|
||
|
TWN
Info Service on Health Issues (Jul22/01)
Trade: South demands coverage of diagnostics & therapeutics
in MC12 decision Geneva, 7 Jul (D. Ravi Kanth) -- Many developing countries have upped the ante for beginning the discussions at the World Trade Organization to cover diagnostics and therapeutics in the Ministerial Decision on the TRIPS Agreement that was concluded at the 12th ministerial conference (MC12) on 17 June. Paragraph 8 of the TRIPS Decision (WT/MIN (22)/30) states: "No later than six months from the date of this Decision, Members will decide on its extension to cover the production and supply of COVID-19 diagnostics and therapeutics." In an unofficial room document circulated on 6 July, seen by the SUNS, several countries such as South Africa, India, Pakistan, Indonesia, Egypt and Tanzania, on behalf of the 59 other countries co-sponsoring the revised TRIPS waiver proposal that was submitted in May last year, demanded the commencement of talks on the extension of the Decision to cover diagnostics and therapeutics. They pointed out that the World Health Organization's Director-General Dr Tedros Adhanom Ghebreyesus "recently noted to the World Health Assembly in May 2022 the supply-side problems for tests and therapeutics, with insufficient funds and insufficient access." RISING COVID-19 CASES At a press conference on 6 July, Dr Tedros expressed concern over the sharp increase of 30% in COVID-19 cases over the past two weeks. He said that "in Europe and America, BA.4 and BA.5 (variants) are driving waves," adding that in "countries like India, a new sub-lineage of BA.2.75 has also been detected, which we're following." Compounding the challenge are a number of factors, said Dr Tedros, listing these factors as: a. While testing has reduced the COVID-19 cases, it obscures the true picture of an evolving virus and the real burden of the COVID-19 disease globally. b. Treatments are not given early enough to prevent serious illness and/or death. c. New treatments, especially promising new oral antivirals (therapeutics), are still not reaching low- and low- middle-income countries, depriving whole populations that need them. He said that "as the virus evolves, vaccine protection - while still really effective at preventing serious disease and death - does wane." He underscored the importance of boosters, especially for the most at-risk. According to Dr Tedros, "each wave of the virus leaves more people with long-COVID or post-COVID conditions." The WHO DG pointed out that the rising COVID-19 cases are not only impacting individuals and their families adversely, but also adds extra burden on the health system, the wider economy and society-at-large. He proposed several steps for tackling the rising cases, including making "new oral antivirals and other treatments available to all." Working with the Global Fund and UNICEF, he said that "WHO has developed an allocation mechanism to support countries as antivirals become available." So far, 20 countries have accepted allocations of Molnupiravir, which has moved into distribution, he said, adding that 43 countries have expressed interest for Nirmatrelvir-Ritonavir - or Paxlovid. The WHO is "still trying to finalize with Pfizer the appropriate terms and conditions for low- and middle-income countries," he said. "This is delaying access and some countries may choose to wait for a generic version of the antiviral, probably available only early 2023 and this will cost lives," Dr Tedros suggested. He called on "Pfizer to work closely with health agencies and countries to ensure its new oral antiviral is available quickly and effectively." It is against this background that the 65 co-sponsors of the proposal argued that "developing countries are affected most." The proponents said that "rapid access to COVID-19 testing and treatments is a priority of the United States' test and treat initiative, having already secured the purchase of 20 million treatment courses of Paxlovid and also for procuring Molnupiravir." In a similar vein, the European Union's strategy "on COVID-19 therapeutics and plan to sustain its preparedness and response to Covid- 19 includes continued testing and access to therapeutics." INCLUSION OF DIAGNOSTICS & THERAPEUTICS Writing in Project Syndicate on 1 July, the WTO's Director-General Ms Ngozi Okonjo-Iweala said "ministers struck a compromise on a long-debated proposal to waive intellectual-property protections related to COVID-19 countermeasures." She argued that "current COVID-19 vaccine supplies remain heavily dependent on the four WTO members that together account for over 90% of exported doses." She complained that "as the pandemic has shown, many import-dependent regions are vulnerable to export restrictions introduced by other countries in the face of domestic crises." But the real worth of the MC12 Ministerial Decision on the TRIPS Agreement, if any, will only come when diagnostics and therapeutics are covered for the production and supply of these two vital products to combat the COVID-19 pandemic, said trade envoys, who asked not to be quoted. Citing figures from the Geneva-based