TRIPS Agreement waiver

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Waiver from certain provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19
Presented2 October 2020
Signatories Flag of South Africa.svg Flag of India.svg

Official co-sponsors
Flag of Kenya.svg Flag of Eswatini.svg (15-16 October 2020)

64 countries by November 2021
PurposeWTO TRIPS waiver proposal
Full text
Wikisource-logo.svg Waiver from certain provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19 at Wikisource
opponents

The TRIPS Agreement waiver (officially titled the Waiver from certain provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19) [1] is a joint intervention communication by South Africa and India to the TRIPS council of the World Trade Organization (WTO) on 2 October 2020. [2] [3]

Contents

The two countries are suggesting a temporary patent waiver for COVID-19 drugs, COVID-19 vaccines and related equipment and technologies in four categories of intellectual property under the TRIPS agreement. [4] [5] [6] The four categories, as enunciated in sections of the TRIPS agreement, cover– copyright, industrial designs, patents and protection of undisclosed information. [7] The duration of the waiver is based on the time frame in which the world can develop an immunity against COVID-19. [6]

Generally, wealthier countries oppose the waiver, while poorer countries support it. [8] [9] Reuters noted that the European Union, the United States and Switzerland, countries opposing the waiver, are home to large pharmaceutical companies and have excellent domestic vaccine availability. [10] [11] In May 2021, Reuters quoted an unnamed industry sources as saying that they were attempting to narrow the waiver, seeing little chance of blocking it. [12]

A waiver would have to be agreed to by all 164 WTO member countries; any one dissenter could scupper the deal. The WTO has not managed to get agreement on any substansive new policy since it was founded in 1995. [12] Proponents (including Oxfam) have accused opponents of stalling, [8] [13] and of filibustering by asking the same questions over and over. [11] In fact, both opponents as well as supporters of the waiver helped to narrow the Overton Window of acceptable international policy when they engaged in escalating strategic framing that eventually secured political attention, and sidelined other possible solutions [14] .

Support

On 15–16 October 2020, at the WTO TRIPS Council meeting Kenya and Eswatini became official co-sponsors while 100 countries welcomed or fully supported the proposal; a number of countries did not support the proposal, [15] [7] particularly members of the European Union and Switzerland. [16] [17] By 16 November 2021 the number of co-sponsors grew to 64. [18] Precedents include an African Union communication to the World Health Organization, urging it to ensure universal access to vaccines, in June 2020. [2] [19] Challenges other than patents would still remain such as access to raw materials. [20]

The European Union, the United States and Switzerland, among others, oppose the waiver. [10] [11] Reuters quoted an unnamed industry sources as saying that they were attempting to narrow the waiver, seeing little chance of blocking it. [12]

Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO), supported the waiver. [8] [21] A significant non-state opponent is Bill Gates, who is heavily involved in vaccine activism. [22] [10] [23] [24] His views on legal monopolies in medicine have been linked to his views on legal monopolies in software. [10] [23]

Arguments

Potential increase in vaccine production

Proponents and opponents often agree that an increase in vaccine production would be good. They often agree that it would improve vaccine equity by vaccinating the world's poor years earlier, and thus reduce the risk of new variants (including vaccine-resistant variants) evolving. [25] [22] [9] [ better source needed ] Proponents argue that the waiver would increase vaccine production, opponents argue that it would not.

Opponents argue that there is a shortage of manufacturing capacity, and waiving licensing cannot remedy it. They argue that developing countries cannot safely manufacture vaccines. [22]

According to Médecins sans Frontières (MSF, also called Doctors without Borders), this is the case for making traditional live vaccines (vaccines that use modified live viruses, like the Oxford–AstraZeneca COVID-19 vaccine). Making live vaccines requires rare expertise and manufacturing facilities that take years to set up. By contrast, it is much easier to make a new type of vaccine, mRNA vaccines, such as the Moderna and Pfizer vaccines. In January 2021, some Moderna shots were being manufactured by a chemical company with no previous vaccine experience. [23]

Trade secrets

Vaccine manufacturers have refused to share manufacturing information with Doctors without Borders and the WHO. [23] [26]

Market incentives

It has been argued that a waiver would make pharmaceutical companies less willing to respond to the next crisis; [22] Pharmaceutical companies have argued that it "would undermine innovation". [9] In rebuttal, it has been argued that vaccine development was publicly funded, and thus presented little or no risk to pharmaceutical companies, [25] [22] and that any portion of development costs not covered by public funds has been recouped many times over by profits. [23] Public funding agreements did not include much transparency. Some estimates are that public funds are paying for the research, development, testing, regulatory approval, manufacturing, and advance purchase orders, so that the manufacturers are taking negligible risk, pointing to tenfold increases in stock prices. The companies also get to keep the IP for technological advances made with public funding, allowing them to make more profit in the future.

