The World Health Organization (WHO), the United Nations’ specialized agency for health, celebrates its 72nd birthday this month. Its work over the past decades and its contribution to public health have often been overlooked. This changed on January 30, 2020, when WHO’s Director-General Dr. Tedros declared the novel coronavirus outbreak (COVID-19) a Public Health Emergency of International Concern. Since then, the organization has been at the forefront of the global response to COVID-19: from monitoring developments and providing daily situation reports to providing guidance to governments and the public, including on physical distancing hand hygiene.
Yet, while some of its initiatives have attracted the limelight (such as virtual concerts under the hashtag #TogetherAtHome), its more technical work continues to go largely unnoticed. These technical areas provide an opportunity for the life sciences industry to work with WHO, to ensure that life-saving health technologies reach patients around the globe.
Manufacturers of therapeutics, vaccines, medical devices and diagnostics — whether licensed or under development — should pay particular attention to the following WHO initiatives:
- SOLIDARITY clinical trials of potential COVID-19 treatments: Conscious that robust data is needed to determine which drugs (or combinations) are the most effective for the treatment of COVID-19, WHO has organized a large, international clinical study in which four untested treatments are compared with each other. They are: (1) remdesivir; (2) a combination of lopinavir and ritonavir; (3) a combination of lopinavir and ritonavir plus interferon beta; and (4) chloroquine. The following countries will join the SOLIDARITY trial: Argentina, Bahrain, Canada, France, Iran, Norway, South Africa, Spain, Switzerland and Thailand.
- Global procurement. WHO is leading the Pandemic Supply Chain Network (PSCN), a public-private collaboration and marketplace that aims to facilitate procurement of essential COVID-19 items for more than 120 countries. To that aim, WHO developed a list of COVID-19 critical items, including diagnostic equipment, personal protective equipment (PPE) and clinical care equipment (such as ventilators). In addition, the WHO developed an Essential Supplies Forecasting Tool that will help manufacturers estimate demand for PPE, diagnostic equipment, biomedical equipment for case management, essential drugs for supportive care and consumable medical supplies.
- Medical equipment for clinical management (including invasive and non-invasive ventilators). WHO is revising technical specifications of medical devices used in intensive care units caring for COVID-19 patients. The medical devices covered are much broader than in WHO’s Disease Commodity Package. The revised technical specifications will soon be published on the WHO’s website. Manufacturers should take note of these technical specifications should they wish to participate in public tenders.
- Respiratory equipment manufacturers. To ascertain available supply, including for purposes of public procurement, WHO launched a survey for respiratory equipment manufacturers. The objective of the survey is to ascertain (i) current production capacity, (ii) potential to ramp up capacity and (iii) risks in manufacturing and distributing medical equipment to meet global demand.
- Emergency Use Listing (EUL) for in vitro diagnostics (IVDs) — assays for the detection of SARS-CoV-2 nucleic acid. The EUL is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and IVDs for use primarily during public health emergencies of international concern, such as COVID-19. The WHO is calling on IVD manufacturers to submit an application for emergency use listing by WHO of assays for the detection of SARS-CoV-2 nucleic acid.
- COVID-19 technical innovation. Last, manufacturers are encouraged to reach out to WHO if they have innovative products that might help in the fight against COVID-19.
Sidley Austin LLPはクライアントおよびその他関係者へのサービスの一環として本情報を教育上の目的に限定して提供します。本情報をリーガルアドバイスとして解釈または依拠したり、弁護士・顧客間の関係を結ぶために使用することはできません。
弁護士広告 - ニューヨーク州弁護士会規則の遵守のための当法律事務所の本店所在地は、Sidley Austin LLP ニューヨーク：787 Seventh Avenue, New York, NY 10019 (+212 839 5300)、シカゴ：One South Dearborn, Chicago, IL 60603、(+312 853 7000)、ワシントン：1501 K Street, N.W., Washington, D.C. 20005 (+202 736 8000)です。