The Lay of the Land
Pricing and Accessibility
- ^ Some regulatory institutions have collaborated with pharmaceutical companies during the pandemic. This is different from the level of heads of government, whose involvement could address various bottlenecks.
- ^ Paul N. Newton, Katherine C. Bond, et. al., “Covid-19 and risks to the supply and quality of tests, drugs, and vaccines,” The Lancet, 9 April 2020, https://doi.org/10.1016/S2214-109X(20)30136-4.
- ^ Ibid.
- ^ UK government press release, “UK leads way as national endorse landmark pledge to make coronavirus vaccines and treatments available to all,” 24 April 2020, https://www.gov.uk/government/news/uk-leads-way-as-nations-endorse-landmark-pledge-to-make-coronavirus-vaccines-and-treatments-available-to-all
- ^ Sara Boseley, “US and UK ‘lead push against global patent pool for Covid-19 drugs,’” The Guardian, 17 May 2020, https://www.theguardian.com/world/2020/may/17/us-and-uk-lead-push-against-global-patent-pool-for-covid-19-drugs
- ^ Ibid.
- ^ Lina Saigol, “AstraZeneca teams up with Oxford University to develop coronavirus vaccine – first results from human trials expected in June or July 2020, Marketwatch, 3 May 2020, https://www.marketwatch.com/story/astrazeneca-teams-up-with-oxford-university-to-develop-coronavirus-vaccine-first-results-from-human-trials-expected-in-june-or-july-2020-04-30
- ^ Jeff Craven, “Covid-19 therapeutics tracker,” Regulatory Force, 8 May 2020, https://www.raps.org/news-and-articles/news-articles/2020/3/Covid-19-therapeutics-tracker
- ^ Juntaro Arai and Rina Mitsutake, “Avigan set for approval this month in Japan as coronavirus drug,” Nikkei Asian Review, 5 May 2020, https://asia.nikkei.com/Business/Pharmaceuticals/Avigan-set-for-approval-this-month-in-Japan-as-coronavirus-drug
- ^ Catherine Burns and Rachael Buchanan, “Coronavirus: thousands signal interest in plasma trial,” BBC News, 2 May 2020, https://www.bbc.co.uk/news/health-52510865
- ^ Takeda Newsroom, “Working together to go faster for patients,” 18 April 2020, https://www.takeda.com/newsroom/featured-topics/working-together-to-go-faster-for-patients/
- ^ National Institute for Health Research, “NIHR and UKRI launch £20 million funding call for novel coronavirus research,” 4 February 2020, https://www.nihr.ac.uk/news/nihr-and-ukri-launch-20-million-funding-call-for-novel-coronavirus-research/23942
- ^ Ibid.
- ^ UK government press release, “COVID-19 treatments could be fast tracked though new national clinical trial initiative,” 29 April 2020, https://www.gov.uk/government/news/Covid-19-treatments-could-be-fast-tracked-through-new-national-clinical-trial-initiative
- ^ For more information about the drug and the trial, see the cover letter from the company’s CEO about the clinical trial: https://www.bergenbio.com/ceo-letter-Covid-19-clinical-trial/
- ^ Reality Check team, “Contaminated blood scandal: where does the UK’s blood supply come from?” BBC News, 28 September 2018, https://www.bbc.co.uk/news/health-45641186
- ^ “Gilead announces results from phase-3 trial of investigational antiviral Remdesivir in patients with severe Covid-19,” 29 April 2020, https://www.gilead.com/news-and-press/press-room/press-releases/2020/4/gilead-announces-results-from-phase-3-trial-of-investigational-antiviral-remdesivir-in-patients-with-severe-Covid-19
- ^ “Coronavirus live news: global cases pass 5.5 million as WHO warns of ‘second peak,’” The Guardian, 26 May 2020, https://www.theguardian.com/world/live/2020/may/26/coronavirus-live-news-covid-19-uupdates-who-drops-hydroxychloroquine-trial-as-mexico-death-toll-questioned
- ^ Chloroquine and hydroxychloroquine are anti-inflammatories, which help counter over-active immune systems, that may be effective in treating Covid-19. The efficacy of the drugs depends on when in the lifecycle of Covid-19 infection they are used. Antiviral drugs are likely to be most effective when administered as early as possible – perhaps even as a preventative – while anti-inflammatory drugs could be damaging if used too early as they could weaken the immune system’s response.