While "Big Pharma" and the state are frequently identified as key to creating the structures that motivate market incentives, philanthropies also play an important role. Indeed, different forms of interaction between firms, state agencies, and philanthropies work together to capture value from biomedical innovation. [27] While some vaccine manufacturers claim they are selling vaccines at cost, and taking no profit, this is impossible to verify because they are not publishing the financial data. [24]

An editorial in The Lancet called waivers "reasonable in a time of global catastrophe", arguing that the global economy would benefit from broader vaccination, because supply chains cross borders, and even areas with very high vaccination rates depend on areas with lower vaccination rates for goods and services. [28] Tedros Adhanom Ghebreyesus also listed the pandemic's effects on child development and education, and argued that companies would still get royalties, likening the arrangements to those used in wartime. [8]

Risk of new variants

Pharmaceutical companies argued that a waiver would "raise the risk of unsafe viruses". [9] [ clarification needed ]

Proponents argue that a waiver would allow vaccinating the world's poor years earlier, and thus reduce the risk of new variants (including vaccine-resistant variants) evolving. [25] [22] [23] These include Tedros Adhanom Ghebreyesus, who argued that poor vaccine coverage meant that the virus had "more opportunities to mutate and potentially undermine the efficacy of vaccines everywhere", warning "We could end up back at square one". [21]

The SARS-CoV-2 Omicron variant has been cited as an example of why the waiver is needed. [29]

Existence of problem

A British World Trade Organization delegate called it "an extreme measure to address an unproven problem". Pharmaceutical companies have argued that the WTO's existing compulsory licensing rules were equivalent to the proposed waiver. [25] [9] Writing for the Cato Institute, James Bacchus agreed, and said that arguments that compulsory licensing (instead of a waiver) would slow production lacked experiential evidence; "There is no evidence of the need for such a waiver", and that there was no evidence that the WTO had not struck the correct balance between making lifesaving vaccines available sooner and preserving innovation-driving incentives. [9] Pharmaceutical companies maintain IP "tickets", with multiple patents, copyrights, trade secrets, and undisclosed test datasets for each medicine they make. Each would need a compulsory license, and it is debated whether the WTO rules could force licensing of all of them. Compulsory licensing also has to be done on a country-by-country basis. Negotiating the bureaucracy has been called "nigh impossible" for the complex multi-country multi-component supply chains of some COVID-19 vaccine manufacture. [25]

Nationalism

Countries have also argued that the waiver is bad because it would let their patents and copyrights be used by countries with whom they have poor relations. [12]

See also

Related Research Articles

<span class="mw-page-title-main">Patent</span> Type of legal protection for an invention

A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention. In most countries, patent rights fall under private law and the patent holder must sue someone infringing the patent in order to enforce their rights.

<span class="mw-page-title-main">Protectionism</span> Economic policy of restraining trade between states through government regulations

Protectionism, sometimes referred to as trade protectionism, is the economic policy of restricting imports from other countries through methods such as tariffs on imported goods, import quotas, and a variety of other government regulations. Proponents argue that protectionist policies shield the producers, businesses, and workers of the import-competing sector in the country from foreign competitors and raise government revenue. Opponents argue that protectionist policies reduce trade, and adversely affect consumers in general as well as the producers and workers in export sectors, both in the country implementing protectionist policies and in the countries against which the protections are implemented.

The Doha Declaration on the TRIPS Agreement and Public Health was adopted by the WTO Ministerial Conference of 2001 in Doha on November 14, 2001. It reaffirmed flexibility of TRIPS member states in circumventing patent rights for better access to essential medicines.

