[Ip-health] Health Policy Watch: Philanthropy Alone Will Not Ensure Global Access To COVID-19 Vaccines – South Africa’s Take

Thiru Balasubramaniam thiru at keionline.org
Wed Nov 25 14:03:29 PST 2020


https://healthpolicy-watch.news/mustaqeem-de-gama-qa-philanthropy-will-not-fix-lack-of-vaccine-access/

Philanthropy Alone Will Not Ensure Global Access To COVID-19 Vaccines –
South Africa’s Take
Interview 25/11/2020 • Kerry Cullinan & Elaine Ruth Fletcher

South Africa is campaigning for the World Trade Organization (WTO) to
waiver intellectual property rights on all products related to COVID-19 for
the duration of the pandemic. Mustaqeem De Gama, Counsellor at the South
African Permanent Mission in Geneva, is leading the campaign. Kerry
Cullinan and Elaine Fletcher spoke to him about the reasons why he sees the
WTO initiative as central to efforts to get COVID treatments and vaccines
to people worldwide.

Health Policy Watch: What kind of support do you have for the waiver
proposal, which was discussed at WTO TRIPS Council on Friday? Other than
India, it seems that mostly smaller countries support it.

Mustaqeem De Gama: From our consultations, we have a feeling that we have
majority support for this proposal. You can actually see it from what
happened in the first meeting of the TRIPS Council where we had introduced
the proposal on 16 October. There were about 40 interventions. At least 30
to 31 were positive, while 9 said they could not support this. About 12 or
13 countries have no condition on their support, 15 or 16 countries support
the waiver but have a few questions, and then the third group said that
they could not support our idea.

We also had statements from the African Group, the Least Developed
Countries group, and from the Africa-Caribbean-Pacific Group, all
favourably disposed to the proposal. I haven’t done a headcount, but I
think a big proportion of the 164 member countries would be in support of
this proposal.

HPW: The ball game seems to flip back and forth between the WTO and the
COVAX initiative: between the WTO, and big philanthropy, donor-driven
models like Bill Gates – which funds a lot of vaccines at accessible prices
and pharma agreements for the creation of voluntary licenses for vaccines
with generic manufacturers – which gives countries the option to act at
national level.

MDG: We are happy to work within the confines of multilateral approaches
with, for instance, the ACT Accelerator [Access to COVID-19 Tools (ACT)
Accelerator], its vaccine access arm, COVAX, and the COVID-19 Technology
Access Pool (C-TAP).

What our waiver proposal says is: let’s make available any drug, vaccine or
technology that will help everyone to deal with COVID-19. So from that
perspective, the COVAX initiative that could make available vaccines to low
and middle-income countries, is welcomed. COVAX is a good start however it
is not a long-term solution.

We are also able to work with voluntary licenses given by companies such as
AstraZeneca.

Every little bit helps us to achieve the quickest possible access, but
these approaches do not result in ramping up the production capacity. They
are limited to only a handful of producers.

Look at the volume projections of the Pfizer vaccine for example: 50
million doses before the end of this year and 1.5 billion by the end of
next year, with pre-order purchases that have already been put in by rich
countries. Even if countries such as South Africa, which self-fund under
COVAX, were to try to purchase this vaccine in the open market, there’s no
guarantee we could get access to enough within the timelines required to
establish effective access.

We are confronted with a situation where, even if COVAX could procure large
volumes, there would not be enough vaccines to cover a substantial part of
the population. It is projected that, for low- and middle-income countries,
only 20% of the population will be covered. But this is not even feasible
now, given various issues that have arisen, such as a two-dose regimen.
This is now becoming the standard and it effectively halves the number of
people who can be vaccinated. There will be limited benefits for the
developing world that has limited ability to pre-purchase vaccines.

By the end of 2021, COVAX could possibly come to an end. From that point of
view, we think that’s the shortcoming of institutions that are run on the
basis of gifting or philanthropy. They are not effective long-term
mechanisms because these only have a short-term time horizon. It’s a good
idea in principle but is hampered by funding problems and issues around
transparency.

