Clin Eval 48（1）2020

COVID-19 response
Special contribution

A Proposal for the Confrontation of
the COVID-19 pandemic
Dirceu Greco 1）
Professor Emeritus, Infectious Diseases and Bioethics,
Federal University of Minas Gerais, Brazil

Taking in consideration,�the world-wide dissemination of the new coronavirus, which has as of 2 May 2020, 3,507,339 confirmed cases, reached 212 countries and territories in all continents, with 245,237 reported deaths, andhas been characterized as a pandemic by the World Health Organization characterized COVID-19 inMarch 11, 2020;
�the increasing number of cases and the lethality rate outside its starting point in China and the speed oftransmission which must be reduced so that the health services available in the countries are able to carefor people with severe symptoms of the disease;�the increasing pressure on the health systems throughout the world, which will certainly be more intensewith the spread to countries outside the so-called developed world, already plagued by poverty, disparity, failing health systems and unemployment, among other problems;�its immediate effect on the most vulnerable communities and individuals;
�the expected long duration and post-epidemic lasting effects on social, health, economic and otherrelated issues,Thus, it is urgent a concerted action of governments, researchers, health professionals and the civil society
aiming at controlling this pandemic. All must be involved in this effort and the participation of the governments, researchers and the international community is crucial:

Governments
Urge national legislative houses and the judiciary to adopt urgent and definitive measures for adequate
financing, to strengthen or establish an universal, equitable, free for all, public health system;
1) Chair of the Brazilian Society for Bioethics, 2019-2021；Member and Vice-chair of International Bioethics Committee of United
Nations Educational, Scientific and Cultural Organization (UNESCO) (2018-2021).

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Governments together with national legislative houses and judiciary should issues laws on the taxation onlarge fortunes;
Continue efforts to mitigate and eventually eliminate the social determinants of ill health, which affect but
are not limited to the elderly, institutionalized people, deprived of their liberty, the poor, unemployed, thoseworking in informal economy, homeless, minorities in the current pandemic 2). This must also include theimmediate provision of social benefits for all these groups of individuals and their families, such as freemonthly distribution of a basic basket of food goods and non-food goods containing essential and non-perishable items;
Most importantly, the current situation is also a real opportunity to establish universal basic income (UBI) 3)
with direct payment to families;
Issue tax incentives (deductions or other) for employers, in order to avoid layoffs and wage cuts for domestic small, medium and large companies workers during the pandemic;
Inform citizens not only of all plans and measures to be implemented, but also of their controversies andpossible adverse effects;
The necessary information must be disseminated in adequate, evidence-based, culturally relevant information, to facilitate citizen participation in the confrontation of health issues that may affect them and others;
The needed health promotion and prevention plans, must be chosen amongst the least intrusive measuresavailable that yield the same results;
Make available to all the full capacity of health services in the country, both public and private, available
equally to all citizens, with special attention to access to intensive care units. Access regulation to ICU beds
must be under the coordination of the national ministry of health;Make sure that the needed financing and support for many other prevailing endemic and/or acute illnesses
is provided during this pandemic;
Ensure adequate protective equipment for health and other hospital personnel involved in the care of
COVID-19 patients. Include a support and protection plan for these professionals to mitigate exhaustion;
Propose the issuing of laws prohibiting patenting of drugs/devices/vaccines that have shown to be effective
against the coronavirus 4);2) In 2015, Globally, 10 percent (700 million people) of the world is living on less than $2 a day. This is the World Bank’s international line for extreme poverty. Adults with less than $10,000 in wealth make up 56.6 percent of the world’s population but holdless than 2 percent of global wealth. Individuals owning over $100,000 in assets (11% of the global population) own 82.8 percentof global wealth. 40% of U.S. population (140 million people) are either poor or low-income.
3) “The COVID-19 pandemic opens a real future for a Universal Basic Income (UBI), a system where everyone receives a standard
amount of money. For several years there has been a surging movement towards it, with some of the more famous supporters
including Elon Musk, the CEO of Tesla and SpaceX and Pierre Omidyar, the founder of eBay. The startup incubator Y Combinator
even launched a study into UBI in the United States”.
Source：Collins V. COVID-19 and Universal Basic Income: Lessons for governments from the tech world. Forbes. 2020 Mar 19.
https://www.forbes.com/sites/victoriacollins/2020/03/19/covid-19-and-universal-basic-income-lessons-for-governments-from-thetech-world/#199e575957ec
4) Chilean Chamber of Deputies approves resolution for compulsory licenses for patents relating to the coronavirus virus - Posted on
March 17, 2020.
https://www.keionline.org/32385− W90 −

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Use the experience acquired in this pandemic to fund for outbreak preparedness as other similar situations
will certainly come 5);
Take special care and abide by laws or directives related to the protection of privacy and confidentiality,
especially in relation to the use data that may have to be collected to help in the control of the pandemic.

