Pan-canadian public health network council report and policy recommendations on the use of antivirals for prophylaxis during an influenza pandemic

[Previous] [Table of Contents] [Next]

Annex 3.3–Legal considerations for the purchase and stockpiling of antivirals for prophylaxis by governments for use during pandemic influenza

Submitted by:
Mara Pollock
Counsel, Public Health Agency of Canada and Health Canada
Legal Services

Intended for: Task Group on Antivirals for Prophylaxis

Comments

You asked me to provide you with a legal framework in which the policy options related to the purchase and stockpiling of antivirals for prophylaxis by governments during pandemic influenza should be considered. I have set out the various legal issues that may arise depending on whether or not governments decide to provide antivirals for prophylaxis. The legal risks to governments may increase or decrease depending on what decision is made and on how implementation is carried out.

Furthermore, serious consideration should be given to the merit of providing antivirals for prophylaxis in circumstances where the scientific evidence of their safety and efficacy is either lacking or inconclusive.

I have also included a number of legal issues that are not directly linked to the issue of whether governments do or do not provide antivirals for prophylaxis. They have been included in this memorandum because they were highlighted as important legal issues for exploration in the context of pandemic influenza both during the Task Group discussions as well as during the September 15, 2006 meeting of FPT legal counsel.

Legal counsel from eight provinces, one territory and the federal government came together in a full-day meeting on September 15, 2006 to discuss the legal issues related to the use of antivirals for prophylaxis during pandemic influenza. In addition, these same counsels were asked to provide comments on this memorandum as it was being developed. This memorandum is the end result of that collaboration.

Background

In May 2006 the Conference of Federal/Provincial/Territorial Ministers of Health directed officials to begin a process aimed at the development of a national policy recommendation on the provision of antivirals for prophylaxis during pandemic influenza. As a result of that request, the Task Group on Antivirals for Prophylaxis was formed and mandated to create an FPT process to be used to develop the national policy recommendation as well as to develop the recommendation itself. A number of factors must be taken into account in the development of this policy recommendation such as impacts on the health system, scientific evidence, economics, ethics, law, F/P/T policies and decisions made by the international community.

In order to present the legal issues in the most pragmatic and understandable fashion for the Task Group, I have set out the issues under four headings.

1. Governments choose not to stockpile antivirals for prophylaxis

2. Governments choose to stockpile antivirals for prophylaxis
   1. priority groups
   2. implementation of decision

3. Intergovernmental F/P/T decision or an individual government decision

4. Other legal issues

Discussion

I) Governments choose not to stockpile antivirals for prophylaxis

a) Negligence - Public

Governments that choose not to stockpile antivirals for prophylaxis could face allegations they were negligent in not protecting the public from, and preventing the spread of, pandemic influenza.

An analogous argument was made in a number of novel cases arising in Ontario. These cases claimed that the province owed a duty of care to the public to protect it from, and prevent the spread of, SARS²² and West Nile Virus.²³

In the case of Eliopoulos v. Ontario (Minister of Health and Long Term Care)²⁴ the plaintiff, Eliopoulos, was bitten by a mosquito and became infected with WNV. He claimed, among things, that Ontario owed him a private law duty of care to take reasonable steps to prevent the spread of WNV. However, the Ontario Court of Appeal found that the province did not owe a private law duty of care to individuals to prevent the spread of WNV

The Plaintiffs claimed that the statutory provisions of the Health Protection and Promotion Act were the source of the government’s duty of care. However, the Court found that the statutory provisions created discretionary powers that were not capable of creating a private law duty. It stated that:

the HPPA created a general public law duty that requires the Minister to endeavour to promote, safeguard, and protect the health of Ontario residents and prevent the spread of infectious diseases. However, a general public law duty of that nature does not give rise to a private law duty sufficient to ground an action in negligence.

The Court stated that the “public health priorities should be based on the general public interest. Public health authorities should be left to decide where to focus their attention and resources without the fear or threat of lawsuits.” The Court also found that even in the event that it was wrong, and that a private law duty of care existed, there were residual policy considerations that militated against finding a duty of care.

