Vaccine compensation regimes in Romania

  1. Are COVID-19 vaccinations obligatory in your jurisdiction? Are you expecting any legislative changes to enable mandatory vaccines for all or certain people (e.g. healthcare professionals, public servants, school children, the elderly, frequent travellers)?
  2. How would any COVID-19 vaccine be paid for in your jurisdiction (is it reimbursed from the public health system)?
  3. What legal regime(s) and regulations govern vaccine compensation in your jurisdiction? Is there specific legislation enacted or anticipated in relation to a COVID-19 vaccine or will it be covered under existing legislation?
  4. Who is covered/eligible for compensation (please cover compulsory and non-compulsory vaccination)?
  5. What damages are compensated, e.g. death, injury, disability, pain, mental suffering of a close person, economic damage (please cover compulsory and non-compulsory vaccination)?
  6. What are the necessary conditions for a person to make a claim for compensation, including burden of proof (please cover compulsory and non-compulsory vaccination)?
  7.  Who would be liable to pay the compensation, e.g. the state, the manufacturer of the vaccine (please cover compulsory and non-compulsory vaccination)?
  8. Is there a de minimis threshold or a cap on compensation?
  9.  Is compensation based on tariffs or individual assessment?
  10.  Can a claimant obtain additional compensation beyond payment made by the compensation system?
  11.  Are you aware of any future legal developments in your jurisdiction with regard to compensation of COVID-19 vaccines?

1. Are COVID-19 vaccinations obligatory in your jurisdiction? Are you expecting any legislative changes to enable mandatory vaccines for all or certain people (e.g. healthcare professionals, public servants, school children, the elderly, frequent travellers)?

No specific legislation is in force regarding COVID-19 vaccinations. Furthermore, the Romanian Health Minister has already explicitly stated that, once available, COVID-19 vaccinations will not be compulsory.

On a more general note, at the time of this writing, Romanian legislation does not provide for any compulsory vaccinations although a draft law is pending in the Romanian parliament that includes an obligation for parents to vaccinate children up to 18 years with the vaccines listed on the Mandatory vaccination scheme

2. How would any COVID-19 vaccine be paid for in your jurisdiction (is it reimbursed from the public health system)?

There is no regulation (currently in force or anticipated) for the reimbursement of the costs of COVID-19 vaccines in Romania. From public announcements made by the Romanian Prime Minister, we know that, once available, COVID-19 vaccinations will be free of charge for citizens classed as vulnerable and they will also receive the first available batches of COVID-19 vaccines.

On a more general note, the vaccines listed on the Mandatory vaccination scheme are free for citizens with health insurance (and they are 100% reimbursed from the public health system), while optional (but recommended) vaccinations can be given at the patient’s request for a fee. 

Furthermore, for the 2020–2021 flu season, while the flu vaccination is optional (but recommended), the Ministry of Health announced in September 2020 that it was starting a free-of-charge annual flu vaccination campaign for people over 65 years, people with chronic illnesses (especially those with respiratory and cardiovascular diseases), healthcare professionals and pregnant women. Individuals in these groups will be prioritised for vaccinations.

There is no specific regulation on compensation for the adverse effects of vaccinations in force in Romania. 
As a rule, the marketing authorisation holder and the manufacturer are liable for the products they place on the Romanian market. 

Law No. 240/2004 on a producer's liability for damages caused by a defective product (Product Liability Law) will apply where claims are made for compensation for damages caused by a defective vaccine. This law was implemented through Directive No. 85/374/CEE on product liability and was amended through Directive No. 1999/34/CE.

However, the application of the provisions of the Product Liability Law does not exclude the injured person’s right to claim damages pursuant to the common rules of Romanian Civil Law. 

Currently, no public consultations are underway on any specific COVID-19 vaccine legislation.

4. Who is covered/eligible for compensation (please cover compulsory and non-compulsory vaccination)?

A person who suffers economic or moral damages can claim compensation, but no specific regulation for vaccine compensation is in force.

5. What damages are compensated, e.g. death, injury, disability, pain, mental suffering of a close person, economic damage (please cover compulsory and non-compulsory vaccination)?

According to the Product Liability Law, the damages that can be claimed include:

  1. damages caused by the death or personal injury of an individual; or
  2. 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; or
  3. 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. 

