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Updated: May 4, 2022
As the COVID-19 vaccination rollout expands, there are a number of medico-legal considerations physicians will want to be aware of.
Collaboration and joint action
Who is permitted to administer the COVID-19 vaccine?
Administration of the COVID-19 vaccination is a regulated act. Regulated acts can only be performed where authorized by law. In most provinces/territories, administration of the COVID-19 vaccination can only be performed by physicians, nurses, and pharmacists.
In an effort to facilitate vaccination, some jurisdictions have expanded the list of qualified health professionals who can administer COVID-19 vaccinations as long as those individuals meet certain requirements (e.g. specified training) or where those individuals are supervised by a health professional who is authorized to perform immunizations (e.g. Manitoba, British Columbia, Quebec, and New Brunswick).
Ontario has also recently implemented a regulation to allow “any person” (such as retired nurses and physicians, paramedics, dentists and firefighters) to administer the COVID-19 vaccination under certain limited circumstances. While the regulation makes an exemption for these persons to administer the vaccine without delegation, it still requires a physician, nurse or pharmacist to be present at the premises where the vaccine is administered and to be accessible to the person administering the vaccine to discuss questions relating to or to give directions with respect to the administration of the vaccine. The person administering the vaccine must also be engaged to do so by an organization that is a party to an agreement with the Minister governing the administration of the vaccine.
In any other circumstance where members are engaged in supervision or delegation of the COVID-19 vaccination, they will want to refer to relevant College policies on supervision and delegation for additional guidance. Members who delegate or supervise the administration of the COVID-19 vaccine to other persons, in accordance with the applicable legislation or regulation, remain eligible for liability protection for medico-legal difficulties arising from the delegation.
How do I engage parents or legal guardians who are reluctant or refuse to vaccinate their children against COVID-19? What if there is a dispute between the parents about the child receiving the vaccine?
- Confirm authorized decision-maker: Physicians will need to be aware of who is legally authorized to provide consent for the child’s vaccination. When a child is not capable of consenting to treatment, the physician providing the vaccine will want to make inquiries of the adult accompanying the child for the vaccination to confirm they are the custodial parent, legal guardian, or have authority to consent on behalf of the child. However, when the physician determines that the child has the capacity to consent, parental/legal guardian consent is not required. In such circumstances, the physician must obtain consent from the child, even when the child is accompanied by a parent or legal guardian.
- Respect decisions of mature minors: Except in Québec, physicians should generally respect an informed decision by a child who they consider to be a mature minor and capable of understanding the risks of accepting or refusing the vaccination. In Québec, the law generally only permits children 14 years of age and older to consent to their own care. Physicians should document the wishes of the minor and the parent/legal guardian, if known, in the medical record along with the physician’s assessment of the child’s capacity to consent and understanding of the risks.
- Explore, address and document reluctance: If a child is not capable of consenting and the parents/legal guardians are reluctant about the vaccine, physicians should explore and address the reasons for their reluctance, answer any questions to the best of their ability, and refer them to other relevant resources for information. Physicians will want to be empathetic and respectful, and remind parents/legal guardians that the best interests of the child are the primary concern. If the parents/legal guardians still refuse to consent to the vaccination, a detailed note of both the consent discussion and the refusal should be made in the medical record.
Manage disputes: Communication problems can arise when a physician receives conflicting directions from parents. Even in cases where the child’s parents are separated or divorced, both parents will typically have the right to provide or refuse consent for treatment on behalf of the child, unless an agreement or court order specifically modifies the rights of the parents. To clarify the authority of each parent to consent on behalf of the child, physicians may request copies of agreements or court orders regarding decision-making. These copies should be kept in the child’s chart. When there is a dispute between the parents, the physician should make reasonable attempts to obtain a consensus in the child’s best interests. If consensus cannot be achieved, the vaccine should not be administered. Physicians may contact the CMPA for further advice in these situations. Depending on the circumstances, it may be necessary to contact the public guardian, child services, or to apply to the court (or an administrative body) for direction.
See also: Shen S, Dubey V. Addressing vaccine hesitancy. Clinical guidelines for primary care physicians working with parents. Can Fam Physician. 2019 March, 65(3) 175-181.