Intellectual property rights (IPRs) have been acknowledged and protected in China since 1980. China has acceded to the major international conventions on protection of rights to intellectual property. Domestically, protection of intellectual property law has also been established by government legislation, administrative regulations, and decrees in the areas of trademark, copyright, and patent.

A compulsory license provides that the owner of a patent or copyright licenses the use of their rights against payment either set by law or determined through some form of adjudication or arbitration. In essence, under a compulsory license, an individual or company seeking to use another's intellectual property can do so without seeking the rights holder's consent, and pays the rights holder a set fee for the license. This is an exception to the general rule under intellectual property laws that the intellectual property owner enjoys exclusive rights that it may license—or decline to license—to others.

The pharmaceutical industry in India was valued at an estimated US$42 billion in 2021 and is estimated to reach $130 billion by 2030. India is the world's largest provider of generic medicines by volume, with a 20% share of total global pharmaceutical exports. It is also the largest vaccine supplier in the world by volume, accounting for more than 60% of all vaccines manufactured in the world. Indian pharmaceutical products are exported to various regulated markets including the US, UK, European Union and Canada.

<span class="mw-page-title-main">Pharmaceutical lobby</span>

The pharmaceutical lobby refers to the representatives of pharmaceutical drug and biomedicine companies who engage in lobbying in favour of pharmaceutical companies and their products.

<span class="mw-page-title-main">Ellen 't Hoen</span>

Ellen F. M. 't Hoen is an international medical activist. She is an expert in medicines policy and intellectual property law and has been a consultant to a number of countries and international organisations. In 2005 and 2006 she was listed as one of the 50 most influential people in intellectual property in the world by the journal Managing Intellectual Property.

<span class="mw-page-title-main">TRIPS Agreement</span> International treaty on intellectual property protections

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an international legal agreement between all the member nations of the World Trade Organization (WTO). It establishes minimum standards for the regulation by national governments of different forms of intellectual property (IP) as applied to nationals of other WTO member nations. TRIPS was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) between 1989 and 1990 and is administered by the WTO.

A biological patent is a patent on an invention in the field of biology that by law allows the patent holder to exclude others from making, using, selling, or importing the protected invention for a limited period of time. The scope and reach of biological patents vary among jurisdictions, and may include biological technology and products, genetically modified organisms and genetic material. The applicability of patents to substances and processes wholly or partially natural in origin is a subject of debate.

<span class="mw-page-title-main">Tedros Adhanom Ghebreyesus</span> Ethiopian public health official (born 1965)

Tedros Adhanom Ghebreyesus is an Ethiopian public health official, researcher, diplomat, and the Director-General of the World Health Organization since 2017. Tedros is the first African to become WHO Director-General, receiving an endorsement for the role by the African Union. He played a role in the response to the Ebola virus epidemic, the COVID-19 pandemic, and the 2022–2023 mpox outbreak.

The Medicines Patent Pool (MPP) is a Unitaid-backed international organisation founded in July 2010, based in Geneva, Switzerland. Its public health driven business model aims to lower the prices of HIV, tuberculosis and hepatitis C medicines and facilitate the development of better-adapted HIV treatments through voluntary licensing and patent pooling. Its goal is to improve access to affordable and appropriate HIV, hepatitis C and tuberculosis medicines in low- and middle-income countries (LMIC). In May 2020, the MPP become an implementing partner of the WHO's Covid-19 Technology Access Pool (C-TAP).

<span class="mw-page-title-main">Coalition for Epidemic Preparedness Innovations</span> Public-private organization for vaccine development

The Coalition for Epidemic Preparedness Innovations (CEPI) is a foundation that takes donations from public, private, philanthropic, and civil society organisations, to finance independent research projects to develop vaccines against emerging infectious diseases (EID).

Access to medicines refers to the reasonable ability for people to get needed medicines required to achieve health. Such access is deemed to be part of the right to health as supported by international law since 1946.

<span class="mw-page-title-main">Economics of vaccines</span>

Vaccine development and production is economically complex and prone to market failure. Many of the diseases most demanding a vaccine, including HIV, malaria and tuberculosis, exist principally in poor countries. Pharmaceutical firms and biotechnology companies have little incentive to develop vaccines for these diseases because there is little revenue potential. Even in more affluent countries, financial returns are usually minimal and the financial and other risks are great.