The research community and the Local/National Research Ethics Committees
Research community must abide to established ethical guidelines to perform research involving humans inany epidemiological situation, independently of involvement of country, ethnicity, sexual orientation, educational and economic backgrounds;
Procedurally there is already in place most of what is needed to ethically and scientifically confront emerging outbreaks. This include, but it is not limited to the availability of several ethical guidelines directed bothto “normal” situations and to emergency health response 6, 7);
Research and clinical trials need to be implemented, on a local basis, but may need at the same time international scientific partnership and may also need a multicenter ethical review collaboration. The latter should
be preferentially coordinated by the WHO Research Ethics Review Committee 8);
The usual timeframes for research ethics review must be reduced, without undermining any of the substantive protections that ethics review is designed to provide. The WHO Guidance for Managing Ethical Issues
in Infectious Disease Outbreaks will be of great help 7). The perceived and many times real urgency mustnever be used to circumvent ethical behavior and human rights;
The process of informed individual consent, the cornerstone of ethically conducted research must always
be applied for the ethical conduct of research 9). In exceptional circumstances it may be waived after a thorough evaluation by the research ethics committee;
Special care must be taken with research involving quarantined individuals, as they will be even more
vulnerable, and this must be reflected in the informed consent procedures and follow-up;

5) In January 2020, as the coronavirus (SARS-CoV 2) outbreak was spreading, WHO DG Tedros Adhanom Ghebreyesus warned thatfunding for outbreak preparedness “has remained grossly inadequate” in the past. “For too long, the world has operated on a cycleof panic and neglect” He urged the 196 member states to “invest in preparedness,” not “panic.”
6) WHO Good participatory practice guidelines for trials of emerging (and re-emerging) pathogens that are likely to cause severe outbreaks in the near future and for which few or no medical countermeasures exist (GPP-EP).
https://www.who.int/blueprint/what/norms-standards/GPP-EPP-December2016.pdf?ua=17) WHO Guidance for Managing Ethical Issues in Infectious Disease Outbreaks.
https://apps.who.int/iris/bitstream/handle/10665/250580/9789241549837-eng.pdf;jsessionid=D4132A5457A67DCE12AED9BAE
F8FCB97?sequence=18) WHO Research Ethics Review Committee (ERC) is a 27-member committee established and appointed by the Director-General.
Its mandate is to ensure WHO only supports research of the highest ethical standards. The ERC reviews all research projects,involving human participants supported either financially or technically by WHO.
https://www.who.int/ethics/review-committee/en/9) Declaration of Helsinki; CIOMS 2016 Ethical guidelines; The Belmont Report; Good Clinical Practice; WHO Handbook for Good
Clinical Research Practice; the Nuremberg Code; UNAIDS/WHO Ethical considerations in biomedical HIV prevention trials; theUNESCO Universal Declaration on Bioethics and Human Rights; and relevant national guidelines-in WHO Good participatory
practice guidelines for trials of emerging (and re-emerging) pathogens that are likely to cause severe outbreaks in the near futureand for which few or no medical countermeasures exist (GPP-EP) (See reference 6).

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Ensure increased and when feasible parity participation of community representatives and local researchers in the discussion of research projects and access during and post emergencies;
Research conducted during an infectious disease outbreak should be designed and implemented in conjunction with other public health interventions. Under no circumstances should research compromise thepublic health response to an outbreak or the provision of appropriate clinical care. All clinical trials must be
prospectively registered in an appropriate clinical trial registry 7);
Transparency, sharing of benefits and sharing/dissemination of data need to be recognised as central values, taking into account all the necessary care in relation to privacy and confidentiality 10);
It is an ethical imperative to provide post-trial access of any prevention or therapeutic product scientifically proven beneficial, for the participants, their families, and their communities, even before full licensing
approval 6);
Establish mechanisms to curb conflicts of interest, including but not limited to the political decisions on
confrontation of the pandemic, the timely and wide dissemination of information, and especially those
involving relations with drug companies 11).