Our waiver proposal is supportive of these processes, but we don’t think
that they go far enough. Every country should be in a position to take
control of the public health challenges that it faces.

HPW: What emerged from the meeting last Friday in the TRIPS Council and
what are the next steps? Are South Africa and its allies going to ask for a
vote on the issue?

MDG: There has been a lot of focus on a vote. But the WTO works on
consensus. We don’t have to go to a vote to get an outcome. We feel that
this process could benefit from greater political oversight in the WTO
General Council, as opposed to the TRIPS Council. We are working on a
report to take to the General Council next month for further consideration
and discussion. Then we will rely on the General Council to give further
direction, including possible recommendations.

We are also trying to demystify the proposal and build further support. At
last Friday’s meeting, there was a good discussion on core issues, but we
ran out of time. So we want to use the next few weeks to reach out to both
like-minded and opposing delegations to explain our position, and also
build a coalition and consensus among like-minded groups.

We want the WTO to show that it is part of the solution to COVID-19, and
not part of the problem. This is an organisation that has competence in
trade-related matters: this is where intellectual property rights come in.
There is a powerful role for the WTO to play to ensure that everyone has
access to what they need to try and address the epidemic, whether it is in
prevention, diagnosis or treatment.

Africa has so far managed the COVID-19 pandemic exceptionally well, with
only an estimated 4% of the world’s cases, but a resurgence of infections
being seen right now underlines the fact that the continent is not immune.
Ensuring equtiable access to vaccines is vital.

HPW: Are you open to fine-tuning this waiver, and possibly confining it to
vaccines, tests treatments, ventilators and PPE –  a more defined set of
 the public goods?

MDG: There are four broad categories of intellectual property rights that
we suggest could be suspended for the duration of the pandemic: copyright,
industrial designs, patents and undisclosed information.

We think that there are good reasons to suspend them. First, COVID
constitutes an international emergency, which is part of the requirements
to invoke the waiver in the first place. Secondly, the waiver has a
specific scope of application. And thirdly, It should be in place until a
vaccination or COVID is largely defeated, that is it applies only for a
limited time period.

HPW: Are you saying that the problems go beyond patents to also include
“trade secrets”, copyright and industrial designs? Can you explain why
these are important right now?

MDG: Currently, a lot of patents require disclosure of information when
they are filed. Companies get a monopoly if they disclose the ‘new thing’
that they did, and for that they get the right to a 20-year patent, for
example.

But many companies are not doing that anymore or rely on other modes of
protection. They are going the “trade secret” route – which is a separate
category under the TRIPS agreement. In the last four or five years, we’ve
seen most industrialised countries upgrade these aspects of their laws that
are not necessarily included in the patent application. For example, what
doses and combinations work could be considered trade secrets and hence
protected. The same applies to test data, medical formulas, in the case of
vaccines and other biological medicines: cell lines and genomic information
can be held as trade secrets.

There is very limited experience in dealing with trade secrets, I cannot
think of any publicly available information where a national authority
would have issued a compulsory licence to enable a local manufacturer to
produce a product that is covered by a “trade secret”, and the same could
be said for industrial designs or copyright. We have to remember that
copyright also protects databases, compilations, algorithms and mobile data
that can be leveraged for the detection and control of COVID-19. These are
novel issues. South Africa requested the TRIPS Council to discuss these
issues previously when it submitted a communication entitled: “Beyond
Access to Medicines and Medical Technologies Towards a More Holistic
Approach to the TRIPS Flexibilities,” dated 17 July 2020, contained in
IP/C/W/666.

We have very little experience in how we could apply government measures to
force disclosure on some of these if the rules are not clear. So, we
thought we should give a little bit of flexibility for things to happen in
the interim which would also give governments the ability to access certain
types of information in order to scale up production or the address aspects
such as detection, prevention and control of the coronavirus.

