[Ip-health] Shreerupa Mitra-Jha in Governance Now: The battle to access affordable medicines heats up

Thiru Balasubramaniam thiru at keionline.org
Fri Mar 17 02:19:57 PDT 2017


The battle to access affordable medicines heats up

UN Human Rights Council discusses access to medicines and the right to
health. Big question: Shouldn’t the right to life come before profits from

Shreerupa Mitra-Jha | March 17, 2017 | Europe

Tobeka Daki, a single South African mother and health activist from the
eastern Cape, died fighting breast cancer in November last year. Her
oncologist had told Tobeka that she needed trastuzumab – a life-saving WHO
essential medicine for the treatment of HER2+ breast cancer – in addition
to undergoing chemotherapy. However, three years after her diagnosis,
Tobeka died because she could not access the prohibitively expensive

In South Africa, the annual price charged by Swiss multinational company
Roche in the private sector for trastuzumab is about $38,365. The few South
African public facilities that have been able to procure the medicine have
done so at $15,735 per year. Analysis by health economists, however, has
shown a year’s worth of trastuzumab can be produced and sold for merely
$240 and that includes a 50 percent profit over the cost of production.

Tobeka’s death snowballed into a passionate cry of health activists,
patients and other stakeholders who launched the Tobeka Daki Campaign (TDC)
on February 7 to enhance access for the suffering millions to unaffordable
drugs and vaccines.

“Roche maintains its high prices and unconscionable profits in every way
possible,” a letter by TDC submitted in one of the sessions discussing
access to medicines issue at the 34th session of the UN Human Rights
Council (HRC) read.

Roche holds multiple evergreen patents on trastuzumab in many parts of the
world, including South Africa where its patents could block biosimilars
from entering the market until 2033.

Evergreening refers to strategies through which pharmaceutical patent
owners use the law and related regulatory processes to extend their high
rent-earning intellectual property rights (IPR) particularly over highly
profitable “blockbuster” drugs. It is not a formal concept in patent law
and indicates a misuse of market powers.

“In 2015, Roche made $8.9-billion profit while CEO Severin Schwan earned
$12 million. It is highly plausible that Roche could cut the price of
trastuzumab dramatically and still be very profitable,” the letter further

The issue of delinking prices of health products from investment into
research and development (R&D) of these products coupled with the growing
need to temper the profits of pharma companies and bring greater
transparency into pricing mechanisms of drugs has resulted in clear battle
lines drawn between the North and the South blocs at multilateral platforms
like the World Health Organisation (WHO), the World Trade Organisation
(WTO) and the HRC. The reason is clear. Most major pharma giants are
headquartered in developed countries while the world leaders in generic
medicines are countries like India and Thailand. The least developed
countries (LDC) of Africa and parts of Southeast Asia are the most acutely
affected by a lack of a steady supply of affordable drugs.

However, if one goes beyond the political imperative of standing up for
domestic rich businesses the battle line on this issue is rather blurry. At
least a third of the world’s population has no regular access to medicines.
For example, as of June 2016, 18.2 million people were living with HIV but
only half were accessing antiretroviral therapy. The moral argument for
drug availability is a question that confronts the developed countries as
much as the poorer ones.

How much profit is too much for  Big Pharma considering that we are talking
of the right to life? How much do these companies actually invest in R&D
and what amount goes into marketing and advertisement? Should governments
be allowed to trade away millions of lives through secret plurilateral
deals? If the enjoyment of the benefits of scientific progress is a right
(the right to science) recognised in the Universal Declaration of Human
Rights and the International Covenant on Economic, Social and Cultural
Rights how are these rights so easily disregarded when most UN member
states have signed on these agreements? What happens to the innovation of
drugs for those diseases, like the neglected tropical diseases (NTD), that
do not yield profits for drug companies and where markets fail to produce
new drugs? Should such patients be allowed to wither away and die?

Affordable drugs – a human right?

The HRC held a high-level panel discussion on access to medicines and the
right to health on March 8. The discussion was facilitated through a
resolution adopted by the HRC in June last year. The decision was reached
upon after spearheading efforts made by countries like Brazil, South Africa
and India among others.

The panel spent a good part of its time discussing the UN
Secretary-General’s High-level Panel on Access to Medicines (UNHLP) that
published its report in September last year. The UNHLP had as its mandate
the task of looking into policy incoherence between the justifiable rights
of inventors, international human rights law, trade and public health in
the context of health technologies.

The UNHLP report has engendered fractious posturing between member states
with many developed countries disregarding the report – even before its
publication – arguing that it is based on a “flawed premise” of assuming
incoherence between IPR and access to medicines.

The mention of the UNHLP report in multilateral platforms has been a
bitterly contested matter, more so since its recommendations, if
implemented, could potentially rein in the price-gouging techniques of
pharma companies.