World Intellectual Property Organization (WIPO) report on the patent landscape, the co-sponsors said that it revealed that between 2020-2021, there were 5,293 patent applications for therapeutics related to COVID-19 in around 40 countries. The number is expected to substantially increase between 2022 and 2023, the WIPO report suggested. According to the co-sponsors, the patent filings related to therapeutics considerably outnumber those on vaccines, at an approximate 4:1 ratio. "Many of these patent applications are for repurposed drugs rather than innovative products developed to treat COVID-19. Government funding has supported a significant part of the research and clinical trial efforts," they said. More importantly, they said that "while some of the patent applications may face challenges in some patent offices, those which are granted will delay entry of generic products that would otherwise increase global supply of COVID-19 treatments," and this will result in price increases which restrict access. Surprisingly, several patent holders issued voluntary licenses for vaccines, but the scope of those licenses are limited. "For example, voluntary licenses under the Medicines Patent Pool (MPP), have been negotiated in relation to two experimental oral antiviral treatments for COVID-19," the co-sponsors said. Apparently, the drug Paxlovid is the most promising oral antiviral treatment for people with high risk of progressing to severe COVID-19, based on available data, they said. "Meanwhile, Molnupiravir reduces the risk of hospitalization or death, particularly for patients with comorbidities," the co-sponsors said. "Under the high profile agreement between the originator and the MPP, only 95 countries can benefit from the potential supply of generics," they said. Further, even within those countries, only a limited number of companies have the capacity to access MPP under the strict requirements of the WHO Prequalification of Medicines Programme (PQP). Although the license will ultimately allow for generic production by companies that signed the license, it has been estimated that new generic companies may only be able to start supplying the treatment in 2023, according to the proposal. As regards diagnostics, "the production of diagnostics is concentrated in high-income countries (HICs)." Unsurprisingly, the "over-reliance on imported diagnostics resulted in scarcity and high prices which restricted access in low- and middle-income countries (LMICs)," the co-sponsors argued. In short, as of December 2021, of the more than 3 billion tests reported across the world, only 0.4% had been performed in low-income countries, they underlined. They pointed out that the expansion of local production to a broader range of geographical locations is the only way to sustainably address this over-reliance. Further, according to the co-sponsors, "patents on Cas enzymes used in CRISPR-based diagnostic tests and recently expired foundational patents on lateral flow rapid diagnostic tests and polymerase chain reaction (PCR) have inhibited expansion of production to LMICs." It is also well known that "access to lifesaving tools, including diagnostic tests, therapeutics, and vaccines, remains concentrated in higher-income countries while many low- and middle-income countries still lag behind." Against this backdrop, the co-sponsors concluded that "extension of the policy tools provided in WT/MIN(22)/30 to therapeutics and diagnostics will help developing countries to address IP barriers to the expansion and diversification of production. This will increase the accessibility of these crucial life-saving COVID-19 tools." The 65 co-sponsors said that "a holistic approach is required to ensure an effective response to COVID-19, however, access to lifesaving drugs remains limited due to patent monopolies, limited supply and high prices." "People's access to important COVID-19 treatments and diagnostics remains challenging in many developing countries due in part to IP barriers and restrictive licensing by pharmaceutical corporations and this must be addressed as soon as possible." They proposed the following schedule of meetings: "The proposed indicative schedule of meetings below is aimed at assisting Members to reach the mandated Decision within the deadline set by Ministers. Formal meeting of the TRIPS Council, 6-7 July 2022 1. Preliminary discussions on the paragraph 8 mandate. Late July 2022 2. Continuation of discussions on the extension of the decision to diagnostics and therapeutics. General Council of 25-26 July 3. TRIPS Council to report to the General Council on progress made in the discussions on the paragraph 8 Ministerial mandate. Early and end September 2022 4. Continuation of discussions on the extension of the decision to diagnostics and therapeutics. Formal TRIPS Council meeting, October 2022 5. The October TRIPS Council meeting should take stock of the discussions to date. November-December 2022 6. During this month, Members must conclude discussion to extend the decision to therapeutics and diagnostics. 7. The Decision is to be taken in the General Council." +
|
||
