The Antitrust has resolved to do not resort to Tar for possible breaches by the Italian Medicines Agency, regarding the modification of the reimbursement regime to the Regions for the return of discounts on new products against hepatitis C. But the president of the Authority John Pitruzzella, during a parliamentary hearing at the Social Affairs Commission of the Chamber, expressed the hope that "the government will take initiatives to ensure that Aifa does not enter into agreements with pharmaceutical companies relating to the presence of confidentiality clauses, or any other element that undermines full transparency , and so that all the data held by AIFA relating to the decisions taken for the marketing authorization of drugs by the AIFA Price and Reimbursement Committee and the Scientific Technical Committee are published”.
Pitruzzella was heard by the Commission on resolution no. 7-0075, of which it is earlier the deputy of the 5 Star Movement Silvia Giordana signed. The president of the Agcm first of all specified that, with respect to the possible anti-competitive effects attributed to the AIFA resolution by a report received from a group of parliamentarians, the agreement established by the Agency with the Gilead company for the purchase of the medicinal specialties Sovaldi and Harvoni envisaged a price/volume discount mechanism, with the return by the company (so-called pay-back) of sums to the Regions as reimbursement of payments on purchases already made. Subsequently, Aifa established that these repayments no longer take place with direct monetary payments, but through the issue of "credit notes" to the regional administrations on future purchases.
Therefore, as Pitruzzella explained in the hearing, "the Authority promptly launched an in-depth discussion with Aifa to understand the reasons for the modification of the reimbursement regime", acknowledging that it was due to "a large amount of outstanding payments by local health facilities. Hence, the request to "however eliminate any possible competitive doubt by means of an opinion pursuant to article 21 bis addressed to Aifa".
The basic problem, according to the Antitrust, is that "the absence of harmonization of the matter at EU level, due to the maintenance of the relative competences in the hands of the Member States, has meant that the question of drug prices has been left to the management at the national level”. Pharmaceutical companies, on the other hand, define discounts and pricing policies on a global level, "with a sort of operational asymmetry that makes it very difficult to reach satisfactory solutions for all the parties involved". Added to all this is the risk that "where prices considered too low by companies are pursued, these could also decide - by virtue of the principle of free enterprise - not to supply an entire state with their products". In the Authority's opinion, such a context "seems to effectively require a strengthening of healthcare-pharmaceutical governance in terms of price negotiation".
"An assessment of the appropriateness of such confidentiality agreements - continued Pitruzzella - must therefore be carried out taking into account a balance between effects for the exclusive benefit of the company and effects for the benefit of the national health system and requires a case-by-case analysis”. The chairman of the Antitrust therefore concluded his speech before the Social Affairs Commission by emphasizing that "from a pro-competitive perspective it is undisputed that a balanced comparison between supply and demand brings benefits of general welfare: in those cases in which it is possible that purchases of pharmaceutical products take place through public procurement procedures, there will be guarantees of price transparency and information asymmetries will be avoided".