“The protection of intellectual property rights must not be allowed to
trump enjoyment of the right to health,” said Kate Gilmore, the UN deputy
high commissioner for human rights to the HRC. “Perhaps that the greatest
obstacles to fulfilling the obligation to ensure access to medicines for
all is political will,” she observed.

“The issue before us is not only a matter of ethics, though it is also
that. It is also a matter of law – international law,” Michael Kirby,
former justice of the high court of Australia and member of the UNHLP, told
the HRC on March 8. He called the UNHLP report “the minimum, prudent
package” to address the prevailing global situation of unaffordable health
products, shortage of drugs and stimulating innovation systems on
delivering drugs for “non-profitable” diseases.

The reputed jurist said that though some of the UNHLP members may have
taken a different path (two members, including the chief of a
pharmaceutical company, had dissenting notes on the report) and some others
would have gone further but everyone agreed on the “core conclusions” of
the report – to negotiate an R&D treaty that will delink the end prices of
health products (drugs, vaccines, diagnostic tools) from investment in the
R&D; the UNSG should initiate an independent review body by 2018 on health
innovation to address market weaknesses “once and for all”; that WTO
members must respect the flexibilities included in the WTO Agreement on
Trade-Related Aspects of Intellectual Property Rights (TRIPS), also in the
context of the right to health; there must be no more pressuring of
countries who evoke compulsory licences, and should counter evergreening
and “other misuse of market practices”.

These statements from the panellists, predictably, drew strong reactions
from the US and the EU.

“The current innovation model has delivered progress in public health,
leading to new and improved treatments as well as extended life expectancy
both in developed and least developed countries,” an EU delegate told the
Council. The paper statement of the EU has the word ‘has’ underlined for
emphasis. There could be “many reasons” for inaccessibility of medicines
(not just IPR) and the EU recognises “that challenges remain to be

“Unfortunately, the concept note for the panel and its composition suggest
a focus on the HLP report that is inconsistent with what was agreed to in
June last year,” the US said. “As the United States and others have
repeatedly made clear, including at the meeting of the WHO’s Executive
Board, the High-Level Panel operated under a flawed premise. The HLP report
inappropriately assumes an incoherence between access to medicines,
intellectual property, and trade, and fails to consider critical barriers,”
the American delegate added.

Not a North-South issue

Both the US and the EU have tried to deflect attention from the focus on
IPR to internal domestic barriers that hinder access to medicines and have
mentioned issues like “under-resourced health systems, a lack of
sufficiently qualified and skilled healthcare workers, inequalities between
and within countries, exclusion, stigma, discrimination and exclusive
marketing rights”.

The problem with this argument is two-fold: though the mentioned problems
may well be barriers for accessing medicines in some developing countries
and LDCs, it does not imply that IPR is not a crucial factor in spiking
drug prices thus making them unaffordable for the majority of people.
Secondly, the argument ignores the fact that in many of the rich countries,
unburdened by issues like having to deal with flailing health systems,
access to medicines has become a consequential political issue finding
sufficient space in election-campaign rhetoric.

Kirby said that during the public hearings of governments, industry, civil
society, and patients held in London, Johannesburg and Bangkok “curiously
the voice that was most haunting” was that of an ambassador from the
Netherlands. “Don’t assume this is just a problem of poor countries or poor
people. This, he said, is a challenge for us all – a challenge for
Netherlands, a rich and inventive country. The cost of essential drugs is
now excessive for our budget,” Kirby told the HRC, quoting the Dutch

“In recent times, the dramatic increase of prices of new and innovative
medicines made them unaffordable to large segments of the population also
in rich countries while threatening the sustainability of health care
systems. In too many countries, prices of new medicines (to treat Hepatitis
C and cancer, for instance) are particularly shocking,” a senior Portuguese
delegate told the Council.

“I’d like to ask the panellists how they would advise States to pursue more
transparency in the determination of costs of R&D for new medicines (in
particular a better traceability of the public funds used in this regard,
in order to better reflect actual costs in the final price of the
medicines),” Portugal questioned the panellists.

These statements indicate that the EU countries may not be as united around
the access issue as the EU statement makes it appear.

Right to health or right to profit?

The facts that profits should not eat into human lives and that universal
access to medicines is an issue that should be top priority for all
governments seem to be common-sensical givens. But, considering that drug
access is such a hugely political issue now, achieving these objectives
becomes an uphill struggle. The battle is being fought on many fronts from
overt assertions to covert threats and complicity between rich governments,
the Big Pharma and multilateral agencies.