- ^ “Coronavirus: WHO halts trials of hydroxychloroquine over safety fears,” BBC, 25 May 2020, https://www.bbc.co.uk/news/health-52799120
- ^ Sermo press release, “Sermo reports jury is still out on Remdesivir; 31% of physicians who have used Remdesivir rate it as highly effective; 38% rate it as somewhere in the middle,” 23 April 2020, https://www.sermo.com/press-releases/sermo-reports-jury-is-still-out-on-remdesivir-31-of-physicians-who-have-used-remdesivir-rate-it-as-highly-effective-31-rate-it-with-low-effectiveness-38-rate-it-as-somewhere-in-the-middle/; also cited in Alice Park, “Vaccines, antibodies and drug libraries. The possible Covid-19 treatments researchers are excited about,” Time, 14 April 2020, https://time.com/5819965/coronavirus-treatments-research/
- ^ Agence France-Presse, “Africans rush for chloroquine as coronavirus tsunami looms,” South China Morning Post, 2 April 2020, https://www.scmp.com/news/world/africa/article/3078039/africans-rush-chloroquine-coronavirus-tsunami-looms
- ^ Ellen Gabler and Michael H. Keller, “Prescriptions surged as Trump praised drugs in coronavirus fight” New York Times, 25 April 2020, https://www.nytimes.com/2020/04/25/us/coronavirus-trump-chloroquine-hydroxychloroquine.html.
- ^ Topher Sanders, David Armstrong, and Ava Kofman, “Doctors are hoarding unproven coronavirus medicine by writing prescriptions for themselves and their families,” ProPublica, 24 March 2020, https://www.propublica.org/article/doctors-are-hoarding-unproven-coronavirus-medicine-by-writing-prescriptions-for-themselves-and-their-families
- ^ “AAPS letter asking Governor Ducey to rescind executive order concerning hydroxychloroquine in COVID-19,” 27 April 2020, https://aapsonline.org/aaps-letter-asking-gov-ducey-to-rescind-executive-order-concerning-hydroxychloroquine-in-Covid-19/ A key passage is worth quoting at length: “Attached and posted here (https://bit.ly/cqhcqresearch) is a summary of peer-reviewed evidence, indexed in PubMed, concerning the use of CQ and HCQ against coronavirus. We believe that there is clear and convincing evidence of benefit both pre-exposure and post-exposure. In addition, Michael J. A. Robb, M.D., of Phoenix is compiling all reports as they come in. As of this date, the total number of reported patients treated with HCQ, with or without azithromycin and zinc, is 2,333. Of these, 2,137 or 91.6 percent improved clinically. There were 63 deaths, all but 11 in a single retrospective report from the Veterans Administration where the patients were severely ill. Most of the data concerns use of HCQ for treatment, but one study included used the medication as prophylaxis with excellent results. Many nations, including Turkey and India, are protecting medical workers and contacts of infected persons prophylactically. According to http://worldometers.info, deaths per million persons from COVID-19 as of Apr 27 are 167 in the U.S., 33 in Turkey, and 0.6 in India.” [Emphasis added.]
- ^ Sarah Boseley, “Vital drug for people with lupus running out after unproven Covid-19 link,” The Guardian, 27 March 2020, https://www.theguardian.com/world/2020/mar/27/vital-drug-people-lupus-coronavirus-covid-19-link-hydroxychloroquine
- ^ Jack Goodman and Christopher Giles, “Coronavirus and hydroxychloroquine: What do we know?” BBC News, 28 April 2020, https://www.bbc.co.uk/news/51980731
- ^ Agence France-Presse, op. cit.