The international community
The International community must join together, through an established institution, namely the United
Nations and its various agencies (e.g., WHO, ILO, UNESCO);
Provide adequate funding for international collaborative research on various aspects of the pandemic,
including epidemiological, clinical, biological, pharmacological and for the development of vaccines;
Make sure that drugs, vaccines and any other product shown to be efficacious be immediately available
and accessible to all who may need them and that no patents be issued in any of these developed products.

Conclusions
Even considering that epidemics may affect underdeveloped and developed countries, their severity ismultiplied when they hit the most vulnerable communities/countries/individuals. Thus, the ethics, health/
medical community must abide to the human rights, ethical and research guidelines to protect them.
However, there are substantive hurdles to their effective application, and these include the prevailing disparities which hamper the realization of human rights of individuals and communities.
In this needed effort, the field of action of the ethics, health/medical communities and society at large must
be expanded beyond the much-needed health care, social support and research to include “non-medical”
activities. These comprise confronting isolationism and the widespread xenophobia; the increasing anti-scientific movement (e.g., anti-vaccination); the underfinancing of health care; taking sides on the need to have10) Report of the IBC on the Principle of the Sharing of Benefits, 2015.
https://unesdoc.unesco.org/ark:/48223/pf0000233230
11) This has become an issue after the 2005 avian flu and during and after the H5N1 epidemic in 2010. There were criticisms to thepharmaceutical industry for non-disclosure of crucial data related to their clinical studies with oseltamivir (Tamiflu) and to WHO
and other institutions in their dealing with these infections - Doshi P, Jefferson T, Del Mar C. The Imperative to Share ClinicalStudy Reports: Recommendations from the Tamiflu Experience. PLoS Med. 2001; 9(4): e1001201.

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all clinical studies data available for scrutiny; close ranks to counteract climate change, which is an importantfacilitator of disease outbreaks; to provide adequate financing to establish access to clean water and adequate
sanitation to all 12); close ranks to equalitarian access to the products of technology 13).
And last and most importantly, this joint effort must aim at urgently addressing the social determinants ofill health that facilitate the establishment and spread of various illnesses. Mechanisms to mitigate, or optimistically eliminate, these disparities must be included in each and every discussion, guidelines and covenants
regarding emerging infectious diseases.

Consulted biography
CIOMS International Ethical Guidelines for Health-related Research Involving Humans, 2016.
https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf
ILO Joint Statement on COVID-19 by International Organisation of Employers and International TradeUnion Confederation.
https://www.ilo.org/wcmsp5/groups/public/---ed_dialogue/---actrav/documents/genericdocument/
wcms_739522.pdf
UN ECOSOC Ministerial Declaration – 2009 High-level Segment - Implementing the internationally agreed
goals and commitments in regard to global public health.
https://www.un.org/en/ecosoc/julyhls/pdf09/ministerial_declaration-2009.pdf
UNESCO IBC&COMEST Statement on COVID-19: ethical considerations from a global perspective.
https://unesdoc.unesco.org/ark:/48223/pf0000373115
UNESCO Universal Declaration on Bioethics and Human Rights 2005.
https://unesdoc.unesco.org/ark:/48223/pf0000146180
UN Universal declaration of human rights, 1948.
https://www.un.org/en/udhrbook/pdf/udhr_booklet_en_web.pdf
WHO Good participatory practice guidelines for trials of emerging (and re-emerging) pathogens that arelikely to cause severe outbreaks in the near future and for which few or no medical countermeasures exist(GPP-EP) 2016. See reference 6.
WHO Guidance for Managing Ethical Issues in Infectious Disease Outbreaks. See reference 7.
Conflict of interest

There is no conflict of interest to be disclosed.
(Submitted April 3, 2020)(Preprint, ver. 1.0 Published April 27, 2020)(ver. 2.0 Submitted May 3, 2020)(Preprint, ver. 2.0 Published May 7, 2020)(Accepted May 24, 2020)(Published June 15, 2020)
Rinsho Hyoka（Clinical Evaluation）．2020；48（1）：W89−W93.
12) Heller L, Mota CR, Greco DB. Short Communication-COVID-19 faecal-oral transmission: Are we asking the right questions?
STOTEN. 2020. 729; 10 August: 138919.
https://doi.org/10.1016/j.scitotenv.2020.138919
13) Klain, R. Politics and Pandemics. NEJM. 2019; 379(23): 2191-3.

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