The H1N1 Pandemic Flu. Some Critical Remarks from a Legal Point of View

Aim: This paper analyses the global and European responses to the break out of the H1N1 virus in 2009 and highlights the major deficiencies of the European authorization procedure of vaccines against H1N1 pandemic flu.
Study Design: The study analyses the institutional reactions to the spread of the H1N1 pandemic flu (commonly called swine flu). The study reports the fundamental steps undertaken by global and European Institutions since 2009 to face the spreading of the H1N1 flu.
Methodology: The study applies a legal methodology proceeding from formal rules towards the substantial effects taking place in the specific health protection field considered.
Results: The analysis of the European authorization procedure of vaccines against H1N1 pandemic flu shows the lack of coordination between Member States and the European Union, as well as coordination between the European Medicines Agency (EMA) and the European Office of the World Health Organization (WHO); moreover, a fundamental violation of the precautionary principle emerged. In the European context, in fact, the principle does not coincide with the temporary nature of the measures, but reflects the fundamental distinction between assessment and risk management.
Conclusions: The supranational mediation of the European Union has offered in many cases the guarantee of health protection within contexts in which the multiplicity of involved interests increases the level of conflict. That mediation has definitely failed in the case of swine flu because of the lack of supranational constituency representation within the European Medicines Agency that allows the intergovernmental component and
the underlying unilateral protection of economic interests to resurface.
In the case of swine flu, the trust relationships between global and European bodies have been affected by the lack of transparency of the responsible organizations (WHO and EMA) and the lack of pluralistic openness to different interests in the decision-making procedures.