E-DRUG: World Trade Organization Enters COVID Pandemic Fray With Dispute Brewing Over Patent Rights
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[Warning: A long and detailed message follows. BS]
Intellectual Property 14/10/2020 - Elaine Ruth Fletcher
A safe, proven vaccine for COVID-19 doesn't yet exist. But the battle for
access is heating up.
Even as the world struggles to come up with a viable COVID-19 vaccine as
well as new treatments, the debate over how to ensure that people around
the world can get access to whatever products are available, now or in the
future, is heating up significantly this week.
The flashpoint is Geneva's World Trade Organization where all eyes are
set upon a closed-door meeting of 164 countries and territories, taking
place Thursday and Friday. Members will meet under the TRIPS Council, a
difficult acronym referring to the powerful WTO agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS) protecting patents in
international trade. A treaty few people outside of the circles of patent
lawyers and medicines advocates really understand, even though it impacts
the daily lives of almost everyone.
A sweeping proposal by India and South Africa to suspend so-called TRIPS
protections of intellectual property (IP) for virtually any health products
deemed necessary to fight the pandemic is set to come before the TRIPS
Council this week.
The proposal would allow countries to waiver patents, copyrights and other
IP not only for the products themselves, but also for their underlying
technologies, without facing WTO charges or penalties for violation of
international trade rules. And the proposal also casts a very broad net;
almost any medical product necessary to test, treat or prevent COVID-19
could be eligible for such a waiver.
While highly technical, the discussion sets the stage for a major public
debate over the growing clamour in low- and middle-income countries to
wipe the slate clean of any patent protections on COVID-related drugs,
tests, protective gear or hospital equipment for as long as the pandemic
lasts.
Like a simmering volcano
The debate over access to medicines that is bubbling up now in the COVID
pandemic is reminiscent of a simmering volcano that occasionally erupts.
The most memorable eruption was at the peak of the HIV and AIDS epidemic that swept across Africa around the turn of the millennium, when countries like South Africa forced major changes in the rules of the patent game.
That paved the way for the WTO Doha Declaration on TRIPS and Public Health in 2001, which introduced so-called 'TRIPS flexibilities' opening up new
channels for countries to permit the generic manufacture and importation of
otherwise costly therapies during health emergencies. This along with
national legal precedents, and new precedent-setting agreements with
industry, helped make antiretrovirals (ARVs) for treating HIV cheaper and
more accessible across Africa and the world.
WTO as Gatekeeper
Despite those historic revisions. WTO has for the past two decades retained
its role through TRIPS as the global gatekeeper of world trade rules
related to patents on vaccines, drugs and other health products. And that,
in turn, is one of the things - although certainly not the only one - that
continues to affect who can manufacture and sell health products, where and
how much they will cost.
Most countries still adhere to global patent rules, and make use of the
'TRIPS flexibilities' very judiciously because they can face claims at WTO, or other kinds of pressure and reprisals from countries hosting the
pharma firms who hold the original patents. As a result, WTO continues to
hold the wheel on when and to what extent IP protections are enforced - or
overlooked.
Still early days
But could the status quo change even more dramatically now? Keep in mind
that we are still in the early days of this debate - partly because there
are still no approved vaccines, or many treatments, available. Just this
week big pharma companies registered some major setbacks in both arenas.
Those included Monday's announcement by Johnson & Johnson that it was
temporarily suspending its trials of a single-dose Covid-19 vaccine 'due
to an unexplained illness in one trial participant'. The vaccine, if proven
safe, would be particularly suited to low and middle-income settings
because not only is it just one dose (others are two) but it does not
require extreme cold storage.
On Tuesday, Eli Lilly suspended a clinical trial for its combination
antibody treatment due to another adverse event - a cocktail similar to
the Regeneron brew that President Donald Trump received last week and which
he pronounced to be a 'virtual cure' disregarding the obvious scientific
principle that an experiment involving only one individual - even the
President - is not proof of widespread efficacy - or even safety.
But hopefully innovation will do its thing and eventually treatments - and
a vaccine - will emerge. What can we expect then? Will someone promise, as
President Trump spontaneously did to the American people, to make the drugs
that he got 'free for everyone' - and really mean it?
Another Watershed Moment?
