Adverse effects of drugs and vaccines in Romania

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 parties involved, a liability claim for damages caused by adverse drugs reactions may be brought in accordance with the provisions of Government Ordinance 21/1992 regarding consumer protection, the Civil Code and/or the Law no. 240/2004.

1. Generally, liability claims are directed against the manufacturer under Law no. 240/2004, with the claimant having to prove that the adverse reactions deem the drug as a “defective product” under this law. “Defective products” are defined under Law no. 240/2004 as products that do not provide the safety that the person is entitled to expect, taking into account all circumstances, including:
   1. how the product is presented;
   2. all foreseeable uses of the product; and
   3. date of release of the product.
2.  According to art 654 par. (2) of Law no. 95/2006, HCPs are not held liable for damages caused in the exercise of the profession when they are due to adverse drug reactions.
3. Under the Romanian Civil Law, any person considered liable for damages can have a case brought against him (theoretically, this includes the state). 

However, tort law requires that a claimant must prove he suffered a wrong due to another person’s negligence or deliberate harm and, most commonly in the case of a vaccination, there is no obviously negligent party. It is for this reason that there is generally no ground for such liability claims against the Romanian state.

With respect to the adverse reactions of the COVID-19 vaccines, it should be noted that the EU states have agreed to bear some of the damages that could be obtained in court as a result of such possible adverse effects of the vaccines. 

Note: The types of liability mentioned at A. and B. above do not, in principle, exclude the risk of the person being held criminally liable, if the deed that caused the damage constitutes a crime according to Romanian law.

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:

Under the civil law rules for contractual liability, the creditor may claim compensation from the debtor if: (i) there is a valid contract concluded between the parties and (ii) there is an injury resulting from the debtor’s non-compliance with the contractual obligations. Generally, for this type of liability, the burden of proof rests with the creditor.

Tort liability is held as a result of the violation of a person’s rights or interests; this represents a rather broad field of indemnifying prejudices and may include those arising out of an accident, illness or injury caused by adverse drugs reactions. For tort liability, the specific conditions that must be proven are the prejudice, the illicit act, the guilt and the causal link between the act and the prejudice. Generally, the burden of proof rests with the claimant, who must prove that the defendant has committed a tort and that he/she suffered losses that may, thus, be compensated.

2.2 Which are the grounds for exclusion of liability?

Contractual liability may generally be limited or excluded as per the pacta sunt servanda principle, so long as this is not contrary to public policy, accepted principles of morality, or limits imposed by law. The parties cannot limit liability for:

• damage caused by a default committed intentionally or by gross negligence; or
• damage caused to physical or mental integrity or health.

According to Law no. 240/2004, any contractual limitation or exemption from liability of the manufacturer is null and void.

Tort liability may generally be limited if the person held liable can prove that all reasonable efforts were made to reduce risks. 

A. Under Law no. 240/2004, limitations or exemptions from liability cannot be set contractually in favour of manufacturers (contractual liability).

For tort liability, the substantive test is proving the causal link between the damage and the defect in the product. Therefore, the manufacturers’ tort liability shall not be held in cases such as where: (i) there could not be concluded that the respective drug is a “defective product” under this law; or (ii) the injured party does not prove the damage, the defect and/or the causal relationship between the two.  

Also, according to art. 7 of Law no. 240/2004, manufacturers are not liable in the following cases:

• The product was not placed on the market by the manufacturer.
• Depending on the circumstances, the defect that caused the damage did not exist at the time the product was placed on the market or appeared after the product was placed on the market, due to causes independent from the manufacturer.
• The product was not manufactured for trading or other form of distribution for the manufacturer's economic purposes and was not manufactured or distributed in the course of its business activity.
• The defect is due to compliance with mandatory requirements imposed by regulations issued by the competent authorities.
• The state of scientific and technical knowledge when the product was placed on the market did not allow discovery of the defect.
• The defect is caused by the consumer, due to non-observance of the instructions for use.

We should also note that if manufacturers would take measures such as conducting extensive clinical trials and/or effective information campaigns, these may generally be considered mitigating factors in the assessment of their liability.

