Adverse effects of drugs and vaccines in Ukraine

1. Drug adverse effects: kinds of responsibility

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

Currently the law relating to responsibility for adverse reactions to drugs, including severe or unpredicted adverse reactions (death and severe damage caused to health) is poorly covered by Ukrainian law. Claims related to adverse reactions to drugs are governed by the general rules of civil (including product liability) and criminal legislation.

Civil responsibility

The general product liability provisions will be applicable to the manufacturer (or importer who placed a product on the market) that may bear civil liability for the damage caused if the product has a defect. Products are defective if they do not meet the level of safety that the consumer has the right to expect considering all the circumstances, including those related to the development, manufacturing, circulation, transportation, storage, consumption, use, destruction (disposal, processing) of these products, as well as the provision of information about such products, including:

  1. presentation of the product to the consumer, including its appearance, composition, packaging, labelling and other information about the product including its consumption, use and destruction (disposal, processing); 
  2. the use of products that can reasonably be foreseen; 
  3. the time at which the product was put into circulation.

Product liability does not depend on the fault of manufacturer (or importer), the affected person does not need to have a contractual relationship with the manufacturer (or importer). 

In other cases, compensation for adverse drug reactions is subject to the general rules set out in Chapter 82 of the Civil Code of Ukraine. 

According to the effective civil legislation, civil liability in case of damage to life and health of patients because of medical malpractice (e.g. improper prescription of drugs) of healthcare professionals (the “HСPs”) is borne by the healthcare institution (employer) or HCP (if the HCP practices individually). HCP/healthcare institution cannot be held liable for damage caused for the manufacturer's failure to meet the quality and safety requirements or for incorrect information on the leaflet or labelling of the drug.

As for the state, unless the person who committed a crime is identified or insolvent, the state is obliged to compensate for the damage caused by injury, other damage to health, or death because of a crime. The state has a right of recourse to a liable person. Also, the state may bear civil liability in case it can be proven that the state registration of the drug was held with violations that brought to adverse reaction.

Criminal responsibility

Officials of the manufacturer (or importer) may be found criminally liable for deliberate introduction of unsafe drugs to the market. The sanction for this crime is a fine ranging from UAH 51,000 to UAH 136,000 (approximately from EUR 1,650 to EUR 4,300), and the potential to be prohibited from holding certain positions or performing certain activities for a term of up to three years. 

Criminal responsibility for a HCP’s medical malpractice, if it caused severe consequences to the patient, entails a prohibition on holding certain positions or performing certain activities for the term of up to five years or correctional labor for up to two years, or restriction of liberty for up to two years, or imprisonment for the same term.

Reform of the drugs regulation in Ukraine

The Draft Law "On medicines" No. 5547 (the "Draft Law"), recently adopted by the Ukrainian Parliament in the first reading, will introduce some additional rules on liability for adverse reactions to drugs. According to Art 35 of the Draft Law, MAH shall be liable in cases of damage to human life and health caused by use of a drug according to the approved summary of product characteristics (the “SPC”) and if an unpredicted adverse reaction causes such damage. Furthermore, the MAH is required to provide compensation for damage to the health of citizens as a result of using their drug if it is proven that the damage to the citizen’s health was caused by inaccurate information contained in the leaflet of the drug.

2. Claiming compensation for damages caused by 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:

In terms of product liability, to claim compensation the affected person should prove:

  1. That they suffered damage;
  2. product defect;
  3. That there is a causal link between the product defect and the damage suffered.

In other cases, compensation for damage is possible provided the following elements are proven:

  1. actual damage was caused; 
  2. illegal actions or omissions have caused the damage;
  3. causal link between the illegal actions or omissions and the damage caused; 
  4. fault of the person who caused the damage. 

It is crucial to prove the causal link between illegal actions or omissions and the damage caused. If the damage is not the result of illegal actions and omissions of the liable person, the latter (or healthcare institution) will not be required to provide compensation for the damage. 

The burden of proof lies with the claimant, who seeks compensation in the court, except for fault (where applicable). The defendant must prove the absence of fault. 

2.2 Which are the grounds for exclusion of liability?

In terms of product liability, manufacturer (or importer) is exempt from liability if:

  1. the manufacturer did not put the product into circulation (e.g. in case a diverted drug is smuggled to Ukraine, or a counterfeit is used instead of a genuine drug);
  2. the defect that caused the damage arose after the manufacturer put the product into circulation, (excluding cases where the defect was due to the design or composition of the product);
  3. the product was not manufactured or distributed by the manufacturer (or importer) in the course of its business (i.e. its commercial activities),
  4. the defect arose as a result of the manufacturer's (or importer’s) compliance with the law or mandatory instructions of public authorities.

The manufacturer of a component of a product shall not be liable if it proves that the product defect can be attributed to the design of the finished product, or to the technical documentation provided to it by the manufacturer of the finished product.

Product liability of the manufacturer may also be reduced in specific circumstances established by the law (e.g. if the actions of the affected person contributed to occurrence of damage).

According to para 5 of Art. 35 of the Law of Ukraine “Fundamentals of Legislation of Ukraine on Healthcare”, HCPs are released from liability if a patient refuses to follow medical prescriptions or violates the prescribed treatment regimen.

