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Gov't passes public vaccination bill


The Government on Wednesday passed a bill concerning the organisation and funding of public vaccination in Romania.

The Government says in a press statement that it funds and conducts vaccination campaigns in Romania, while also providing effective and safe vaccines, duly authorised according to the law.

At the same time, the bill establishes the obligation to vaccinate children with the vaccines provided for in the National Vaccination Schedule, as well as those administered in special epidemiological situations to the whole population or groups of the population.

The categories of mandatory immunisations are: vaccinations included in the National Vaccination Schedule for Children; vaccinations imposed by epidemiological situations involving vaccination as an intervention measure in order to contain vaccine-preventable diseases; vaccinations for the medical and sanitary staff in public and private healthcare facilities; vaccinations for other staff in public and private establishments that by nature of their jobs are exposed to additional infectious diseases or may be sources of infection that could endanger public health, as established by government decision.

"The responsibility for bringing the children up for vaccination rests with the parents, the legal representative or the person responsible for raising and caring for a child under special protection measures, as the case may be," the statement says.

According to the Executive, in the case of mandatory vaccination, consent to vaccination is presumed to be given, and the refusal to vaccinate the child is recorded in writing.

"At the time of joining a collective social setting, the receiving institution should be under an obligation to request production of a certificate issued by the family doctor who has the health records of the joining person certifying whether or not the vaccinations have been performed. The mandatory vaccine antigens for children upon joining a collective social setting are against diphtheria, tetanus, pertussis, measles, rubella, mumps, and hepatitis B."

According to the Government, the Ministry of Health, the National Healthcare Insurance House (CNAS) and the ministries and institutions with an own sanitary network, finance and conducts the vaccination activity in Romania.

The bill also provides for the establishment and operation of a Technical Coordination Group for Vaccination Activities (GTCAV), a consultative committee of the Ministry of Health, with a role in developing the National Vaccination Strategy and coordinating the vaccination activity at national level. Vaccination boards will be set up at the county public health directorates and the Bucharest City healthcare directorate.

The bill also creates the legal framework required for effective official intervention in special epidemiological situations by regulating fixed and mobile vaccination centers and by setting up special intervention teams.

At the same time, the bill establishes the creation of a reserve stock of vaccines and consumables, at least equal to the annual demand, with a minimum validity of 18 months. The stock will be used in special epidemiological situations or in the event of supply disruptions at vaccine manufacturers.

"The Ministry of Health will undertake to secure the circumstances for best diagnosis and treatment of any adverse reactions to vaccines, as well as compensation for any long-lasting effects, if causal relationships are proven."

Implementation regulations are to be approved within 12 months of the date of the bill being published with the Official Journal.

The bill will be submitted to Parliament for debate and adoption. It would come into force on January 1, 2018.