Abstract

In most European countries, facemasks use is recommended or mandatory in enclosed spaces where physical distancing is not possible. In Spain, this measure was first extended to open public spaces and later made mandatory regardless of whether or not the interpersonal safety distance can be kept. At present, there is no evidence on the effectiveness of universal masking of healthy people in the community to prevent infection with respiratory viruses, including SARS-CoV-2. The mandatory use of masks poses some ethical questions. Firstly, it entails a paternalistic action. Secondly, application of the principle of precaution becomes questionable when there is no clear benefit-risk relationship. Thirdly, compulsoriness can interfere with equity of public health actions. Fourthly, it can result in social stigma and discrimination against those who do not wear one, even though they well may have good reasons for doing so. Lastly, this measure may generate confusion in the population, along with an altered perception of the risk. The World Health Organization recommends its use in public places with a high potential risk of transmission and where other prevention measures, such as physical distancing, are not possible. Mandatory use of masks in public open spaces, regardless of the risk of transmission or of whether or not the interpersonal safety distance can be kept, is an intrusive measure that restricts individual freedoms, and would not appear to be justified on the basis of available scientific evidence. What we need are recommendations explaining where, when, how and what type of mask to wear.

Keywords:
Face masks; Public health ethics; COVID-19; Disease transmission; Individual freedom; Stigma; Inequity; Spain

Resumen

En la mayoría de los países europeos, el uso de mascarillas es recomendado u obligatorio en espacios cerrados donde no es posible mantener la distancia física de seguridad. En España, la obligatoriedad se amplió primero a los espacios públicos abiertos y más tarde independientemente de la distancia de seguridad. En la actualidad no hay pruebas de la efectividad del uso universal de mascarilla para prevenir el contagio de virus respiratorios, incluido el SARS-CoV-2. El uso obligatorio de mascarilla plantea cuestiones éticas. Primero, implica una acción paternalista. Segundo, la aplicación del principio de precaución es cuestionable cuando no existe una relación clara beneficio-riesgo. Tercero, puede interferir en la equidad de las acciones de salud pública. Cuarto, puede dar lugar a un estigma social y a la discriminación de quienes no hacen uso de ella, aunque tengan buenas razones para ello. Por último, esta medida puede generar confusión en la población, junto con una percepción alterada del riesgo. La Organización Mundial de la Salud recomienda su uso en lugares públicos con un alto riesgo de transmisión y donde no sea posible aplicar otras medidas de prevención, como la distancia física. El uso obligatorio de mascarilla en espacios públicos abiertos, independientemente del riesgo de transmisión o de que se pueda o no mantener la distancia de seguridad, es una medida intrusiva que restringe las libertades individuales y no parece justificarse sobre la base de las pruebas científicas disponibles. Lo que necesitamos son recomendaciones explicando dónde, cuándo, cómo y qué tipo de mascarilla usar.

Palabras clave:
Mascarilla; Ética y salud pública; COVID-19; Transmisión de enfermedades; Libertades individuales; Estigma; Inequidad; España

Introduction

The use of face masks in public spaces has become a political issue in some countries. In the United States, the President Trump has changed his mind from rejecting the use of face masks in public¹1. Weissert W, Lemire J. Face masks make a political statement in era of coronavirus. The New York Times. 7 May 2020. Available at: https://apnews.com/article/virus-outbreak-donald-trump-ap-top-news-politics-health-7dce310db6e85b31d735e81d0af6769c. (by Associated Press).
https://apnews.com/article/virus-outbrea... to say that it is patriotic to wear a face mask when you can't socially distance.²2. Trump DJ. We are united in our effort to defeat the invisible China virus, and many people say that it is patriotic to wear a face mask when you can't socially distance. There is nobody more patriotic than me, your favorite President! pic.twitter.com/iQOd1whktN. Donald J. Trump (@realDonaldTrump) July 20 2020. https://twitter.com/realDonaldTrump/status/1285299379746811915
https://twitter.com/realDonaldTrump/stat... In most European countries, face masks use is recommended or mandatory in public transport and enclosed spaces where physical distancing is not always possible.³3. Royal Society. Face masks and coverings for the general public: behavioural knowledge, effectiveness of cloth coverings and public messaging. 2020. Available at: https://royalsociety.org/-/media/policy/projects/set-c/set-c-facemasks.pdf?la=en-GB&hash=A22A87CB28F7D6AD9BD93BBCBFC2BB24.
https://royalsociety.org/-/media/policy/... In Spain, this measure, first limited to public transport, was extended on May 20 to open public spaces: the use of face masks is compulsory for all persons over the age of six, whether in the street, outdoors, or in closed spaces used by or open to the public, in all cases where it would not be possible to maintain a safe interpersonal distance of at least 1.5 metres.⁴4. Ministerio de Sanidad. Orden SND/422/2020, de 19 de mayo, por la que se regulan las condiciones para el uso obligatorio de mascarilla durante la situación de crisis sanitaria ocasionada por el COVID-19. BOE No. 142, 20 May 2020: 33600-02. Available at: https://www.boe.es/boe/dias/2020/05/20/pdfs/BOE-A-2020-5142.pdf.
https://www.boe.es/boe/dias/2020/05/20/p... Finally, in all regions of Spain the use of face masks has been made mandatory in most circumstances throughout the months of July and August, regardless of whether or not the interpersonal safety distance can be kept.⁵5. Nadeu F. ¿En qué comunidades es obligatoria la mascarilla en España? El Periódico, 28 June 2020. Available at: https://www.elperiodico.com/es/sociedad/20200728/mascarilla-obligatoria-donde-comunidades-espana-8036602.
https://www.elperiodico.com/es/sociedad/...

