India og Sør-Afrika har foreslått i WTO å gi unntak for patenter på Covid-19 medisinsk teknologi så lenge pandemien varer. Dette unntaket (waiver) ble diskutert på TRIPS-rådsmøtet 15 oktober 2020.
Organisasjoner fra hele verden støtter dette aktuelle og nødvendige initiativet og oppfordrer medlemmene av Verdens handelsorganisasjon til å vedta forslaget. Sivilsamfunnsbrevet er signert av 379 nasjonale, regionale og globale organisasjoner og nettverk.
Under er teksten til samfunnsbrevet, og her er brevet med signaturer (engelsk).
I forslaget fra India og Sør-Afrika skal unntaket vare til en vaksine er tilgjengelig globalt og verdens befolkning har utvikla immunitet mot viruset.
Det betyr at land ikke trenger å gi eller håndheve patenter eller andre rettigheter som designrett, opphavsrett og handelshemmeligheter på Covid-19 relaterte medisin, vaksiner, diagnostikk og annen medisinsk teknologi så lenge pandemien varer.
Dette forslaget er viktig, ettersom det muliggjør en rask løsning for et globalt samarbeid om utvikling, produksjon og forsyning av en vaksine og andre medisinske produkter.
CIVIL SOCIETY LETTER
PROPOSAL BY INDIA AND SOUTH AFRICA ON WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT FOR THE PREVENTION, CONTAINMENT AND TREATMENT OF COVID-19
Dear Members of the World Trade Organization,
We the undersigned organisations call on all WTO Members to strongly support the adoption of the decision text proposed by India and South Africa in their proposal for “Waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID19” (Waiver Proposal).
When COVID-19 was declared to be a pandemic, there was overwhelming consensus that to curb the spread of COVID-19, there was an urgent need for international collaboration to speed up product development, scale up of manufacturing, expand the supply of effective medical technologies and ensure everyone, everywhere is protected. There were even calls including from several Heads of State for COVID-19 medical products to be treated as global public goods.
Seven months into the pandemic, there is no meaningful global policy solution to ensure access. Instead, there is an inequality of access to critical technologies that are needed to address the pandemic. Many countries, especially developing and least developed countries struggling to contain COVID-19 have experienced and are facing acute shortages of medical products, including access to diagnostic testing [1]. Furthermore, wealthy nations representing only 13 percent of the global population have locked up at least half of the world’s potential vaccine supply [2].
In this pandemic, the pharmaceutical industry has mainly pursued “business as usual” approaches, entrenching monopolistic intellectual property (IP) controls over COVID-19 health technologies that restrict scale-up of manufacturing, lock out diversified suppliers, and undermine competition that results in lower prices. A few companies, such as Astra Zeneca, have pledged not for profit prices during the pandemic, and yet by maintaining control over these technologies, can unilaterally declare the end of the pandemic and increase prices to maximise profits, even if it undermines international efforts to save lives [3].
The COVID-19 Technology Access Pool (C-TAP) launched by WHO (to voluntarily share knowledge, IP and data), has been rejected by the pharmaceutical industry [4]. Instead, companies continue sign secretive and restrictive licensing agreements [5]. For example, Gilead Sciences’ secret licensing agreements for remdesivir, a medicine that was developed with substantial public funding, are restricted to a few manufacturers of its choosing, thereby preventing low-cost supply to nearly half of the world’s population. Unsurprisingly, there have been global shortages of the medicine, with many developing countries yet to see even a single vial of the treatment exported to them. Given the medicine’s limited effectiveness, we are deeply concerned that such an approach for a safe and effective therapy will exclude even more people from treatment access.
Additionally, emerging intellectual property infringement disputes on COVID-19 technologies threatens to block collaborative research and development and manufacturing of COVID-19 medical products [6] .
These restrictive business strategies have directly translated into exorbitant pricing and profiteering [7]. With entire health systems already overwhelmed by COVID-19 and with governments facing a looming economic crisis, the health budgets of many countries simply cannot sustain highly priced COVID-19 medical products. These realities will also hinder production by any competent manufacturer and impede the full freedom to collaborate, in developing, producing, importing and exporting the needed medical products.
While the TRIPS Agreement contains flexibilities that can promote access, many WTO Members may face challenges in using them promptly and effectively. For instance, compulsory license offers a “product by product”, and “country by country” approach with variations in national laws, whereas the pandemic requires collective global action to tackle IP barriers and facilitate technology transfer. Where the IP barrier is beyond patents, national laws may not provide for sufficient flexibilities. Further, Article 31bis, a mechanism to supply countries with insufficient manufacturing capacity, does not provide an expedited solution and many countries have also opted out of using the mechanism.
Unless concrete steps are taken at the global level to address intellectual property and technology barriers, the abovementioned failures and shortcomings will replay as new medicines, vaccines and other medical products are rolled out. Access will have to be rationed, with devastating effects for public health and global economic recovery.
In a global pandemic where every country is affected, we need a global solution. Adoption of a Waiver at the WTO level will suspend implementation, application and enforcement of the relevant provisions of the TRIPS Agreement in relation to prevention, containment, and treatment of COVID-19. It enables an expedited, open and automatic global solution to allow uninterrupted collaboration in development, production and supply, and to collectively address the global challenge facing all countries. It’s time for governments to take collective responsibility and put people’s lives before corporate monopolies.
Therefore, we strongly request you to unequivocally support the adoption of the proposed Waiver at the upcoming TRIPS Council meeting.
[1]https://www.un.org/development/desa/dpad/wp-content/uploads/sites/45/LDC-testing-30-Sep.pdf
[2]Small group of rich nations have bought up more than half the future supply of leading COVID-19 vaccine contenders, https://www.oxfam.org/en/press-releases/small-group-rich-nations-have-bought-more-half-future-supply-leading-covid-19
[3]Astra Zeneca vaccine document shows limit of no-profit pledge, Financial Times, 7th October 2020.
[4]Pharma leaders shoot down WHO voluntary pool for patent rights on Covid-19 products, Pharmalot, 28th May 2020.
[5]Voluntary licenses and access to medicines, MSF October 2020, https://msfaccess.org/sites/default/files/2020-10/MSF-AC_IP_VoluntaryLicenses_summary-brief_Oct2020.pdf
[6]See for example:
Pfizer-BioNTech, Regeneron sued for patent infringement with COVID-19 products, https://www.fiercepharma.com/pharma/pfizer-biontech-regeneron-sued-for-infringement-allele-s-patent-their-covid-19-products; Lawsuit reveals intellectual property is holding back production of CEPI- and Gates Foundation-funded COVID-19 vaccine candidate, https://twn.my/title2/briefing_papers/twn/Hammond.pdf; Pandemic intellectual property dispute deepens as Inovio iscountersued, leaving its COVID-19 candidate in limbo, https://twn.my/title2/briefing_papers/twn/Inovio%20countersued%20IP-COVID%20Jul%202020%20Hammond.pdf; Patent dispute looms as a major complication for Moderna’s COVID-19 vaccine, https://twn.my/title2/briefing_papers/twn/Moderna%20IP-COVID%20Aug%202020%20Hammond.pdf
[7]For example, price of remdesivir in the US amounts to US$ 3120 per treatment and licensed generic versions in India cost US$ from 587 to 792 per treatment course, while the estimated minimum cost to manufacture remdesivir with a reasonable profit margin is only US$ 9 per treatment course.