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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
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 Public Health Agency of Canada (PHAC) has announced the implementation of a pan-Canadian no-fault vaccine injury support program for all Health Canada approved COVID-19 vaccines. This program is built on the model that has been in place in Québec for a number of years. PHAC reports that the intent of the program is to “ensure that all Canadians have fair access to support in the rare event that they experience an adverse reaction to a vaccine.” Further details regarding the program are pending. 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 mandatory vaccination policy?
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 policy that applies to them, bearing in mind their ethical, professional and legal obligations. Failure to comply with your facility’s mandatory vaccination policy could lead to discipline. In particular, non-compliance with the policy may result in remedial and/or disciplinary action by the hospital or health authority and may lead to an investigation by the College.
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.
Need more medico-legal information amid COVID-19? Visit the CMPA COVID-19 Hub