COVID-19 vaccinations: Considerations for return to work planning in the United States
Authors
Krupa Kotecha
As the COVID-19 vaccine rollout continues, a significant question for U.S. based employers will be whether or not to implement a mandatory vaccination program, along with other return-to-work measures. Guidance published by the Equal Employment Opportunity Commission (EEOC) in December 2020 (EEOC Guidance) suggests that a mandatory vaccine program is lawful, subject to a number of caveats and statutory considerations. Employers should carefully consider these caveats and considerations prior to implementing any mandatory vaccination regime. For employers with workforces in Canada, see our bulletin discussing considerations in the Canadian context.
What you need to know
- EEOC Guidance paves the way for employers to implement mandatory vaccination programs, with exceptions for accommodations. Employers must reasonably accommodate employees who have a disability covered under the Americans with Disabilities Act or whose sincerely held religious beliefs or practices prevent them from taking the vaccine under Title VII of the Civil Rights Act of 1964, to the point of undue hardship.
- Employees’ privacy considerations under the Americans with Disabilities Act are engaged if their employer collects medical information (which includes the collection of pre-screening information if an employer administers the vaccines internally, as well as the submission of vaccination records if the vaccines are administered off-site).
- Employers must check other laws, regulations, directives or guidance regarding COVID-19 vaccines, particularly as state laws regarding employer vaccination programs vary.
1. The Americans with Disabilities Act
The Americans with Disabilities Act (ADA) protects qualified employees with a disability from discrimination in the workplace. As the ADA limits an employer's ability to make disability-related inquiries or require medical exams, a mandatory vaccination program implicates key employee protections provided by the ADA.
Vaccination is not a medical examination
The EEOC Guidance states that the administration of a COVID-19 vaccination to an employee by an employer or a third party on behalf of the employer is not a “medical examination” under the ADA as the employer is not seeking information about the employee’s impairments or current health status by administering a vaccine to protect the employee against COVID-19. However, if an employer requires employees to be vaccinated and the employer administers the vaccine, pre-screening questions may result in disclosure of information triggering the ADA’s restriction of disability-related inquires, thus exposing an employer to liability.
Disability-related inquiries are protected under the ADA
Employers asking pre-screening questions may elicit information about a disability of a current employee. The ADA precludes employers from such pre-screening inquiries unless the questions are job-related and consistent with business necessity (the ADA standard)1. To satisfy this standard, the EEOC requires an employer to have a reasonable belief, based on objective evidence, that an employee who does not answer the questions, and therefore, does not receive a vaccination, will pose a “direct threat” to the health or safety of the workplace.
A direct threat is defined as a “significant risk of substantial harm to the health or safety of the individual or others that cannot be eliminated or reduced by reasonable accommodation”2, to be determined on the basis of the best available objective medical evidence. Although the EEOC, in its Pandemic Preparedness in the Workplace and the Americans with Disabilities Act Guidance, classified COVID-19 as a direct threat, this classification alone does not provide sufficient footing to meet the ADA standard. Employers must assess, on a case-by-case basis, four factors to determine whether the employee poses a direct threat in the workplace: 1) the duration of the risk; 2) the nature and severity of the potential harm; 3) the likelihood the potential harm will occur; and 4) the imminence of the potential harm3.
The EEOC Guidance clarifies that an employer’s request that an employee provide proof of a COVID-19 vaccination is likely not a disability-related inquiry, as simply requesting such proof is not likely to elicit information about a disability. Further inquiries made by the employer, however, such as inquiries relating to why an individual did not receive a vaccination, are likely subject to the ADA standard.
The EEOC Guidance provides that disability-related screening questions can be asked without employers needing to meet the ADA standard in two situations: 1) if the vaccine is offered on a voluntary basis and the decision to answer pre-screening, disability-related questions is also voluntary4; or 2) if the employee receives the vaccine from a third party who does not have a contract with his or her employer.
Confidentiality
The ADA requires all medical information about a particular employee to be stored separately from the employee’s personnel file to limit access to such information. Medical information includes historical diagnoses, treatments and whether or not an individual has requested or is receiving a reasonable accommodation. Employers should ensure only those who “need to know” the identity and medical condition of each employee are provided this information.
