[Ip-health] Health Policy Watch: The World On Fire: Five Global Health Stories To Watch In 2020 – Part II

Thiru Balasubramaniam thiru at keionline.org
Thu Jan 23 08:30:26 PST 2020

For the full piece, please read Part II of Health Policy Watch's two-hander
on this link:


The World On Fire: Five Global Health Stories To Watch In 2020 – Part II
21/01/2020 by Elaine Ruth Fletcher

*“*Creaking health systems” are among the leading risks faced by the global
community, according to the World Economic Forum’s Global Risks 2020 Report
People live longer, but health gains have also plateaued in recent decades.
Threats from longstanding infections as well as those from emerging
diseases pose a double set of challenges.

Along with that, the growing burden of non-communicable diseases and aging
populations, coupled with workforce shortages, have emerged as new and
destabilizing forces to health systems. In an era of rapid technological
advances, health systems are struggling to define who should pay for
promising new treatments, and how much, when new gene and cell therapies
can cost as much as US $2 million per patient.  Like climate change, health
risks pose an “expensive and expanding” transnational challenge.”

Following on from Part I
, *Health Policy Watch’s* interviews with leading global health experts
zoomed into four key issues facing health systems in the decade leading up
to the 2030 Sustainable Development Goals milestone:

   - Emergence of new diseases at an increasing rate and intensity – as
   reflected in the Wuhan outbreak of a new coronavirus;
   - Stalled action on medicines price tranparency – watch to see if
   European countries take a lead this year in adopting stronger measures;
   - Failing medicines markets contributing to the rise of anti-microbial
   resistance (AMR) – when prices for other vital drugs, particularly
   antibiotics, dip too low;
   - Non-communicable Diseases (NCDs) and Universal Health Coverage – how
   these issues are linked to each other, and to the global “syndemic” of
   obesity, undernutrition and climate change.

A broader pattern of health inequalties, which also hold back development,
is a crosscutting problem, raised by global health leaders.

“We are living in a world where extreme inequality is out of control,” new
Executive Director of UNAIDS, Winnie Byanyima declared at the opening of
the World Economic Forum’s annual meeting in Davos, Switzerland.

Stalled European Action on Medicines Price Transparency

Advocates pressing for greater transparency around medicines prices, will
be watching the European arena closely this year for signals and practical
examples of measures that other countries and regions might follow. This
follows passage of a landmark World Health Assembly resolution
the issue last May, which proponents believe would help curb rising prices
seen for many drugs in markets of rich and poor countries alike.

Following the WHA resolution, Italy’s government and France’s Parliament
approved new rules to require pharma companies to disclose public
contributions received for R&D on new drugs – as part of requests for
reimbursement by the public health system of new drug costs. But
implementation of the new measures stalled at year’s end – over procedural
issues in France and following a government reshuffle in Italy.

In Italy, new Health Minister Roberto Speranza, who took office in
September, failed to publish the transparency decree signed by the former
Health and Finance ministers in August, just prior to a government
reshuffle. And the rule can’t take effect until it is published in the Italian
Gazette <https://en.wikipedia.org/wiki/Gazzetta_Ufficiale>, the official
government journal. Why that final step hasn’t been taken by Speranza, who
represents the far-left *Article One* party, remains a mystery.

“It is already five months, and this decree only needs to be published in
the Italian Gazette. It doesn’t need to be discussed,” said one observer.
“It would be indeed surprising to see a far-left Minister blocking a
transparency measure that could benefit people in order to protect pharma

Transparency advocates are hopeful that the logjam might be unlocked after
WHO scientist Nicola Magrini takes on his new position as head of the
Italian Medicines Agency (AIFA), after accepting Speranza’s offer of the
post earlier this month.

However, it remains to be seen if Magrini will have a range of action
comparable to that of his predecessor, Luca Li Bassi
In his brief year-long tenure under former Health Minister Giulia Grillo,
Li Bassi paved the way for a series of national reforms in medicines
markets as well as making Italy the lead sponsor of the WHA transparency

In France, things remain equally unsettled. A similar measure for
disclosure of public contributions to R&D as part of medicines
reimbursement requests was attached to the French Social Security Budget
for approval in the Parliament. It’s passage in early December was
celebrated by French civil society groups, led by l’Observatoire
Transparence Médicaments <https://twitter.com/OTMeds> (The Observatory for
Medicines Transparency).

But shortly after the bill’s approval, the French Constitutional Council
struck the provision down on a technicality, which now must be overruled by
the government.

In early January, French MP Caroline Fiat filed a public question to Health
Minister Agnès Buzyn
asking her if the government will issue such a decree. But Prime Minister
Emmanuel Macron is unlikely to approve such a move anytime soon, observers

“The decision is highly political. The feedback we have is that the Elysée
does not want this amendment and so the chances for the government to issue
a decree are very thin,” said one well-placed observer.

