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THE CONUNDRUM OF IPR WAIVER OF COVID 19-VACCINES: A GLOBAL SCENARIO
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THE CONUNDRUM OF IPR WAIVER OF COVID
19-VACCINES: A GLOBAL SCENARIO
AUTHORED BY - AKSHITA KAUSHIK
Since the onset of the COVID-19 Pandemic
, the havoc that was wreaked in India and the chances of new variants affecting
the world at large ignited the debate as to how countries could ensure affordable
and equitable access to key drugs and the vaccines , and with regard to the
same, a great deal of vulnerabilities and inequities in the global healthcare
system came into the picture. Since 2019, the virus hit the whole world , and
presently , in 2023 , this is the fourth year going on , with more than 76 crore confirmed
cases of COVID-19 as of June 2023 , as per the World Health
Organization ,it is the cold and overwhelming reality that the people have
become accustomed to living with the virus .To overcome this , two methods were
thought of , the first one being the herd immunity and the second one being administering
the vaccine to all , where the first one should have been quite disastrous .Here,
a key role was played by the COVID-19 vaccines in developing the immunity of an
individual against the SARS-CoV-2
or the COVID-19.
While,
more than 48% of the United states was fully vaccinated, only 15% of the
world stood to be vaccinated . of which only 8.9% people in low
income countries received two doses .such disparities caused the members of the
World Trade Organization , such as India and South Africa to call
for a waiver of Intellectual property(hereinafter referred to as IP) enforcement
related to diagnostics , vaccines , medicines ,ventilators etc. Along
side these , the United states also extended its support for temporarily
waiving off the Intellectual property rights protection under the TRIPS granted
to the COVID-19 vaccines . Further , at the 12th Ministerial
conference of the World Trade Organization conducted in Geneva on June 17th 2022 , a significant deal regarding partially
waiving off the Intellectual property restrictions on manufacture and
production of COVID-19 vaccines for the upcoming five years was also approved
by the participating countries. Though , no such mention was made with regard
to the diagnostic kits, medicines , equipments etc
IPR
waiver – meaning
In
general , an IP waiver releases the rights of an individual or company’s
invention to another and in today’s tech savvy world , the area of IP waiver is
a hot-topic. A waiver essentially would mean that a country would get the
access to raw materials and technologies that would aid it in shooting the
production of that desired advancement. The TRIPS agreement needs for some of
its member countries to , including the United States to have “minimum”
intellectual property protections. This is usually called as a “Patent
waiver” .The TRIPS’S proposal aims at waiving part II ,Section 5
Patents of the TRIPS agreement and
linked sections only with regard to the “health products and
technologies including diagnostics, therapeutics, vaccines, medical devices,
personal protective equipment, their materials or components, and their methods
and means of manufacture for the prevention, treatment or containment of
COVID-19”In India and various other countries a debate had been going
on with regard to the Patent waiver of the vaccine. A patent waiver
essentially means the extreme version
of technology transfer via licensing or sale of patent , which
includes sharing of the following for a greater good-
Article
27 requires that “some members” issue patents to inventions
that are –
a.
New
b.
Involve an inventive step and
c.
Capable of industrial application
Further
, according to Article 28, a patent owner may prohibit anyone from
"making, using, offering for sale, selling, or importing"
(infringing) the patented innovations.
At last, Part III of the TRIPS Agreement discusses possible
repercussions of patent infringement. The offender may be held accountable for
monetary damages, plus the Member's judicial power may issue injunctions.
Arguments
for IPR waiver of the vaccine-
Ensuring
Equitable Access: Waiving IPR would allow for the rapid scaling up of vaccine
production and encourage technology transfer to LMICs, enabling them to produce
affordable vaccines and address supply shortages.
Addressing
Global Health Emergency: The magnitude of the COVID-19 pandemic calls for
extraordinary methods. Critics argue that protecting intellectual property at
the expense of human lives and public health is ethically unacceptable.
