[Ip-health] please post - thank you

Ed Silverman pharmalot at gmail.com
Thu Mar 4 04:33:06 PST 2021


*https://www.statnews.com/pharmalot/2021/03/03/covid19-coronavirus-vaccine-south-africa-india-wto/
<https://www.statnews.com/pharmalot/2021/03/03/covid19-coronavirus-vaccine-south-africa-india-wto/>*

*South Africa Official Explains Why World Trade Rules Should Be Waived To
Fight Covid-19*


*By Ed Silverman *

*Last fall, the governments of India and South Africa asked the World Trade
Organization to waive some provisions
<https://www.statnews.com/pharmalot/2020/10/03/wto-covid19-coronavirus-patents-india-southafrica/>
in
a trade agreement
<https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm>
governing
intellectual property rights so that Covid-19 medical products can be more
easily accessed, especially by low-income countries. Their argument is
that, unless a waiver is issued, diagnostics, medicines, and vaccines will
not be available promptly in sufficient quantities and at affordable prices
to meet global demand. But the effort has stalled as some wealthy nations
have balked at the idea. The U.S. Chamber of Commerce says
<https://www.uschamber.com/press-release/us-chamber-statement-proposed-wto-ip-rights-waiver>
the
proposal is “misguided and a distraction from the real work of reinforcing
supply chains.” For its part, the pharmaceutical industry insists that
intellectual property is not a barrier to access. Meanwhile, the incoming
WTO director-general last week hinted at a “third way” that could involve
licensing agreements. *

*We spoke with Mustaqeem De Gama, the counselor at the South African
Mission in Geneva, about the rationale and prospects for the proposal,
which will be discussed at yet another WTO meeting next week. This is an
edited version of our conversation. *

*So let’s start at the beginning. Why did you push this proposal?*

We have been very clear, at all times, that we prefer initial collaborative
efforts in an international forum from the get-go. We have indicated that
we are not opposed to COVAX, the World Health Organization program that
allows countries to pool resource and purchase vaccines together. But there
are various interests at play. The COVAX objectives are very limited. The
goal is to cover 20% of needs of countries that participate in the scheme.
This means that 80% of any country’s needs — whether they self-finance
their purchases or otherwise — would involve purchasing vaccines on the
open market. That’s a shortcoming. It may be a good start and enable
countries to start to immunize the most vulnerable populations, but not
reach herd immunity.

We need further collaborative efforts but we’re not seeing a great uptake
by companies. Some companies have entered into licenses with others to
manufacture a product, but they are not transparent. We don’t know how much
is produced or who it is being produced for. The voluntary approaches we
are seeing are much more restrictive than what we need to address Covid.

So we introduced this waiver to ensure the level of production is
increased. It’s a legal mechanism that’s been used before… It’s been a
prolonged systemic concern we have and has floated up with Covid. We don’t
think the flexibilities we have currently will help us address Covid… But
the waiver for Covid would last only as long as it takes for us to address
the Covid situation.

*But the pharmaceutical industry insists intellectual property is not a
barrier to greater access. Why do you believe the industry is wrong?*

It would be dishonest for me to say that it is not a multi-dimensional
issue over and above intellectual property. There are other issues, as
well. But to our mind, the IP issue predominates. Many of the manufacturers
we are in contact with in the developing world say they reached out to
several originator [brand-name pharmaceutical] companies for a voluntary
license and to produce products in order to satisfy demand. The current
capacity of world production of vaccines is 2.5 billion to 5 billion doses
per annum, but what we require for everyone to be vaccinated for Covid is
10.5 billion doses, since two vaccines so far require two doses… It’s
impossible for companies that hold patent rights to do this within a
reasonable period of time.

Even if we added a bit more capacity, it would take five to seven years for
that capacity to ramp up. If other companies would be allowed to do this,
it would be less time. It’s better to do so over one, or two or three
quarters. So clearly the IP rights are a substantial barrier. If we think
of it, IP rights are not absolute. These rights can be limited under
various circumstances. And we do that regularly. If an IP holder uses
rights in an inappropriate way, we have antitrust rights to say we can take
those rights away and impose damages. Or if it is proven a company
exercised its rights in a way that damages public health. Articles 7 and 8
of the TRIPS agreement
<https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm>[a WTO agreement
known as the Trade-Related Aspects of Intellectual Property Rights]
recognize this, because IP held privately has a great impact on the public
interest. So from that perspective, it’s legitimate to limit these rights.
The issue is exacerbating supply shortages. We feel if we listed IP
barriers for Covid-related products, we would be able to address the
problem in the shortest amount of time, so we can have more people
collaborate to address the problem.

