AGCM

PRESS RELEASE

PRESIDENT PITRUZZELLA’S PARLIAMENTARY HEARING: “FULL TRANSPARENCY ON HEPATITIS C DRUG PRICES”

The ICA decided not to resort to the TAR (Regional Administrative Court) for possible non-fulfilments of AIFA (Agenzia Italiana del Farmaco - Italian Drug Agency), with reference to its modification of the refund regime to Regions for the restitution of discounts on new products against hepatitis C. However, the ICA’s president Giovanni Pitruzzella, during a parliamentary hearing before the Commissione Affari Sociali della Camera (the Chamber’s Social Affairs Committee), encouraged the government “to take initiatives aimed at forbidding AIFA to sign non-disclosure agreements with pharmaceutical companies, or any other element capable of undermining full transparency, and at obliging it to publish the data in its possession concerning decisions made by AIFA’s Prices and Refunds Committee and Technical-Scientific Committee as regards the authorization to place drugs on the market”.

Pitruzzella’s Parliamentary hearing concerned resolution n. 7-0075, leading signer Silvia Giordana, deputy of Movimento 5 Stelle. On the basis of a report submitted by a group of members of the Parliament, the ICA’s president specified that the agreement established between AIFA and the company Gilead for the purchase of drugs Sovaldi and Harvoni providing for a mechanism of price/volume discounts can have anti-competitive effects. According to the agreement, the company was to pay back amounts to the Regions as a refund of payments for purchases already carried out. Subsequently, AIFA decided that these refunds were no longer to be carried out through direct monetary payments, but through “credit notes” issued to regional administrations with reference to future purchases.

Therefore, as explained by Pitruzzella during the hearing, “the ICA promptly launched an in-depth investigation against AIFA aimed at understanding the reasons leading to the change of the refund regime,” finding that it was due to “a large amount of payments still unfulfilled by the local health structures.” Hence, the request “to eliminate all possible competitive doubts by means of an opinion pursuant to article 21 bis addressed to AIFA”.

The basic problem, according to the ICA, lies in “the absence of harmonization of the matter at EU level, since all relevant competences have been maintained under the Member States’ responsibility, causing the drug prices issue to be managed at national level”. Whereas, pharmaceutical companies define discounts and price policies at global level, “which causes a sort of operational asymmetry making it very difficult to reach satisfactory solutions for all the parties involved”. Moreover, the risk is that “when applying prices considered too low by the mentioned companies, the latter can even decide – on the basis of the principle of free enterprise – not to provide their products to an entire State”. According to the ICA’s opinion, such a context “requires a strengthening of the sanitary-pharmaceutical governance in terms of price negotiation”.

“The assessment of the appropriateness of the mentioned non-disclosure agreements – Pitruzzella continued – must be carried out keeping into account a balance between the effects to the exclusive advantage of the company and the effects to the advantage of the national health system, requiring an analysis case by case.” The ICA’s president concluded highlighting that “in a pro-competitive perspective it is obvious that a balance between demand and supply entails general welfare benefits. In the cases in which it is possible for pharmaceutical products to be purchased through public procedures, this will guarantee price transparency, thus avoiding informative asymmetries”.

Rome, 2 March 2016