The proposal has caused a lot of anxiety for many countries, however
Mustaqeem De Gama believes there is no need to invalidate half of the TRIPS
agreement, as countries fear.

HPW: How will the waiver happen in an orderly and legal fashion?

MDG: The proposal has caused a lot of anxiety for many countries. They ask
if we are saying that we need to invalidate half of the TRIPS agreement.
Our answer is a very simple ‘no’. The waiver will be agreed at the level of
international commitment and every country will decide on how it wants to
benefit from the waiver.

We don’t believe that countries will suspend all the IP rights that are
mentioned, nor are they required to do so. They may do it selectively. Some
don’t have production capacity but may want to import generic versions of
medicines that could be effective, not only for COVID but also for the
comorbidities that are associated with COVID. They may import a very narrow
range of pharmaceuticals, or they may want to import a vaccine if it is
being produced. Other countries may have needs on the diagnostic side. Some
countries may have needs in terms of testing, access to buffers, and so
forth. The waiver presents a bespoke solution to all countries that need
it. If a country decides that it does not need to invoke the waiver, it is
free to do so as well.

Countries will have to decide what their greatest needs are and implement
the waiver from that perspective. The waiver is not a blank cheque to waive
all legitimate IP obligations. That’s why we’ve limited the scope of
application to cover on COVID and related products and processes, and left
it to the discretion of individual members to invoke aspects that they
require.

HPW: But if each country can invoke that part of the waiver that it wants
to use, wouldn’t that create a real hodgepodge that undermines an
international agreement?

MDG: We have the 2003 waiver decision that creates an exception for
countries that don’t have manufacturing capacity, now embedded in Article
31bis of the TRIPS agreement. Countries may invoke this system, known as
the paragraph 6 system, however the procedure is fraught with both
procedural and substantive hurdles which makes it difficult to use. It has
only been used once.

Nonetheless, when this waiver was implemented, certain industrialized
countries indicated that they would not use this waiver in any way while
other countries said they will only use it in emergency situations. It is
no different with this waiver proposal, countries may choose they want to
use the waiver and – for transparency purposes – may notify the WTO just as
would have been envisaged under the 2003 waiver.

When countries invoke the waiver, the “law of the jungle” will not apply.
At a national level, when you issue a compulsory license, there are
specific processes that are followed in which the rights of all parties are
protected, including the licensor and the licensee. The principle of good
faith also applies in this situation.

HPW: You are saying this won’t be the “law of the jungle”. How will that be
ensured?

MDG: People are creating this Frankenstein monster about the waiver but
this should not be the case. This is an opportunity to have collaborations
that will strengthen our ability to deal with future pandemics. The waiver
is a short-term solution, it is opening up the possibility for longer-term,
more sustainable solutions. We have to build a better system after COVID to
ensure resilience in the face of future challenges.

In a pandemic of this nature, it’s unlikely that states will act in bad
faith and do things that they are not allowed to do. Once the period for
which the license has been granted is over, those rights are fully
recovered by the rights holder. But we also believe in the process we could
create other avenues for collaboration. It is in our common interest to
protect IP, but only to the extent that it respects the balance between
rights of holders and the public interest. Thus when such rights are
‘limited’ it is done under conditions of the rule of law and national legal
parameters that will ensure that such information is nonetheless protected.

I can’t imagine that my grandmother and her friends will now request the
‘recipe’ for a vaccine, to make it in a kitchen sink. There are only a
handful of countries and producers that can do that. The fear of abuse is
totally irrational and unfounded.

HPW: AstraZeneca has come out with news that their vaccine is 90%
effective, and as well as not requiring freezer storage, that vaccine can
be sold at US$3 a dose – isn’t that good news still for low and
middle-income countries like South Africa?

MDG: We have AstraZeneca saying their vaccine is 90% effective, Moderna
saying theirs is 95%, and then you have a restatement from Pfizer. There’s
no peer review on the exact figures so who is to say that these companies
are correct. There is still a way to go with most of these vaccines. We
cannot go on the companies’ words. They will have to submit vaccines for
regulatory approval. Let’s see whether authorities share the same views as
the companies as to the efficacy claim around their vaccines.