In order for an action in negligence against the Crown to succeed, plaintiffs must first establish that the Crown had a duty of care toward them. If a duty of care is found, considerations may still exist that negate the imposition of a duty. For example, it is well established in Canada that the Crown can be exempt from a duty of care where it makes a pure policy decision. Government actors can be liable in negligence for operational decisions but not true policy decisions.²⁵

In Just v. British Columbia the Supreme Court of Canada distinguishes a “policy” decision from an “operational” decision as follows:

policy decisions are generally made by persons of a high level of authority in the agency, but may also properly be made by persons of a lower level of authority. The characterization of such a decision rests on the nature of the decision and not on the identity of the actors. As a general rule, decisions concerning budgetary allotments for departments or government agencies will be classified as policy decisions.²⁶

The Supreme Court of Canada in Brown v. British Columbia (Minister of Transportation and Highways) describes the difference between “policy” and “operational” decisions as follows:

True policy decisions involve social, political, and economic factors. In such decisions, the authority attempts to strike a balance between efficiency and thrift, in the context of planning and predetermining the boundaries of its undertakings and of their actual performance. True policy decisions will usually be dictated by financial, economic, social and political factors and constraints.

The operational area is concerned with the practical implementation of the formulated policies; it mainly covers the performance or carrying out of a policy. Operational decision will usually be made on the basis of administrative direction, expert or professional opinion, technical standards or general standards of reasonableness.²⁷

Not only can the Crown be exempt from a duty of care where it makes a pure policy decision, it can also be exempt from the imposition of a duty if an explicit statutory exemption exists.²⁸

A decision not to purchase antivirals for prophylaxis is unlikely to be based on a statutory exemption but may fall within the description of a pure policy decision. If the decision not to purchase antivirals can be characterized as a true policy decision, governments may be exempted from the imposition of a duty of care if one were to be found.

It is important to note, however, that a policy decision is subject to the overarching requirement of good faith. The exercise of discretion in making a policy decision must always be done in good faith; otherwise, the policy decision can be challenged.²⁹ If a decision is based on a well-developed analysis of such factors as scientific and economic evidence as well as ethical, legal and political issues, the decision may be more likely to be considered a policy rather than an operational decision.

b) Governments as employers - specific legislative requirements

The second consideration for governments choosing whether or not to provide antivirals for prophylaxis is whether there are any specific legislative requirements for them, as employers, to provide antivirals for prophylaxis.

The regulation of occupational health and safety is divided among fourteen mutually-exclusive jurisdictions (i.e., federal, provincial, and territorial) and every jurisdiction has independently enacted legislation to address matters that fall within its jurisdiction. Given the legislative framework and the variety of work environments, there is no homogeneous answer to whether governments, as employers, must provide antivirals for prophylaxis in order to maintain a safe work environment. Each government should examine its legislation to determine whether there are any requirements for them to provide antivirals for prophylaxis to their employees.

c) Governments as employers – general legislative requirements

Even if there are no specific legislative requirements to provide antivirals for prophylaxis, governments may still have a general legislative requirement to provide antivirals for prophylaxis in order to ensure a safe work environment.

All occupational health and safety legislation sets out general responsibilities of employers to ensure a safe work environment. They also set out the responsibilities of workers to adhere to safe workplace practices and regulations. Additionally, each piece of legislation provides for the right of workers to refuse unsafe work. In some jurisdictions, it is the duty of a worker not to work where there exists danger to him/her or another worker.

Governments, as employers, could face allegations that they were negligent in not ensuring a safe working in environment by not providing antivirals for prophylaxis to employees. Similar allegations are being made by some hospital employees in Ontario that the province was negligent because it failed to provide adequate workplace safety precautions and adequate protective equipment to hospital employees during the SARS outbreak. The employees are claiming that the province was negligent in not protecting them from, and preventing the spread of, SARS.³⁰ Similar claims could be made in the context of pandemic influenza. Claims could be made that by not providing antivirals for prophylaxis governments were negligent in not protecting employees from, and preventing the spread of, pandemic influenza.

The Ontario government is also facing claims that it issued, but did not communicate, the contents of directives with which nurses were required to comply, and as well failed to ensure nurses’ health and safety under the Occupation Health and Safety Act.³¹

Employee-employer relationships can be governed by collective agreements, by statute or by contracts of employment or a combination thereof. The nature of the Crown’s duty to employees, therefore, will vary with the nature of the relationship. For example, in some provinces, paramedics and community care workers are employed by private companies and thus are not employees of the province. In one province (Nova Scotia) home-care nurses are directly employed by the province.