Generalised use of face masks by the general public to reduce community transmission of COVID-19 was first justified on the principle of precaution.⁴4. Ministerio de Sanidad. Orden SND/422/2020, de 19 de mayo, por la que se regulan las condiciones para el uso obligatorio de mascarilla durante la situación de crisis sanitaria ocasionada por el COVID-19. BOE No. 142, 20 May 2020: 33600-02. Available at: https://www.boe.es/boe/dias/2020/05/20/pdfs/BOE-A-2020-5142.pdf.
https://www.boe.es/boe/dias/2020/05/20/p... The argument put forward to extend this measure to all circumstances is extremely attractive and tempting, i.e., the compulsory wearing of masks would serve to avoid more restrictive measures affecting individual liberties.⁶6. Generalitat de Catalunya. Resolución SLT/1648/2020, de 8 de julio, por la que se establecen nuevas medidas en el uso de la mascarilla para la contención del brote epidémico de la pandemia de COVID-19. Diario Oficial de la Generalitat de Catalunya Núm. 8173, 2020. If it were in fact true that their use outdoors could prevent future lockdowns, nobody well aware of it would leave home without wearing one. However, we are afraid that this is not the case. Unfortunately, the evolution of the pandemic is getting worse in Spain since mid July, in spite of the generalized use of masks following the new mandatory regulations.⁷7. Ministerio de Sanidad. Actualización n. 174. Enfermedad por el coronavirus (COVID-19). 06.08.2020 (datos consolidados a las 14:00 horas del 06.08.2020). Situación en España. Available at: https://www.mscbs.gob.es/en/profesionales/saludPublica/ccayes/alertasActual/nCov-China/documentos/Actualizacion179COVID-19.pdf.
https://www.mscbs.gob.es/en/profesionale...

In this article we analyse the scientific basis and the ethical implications of the mandatory use of face masks as it has been implemented in Spain, including settings where there is a very low risk of transmission (open, uncrowded spaces) even in situations where it is possible to maintain the safety distance.

The scientific evidence

What does science have to say about the use of face masks by the general healthy population? After reviewing the pertinent scientific evidence, the World Health Organization (WHO), in its interim guidance on the topic published on 6 April, reached the following conclusion: “The wide use of masks by healthy people in the community setting is not supported by current evidence and carries uncertainties and critical risks”.⁸8. World Health Organization. Advice on the use of masks in the context of COVID-19: interim guidance, 6 April 2020. Available at: https://apps.who.int/iris/handle/10665/331693.
https://apps.who.int/iris/handle/10665/3... These guidelines were updated on 5 June to include new relevant scientific evidence on the use of face masks in the prevention of COVID-19 transmission.⁹9. World Health Organization. Advice on the use of masks in the context of COVID-19: interim guidance, 5 June 2020. Available at: https://apps.who.int/iris/handle/10665/332293.
https://apps.who.int/iris/handle/10665/3... The conclusion reached is very similar: “At present, there is no direct evidence (from studies on COVID19 and in healthy people in the community) on the effectiveness of universal masking of healthy people in the community to prevent infection with respiratory viruses, including COVID-19”. Nonetheless, the guide advises that the following criteria be borne in mind when considering whether to recommend the use of masks to the general public:

Based on these criteria, the WHO recommends the use of non-medical masks (or medical masks for people aged ≥60 years and anybody with underlying comorbidity associated with a worse COVID-19 prognosis) in the following circumstances:

