Costa Rica Urges WHO To Lead Global Initiative For Pooled Rights To COVID-19 Diagnostics, Drugs & Vaccines Drug & Diagnostics Development 24/03/2020 • Elaine Ruth Fletcher & Svĕt Lustig Vijay Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Carlos Alvarado Quesada, President of Costa Rica Costa Rica’s president, Carlos Alvarado Quesada has appealed to Dr Tedros Adhanom Ghebreyesus, Director General of the World Health Organization, to “pool rights to technologies that are useful for the detection, prevention, control and treatment of the COVID-19 pandemic”. The presidential letter dated Monday, 23 March, and co-signed by Minister of Health, Daniel Salas Peraza, proposed that the global pool “should include existing and future rights in patented inventions and designs, as well as rights in regulatory test data, know- how, cell lines, copyrights and blueprints for manufacturing diagnostic tests, devices, drugs, or vaccines”. “It should provide for free access or licensing on reasonable and affordable terms, in every member country.” In the letter, first published by the advocacy group, Knowledge Ecology International, Costa Rica also echoed an earlier request by Chile for the WHO’s Global Observatory to compile a comprehensive database to document all R&D activity related to COVID-19 with clinical trial cost estimates, and the subsidies provided by governments and charities. “Improving transparency through the Global Observatory on Health R&D, as mandated in the resolution, would allow us to better understand the costs of developing these technologies and what roles are being played by each actor” ,said Luis Villaroel, Director of Corporación Innovarte in Chile, an advocacy group, in a statement. Compulsory licenses that override existing or future patents on promising COVID-19 treatments have been approved or are under consideration by a growing number of nations, including Costa Rica, Chile, Colombia, Peru, Malaysia, the Netherlands and Israel, to enable their citizens to gain access to patented medical products related to Covid-19 at an affordable price. Last Friday, a resolution to issue compulsory licenses was approved by a committee in Ecuador’s National Assembly. “If in situations like the current one, the intellectual property system cannot provide solutions for the benefit of the population, we should necessarily rethink the model”, said Hernan Nuney, the executive director of the Ecuadorian Institute for Intellectual Property to Knowledge Ecology International, an advocacy group focused on patent and medicine issues. Under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement of the World Trade Organization (WTO), a country can approve a compulsory licence to a generic drug maker or public agency to enable a patented medicine to be produced without the brand-name company’s consent. In other words, a compulsory licence can suspend a monopoly run on a patent, enabling others than the patent holder to manufacture and to supply the product. Last week, US drugmaker AbbVie waived worldwide restrictions on its Lopinavir/Ritonaivr HIV combination drug, marketed under the brand name Kaletra, which is now being studied as a treatment for COVID-19. “Given this important public health crisis, AbbVie commits that we will take all steps necessary to remove any potential barriers to alternate sources of supply, including dedicating to the public our intellectual property related to lopinavir/ritonavir”, said an AbbVie spokeswoman. Abbvie represents the first large drugmaker to have prioritized provision of the medicine around the world over potential financial gains from potential COVID-19 treatments. Kaletra had patent protection until at least 2026 in certain regions, according to MedsPaL, a medecines patents and licenses database. However, a study of 199 hospitalized patients published in the New England Journal of Medicine found that the lopinavir/ritonavir combiation only led to a median 1 day improvement in patients’ outcomes over the standard of care, leading authors to conclude that there was essentially “no benefit” of the treatment over standard of care, although they said that future trials in patients with severe illness would still be needed to exclude or confirm the drug’s potential. The findings, were “not unexpected” because these antiretroviral drugs [lopinavir/ritonavir] are not at all targeted to coronavirus proteins – this was always something of a long shot”, said one Derek Lower in a blog in Science Translational Medicine. Even so, a day later, Israel approved the issuance of a compulsory license for generic versions of the drug should it be needed for COVID-19 treatment, saying that the decision to override the patent rights still in force locally until 2024 was justified insofar as the Kaletra formulation is currently unavailable. “The company with the patent and official importer in Israel are not able to supply the necessary inventory for this drug,” said the Justice Ministry in a statement explaining the decision. “The state will be able to import generic substitutes from countries where the patent has expired.” Despite AbbVie’s subsequent decision to waive patent rights, the Israeli move was regarded as an important precedent among medicines access advocates, which noted that Israel is a member of the Organisation of Economic Development and Co-Operation (OECD), and OECD member states rarely override patent rules. A comprehensive list of therapies for Covid-19 can be found here. While many are already existing drugs