- ^ Tan Hui Yee, “Lupus patients hit by run on drug chloroquine after claims it wards against coronavirus,” Strait Times, 25 March 2020, https://www.straitstimes.com/asia/se-asia/run-on-drug-chloroquine-despite-unproven-belief-as-ward-against-coronavirus-affecting
- ^ Camille Malplat, “Africans rush for chloroquine as virus tsunami looms” The Jakarta Post, 1 April 2020, https://www.thejakartapost.com/news/2020/04/01/africans-rush-for-chloroquine-as-virus-tsunami-looms-1585752420.html
- ^ Paul N Newton, Katherine C. Bond, et al., “COVID-19 and risks to the supply and quality of tests, drugs, and vaccines,” The Lancet, 9 April 2020, https://doi.org/10.1016/S2214-109X(20)30136-4
- ^ Kristian Thorlund, et al., “A real-time dashboard of clinical trials for COVID-19,” The Lancet, 24 April 2020, https://doi.org/10.1016/S2589-7500(20)30086-8
- ^ Comment, “Global coalition to accelerate Covid-19 clinical research in resource-limited settings,” The Lancet, 2 April 2020, https://doi.org/10.1016/S0140-6736(20)30798-4
- ^ For the universe of Covid-19 trials that include: basic science; diagnostic tests; expanded access; interventional; observational; prevention; and prognosis, see “COVID-19 Trials Tracker,” available at http://covid19.trialstracker.net/
- ^ https://www.therapeuticsaccelerator.org/
- ^ Angel Au-Yeung, “A Bill Gates-backed accelerator for Covid-19 therapeutics treatment partners with Madonna and Mark Zuckerberg’s Chan-Zuckerberg initiative,” Forbes, 3 April 2020, https://www.forbes.com/sites/angelauyeung/2020/04/03/a-bill-gates-backed-accelerator-for-Covid-19-coronavirus-therapeutics-treatment-partners-with-madonna-and-mark-zuckerbergs-chan-zuckerberg-initiative
- ^ EMA press release, "Update on treatments and vaccines against COVID-19 under development,” 31 March 2020, https://www.ema.europa.eu/en/documents/press-release/update-treatments-vaccines-against-Covid-19-under-development_en.pdf
- ^ INSERM press release, “Launch of a clinical trial against Covid-19,” 22 March 2020, https://presse.inserm.fr/en/launch-of-a-european-clinical-trial-against-Covid-19/38737/
- ^ For more information, see “Covid-19: Horizon 2020 partly funding Innovative Medicines Initiative fast track call,” 3 March 2020, https://ec.europa.eu/info/news/covid19-horizon-2020-partly-funding-innovative-medicines-initiative-fast-track-call-2020-mar-03_en
- ^ Innovative Medicines Initiative, “IMI2- Call 21,” https://www.imi.europa.eu/apply-funding/open-calls/imi2-call-21
- ^ Florin Zubașcu, “Viewpoint: we need a coordinated global R&D response against the novel coronavirus,” Science|Business, 10 March 2020, https://sciencebusiness.net/viewpoint/viewpoint-we-need-coordinated-global-rd-response-against-novel-coronavirus
- ^ Carolyn Y. Johnson, “Chaotic search for coronavirus treatments undermine efforts, experts say,” Washington Post, 15 April 2020, https://www.washingtonpost.com/health/2020/04/15/coronavirus-treatment-cure-research-problems/
- ^ Ibid.