Promoting
Collaborative Research and Development: An IPR waiver could encourage collaborative
efforts among pharmaceutical companies, research institutions, and
manufacturers, facilitating technology sharing and knowledge exchange to
develop effective vaccines.
Overcoming
Manufacturing Barriers: The complex manufacturing processes involved in vaccine
production often require specialized facilities and know-how. An IPR waiver
would allow more manufacturers to produce vaccines, increasing global supply
and reducing dependence on a limited number of companies.
Counterarguments
and Concerns
Critics
of the IPR waiver proposal raise several valid concerns that warrant careful
consideration:
Impact
on Innovation: Critics argue that an IPR waiver may disincentivize future
investment in research and development. Pharmaceutical companies rely on patent
protection to recoup their investments and fund future innovation. Removing
patent rights could diminish the motivation to develop new vaccines and
treatments, potentially impacting future healthcare advancements.
Technology
Transfer Challenges: While an IPR waiver may allow LMICs to produce vaccines,
technology transfer is a complex process that requires significant
infrastructure, technical expertise, and regulatory capabilities. Simply
waiving patents may not guarantee
GLOBAL
SCENARIO – IPR WAIVER
United
states
In a
ground breaking move , the united states in 2021 supported the waiving off of
the COVID 19 vaccines , despite the fact that it believes in covid 19 wiaver .The
WHO’s director general – Tedros Adhanom also went on to praise this decision .
Though many of the pharmaceutical companies like AstraZeneca, Pfizer and
Johnson & Johnson of the United states opposed this decision of the biden
administration and stated that The Biden Administration has taken an
unprecedented move in the middle of a dangerous pandemic, undermining our
global response and jeopardising safety." Though , later on On President
Joe Biden confirmed that the White House will support the World Trade
Organization's IP waiver request.
South Africa-
In June 2022 , south Africa supported
the WTO agreement to let the developing nations to produce their own vaccines /
ingredients etc which were under patent . For the time being, the agreement doesn’t
include testing and costly medical therapies against COVID, which the WTO also
ruled out. South Africa has three sites: Aspen in Durban, Afrigen in Cape Town,
and Biovac, also in Cape Town, where the Pfizer- vaccine is manufactured.
Afrigen's biotech collaboration creates the RNA shot using the Moderna formula,
the first to be created using a widely used vaccination without the developer's
cooperation and consent.
United Kingdom –
Both
the Labour Party and the Scottish Government
have supported a vaccination
rights waiver. They both think that this will assist promote global production
while also lowering the chance of new variations of concern developing.
Compromise
deal of 2022 –
The
deal covers the following areas-
• Allows developing nations to
authorise the use of patented materials for the manufacture of Covid-19
vaccines without the consent of the rights holder to produce vaccines, for
domestic markets and eligible countries. Rights holders would also get
compensated.
• Covers a period of five years
• States the WTO will consider its
extension to therapueutics and diagnostics withing 6 months
As per
the deal For the upcoming five years, developing nations will be allowed to
utilise patented materials and ingredients in the production of Covid-19
vaccines for domestic and eligible markets without the approval of the holder
of the rights
DOMESTIC
SCENARIO – IPR WAIVER OF COVID 19 VACCINES
In
2021 , alongside South Africa , India was also one of the countries that
supported the idea of waiver of COVID 19 vaccines to counter the “Pandemic
equitably”. The initial pitch, made in October 2020
by South Africa and India and supported by over 100 countries, sought for a
waiver of TRIPS safeguards for COVID-19 medical items like as vaccinations,
medications, diagnostics, ventilators etc.
In
2021 , India and south Africa made a joint proposal before the WTO to temporarily
waive off the IP protection on COVID 19 Vaccines , though the situations were a
deadlock . as per the joint proposal of India and south Africa the waiver would
guarantee that intellectual property rights (IPRs) "do not create hurdles
to prompt access to inexpensive medical products, including vaccines and
medicines, or to scaling-up of the development, research, manufacturing, and
distribution of medical supplies necessary for battling COVID-19."
