On Friday, 24 July 2020, Italy officially published the long-anticipated Pricing and Reimbursement Decree in the Gazzetta Ufficiale della Repubblica Italiana setting in motion Italy’s place as the first country to implement the WHO transparency resolution (WHA72.8).
In statement before the WHO EURO regional committee in September 2019, Italy described the key features of the Pricing and Reimbursement Decree including mandatory requirements on the disclosure of public contributions to R&D, patent transparency, and the provision of annual reports regarding sales data, revenues and marketing expenses.
The Decree includes some important aspects related to transparency. In particular, the pharmaceutical companies seeking reimbursement from the National Health System, are requested to provide information on marketing, sales and reimbursement in other countries, including negotiated prices. Moreover, information should be provided with regard to public contributions and incentives received on research and development (R&D) programs, as well as clear and up to date information on the patent status of the concerned medicinal product. Finally, the pharmaceutical companies, as part of the final agreement for medicines reimbursed by the National Health System, will be obliged to provide annual reports regarding sales data, revenues and marketing expenses.
Dr. Luca Li Bassi, former Director-General of AIFA (the Italian Medicines Agency) was the architect of this historic decree. He provided KEI the following perspectives noting that transparency can serve as an effective tool to promote solidarity and collective action in the COVID-19 response.
“The need for more transparency in the pharmaceutical markets was already felt as a priority by all delegations at WHA72 but has become even greater during the pandemic. It’s only through sharing information and data that we will collectively learn how to best fight this virus and find effective therapies and vaccines to reverse its course and save lives. The cooperation and solidarity advocated now by many global health institutions can only occur through the transparent sharing of knowledge and information for the benefit of humanity.
This is an important reform for Italy as the old rules dated back almost 20 years. This Decree will now put AIFA in a much stronger position to negotiate reimbursement levels based on more solid analysis and evaluations. I am also confident that other countries will take it as an example to implement similar steps, or possibly more, towards the full implementation of the WHA Resolution.”
The publication of the Pricing and Reimbursement Decree in the Gazzetta Ufficiale della Repubblica Italiana will give immediate effect to the decree.