Medical masks have demonstrated their ability to reduce detection of influenza virus RNA in respiratory droplets and coronavirus RNA in aerosols, with a trend towards reduced detection of coronavirus RNA in respiratory droplets.¹⁰10. Leung NHL, Chu DKW, Shiu EYC, et al. Respiratory virus shedding in exhaled breath and efficacy of face masks. Nature Medicine. 2020;26:676-80. Non-medical masks, on the other hand, are as much as three time less effective in the control of emission of microorganisms.¹¹11. Davies A, Thompson K-A, Giri K, et al. Testing the efficacy of homemade masks: would they protect in an influenza pandemic? Disaster Medicine and Public Health Preparedness. 2013;7:413-8. A recent systematic review and meta-analysis of the scientific literature, which analysed 172 observational studies conducted in 16 countries across all continents, found that a physical distance of more than one metre is highly effective in the prevention of virus transmission.¹²12. Chu DK, Akl EA, Duda S, et al. COVID-19 Systematic Urgent Review Group Effort (SURGE) study authors. Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis. Lancet. 2020;395:1973-87. The scientific data that support the preventive effect of wearing masks by the general population are of low quality, and come, in the majority of cases, from studies focusing on homes or case contacts. Risk of transmission depends on the intensity and duration of contact,¹³13. Klompas M, Morris CA, Shenoy ES. Universal masking in the Covid-19 era. N Engl J Med. 2020;383:e9. two factors found in the family environment, where wearing a mask has been shown to be effective for reducing transmission.¹⁴14. Wang Y, Tian H, Zhang L, et al. Reduction of secondary transmission of SARS-CoV-2 in households by face mask use, disinfection and social distancing: a cohort study in Beijing, China. BMJ Glob Health. 2020;5: e002794. However, it is not clear whether mask use outdoors is related to the low COVID-19 rates in some countries, since this is just one of the many measures applied in places where there are excellent epidemiological surveillance systems with a proven capacity to control new COVID-19 outbreaks fast and effectively,¹⁵15. Shin YP, Young-Man K, Seonju Y, et al. Coronavirus disease outbreak in call center. South Korea. Emerg Infect Dis. 2020;26:1666-70. and where good hand-hygiene practices and respiratory etiquette have long been widespread among the population,¹⁶16. Lo JY, Tsang TH, Leung YH, et al. Respiratory infections during SARS outbreak, Hong Kong, 2003. Emerg Infect Dis. 2005;11:1738-41. unlike European countries, like Spain, where efforts have only recently begun to raise public awareness about the importance of such measures. The recommendation to the general healthy population to wear a mask, reserved for settings with a high risk of transmission, is a measure that is complementary to those required for basic prevention, namely:

Unlike most countries of the European Union, in Spain is mandatory for the general public to wear a face mask in all cases where it would otherwise not be possible to maintain a physical distance of 1.5 metres,⁴4. Ministerio de Sanidad. Orden SND/422/2020, de 19 de mayo, por la que se regulan las condiciones para el uso obligatorio de mascarilla durante la situación de crisis sanitaria ocasionada por el COVID-19. BOE No. 142, 20 May 2020: 33600-02. Available at: https://www.boe.es/boe/dias/2020/05/20/pdfs/BOE-A-2020-5142.pdf.
https://www.boe.es/boe/dias/2020/05/20/p... without drawing any distinction between situations of high potential risk of transmission, such as closed crowded spaces (bars, restaurants, workplaces, churches, musical halls, gymnasiums or health facilities) where people remain for prolonged periods of time, singing or talking loudly,¹⁵15. Shin YP, Young-Man K, Seonju Y, et al. Coronavirus disease outbreak in call center. South Korea. Emerg Infect Dis. 2020;26:1666-70.^,1717. Furuse Y, Sando E, Tsuchiya N, et al. Clusters of coronavirus disease in communities, Japan, January-April 2020. Emerg Infect Dis. 2020;6. Available at: 10.3201/eid2609.202272.
https://doi.org/10.3201/eid2609.202272...

18. Greenhalgh T, Schmid MB, Czypionka T, et al. Face masks for the public during the covid-19 crisis. BMJ. 2020;369:m1435.

19. Hammer L, Dubbel P, Capron I, et al. High SARS-CoV-2 attack rate following exposure at a choir practice -Skagit County, Washington. March 2020. MMWR MorbMortal Wkly Rep. 2020;69:606-10.