2. Exemptions under the ADA and Title VII of the Civil Rights Act of 1964
Employers planning to implement mandatory vaccination programs must consider the mechanisms for employees to request and receive accommodations. Title VII of the Civil Rights Act of 1964 (Title VII) provides that an employer must provide reasonable accommodation for an employee’s sincerely held religious belief, practice, or observance, to the extent that such accommodation does not impose an undue hardship on the employer5. Employers may consider granting exemptions on a broader basis than that required under federal law to accommodate disabilities under state or local law. For instance, in litigation involving mandatory flu vaccination policies, courts have reached different conclusions on whether allergic reactions qualify as a disability under the ADA, depending on intensity, duration and other particulars of an individual’s reaction6. As a result, offering health-related exemptions beyond statutory requirements may be appropriate.
EECO’s clarification of undue hardship
If an employer, through the four-factor analysis, determines an exempt employee poses a direct threat at the workplace, the employer should explore if reasonable accommodations that eliminate or sufficiently reduce the risk of harm are possible. Under the ADA, employers are encouraged to use a flexible, interactive process to assess potential reasonable accommodations7. Undue hardship generally means significant difficulty or expense under the ADA. Under Title VII, undue hardship is a slightly lower threshold, at more than a de minimis cost or burden for the business. In the context of COVID-19, the EEOC Guidance notes an employer’s analysis may include analyzing the prevalence of workplace employees who have received the COVID-19 vaccination or employees’ contact with those with unknown vaccination status.
The EEOC Guidance acknowledges that there may be situations where an accommodation is not possible to eliminate the direct threat or reduce it to an acceptable level. In these cases, the EEOC Guidance states it would be lawful for the employer to exclude the employee from the workplace. However, this does not mean employers may automatically terminate employees who cannot both comply with a mandatory vaccine policy and be reasonably accommodated. Employers must determine if any other rights apply under equal employment opportunity laws or other federal, state, and local authorities.
3. Title II of the Genetic Information Nondiscrimination Act
Under Title II of the Genetic Information Nondiscrimination Act (GINA), employers may not inquire about or discriminate on the basis of genetic information, except in narrow circumstances. The EEOC Guidance states administering a COVID-19 vaccination to employees or requiring employees to provide proof of vaccination does not violate GINA. Nevertheless, employers must not violate GINA through pre-vaccination medical screening inquiries that ask about employees’ family medical histories or immune systems, nor can they outsource pre-screening to a to a third party that makes such inquiries.
4. Pregnancy Discrimination Act
The EEOC Guidance reminds employers that under the Pregnancy Discrimination Act, women affected by pregnancy, childbirth, and related medical conditions must be treated the same as other similarly-situated employees. As a result, employees unable to receive the vaccine due to pregnancy-related medical conditions may be entitled to reasonable accommodations.
5. Other Employer Considerations
Occupational Safety and Health Act
The Occupational Safety and Health Administration (OSHA) issued guidance on January 29, 2021 for preventing the spread of COVID-19 in the workplace. The guidance provides best practices for COVID-19 prevention programs but does not comment on the implementation of vaccination policies in the workplace. The OSH Act imposes a general duty on employers to keep workplaces free from recognized hazards that cause, or are likely to cause, serious physical harm to employees8. This may be the case where COVID-19 is present in the workplace and the employer’s existing efforts to control exposure are insufficient. Determining if the hazard reaches the level of “serious physical harm” is a fact-specific exercise. OSHA categorizes an employee’s risk of workplace exposure from COVID-19 in four categories, from “lower exposure risk” (which includes office employees), to “very high-risk exposure” (which includes health care employees performing aerosol-generating procedures). Based on their employees’ actual exposure risk, as to which the OSHA categories are just a general guide, employers should take appropriate mitigating actions. Employers that choose not to mandate a mandatory vaccination policy always have the option of implementing a voluntary scheme that encourages or makes it more feasible or convenient for employees to receive one of the vaccinations.
National Labor Relations Act
Unionized employers should be mindful that collective bargaining agreements (CBAs) may limit an employer’s ability to mandate employee vaccinations, unless required by the local, state, or federal law. Certain CBAs may obligate an employer to pay for lost work time, for example, in cases where the employee spends time waiting to receive medical attention during the employee’s regular work hours.
