[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

Paul Fehlner pfehlner at revisiontx.com
Tue Apr 7 12:32:09 PDT 2020

Exercises the intellectual property flexibilities provided by TRIPS makes sense in the context of COVID-19. However, by creating a public benefit entity to proactively seek approvals of repurposed generic drugs, it would be possible to actively control issues of price and access without relying on declarations of compulsory licenses (which in any event only apply to patent rights) or generating friction between governments. Shouldn’t we use all the tools available?

Paul Fehlner
President & CEO
reVision Therapeutics, Inc.
pfehlner at revisiontx.com

> On Apr 7, 2020, at 1:34 AM, Thiru Balasubramaniam <thiru at keionline.org> wrote:
> https://www.dailymaverick.co.za/article/2020-04-06-a-redeeming-moment-for-the-sa-government-a-case-for-compulsory-licensing-in-the-age-of-covid-19/
> 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
> development.
> 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
> <https://fixthepatentlaws.org/brochure/Fix%20the%20patents%20web.pdf>
> 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
> be.
> 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
> around:
>   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
> Health).*
> -- 
> Thiru Balasubramaniam
> Geneva Representative
> Knowledge Ecology International
> 41 22 791 6727
> thiru at keionline.org
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