Some provinces/territories are requiring proof of vaccination to access certain services and settings. Can I ask patients (or family members/caregivers/others attending with patients) about their vaccination status and request proof of vaccination?
Provincial/territorial proof of vaccination requirements do not apply to accessing essential services such as healthcare. However, it may be reasonable to ask patients and others attending with patients about their vaccination status if it is relevant to providing care to the patient. It would not be appropriate to ask patients and others about their vaccination status in order to deny care to patients. A refusal to provide care could put a physician at risk of a College complaint, human rights complaint and/or civil action, the success of which will depend upon the specific circumstances.
It may also not be reasonable to ask for proof of vaccination status. It may be difficult for some patients and individuals to provide this information. Demanding proof of vaccination may also undermine the trust in the doctor-patient relationship.
Once more of my patients are vaccinated, how do I manage unvaccinated patients in my practice?
As more patients are vaccinated, physicians will need to be mindful of the vaccination status of patients in their practice. Despite a patient’s refusal to be vaccinated, physicians should make every effort to continue to care for unvaccinated patients in the existing doctor-patient relationship in accordance with current standards of care. A refusal to provide care could put a physician at risk of a College complaint, human rights complaint and/or civil action; the success of which will depend upon the specific circumstances.
Physicians will want to make best efforts to find reasonable alternatives to provide care to patients who refuse to be vaccinated. Physicians may offer to see these patients using virtual care, if appropriate. For patients who require an in-person visit, scheduling appointments at different times of the day or week to treat unvaccinated patients could be another approach. Physicians should also refer to public health guidance for treating patients in these circumstances.
For additional assistance and advice on caring for patients who refuse to be vaccinated, physicians should consult with the expectations and guidance of their College and local public health authority, as well as contact the CMPA directly.
I have been asked to sign a medical directive for the administration of the COVID-19 vaccination. What are the medical liability risks?
Physicians who are involved in developing a medical directive will be expected to ensure it is clinically appropriate and reflects the expected standard of care in the circumstances. A physician authorizing a medical directive should be comfortable with its contents and have consulted with healthcare professionals who have expertise in vaccination programs, if the physician does not have this expertise. It is also important that the medical directive include sufficient detail to ensure that it can be properly implemented. This includes articulation of a clear process for obtaining and documenting informed consent. Reassurance should also be obtained that the individuals who will be implementing the directive are competent and have the necessary information to administer the vaccine.
I have heard about the federal government’s Vaccine Injury Support Program. Does this protect me from liability if I recommend or administer the COVID-19 vaccine?
The Vaccine Injury Support Program (VISP) is a pan-Canadian no-fault vaccine injury support program for all Health Canada approved vaccines – including COVID-19 vaccines – that are administered in Canada on or after December 8, 2020. The VISP is built on the model that has been in place in Québec for a number of years. Patients vaccinated in Québec will continue to receive coverage from the longstanding Québec Vaccine Injury Compensation Program. The purpose of the VISP is described as “to ensure that all people in Canada who have experienced a serious and permanent injury as a result of receiving a Health Canada authorized vaccine…have fair and timely access to financial support.” Further details regarding the VISP can be found here. The CMPA supports broader liability protection for physicians and other healthcare providers so that their good faith efforts in recommending and administering the vaccination will not put them at increased medico-legal risk.
Do I have an obligation to be vaccinated against COVID-19? What are the repercussions if I do not comply with my facility’s or government’s mandatory vaccination policy? Will the CMPA assist me with College or hospital matters arising from my refusal to be vaccinated?
The CMPA generally encourages physicians to be aware of any mandatory vaccination programs applicable to their practice setting. Physicians will want to reasonably consider any mandatory vaccination policies that applies to them, bearing in mind their ethical, professional and legal obligations. Failure to comply with mandatory vaccination policies could lead to discipline. In particular, non-compliance with any applicable policy may result in remedial and/or disciplinary action by the hospital or health authority and may lead to an investigation by the College.
The CMPA generally assists members with College matters relating to the professional practice of medicine; however, CMPA assistance will not generally be available for matters primarily arising from business or personal issues. The CMPA’s assistance for hospital matters is generally limited to ensuring that the member is treated fairly when there is a loss or threat of loss of privileges. The CMPA does not generally extend assistance to members to assist them in advocating for changes to government, hospital or College policies.