Since the HIV crisis of the 1990s countries are allowed to suspend the
rules in emergencies. They can issue their own licenses for generic or
biosimilar drug manufacture or imports under the 'TRIPS flexibilities'
introduced by the Doha Declaration. And UN supported mechanisms, such as
the Medicines for Patents Pool (MPP) have also since emerged. They have
wracked up an impressive track record in the negotiation of 'voluntary'
generic licenses with big pharma for urgently needed drugs, including new
generation hepatitis cures.
Most of the time, it has been poor countries that have issued waivers or
licensing to manufacture generic versions of a patented drug, while rich
countries could afford to buy them, even at premium prices.
But now, pressures are growing in rich countries, as well. Countries in
high-income Europe have struggled with shortfalls or high prices for the
few Covid therapies already available. A shortage of Remdesivir is making
headlines in the Netherlands, observes Ellen 'tHoen, who heads the
Dutch-based non-profit advocacy group, Medicines, Law & Policy, in a recent
op-ed.
The South African/Indian initiative has recently gained institutional
support from the UN-affiliated Unitaid, a group of European Union MPs,
Doctors Without Borders, and other advocacy groups including Geneva-based
Drugs for Neglected Diseases initiative (DNDi): 'We strongly support the
proposal of South Africa and India, said DNDi Executive Director Bernard
Pecoul on Monday.' 'We urge other countries to support this proposal
without delay and to make use of TRIPS flexibilities where intellectual
property barriers already exist, to ensure that all people - including the
poorest, the most vulnerable and those at highest risk - are guaranteed
timely and equitable access to the fruits of scientific progress in this
pandemic.'
While not an outright endorsement, a WHO spokesperson also said, 'We are
aware [of the WTO moves] and WHO of course welcomes any countries' efforts
to expand access in an equitable way, and any effective and practicable
initiative that may lead to equitable access.'
Radical TRIPS Council Decision. Unlikely WTO TRIPS Council meeting, pre-pandemic.
However, it remains highly unlikely that the TRIPS Council would back the
kind of sweeping waiver on patent rules as well as copyrights - for all
drugs, vaccines and technologies - that the South African and Indian
sponsors are proposing. Industrialized countries, including European
countries which may even be suffering from shortages, would not go along
with such a move, observers say.
And it is also unlikely that the WTO's new director-general, whose
appointment is pending, would openly take sides. Among the two final
candidates left in that race, Nigeria's Ngozi Okonjo-Iweala is considered
to be the front-runner, ahead of Republic of Korea's Yoo Myung-hee.
Despite Okonjo-Iweala's sensitivity to global health issues, she currently
is board chair for Gavi, The Vaccine Alliance, she will not want to burn
her bridges too quickly with industry, pundits predict.
'The WTO is highly likely to acquire Okonjo-Iweala - who wants to make the
public-private approach work,' said Financial Times's world trade editor
Alan Beattie, in a recent piece.
She told us in an interview in July: 'We're saying we need to get these
vaccines to everyone at affordable prices [but] how do we protect
intellectual property, because without that you will not have the
innovation, and the research?' Conversations between Okonjo-Iweala and
India/South Africa might get a bit spicy.'
He and others also point out that in the case of vaccines which are complex
and sensitive to manufacture, 'IP is not the gating factor'. These require
a complex set of technologies that can take years for a country to develop.
However, the sweeping nature of the South African and Indian waiver
proposal also means that if it were approved, then patents on almost any
other technology associated with Covid treatment, could effectively be put
on pause. And since Covid can involve so many organs of the body, from
heart, to lungs to brain - that means almost anything.
Voluntary Patent Pool: A Third Way?
Short of a sweeping WTO move, almost certain to be dismissed in its current
formulation by countries with big pharma interests, the third way,
advocates say, is country backing for the WHO co-sponsored Covid-19
Technology Access Pool (C-TAP). Effectively an expanded version of the
successful Medicines Patent Pool model. CTAP is designed to offer a
voluntary approach to the pooling or sharing of COVID-19 technologies and
related IP.
But in contrast to the Gavi and WHO co-sponsored vaccine procurement pool,
called COVAX, which has recruited 180 countries into pre-purchase
agreements for expected COVID-19 vaccines, only 41 countries have signed up
to the C-TAP pool - reflecting the lackluster support voluntary approaches
to patent pooling have received. Industry has also repeatedly said that it
doesn't see itself as a player in C-TAP - and without industry the
initiative would have no meaning.
