Italy: Pharma May Have To Disclose Confidential Info Under New Pricing Rules
Executive Summary
Drug companies have their last chance to negotiate which documents and information Italy’s regulator, AIFA, will be entitled to request of them when they submit pricing and reimbursement applications.
Draft guidelines that once finalized will implement new rules on pricing and reimbursement negotiations in Italy reveal that drug companies may have to disclose confidential information relating to the prices of their products in other EU member states.
The guidelines, which are out for public consultation until 30 September, say that companies must inform the regulatory body, AIFA, of the price or discount obtained in another member state.
Where such information is subject to confidentiality agreements, the company must indicate the relevant counterparty and the date and duration of the agreement, according to law firm Baker McKenzie.
“In this respect, it will be interesting to see how pharma companies will react to said requirement during the consultations with the AIFA,” the law firm said.
The draft guidelines were launched for consultation on 16 September. They will implement “the long-awaited Decree of 2 August 2019… on price and reimbursement negotiation… that updates the previous system introduced almost 20 years ago by Decree no. 3/2001,” noted the law firm Herbert Smith Freehills.
The guidelines explain what information and documentation companies will have to submit to support their pricing and reimbursement applications to AIFA, which is Italy’s medicines agency and pricing and reimbursement body.
Revenues & Marketing Expenses
There is other highly confidential information that a company will have to disclose, according to the draft guidelines. This includes specific annual reports regarding sales data, revenues and marketing expenses, said Herbert Smith Freehills.
“Moreover, with respect to public R&D subsidy, the MA [marketing authorization] holder must specify the total amount received, if there are any IP rights arising from said R&D activity (even if not related to the product at issue) and if so, the patent details such as the number [of the] patent and the identity of the patent owner,” the law firm said.
In addition, “the MA holder must provide information on any pending patent rights protecting the product,” it noted. “In this case, the information to be disclosed under the consultation draft of the guidelines is of an even more sensitive nature: for each ‘patent right that is relevant for the market exclusivity of the medicinal product at issue,’ the MA holder must disclose, in addition to general information such as expiry date, also information potentially confidential, such as any patent licence or any action pending or settled regarding this right.”
“The importance of the current public consultation opened up by AIFA is therefore clear,” Herbert Smith Freehills declared.
“If these draft guidelines are implemented, in conducting its assessment and ultimately in setting the price and reimbursement, AIFA will rely heavily on the extensive and often confidential or commercially sensitive information that will need to be submitted by the MA holder in the dossier,” the law firm said.
“This is the last occasion for companies and stakeholders to negotiate the documents and information that AIFA would be entitled to request and, ultimately, to safeguard the companies’ confidential and commercially sensitive information.”
The Decree
The August 2019 decree that will change Italy’s pricing and reimbursement system was published in the Official Gazette in July 2020.
The overarching goal of the decree is to reduce expenditure and cut the cost of medicines.
Among other things, it formally shifts the pricing and reimbursement system to one where companies must demonstrate that their new product offers added therapeutic value over existing therapies.
It also forces a greater degree of transparency on companies and obliges them to reveal the public subsidies they have received for developing products that are under review for reimbursement by the national health system.