Italy’s drug pricing reform in trouble as Prime Minister Conte resigns
On 1st August 2019, Italy’s State-Regions Conference approved a decree to reform the pharmaceutical pricing system of the country. A press release issued by the Ministry of Health states that the ‘Price Decree’ changes the procedures for the negotiation of the price of drugs by Italian Medicines Agency (AIFA). Its adoption is in response to the need to introduce updated and adequate criteria for the development of drug policy and in compliance with the necessary transparency.
Among the novelties, the Decree puts emphasis on the added therapeutic value that the medicine must ensure in relation to the main comparative treatments. Furthermore, the company is requested to provide reassurance on its productive capacity and to manage possible unforeseen events, as well as to anticipate the activities it intends to carry out in order to guarantee the adequate supply of the drug.
The Decree does not precisely state that its intention is to lower drug prices, but the proposed reforms and recent pronouncements by the Minister of Health and the Director General of AIFA suggest that cutting costs is likely to be a key objective. The new pricing procedure will apply primarily to drugs in class A (medicines reimbursed by the National Health Service) but will also affect drugs in class C (medicines that are not reimbursed).
Despite the fact that State-Regions Conference had approved a price decree, things don’t seem to be going well for the Italian pharmaceutical pricing system. On 13th August 2019, Deputy Prime Minister and leader of the Northern League, Salvini announced a motion of no confidence against Prime Minister Conte, after growing tensions within the majority. Many political analysts believe the no confidence motion was an attempt to force early elections to improve League’s standing in Parliament, ensuring Salvini could become the next Prime Minister. On 20th August, following the parliamentary debate, the Prime Minister resigned his post to President Mattarella.
The government has yet to indicate a timetable for publication of the decree in the Official Gazette and implementation of the reforms. If the decree is published in Official Gazette, it will have to be approved by the Parliament within 60 days if it is to remain in force. That would be impossible if an election is called and might be difficult to achieve in time if a new administration is formed. The industry will, therefore, wonder what happens in Italy to assess the potential impact of these changes not just in Italy but also in other countries.
– Dr. Saurabh Patil, Associate Business Analyst
- Italy’s new drug reimbursement rules, other pharma policies at risk as government coalition falls apart; Robert Galbraith, APM Health Europe, 19/08/2019.
- Italy drafts tough new reimbursement rules including pricing information from other markets, proof of added value; Robert Galbraith, APM Health Europe, 02/08/2019. https://www.apmhealtheurope.com/freestory/0/64981/italy-drafts-tough-new-reimbursement-rules-including-pricing-information-from-other-markets–proof-of-added-value
- Drug pricing reform in Italy—significant implications at home and abroad; Neil Grubert, Linkedin, 15/08/2019. https://www.linkedin.com/pulse/drug-pricing-reform-italysignificant-implications-home-neil-grubert?trk=related_artice_Drug%20pricing%20reform%20in%20Italy—significant%20implications%20at%20home%20and%20abroad_article-card_title
- Health, 400 million euros for waiting list reduction, new rules in the emergency room and new criteria for reimbursement of drugs. Giulia Grillo: “Today we take important measures home to improve the system; Press release n. 105, Ministry of Health, Italy, 01/08/2019. http://www.salute.gov.it/portale/news/p3_2_4_1_1.jsp?lingua=italiano&menu=salastampa&p=comunicatistampa&id=5248