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Catastrophic rights

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The Persons With AIDS Coalition of Vancouver has complained to the B.C. Civil Liberties Association that they and their physicians are being frustrated, by the Health Protection Branch of Health and Welfare Canada, in their efforts to obtain promising treatments for AIDS and its related conditions. The Health Protection Branch controls access to “new” drugs in roughly three different ways. Under the authority vested in it by the Food and Drug Act, it licenses drugs from other jurisdictions which comply with Canadian standards of effectiveness and safety; it vets the research protocols for drugs which are being developed in Canada; and it administers the special “sale of new drug for emergency treatment” section of the Act.

The Civil Liberties Association has identified a civil rights issue in connection with the administration of the “emergency treatment” provision of the Act, and we shall address that issue in the body of this brief. The other two controlling functions of the HPB raise issues which fall outside both our mandate and expertise, but we shall nonetheless speak to them briefly as they are of special concern to both our complainants and ourselves.

Whatever ordinary right we believe patients have to determine the course of their treatment, AIDS people claim that the right to self-determination of the catastrophically ill is properly viewed as stronger yet. On the other hand, it is claimed that there are legitimate and substantial public interests served by governmental control of prescription drugs, and that these important interests of all Canadians ought not to be sacrificed to the special but narrower interests of a small group of patients.

The B.C. Civil Liberties Association has more than a theoretical interest in this issue. Persons with AIDS face, in 1988, certain death. And it can be said of them, without over-generalizing or sentimentalizing their situation, that they are typically young and productive persons who are very far from the comfort that age and a complete life can afford us in the teeth of annihilation. They press us, both by their numbers and the special features of their plight, to bring sensitive and timely deliberation to the challenge they pose to both our institutions and our humanity.

That said, the Civil Liberties Association sees this matter as one in which there is a conflict between a claim for individual rights and an opposing claim for a public interest. We approach the task of identifying a resolution of this conflict with diffidence, but not without some experience. In addition to our 25 year involvement with patients’ rights generally, we have brought special consideration to the range of civil rights issues raised or touched upon by the specific difficulties that AIDS poses for public policy.

In the past year we have joined with public health officials to support public education rather than mandatory widespread testing as the best means of preventing the spread of AIDS within specific communities and among the general public. We secured the support of the Vancouver City Council, the Provincial ombudsman, and the B.C. Medical Association—as well as other public bodies—in our advocacy of amendments to the provincial Human Rights Act to prohibit unjustifieddiscrimination against persons on the basis of a medical condition. We regard such a political initiative as an important means of creating a social environment which will encourage behavior (voluntary testing and consultation with public health workers) that has proven most successful in the prevention of the spread of AIDS. While this lobby is still in process, we have been very encouraged by the responsiveness of the government both at the political and the official levels. Further, we cooperated with the B.C. Ministry of Health in crafting amendments to the B.C. Health Act in order to prevent the wilful or careless spread of AIDS.

We also participated in a process initiated by the City of Vancouver to develop guidelines for responding to civic workers infected with AIDS. Most recently we have addressed the special concerns of surgeons working with infectious patients. Throughout—and this is the point of the above brief recital—the Association has attended to the importance of striking a careful balance between individual rights and the public interest. Although it is sometimes thought that the “mandate” of civil libertarians is solely the defense of individual rights and freedoms, a more complete account would be that we are committed to the preservation and enhancement of self-government. The BCCLA recognizes, within the context of that broad commitment, an obligation to not only identify individual rights for the purpose of fighting for them, but also to “define” them with a view to understanding their proper limit when confronted by conflicting rights or interests.

