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:
- 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);
- the use of products that can reasonably be foreseen;
- 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.
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