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MSF calls for no patents or profiteering on COVID-19 drugs and vaccines
by Medicins sans Frontieres (MSF)
Doctors Without Borders
 
Geneva, 26 July 2021
 
Opposing countries must stop filibustering negotiations on ‘TRIPS Waiver’ at WTO
 
As countries prepare for the World Trade Organization (WTO) General Council meeting tomorrow, Médecins Sans Frontières/Doctors Without Borders (MSF) urged the European Union (EU), Norway, the UK, and Switzerland to stop stalling the landmark proposal to waive intellectual property (IP) on lifesaving COVID-19 medical tools at the WTO, and join forces with more than 100 countries supporting it by openly engaging in formal negotiations to expedite the consensus. Since the proposal was first tabled nearly 10 months ago, the pandemic has worsened and increasingly hit many countries across Africa, Latin America and Asia, with the disease having killed officially more than 4 million people globally.
 
“As many countries in Africa right now are reporting a high number of deaths due to the spread of new and existing variants of COVID-19, these governments are in dire need of vaccines, diagnostics, oxygen and other treatments to help save lives of critically ill patients,” said Dr Tom Ellman, director of MSF’s Southern Africa Medical Unit.
 
“While the World Health Organization recommends two newer therapeutics for patients with severe COVID-19, medical practitioners and their patients in many low- and middle-income countries cannot access them due to monopolies, limited supply and high prices.
 
It is outrageous to see countries blocking the TRIPS Waiver that is desperately needed as an important tool to remove legal barriers and allow production to be scaled up by multiple manufacturers for critical COVID-19 drugs, diagnostics and vaccines.”
 
Countries opposing the Waiver proposal often point to relying on voluntary actions by pharmaceutical corporations to ensure access to essential COVID-19 medical tools.
 
But in reality, corporations have failed to act, and continue to follow a business-as-usual approach by securing monopolies and charging exorbitant prices for essential COVID-19 medical tools.
 
The World Health Organization (WHO) recently recommended two newer therapeutics – tocilizumab and sarilumab – for the treatment of critically and severely ill COVID-19 patients. However, access to these drugs remains limited due to patent monopolies, limited supply and high prices.
 
The pharmaceutical corporation Roche supplies tocilizumab and continues to charge high prices for the medicine, and recently announced a half-hearted decision to not enforce its secondary patents on the medicine in a selected number of countries.
 
Sarilumab is under wide patent protection globally by Regeneron, which has applied for and been granted patents for the drug and its formulation in at least 50 low- and middle-income countries.
 
The drug is exorbitantly priced at US$1,830 per dose in the US. Two new potential COVID-19 therapeutics, casivirimab and imdevimab, are also patented by Regeneron and are being sold as a cocktail at a dose price of $820 in India, $2,000 in Germany and $2,100 in the US. These high medicine prices and monopolistic actions are barriers to global access.
 
Recently, the companies Pfizer and BioNTech, who hold a large number of patents, trade secrets and other manufacturing information needed to produce WHO-approved mRNA vaccines, which can be scaled up in production quickly, have engaged in yet another bilateral, confidential fill-and-finish contract manufacturing agreement with a South Africa vaccine producer, despite the demand for vaccine independence on the continent and the opportunity to join the South Africa-hosted global technology transfer hub for mRNA backed by WHO.
 
The proposed TRIPS Waiver, if adopted, would provide countries with an effective and expeditious way to remove key IP barriers and legal risks in the pandemic and facilitate scaling up and diversity of production and supplies.
 
It would provide countries with the policy space to expeditiously address IP barriers and risks to increase manufacturing, scale-up, registration, and supply of COVID-19 vaccines, medicines, diagnostics and other health technologies, as well as facilitate easier collaboration in their research and development (R&D).
 
While many low- and middle-income countries affected with new dangerous variants are hit by COVID-19 deaths and shortages of hospital beds and oxygen, access to vaccines in these countries to protect against the disease and to reduce risk of developing the serious illness remain abysmally low.
 
Removal of legal uncertainties through adoption of TRIPS Waiver and transfer of technology by pharmaceutical corporations can allow manufacturers in low- and middle-income countries to scale up production and supply of COVID-19 medical tools.
 
“At a moment when we are in race against time to save lives and control the spread of unchecked transmission and development of new dangerous variants, pharmaceutical corporation’s business-as-usual approach is intolerable.
 
With potentially promising treatments in the pipeline, opposing countries must stop filibustering the waiver proposal and support it to cover not just vaccines, but also treatments, diagnostics and other health technologies,” said Ellman.
 
Despite the clear long-term public health benefits of the TRIPS Waiver, a small group of nations continues to vigorously stall the negotiations on this landmark proposal at the WTO.
 
In an attempt to derail the process, the EU submitted a competing proposal at the WTO and pushed for its immediate discussion instead of prioritising the completion of negotiations on the heavily supported Waiver proposal.
 