Each employer, therefore, will have to examine the basis for its employee-employer relationship, each specific work environment, the scientific evidence, and the standard of practice for particular work environments to determine whether it has a responsibility to provide antivirals for prophylaxis. For example, employers that currently provide antivirals for prophylaxis in certain environments (e.g., retirement residences, nursing homes) on a routine basis for seasonal influenza may find it difficult to withhold antivirals for prophylaxis for pandemic influenza in the same environment under similar conditions.

II) Governments choose to stockpile antivirals for prophylaxis

Priority groups

Governments that choose to stockpile and provide antivirals for prophylaxis will be faced with the question to whom and on what basis should antivirals be provided. If governments decide that only certain individuals will receive prophylaxis, and create priority lists to enumerate these individuals, governments could face Charter challenges under section 15 (equality rights) and /or under section 7 (life, liberty and security of the person). They could face arguments that the restrictions on access to, and distribution of, antivirals were discriminatory (s.15) or that the restrictions deprived an individual of their right to life, liberty or security of the person (s.7).

a) Canadian Charter of Rights and Freedoms ³²

Section 15

It is important for governments that decide to create priority groups to retain evidence that the decision was based on sound scientific, social, economic, and ethical policy rationale. They should be able to demonstrate that the composition of the lists was based on reasonable, fair and rational considerations.

In order to prove a violation of s.15 (1) of the Charter individuals would have to show that the denial of antivirals to some Canadians and not others was based on one of the grounds listed in s.15 (1) (race, national or ethnic origin, colour, religion, sex, age or mental or physical disability) or on a ground that the court would consider analogous (e.g. Aboriginal residency) to those specified in the section.

In Law v. Canada (Minister of Citizenship and Immigration),³³ the Supreme Court provided a framework for the analysis of a s. 15(1) claim. The approach adopted and applied by the Court focuses on three central issues:

1. Does the impugned law impose differential treatment between the claimant and others, in purpose or effect?
2. Is the differential treatment based on one or more enumerated or analogous grounds of discrimination? and
3. Does the differential treatment discriminate in a substantive sense, bringing into play the purpose of s. 15(1) in remedying prejudice, stereotyping, and historical disadvantage?

Under the third issue, the Court has provided four contextual factors that should be considered in determining the existence of discrimination. This is not a comprehensive list and not every factor will necessarily be relevant in every case. The factors are: (i) pre-existing disadvantage, (ii) correspondence between the distinction and the claimant’s characteristics or circumstances, (iii) ameliorative purpose or effect, and (iv) nature and scope of the interests affected. ³⁴

Even if a court held that s. 15(1) has been violated, a government would then have the opportunity to try to show, under s.1 of the Charter, that the denial was a reasonable limit that could be “demonstrably justified in a free and democratic society.”

The first requirement under s. 1 is that any limitation on a Charter right must be prescribed by law. The Supreme Court has held that legislation, regulations, a rule of the common law;³⁵ an exercise of discretionary authority and a decision made pursuant to a statute³⁶ qualify as being prescribed by law. The Court has yet to definitively determine whether government policies and directives constitute “prescribed by law.”³⁷

If a court did find that governmental policy qualified as being “prescribed by law” it would undertake the same Charter analysis that it uses to determine whether an infringement resulted from a government action based on law. All government action, including decisions in the form of policy or statute, should comply with the Charter.

In order to override a Charter right, the government must first establish that it has a pressing and substantial objective and that the law or measure is rationally connected to the pressing and substantial objective. The law or regulation must be shown to be carefully tailored to achieve the government’s objective: it cannot be arbitrary, unfair or based on irrational considerations.³⁸ The government should retain the convincing and compelling evidence it used in support of the objective for future reference.

The government must then establish that the law or measure impairs the right in question as little as possible. It should impair the right no more than is necessary to attain the government’s pressing and substantial objective. To meet this requirement the government must have evidence that it considered other alternatives for meeting its objective and the reasons for rejecting any less rights-intrusive, yet equally effective, measures.³⁹ In the case of pandemic influenza, governments could produce the Canadian Pandemic Influenza Plan as evidence that they considered and ultimately recommended the use of alternatives such as personal protective equipment, antivirals for treatment, vaccines, and a host of public health measures to meet the objective.

Courts show greater deference to Parliament in situations involving a large number of interlocking and interacting interests and considerations.⁴⁰ The decision about whether or not to purchase and stockpile antivirals for prophylaxis is extremely difficult given the myriad interests (general public, health care workers, first responders, emergency workers etc.,) and considerations (scientific, health system, legal, political, ethical, financial⁴¹ etc.,) that must be identified and analyzed.

