Tell governments to stop blocking the WTO Waiver on monopolies of COVID-19 medical tools
by ICJ, Médecins Sans Frontières (MSF), agencies
12:49pm 26th Nov, 2021
Nov. 2021 (MSF)
After more than a year of delay, the negotiation for a temporary waiver on intellectual property (IP) rights for COVID-19 medical tools under the World Trade Organization (WTO)’s Agreements on Trade-related Intellectual Property Rights (TRIPS) is speeding up, with countries engaging on the proposal to advance the negotiation before the 12th WTO Ministerial Conference in Geneva on November 30-December 3, 2021.
The waiver, as initiated by South Africa and India in October 2020, and supported by multiple WTO members could provide a critical legal pathway for countries to facilitate more diversified and sustainable production and supply of COVID-19 medical tools.
Médecins Sans Frontières (MSF) considers the adoption and implementation of the waiver are among the key actions that governments should take to turn the corner of the access challenges in COVID-19. We underline the following key elements as essential for inclusion in final text of the TRIPS waiver.
All essential medical technologies beyond vaccines
The scope of technologies under the waiver should go beyond vaccines. Ensuring access to all medical countermeasures is necessary to end the pandemic. MSF believes that the waiver must also cover other medical tools particularly medicines and diagnostics, as well as their underlying technologies, raw materials, components, manufacturing data, methods, delivery devices and process of production.
Our experience in working in public health emergencies and some of the most difficult situations in the world, has made clear that testing and treatments are essential to infectious disease prevention and mitigation. A waiver that does not cover all of these elements will be a failure.
Intellectual property barriers beyond patents
The TRIPS Waiver proposal has brought clear recognition to multiple types of IP barriers, beyond patents, that are challenging access to COVID-19 medical tools. Particularly, often regulatory information related to the manufacturing of the medical product is available to the drug regulator but not disclosed, even when required in the public interest.
This information submitted to authorities is not revealed and is treated as a trade secret, impeding the early entry of follow-on manufacturers for biotherapeutics, vaccines and other health technologies.
The current rules under the TRIPS agreement do not provide comprehensive and expeditious options to remove these legal obstacles including those posed by Article 39 of TRIPS agreement and provisions related to IP enforcement in a pandemic.
In addition, IP enforcement and disputes both under WTO framework and other trade agreements could hinder governments’ legitimate action in removing all IP barriers in the pandemic. It is imperative for the waiver to have clear effect to enable suspension of IP enforcement at national levels and remove all legal risks of governments being sued in front of any dispute settlement mechanism for implementing the waiver.
The final text of the waiver must include lifting any and all forms of IP and their enforcement through any dispute settlement mechanism that may hinder production and supply of or access to, COVID-19 medical tools. In particular, such IP would include patents, data exclusivity, trade secrets or any other protection of undisclosed information.
Sufficient duration for production and supply
The waiver must be of sufficient duration to help overcome the challenges of access to COVID-19 medical tools. There are many uncertainties associated with COVID-19 with the continuous emergence of new variants and gaps in treatment. The duration of the waiver should create an environment to prepare, scale up, diversify and sustain manufacturing and supply of COVID-19 vaccines, medicines, diagnostics and other medical tools and their materials and components.
The waiver should have a minimum duration of 5 years and be extendable to accommodate the ongoing uncertainty of the pandemic.
States must prioritize health and equality over profits and vaccine hoarding, UN experts say. (OHCHR)
UN human rights experts have urged States to act decisively to ensure that all people have equal and universal access to COVID-19 vaccines, particularly those in low-income countries who have largely been left out of the global response.
“The postponement of the World Trade Organization (WTO) 12th Ministerial Conference should not be a reason to delay progress already made: on the contrary, it confirms the urgent need to take collective action to address vaccine inequality,” said the experts. The ministerial conference, which had been due to be held from 30 November, has been postponed indefinitely after an outbreak of the particularly transmissible strain of COVID-19 Omicron led several governments to impose travel restrictions.