Meanwhile, the NGOs have gone back to the media to make their case.

Requiring disclosure of public contributions for R&D costs can  ensure that
the public doesn’t “pay twice” for medicines – once during the R&D process
and again at the cash register, said Pauline Londeix, co-founder of
Observatoire Transparence Médicaments, in a recent Le Monde OpEd,
with another French NGO, Santé Diabète.

The controversy raging over a costly new gene therapy, Zolgensma, which
treats spinal muscular atrophy in babies, is one example of such double
billing, the Op-Ed stated. The drug has been priced at €2 million, even
though French public charities contributed to its development. Recently,
the patent holder Novartis proposed a lottery to select some infants that
could be treated for free – although that idea raised even more ire.

“As if this lottery were not shocking enough, the scandal doesn’t end at
this shameful strategy….because Zolgensma was developed thanks to Telethon,
money from tax-free donations, and public and charitable funds,” Londeix
and her co-authors noted.
Disclosure of Clinical Trial Results also in Dispute

On a related front, transparency advocates in Europe as well as the United
States have battled over the disclosure of clinical trial results from drug

In Europe, attention focused on a pharma appeal to the European Court of
Justice <https://en.wikipedia.org/wiki/European_Court_of_Justice> regarding
the European Medicines Agency’s
of publicly sharing summary reports of clinical trial results for new drugs
undergoing approval.

A 2018 European court ruling that upheld the EMA practice was appealed to
the Court of Justice
<https://en.wikipedia.org/wiki/European_Court_of_Justice>, by Merck and PTC
Therapeutics, on the grounds that it violated confidentiality and harmed
their commercial interests. Fears that the High Court might upend the lower
court’s ruling climaxed late last year, following a September legal review
<http://curia.europa.eu/juris/document/document.jsf?docid=217636&doclang=EN> of
the case by Court of Justice Advocate General
<https://en.wikipedia.org/wiki/Advocate_General>, Gerard Hogan, who held
that disclosure of trial results could indeed undermine companies’
commercial interests. In December 2019, 35 civil society groups issued an open
on authorites to protect the current EMA policy of publishing the summaries.

“Without information and knowledge about the real benefits of drugs, how
can informed decisions be made for the benefit of patients?” said one

On Wednesday, (22 January), however, those fears were allayed when the High
Court rejected both pharma appeals
The decision, “confirms the right of access to documents contained in the
file of a marketing authorization application,” according to a press
release issued by the court, adding that “objections to such access must
explain the nature, purpose and scope of the data whose disclosure would
undermine commercial interests.”

In the United States, media attention has focused on lax enforcement of a
new FDA rule that requires trial sponsors to report their results on the
data base of ClinicalTrials.gov  <http://clinicaltrials.gov/>within 1 year
of a study’s completion. A study published last week by
 *The Lancet* found that only about 40% of trials were compliant.
Government agencies lack sufficient budget as well as high-level political
backing  to enforce the rule, critics have said.

At the same time, the Germany’s drug regulatory agency has taken a stronger
line with academic researchers on the same issue, threatening to cut off
funding to universities that fail to publish studies, as requested by
current EU legislation.

And a recent OECD report
called out the need for more transparency in relation the performance of
medicines – saying that health system reimbursement contracts requiring
such information would also be useful for other payers, scientists and the
general public.
European Countries Explore Ways to Negotiate Over Prices as a Bloc

Meanwhile, groups of European countries are also looking for ways to share
analysis and information on the value and benefits of new drugs eventually
to negotiate more effectively together. The ten southern European countries
of the so-called Valletta Group
hopeful that Croatia will put the issue on the agenda of the European
Employment, Social Policy, Health and Consumer Affairs Council
<https://www.consilium.europa.eu/en/council-eu/configurations/epsco/> [EPSCO]
sometime in 2020, Malta’s Deputy Prime Minister and Health Minister
told *Health
Policy Watch* in a recent interview.

And the new Spanish government of Prime Minister Pedro Sánchez, has also
pledged action on transparency in medicine prices under its four-year
“social patriotism” programme

“On medicines, the issue of high prices is not disappearing anytime soon,”
said Suerie Moon, co-director of Geneva Graduate Institute’s Global Health

“In the first week of January alone, the US saw price spikes on over 500
medicines by 100 companies
she observed. “Other more-regulated countries may not see the same kind of
price increases, but are still struggling with the budget implications of
drugs that are priced at hundreds of thousands to millions of dollars of
Swiss francs/Euros per patient.

“I think we’ll see more legislative action at national level, particularly
in Europe, to address the affordability issue. Importantly, there is also
growing appetite to re-examine and potentially reform the underlying R&D
system that generates such high prices — and this implies an ongoing demand
for increased transparency of that system. But putting in place any kind of
meaningful reform will require at least some international cooperation —
and that remains in short supply.”


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

More information about the Ip-health mailing list