Finally, the government must establish proportionality between the effects of the measures, which are responsible for limiting the Charter right, and the pressing and substantial objective.⁴² This step requires a balancing of the objective against the infringement of the right. The more serious the injurious effects, the more important the objective must be. The government should have evidence to show that the measure nearly or fully achieves its objective as well as evidence of the actual beneficial effects of the measure imposing the limit.

Section 7

Governments that choose to provide antivirals for prophylaxis based on priority lists could be seen to be limiting or prohibiting an individual’s access to antivirals and thus infringing his or her s. 7 Charter rights.

The Supreme Court has held that s. 7 provides three separate and distinct rights – life, liberty, and security of the person.

The right to life may be engaged where an individual’s access to antivirals is prohibited, restricted or delayed by government action and it results in the individual’s death. The right to security of the person may be engaged where the government has restricted or limited access to antivirals and it causes serious physical suffering or severe psychological stress to an individual who is not on a priority list but whose life and health would be seriously threatened if they developed influenza. In addition, members of the individual’s family may try to argue that they also suffered severe psychological stress as a result of the government action and thus claim a violation of their right to security of the person, especially if the person denied access to antivirals is a child.

The Court has held that an individual’s liberty and security of the person interests can be engaged by government action which impairs an individual’s health and well-being.⁴³ This could form the basis of a claim that governments impaired the health and well-being of individuals who are not listed in the priority groups created by the government. It should be remembered, however, that individuals would still be free to purchase antivirals for prophylaxis and that a government’s decision to create priority groups is not a bar to private purchases.

A breach of s. 7 only occurs if the deprivation of one of life, liberty or security of the person is not done in accordance with the principles of fundamental justice. The principles of fundamental justice can be procedural or substantive.

Included in the principles of fundamental justice that have been upheld by the courts are vagueness,⁴⁴ and arbitrariness.⁴⁵

In order not to be arbitrary, the limitation of a s. 7 interest requires a real connection on the facts of the case. With respect to the creation of priority groups, the government should ensure that the law or regulation authorizing or establishing the list is not arbitrary. In Chaoulli, supra, a majority of the Supreme Court stated that a law is arbitrary where “it bears no relation to, or is inconsistent with, the objective that lies behind it. To determine whether this is the case, it is necessary to consider the state interest and societal concerns that the provision is meant to address.”⁴⁶

To demonstrate a real connection on the facts of the case it is important to create and retain an evidentiary and policy basis and rationale that connect the government objective with the limitation. If governments create priority groups, governments should retain evidence that the decision to create priority lists was based on sound scientific, social, economic, ethical and legal policy rationale in order to demonstrate that the deprivation of a s.7 right was in accordance with the principles of fundamental justice.

b) Protection of personal information and information sharing

i) Privacy and Personal Information legislation

When developing priority groups and identifying individuals within those groups (e.g. immunocompromised individuals) the legal principles related to the protection of personal information and to information sharing should be respected.

The following general principles relating to the protection of personal information and information sharing apply equally to all jurisdictions in Canada. It is important to note that government and non-government entities are governed by different privacy and personal information protection legislation. The federal Privacy Act⁴⁷ governs the protection of personal information of individuals held by a government institution and the ability of individuals to access their own information. The Personal Information Protection and Electronic Documents Act⁴⁸, on the other hand, governs organizations that collect, use or disclose personal information in the conduct of commercial activities. Both of these pieces of legislation allow governments or non-government entities to disclose personal information without consent in very specific circumstances.

Ideally, the collection of personal information should be voluntarily given from the individual to whom the information pertains. In addition, the person from whom the information is being collected should be notified at the time of collection of the purpose for which the collection is being done. Furthermore, the person should be notified to whom the information will be disclosed and of the purpose of such disclosure.Once an entity has collected personal information, such information may only be used for the purpose for which it was collected or for a purpose consistent with that purpose. Further, entities may only collect the minimal amount of personal information necessary to fulfill their mandates. When an entity wishes to share personal information, it can only share the information for the purposes for which is was collected.

Although the disclosure of personal information should ideally be done with the consent of the individual to whom the information pertains, there are circumscribed circumstances in which disclosure is permitted without consent.