“States have a collective responsibility to use all available means to facilitate faster and more equal access to vaccines worldwide,” they said. This includes the introduction of a temporary waiver of relevant intellectual property rights under the WTO Agreement on Trade-Related Intellectual Property Rights (TRIPS Agreement) to ensure that protection of vaccine patents does not become a barrier to the effective enjoyment of the right to health.
“States also have the individual responsibility to ensure the equal distribution of vaccines within and between countries by avoiding hoarding and stepping up distribution. Moreover, businesses have an independent responsibility to ensure that their actions do not result in adverse impacts on human rights”, said Surya Deva, Chairperson of the Working Group on business and human rights.
Addressing the health crisis equitably must take priority over profit maximization by corporations and vaccine hoarding by high-income countries, the experts said.
“Every person must have access to a COVID-19 vaccine that is safe, effective and timely," the independent experts appointed by the Human Rights Council said in relation to WTO ongoing negotiations. "The priority should be to ensure that all people everywhere can enjoy the benefits of scientific progress and the highest attainable standard of health."
Of nearly 8 billion COVID-19 vaccine doses administered globally to date, only 5.5 percent have gone to low-income countries, according to Our World in Data, a scientific publication which tracks pandemic-related data.
On 14 October, the experts sent 44 letters to the WTO, G7 and G20 States, the European Union and pharmaceutical companies urging equal and universal vaccine access. So far, only six responses have been received.
“We are deeply concerned that those who have suffered gravely – for example, people living in poverty and other marginalized individuals without access to social protection, water, essential health services or information about the pandemic – are those who are being left behind in regard to the global vaccination campaign," said Olivier De Schutter, Special Rapporteur on extreme poverty and human rights.
“Any other approach which disregards human rights will be counter-productive in our interconnected world, and will increase negative impacts and risks, including the emergence of new variants, such as Omicron, which may render existing vaccines less effective. No one is safe until all of us are safe,” the experts concluded.
Global jurists call for waiver of global intellectual property rights for COVID-19 vaccines - International Commission of Jurists (ICJ)
Member States of the WTO who block or otherwise impede the adoption of a waiver of intellectual property rights for COVID-19 vaccines and other therapeutics are breaching their legal obligations to realize the rights to health, equality, life and science, the ICJ said today in an expert legal opinion published with the endorsement of over 85 jurists from across the world.
“International law requires that States stop impeding the TRIPS waiver and instead ensure global health solidarity in access to COVID-19 vaccines and therapeutics”, said Sam Zarifi, ICJ’s Secretary General, in Geneva.
On 2 October 2020 South Africa and India submitted a proposal to the WTO Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS), proposing a temporary waiver of the application of certain provisions of the TRIPS Agreement to allow for all States to ensure access to the full range of diagnostics, medications, vaccines, therapeutics, and other relevant health products required for the containment, prevention, and mitigation of COVID-19.
This proposal has received the support of more than 100 States but continues to be opposed actively or otherwise obstructed by other States, including UK, Norway, Switzerland, Germany and the European Union.
A number of UN Treaty Bodies and Special Procedures of the UN Human Rights Council have called upon States to desist from impeding the waiver to ensure that all States can realize their human rights obligations.
The expert legal opinion, which has already been endorsed by more than 85 prominent legal experts, sets out States’ human rights obligations in detail, concluding that as the WTO meets later this month it is incumbent on all States to desist from blocking the TRIPs waiver.
These obligations are set out in several international treaties to which the significant majority of WTO member States are bound. Some 87% of WTO member States bear concurrent treaty obligations under the International Covenant on Economic, Social and Cultural Rights (ICESCR), and 88% of WTO member States bear concurrent treaty obligations under the International Covenant on Civil and Political Rights (ICCPR).
“As the opinion published today decisively details, States must cooperate to ensure the full realization of all human rights including in terms of their immediate obligations to ensure comprehensive access to COVID-19 vaccines and therapeutics”, said Zarifi.
“What’s more there is ample precedent with this WTO for the issuing of such a waiver in order to protect public health, in the public interest”.
The opinion, which was elaborated through a collaborative effort with a wide range of experts and civil society organizations from around the world, remains open for further sign-on.
* Human Rights Obligations of States to not impede the Proposed COVID-19 TRIPS Waiver – See Report/Executive Summary via link below.