20. Jang S, Han SH, Rhee J-Y. Coronavirus disease cluster associated with fitness dance classes. South Korea. Emerg Infect Dis. 2020;26:1917-20.^-2121. Miller SL, Nazaroff WW, Jimenez JL, et al. Transmission of SARS-CoV-2 by inhalation of respiratory aerosol in the Skagit Valley Chorale superspreading event. medRxiv. 2020. Available at: 10.1101/2020.06.15.20132027.
https://doi.org/10.1101/2020.06.15.20132... and those in which the risk of transmission can be considered nil or negligible, such as when meeting another person while walking along the street.²²22. Klompas M, Morris CA, Sinclair J, et al. Universal masking in hospitals in the Covid-19 era. N Engl J Med. 2020;382:e63. All regions of Spain have gone further, making the use of masks mandatory in most circumstances, although the safety distance can be maintained.⁵5. Nadeu F. ¿En qué comunidades es obligatoria la mascarilla en España? El Periódico, 28 June 2020. Available at: https://www.elperiodico.com/es/sociedad/20200728/mascarilla-obligatoria-donde-comunidades-espana-8036602.
https://www.elperiodico.com/es/sociedad/...

A group of researchers has made an appealing to the medical community and to the relevant national and international bodies to recognize the potential for airborne spread of COVID-19,²³23. Morawska L, Milton DK. It is time to address airborne transmission of COVID-19. Clin Infect Dis. 2020. Available at: 10.1093/cid/ciaa939, (Online ahead of print).
https://doi.org/10.1093/cid/ciaa939... based on three types of evidence:

The WHO updated on July 9 a scientific article from March 29 on modes of transmission of SARS-CoV-2 and their implications for prevention and control recommendations, including new scientific evidence available on transmission of the virus that causes COVID-19²⁴24. World Health Organization. Transmission of SARS-CoV-2: implications for infection prevention precautions. Scientific brief, 09 July 2020. Available at: https://www.who.int/publications/i/item/modes-of-transmission-of-virus-causing-covid-19-implications-for-ipc-precaution-recommendations.
https://www.who.int/publications/i/item/... Regarding potential air transmission, the WHO reaches the following conclusions:

Taking into account these pieces of evidence, the WHO recommends the use of face masks in public places where there is community transmission and where other prevention measures, such as physical distancing, are not possible. For more detailed advice on the use of masks in the context of COVID-19 it refers to its June 5 Interim guidance.⁹9. World Health Organization. Advice on the use of masks in the context of COVID-19: interim guidance, 5 June 2020. Available at: https://apps.who.int/iris/handle/10665/332293.
https://apps.who.int/iris/handle/10665/3... In addition, the WHO encourages, at all times, to practice frequent hand hygiene, physical distancing from others when possible, and respiratory etiquette; avoid crowded places, close-contact settings and confined and enclosed spaces with poor ventilation; wear fabric masks when in closed, overcrowded spaces to protect others; and ensure good environmental ventilation in all closed settings and appropriate environmental cleaning and disinfection.

Ethical implications

The imposition of the mandatory use of face masks, especially in settings where there is a low risk of transmission (open, uncrowded spaces), poses some ethical questions. Firstly, it entails a paternalistic action by the authorities, which tend to treat citizens like children. It is more important, and would be more respectful, to inform them appropriately about contexts that pose a high risk of transmission where wearing a mask might be of some benefit, and the possible risks associated with incorrect fitting, use or removal. Public health measures need to enlist the full force of individual responsibility, something that is better attained with measures which are less restrictive of individual freedoms, such as persuasion and the power of conviction, than with compulsory measures and penalties.²⁵25. Buchanan DR. Autonomy, paternalism, and justice: ethical priorities in public health. Am J Public Health. 2008;98:15-21. Moreover, clear and trustworthy public communication on the part of governments, providing transparent and convincing justifications for the decisions taken, is particularly important in helping create and maintain such trust.²⁶26. Nuffield Council on Bioethics. Ethical considerations in responding to the COVID-19 pandemic. London: Nuffield Council on Bioethics, 17 March 2020. Available at: https://www.nuffieldbioethics.org/assets/pdfs/Ethical-considerations-in-responding-to-the-COVID-19-pandemic.pdf.
https://www.nuffieldbioethics.org/assets... It is true that public health policies sometimes require paternalistic and mandatory measures to protect population health and prevent disease, but these measures must be considered as a last resort when no other non-mandatory measures can be applied. But they must be evidence-based and necessary to achieve the public health goals intended, which is not the case for facemasks in general population. Secondly, the principle of precaution may justify the use of coercive measures that limit individual freedoms in order to prevent a possibly serious risk to the health of the population. However, their application becomes more questionable when measures are applied for which there is no clear benefit-risk relationship, as in the case now before us (Table 1). Additionally, the substantial financial resources required to maintain the continued use of masks by the general public could be better allocated to other public health measures of tried and tested efficacy, such as the promotion of the appropriate respiratory etiquette and hand hygiene. What is more, if it were to be shown that the benefit of compulsory use of masks in Spain was outweighed by the potential risks associated with their misuse (an apparently common phenomenon, judging by what one sees daily in TV news bulletins or on any city street), we would be confronted with a prejudicial health intervention which failed to comply with the maxim “primum non nocere” (first, do no harm), a precept that should govern all health actions.