- ^ CA government press release, “Prime Minister outlines Canada’s Covid-19 response,” 11 March 2020, https://pm.gc.ca/en/news/news-releases/2020/03/11/prime-minister-outlines-canadas-Covid-19-response
- ^ Canadian Institutes of Health Research, “Canadian 2019 Novel Coronavirus (Covid-19) Rapid research Funding Opportunity Results,” 19 March 2020, https://cihr-irsc.gc.ca/e/51908.html
- ^ For a detailed list, see “Vaccines and treatments for Covid-19: List of all Covid-19 Clinical Trials Authorised by Health Canada,” https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-clinical-trials/list-authorized-trials.html#wb-auto-5
- ^ Joel Achenbach, “Study finds Africans more genetically diverse than other populations,” Washington Post, 1 May 2009, https://www.washingtonpost.com/wp-dyn/content/article/2009/04/30/AR2009043002485.html
- ^ Ibid. See also Clint Witchalls, “Few clinical trials are done in Africa: Covid-19 shows why this urgently needs to change,” The Conversation, 6 April 2020, https://theconversation.com/few-clinical-trials-are-done-in-africa-Covid-19-shows-why-this-urgently-needs-to-change-135117
- ^ US National Library of Medicine, https://clinicaltrials.gov/ct2/show/NCT04333732?cond=COVID-19&map_cntry=ZA&draw=2&rank=1 More specifically, “[h]ealthcare worker based in a primary, secondary or tertiary healthcare setting with a high risk of developing Covid-19 due to their potential exposure to patients with SARS-CoV-2 infection.”
- ^ Antoaneta Roussi and Amy Maxmen, “African nations mission from coronavirus trials,” Nature, 3 April 2020, https://www.nature.com/articles/d41586-020-01010-7
- ^ Ibid.
- ^ US National Library of Medicine, https://clinicaltrials.gov/ct2/show/NCT04343001?cond=COVID-19&map_cntry=NG&draw=2&rank=1#contacts
- ^ Interview with Professor Haleema Shakur-Still and Professor Ian Roberts, co-leads of the clinical trial in Nigeria and Pakistan, and on faculty at London School of Hygiene & Tropical Medicine.
- ^ Covid-19 Clinical Research Coalition, “Comment: Global Coalition to accelerate COVID-19 clinical research in resource-limited settings,” The Lancet, 2 April 2020, https://doi.org/10.1016/S0140-6736(20)30798-4
- ^ Yannis Natsis, “Will pharma commit to delivering affordable therapeutics against COVID-19?” European Public Health Alliance, 6 April 2020, https://epha.org/will-pharma-commit-to-delivering-affordable-therapeutics-against-Covid-19/
- ^ Ibid.
- ^ Emma Wilkinson, “India and China spark concerns for UK drug supplies,” The Pharmaceutical Journal, 28 August, 2019, https://www.pharmaceutical-journal.com/news-and-analysis/features/india-and-china-spark-concerns-for-uk-drug-supplies/20206998.article
- ^ Andrew Hill, “Ways to safeguard UK drug supplies during Covid-19 and beyond,” The Pharmaceutical Journal, 15 April 2020, https://www.pharmaceutical-journal.com/news-and-analysis/opinion/comment/ways-to-safeguard-uk-drug-supplies-during-covid-19-and-beyond/20207897.article
- ^ “Global calls for compulsory Covid-19 patent licensing build,” I Am Media, 21 May 2020, https://www.iam-media.com/coronavirus/global-calls-compulsory-covid-19-patent-licensing-build
- ^ “Covid-19 emergency may expose compulsory licensing limits,” IAM – Media, 24 March 2020, https://www.iam-media.com/coronavirus/Covid-19-emergency-may-expose-compulsory-licensing-limits
- ^ Ibid.
