[Ip-health] Activists demand Johnson & Johnson drop the price of vital TB medicine bedaquiline

Lotti Rutter lotti at healthgap.org
Thu Jun 13 07:00:51 PDT 2019

**Apologies for cross posting* *

*Activists demand Johnson & Johnson drop the price of vital TB medicine

*- Call on governments to remove patent barriers to generic supply of
lifesaving drug*


*13 June 2019, Durban* — Today activists stormed the corporate stall of
multinational pharmaceutical company Janssen Pharmaceuticals (a subsidiary
of Johnson & Johnson) at the 9th South African AIDS Conference. The
activists demanded that Janssen urgently drop the price of bedaquiline—a
lifesaving treatment for drug resistant tuberculosis (DR-TB)—in South
Africa and across the world.

“Globally people are suffering and dying needlessly of DR-TB because
governments are unable to afford to procure bedaquiline to save their
lives. Instead, people with DR-TB face severe pain and risk deafness taking
horrendous treatments that have little value in treating this disease,”
said Phumeza Tisile, an XDR TB survivor working with TB Proof.

Bedaquiline was recommended as a core agent for treating DR-TB by the World
Health Organization (WHO) in 2018 but virtually no high burden DR-TB
countries have been able to make this drug widely available. It is less
toxic and far more effective at curing people than previous drugs, marking
a major advance in DR-TB treatment. It replaces the painful injectable
drugs (kanamycin, capreomycin, and amikacin) that cause high rates of
hearing loss and many other severe side effects. However, many people
across the world are still unable to access bedaquiline because of the high
price tag, forced to endure inferior, less effective, and more toxic

Janssen—which introduced the medicine and got accelerated approval for it
by the United States Food and Drug Administration (US FDA) in 2012—has
employed a complex set of strategies involving ad-hoc discounts, donations,
abusive patenting and non-transparent pricing to obstruct affordable access
to the drug in countries where it is  needed the most. The research and
development (R&D) of bedaquiline has benefited greatly from public and
philanthropic funding and government tax credits. As a reward for
developing bedaquiline, Janssen also received a US FDA “priority review
voucher” which it used to secure expedited FDA review of a biologic
medicine (Tremfya), expected to generate $1.56 billion in sales in 2020. At
the same time, it is governments of the developing world and international
NGOs that have largely provided the data for the WHO recommendation for
large scale adoption of bedaquiline and practically borne the costs of the
later stage clinical development of the drug.

Despite large-scale public investment in the R&D for this drug, Janssen
currently charges the South African government and other
<http://www.stoptb.org/gdf/drugsupply/bedaquiline.asp>Global Drug Facility
(GDF) eligible countries around $67 per person per month
<http://www.stoptb.org/gdf/drugsupply/bedaquiline.asp> ($400 for a
six-month course) for bedaquiline. For non-GDF countries, Janssen announced
a tiered pricing structure whereby countries would be charged $900, $3,000
or $30,000 for a six-month course, depending on the economic status and TB
burden of the country. However, researchers from the University of
Liverpool have estimated that bedaquiline could be produced and sold
profitably for between $8 and $16 per month (between $48 and $96 for six
months)—roughly 25% of the price charged to the South African government
and others through the GDF and about 0.3% of the price charged in other
wealthier parts of the world. The price of bedaquiline becomes even more
unsustainable for patients who might require it for 18 to 20 months.

Janssen has attempted to deflect pressure from activists by launching a
donation program with USAID for some Global Fund eligible countries; but
that programme ended in March 2019, highlighting the unsustainability of
such approaches. “Donations are public relations exercises—reliance on
not only creates dependence on a single supplier but also stifles
governments' willingness to pursue more sustainable pathways such as local
production by generic manufacturers,” said Umunyana Rugege from SECTION27. As
in India recently demanded that the Indian government stop receiving
the company. “Janssen’s discounts and donations may provide it with a
much-needed PR boost to divert public attention and scrutiny from their and
J&J’s growing list of scandals and lawsuits—from faulty hip implants in
India to the irresponsible promotion of opioids in the United States—but
they do little to provide people with DR TB with a sustainable, predictable
supply of bedaquiline.” As it stands with the donation programme having
ended, there is now no clarity on how countries can procure bedaquiline at
the current $400 price.

The WHO estimates that there were 558,000 people with drug resistant TB
across the world in 2017. In South Africa alone, this is estimated at
14,000 people, a number that appears to be coming down, largely as a result
of widespread HIV treatment coverage that means people living with HIV are
healthier and less likely to contract TB. However, with many people with TB
in the country going undiagnosed even today, this number could be much
higher than estimated.

“Overinflated price tags mean many people die without accessing lifesaving
treatments. They also force governments to divert scarce health budgets to
drug procurement at the expense of broader health spending needs,” said
Anele Yawa from the Treatment Action Campaign. “The South African
government, unlike many governments, are doing the right thing: Changing
national guidelines to recommend bedaquiline for DR-TB treatment and making
sure people with DR-TB can access it. However, whilst this is a good thing,
the price should be lower so that we have more money for other things like
hiring more health workers to find, diagnose and treat people with TB
including those currently going undiagnosed, or on improving TB infection
control in public spaces, or buying and rolling out diagnostics tests at
clinics like the TB LAM test shown to prevent deaths among PLHIV with
advanced HIV disease.”

“Janssen must immediately drop the price of bedaquiline to ensure that all
people with DR-TB are able to access it, in South Africa and across the
world,” said Lotti Rutter from Health GAP. “Further Janssen must stop
impeding access through their strategies to control the price and rollout
of bedaquiline. Be it through abusive patenting that is extending their
patent monopoly beyond the 20 years allowed, or through setting ad hoc
prices and discounts as well as rolling out a donation program that allows
Janssen to selectively pick who gets what price, and who will live and who
will die.”

“We cannot wait any longer whilst Janssen plays its malicious games with
our lives. It is time for the government to act. Given how much our
governments have invested in the development of bedaquiline, and the people
with DR-TB who have made the clinical trial process possible—this is the
“people’s drug”,” continued Rutter. “We demand that governments the world
over revoke all secondary patents on bedaquiline as well as issue
compulsory licenses now to bypass the drug’s patents and ensure access to
multiple sources of more affordable generic bedaquiline.”




Ngqabutho Mpofu (Treatment Action Campaign): +27 61 807 6443 |
ngqabutho.mpofu at tac.org.za

Lotti Rutter (Health GAP): +27 82 065 5842 | lotti at healthgap.org

*Lotti Rutter*
Associate Director
International Policy & Advocacy
Health GAP

Cell: +27 82 065 5842 (South Africa)
Phone: +1 347 263 8438 x104 (US)
Twitter: @HealthGAP @lottirutter
Skype: lotti.rutter

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