|Waiver from certain provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19|
|Presented||2 October 2020|
|Purpose||WTO TRIPS waiver proposal|
|Waiver from certain provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19 at Wikisource|
Waiver from certain provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19is a joint intervention communication by South Africa and India to the TRIPS council of the World Trade Organization (WTO) on 2 October 2020.
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.The four categories, as enunciated in sections of the TRIPS agreement, cover– copyright, industrial designs, patents and protection of undisclosed information. The duration of the waiver is based on the timeframe in which the world can develop an immunity against COVID-19.
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.By 18 June 2021 the number of co-sponsors grew to 62. Precedents include an African Union communication to the World Health Organization, urging it to ensure universal access to vaccines, in June 2020. Challenges other than patents would still remain such as access to raw materials.
Médecins Sans Frontières, sometimes rendered in English as Doctors Without Borders, is an international humanitarian medical non-governmental organisation (NGO) of French origin best known for its projects in conflict zones and in countries affected by endemic diseases. In 2019, the group was active in 70 countries with over 35,000 personnel mostly local doctors, nurses and other medical professionals, logistical experts, water and sanitation engineers and administrators. Private donors provide about 90% of the organisation's funding, while corporate donations provide the rest, giving MSF an annual budget of approximately US$1.63 billion.
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.
Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions is a European Union directive in the field of patent law, made under the internal market provisions of the Treaty of Rome. It was intended to harmonise the laws of Member States regarding the patentability of biotechnological inventions, including plant varieties and human genes.
The Doha Development Round or Doha Development Agenda (DDA) is the trade-negotiation round of the World Trade Organization (WTO) which commenced in November 2001 under then director-general Mike Moore. Its objective was to lower trade barriers around the world, and thus facilitate increased global trade.
The pharmaceutical industry in India, US$40 billion by value, world's 3rd largest by overall volume and world's largest as provider of generic medicines globally, with 20% and 3.5% share of total global pharmaceutical exports by volume and value respectively to more than 200 countries and territories in 2021. With industry standards compliant mega production capabilities and large number of skilled dometic workforce, Indian exports meet the standards and requirements of highly regulated markets of USA, UK, European Union and Canada. According to the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, domestic pharmaceutical market turnover reached Rs 129,015 crore in 2018, growing 9.4 per cent year-on-year and exports revenue was US$17.28 billion in FY18 and US$19.14 billion in FY19.
Universities Allied for Essential Medicines (UAEM) is a student-led organization working to improve access to and affordability of medicines around the world, and to increase research and development of drugs for neglected tropical diseases. Supported by an active board of directors and guided by an advisory board that includes Partners in Health co-founder Paul Farmer and Nobel Laureate Sir John Sulston, UAEM has mobilized hundreds of students on more than 70 campuses in more than 15 countries. These student advocates have convinced universities worldwide to adopt equitable global access licensing policies for licensing their medical research, in order to make life-saving health innovations affordable and accessible in low and middle income countries. UAEM has published two student-led research projects—the University Report Card, which ranks universities on their contributions to global health and has received coverage in The New York Times and others; and Re:Route, a mapping of biomedical research and development (R&D) alternatives.
James Packard "Jamie" Love is the director of Knowledge Ecology International, formerly known as the Consumer Project on Technology, a non-governmental organization with offices in Washington, D.C. and Geneva, that works mainly on matters concerning knowledge management and governance, including intellectual property policy and practice and innovation policy, particularly as they relate to health care and access to knowledge.
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.
The cost of HIV treatment is a complicated issue with an extremely wide range of costs due to varying factors such as the type of antiretroviral therapy and the country in which the treatment is administered. The first line therapy of HIV, or the initial antiretroviral drug regimen for an HIV-infected patient, is generally cheaper than subsequent second-line or third-line therapies. There is also a great variability of drug prices among low, middle, and high income countries. In general, low-income countries have the lowest cost of antiretroviral therapy, while middle- and high-income tend to have considerably higher costs. Certain prices of HIV drugs may be high and difficult to afford due to patent barriers on antiretroviral drugs and slow regulatory approval for drugs, which may lead to indirect consequences such as greater HIV drug resistance and an increased number of opportunistic infections. Government and activist movements have taken efforts to limit the price of HIV drugs.
GAVI, officially Gavi, the Vaccine Alliance is a public–private global health partnership with the goal of increasing access to immunization in poor countries.
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.
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). Economics research finds evidence that the pool increases generic diffusion in LMIC and upstream innovation. In May 2020, the MPP become an implementing partner of the WHO's Covid-19 Technology Access Pool (C-TAP).
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.
A COVID‑19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 (COVID‑19). Prior to the COVID‑19 pandemic, an established body of knowledge existed about the structure and function of coronaviruses causing diseases like severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). This knowledge accelerated the development of various vaccine technologies during early 2020. On 10 January 2020, the SARS-CoV-2 genetic sequence data was shared through GISAID, and by 19 March, the global pharmaceutical industry announced a major commitment to address COVID-19. The COVID‑19 vaccines are widely credited for their role in reducing the spread, severity, and death caused by COVID-19.
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.
The Oxford–AstraZeneca COVID-19 vaccine, codenamed AZD1222, and sold under the brand names Covishield and Vaxzevria among others, is a viral vector vaccine for prevention of COVID-19. Developed by Oxford University and AstraZeneca, it is given by intramuscular injection, using as a vector the modified chimpanzee adenovirus ChAdOx1. Studies carried out in 2020 showed that the efficacy of the vaccine is 76.0% at preventing symptomatic COVID-19 beginning at 22 days following the first dose and 81.3% after the second dose. Another analysis showed that, for symptomatic COVID-19 infection after the second dose, the vaccine is 66% effective against the Alpha variant, and 60% against the Delta variant.
As of 3 July 2021, 3.19 billion COVID-19 vaccine doses had been administered worldwide based on official reports from national health agencies collated by Our World in Data.
Vaccine Maitri is a humanitarian and commercial initiative undertaken by the Indian government to provide COVID-19 vaccines to countries around the world. The government started providing vaccines from 20 January 2021. As of 9 April 2021, India had delivered around 64.5 million doses of vaccines to 85 countries. Of these, 10.5 million doses were gifted to 45 countries by the Government of India. The remaining 54 million were supplied by the Serum Institute of India under its commercial and COVAX obligations. In late March 2021, the government temporarily froze exports of the Oxford–AstraZeneca COVID-19 vaccine, citing India's own COVID crisis and the domestic need for these vaccines.
COVID-19 vaccination programs have begun in many countries and territories in Africa. As of 1 July 2021, vaccination campaigns had started in 51 African countries with 35 million people receiving at least one dose.
But the proposal has found a number of co-sponsors in Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt, the African Group, Maldives, Fiji and Namibia, among others.