There is acute inequality in access to COVID-19 vaccines across and within States. The World Health Organization (WHO) has repeatedly decried the fact that the African continent accounts for a mere 2% of global vaccinations against COVID-19, despite Africa constituting approximately 17.5% of the world’s population.
Only 15 out of 54 African nations had met the WHO’s target to vaccinate 10% of each country’s population by the end of September 2021. The UN Secretary General has described this situation as ‘a moral indictment of the state of our world’ and an ‘obscenity’.
On 14 October 2021, six independent UN experts sent a total of 44 letters to G7 and G20 States, the European Union, and the World Trade Organization, as well as pharmaceutical companies calling “for urgent collective action to achieve equal and universal access to COVID-19 vaccines”, including through the issue of a TRIPS waiver.
The International Commission of Jurists has consistently supported the TRIPs waiver, including at the UN Human Rights Council and the UN Committee on Economic, Social and Cultural Rights.
The ICJ’s research has documented the far-reaching and devastating impact of the failure to adopt such a waiver in a range of contexts including Southern Africa, Thailand, Nepal, Palestine, and Colombia.
The world has recorded 5 million COVID-19 deaths. (agencies)
Nearly two years into a pandemic that continues to rage, the world has now reported its 5 millionth COVID-19 death, according to a count of global deaths maintained by Johns Hopkins University.
But official figures reported by national governments fail to capture the true toll of the COVID-19 pandemic. This is because deaths are only included in the tally if COVID-19 is officially determined to have been a factor.
Yet many people have died without ever knowing they have the virus. Others who died from non-COVID causes may not have done so if hospital systems had not been so stretched. Other COVID-19 deaths have occurred outside the health system, and were therefore never counted in the official toll.
"People are saying 5 million, but in reality, it's much more than that," says Professor Ali Mokdad from the United States' Institute for Health Metrics and Evaluation (IHME). "There is a huge difference between what is being reported, and what is out there in terms of the true number of deaths."
The clearer way to understand the death toll of the pandemic is by looking at each nation's "excess deaths". This figure reflects the number of people who have died for any reason since the pandemic began, over and above the average number of people that are expected to die in a typical year.
And many countries — even with no shortage of vaccines — are still recording many more deaths than in the pre-pandemic baseline.
The United States is one of those nations. The US is currently recording as many as 20,000 deaths a week over and above historical norms.
Professor Mokdad estimates that only around 50 per cent of COVID-19 cases are being detected in the United States.
Analysis by The Economist estimates the true global death toll to be somewhere between double and four times the reported figures. This would put the real death toll anywhere between 10.2 million and 19.2 million.
The publication's model puts the most likely figure at more than 16 million deaths, more than triple the figures being reported by authorities.
The country with one of the highest excess death levels through the pandemic is Peru. The country's weak health system played a significant role in the catastrophic outcome. Hospitals were overwhelmed, and demand for oxygen far outstripped supply. According to an article published by The BMJ medical journal, Peru has just 1,656 intensive care beds for its 33 million population.
Earlier this year, the country revised its COVID-19 death toll to almost three times its initial estimate, pushing it to the top of the list of countries with the highest death rate per capita.
The revision followed long-running warnings from experts that COVID-19 deaths were being undercounted. As of this week, more than 200,000 people have died of COVID-19 in Peru, according to the Johns Hopkins tally.
Across the world, COVID-19 testing is also inaccessible for many, leading cases and deaths to go undetected.
"The reality is, not every country is able to do testing appropriately — and it's expensive," Professor Mokdad says, adding that this is a particular issue for poorer nations. This low detection rate, he says, is the key driver for underreporting deaths.
As Europe heads into winter, the region is recording almost one third of the world's officially-reported deaths. Countries on the continent are battling combinations of low vaccination rates (particularly in eastern Europe) and waning immunity in nations that were among the world's fastest to mass vaccinate (particularly in western Europe).
The Financial Times reports that Russia’s excess mortality has soared since start of Covid pandemic - 753,000 more people have died during the pandemic compared with historical trends.
