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“Based on the data presented above, we are not facing a scenario where we have a lack or lack of IP-induced capacity to manufacture COVID-19 treatments and diagnostics. “
A submission by the governments of Mexico and Switzerland to the World Trade Organization’s (WTO) Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) on Tuesday raised a number of questions about the possibility of extending an intellectual assets (IP) royalty for the COVID-19 vaccine for curative and diagnostic purposes.
The Council met informally in September to discuss the extension, which technically has a deadline of December 19, six months after the Ministerial Conference finalized an exemption on “patented subject matter required for the production and source of COVID-19 vaccines” only. The final agreement provided for extending the exemption to “the production and distribution of COVID-19 diagnostics and therapeutics” within six months of its adoption.
The letter questions the need for such an extension given the existing landscape. Regarding source and demand, the letter notes that “there is no shortage of healing products. Instead, much of the productive capacity of innovators remains idle due to lack of demand. “According to an Airfinity report compiled for Pharmaceutical Research and Manufacturers of America (PhRMA), “[g]he governments and NGOs purchased 35 million COVID-19 remedies for LMIC [low- and middle-income countries] by 2022, but were unable to administer 10 million as of September this year,” the letter read. Continues:
“Diagnostic corporations that work a lot with WHO and offer them standard collection kits have reported a peak of surplus products to order. These are logistical and distribution problems, which are similar to intellectual property, but need to be solved. “
The letter also notes that 138 bilateral voluntary licensing agreements covering 127 countries between innovators and corporations have been concluded under the Medicines Patent Fund. These licenses are royalty-free and have resulted in 191 COVID-19 remedy production sites worldwide. Merck/MSD, Pfizer, Shionogi and Gilead have entered into such agreements for various solutions.
In addition, a number of mechanisms for the affordability and accessibility of LMICs already exist, which add tiered pricing schemes and agreements with non-governmental organizations (NGOs). For example, in September 2022, Pfizer signed an agreement with the Global Fund to acquire up to 6 million resources for 132 countries eligible for the Global Fund.
Ultimately, any country must ensure that public suitability is protected and that TRIPS rights do not impede this objective, but based on the available evidence, they express scepticism about the practical effect of extending the TRIPS waiver:
“If a formulated challenge related to access to COVID-19 treatments and diagnostics is conclusively demonstrated and this lack of access is due to the existing IP formula, measures will need to be taken on stage to ensure barrier-free access. However, based on the data presented above, we are not facing a scenario where we have an IP-induced lack of access or a lack of capacity to manufacture COVID-19 treatments and diagnostics. Therefore, it is not necessary to adjust the IP formula.
Extending the repeal in such cases would leave inventors with incentives to take on the threat of R.
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), which provided much of the knowledge on which the Mexico-Switzerland letter is based, said in an email to IPWatchdog that it “calls for weakening the very framework that allowed [the pharmaceutical industry] to react to the pandemic] distracts from the genuinely demanding situations that are being addressed. There is no evidence or explanation as to why to seek a TRIPS waiver for COVID-19 treatments and diagnostics. “
IFPMA also warned that the “unintended consequences” of an extension “will likely overburden regulatory systems and be borne by patients. “
While the deadline for a ruling on the extension is theoretically December 19 (the first straight day after six months since the last vaccine waiver agreement), at the last WTO General Council, the U. S. has been asked to reach a ruling on the extension. The U. S. government indicated that its opinion was a resolution on whether to even get started negotiations. That was all he would have to take a stand on in six months’ time, and his delegation had supported it.
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