the manufacturer and healthcare professionals (there are very rare situations where off label use may be mandated by the State).

As a general rule, a manufacturer should not be liable for the consequences of using a drug contrary to the instructions, contraindications or special warnings provided in the medicinal product characteristics and patient leaflet. 

The liability of healthcare professionals for adverse effects resulting from off-label use may be affected depending on the circumstances of administering the drug, in particular whether the off-label use is qualified as a medical experiment, what other methods of treatment are available and whether the patient gave informed consent for such treatment.

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

Apart from the Compensation Fund mechanism described below, there are no specific provisions regarding liability for adverse reactions concerning vaccines. There may only be some specifics, depending on the type of vaccines (be it compulsory or recommended/voluntary) – e.g. as a rule, for compulsory vaccines the state would be responsible.

As mentioned above, in January 2022 the Polish legislator introduced a compensation system for vaccines – the Compensation Fund. Its aim is to facilitate a quick path for obtaining compensation in case a patient has suffered adverse effects as mentioned in the Characteristic of a Medicinal Product within 5 years of vaccination. The patient can claim compensation from the Compensation Fund if the said adverse effects resulted in:

1. hospitalisation for at least 14 days; or 
2.  an anaphylactic shock requiring observation in the ER or hospitalisation for less than 14 days.

As a rule, the amount of compensation depends on the length of hospitalisation and may be increased, for example, if surgery is required. The compensation can amount up to PLN 100,000 (approx. EUR 21,500). Funding for the Compensation Fund comes from a variety of sources, including obligatory payments made by pharmaceutical companies that supply vaccines. 

Initially, in 2022, the compensation system applies only to COVID-19 vaccines. However, as of 
1 January 2023, it will also apply to compulsory and voluntary vaccinations associated with emergency anti-epidemic measures other than COVID-19 vaccines. In order to receive compensation, a patient must submit an application to the Patient Ombudsman. The application should be reviewed within 3-4 months. 

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

See answer in 5.1 above. As to compulsory vaccinations - see answers 2.1 with regard to claims against the State based on the equity principle. 

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

In Poland, there are two types of insurance: (i) property insurance, including third-party liability insurance, which may cover any property-related interest which is not contrary to the law and which may be assessed in monetary terms and (ii) personal insurance which may cover primarily personal goods, such as life or health. 

In general, property insurance can cover civil liability (i.e. liability for damage caused to third parties in case of contractual or tort responsibility) and administrative liability (i.e. purely administrative penalties and fines). However, criminal liability (i.e. penalties and fines of a criminal character) is non-insurable. 

As a rule, insurance covers the period starting at the earliest from the date of conclusion of the insurance contract. With certain limitations, it is possible to cover a period preceding the conclusion of the insurance contract (it will be ineffective if at the time of conclusion of the contract either party knew or could have learned with the observance of due diligence, that the insured event had occurred or its occurrence is impossible). 

6.2 Is there any compulsory insurance?

Healthcare professionals (i.e. a healthcare provider as defined in the Act of 15 April 2011 on healthcare activity, a doctor, a nurse or a physiotherapist) are obliged to have mandatory third-party civil liability insurance. This insurance covers damages resulting from the provision of healthcare services or the unlawful failure to provide healthcare services. Moreover, physical persons who provide health care services, but who are not healthcare providers within the definition provided above and entities carrying out activities related to the supply of medical devices, are also obliged to have mandatory third-party civil liability insurance covering damages caused during the provision of healthcare services carried out under a healthcare services contract financed from public funds. 

As a side note, there are separate compulsory insurances related to clinical trials and medical experiments.

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

ADR claims usually require an opinion of a court appointed expert or medical institutes that are decisive in establishing causality. As such, matters are usually complex and the availability of experts or institutes is limited, the waiting time for an opinion can be significant, which can impact the duration of ADR cases.