On the contract stipulated by the Ministry of Health with Novartis Vaccines and Diagnostics for the supply of the Focetria* pandemic vaccine to Italy, "we are willing to discuss any proposal with the Government", provided it is "constructive and plausible". This is how Rino Rappuoli, global head of vaccine research at the Swiss pharmaceutical multinational Novartis, replies to journalists on the possible scope for renegotiating the agreement worth over 180 million euros. Most of the doses of anti-influenza A vaccine so far delivered by the company to Italy (about 10 million out of the total of 24 million covered by the contract) have remained unused. Hence the government's hope of finding a way to avoid further product surpluses. Rappuoli then replies to the controversy over the conditions of the contract signed between Novartis Vaccines and Diagnostics and the Italian Ministry of Health, an agreement that has been judged by many to be too unbalanced in favor of the pharmaceutical giant. "Novartis has entered into supply contracts with about fifty countries around the world, producing 100 million doses globally, half of which in the Siena plants and the other half between the British and German sites", highlights the manager Research vaccines from the Basel group. And "the conditions of the contract were the same everywhere", he assures. Including the clause that relieves Novartis from liability for any damage caused by the vaccine and not related to manufacturing defects. "It is – Rappuoli points out – an absolutely normal clause when the contract concerns a vaccine that has not yet been produced or registered" with the regulatory authorities, as happens in the case of an emergency vaccine against an exceptional event such as an influenza pandemic. In this scenario, "if a government wants to push for a company makes the product available as quickly as possible, accepts these "special" conditions.
Pharmacist33 – 27 January 2010 – Year 6, Number 13