Apart from the specific provisions of the Product Liability Law, the common liability provisions of Romanian Civil Law also apply in cases of physical and moral damage to individuals and economic damage to individuals and legal entities.

6. What are the necessary conditions for a person to make a claim for compensation, including burden of proof (please cover compulsory and non-compulsory vaccination)?

There are no compulsory vaccinations in Romania as of the writing of this advisory.

Claims under the Product Liability Law

The party claiming compensation must prove the damage caused, the defect in the vaccine and the causal relationship between the two. 

A product is defective if it does not provide the safety a person is entitled to expect, taking all circumstances into consideration, including:

  1. the manner in which the product is presented;
  2. all the uses that it could reasonably be expected to have; and
  3. the time when the product was put into circulation.

The manufacturer (i.e. producer) is not liable for damages caused by a defective product if:

  1. the manufacturer did not put the product into circulation; or
  2. having considered all circumstances, it is probable that the defect, which caused the damage did not exist when the product was put into circulation or that this defect only became apparent after; or
  3. the producer neither manufactured the product for sale or any form of distribution for economic purpose, nor manufactured or distributed the product as part of its business; or
  4. the defect is due to the compliance of the product with the mandatory requirements issued by the public authorities; or
  5. the scientific and technical knowledge when the product was put into circulation was not such that the existence of the defect could be known; or
  6. the defect is due to the consumer’s non-compliance with the instructions for use provided in the technical documents accompanying the product, demonstrated on the basis of a specialised technical expert report.

Claims under the common liability provisions of Romanian Civil Law 

In claims under the common liability provisions of Romanian Civil Law (i.e. tort liability), the claimant must prove that the damage was caused directly by the person via the vaccine, contrary to the general legal obligation not to cause damage to third parties and possibly contrary to other legal obligations (if other provisions are also breached).

7. Who would be liable to pay the compensation, e.g. the state, the manufacturer of the vaccine (please cover compulsory and non-compulsory vaccination)?

There are no compulsory vaccinations in Romania as of the writing of this advisory.

Claims under the Product Liability Law can only involve the liability of producers.   

According to the Product Liability Law, the producer means:

  1. the manufacturer of a finished product, the manufacturer of any raw material, and the manufacturer of a component part; or
  2. any person who, by putting a name, trademark or other distinguishing feature on the product, presents himself as its producer; or
  3. any person who imports into Romania a product for sale, leasing, purchase or any form of distribution in their business, who will additionally be deemed to be its producer and have the responsibility of a producer; or
  4. any person who imports a product from the EU for sale, leasing, purchase or any form of distribution in their business, who will additionally be deemed to be its producer and have the responsibility of a producer; or
  5. where the producer of the product cannot be identified, each supplier of the product will be treated as its producer unless he or she informs the injured person, within a reasonable time, of the identity of the producer or of the person who supplied them with the product. The same will apply, in instances where a product is imported, if this product does not indicate the identity of the importer referred to in points (iii) and (iv), even if the name of the producer is indicated.

In addition, the ECJ decision in Case C-621/15, N.W. v. Sanofi Pasteur MSD SNC (June 21, 2017) affirms the individual’s right to sue vaccine manufacturers (see here).

Finally, under the common liability provisions of Romanian Civil Law, the liability of any person considered liable for damages can have a case brought against him (theoretically, this includes the state). However, as indicated by the WHO, tort law requires that a claimant prove he suffered a wrong due to another person’s negligence or deliberate harm. The problem with this process, in the case of a vaccination, is that often there is no obviously negligent party. A court-based approach to compensation can be unfair and unpredictable, resulting in high monetary awards in some cases, while those who do not seek legal recourse receive nothing (see Bulletin of the WHO Volume 89: 2011).

8. Is there a de minimis threshold or a cap on compensation?

In the absence of specific rules on vaccine compensation, no thresholds for compensation are provided.

9. Is compensation based on tariffs or individual assessment?

Compensation is determined based on individual assessments according to the evidence provided. In cases of moral damages, the court will determine fair compensation.

10. Can a claimant obtain additional compensation beyond payment made by the compensation system?

No compensation system for vaccine damages is currently in place.

Currently there is no publicly available information on future legislative initiatives.

Portrait of Horea Popescu
Horea Popescu
Managing Partner
Bucharest
Portrait of Valentina Parvu
Valentina Parvu
Senior Associate
Bucharest