B. and C. As mentioned in Q1.1 above, HCPs are not held liable for damages caused in the exercise of the profession when they are due to adverse drug reactions and there would generally be no ground for such liability claims against the Romanian state. 

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

The general time limit under the Civil Code is of 3 years, running from the date when the injured party knew or should have known both of the damage and of the person who is responsible for it.

For claims against manufacturers under Law no. 240/2004, the time limit is of 3 years, running from the date on which the injured party had or should have been aware of the existence of damage, defect and identity of the manufacturer; the claim for damages may not be brought after 10 years from the date on which the manufacturer put the product into circulation.

2.4 Which damages can be compensated?

As mentioned in Q1.1 above, depending on the parties involved, a liability claim for damages caused by adverse drugs reactions may be brought in accordance with the provisions of Government Ordinance 21/1992 regarding consumer protection, the Civil Code and/or the Law no. 240/2004.

According to Law no. 240/2004, the damages that can be claimed include:

• damages caused by the death or personal injury of an individual; 
• damage to, or destruction of, any item which is worth at least RON 200 (approximately EUR 40), provided that the item is principally intended for private use and was used by the injured person as intended; 
• damage to, or destruction of, any item, which is worth at least EUR 500, provided that the item is principally intended for private use and was used by the injured person as intended.

Claimants may file civil and/or criminal actions against a manufacturer, to claim compensation of damages caused by the adverse drugs reactions (e.g. in case of bodily and health harm, for the lack of working capacity caused to the injured party, healthcare expenditures, the increase of the injured party’s living costs, etc).

It should be noted that, generally, consumers have the right to be protected against the purchase of a product that may harm their life, health and safety; they have the right to be reimbursed for damages caused by the inadequate quality of products and services.

Medical expenses, loss of income, repair costs, personal injury, and/or pain and suffering are examples of compensable damages under the more general (civil law) tort liability.

In certain cases, damages may be compensated if the injured party’s family and social life has been reduced as a consequence of the adverse drug reactions.

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

Under the Civil Code, the claimant shall claim compensation from the person responsible for the damage (e.g. the manufacturer). 

The insurer may be brought into court as a third party, being contractually liable within the limits of the insurance contract. 

The compensation is usually paid by the insurer directly to the claimant; it may also be paid to the manufacturer, if it is proven that the claimant was already compensated by the manufacturer.

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

According to art. 14 of the MOH Order no. 1018/2014, the authorisation issued by the Romanian National Agency of Medicines and Medical Devices for compassionate use programs does not exclude the civil or criminal liability of the manufacturer.  

Therefore, it could be interpreted that the manufacturers’ liability may be triggered even if the adverse drugs reactions would occur within a compassionate use program, provided that the conditions for claiming compensation are met.

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

When choosing an off-label treatment option, HCPs must inform their patients correctly and completely of all potential risks, including of the adverse drug reactions.

HCPs assume their own responsibility for off-label uses and may be held liable for the damages that may occur, in proportion to their individual degree of guilt.

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

There is no specific regulation on compensation for the adverse effects of vaccinations in force in Romania. 

Generally, liability lies with the marketing authorisation holders and manufacturers for the products they place on the Romanian market. 

As previously noted, Law no. 240/2004 applies where claims are made for compensation for damages caused by a defective vaccine; the injured person also has a right to claim damages pursuant to the common rules of Civil Law and/or the legislation on consumer protection. 

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

There is no specific regulation for vaccine compensation in force. Also, there are no compulsory vaccinations in Romania as of the writing of this advisory.

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

Any person who is legally resident in Romania can benefit from the national health insurance system from the date of starting the contribution payment to the fund.

Examples of medical services insured are as follows:

• costs for emergency medical and surgical services;
• day and continuous hospitalisation services;
• in-home medical care;
• medicines with or without a personal contribution for outpatient treatment;
• medical devices.

Romania offers benefits of a universal healthcare system and persons who do not have medical insurance may receive healthcare if, for example, they urgently need an operation.

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

N/A