In Manitoba, for example, the Personal Health Information Act permits a trustee to disclose personal health information without consent “if the trustee reasonably believes that the disclosure is necessary to prevent or lessen a serious and immediate threat to (i) the health or safety of the individual the information is about or another individual, or (ii) public health or public safety;…” ⁴⁹ In addition, in Ontario, the Personal Health Information Protection Act permits a health information custodian to disclose personal health information about an individual “if the custodian believes on reasonable grounds that the disclosure is necessary for the purpose of eliminating or reducing a significant  risk of serious bodily harm to a person or group of persons.”⁵⁰ Consequently, each jurisdiction should determine whether it has the authority to individually identify certain members within priority groups.

ii) Charter - Section 8

Furthermore, governments should be cognizant of the rights protected under s.8 of the Charter when developing priority groups and identifying individuals within those groups.

Section 8 states: “Everyone has the right to be secure against unreasonable search or seizure.” The objective of s. 8 of the Charter is to protect individuals from unjustified state intrusions upon their privacy. It has been interpreted to afford protection to people, not places, against intrusions on personal privacy. Each case must involve a consideration of what is a “reasonable privacy expectation” in light of the facts.

Consideration may be given to the following factors in determining whether a reasonable expectation of privacy exists: presence at the time of the search; possession or control of the property or place searched; ownership of the property or place; historical use of the property; ability to regulate access to the place; existence of a subjective expectation of privacy; objective reasonableness of the expectation.

Documents of a personal and confidential nature or that reveal a personal core of biographical information do carry an expectation of privacy sufficient to attract constitutional protection.

As noted above, there may be restrictions on individual identification due to privacy considerations. Some individuals who chose the non-nominal options for certain types of testing (e.g., AIDS, HIV), for example, may not be able to be contacted without having their privacy rights violated. Lastly, there may be restrictions on whether the information can be shared in developing priority groups as well as in trying to identify who falls within particular priority groups once the groups are developed. Governments will be faced with trying to identify those most as risk, e.g., immunocompromised individuals, while not breaching individual privacy rights in the process.

Implementation

a) Negligence

The second issue that governments must consider is the proper implementation of the policy decision. If governments choose to purchase antivirals for prophylaxis they could face allegations they were negligent in the manner in which a policy decision was implemented.

As noted above, the Crown may be exempt from the imposition of a duty in situations which arise from its pure policy decisions. However, the implementation of those decisions may well be subject to claims in tort.⁵¹

As a result, when implementing the chosen policy on the purchase and provision of antivirals for prophylaxis during pandemic influenza, governments should do everything possible to communicate the policy decision to all Canadians in a clear and consistent manner. There should be a common understanding as to how particular populations, such as First Nations on reserves and Inuit will be served. In addition, once an implementation plan is established and communicated, care should be taken to follow it precisely unless necessary modifications due to new medical, scientific, social, economic, or policy considerations justify a change.

b) Distribution

One important aspect of implementation is the proper distribution of antivirals to the Canadian population in accordance with the stated plan. Distribution can occur in a number of ways. For example, antivirals could be distributed through regular health care service mechanisms such as hospitals, family physicians, clinics, or pharmacies or could be distributed through specially appointed antivirals clinics. There may be concerns about liability by all entities along the distribution chain if they will be distributing drugs for off label purposes and they may seek indemnification from the government.

Not all provinces will have the same level of control over the distribution of antivirals to their citizens given the varied nature of health care delivery across the country. Many provinces, for instance British Columbia, Alberta, Ontario and Newfoundland and Labrador do not have direct control over health care delivery due to the creation of regional health authorities. Prince Edward Island, on the other hand, does have direct control over health care delivery. Consequently, those provinces with regional health authorities do not control the distribution of drugs; they can only recommend a process to be followed by regional health authorities whereas provinces such as P.E.I. do control the distribution of drugs within their provinces.

In some cases regional health authorities are corporations and in others they are charitable organizations. Some of the provinces with regional health authorities could take control over the distribution of antivirals by declaring a state of emergency under their public health legislation or their emergency legislation. Most provincial emergency or public health statutes, however, use language such as “imminent danger” or “impending situation” as the test for whether or not an emergency can be declared. Provinces, therefore, are not likely to declare states of emergency, if a disease outbreak occurs in another province.