Email records and memoranda released by the US Centers for Disease Control
accessed by Knowledge Ecology International (KEI), an award-winning
American organisation working on IPR and access to medicines, though the
US’ Freedom of Information Act (FOIA) show that representatives of the WHO
and the US government opposed including India’s proposed agenda item on the
UNHLP for discussion at the 140th WHO Executive Board meeting held in

An email from September 30 shows that an American official, Rachel Wood,
wrote an email to her colleagues Joel Stanojevich and Peter Mamacos,
advising them that “Of our priority items ... WHO suggested removing
India’s access to medicines proposal, so Dr Frieden didn’t need to”.

Several health activists across the world were outraged and demanded an
explanation from the WHO director-general Margret Chan for the UN health
agency’s reasons for rejection of the request.

“We congratulate the Panel for their bold effort. It’s unfortunate that
some members and even WHO are undermining any discussion on the report,”
the Indian statement read though it could not be delivered to the Council
for the constraint of time.

“We have recognised, and this is very important, that it is a matter of
state sovereignty for states to lay down the criteria for granting patents
and also for states to determine health emergencies to take particular
measures,” Ruth Dreifuss, former president of Switzerland, chair of the
Global Commission on Drug Policy and co-chair of the UNHLP, told Council
members. It is “absolutely important” to deal with matters of transparency
in health products, Dreifuss stressed. However, “subsequent negotiations
have reduced the Doha declaration flexibilities or put countries under
pressure countries from evoking these flexibilities,” she observed.

In Brazil and Argentina, Roche is one of the pharma companies litigating
against those governments for their attempts to use TRIPS flexibilities,
i.e., legal international safeguards to protect public health, the TDC
letter states.

Last year, a Colombian news network reported that a top US Senate Finance
Committee aide, who works for Committee chairman senator Orrin Hatch,
threatened to withdraw American funding for the Colombian peace process if
the Colombian health ministry allows generic production of the patented
leukaemia drug imatinib.

Five law suits have been filed in India and Argentina in February alone
this year for slashing the cost of life-saving medicines for treating the
liver disease hepatitis C. Litigants have argued that the latest class of
antiviral drugs does not merit the 20-year patent monopoly that the drug
manufacturers have asked for in the two countries. The treatment, which
runs over three months, currently costs more than the average annual
salaries of people from middle-income countries. The rich country citizens
do not fare much better in this regard.

In another instance, the Delhi high court this month has asked the central
government to explain the basis on which the Indian patent office has
rejected a patent of the University of California’s prostate cancer drug
Xtandi (the university claims to have invented the drug). Astellas Pharma,
a Japanese pharmaceutical company that has marketing right for the drug,
charges Rs 3.35 lakh for a month’s supply.

International activists hope that successful litigations in poorer
countries may trigger off similar lawsuits in the developed parts of the

Greater transparency in drug prices is a noisy fight, especially in
developed countries.

The US-based Interfaith Center on Corporate Responsibility (ICCR) reported
that long-term shareholders are “outraged” that major American drug
companies, including AbbVie, Amgen, Biogen, Bristol-Myers Squibb Company,
Eli Lilly, Gilead Sciences, Johnson & Johnson, Merck & Co., Pfizer, and
Vertex Pharmaceuticals, scuttled shareholders’ proposals to elicit greater
transparency around excessive price increases on critical drugs. At least
16 American states have introduced legislation calling for greater drug
transparency. A recent Kaiser poll indicated that 74 percent of the public
believes that the pharmaceutical industry puts profits before the needs of
people, ICCR says on its website.

Apart from these attempts to thwart attempts to discipline the drug
industry, mega trade deals also remain handy tools for rich countries to
arm-twist weaker governments from eating into the profits of their pharma

“The RCEP [Regional Comprehensive Economic Partnership] will be a massive
trade agreement and the content of the IP Chapter is important. It will
bind India and China, two countries left out of the TPP [Trans-Pacific
Partnership],” Jamie Love, the founder of KEI, had said in a statement last
year.  “There are proposals for patent extensions, restrictive rules on
exceptions to copyright, and dozens of other anti-consumer measures,
illustrating the power of right-holder groups to use secret trade
negotiations to limit democratic decisions that impact access to knowledge,
the freedom to innovate and the right to health, in negative ways,” Love

Médecins Sans Frontières, in a statement to the HRC, urged the UN high
commissioner for human rights’ office to perform human right public health
assessments of trade agreements, so that bilateral and regional trade and
investment treaties do not include provisions that interfere with
government obligations to fulfil the right to health as recommended in the
UNHLP report.

“We will never forget the voices of those who are left behind, many of them
women or girls, families forced to beg for charity for patented
medicines…,” Kirby told the Council. “Unless the world and the UN, and this
Council act now… millions will be left behind and millions will die.”

shreerupa at gmail.com

(The story appears in the March 16-31, 2017 issue of Governance Now)

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