Adverse effects of drugs and vaccines in Russia

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

Depending on the cause for adverse reaction and consequences for patient, the following liability may apply:

1. Manufacturers

Should an adverse reaction occur and results in harm to the people’s health, the manufacturer may be subject to civil liability (reimbursement of damages).Furthermore, the circulation of medicine may be suspended by the competent authority.

2. Healthcare professionals

Healthcare professionals are not liable for adverse reactions. However, HCPs may be criminally liable for harm inflicted to the patient’s life or health due to the breaches of medical practice rules (e.g. misuse of medicine, off label prescription, etc.). Meanwhile healthcare institutions (medical sites) are liable for damages incurred by the affected patients under civil law (e.g. real damages arisen from harm to health, loss of profit, moral damages).

3. State

As a rule, the state has no liability for adverse effects, except for post-vaccinal complications (see Question 5 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:

As a general rule, product manufacturers are obliged to compensate damages to consumers, provided there is a cause-and-effect relationship between the damage and application of the product (unless there is a valid defense as described in point 2.2 below). 

More specifically the pharmaceutical manufacturer is liable if the harm is caused by a medicine:

1. failing to comply with the registration dossier (in terms of quality or otherwise); and/or
2. supported by false information on the package leaflet.

2.2 Which are the grounds for exclusion of liability?

The pharmaceutical manufacturer may be released from liability in case of a valid defence, including the following circumstances:

1. harm is caused by a force-majeure event; 
2. harm is caused by a consumer’s failure to comply with package leaflet;
3. medicines defect causing adverse reaction occurs due to breaches of transportation and (or) storage rules by distributors or retailers;
4. harm is caused due to a wrong prescription made by a doctor. 

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

The manufacturer is liable for the adverse reactions subject to conditions specified in Questions 2.1 and 2.2 above, if the rooting defect occurs within the shelf life of a medicine. Should the shelf life for a medicine not be set (even though it is obligatory), the manufacturer will be liable irrespective of the moment of defect occurrence. 

In turn, the claim may be submitted during an unlimited period of time. However, after expiration of three years from the moment of harm infliction, the claim of damages will be satisfied only in respect of the last three years elapsed.

2.4 Which damages can be compensated?

The following damages are compensated: 

• real damages (e.g. expenses for medical care, etc.); 
• loss of profit (e.g. loss of salary due to medical inability to work)
• moral damages (compensation for physical and emotional suffering).

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

The insurance of liability of pharmaceutical manufacturer is voluntary (except for clinical trials). The insurance company is therefore not necessarily involved in the case. However, if it is, the compensation may be claimed directly to the insurance company.

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

No special rules or exemptions are provided for the compassionate use program.

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

As a general rule, off label use is prohibited in Russia. 

So, if a doctor would prescribe off label use and that use would harm the patient, it may release the manufacturer from liability and/or impose liability to the healthcare institution. 

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

Russian law provides for special compensations in case of post-vaccinal complications as described below. 

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

The state guarantees social compensation for persons who have post-vaccinal complications caused by any vaccination included in the calendar of vaccinations (a list of vaccination to be received by certain categories of people).

Such social compensation can include the following:

• lump sum for post-vaccine complications or patient’s death; 
• monthly allowance if the patient has been disabled due to post-vaccine complications; 
• temporary incapacity allowance.

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

There is no compulsory insurance for pharmaceutical manufacturers or other parties involved except for clinical trials. Such insurance may be got on a voluntary basis.

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

There are no special procedures for ADR claims.