British Columbia has regulatory powers under its health act⁵² that allow for some proactive steps to be taken in anticipation of an emergency. The majority of the provinces, however, can only call upon the powers contained in the emergency or public health acts once an emergency is declared.

c) Prescriptions

The proper distribution of antivirals to the Canadian population depends very much on the ability of individuals to obtain the necessary prescription for the drugs. The Food and Drugs Act and Regulations prohibits the sale of Schedule F Drugs, of which zanamivir, oseltamivir and amantadine are a part, unless the sale is made pursuant to a verbal or written prescription.⁵³ Prescription is defined in the Regulations to mean “an order given by a practitioner directing that a stated amount of any drug or mixture of drugs specified therein be dispensed for the person named in the order”.⁵⁴ A practitioner is defined in the Regulations “as a person authorized by the law of Canada to treat patients with any drug listed or described in Schedule F to the Regulations”.⁵⁵

It is provincial and territorial legislation, however, that specifies which medical professionals are authorized to write prescriptions for Schedule F drugs. In some jurisdictions only physicians are authorized to write prescriptions for Schedule F drugs, while in other jurisdictions physicians, as well as nurse practitioners, are authorized to write prescriptions for Schedule F drugs. To complicate matters, in some jurisdictions nurse practitioners are authorized to prescribe only certain Schedule F Drugs, but not all of them.

If provincial legislation allows, it may be possible in certain contexts such as in nursing homes or retirement residence settings for physicians or nurse practitioners to issue one prescription for all residents of the home.

d)Drug approval and uses outside of labeling

Some prophylactic uses of antivirals during a pandemic may be “off label” (outside of the scope of manufacturers’ approved labeling). The federal Minister of Health is responsible for the administration and enforcement of the Food and Drugs Act.⁵⁶ In this capacity, the Minister is responsible for authorizing the advertising and sale of a new drug when the uses recommended by the manufacturer are supported by sufficient evidence provided in a new drug submission. The Food and Drug Regulations⁵⁷ prohibit the marketing of a new drug for purposes other than the uses included by a manufacturer in a new drug submission that has been approved by the Minister.

Manufacturers are not required to include all acceptable uses of a drug on a product’s label. There may be no concern with any given off label use of antivirals from a scientific perspective. Difficulties arise, however, if a drug is being advertised for sale and distribution for uses not included in a new drug’s approved label. Where manufacturers are aware that antiviral drugs they manufacture are being distributed by public health authorities for off label purposes the manufacturers may not be willing to sell the drugs without an indemnification from government. If governments distribute antiviral drugs for purposes other than those directed on the manufacturers’ labels, there may be an increased likelihood that governments will be assuming the liability for any adverse affects.

III. Intergovernmental Federal/Provincial/Territorial policy or an individual government policy

a) Canadian Charter of Rights and Freedoms

Although there is no requirement for a consistent, uniform decision across jurisdictions, dissimilar policy decisions could expose governments to claims of breach of duty of care and/or Charter breaches under s. 15 (equality rights) and / or s. 7 (life, liberty and security of the person). Governments that do not provide antivirals when others do could face claims that the decision is discriminatory, and / or threatens the life, liberty and security of the individual.

Section 15 and Section 7

Governments that decide not to purchase antivirals could face claims that individual equality rights were violated because of an unequal distribution of antivirals across Canada. Much of the analysis set out in section II, i) Priority Groups, Section 15 is applicable in this context as well. Just as the creation of priority groups that determine access to antivirals for prophylaxis could be seen as discriminatory so too could the decision by some governments not to provide antivirals for prophylaxis while others do.

In addition, governments that choose not to provide antivirals when others do could be seen to be prohibiting or limiting an individual’s access to antivirals, and thus engaging the rights protected under s. 7 of the Charter. Much of the analysis set out in section II, i) Priority Groups, Section 7 is applicable in this context as well. Just as the creation of priority groups could be seen to be limiting or prohibiting access to antivirals for prophylaxis so too could the decision by some governments not to provide antivirals for prophylaxis while others do.

Governments are not required to come to a consistent, uniform decision across jurisdictions. Although not necessary in law, a policy decision that is consistent across Canada may be more easily defended to the public as being reasonable and justifiable. Furthermore, if Canada’s position is similar to other developed countries, such as the US and the UK, the public’s perception of a reasonable and justifiable decision is reinforced. However, governments can still establish that their particular law or regulation has been carefully tailored to achieve their objectives if dissimilar policy decisions exist across Canada. Governments should retain the convincing and compelling evidence they used in support of their decisions for future reference.