Furthermore, under the Draft Law, the MAH, manufacturer and/or importer shall not be liable for the consequences of drugs not being used in line with the approved SPC.

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

The standard time limit for claims is three years. 

No time limit is applied in case of claims related to compensating the damages caused by injury, other damage to health, or death (except when caused by defective products). 

Time limit in case of damage caused by defective products (3 years) shall begin running from the day when the claimant became aware or should have become aware of the existence of the damage, product defect and the identity of the manufacturer (importer). Damage shall be reimbursed if it is caused within ten years from the date the product was put into circulation, provided that the claimant filed a lawsuit against the manufacturer (importer) before expiration of this period.

2.4 Which damages can be compensated?

All kinds of damages incurred, including material (costs of drugs, prosthetics, diagnostics, treatment and rehabilitation, enhanced nutrition, outpatient care, etc., or lost opportunities) and moral damages.

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

As an insurance agreement may be classified as a third-party beneficiary agreement, an injured party may choose to claim compensation either from the insurance company or from the damaging party.

3. Compassionate use programmes

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

Compassionate use programmes, as understood by the EU laws, are not yet available in Ukraine. However, non-authorised drugs may be imported to Ukraine and used in specific cases expressly permitted by the law (e.g. for individual use). At the same time, there are no special regulations considering responsibility for adverse drugs reaction in this case. In most cases (save for the situations when non-authorised drugs are imported under respective permits of the Ministry of Health by drug importers, and not individuals) application of product liability to non-authorised drugs may be contested, as such products were not “put into circulation” as required by the product liability legislation. Otherwise, general rules on civil/criminal liability will be applicable. 

There are currently 2 draft laws concerning introduction of compassionate use programs into the Ukrainian legislation: the Draft Law already mentioned, and another one (No. 5736) dedicated solely to the topic of compassionate use and other expanded access tools. Neither of these draft laws establish separate rules regarding liability in connection with adverse drug reactions.

4. Off-label use

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

So far, off-label drug use is expressly allowed by law only with regards to treatment of COVID-19. Otherwise, off-label drug use is not directly regulated by the Ukrainian legislation, so there are no specific rules on liability for adverse effects of drugs in this context. 

One of the circumstances to be taken into account in this case is whether the Ukrainian state authorities have approved the off-label use. If the off-label use is not approved, the manufacturer (or importer) may not be aware of the off-label use, so it is doubtful that the adverse effect of a drug in this case could be considered a product defect for product liability purposes. If off-label use is not approved and HCP has decided to use the drug against the approved indications, the healthcare services could be recognized as provided with insufficient quality due to medical malpractice. In this case, apart from criminal responsibility, a HCP themself (if being an individual healthcare services provider) or represented by the healthcare institution (if employed by it) would be liable for all damages caused. However, compensation may be denied if the medical informed consent of the patient was obtained.

If off-label use is approved, this will be a shield for HCPs/healthcare institutions against potential medical malpractice claims in case of off-label prescription. Manufacturer would be regarded as being able to foresee such use, which will increase the likelihood of product liability claims. At the same time however, this opens another avenue for the manufacturer to claim release from liability in this case through compliance with the legislation/instructions of authorities.

5. Vaccines

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

There is no separate procedure for compensating damages caused by adverse reactions to vaccines. The only established exception is for COVID-19 vaccines. When authorised by the Cabinet of Ministers, the Ukrainian Ministry of Health may release from liability the manufacturers and/or MAH, including their staff, as well as HCPs, and other persons involved in vaccination-related activities, concerning any consequences caused by using approved (on-label) COVID-19 vaccines and biologics. The state budget compensates damages. In this context, the Ukrainian Government recently adopted a mechanism of lump-sum compensation of damages arising in connection with severe COVID-19 vaccine complications from state funds. State funds may also be used to cover damages arising in connection with COVID-19 vaccine complications under national or foreign court decisions.

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

None, except for severe adverse COVID-19 vaccines reactions, where compensation is to be covered by the state budget.

6. Insurance issues

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

Pursuant to Art. 7 of the Law of Ukraine "On insurance", professional liability insurance for persons who can damage third parties is mandatory, but only for those listed in the resolution by the Government of Ukraine. Since this list has not been approved yet, HCPs professional liability is subject to voluntary insurance. 

The insured can be a health care institution or a HCP, regardless of whether he/she are engaged in private medical practice or employed.

7. Procedural issues (litigation)

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

There are no particular procedural issues relating specifically to ADR claims. However, there are essential particularities concerning claims for damage caused by damage to health, which need to be considered:

  • Claimant has a choice to which court to file a claim: 
  1. at the respondent’s registered location/place of residence or stay;
  2. at the claimant’s registered place of residence/stay; or
  3. at the place where damage occurred.
  • Courts are required to assign experts upon a party’s motion when it is necessary to establish the nature and extent of the damage to health;
  • Courts’ decisions under such claims (i.e., to collect damages) may be subject to immediate enforcement (i.e. as soon as the decision is announced in the court hearing, in contrast to “regular enforcement” which may occur only after the decision enters into force), provided that the court explicitly rules so.
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