<span class="mw-page-title-main">Deployment of COVID-19 vaccines</span> Distribution and administration of COVID-19 vaccinations

As of 3 January 2024, 13.53 billion COVID-19 vaccine doses have been administered worldwide, with 70.6 percent of the global population having received at least one dose. While 4.19 million vaccines were then being administered daily, only 22.3 percent of people in low-income countries had received at least a first vaccine by September 2022, according to official reports from national health agencies, which are collated by Our World in Data.

<span class="mw-page-title-main">Proprietary drug</span>

Proprietary drug are chemicals used for medicinal purposes which are formulated or manufactured under a name protected from competition through trademark or patent. The invented drug is usually still considered proprietary even if the patent expired. When a patent expires, generic drugs may be developed and released legally. Some international and national governmental organizations have set up laws to enforce intellectual property to protect proprietary drugs, but some also highlight the importance of public health disregarding legal regulations. Proprietary drugs affect the world in various aspects including medicine, public health and economy.

Vaccine equity means ensuring that everyone in the world has equal access to vaccines. The importance of vaccine equity has been emphasized by researchers and public health experts during the COVID-19 pandemic but is relevant to other illnesses and vaccines as well. Historically, world-wide immunization campaigns have led to the eradication of smallpox and significantly reduced polio, measles, tuberculosis, diphtheria, whooping cough, and tetanus.

Priti Krishtel is a lawyer and advocate for patent reform and increased public participation in the patent system. She co-founded the United States-based nonprofit organization the Initiative for Medicines, Access, and Knowledge.

<span class="mw-page-title-main">Initiative for Medicines, Access, and Knowledge</span> Nonprofit organization

The Initiative for Medicines, Access, and Knowledge, known as I-MAK, is a U.S.-based global 501(c)(3) organization that advocates in the public interest for affordable access to medicines, and a medicines system that is more inclusive of patients and the public.