In
2022 , in the WTO , India tore into those nations which opposed IPR
waiver of the vaccines. The commerce and industry minister -Piyush Goyal also tore
into those countries that apparently opposed the waiver of the vaccines and
other therapeutics and made following statements –
1.
1. "Several pharmaceutical giants, for profit, and some
countries, for profit, have stripped away the rights of the poor to be
vaccinated." Profits are their first objective.
2.
He further focused that despite , the high death toll , countries
are not ready to help those in need
3.
He further added that,
although affluent countries have already provided 2-3 doses to their whole
population, many developing countries are still fighting to get their first
dose.
4.
. Another troubling statistic is that pharmaceutical behemoths
like Pfizer and BioNTech had supplied less than 1% of their entire vaccination
supply to low-income nations, while Moderna had delivered only 0.2%
5.
In order to gain support for the India-South Africa proposal (the
combined request was presented at the WTO demanding the rights to produce
Covid-19 vaccines and treatments,) the WTO granted a temporary waiver of 6
months in June 2022. Goyal met with
South African Minister Abraham Patel as well as US Trade Representative
Katherine Tai today. Piyush Goyal said the IP rights waiver
for five years agreed upon during the 12th ministerial conference of the WTO
would help developing countries manufacture patented Covid-19 vaccines.
He emphasised that the Global South currently accounts
for more than half of global economic growth, with South-South trade reaching
$5.3 trillion by 2021. Mr Goyal also pitched for increasing efforts at the WTO
and has also said there was a need for depoliticization of the global supply of
essential medicines.
He also went on to state “A vaccine in
India gets produced for $1.5, whereas many parts of the world are paying $38 to
$40 plus. India has agreed with 80 countries or more to give a TRIPS
[Trade-Related Aspects of Intellectual Property Rights] waiver’. ..this is
nothing near a TRIPS waiver, ... this is a little elevation from compulsory
licensing," Goyal said at a meet with co-sponsors of TRIPS waiver. Further
this came in the wake of Global Innovation Policy Centre (GIPC) of the US
Chamber of commerce report , in which the following were highlighted, "the
WTO's move to eliminate IP protection for vaccines incentivise political
scapegoating over investing in solutions. This threatens the global framework
for IP protections and jeopardises the future of innovation”
WHY
SHOULD THE WAIVER OCCUR , IF THERE CAN BE COMPULSORY LICENSING?
Patents
are a type of intellectual property right that is given to people or companies
for an invention that is considered new in nature and has some practical use.
Typically, the legal duration for patent protection is 20 years. During this
time, the investor is vested with exclusive rights to use the intellectual
contents of the patent, while third parties are not permitted to do so.
Although,
there is one way in which the controller general of the patent office can
enable a third party to manufacture, use, sell, and/or distribute a patented
product without obtaining the patent owner's approval or a licence. Such an action,
known as Compulsory licencing, are codified in Chapter 16
of the Indian Patents Act of 1970 and Section 31 of the Trade Related Aspects
of Intellectual Property Rights (TRIPS) agreement.
As per
W.T.O , Compulsory licensing is when a government allows someone
else to produce a patented product or process without the consent of the
patent owner or plans to use the patent-protected invention itself. It is
one of the flexibilities in the field of patent protection included in the
WTO’s agreement on intellectual property
In India , the aspect of compulsory
licensing is governed by section 84 of the PATENTS ACT , 1970.
It mentions the grounds of granting compulsory licensing on the PATENT , which
are as follows-
In the international domain ,vaccines
could not get compulsorily licensed due to the following reasons-
1) Since many countries lack the
domestic infrastructure to manufacture , they would have to rely upon licensing
only under ARTICLE 31
WHEREBY , the process of the same is –
STEP 1-The
importing country has to notify of its intention to issue a compulsory licence,
with information of the name of the product and the quantities to be imported,
and enforce measures to prevent re-exportation.
