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.