References

  1. ↑ "Waiver from certain provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19". World Trade Organization. 2 October 2020. Archived from the original on 11 June 2021. Retrieved 18 June 2021.
  2. 1 2 Ghosal, Aniruddha; Anna, Cara (3 October 2020). "India, South Africa ask WTO to ease IP rules for COVID-19". AP NEWS. The Associated Press. Retrieved 2021-06-18.
  3. ↑ Dabade, Gopal (2020-10-12). "Avoiding patents for Covid-19 vaccines". Deccan Herald. Retrieved 2021-06-18.
  4. ↑ "In landmark move, India and South Africa propose no patents on COVID-19 medicines, tools during pandemic". Médecins Sans Frontières Access Campaign. Médecins Sans Frontières. 7 October 2020. Retrieved 2021-06-18.
  5. ↑ "5 reasons a new proposal by India and South Africa could be a gamechanger in the COVID-19 response". Médecins Sans Frontières Access Campaign. Médecins Sans Frontières. 11 October 2020. Retrieved 2021-06-18.
  6. 1 2 "WTO COVID-19 TRIPS waiver proposal: Myths, realities and an opportunity for governments to protect access to lifesaving medical tools in a pandemic" (PDF). Médecins Sans Frontières. December 2020. Retrieved 18 June 2021.
  7. 1 2 "Members discuss intellectual property response to the COVID-19 pandemic". World Trade Organization. 20 October 2020. Retrieved 2021-06-18.
  8. 1 2 3 4 Boseley, Sarah (5 March 2021). "WHO chief: waive Covid vaccine patents to put world on 'war footing'". the Guardian. Retrieved 2 January 2022.
  9. 1 2 3 4 5 6 Bacchus, James. "An Unnecessary Proposal: A WTO Waiver of Intellectual Property Rights for COVID-19 Vaccines". Free Trade Bulletin. No. 78. Cato institute.
  10. 1 2 3 4 Allison, Simon (30 January 2021). "Bill Gates, Big Pharma and entrenching the vaccine apartheid". The Mail & Guardian. Retrieved 2 January 2022.
  11. 1 2 3 Farge, Emma (January 19, 2021). "Backers of IP waiver for COVID-19 drugs make fresh push at WTO". Reuters. Retrieved 2 January 2022.
  12. 1 2 3 4 Lawder, David (6 May 2021). "WTO vaccine waiver could take months to negotiate, faces opposition -experts". Reuters.
  13. ↑ Fischer, Sara E.; Vitale, Lucia; Agutu, Akinyi Lisa; Kavanagh, Matthew M. (2024-02-01). "Intellectual Property and the Politics of Public Good during COVID-19: Framing Law, Institutions, and Ideas during TRIPS Waiver Negotiations at the WTO". Journal of Health Politics, Policy and Law. 49 (1): 9–42. doi:10.1215/03616878-10910269. ISSN   0361-6878.
  14. ↑ Fischer, Sara E.; Vitale, Lucia; Agutu, Akinyi Lisa; Kavanagh, Matthew M. (2024-02-01). "Intellectual Property and the Politics of Public Good during COVID-19: Framing Law, Institutions, and Ideas during TRIPS Waiver Negotiations at the WTO". Journal of Health Politics, Policy and Law. 49 (1): 9–42. doi:10.1215/03616878-10910269. ISSN   0361-6878.
  15. ↑ "India and South Africa proposal for WTO waiver from intellectual property protections for COVID-19-related medical technologies (Briefing Document)" (PDF). Médecins Sans Frontières. 18 November 2020. Retrieved 18 June 2021.
  16. ↑ Robinson, Mary (1 December 2021). "Vaccine waiver is a moment of truth for EU values". Politico.
  17. ↑ Hannah, Erin; Scott, James; Trommer, Silke; Harman, Sophie (May 12, 2021). "TRIPS waiver: US support is a major step but no guarantee of COVID-19 vaccine equity". The Conversation . Retrieved 2021-12-23.
  18. ↑ Nandi, Shreya (2021-11-15). "India in talks with EU, Australia and Japan to allay TRIPS waiver concerns". Business Standard India . Retrieved 2021-12-23.
  19. ↑ Prabhala, Achal; Kuruvilla, Benny; Brown, Burcu Kilic and Dana (2020-10-15). "We can't let the WTO get in the way of a 'people's vaccine'". The Guardian. Retrieved 2021-06-18.
  20. ↑ Aanchal Magazine; Prabha Raghavan (2021-05-11). "Explained: Intellectual property waiver for Covid-19 vaccines". The Indian Express. Retrieved 2021-06-18.
  21. 1 2 Ghebreyesus, Tedros Adhanom (5 March 2021). "A 'me first' approach to vaccination won't defeat Covid | Tedros Adhanom Ghebreyesus". the Guardian. Retrieved 2 January 2022.
  22. 1 2 3 4 5 6 Cao, Sissi (28 April 2021). "Bill Gates' Comments On COVID-19 Vaccine Patent Draw Outrage". Observer. Retrieved 2 January 2022.
  23. 1 2 3 4 5 6 Mookim, Mohit (19 May 2021). "The World Loses Under Bill Gates' Vaccine Colonialism". Wired. Retrieved 2 January 2022.
  24. 1 2 Hancock, Jay (25 August 2020). "They Pledged to Donate Rights to Their COVID Vaccine, Then Sold Them to Pharma". Kaiser Health News. Retrieved 2 January 2022.
  25. 1 2 3 4 5 Stiglitz, Joseph E.; Wallach, Lori (April 26, 2021). "Opinion: Preserving intellectual property barriers to covid-19 vaccines is morally wrong and foolish". Washington Post. Retrieved 2 January 2022.
  26. ↑ "MSF: TRIPS waiver must be urgently adopted despite WTO Ministerial Conference postponement". Doctors Without Borders - USA.
  27. ↑ Sparke, Matthew; Williams, Owain (2024-01-19). "COVID and structural cartelisation: market-state-society ties and the political economy of Pharma". New Political Economy: 1–18. doi:10.1080/13563467.2024.2304180. ISSN   1356-3467.
  28. ↑ The Lancet Infectious Diseases (September 2021). "COVID-19 vaccine equity and booster doses". The Lancet. Infectious Diseases. 21 (9): 1193. doi:10.1016/S1473-3099(21)00486-2. ISSN   1473-3099. PMC   8360703 . PMID   34391506.
  29. ↑ "MSF: TRIPS waiver must be urgently adopted despite WTO Ministerial Conference postponement". Doctors Without Borders - USA. Retrieved 2 January 2022.
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