“Instead of acting with urgency and in global solidarity, the EU submitted a separate proposal that is an attempt to limit some of the key public health safeguards used by countries. It provides nothing significantly new nor helpful to address the limitations of the current rules and to alleviate the spiraling COVID-19 pandemic,” said Yuanqiong Hu, Senior Legal and Policy Advisor for MSF’s Access Campaign.
 
“This move clearly demonstrates a questionable and troubling ploy by the EU to derail the growing global consensus for a more expeditious option to overcome intellectual-property barriers in the pandemic, in order to save more lives.
 
As the virus continues to claim millions of lives around the world, we cannot afford to lose more precious time.”
 
Originally proposed by India and South Africa in October 2020, the Waiver proposal is now officially backed by 63 co-sponsoring governments, with around 100 countries supporting the proposal overall.
 
It has gained worldwide support by hundreds of civil society organisations, academics, scientists, medical associations, trade unions and United Nations agencies, including the WHO and UNAIDS. Recently, more than 100 IP lawyers and academics published a letter in support of the TRIPS Waiver.
 
http://msfaccess.org/opposing-countries-must-stop-filibustering-negotiations-trips-waiver-wto http://peoplesvaccine.org/our-demands/
 
Apr. 2020
 
Medecins Sans Frontieres (MSF) has called for no patents or profiteering on drugs, tests, or vaccines used for the COVID-19 pandemic, and for governments to prepare to suspend and override patents and take other measures, such as price controls, to ensure availability, reduce prices and save more lives.
 
Already, Canada, Chile, Ecuador and Germany have taken steps to make it easier to override patents by issuing 'compulsory licence' for COVID-19 medicines, vaccines and other medical tools. Similarly, the government of Israel issued a compulsory licence for patents on a medicine they were investigating for use for COVID-19.
 
Following intense criticism from civil society groups and MSF, pharmaceutical corporation Gilead just gave up a special designation from the United States Food and Drug Administration (US FDA) that would have allowed for extended monopoly control over the 20-year patents it has filed for in more than 70 countries for its potential COVID-19 treatment candidate, remdesivir.
 
Preliminary results of clinical trials using remdesivir to treat COVID-19 are expected in April. However, Gilead has yet to commit to not enforcing its patents globally.
 
'Gilead has no business profiteering from this pandemic and must commit to not enforce or claim its patents and other exclusive rights', said Dana Gill, US Policy Advisor for MSF's Access Campaign.
 
'Otherwise, Gilead is setting itself up to charge whatever it wants for remdesivir during this global health crisis, and for years to come. This is even more outrageous when you consider the tremendous amount of taxpayer dollars and public resources that have already contributed to the research and development of remdesivir'.
 
MSF is deeply concerned about access to any forthcoming drugs, tests, and vaccines for COVID-19 in places where MSF works and in other countries affected by this pandemic, and is urging governments to prepare to suspend or override patents for COVID-19 medical tools by issuing compulsory licenses. Removing patents and other barriers is critical to help ensure that there are sufficient suppliers selling at prices everyone can afford.
 
'We know too well from our work around the world what it means to not be able to treat people in our care because a needed drug is just too expensive or simply not available', said Dr Marcio da Fonseca, Infectious Disease Advisor at MSF's Access Campaign.
 
'In countries where pharmaceutical corporations enforce patents, we urge governments to set the wheels in motion to override these monopolies so they can ensure the supply of affordable drugs and save more lives'.
 
US diagnostic test maker Cepheid provides another example of pandemic profiteering. The corporation just received US FDA Emergency Use Authorization for a rapid COVID-19 test (Xpert Xpress SARS-CoV-2) that delivers results in just 45 minutes, using existing testing machines that have been routinely used for tuberculosis (TB), HIV and other diseases.
 
Cepheid just announced they will charge US$19.80 per test in developing countries, including the world's poorest countries where people live on less than two dollars per day. MSF and others research on Cepheid's TB test (which uses a similar test cartridge for TB for which the corporation charges $10 in developing countries), shows that the cost of goods, including manufacturing, overhead, and other expenses, for each cartridge is as low as $3, and therefore each test could be sold at a profit for $5.
 
'With a pandemic raging, now is not the time to test the highest prices the market will bear', said Stijn Deborggraeve, Diagnostics Advisor at MSF's Access Campaign. 'We know now how critical testing is in this pandemic, so the tests need to be affordable for all countries'.
 
MSF warned that high prices and monopolies will result in the rationing of medicines, tests, and vaccines, which will only serve to prolong this pandemic.
 
'Pharmaceutical and diagnostics corporations are choosing to be part of the problem rather than part of the solution, showing that even in this acute global health crisis, they won't do the right thing', said Gill.
 