Such is our task in the present case, and we begin with a consideration of the claim, made by AIDS persons and others, that their rights ought not be viewed as limited to the “security of the person” protections of the Canadian Charter that are ordinarily associated with patients, rights—such as the right to privacy and the right to refuse medical treatment. In addition to, and perhaps more fundamental than these “traditional” patients rights, the AIDS people claim a right to be personally active in the attempt to “secure their person” from the most final and irrevocable of all threats to personal security—the threat of death. The Association is in complete agreement with this claim, and we offer the following formulation of it:

An adult person confronting the catastrophe of proximate and certain death has a right to elect, for themself, any medical treatment whatsoever that does not cause direct harm to others.

If we were pressed to justify this “catastrophic right,” we would be tempted to suggest something Lockean about the final ownership of one’s own body and life… or perhaps to turn to Hobbe’s fearful insistence that all social covenants are overshadowed by a right to preserve one’s own existence… but we prefer, finally, to rest upon the simple human decency of yielding to what is perhaps the most elemental claim that can be made for individual liberty—the desire to be free to try to save oneself.

In any case, we don’t expect to be pressed for justification. Once the proviso is made that it is not an “absolute” or unexceptionable right, just about all Canadians recognize an individual right to “spend” one’s own life in whatever effort promises some measure of personal hope. And, as long as only the catastrophic patient is involved in the acquisition and administration of the treatment, the right is practically absolute. We would want to intercede, at least in an initial instance, of what appeared to be the precipitous or uninformed selection of a treatment that struck us as equivalent to suicide; but if the catastrophic patient persisted in their choice, we would have to accede as certainly as we would have to accede to the firm determination of a person who refused treatment on grounds of religion or conscience.

The case is different when the patient requires the collaboration of others in the positive and active effort to acquire and administer treatment. It is one thing for society to omit action which would save an individuals life when that individual firmly refuses treatment; it is quite another for society to become active in the acquisition and administration of a treatment that is regarded by the relevant medical authorities as inefficacious or positively dangerous to health. This is the precise point at which a catastrophic right can come into conflict with the rights (and obligations) of those others that are potential “recruits” in an effort to secure and administer a catastrophic treatment.

Ordinarily, practically, and for the purposes of this brief, the catastrophic patient looks to her or his physician as the source of treatment. And physicians are bound by the limitations imposed upon the sale of drugs in Canada by our Food and Drug Act. What this means, in practical terms, is that the Health Protection Branch is the “turnstile” through which all drugs (whether developed in Canada or elsewhere) gain access to the Canadian market. Since drugs are typically sold rather than given away, it can be seen that a “marketing” authority is, effectively, an absolute authority in terms of its ability to control the use of prescription drugs in Canada. It was, evidently, meant to work that way, and it has worked that way.

We are aware of the existence of serious arguments which question the general health benefits of a scheme of prescription drug control (see, for instance, Sam Peltzman, University of Chicago, “The Health Benefits of Mandatory Prescriptions,” The Journal of Law and Economics, 1987); and we have canvassed the argument of some libertarians that government control of prescription drugs is an unacceptably paternalistic interference with individual liberties. The BCCLA is unpersuaded by these arguments. The responsible and professional administration of the Food and Drug Act can, in our view, provide an important measure of safety and convenience to all Canadians, and is perhaps a vital protection for the very many helpless and credulous among us. We see these benefits as decidedly outweighing whatever threat to the vitality of our freedoms is posed by the admittedly paternalistic elements of the system. In arguing thusly, we stress the difference between the Fundamental Freedoms identified in our Charter as protecting the mental and spiritual integrity of the citizenry and those other freedoms (such as the security of the person protections) that, however important, are more accessible to limitation than can be saved by the first section considerations of the Charter.

The catastrophic patient typically requires, therefore, the collaboration of two authorities when electing extraordinary or experimental treatment. She or he must convince their physician that the treatment is at least not a certain net threat to their health (otherwise the physician may legitimately regard it as immoral or unprofessional to comply). And their physician confronts, in turn, the Health Protection Branch with its mandate to conservatively regulate the prescription drug market. Given the general concern of the HPB to apply strict standards of effectiveness and safety to drugs sponsored for licensing by pharmaceutical companies, and to protect Canadians from untested products, it could reasonably be expected that the Branch would pose a formidable institutional obstacle to the exercise of catastrophic rights. For, even with an attending physician committed to the chosen course of catastrophic treatment, it would seem that the very raison d’etre of the HPB would preclude its compliance or collaboration in its acquisition.

