[Ip-health] Health Policy Watch: Italian Health Minister Moves To Replace Key Architect of WHA Resolution On Drug Price Transparency

Thiru Balasubramaniam thiru at keionline.org
Thu Nov 7 11:49:47 PST 2019

This article is best viewed by reading it on the Health Policy Watch link:


Italian Health Minister Moves To Replace Key Architect of WHA Resolution On
Drug Price Transparency
07/11/2019 by Elaine Ruth Fletcher

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.

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”.

“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.

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

“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.

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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