Even Moderna, which recently pledged to not enforce our patent' related
to its new COVID-19 vaccine candidate, if it is approved, for the duration
of the pandemic, has been cool about the C-TAP pool:
'Our statement speaks to our intentions with respect to intellectual
property during the pandemic. We remain open to dialogue on other
approaches to solving important access needs. Moderna understands the
important role that multilateral organizations will play in helping to
expand access and protect populations around the world' said a Moderna
spokesperson, in response to a Health Policy Watch query about whether the
company would offer their product for sale through the WHO co-sponsored
COVAX pool.
But with regards to C-Tap, he was much more cool, saying: 'We believe it is
premature to make commitments to patent pools for emerging technologies
such as mRNA.'
WHO, however, is still trying to sound upbeat about the intiative, saying
that once more concrete plans are in place, more industry and country
support will also follow.
'As with many new initiatives, the effort requires more dialogue and
information exchange,' said a WHO spokesperson. 'We have been finalizing an operational plan for it that maps out much more clearly how different stakeholders (governments, industry, researchers and research funders, civil society, etc.) can contribute, and highlights the benefits that can be obtained from such an initiative. i.e. faster and more reliable science' the spokesperson added. 'With that plan, we are
reaching out to potential contributors and are already in discussions with
some potential new countries.'
The Medicines Access Advocates
Ellen 'tHoen is one among a growing chorus of advocates who say that
countries need to be considering right now how the rules of the game can
and should be changed proactively - before the various national crises over
access to different drugs and treatments snowballs into a worldwide
firestorm. Says 'tHoen in a recent op-ed:
'The success of C-TAP will depend on the political support it will receive.
But persuasion will need to come from governments and institutions that
spend public resources on the development of new drugs and vaccines by
demanding from their recipients that they share the IP and know-how they
create with those public funds, with the WHO C-TAP.
'Unfortunately, despite the lofty promises of the vaccine as a global
public good, wealthy nations are not making such demands. It is therefore
understandable that developing countries are also looking at non-voluntary
measures such as the proposal for a temporary waiver from certain
provisions of the TRIPS Agreement for the prevention, containment and
treatment of Covid-19. No doubt this will be met with opposition from
wealthy countries and drug companies.
'But those countries and companies who refuse to make the WHO C-TAP a
success while telling developing countries they are not entitled to take
measures to protect public health in the midst of a global health crisis
are not credible.'
She also points out that in the Covid research race, 'countries have
coughed up unprecedented sums of public money to conduct research - meaning
that they should also own more of the associated knowledge. At the same
time, due to the complexity of vaccine manufacture, countries will not
anyway begin to manufacture, helter skelter, the most cutting edge
products.'
'Governments around the globe are carrying the financial risk of developing
new health technologies and in particular vaccines by pouring billions of
public monies into research and development. The EU tracker of pledged
resources for access to tests, treatments and vaccines today stands at E16
billion. Therefore, the often-heard argument that monopoly rights are
needed to allow the inventor to recoup his or her investment does not seem
to apply.
Industry begs to differ
'Intellectual property is not a hindrance but a help to end COVID-19;
indeed the current level of risk-taking would be impossible without a
flourishing innovation ecosystem built on strong IP incentives,' counters
Thomas Cueni, director general of the International Federation of
Pharmaceutical Manufacturers and Associations (IFPMA).
'For this reason, the TRIPS Council proposal by South Africa and India is
incorrect in portraying intellectual property as a barrier to the
collaboration and manufacturing of COVID-19 technologies. It does not
correspond with our experience.
'On the contrary, it is IP that has enabled collaboration between
bio-pharmaceutical innovators and governments, universities and other
research partners to speed up progress on our most pressing unmet medical
needs, including hundreds of potential Covid-19 treatments and vaccines for
patients around the world.'
Cueni goes on to say that the pandemic moment is also not the ideal time to
stir the simmering lava-pot of IP disputes.
Suspending key protections of the TRIPS agreement, would send the wrong
message to industry investors that have 'taken huge risks', he points out.
And this, 'at a time when unprecedented efforts across the board are being
made to control and hopefully end this pandemic and prepare for any future
health crisis, we need innovation and science more than ever.'
How the drama plays out and concludes remains unknown. But one thing is
certain. The decisions made behind closed doors in the stone fortress-like
WTO headquarters on the tranquil shores of Geneva's Lake Leman, by a
council of countries operating under the acronym of TRIPS, will echo back
to the hospital wards and clinics around the world, where dramas of life
and death are being played out for millions of people every day.
Published in Collaboration with Geneva Solutions, the new Geneva-wide
platform for constructive journalism covering International Geneva.
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
thiru@keionline.org