IV) Other legal issues

The following legal issues are not directly relevant to the issue of whether or not governments choose to purchase and stockpile antivirals for prophylaxis for use during pandemic influenza. They have been included in this memorandum because they were highlighted as important legal issues for exploration in the context of pandemic influenza both during the Task Group discussions as well as during the September 15, 2006 meeting of FPT legal counsel.

a) Workers’ compensation

For the most part, workers’ compensation programs are designed to compensate workers that suffer from personal injury by accident arising out of, and in the course of, employment or from occupational disease due to the nature of the employment. Unfortunately, the line between what is caused by work and what is caused by non-work factors is often difficult to draw.Injuries with obvious external symptoms (cuts, fractures, burns, contusions) caused by an external event (a fall, being hit by an object or caught in a machine) are generally not difficult to identify as being caused by work and thus as being compensable. It is not so easy, however, to determine whether a disease is caused by work and thus whether it is compensable as an occupational disease. The fundamental challenge in occupational disease claims is to link a disease to a worker’s occupation. While a medical practitioner can diagnose a disease, it can be very difficult to determine whether the disease was caused by the employment.

Manitoba⁵⁸ and Prince Edward Island⁵⁹ have tried to address this uncertainty in their legislation by excluding from the definition of occupational disease “an ordinary disease of life”. Their legislation provides that, where an occupational disease is due in part to the employment and in part to a cause other than the employment, the disease is compensable only if the Workers’ Compensation Board is of the opinion that the employment cause is the “dominant” cause. The Nova Scotia Act⁶⁰ has attempted to address the uncertainty by permitting the government to exclude an occupational disease by regulation.

In a pandemic influenza situation, it could prove difficult to determine whether influenza was caused by employment, especially for health care workers, emergency responders or those working directly with ill people, given the prevalence of the disease in the community at large. Given this difficulty, it may prove challenging to determine whether workers should be compensated if they contract pandemic influenza.

b) Employment insurance benefits

Under the Employment Insurance Act,⁶¹ employment insurance special benefits are payable to claimants who qualify for employment insurance and are unable to work due to illness, injury or quarantine. The Act requires that claimants obtain a medical certificate to prove illness, injury or quarantine. In addition, the Act stipulates claimants are entitled to benefits only after a two-week waiting period has elapsed. Where no formal quarantine order is made but preventive measures requiring employees to stay home are recommended individuals may have difficulty qualifying for benefits. As a result, individuals may be less likely to follow recommendations thus aggravating instead of ameliorating the effects of the pandemic. In addition, in this scenario individuals would not be able to comply with the present criteria requiring a medical certificate to prove that they were quarantined. Finally, the two-week waiting period could cause hardship for those individuals who are only in need of benefits for a short period of time while they recover or are in quarantine.

In the event of pandemic influenza, the Act may need to be more flexible with respect to who qualifies for benefits. An example of how the Act could be altered to accommodate a pandemic situation can be seen in how the Act was amended during the SARS crisis. At that time, the Employment Insurance Regulation was amended for 6 months to allow for a waiver of the waiting period as well as the relaxation of the rule to provide a medical certificate. The amendment was in place for only six months, however.

c)Complaints process

It might be advisable to establish a complaints process to address issues specific to the implementation of the policy. A process tailored to deal with implementation issues such as providing access to antivirals for eligible individuals who are having difficulties gaining access to them may well prevent future legal actions.

Conclusion

There are many factors that must be carefully considered when developing the policy recommendation on whether or not governments purchase and stockpile antivirals for prophylaxis. Although the legal considerations related to the policy recommendations should be carefully considered, they should not be the driving force behind the recommendation. Once a recommendation is put forward and a decision is made, the legal issues and risks related to that decision should be examined more thoroughly by each jurisdiction.However, some of the guiding principles that emerge from the above exploration of legal issues are: (1) governments should retain the convincing and compelling evidence that they used to come to their decisions; (2) the decisions should be based on an comprehensive analysis of all relevant factors and should be based on sound scientific, social, economic and ethical policy rationale; (3) any decision to restrict access to antivirals by creating priority groups should be based on fair, reasonable, and rational considerations; (4) the implementation of any policy should be communicated widely in a clear and consistent manner and once the plan is established and communicated, it should be carried out precisely unless necessary modifications due to new evidence justify a change.

[Previous] [Table of Contents] [Next]