that are being tested for efficacy against the SARS-CoV2 virus, there are also some two dozen new therapeutics in the pipeline as well as over 60 COVID-19 vaccine candidates. Some of the top candidates are the focus of a WHO-organized SOLIDARITY trial, which was announced last week, as an umbrella effort to bring disparate clinical trials together. These top candidates include remdesivir, originally developed by Gilead Pharmaceuticals as a treatment for Ebola, for which it failed to show results. But in the case of COVID-19, there have been scattered observational reports showing improvement, and it is currently the focus of at least five separate clinical trials. A third leading candidate is the antimalarial drug hydroxychloroquine, in combination with the antibiotic, azithromycin. Initial, positive results from a small French trial were reported late last week, involving a total of 42 patients, 26 of whom received the experimental drug combination, with a significant reduction in viral loads amongst 20 patients who received the full course of treatment. Rush For Treatments Comes Against Rising Cases in Europe, Americas, Africa & South-East Asia The rush to find treatments came against the sharp rise of cases seen worldwide almost everywhere outside of western Asia, and now approaching half a million mark. The biggest new regional uptick was now being seen in Latin America and the Caribbean, where some 5317 cases had been recorded as of the 24th of March, along with 57 deaths. Brazil and Chile accounted for the most cases with 1857 and 733 people affected. Argentina, Bolivia, the Brazilian state of São Paulo and Colombia have introduced obligatory nationwide (or statewide) quarantine while others have curfews in place. Meanwhile, Brazil and Uruguay have sealed their border to prevent incoming visitors to Brazil. As the coronavirus spreads in Brazil and Colombia, indigenous tribes are closing off their reserves to visitors. Though no cases have been confirmed yet among the indigenous populations, tribes that have limited interaction with outsiders have historically experienced low immunity against respiratory diseases in general. Therefore, “with the coronavirus threat, there is the possibility of really exterminating an entire people”, warns Paula Vargas, Brazil program manager for Amazon Watch, an indigenous rights group. Regionally, Africa was also showing a significant increase in transmission, with 1396 confirmed cases in 43 countries. Egypt, South Africa and Algeria have the highest number of cases with 294, 274 and 201 infections respectively. In Italy, 5,246 new cases had been reported over the past 24 hours. However, for the third day running, new cases remained below the peak of 6,600 new cases on Saturday 21 March, leaving some hopes that trends might be steadying out in the country of 60 million people that has experienced almost as many cases as in China’s population of 1.4 billion. Per capita, Switzerland’s cases were closely following those of Italy, with about 900 infections per million people, according to the latest data, although some of the increase could be attributed to more extensive testing than elsewhere in Europe. Switzerland has recently tightened its border controls, and was ramping up other response measures. Global tracking of active cases of COVID-19 (middle) around the world as of 19:31 PM CET 24 March. Numbers change rapidly. France Access Group Protests Health Ministry Inertia on COVID-19 Testing In neighboring France, Minister of Health, Oliver Veran, came under fire on Monday after saying that France would not undertake massive testing for COVID-19 until the current lockdown was over, and newer rapid tests, as well as blood tests to identify people that have antibodies to the virus were developed. In a press statement, the French Observatory for Medicines Transparency, denounced Veran’s policy as contradicting WHO. “The WHO has not said ‘wait for serological tests’, the WHO has said ‘test, test, test,’ protested Pauline Londeix, co-founder of the group. “Widescale testing would help identify COVID-19 in groups such as health workers, cleaners, and store clerks, who might have light or asymptomatic cases but could potentially infect many others if they were not identified, allowing them to isolate themselves, recover and protect others,” she said. “The more days that pass, the more it appears clear to us that pseudo-medical decisions have been taken by the [French] government concerning COVID-19 testing, due to economic considerations, first and foremost. Our country, one of the seven largest industrial powers in the world, and supposedly blessed with an important biomedical industrial sector, is continually out of step, and constantly being forced to improvise”, Londeix added. She said the government should elaborate a clear test strategy and ramp up national public production of test kits, including reagents and their raw materials, as well as alcoholic gel and protective masks for health workers as soon as possible. Although patents on most of the standard, low-throughput PCR technologies, the letter also expressed concerns that control over high-volume diagnostic test tools remains concentrated in the hands of a few key pharma and diagnostic test manufacturers, such as Roche, Abottt/Alere, Biomérieux, Quiagen and Thermo Fisher, who hold the rights to their respective test platforms. Gauri Saxena contributed to this story Image Credits: Johns Hopkins CSSE. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.