Thirdly, compulsoriness can interfere with the necessary equity of public health actions, unless accompanied by complementary measures, such as government-subsidised distribution, free of charge to the end user, designed to ensure that low-income persons are able to acquire the most adequate masks in the right quantities for the goal being pursued. In addition, mandatory use of masks on a population scale should be accompanied by mass media campaigns that explain how to use the masks, what type is most suitable in each case, and the potential benefits and risks of their use by the general healthy population.

Fourthly, the obligation to use a mask may lead to those who do not wear one being socially stigmatised and, ultimately, discriminated against, even though they may have good reasons for this, whether because they take great care to maintain the required safety distance and only use masks when this is not possible, or because they come within one of the exceptions to the obligation to use a mask designated by the health authorities.

Lastly, this measure may generate confusion in the population, along with an altered perception of the risk, with the ensuing unfounded fear of becoming infected by virtue of simply meeting or passing by someone in the street who is not wearing a mask, and the mutual distrust among the public that can flow from this.

The WHO's and ECDC's (European Centre for Disease Prevention and Control) guidelines on the wearing of masks have remained largely consistent during the coronavirus pandemic and are two good examples of the prudence that is called for in these cases. While the former organisation only recommends the use of masks by healthy people in contexts of high risk of transmission when there is no capacity to implement other preventive or containment measures,⁹9. World Health Organization. Advice on the use of masks in the context of COVID-19: interim guidance, 5 June 2020. Available at: https://apps.who.int/iris/handle/10665/332293.
https://apps.who.int/iris/handle/10665/3... the latter states that “the use of face masks in the community could be considered (only as a complementary measure), especially when visiting busy, closed spaces, such as grocery stores, shopping centres, or when using public transport, etc.”.²⁷27. European Centre for Disease Prevention and Control. Using face masks in the community. Reducing COVID-19 transmission from potentially asymptomatic or pre-symptomatic people through the use of face masks. ECDC, 8 April 2020. Available at: https://www.ecdc.europa.eu/en/publications-data/using-face-masks-community-reducing-covid-19-transmission.
https://www.ecdc.europa.eu/en/publicatio...

Conclusion

With the degree of uncertainty currently surrounding the balance of potential benefits and harms of wearing masks in the general healthy population, especially in settings where there is a low risk of transmission (open, uncrowded spaces), it would seem more prudent to issue flexible recommendations than a set of compulsory measures aimed at restricting individual freedoms. While scientific evidence may support the advice to wear masks in certain circumstances, such as in public transport, closed crowded spaces or mass gatherings of any kind, where safe physical distancing cannot be continuously maintained and which should therefore be avoided if at all possible, any such recommendation should be combined with suitable information on how to use them and the potential risks of misuse. Mandatory use of masks in public spaces by the general healthy population, regardless of the potential risk of transmission or of whether or not the interpersonal safety distance can be kept, as has been implemented in Spain, is an intrusive measure that restricts individual freedoms, and would not appear to be justified on the basis of available scientific evidence regarding the potential benefits and risks associated with this practice. Moreover, the compulsoriness of wearing a mask should be accompanied by measures designed to ensure that the entire population, and the lower-income strata in particular, enjoys unrestricted access to these, while simultaneously preventing the possible risk of a shortage -present or future- of medical masks and respirators. What is needed, in contrast, are prudent measures, with soundly based recommendations, and effective communication campaigns to explain to the population where, when, how, and what type of mask it is advisable -or inadvisable- to wear. When the narrative changes because the scientific evidence changes, it is a sign that one is living in a mature society. But when the narrative changes without substantial changes in the scientific evidence which would justify this, and no other convincing reasons are given at the time for such a change of criterion, this means that something is not right.

References

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History