'We strongly call on governments to recognise how many lives are on the line and use their powers to make medicines, tests, and vaccines available, accessible, and affordable for everyone'.
 
http://www.msf.org/no-profiteering-covid-19-drugs-and-vaccines-says-msf http://www.msf.org/diagnostic-company-cepheid-charging-more-it-should-covid-19-tests http://www.citizen.org/article/covid-19-principles-for-global-access-innovation-and-cooperation/ http://www.unaids.org/en/resources/presscentre/featurestories/2020/may/20200514_covid19-vaccine-open-letter http://ipaccessmeds.southcentre.int/covid-19-pandemic/ http://theintercept.com/2020/06/02/big-pharma-coronavirus-treatment-price-gouging/ http://msfaccess.org/covid-19-action http://www.msf.org/covid-19 http://peoplesvaccine.org/


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Address the social and economic conditions that underpin organ markets
by Sean Columb
Thomson Reuters Foundation, agencies
 
I first travelled to Cairo, Egypt in 2014. At the time, there was very little evidence of organ trading. There were only a handful of media reports and academic studies, largely commenting on the ethics of organ donation. A report by the World Health Organization (WHO) suggested that Egypt was a key destination for patients purchasing black market organs.
 
As an academic, I was interested in how the organ trade emerged and what impact laws prohibiting organ sales had on people targeted for their organs. On a more personal level, I wanted to connect with people whose lives had been shaped by political and social violence and bear witness to their stories. To do this, I knew that I would have to learn from people who had first-hand experience of this illegal industry.
 
Over the past five years I have travelled back and forth from Liverpool interviewing African migrants who have sold or brokered the sale of kidneys in Cairo. On my last visit I filmed a documentary with BBC Panorama “Exposing the Illegal Organ Trade.”
 
As part of the documentary, I met a Sudanese man in his late thirties. Okot had been working as an organ broker in Cairo since 2003. He described the organ trade as a family business, an economic lifeline in a hostile environment. The price of a kidney, Okot explained, depends on the seller’s ability to negotiate.
 
“For someone to sell his kidney…it depends on the person himself,” he said. “If he is in the know, you will give him one price. If he doesn't know, then you will give him another [lower] price.”
 
The United Nations Office on Drugs and Crime (UNODC) has documented over 700 incidents of organ trafficking, primarily from North Africa and the Middle East. But these figures are extremely conservative at best. According to Okot, he deals with between 20 and 30 organ sellers per week. I asked him if he felt any remorse for the people that he recruits.
 
“I feel bad for them, I always give them their money, but there are other brokers who would agree with you on a price, then disappear after the surgery without paying you,” he said. “This happens at least 40% of the time.”
 
India, Philippines, Pakistan, Egypt and China (where organs are reportedly harvested from executed prisoners) have been identified - by bodies from the World Health Organization to the European Parliament - as commercial hubs for organ trafficking. There have also been cases in Kosovo, South Africa, Costa Rica, and Turkey.
 
Although it is a criminal offence to buy or sell an organ (worldwide with the exception of Iran) new cases continue to emerge, the United Nations has warned.
 
According to the Global Observatory on Donation and Transplantation (GODT) the number of transplants that take place each year accounts for only 10% of global needs. Increased demand for kidney transplants, in particular, has been intensified by a lack of altruistic donations and restrictive access to transplant services. This has led to a reliance on criminal groups who source organs from vulnerable people.
 
Most people are not paid what they are promised. In the worst cases their organs are taken by force. Hana, a young asylum seeker that I interviewed in 2018, was taken to an apartment where her kidney was forcibly removed.
 
“They took my passport and clothes,” she said. “Then they drugged me. When I was awake, I found myself alone. I was in pain and there was blood on my side coming from a bandage. I had no idea what was happening.”
 
Rather than deterring the organ trade, criminal sanctions have been used by criminal groups to silence their victims.
 
Although it is unlikely that someone who has been trafficked for organ removal would be prosecuted, arrest and detention is a very real possibility for migrant workers and asylum seekers who are classified as “illegal” by immigration authorities. Hana was afraid to go to the police. The traffickers told her that if she reported them, she would be arrested for selling her kidney.
 
Worldwide, the number of illegal transplants is believed to be somewhere in the region of 10,000 per year ( a very conservative estimate). Fewer (altruistic) donations as a consequence of the COVID 19 pandemic is likely to increase global demand further.
 
There is a pressing need for legal reform and political action that looks beyond prohibitive measures and addresses the social and economic conditions that underpin organ markets.
 
Prioritizing investment in impoverished communities and developing equitable transplant services, within and between countries, would go a long way in reducing the commercial incentive for illegal transplants.
 
* Sean Columb is a Senior Lecturer in Law at the University of Liverpool. He is the author of Trading Life: Organ Trafficking, Illicit Networks, and Exploitation.
 
(Global and national Organ Trafficking is a largely unresearched and neglected crime, with hundreds of thousands of victims each year worldwide. With donors willing and unwilling from predominantly lower socio-economic backgrounds)
 
http://www.pbs.org/newshour/world/in-nepals-kidney-valley-poverty-drives-an-illegal-market-for-human-organs http://www.pbs.org/newshour/show/human-trafficking-victims-forced-to-sell-their-organs-share-harrowing-stories http://www.euronews.com/2022/01/12/extreme-poverty-drives-afghans-to-sell-vital-organs-to-feed-families


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