In fact, however, the Food and Drug Act contains a provision which we believe affords at least the possibility of striking a balance between catastrophic rights and the public interest served by the control of prescription drugs. This is the “sale of new drug for emergency treatment” (C.08.010-11) provision. We understand that the emergency treatment provision was originally put in place in order to deal with the infrequent but real need for so-called “orphan drugs” (drugs which, because of the rarity of the disease for which they are specific, are without a sponsoring “parent” in any of the pharmaceutical companies in the Canadian market). Whatever the historical precedent, however, this provision seems to provide the Health Protection Branch with the degree of statutory flexibility needed to steer a balanced course between its general responsibility for public health interests, and its obligation to be responsive to the special character of catastrophic rights.

We understand that there has been some confusion, within the Health Protection Branch, as to the appropriate scope of the notion of “emergency” in administering the emergency treatment provision. We offer the opinion that a proper regard for catastrophic rights partly answers this question by underscoring the necessity for at least that degree of flexibility in administering the Food and Drug Act that makes genuine responsiveness to those needs possible. A terminal illness in a person of middle years or younger is a catastrophic illness; and a catastrophe is appropriately regarded and acted upon as an emergency.

We are aware of the view that the single and individual patient with a rare catastrophic illness represents an “emergency,” while a large group of patients with the same catastrophic illness represents an opportunity for a clinical trial which could be compromised if they claimed and exercised catastrophic rights. This is an argument in which the public health benefits for (say) all AIDS patients over the long term is best served by refusing to honour catastrophic rights so that the efficacy of experimental treatments can be properly established. There is some merit to this argument; or at least one might say that there could be some merit to this argument if the general state of anti-viral research and experimentation in Canada were sufficiently advanced for us to make out a credible case to a patient group for them to cede their catastrophic rights. As things stand, however, we regard it as nonsensical for catastrophic patients to cede their rights to self-determination in their treatment because of what can be seen to be little more than an institutional affection for the ideology of research rather than its vigorous pursuit.

An appropriate degree of responsiveness to catastrophic rights would seem, to us, to consist (for the HPB) in the liberal interpretation of the emergency treatment provision in a spirit of colleagueality with the requesting physician and patient. The general paternalistic mission of the Branch should be suspended when the special case of the catastrophic patient is before it; and the Branch should be willing to recognize that its legitimate institutional interest in protecting the life and health of all Canadians in general becomes obnoxiously irrelevant when opposed to the exercise of a catastrophic right.

In any case, we take it as fundamental that a catastrophic right should be honoured unless the patient is persuaded to cede it in order to be part of a clinical trial or experiment. The experience in Canada and in other jurisdictions supports the view that sufficient numbers of catastrophic patients are usually willing to forgo their catastrophic rights so that strictly controlled research work can proceed. There is simply no need—let alone justification—for denying catastrophic rights in order to protect “future generations” of catastrophic patients.

Our investigation of the complaint of the Persons With AIDS Coalition of Vancouver has convinced us that the Health Protection Branch administration of the emergency treatment provisions of theFood and Drug Act does not recognize or respond to the catastrophic rights of AIDS patients and their practitioners. Although there has been some move towards liberalization of the response to catastrophic patients, this informal policy change has fallen far short of the reforms that respect for catastrophic rights would properly motivate. To the extent that we have succeeded in mapping out some islands of firm policy in the remarkably amorphous structure of the HPB, we have been very disturbed by its insensitivity to the special circumstances of the catastrophic patient. We have been unable, in our investigation, to satisfy the interests of either our complainants or ourselves in determining precisely the policy guidelines of the Branch in administering the emergency treatment provision. This is information which only the Branch can supply by immediately making public the policy guidelines referred to by its officials. Patients and practitioners who are discouraged from the attempt to exercise a right by the widely held view that those rights will not be recognized by the relevant authority are persons who are, in real measure, deprived of their rights.

