[Ip-health] Near-Monopolies On HCV Diagnostics Curb Competition, Keep Prices High, Research Finds (IP Watch)

Pauline Londeix pauline.londeix at gmail.com
Wed Oct 24 07:24:57 PDT 2018

Near-Monopolies On HCV Diagnostics Curb Competition, Keep Prices High,
Research Finds



Monopoly prices of diagnostic tools and lack of competition in the
market constitute a barrier to treatment for people with hepatitis C
virus (HCV), but the increased use of “open” diagnostic platforms
could reduce prices, a health advocacy research study has found.

The study focused on access to HCV diagnostics in Morocco, and
compared levels of access for countries in the Middle East and North
Africa (MENA) region.

The results are detailed in the report Diagnosis and monitoring of
hepatitis C (HCV) in Morocco: Current Status and strategies for
universal access, published in May 2018 by the Association de Lutte
Contre le Sida (ALCS) in Morocco. The report was written by Pauline
Londeix, consultant on access to medicines and diagnostics in low and
middle-income countries, and former vice president of Act Up-Paris.

The report found that the companies Abbott, Roche and Cepheid “benefit
from a near-monopoly of platforms used in Morocco to measure HIV and
HCV viral loads.” Countries that purchase diagnostic platforms from
these companies also generally enter into exclusivity contracts with
them, establishing monopolies on the supply of materials needed to
complete each test, the report explains.

“The purchase of equipment from manufacturers such [as] Roche, Abbott
and Cepheid forced buyers to also purchase reagents orders from the
same manufacturer. In other words, the Moroccan public sector is
equipped exclusively with closed platforms,” the report states.

Due to the exclusivity contracts and the brand-specific compatibility
of these platforms, the prices of the “reagents” required for each
viral load test are not subject to competition, and are set at
monopoly prices, Londeix explained in an interview with Intellectual
Property Watch.

“It is really critical that all the actors working on ‘access to
health’ start thinking more about diagnostics, and see how they can
help to remove the barriers, and that the open platform can be part of
the solution,” she said.

Lack of Access to HCV Diagnostics

The World Health Organization’s Global Health Sector Strategy on Viral
Hepatitis 2016-2021[pdf] states that “[e]arly diagnosis of hepatitis
infection is critical for effective treatment and care” and that
“[m]edicines, vaccines, diagnostics and other commodities will
constitute an increasingly important component of national hepatitis
budgets, particularly as treatment is expanded,” calling for
strategies that foster “generic competition” to promote access.

“Of the estimated 71 million people living with chronic HCV, only an
estimated 20% are aware of it. Lack of national guidelines and limited
access to testing remain a bottleneck, both for gauging the burden of
disease, and for planning effective implementation and scale-up of HCV
treatment programmes,” according to a Médecins Sans Frontières (MSF,
Doctors Without Borders) product guide on HCV viral load testing.

“Several laboratory-based platforms are commercially available,
including from Abbott, Biocentric, Hologic and Roche, among others,”
the MSF guide states. “But the high prices for these tests impede
large-scale implementation; they are a significant part of the expense
for the full diagnostic and treatment package.”

Two rapid point-of-care serological tests have been developed to
“facilitate decentralized HCV testing programmes,” but there is “an
urgent need to further expand the list” of rapid point-of-care options
to “foster competition and create a more healthy market,” according to
the MSF guide. Even when these rapid tests are scaled-up, viral load
tests will still be needed to monitor and assess treatment, Londeix

Company Perspectives

In response to the need for access to HCV diagnostics, Roche commits
“to enabling improved patient management by delivering innovative,
high-quality diagnostic products where they are needed most,”
according to the Roche website.

Abbott is “constantly searching for new ways to help improve the tests
available to diagnose people living with HCV. Part of that process
involves studying the barriers to access to testing that hinder
eliminating this serious disease,” according to Gavin Cloherty,
director of infectious disease research for Abbott’s diagnostics
business, quoted on the Abbott website.

Cepheid announced on 23 July that it would lower the price of its
Xpert HCV diagnostic test, “to make the tests more accessible to
lower-income countries,” according to the Cepheid website.

Monopoly on Liver Fibrosis Diagnostics

In addition to the quasi-monopolies on viral load diagnostics, and the
lack of competition for rapid diagnosis tests, there is also a global
monopoly on non-invasive platforms for diagnosing liver fibrosis, a
result of untreated HCV, according to the ALCS report.

These platforms, FibroTest and FibroScan, were developed with public
funding in France, patented, and exclusively licensed for
commercialization to BioPredictive and EchoSens, respectively,
according to the report.

“The issue with FibroTest and FibroScan lies in the fact that these
technologies are in the hands of two firms, taking advantage of a
perfect world monopoly,” says the report. “Not only were patents
filed, which is a barrier, but also the know-how necessary for the
development of such platforms would take years for others to
independently [develop].”

“The report of the UN’s High-Level Panel on Access to Medicines calls
for the use of open licenses in this type of situation,” the report
notes. Rather than granting exclusive licences to companies for
commercialization, resulting in monopolies of critically-needed
diagnostic technology, the report argues that these technologies
should instead serve the public interest in the form of open licences
for generic production and competition.

Open Diagnostic Platforms for HCV

“The international community, particularly the WHO and others, should
help countries to start producing diagnostics locally, where it is
possible. When we look at the HIV viral load patent landscape, we see
that most of the patents have expired, which means that today other
companies could produce open platforms, and all these technologies.
The WHO should assist countries in the local production of
diagnostics. It should also provide more clarification of the
regulations for regions, because apparently it’s complicated or can be
sometimes confusing [for governments],” Londeix said.

Open diagnostic platforms for HCV are currently available, such as the
platform developed by Biocentric, which accepts reagents and
components from multiple different brands, according to the report.
Londeix explained that these platforms are not yet used extensively
enough to bring about price competition for reagents, and called on
countries to switch to open platforms, and on the WHO to promote the
use of open diagnostic platforms.

“Open platforms accept reagents from a much wider variety of
suppliers, therefore ensuring stronger competition and lower prices.
As closed platforms induce systemically higher operating costs,
Morocco must immediately opt to equip its HCV response with open
platforms to foster competition, reduce costs, and provide leverage in
price renegotiations with Abbott, Roche and Cepheid,” the report

“One of the ways forward could be to have an incentive for countries
to really use open platforms,” Londeix said, “because if many
countries start using open platforms, even if it doesn’t lead to a
decrease of the prices [of reagents] right away, it could introduce
competition, which would be very efficient for the long-term.”

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