Italian Health Minister Moves To Replace Key Architect of WHA Resolution On Drug Price Transparency

In a move fraught with international political overtones, Italy’s new Minister of Health is moving to replace the Director General of the Italian Drug Agency (AIFA), Dr Luca Li Bassi, who was the key architect of the May World Health Assembly (WHA) resolution supporting greater price transparency in medicines markets, Health Policy Watch has learned.

The potential replacement of Li Bassi, a seasoned career public health professional, comes only a year after he was selected to fill the top civil service position at AIFA in an international, juried competition.

Luca Li Bassi holding Italy’s placard at the 72nd World Health Assembly with other lead co-sponsors of the WHA Transparency Resolution.

The move against Li Bassi has stirred protest among civil society drug access groups, which this week sent an open letter to the new Italian Health Minister, Dr Roberto Speranza asking him to reconsider the move.

The petition, signed by 21 organizations and about two dozen leading medicines access advocates, follows the publication last week on Italy’s Ministry of Health’s website of a call for applications for the position of director-general of AIFA (Agenzia Italiana del Farmaco).

The advertisement for a replacement for Li Bassi follows a September reshuffle in the Italian government whereby the left-wing Italian Article One party, in which Speranza is a leader, joined the Five Star party in the national government. As a reward, Article One received the health portfolio and Speranza was named as Health Minister. That portfolio had previously been held by Five Star Party member Giulia Grillo, who had taken over the job as Health Minister in 2018 under a Five Star party platform pledged to lower Italy’s soaring drug prices.

Grillo’s appointment of Li Bassi in October 2018, shortly after being appointed was a first step in that direction – and it set something of a precedent in Italy’s highly politicized government circles – due to the rigorous candidate selection process, overseen by an international panel of three public health experts. The process was even the focus of a Lancet opinion piece co-authored by Grillo, who admitted it was “quite unusual for Italy” but cited it as evidence that she and her government were committed to making policy choices anchored in “scientific-based methods”.

Luca Li Bassi in a recent interview on Italian national TV, Rai3

“We will apply the same methods, based on international reputation and meritocracy, that have worked well for AIFA and CSS for all future decisions concerning the leadership roles in the health system,” Grillo declared in the Lancet article published in August 2019.  Only a month later, following the government reshuffle, Grillo was out of a job.

In the intervening year that Li Bassi has held the post, he has rapidly made a name for Italy and himself in global health circles – initiating the unprecedented WHA proposal on the drug transparency resolution in February 2018, and then steering it to approval in the May WHA.  Li Bassi was widely credited for helping member states reach “common ground” in what  Angola’s Health Minister Silvia Paula Valentim Lutucuta described as “one of the most complex and polarising issues in 21st century global health.” Lutucuta chaired the WHA Committee A, which oversaw the WHA negotiations on the price transparency resolution.

But following September’s replacement of Grillo by Speranza in the government reshuffle, Li Bassi’s days now may be numbered, his supporters fear. Ironically, Speranza comes from an ardently left-wing party that would presumably be sympathetic to the price transparency agenda.  But that, informed observers remark, has apparently not made him immune to the time-worn traditions of patronage politics, including political appointments for key civil service posts.

Public notice for expressions of interest for the post of Director General of the Italian Drug Agency – AIFA
Protest By Civil Society Leaders Over Italian Move

In the civil society letter of protest to Speranza over Li Bassi’s possible replacement, the AIFA director was lauded for his role in “overcoming enormous opposition from vested interests” to see the May WHA resolution on “Improving the transparency of markets for medicines, vaccines, and other health products” approved.

“It is difficult to convey how great a challenge it was to get the WHA to consider, let alone approve a resolution dealing with transparency, given the longstanding drift towards greater secrecy and less transparency in every aspect of the development and pricing of medicines,” the signatories said.

“His expertise, commitment, compassion, diplomatic skills and tirelessness were critical to the adoption of the resolution,” the signatories noted. “It is very rare to see a senior government official do so much in such a short time to raise awareness across the global community of the need to change course on issues fundamental to – and perceived as contrary to –  the interests of the largest pharmaceutical companies in the world.

The groups also pointed to Li Bassi’s previous record with other UN agencies, non-profits and global health groups, such as the Global Fund to Fight AIDS, TB and Malaria, where he helped pioneer a transparent drug procurement system.

“Many of us worked with Dr Li Bassi during his earlier efforts to provide access to affordable drugs for the treatment of HIV in developing countries. His work in establishing the Global Price Reporting Mechanism (GPRM) at The Global Fund has been recognised as an example of the value and feasibility of implementing transparency policies in the pharmaceutical sector,” the letter stated.

Under Li Bassi, AIFA had been expected to help lead a group of technical experts from the so-called Valletta Group of countries to take forward some of the key outcomes of the WHA drug transparency resolution into a dialogue with the European Commission’s Employment, Social Policy, Health and Consumer Affairs Council. The aim was to develop framework legislation for European countries to voluntarily band together share price data and bargain collectively with industry on pharma prices.

Should Li Bassi be moved out and a leadership vacuum created, the plans of the Valletta group may be delayed, observers have said.

Leadership on CAR-T Therapies and & Locally-supported Research

In addition to the work pioneering the WHA drug transparency resolution, Li Bassi has also been setting precedents in Italy on the support and promotion of local cutting-edge research, leading to more affordable, cell and gene therapies, colleagues told Health Policy Watch.

He persuaded the Ministry of Health to establish a national public project, investing 60 million Euros to create Italian hospital-based production facilities for CAR-T cells.  The initiative should help keep the cost of the therapies down as use of the new gene therapies to fight cancer expands.

Li Bassi also created an innovative initiative with the pharmaceutical companies Gilead and Novartis, which hold patents on CART-T treatments for lymphoma and leukaemia, to reimburse the companies in accordance with the survival rates of the patients who get the therapies – keeping treatment costs down while incentivizing therapies that prolong life expectancy.   Through another initiative, AIFA and the Ministry are investing public funds in home-grown Italian research into CART-T therapies for other conditions, particularly for children.

“In addition to his work on transparency, Dr Li Bassi is one of the leading exponents of strategies to make new technologies, such as cell and gene therapies, more affordable,” notes the civil society letter to the minister. ”To this end, his effort to empower Italian research institutions to develop new CAR-T therapies within the public health system, is extremely important not only for Italy, but also as a progressive example for other countries.

“He has reached out to the leading scientific, technical and legal experts to advance this work, and has done so at a very critical moment, given the emerging regulatory, legal and reimbursement regimes that are only now being tested. Italy is one of the few countries to undertake pro-active assessments of possible ways forward in these areas, and this is largely the result of Dr Li Bassi’s willingness to challenge the status quo and to prioritize the public interest.”

 

Beatrice Marone contributed to this article.

Image Credits: Rai3, HP-Watch/E Fletcher, Italian Ministry of Health.

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