As the pandemic landscape shifts along with growing vaccination rates, experts believes it's crucial to get the statistics right to allow for planning and response to emerging surges in case numbers. Government policy should be informed by timely, reliable information on who's dying of what and how that is changing, they say.
The window of opportunity for ending this pandemic and preventing the next is closing rapidly, writes Elhadj As Sy - co-chair of the Global Preparedness Monitoring Board
Two years ago, three months before coronavirus erupted, the Global Preparedness Monitoring Board (GPMB) issued a warning to the international community that a pandemic was only a matter of time, and that the world was not prepared. Tragically, we were proved right.
After 20 months of Covid-19, with nearly five million directly attributed deaths and economic devastation, we say again that the world is not prepared. It has neither the capacity to end the current pandemic in the near future, nor to prevent the next one.
We should not be surprised by the catastrophic failures of this pandemic. They are rooted in a long history of inequality and inaction. We should feel deep shame over the multiple tragedies that have shattered our lives. We should grieve and be angry. Because millions of deaths – many preventable – is neither normal nor acceptable.
Covid has exposed a broken world of haves and have-nots where access to vaccines, treatments and PPE depends on your ability to pay. Most glaringly, it is the imbalance of vaccines that strikes at our moral fibre and confirms that this pandemic is no longer a problem shared. Rates of vaccine distribution almost perfectly track income distribution.
The lack of global equity is due in part to the fundamental misunderstanding of global solidarity as being founded on generosity, not justice. It is also caused by longstanding systemic inequities in the global health emergency and broader international system.
Financing health emergency preparedness and response is based largely on ad hoc, bilateral and multilateral development assistance. Low- and middle-income countries are often under-represented and opportunities to engage communities and civil society are meagre, further marginalising vulnerable groups.
Covid erupted into a polarised world characterised by heightened nationalism, distrust and inequality. It has only accelerated those trends.
The inadequacies start at the top. The UN general assembly, UN security council, World Health Assembly, G7 and G20 leaders among others, have little to show for their efforts other than declarations of intent.
Worse, while the key to containing the pandemic and preparing for the next is collective action, current processes to reform the health emergency ecosystem are splintered and could exacerbate the existing fragmentation.
For all the pandemic’s challenges, it has also offered an opportunity. It has given us occasion to celebrate the life-saving and inspiring role that science can play in mitigating dangerous diseases. We have seen the kindness, comfort and solidarity that people can offer one another. We have also reached a consensus that the global health emergency system needs fundamental reform.
Preparedness starts with communities and countries. Every country has the responsibility for the protection of its own population. Every country must follow through on the commitments it has made to its people. Every country can – and must – do more.
But global preparedness is greater than the sum of national preparedness. It needs concerted, collective and coordinated action. At its heart must lie a new global social contract which prioritises equity, accountability, solidarity, reciprocity and inclusivity.
This is why the GPMB, in its new report, is calling for stronger political leadership and accountability to change the way the international community prepares for future health emergencies.
We are calling on countries – including those from the global south – to work together with civil society, the private sector and other stakeholders, to take urgent steps to strengthen the ecosystem of pandemic preparedness and response; to negotiate an international agreement in WHO; to create a new financing instrument at the World Bank; and to develop end-to-end mechanisms to advance public goods for health emergencies and share data. And at the heart of this ecosystem, we need an empowered WHO, strengthened with resources and authority.
We also stress the importance of independent monitoring, which plays an essential role in keeping our leaders, governments and institutions accountable. Together, these actions will help to create a coherent plan for global preparedness and monitoring. As we move forward with these solutions, we must be mindful of the lessons of the past, and design for equity and interdependence.
The window of opportunity for change is fast disappearing. As life in some parts of the globe returns to a new normal, and the world’s attention is distracted elsewhere, the urgency fades.
We know what we need to do. There have been hundreds of recommendations to reform the system. We just cannot seem to do it. But do it we must. We have learned the hard way that disease knows no borders. None of us is safe until all of us are safe. We must move from words to action.
* Elhadj As Sy is co-chair of the Global Preparedness Monitoring Board, an independent body working to chart a roadmap for a safer world.
http://www.gpmb.org/news http://theindependentpanel.org/news/ http://coronavirus.jhu.edu/map.html
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