[Ip-health] Fatima Hasan for The Daily Maverick: A redeeming moment for the SA government: A case for compulsory licensing in the age of Covid-19

Thiru Balasubramaniam thiru at keionline.org
Mon Apr 6 22:34:26 PDT 2020


South Africa has a frontline moment now of preventing pharmaceutical
profiteering in a time of pandemic. The government is ideally located for
leading the charge and agenda for the Global South when it comes to the
regulation of vaccinations, testing and medicines.

This has to be the South African government and the ruling party’s
redeeming moment.

With Covid-19, it is hoped that our country finally understands why, in one
of the world’s most unequal countries, life-saving testing, vaccinations
and medicines matter, and why the companies and researchers that make them
must be regulated. It literally is the difference between life, sickness
and premature death.

Crucially, Covid-19 could be the catalyst for human solidarity but also
opening up, showing that diagnostic (testing), medicine and vaccine access
is a right for all people, not just the wealthy or the insured, so that
globally we move away from the notion of health as a commodity. This will
enable us to scale up testing and care much sooner and more affordably than
we ever did with HIV and Aids and begin to invest more in research and

But if we rely exclusively on the goodwill and solidarity of the companies
that develop and produce these tests, vaccines and medicines (and
equipment), and do not keep a close eye on how intellectual property
regimes can regrettably prop up profiteering over patients’ health and
lives, we may not get that far.

The HIV/Aids crisis in our country, which resulted in thousands of
premature and avoidable deaths through state-sanctioned denialism and
inadequate regulation, has taught us valuable lessons about profiteering
and prioritisation in a time of great patient need, and government’s
refusal to use certain cost curtailing mechanisms available to it. Often,
people living with HIV/Aids and their legal representatives had to engage
in adversarial and prolonged legal action to expand medicine access here
and elsewhere. This is why, now, as a country, we cannot afford to rely
solely on the goodwill of the pharmaceutical industry.

Even the *Financial Times* in a recent editorial suggested that:

*“The desire to be responsible members of society, and recognised as such,
is one motivation for companies to share intellectual property. Some will
also realise they have little choice. Trade rules allow compulsory
licensing. Such a radical step – allowing countries to make drugs cheaply
without the patent holder’s consent – is justified. Universal access is
likely to be required to get the pandemic under control. Desperate diseases
require desperate measures.”*

But even as far back as the HIV/Aids crisis (late 1990s) organisations
working on health and patients’ rights had (and continue to) called for
South Africa’s overly protectionist patent laws to be amended, a call that
since 2011 has been formally led by over 40 organisations working alongside
Doctors Without Borders (MSF), Treatment Action Campaign, SECTION27 and
others, under the banner of the Fix the Patent Laws Campaign. The broad
campaign has bravely and for a long time argued that the government should
urgently fix our national patent laws by changing the apartheid-era Patents
Act 57 of 1978 to “balance the rights of patients with the rights of
patent-holders” in line with the South African Constitution – and include
“all the life-saving provisions in the TRIPS Agreement” – by finalising the
amendments to the Patents Act, and also by ensuring the “efficient and
transparent registration of medicines” by the South African Health Products
Regulation Agency

Amendments and reforms aside, to date, our government has never used the
power it has to issue a compulsory licence, not even for the HIV/Aids and
TB deadly co-epidemics, nor for cancer treatment.

And, since the quickly imposed lockdown in South Africa to flatten the
Covid-19 curve was announced barely 10 days ago, civil society
organisations and the media have been monitoring and holding to account the
exercise of power of our government departments, alongside the practices of
large food retailers, faith organisations, the taxi industry, the tobacco
industry, big business and financial institutions, hospital groups, the
police and army, among others, by asking them to course correct on a daily
basis. The pharmaceutical industry is not in this line of review. It should

With several global developments in the field of technology for rapid
testing and vaccine development (see below) it is a matter of grave urgency
that the National Command Council mandated to deal with all aspects of our
country’s response to Covid-19 monitor and intervene to make use of
mechanisms available to it, and to prevent pharmaceutical monopolies from
emerging (including generic monopolies), with high levels of transparency

   1. Funding by government and research institutions (i.e. public funds)
   for technology, vaccine and medicine development;
   2. The status of patent registration or extension applications -related
   to Covid-19; and
   3. Government’s clear plans to use flexibilities permitted under
   international trade law to make use of mechanisms that avoid excessive
   prices and ensure multiple suppliers, including issuing compulsory licenses.

Given that we have a health minister who is rooting the country’s response
to the Covid-19 pandemic in evidence and science, alongside strong
community mobilisation and solidarity, unprecedented humanitarian efforts,
an independent media and strong civil society oversight, with a judiciary
that remains independent, right now South Africa is ideally located for
leading the intellectual property reform charge and agenda for the global
South. It is our government’s redeemable moment. And we will not be alone:
other countries such as Canada, Chile, Ecuador and Germany have already
unequivocally indicated their governments’ intention to use compulsory
licensing for Covid-19.