Beyond the substantive issue of the actual policies of the HPB is the issue of the timely availability of officials of the Branch to respond to requests from practitioners. We understand that the policy of the Branch is to offer its services only during Ottawa working hours. In the case of an emergency service in a country of five time zones, this is a remarkable departure from fair and adequate process. We therefore strongly urge that the Branch decentralize the provision of this service by seconding physicians in several major cities to administer the emergency treatment provision in liaison with the Ottawa centre. If the case can be made out that this remedy is too costly, we would urge, as a second best alternative, that the HPB immediately begin to offer access to its officials in Ottawa on a 24 hour basis.

There remains the question and issue of civil liability when a catastrophic right is exercised. We would suggest that one of the virtues of making explicit the notion and exercise of catastrophic rights is that the patient should waive all right to hold civilly liable anyone cooperating with them in acquiring an emergency treatment. If catastrophic patients expect their special circumstances to be seen and treated as genuinely special, they must, in their turn, recognize the right of those who cooperate with them to be relieved of the threat of being sued for their trouble by either the patient or his survivors.

Summary:

As a special case of those patients’ rights that we locate in section seven of the Canadian Charter of Rights and Freedoms, the BCCLA recognizes that a medical catastrophe gives the patient suffering it a catastrophic right to a remarkable degree of autonomy in electing treatment.

Specifically, we argue that an adult person confronting the catastrophe of proximate and certain death has a right to elect, for themself, any medical treatment whatsoever that does not cause direct harm to others.

We also find that the paternalism of the Food and Drug Act imposes a reasonable limit on Canadian freedoms in that the benefits it provides all Canadians very substantially outweigh whatever threat it represents to the vitality of our individual freedoms.

There is a need to strike a proportional balance between the public interests sought by the Food and Drug Act and the special individual right to catastrophic treatment.

We identify the appropriate administration of the “sale of new drug for emergency treatment” of theAct as answering the need for such a proportional balance. Since it can make little or no sense to prevent a person who is certainly dying from using an untested medicine that might kill them sooner, the Health Protection Branch should regard catastrophic patients as falling outside the general and legitimate range of their paternalistic mission.

Recommendations:

1. The Health Protection Branch should immediately publish the policy guidelines presently used by it in administering the emergency treatment provision of the Food and Drug Act.

2. The Health Protection Branch should reform its policy guidelines to take catastrophic rights into account, and then publish the reformed policy.

3. The Minister of Health and Welfare Canada should decentralize the administration of the “emergency treatment” provision of the Food and Drug Act to take the fact of Canada’s size into account.

4. The Health Protection Branch should immediately begin to offer the services of its officials on a 24 hour basis.

Appendix

Suppose the Health Protection Branch (HPB) changed its policies so as to answer the concerns expressed in the body of the BCCLA discussion paper on catastrophic rights. Would persons with AIDS then be able to obtain greatly improved access to any untested drug which they thought would help them? Sadly, the answer is “No.” What this shows is that the problem goes deeper and is more complex than has been realized.

Part of the problem, albeit a minor part, is that the conservative attitude towards the dispensing of untested drugs which was criticized in the discussion paper is in fact shared by many health care professionals outside HPB.

Some physicians are very reluctant to use the emergency provisions to obtain such drugs for AIDS patients when information about administering the drugs (e.g., dosages) is lacking, when their effectiveness is unknown, or when there is a potential for serious side-effects. This reluctance is especially strong when a viable substitute is available. Such a conservative attitude is obviously to be encouraged in most circumstances. For persons with AIDS, however, who are desperate to try anything to stave off immanent death, this attitude lacks the normal rationale. At a minimum, a physician who has an AIDS patient should be prepared to comply with a request for drugs that are being tested or used elsewhere in the treatment of AIDS. In today’s world, information about the administration of such drugs can be easily obtained and should not interfere with access.

