On 27 May 2015, the Italian Competition Authority (ICA) issued a decision launching a sector inquiry into the supply of vaccines for human use.

The ICA has stated that it has launched the sector inquiry because of:

  • the importance of vaccines in terms of health care costs borne by the Italian National Health Service (over €300 million per year);
  • the products at hand are procured through public tenders; and
  • the prices of some of the key vaccines seem to be increasing.

However, reading between the lines of its decision, the ICA appears to be focusing on potential excessive pricing, although it is expected that the inquiry will also look for possible collusive practices. Indeed, the ICA expresses initial views that:

  • each vaccine may constitute a separate and distinct market (and, consequently, a monopoly);
  • despite increased use of centralised tenders, Italian demand for vaccines for human use appears to remain fragmented with local health authorities running their own tenders;
  • potential genericisation does not impose a competitive constraint; and
  • the prices of most vaccines are increasing, and those prices do not appear to be linked to the quantity supplied.

At this stage, the ICA is adopting a novel approach to information gathering, using a “call for input” to companies active in this sector in Italy and other stakeholders. While this means that companies and other stakeholders are, at this stage, free to decide whether and to what extent they wish to submit information, the ICA can send out questionnaires to companies at any stage of the sector inquiry.

The “call for input” relates to:

  • the commercial dynamics related to vaccines for human use;
  • critical competitive issues in the markets for vaccines for human use, specifically considering the Italian situation in the light of the current regulatory environment (e.g. the National Vaccination Plan); and
  • efficiencies and critical issues relating to public tender procedures for the purchase of vaccines for human use.

The deadline to submit information is 10 July 2015.

Since sector inquiries usually lead to investigations, companies should carefully assess the appropriateness of participating in the “call for input”.