- ^ CR government press release, “Costa Rica submits proposal for WHO to facilitate access to technologies to combat Covid-19,” 24 March 2020, https://www.presidencia.go.cr/comunicados/2020/03/costa-rica-submits-proposal-for-who-to-facilitate-access-to-technologies-to-combat-Covid-19/ and cited in Achal Prabhala and Ellen’t Hoen, “We’ll find a treatment for coronavirus – but drug companies will decide who gets it,” The Guardian, 15 April 2020, https://www.theguardian.com/commentisfree/2020/apr/15/coronavirus-treatment-drug-companies
- ^ Brook Baker, “Rationale for supporting Costa Rica’s proposal for emergency Covid-19 technology IP pool for all countries,” Health Gap, 25 March 2020, https://healthgap.org/rationale-for-supporting-costa-ricas-proposal-for-emergency-covid-19-technology-ip-pool-for-all-countries/
- ^ Letter from Marisol Touraine (Chair, Unitaid Executive Board) and Dr Philippe Duneton (Executive Director, a.i Unitaid) to Dr. Tedros (Director General, WHO), 25 March 2020, https://www.healthpolicy-watch.org/wp-content/uploads/2020/03/unitaid.pdf
- ^ https://www.sermo.com/press-releases/sermo-reports-jury-is-still-out-on-remdesivir-31-of-physicians-who-have-used-remdesivir-rate-it-as-highly-effective-31-rate-it-with-low-effectiveness-38-rate-it-as-somewhere-in-the-middle/
- ^ Ellen’t Hoen, “Covid-19 and the comeback of compulsory licensing,” Medicine, Law, and Policy, 23 March 2020, https://medicineslawandpolicy.org/2020/03/Covid-19-and-the-come-back-of-compulsory-licensing/. The English translation of the resolution is available at https://www.keionline.org/chilean-covid-resolution. The key text is, “the coronavirus epidemic worldwide and in our country, and its risks to the health of the Chilean population, in accordance with the aforementioned, constitute sufficient justification for the granting of the non-voluntary licenses contemplated in article 51º No. 2 of Industrial Property Law No. 19.039 to facilitate access to vaccines, drugs, diagnostics, devices, supplies, and other technologies useful for the surveillance, prevention, detection, diagnosis and treatment of people infected by the coronavirus virus in Chile, for public health reasons and/or national emergency, as provided in international laws, particularly the Doha Declaration on the TRIPS Agreement and Public Health.”
- ^ The English text of the resolution is available at https://www.keionline.org/ecuador-CL-coronavirus-resolution: “Demand the President of the Republic and the Minister of Public Health of Ecuador, that within the declaration of a State of Health Emergency, include the administrative and technical mechanisms for the establishment of compulsory patent licenses, access to test data and access to other technologies for the availability of vaccines, drugs, diagnoses, devices, supplies, and other useful means for the surveillance, prevention, detection, diagnosis, and treatment of people infected with the Coronavirus (COVID-19) and other variations in order to guarantee the right to health through its free access or at an affordable costs. Article 2.- Require the Minister of Public Health of Ecuador that within the declaration of State of Health Emergency also provide for non-commercial public use or the compulsory license of patents, as well as access to test data for pharmaceutical products for the production, import or massive use in Ecuador of vaccines, drugs, diagnoses, devices, supplies, and other useful technologies for the surveillance, prevention, detection, diagnosis, and treatment of people infected with the Coronavirus (COVID-19) and others variations, in coordination with the competent technical organizations.“
- ^ Francois Pochart, “Compulsory licenses granted by public authorities: an application in the Covid-19 in France?” Kluwer Patent Blog, 23 April 2020, available online at http://patentblog.kluweriplaw.com/2020/04/23/compulsory-licenses-granted-by-public-authorities-an-application-in-the-covid-19-crisis-in-france-part-1/?doing_wp_cron=1590504122.8295719623565673828125
- ^ “Compulsory licensing in Canada – revisited,” Life Sciences Intellectual Property Review, 21 April 2020, available online at https://www.lifesciencesipreview.com/article/compulsory-licensing-in-canada-revisited
- ^ See https://www.statnews.com/wp-content/uploads/2020/04/brazil-cl-proposal-1.pdf for the proposed bill. One relevant passage is “The declaration of public health emergency of international concern by the World Health Organization (WHO) or the declaration of public health emergency of national concern by the competent national authorities automatically warrants the granting of compulsory license for national emergency of all patent applications or patents in force relating to technologies used to address the respective health emergency, such as vaccines, medicines, diagnostic tests, reagents, medical devices, personal protective equipment, supplies and any other technologies used to meet health needs related to the emergency.”