Italy Publishes National Regulation Requiring Pharma Disclosure Of Public Support For R&D On New Drugs
Head of the Italian Medicines Agency Luca Li Bassi at 72nd World Health Assembly, where he led approval of a historic resolution on price transparency in medicines markets.

Italy has become the first nation to require pharmaceutical companies to disclose secret data about any public subsidies it may have received for the development of a new drug, during negotiations over drug pricing and reimbursement with national regulatory authorities, according to a decree published Friday in the nation’s official gazette.

The decree, following on from last year’s milestone World Health Assembly resolution on transparency of markets for health products, represents a “very important” step towards enabling government authorities to negotiate more effectively with the private sector over new drug prices, Luca Li Bassi, former Director-General of the Italian Medicines Agency (AIFA), told Health Policy Watch.

“The Decree is a very good step forward that addresses the asymmetry of information at the negotiating table with the private sector”, said Li Bassi, who was also the leading architect, on behalf of the Italian Government, of the WHA transparency resolution from 2019. “Having information is vital when you’re negotiating, otherwise you’re negotiating blindly.”

Luca Li Bassi holds his transparency award

The decree was actually approved by Italy’s Ministers of Health and Finance in August 2019.  But after a government reshuffle in the fall, it languished in limbo due to a technicality – as it had not been published in the official Italian government gazette.  Last Friday, it finally surfaced, observers say at an opportune moment as Italy’s badly hit health system recovers from the first wave of the pandemic. COVID-19 has also churned up further debate over issues of drug access, pricing and transparency  – as pharma companies and countries scramble to research and acquire technologies that could better treat the viral disease.

“For a COVID-19 pandemic response to be effective and legitimate, it is critical to ensure that transparency is upheld, particularly when it comes to clinical trials, pricing and supply schemes,” said Jaume Vidal, Senior Policy Advisor of Health Action International, to Health Policy Watch. “The decree clearly shows that the need for greater transparency on medicine prices and R&D costs is still in the agenda more than a year after the historic Italy-led WHA resolution was approved.”

According to Li Bassi, the decree will strengthen AIFA’s negotiating position with pharmaceutical companies as they seek reimbursement for their innovations. It will provide public health authorities not only with data about contributions public sources may have made to the R&D of a new drug, but also about sales revenue, marketing costs and the status of relevant patents. The new regulations also require pharmaceutical companies to submit information to AIFA about reimbursement prices in other countries. That would provide Italian government authorities with a means to compare reimbursements, and thus prices, for the same health products across countries. 

“Most importantly, this decree enables AIFA to make a far better informed analysis of the reimbursements demands made by suppliers, resulting in a significantly transformed negotiation process across the table”.

The decree is also a “very important step” that could encourage other countries to follow in the same direction, and for more collaboration to spearhead the transparency agenda in the future, said Li Bassi: 

“Anything that can be done to enhance transparency in the biopharmaceutical sector is definitely going to be useful.”

Image Credits: Twitter/@Italy_UNGeneva, l'Observatoire Médicaments Transparences.