Health Insurance Portability and Accountability Act
In instances where vaccines are not administered on-site, employers requiring employees to show proof of vaccination must consider employees’ privacy rights. In addition to the ADA’s confidentiality obligations and state and local laws, the Health Insurance Portability and Accountability Act (HIPPA) applies to certain “covered entities”. Employer group health plans are HIPPA-covered entities; as a result, the dissemination of health plan records, such vaccination records, to employers is prohibited by HIPPA. As a result, health plans are prohibited from providing the employer with an employee’s vaccination records directly, but the employer can still request vaccination proof from the employee as discussed in Section 3 above.
Looking ahead
Employers contemplating whether a mandatory vaccination program is appropriate to keep their workplace safe must first recognize that widespread vaccine availability is not expected until spring of 2021, at the earliest. Along with vaccine availability, employers must consider their response to and communication addressing employee concerns surrounding mandatory vaccinations, including processes for employees requesting accommodations for health and religious reasons. Employers should ensure any vaccine-related questionnaires do not contain unnecessary screening questions and are narrowly tailored, and must also have methods in place to keep any employer-required documentary proof of employee’s vaccinations confidential.
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1 42 U.S.C. § 12112; 29 C.F.R. § 1630.14.
6 See, for example, Norman v. NYU Langone Health System, 19 Civ. 67 (AT) (S.D.N.Y. 2020) where the plaintiff claimed the flu vaccine caused her shortness of breath and chest palpitations, a reaction which impaired the major life activity of breathing. Torres J. of the United States District Court held the plaintiff failed to establish that her allergic reactions to the flu vaccine constituted a disability at the time of her requested accommodation. However, the court noted some reactions to vaccines can be severe enough in intensity, duration, frequency, or after-effects to rise to the level of a disability under the ADA, see also Hustvet v. Allina Health Systems, 283 F. Supp. 3d 734 (D. Minn. 2017).
7 42 U.S.C. §§ 2000e(j); 42 U.S.C. § 12111(10)(A) and (B); 29 C.F.R. § 1630.2(p)(2).
Le mois dernier, le Canada a publié sa première Stratégie industrielle de défense (la Stratégie), qui souligne l’engagement du Canada à développer une base industrielle de défense solide et à stimuler la croissance économique. Ces efforts pourraient aussi comprendre le renforcement de l’état de préparation à la biodéfense et aux contre-mesures médicales, ce qui pourrait constituer des débouchés pour le secteur canadien des sciences de la vie en raison de l’importance accordée aux capacités nationales en ce sens et de la nécessité d’atténuer les risques d’urgences sanitaires.
Développement de contre-mesures médicales au Canada
Comme indiqué dans les bulletins précédents, le quatrième pilier de la Stratégie est axé sur la « sécurisation des chaînes d’approvisionnement pour les intrants et les biens clés » par le renforcement de la production nationale et le stockage de ressources. L’accent est mis tout particulièrement sur les contre-mesures médicales, en précisant que nos « alliés ont établi un lien explicite entre l’état de préparation à la biodéfense et aux contre-mesures médicales et leur sécurité économique et nationale, en élaborant de nouvelles stratégies et de nouveaux mécanismes pour faire progresser ces travaux ». Les contre-mesures médicales désignent divers produits réglementés pouvant être utilisés pour protéger la population lors d’une situation d’urgence de grande ampleur, comme l’éclosion d’une maladie ou une attaque impliquant des armes chimiques, biologiques ou nucléaires. Il peut s’agir de vaccins, de médicaments thérapeutiques et produits biologiques, de dispositifs de tests diagnostiques, des équipements de protection individuelle ou industrielle, et d’autres dispositifs médicaux. Les contre-mesures médicales sont essentielles à la réduction et à l’atténuation des dommages lors d’une urgence de santé publique.