Significantly, Costa Rica has proposed to the WHO the creation of a *global
pooling mechanism* for “rights in the data, knowledge and technologies
useful in the prevention, detection and treatment of the coronavirus/
Covid-19 pandemic”. Our government should unequivocally support this
proposal and endorse it, to make it a reality for the Global South. This
includes pooling the “rights relating to patents on inventions and designs,
regulatory test data, research data including outcomes, know-how, cell
lines, copyrights and blueprints for manufacturing, as these rights relate
to equipment, diagnostic tests, devices, medicines, vaccines, and other
medical tools”. Such a pool “would allow for competitive and accelerated
production of needed Covid-19 technologies”. This is not unusual, as some
pharmaceutical companies have joined intellectual property pools in the
past for HIV/Aids, TB and Hepatitis C treatment to be extended to
low-income countries at affordable prices.

UNITAID has also just announced that the mandate of the Medicines Patent
Pool (MPP) (a patent pool set up for HIV/Aids) has been temporarily
extended to include any health technology that could contribute to the
global response to Covid-19, and where licensing could facilitate
innovation and access.

Médecins Sans Frontières (MSF) International  <https://www.msf.org/>(Doctors
without Borders) with hundreds of other organisations, have, for example,
publicly called on all “governments to prepare to suspend and override
patents and take other measures, such as price controls, to ensure
availability, reduce prices and save more lives”. This does not only apply
to basic food items, but to all the elements of testing and to vaccine
development as well.

Why is all of this significant? Technologies for Covid-19 testing and
treatment are in the pipeline and need to be monitored from the lens of
“affordable access”. Here are some of the companies that our government and
all of us need to monitor and/or engage with:

Gilead is developing a potential vaccine. The lead candidate is remdesevir. Due
to global and public pressure of more than 150 civil society organisations
and individuals including Doctors without Borders (MSF), who sent an open
letter to Gilead expressing concerns about how its current approach to
remdesivir, a potentially key treatment for Covid-19, may hinder access for
those who need it, in the last two weeks, Gilead gave up a special
designation that it had sought from the United States Food and Drug
Administration (US FDA) that would have allowed for “extended monopoly
control over the 20-year patents it has filed for in more than 70 countries
for its potential COVID-19 treatment candidate, remdesivir”.

But this too has some limitations, because Gilead has yet to commit to not
enforcing its patents globally. And if it issues licences voluntarily, that
aspect must be monitored too, given Gilead’s own past conduct in South
Africa and its preference for Aspen. According to Doctors without Borders
(MSF), preliminary results of clinical trials using remdesivir to treat
Covid-19 are expected in April.

This is why transparency of the CIPC is critical, to track patent seeking
during this crisis, presumably through an already established government IP
task team that is independent of big business and the law firms that
represent the pharmaceutical industry.

Diagnostic test maker, Cepheid: Doctors Without Borders (MSF) reports that
the corporation has just received US FDA Emergency Use Authorisation for a
rapid Covid-19 test (Xpert Xpress SARS-CoV-2) that delivers results in just
45 minutes, using existing testing machines that have been routinely used
for tuberculosis (TB), HIV and other diseases. And that Cepheid will
“charge around R353 per test in developing countries, including the world’s
poorest countries where people live on less than R40 per day”. Doctors
Without Borders calculates that the test, even with a reasonable profit
margin, should be in the region of R88). The NHLS in its recent statement
on expanding community testing in South Africa for Covid-19, suggests that
it will be making use of this testing kit too.

In addition:

   -  Global media reports suggest that about 35 companies and academic
   institutions are working on a vaccine, at least four of which already have
   candidates they have been testing in animals and will be used in human
   trials soon; for example, Johnson & Johnson announced a potential vaccine
   that could be available by 2021.
   -   Abbott Laboratories has also launched a rapid test kit.
   -   AbbVie, which makes a potential treatment known as Kaletra, gave up
   its global intellectual property rights for the drug, after Israel issued a
   compulsory licence that enables the country to use it against coronavirus
   (if effective) without the patent holder’s consent.
   -   Roche, “which makes testing kits for the virus, agreed to share the
   recipe for its testing liquid with the Netherlands after lawmakers there
   accused it of rationing supply and significantly decreasing national
   testing capabilities”.

At the next presidential Covid-19 briefing and address to the nation, let
us hope that President Cyril Ramaphosa sets out the government’s
unequivocal position on this issue. An effective public health and
socio-economic response to Covid-19 in South Africa, that dramatically
reduces the expected morbidity and mortality, gravely depends on his
actions and commitment to prevent pharmaceutical profiteering in a time of
a pandemic. DM

*Fatima is a human rights lawyer and social justice activist, she was part
of the legal team that represented the TAC and others in challenging
pharmaceutical monopolies during the early years of the Aids epidemic in
South Africa, she has also served as a Special Adviser to a Minister of

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

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