We ought also to observe how companies will share data about their
vaccines. Will vaccines make less people infectious or will they only
prevent severe illness? This is not yet clear from information that
companies have made available. Since the SARS-CoV-2 virus accumulates in
the upper respiratory tract before causing symptoms, there is the
possibility that vaccines will not necessarily prevent people from
spreading the virus even if they may be largely immune to the virus. I
think there is still a long way to go with COVID-19.

While pricing may be cessional for as long as the pandemic lasts, companies
have ultimate discretion on how they will apply these in a highly lucrative
market which is estimated to be worth in excess of US$40 billion worldwide.
Who will make the decision when the pandemic is over? I think without
intervention, profit will prevail over lives.

HPW: What about global production capacity to make a vaccine?

MDG: Many pharmaceutical companies have sold or outsourced their production
capacity, including companies such as Moderna and AstraZeneca. This is a
problem because they have very little in-house production and are reliant
on third-party producers.

This is why they are now licensing to third parties in the developing
world, not because they are magnanimous but because they just don’t have
the capacity to produce at the rate that is required.

You’ll see more and more of these voluntary licenses, but it’s a throwback
to the model that pharmaceutical companies and biotechnology companies
would have chosen to advance their agendas. The fact that they entered into
these licensing agreements does not indicate it is because they like us: it
shows they need us.

HPW: You indicated in your address to the TRIPS Council on Friday that some
pharmaceutical companies that had declared that they would operate on a “no
profit principle’’, but some of these companies have retained the legal
power in their licensing agreements to suspend this principle as early as
July 2021. What’s the implication of that?

MDG: Allowing companies to say when the pandemic is over is certainly
problematic. The signals of the ‘home country’ is likely to be decisive in
such a decision. But as soon as that country declares the pandemic is over
in its own territory, companies will invoke provision in  the licensing
conditions entitling them to move from no profit to exorbitant profit.

Part of the transparency requirements that we put on the table, asks
companies to make available the licensing agreements in full so that we can
know what it costs for them to produce their vaccine, as well as disclosing
any funding received from governments, whether directly through subsidies
or indirect through collaboration with publicly funded institutions. The
same logic would apply to disclosure of information regarding the effect of
vaccines: how long immunity lasts, whether boosters will be required
outside a two dose regimen that frontrunners are signaling. If so, how
long? Six months, a year or longer? It’s just too early to tell. COVID-19
seems likely to become endemic.

At present, we don’t even know what the collaboration agreements might
mean. Information has emerged of a collaboration agreement with Aspen (a
generic manufacturer) in South Africa but we don’t know what the full
extent of their license agreement is except to say that 300 million doses
will be produced. We are not certain whether some doses will go to South
Africa. If so, how many, and what will go to the African continent?

HPW: Why is South Africa one of the countries leading this campaign?

MDG: South Africa’s stance is not new. The country took pharmaceutical
manufacturers to court for medicine pricing under President Nelson
Mandela’s government, while Dr. Nkosazana Dlamini-Zuma stood accused of
trying to steal IP rights because of amendments to health legislation. The
positions that we have taken are consistent with the mandates that we have
in our Constitution on access to health and the right to life.

Our delegation has raised these issues for at least the last 4 years in the
TRIPS Council, but was met with deafening silence. When confronted with
issues of access, high pricing, and the unfair competitive practices of
pharmaceutical companies, developed countries merely respond that these are
not matters for the TRIPS Council and that they should be dealt with
somewhere else. But if these matters are raised in the World Health
Assemblies, then they say these are IP matters that should not be raised in
the World Health Organisation so where should we raise these issues?


Mustaqeem de Gama is a Counsellor at the South African Mission in Geneva
and is accredited to the WTO and UN. He previously worked at the Department
of Trade and Industry in South Africa where he headed the International
Trade and Investment Directorate.


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


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