Exploiter les voies réglementaires mises en place lors de la pandémie de COVID-19
Pendant et après la pandémie de COVID-19, le Canada a mis en place plusieurs nouvelles voies réglementaires comme mécanismes d’accélération des approbations de produits médicaux, ce qui pourrait offrir au gouvernement des options pour déployer des contre-mesures médicales afin de faire face aux risques pour la santé publique. Au début de la pandémie, Santé Canada a émis diverses ordonnances provisoires pour permettre l’importation et la vente de médicaments et de dispositifs médicaux qui n’avaient pas eu l’approbation des voies réglementaires traditionnelles. Or, Santé Canada a plutôt fait confiance aux voies d’approbation réglementaire et de l’exemption de certaines exigences en homologation de produits des pays impliqués dans la transaction. Beaucoup de ces règles provisoires ont depuis été officiellement intégrées à la réglementation en vertu de la Loi sur les aliments et drogues et ont été appliquées bien après la COVID-19. Conformément au Règlement sur les aliments et drogues, Santé Canada tient à jour la Liste des maladies qui menacent la santé publique et utilisera une procédure d’autorisation modifiée pour les médicaments d’urgence de santé publique pouvant traiter les affections figurant sur la liste. De même, le Règlement sur les instruments médicaux a établi une liste d’instruments médicaux répondant à un besoin urgent de santé publique, ce qui permet à Santé Canada d’autoriser la commercialisation de ces instruments de manière accélérée. Ces outils réglementaires sont utilisés automatiquement quand une situation médicale présente un grand risque pour la santé publique au Canada et nécessite une action immédiate pour contrer ce risque.
Le rôle de la Stratégie dans le renforcement du régime réglementaire de la santé au Canada
La stratégie prévoit que le Canada adoptera une approche proactive en matière de planification en amont des crises sanitaires. Le gouvernement entend s’assurer que les produits médicaux sont déjà disponibles au Canada afin qu’ils puissent être distribués rapidement en cas d’urgence. D’autres modifications récentes au Règlement sur les aliments et drogues permettent de prépositionner au Canada tous les médicaments d’urgence en santé publique, ce qui signifie qu’ils peuvent être importés dans des installations d’entreposage canadiennes avant que leur mise sur le marché n’ait été autorisée. La Stratégie s’appuie sur ces fondements, en faisant référence à l’organisme existant Préparation aux crises sanitaires Canada (PCSC), un organisme opérationnel spécial au sein d’Innovation, Sciences et Développement économique Canada (ISDE), et à un nouveau Fonds des sciences de la vie, lesquels « collaborent avec des partenaires internationaux et de soutenir l’élaboration et la production de contre-mesures médicales ». PCSC supervise la Stratégie en matière de biofabrication et de sciences de la vie du Canada, qui vise à développer un secteur national des sciences de la vie fort et compétitif doté de capacités de biofabrication de pointe, en mettant l’accent sur la capacité à se préparer et à faire face aux futures priorités et crises sanitaires. Dans cette optique, il y aura des occasions pour les fabricants de nouer des collaborations de recherche et des accords commerciaux ou d’approvisionnement liés aux contre-mesures médicales financées par des programmes fédéraux.
Étroitement lié aux capacités nationales, le pilier III de la stratégie implique « Investissement ciblé pour renforcer un secteur canadien de la défense novateur », avec la promesse que le gouvernement fédéral « soutiendr[a] la recherche et le développement, protéger[a] la propriété intellectuelle, soutiendr[a] les petites et moyennes entreprises, investir[a] dans les compétences et la formation, et encourager[a] les exportations afin de créer un secteur de la défense agile et concurrentiel à l’échelle mondiale ». La nécessité de favoriser le développement de la propriété intellectuelle (PI) et la conservation des droits du Canada est mentionnée à plusieurs reprises dans la Stratégie. Par exemple, la Stratégie prévoit l’établissement de partenariats officiels avec l’industrie canadienne qui « [assureront] la propriété et le contrôle nationaux de la propriété intellectuelle (PI) et des capacités essentielles. » La Stratégie reconnaît l’immense talent des établissements canadiens et la précieuse recherche qui y est menée actuellement et qui est déjà financée par des subventions de recherche d’organismes tels que le Conseil de recherches en sciences naturelles et en génie et les Instituts de recherche en santé du Canada, et fait aussi référence à l’engagement de 1,6 milliard de dollars pour de nouveaux fonds de recherche dans le budget de 2025. Cette prise de conscience de la nécessité de promouvoir et de soutenir l’innovation au Canada laisse présager des possibilités de financement, notamment dans les domaines où le Canada accuse un retard en matière de production nationale et où des engagements d’investissement et de fabrication au Canada peuvent être pris.
Prochaines étapes
Dans les prochains mois, nous prévoyons que le gouvernement du Canada publiera d’autres directives et des mesures de suivi. L’équipe de défense des conservateurs poursuivra sa couverture de perspectives sur la défense au Canada en publiant une analyse supplémentaire pour donner des précisions sur l’incidence de la Stratégie sur de multiples secteurs.