STEP 2 -The exporting country must similarly
inform of its intention to grant a compulsory licence, with the information
specifying the product, export quantities and the final destination, whereby
the products have to display differentiated features indicating that they are made
under the licence, and post this information on a website
WHY CAN COMPULSORY LICENSING NOT BE A
GREAT IDEA?
On May 5, 2021, the Government of
India announced that it would waive off the import duties on COVID-19 vaccines
and related supplies. This step was taken to facilitate the availability of
vaccines in the country.
Additionally, on May 21, 2021, the
Indian government released new guidelines for the fast-track approval of
foreign COVID-19 vaccines that have been granted emergency use authorization by
recognized regulatory authorities abroad. These guidelines aimed to expedite
the availability of vaccines in India.
As per what was stated by NITI AAYOG member
VK paul , that compulsory licensing might not be a great idea since, it is not a 'formula' that matters and other
aspects like sourcing of raw materials and training of human resources also
need to be taken into consideration,
He also further stated that there has
been a new step that has been taken by Bharat
Biotech & 3 other entities to enhance production of Covaxin
The Commerce Standing Committee of Parliament has requested that the Centre conduct a comprehensive review of the country's intellectual property rights (IPR) policy. The group also suggested "compulsory licencing" for producers to address the scarcity of vaccinations and medications during the Covid-19 Pandemic, as well as modifications to the Indian Patent Act, Trade Marks Act, and Copyright Act to match modern needs.
The Commerce Standing Committee of Parliament has requested that the Centre conduct a comprehensive review of the country's intellectual property rights (IPR) policy. The group also suggested "compulsory licencing" for producers to address the scarcity of vaccinations and medications during the Covid-19 Pandemic, as well as modifications to the Indian Patent Act, Trade Marks Act, and Copyright Act to match modern needs.
CONCLUSION-
In conclusion, the debate surrounding
the waiver of intellectual property rights (IPR) for COVID-19 vaccines has been
a contentious issue globally. The call for an IPR waiver has been driven by the
need for equitable access to vaccines, especially in low-income countries, to
address the ongoing pandemic. Supporters argue that waiving IPR would
facilitate technology transfer, encourage collaboration, and ensure affordable
vaccine production, thus helping to overcome supply shortages and address the
global health emergency.
However, critics express concerns
about the potential impact on innovation and future investments in research and
development. They argue that patent protection is crucial for incentivizing
pharmaceutical companies to develop new vaccines and treatments. They also
highlight the complex challenges of technology transfer and the need for
infrastructure, expertise, and regulatory capabilities to ensure effective
production
Despite these concerns, several
countries have shown support for the IPR waiver. The United States, South
Africa, and India have been at the forefront of this movement, advocating for
temporary waivers to facilitate the production of COVID-19 vaccines. The
compromise deal reached at the World Trade Organization (WTO) in 2022 allowed
developing countries to use patented materials for vaccine production without
the rights holder's consent for a five-year period.
While the IPR waiver for COVID-19
vaccines has its merits in terms of addressing global health disparities, it is
essential to strike a balance between ensuring equitable access and
incentivizing innovation. Efforts should focus not only on waiving IPR but also
on promoting technology transfer, capacity building, and collaborative research
and development. Additionally, a comprehensive review of intellectual property
rights policies and their impact on public health should be undertaken to
address the evolving needs of the healthcare sector.
Ultimately, the global community
needs to work together to find sustainable solutions that prioritize public
health while also fostering innovation and ensuring the availability of
life-saving vaccines to all those in need.
Article Information
THE CONUNDRUM OF IPR WAIVER OF COVID 19-VACCINES: A GLOBAL SCENARIO
Authors: AKSHITA KAUSHIK
- Journal IJLRA
- ISSN 2582-6433
- Published 2023/06/23
- Issue 7
About Journal
International Journal for Legal Research and Analysis
- Abbreviation IJLRA
- ISSN 2582-6433
- Access Open Access
- License CC 4.0
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