AGCM

In the Authority's view, regulation throughout the pharmaceutical supply chain must motivate companies to carry out adequate research and development, offer an incentive for parallel imports of lower-cost pharmaceuticals and at the same time promote competition amongst pharmaceuticals that are not covered by patents so as to encourage the entry of manufacturers of generic drugs.

Article 5 of the decree accompanying the 2008 budget, by modifying the mechanisms for reimbursement of pharmaceuticals by the National Health System, proposes instead, for the coming years, a market structure that in large measure conserves the present relative positions of suppliers. That risks causing, if not a total “freeze”, at least a slowing down of the market dynamic amongst competitors.

In the Authority's view, it is necessary to adopt criteria that create an incentive and reward for companies that invest in research and development: the percentage of incremental resources the decree sets aside for reimbursing the expenditure of the most innovative companies is too small for this purpose. It would therefore be advisable to increase it, reducing instead the percentage of resources assigned to the generality of companies on the basis of ‘historical quotas’.

The decree law should also include mechanisms that, by modifying the present rules for prescribing medicines and attributing margins to pharmacies, promote price competition from generics companies and parallel importers whose positive effects for consumers and the National Health System are still extremely limited in Italy compared with most other European countries.

Rome, 29 October 2007