Compensation regimes in light of COVID-19 vaccines in Romania

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

On 3 December 2020, Romania announced an official Strategy for vaccination against COVID-19 (the “COVID-19 Vaccination Strategy”).

According to this Strategy, vaccination against COVID-19 is not compulsory.

It also set out three phases for COVID-19 vaccination in Romania:

  • Phase 1 – vaccination of healthcare professionals from both the public and private sector;
  • Phase 2 – vaccination of (i) people at risk (i.e. people above the age of 65 and people with chronic diseases) and (ii) people working in key, essential areas (e.g. Parliament, Government, law enforcement agencies); and
  • Phase 3 – vaccination of the general population. 

On a more general note (not linked to COIVID-19 vaccination), at the time of writing, a draft law is pending debate in the Romanian Parliament that would include an obligation for parents to vaccinate their children (up to 18 years old) with vaccines included in 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)?

According to the COVID-19 Vaccination Strategy, COVID-19 vaccination will be voluntary and free of charge. This is in line with previous statements made by the Romanian Prime-Minister and the Romanian Health Minister.

On a more general note, 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 (recommended) vaccinations can be given, at the patient’s request, for a fee.

There is no specific regulation on vaccine compensation regarding adverse effects of a vaccine in force in Romania.

The COVID-19 Vaccination Strategy provides, as one of the key aspects for its implementation, for the creation of a legal framework for the analysis and compensation of any possible long-term effects related to COVID-19 vaccination if there is a causal relationship between vaccination and those effects. As no further guidance in this respect has been provided so far, the general rules will apply. 

To this end, the marketing authorisation holder and the manufacturer are liable for the products that they put on the Romanian market. 

Law no. 240/2004 regarding the producers’ liability for damages caused by a defective product (the “Product Liability Law”) will apply where claims are made for compensation for damages caused by a defective vaccine. Directive No. 85/374/CEE regarding product liability (as amended through Directive No. 1999/34/CE) was implemented into national legislation through the Product Liability Law. The application of the provisions of the Product Liability Law do not exclude the injured person’s right to claim damages pursuant to the common rules of Romanian Civil Law.

However, it is worth mentioning that, according to the COVID-19 Vaccination Strategy, surveillance and reporting of adverse effects after vaccination will be performed in the short term, more precisely within the first 30 days after each dose is administered, and in the long term, pursuant to the recommendations of the European Medicines Agency and of the manufacturer/manufacturers.

An individual electronic reporting system for possible post-vaccination adverse effects will be developed with reporting to be made by individuals using the number on their vaccination certificate. Also, it will be mandatory for doctors to report  any adverse effects from the vaccine that they observe, in accordance with local regulations and on the recommendation of the European Medicines Agency.

Failure to comply with the aforementioned reporting procedure and recommendations may result in limitation to the liability of the manufacturer/manufacturers.

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 there is no specific regulation for vaccine compensation 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 damage that can be claimed includes:

  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)?

Note: There is no compulsory vaccination in Romania as of the date of this advice.

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 which a person is entitled to expect, taking all circumstances into consideration, including:

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

The manufacturer (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 afterwards; 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 the Romanian Civil Law (liability in tort) 

In claims under the common liability provisions of Romanian Civil Law (tort liability), the claimant must prove that the damage was caused directly by the damaging 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 particular 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)?

Note: There is no compulsory vaccination in Romania as of the date of this advice.

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 his/her name, trademark or other distinguishing feature on the product, presents him/herself 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 European Union 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 the Case C-621/15, N.W. v. Sanofi Pasteur MSD SNC (June 21, 2017) affirms the individual’s right to sue vaccine manufacturers.

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 them (theoretically, this includes the state). However, as indicated by the World Health Organisation, tort law requires a claimant to prove that he or she 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 World Health Organization 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 assessment 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
Portrait of Cosmin Cretu
Cosmin Cretu
Associate
Bucharest