Title: Vaccines in the Italian healthcare system: Regulation and measures to support and prevent

Maria Carmen Agnello

University of Bologna, Italy


I am a lawyer and I deal with health law, especially in land assistance, hospitals in relation to the rights of citizens to the appropriateness of the provision of health services. In this regard, I attended a Master in Public Policies and Health Management where I did an internship in risk management with the thesis on the evolutionary lines of the health organization. In the professional field, I have experience in health-related purchases of the epidemiological needs of the population. I studied these issues in the legal activity and through the development of scientific publications at national and international level.


Vaccines are considered a priority in ensuring epidemiological safety through the extension of vaccination coverage and the provision of preventive and support measures. In particular, the awareness of the need for vaccinations and the responsibility of the institutions, including the regional one, has increased in the national health system to ensure a broader and more effective coverage. In this context it was necessary to introduce measures to maintain the balance in the risk / benefit ratio. At the planning level, the national health system has foreseen the achievement of the priority objectives of national vaccination prevention 2017/2019, as a consequence of the Regional commitments and respect of the obligations assumed at European and international level. The National Vaccine Plan has provided targeted actions for communication, information, planning and implementation of vaccination. L. 2017, n. 119 has expanded vaccinations based on scientific evidence and initiatives to increase awareness of benefits. In implementing this certification obligations are foreseen which have led to numerous bureaucratic difficulties and regional diversifications. The Italian legislator has provided for sanctions whose application required further action to guarantee the dissuasive purpose.
   Health policies are aimed at overcoming the current critical issues in managing the extensive vaccination obligation, through a reduction and flexibility in the obligation of the same. The obligation is applicable when necessary as for measles unlike other diseases such as for the hexavalent that could return to the pre-Lorenzin regime. The flexibility of vaccination refers to the possible diversification at different times or parts of the country, according to epidemic needs, as in France and Spain ". In overcoming the bureaucratic knots, the measures are to guarantee the right to school as the health of immunosuppressed children through the establishment of a specific registry and the recognition of operating margins for families and institutions.