Members are encouraged to contact their provincial/territorial medical association or federation for more information regarding policy initiatives and measures with respect to mandatory vaccine policies.
Do I have an obligation to implement a mandatory COVID-19 vaccination policy at my private office or clinic? What should I do if my employees do not comply with this policy?
Clinics and private offices generally have an obligation to provide a safe environment for their patients and staff pursuant to occupational health and safety legislation. Members are encouraged to consult with their local public health authority and/or their personal or business legal counsel to assess the necessity of a mandatory COVID-19 vaccination policy and any consequences for non-compliance.
Is the informed consent process different for the COVID-19 vaccination? What if a patient refuses to be vaccinated?
While vaccines are not new, COVID-19 vaccines may be novel in the manner in which they have been developed and approved. As with other novel treatments, special care should be taken when obtaining informed consent to disclose all of the known risks, side effects and discomfort that might be encountered (regardless of how remote the risk might be). In addition, it is generally expected that the patient will be informed if there may be other risks not yet known and the anticipated benefits may not be achieved.
Generally speaking, the healthcare professional who is proposing the treatment is responsible for ensuring that informed consent is obtained from the patient. However, the act of obtaining informed consent can be delegated to another healthcare provider (e.g. under a medical directive for the administration of the vaccine). Regardless of which healthcare professional obtains the patient’s informed consent, it is essential to document the content of the consent discussion with the patient, including reference to the information provided and any questions asked and answered. Many provincial/territorial governments have prepared standard informed consent forms to assist in the consent process. Where a consent form is used, there should still be a mechanism to document additional information and questions addressed with the patient receiving the vaccination.
If a patient is reluctant about receiving a COVID-19 vaccine, you will want to explore and address the reasons for the patient’s concern, answer any questions to the best of your ability and consider referring the patient to other relevant resources for additional information. If the patient still refuses to be vaccinated, a detailed note of both the consent discussion and the refusal should be made.
Will the CMPA assist me with medico-legal difficulties related to the rollout of COVID-19 vaccines?
The CMPA remains committed to providing members with liability protection for medico-legal difficulties arising as a result of care provided in Canada in the context of the COVID-19 efforts, including related to the deployment of vaccines.
Physicians who are involved in developing medical directives are also generally eligible for CMPA assistance if they face medico-legal difficulties as a result of the medical content of the medical directive. Examples include the patient selection exclusion criteria or informed consent process. The CMPA will not generally extend assistance with respect to administrative or logistical issues associated with the vaccination process, such as decisions about prioritization of individuals eligible to receive vaccines. Physicians who are involved in these issues should ensure that the organization that they are being asked to serve will provide them with full defence and full indemnification in the event of medico-legal difficulties that arise from this role.
Will the CMPA assist me with medico-legal difficulties related to the administration of COVID-19 vaccines to non-residents?
CMPA members will be eligible for CMPA assistance when administering vaccines in Canada, without regard to whether an individual is a resident or non-resident of Canada. The CMPA’s assistance will include support for matters brought inside or outside of Canada in relation to the administration of COVID-19 vaccines. The CMPA remains committed to providing members with liability protection for medico-legal difficulties arising as a result of care provided in Canada in the context of the COVID-19 efforts, including related to the administration of vaccines.
While the CMPA does not generally provide assistance to members for matters arising outside of Canada, the CMPA appreciates the unique circumstances of the pandemic and the public health objective of broad vaccination. In the context of COVID-19 vaccine administration only, CMPA members do not need to ask non-residents to execute the Governing Law and Jurisdiction Agreement or confirm that the vaccine is not reasonably available in the patient’s home country in order to be eligible for CMPA assistance.
My patients are asking if my staff have been vaccinated against COVID-19. Are they entitled to that information?
An employee’s vaccination status is personal health information. Just as it would with other personal health information, the clinic has an obligation to treat the vaccination status of its employees as confidential information. Vaccination status of health care providers should not be shared with patients. The clinic does have an obligation to offer care in a safe manner. Therefore, the clinic will need to ensure that appropriate precautions are being taken to protect both the health care providers and the patients who attend at the clinic. The clinic should continue to follow precautions outlined by the Ministry of Health and/or College for providing in-person care.
Need more medico-legal information amid COVID-19?
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