We’ve heard many opponents [to our proposal] say you *can* use TRIPS
flexibilities. But that’s not really the case. The TRIPS agreement is
directed at specific health problems that a specific country or region may
face. I emphasize that it is directed at a country or region. These
flexibilities were never designed to operate under circumstances where a
health emergency is a global one. So an action by one country will be
ineffectual to address the pandemic. More importantly, it may cause
unintended consequences for other regions. We’ve seen export restrictions
in the European Union over vaccine production. The WHO called this a
catastrophic moral failure. We’re dealing with an apparent market failure
and a regulatory failure by governments that are not acting to address the
problem of ensuring that more companies can produce. So we know and we see
that IP is the most substantial barrier.

*You’ve noted more collaboration is needed and other companies should be
permitted to get involved with production. But more big vaccine makers are
working with other big vaccine makers to boost production. Merck just
agreed to work with Johnson & Johnson. How is that not solving the problem?*

If there was full transparency, we could know how many more doses will be
produced and where they would go to. And also we would like to know the
pricing for those doses coming out of those collaborative efforts. What we
do know is that companies not able to finalize or make their own vaccines
are now obtaining licenses from the originators or working with. But all of
it is concentrated in the West. Why is it that these licenses are given
more freely only to companies that are situated in the West? There have
been voluntary licenses given to producers in the developing world, such as
the Serum Institute (of India), but these are few and far between. Every
region should have at least a few companies that can produce.

It’s good to have more production coming in, but the method used to choose
producers is excluding many potential producers in the developing world.
This sends a negative message, because there should be much wider
allocation of these licenses. And one thing quite apparent is the lack of
transparency in how these arrangements work.

South Africa has one producer of the Johnson & Johnson vaccine. It’s Aspen
Pharma, but they’re subject to nondisclosure. What we do know is that, of
300 to 400 million doses the company will produce, only 9% will be
available in South Africa. So one of the concerns is these producers will
target only rich countries that made preorders before they do anything
about the rest of the world. So yes, capacity is being added but if one
looks, there is still more capacity that can be added on a short-term
basis. Why is that not being tapped?

*There’s an argument over just how fast production can be expanded, that
it’s not as easy as flipping a light switch to supply vaccines, especially
those based on newer technologies, just because a license agreement is
reached. What do you say to that?*

I think it’s a dishonest argument. If we look at the profile of vaccine
producers, what we will see is the WHO has a pre-qualifications list and
that 74 out of 100-plus are from the developing world. Clearly, this
indicates there is already an industrial base where we have a sustainable
number of vaccine producers. Secondly, it’s not going to happen overnight,
so yes, we would need time. But that’s OK if you look at the projected
delays in fighting the pandemic if we don’t radically expand the supply to
handle mutations and any follow-up jabs. There’s capacity in the developing
world if the recipe is shared. It’s not as if we’re starting from where a
factory has to be built and people trained. It’s already there. We can
expand capacity in a very targeted way to address this issue. Many people
are also saying well, okay, what about a new type of vaccine. MRNA
<https://www.statnews.com/2020/11/10/the-story-of-mrna-how-a-once-dismissed-idea-became-a-leading-technology-in-the-covid-vaccine-race/>
 is not a brand new technology. There’s been work done in other contexts,
such as cancer. The application to Covid 19 is a novel application, but the
scientific infrastructure already exists in the developing world. So it’s
not an honest narrative that’s been put forward.

*I want to ask you about the incoming WTO Director General, Ngozi
Okonjo-Iweala, who mentioned a “third way” to address the issue and pointed
licensing agreements. What are your thoughts on that?*

I think things have moved forward in Geneva and the tone of the discussion
is very different now, because everyone understands the problem and that we
need to find a solution. As far as proposal, we’ve exhausted the
evidentiary phase – how the waiver would operate, the limits, and the IP
and whether the TRIPS flexibilities are sufficient.

We want to move to a text-based discussion and we hope the next phase will
address this. Do we see this meaning that we have consensus? No, but we
have a lot of sympathy in the room. And it does give credence to the slogan
that ‘No one is safe until everyone is safe.’ Even if you roll out a
vaccination program in your country, if you don’t have the same courtesy in
every country, the virus could mutate and undo much of the vaccine
administration. From that perspective, we realize something needs to be
done. The new director-general has spoken about this third way for
companies to extend voluntary licenses to producers in the developing
world. Whether this will happen at the scale that is required is
questionable.

I haven’t had a formal presentation, though. At this point, we’re open to
ensure we have speedy access to vaccines as soon as possible. But no one
has actually spoken to us. We can only guess what it means.. If it could
ramp up vaccination, it could be a good thing. But if its only pertains to
vaccines, it only addresses part of the problem, because there are also
therapies and diagnostics. This is not to be negative. We don’t know the
content, but we are willing to talk about it.
-30-s


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