Other physicians feel that we should only make such drugs available as part of carefully controlled clinical trials. Otherwise, aside from anecdotal evidence we are none the wiser about their effectiveness or safety. What is paramount in their minds is our need to have this knowledge for the sake of future AIDS sufferers. It is not a lack of compassion which fuels this attitude, but the desire for a long-term, sober approach to the horror of AIDS.

The BCCLA understands the need for clinical trials. our research has indicated that one of the major stumbling blocks to the availability of untested drugs is the lack of such trials. We applaud the efforts of clinicians to write the protocols for them, and to encourage persons with AIDS to participate. (We make special note of those persons with AIDS who unselfishly agree to participate in double blind trials, knowing they may well be getting a placebo.) However, for clinicians to refuse to prescribe untested drugs except where their use is part of a clinical trial is wrong. If there are conceivable circumstances in which our need for more knowledge about promising drugs provides an exception to the right of a person in catastrophic circumstances to try to save his life in whatever way he thinks best, they are so extraordinary as to properly form no part of our consideration here.

The major problem with respect to the accessibility of untested drugs, however, is not this conservative dispensing attitude, but rather the unavailability of the drugs. Many are simply not physically available in Canada. Why this is so involves a long and complex chain of circumstances which we do not pretend to completely understand. Some factors are beginning to emerge, though, and we wish to bring them into sharper focus.

Pharmaceutical companies are, for the most part, multinationals. Few drugs are produced in Canada. The only motive that such a company has for shipping drugs here is that they believe it is, or has the potential to be, profitable to do so. Thus there is little impetus for the company to respond quickly, if at all, to requests for small quantities such as might be required for emergency use. The expectation of relatively large clinical trials provides a stronger motive, especially in Canada where the companies are allowed to charge for the drugs used in trials.

However, most companies prefer to run their own trials, at their own expense, and to retain control over the protocols, so as to guarantee that the trials would satisfy health officials in larger, more lucrative markets. This makes economic sense only when they expect the trials to be successful. When this expectation is not high, it is in their interests to let others write the protocols, run the trials, pay for the relatively large expenses involved.

In Canada, we do not have the infrastructure needed to quickly respond to news of a promising anti-viral drug. Unlike cancer or heart research, viral research is not a glamorous area in which to work. (one prominent viral researcher confided to us that the only reason he stays in Canada is because his family wishes to continue to live here.) As well, the protocol requirements in Canada for clinical trials are rigorous. The result is that the question, “Who is supposed to write the protocols and run the trials?” is too often answered by a resounding silence. Many physicians who have tried have ended up frustrated and loathe to try again. It is not the mandate of HPB to write the protocols or run the trials, nor are they willing to ease their rigorous requirements. Even when HPB actively courts pharmaceutical companies to run trials here, the results are too often disappointing. (Lyphomed, a company which produces aerosolide pentamadine, backed off at the last minute from a planned trial here, apparently at the instruction of its head office in Chicago.)

Though we do not think that the solution is to simply throw money at the problem, it is clear that part of the remedy involves increased funding for anti-viral research and research into AIDS related diseases here in Canada. We cannot continue to depend upon multinational drug companies to respond to the needs of Canadians with AIDS. With increased funding we can afford to attract researchers with expertise in these areas, and to underwrite their clinical trials. Since most promising drugs would then be available as part of such trials, there would be less need for AIDS patients to exercise their catastrophic rights.

Finally, there is an attitude which, if it exists, needs to be confronted: The perhaps unvocalized belief on the part of some that AIDS is primarily a homosexual problem, one brought on themselves by homosexuals, and so one not deserving of large amounts of already scarce resources. To whatever extent such an attitude plays a part in the lack of funding, it needs to be unearthed and challenged.