Delisle v. Canada (Attorney General)

Delisle v. Canada (Attorney General)
Court (s) Database
Federal Court Decisions
Date
2006-07-28
Neutral citation
2006 FC 933
File numbers
T-2138-04, T-2139-04, T-2140-04, T-698-04
Decision Content
Date: 20060728
Citation: 2006 FC 933
BETWEEN:
Docket: T-698-04
LÉOPOLD DELISLE
Applicant
- and -
THE ATTORNEY GENERAL OF CANADA
-and-
MINISTRY OF HEALTH (HEALTH CANADA)
-and-
DIRECTOR GENERAL
THERAPEUTIC PRODUCTS DIRECTORATE (HEALTH CANADA)
Respondents
BETWEEN:
T-2138-04
DANY LAFOREST
Applicant
- and -
THE ATTORNEY GENERAL OF CANADA
-and-
MINISTRY OF HEALTH (HEALTH CANADA)
-and-
DIRECTOR GENERAL
THERAPEUTIC PRODUCTS DIRECTORATE (HEALTH CANADA)
Respondents
BETWEEN:
T-2139-04
LAURENT LÉGÈRE
Applicant
- and -
THE ATTORNEY GENERAL OF CANADA
-and-
MINISTRY OF HEALTH (HEALTH CANADA)
-and-
DIRECTOR GENERAL
THERAPEUTIC PRODUCTS DIRECTORATE (HEALTH CANADA)
Respondents
BETWEEN:
T-2140-04
DANIEL GRANDMONT
Applicant
- and -
THE ATTORNEY GENERAL OF CANADA
-and-
MINISTRY OF HEALTH (HEALTH CANADA)
-and-
DIRECTOR GENERAL
THERAPEUTIC PRODUCTS DIRECTORATE (HEALTH CANADA)
Respondents
REASONS FOR JUDGMENT
LEMIEUX J.
I. Introduction
[1] There are four applications for judicial review, to be jointly examined, regarding some decisions by the federal authorities made under Health Canada’s Special Access Programme (the “SAP”) and especially the January 23, 2004 decision by the Director of the Senior Medical Advisor Bureau (the “Director”). The effect of this decision is two-fold:
1o it stated a public policy: access via the SAP to a product known as 714-X, a medication which has not been licensed by Health Canada, nor elsewhere, but whose sale has been authorized in Canada, since 1989 via the SAP following requests for access submitted by several physicians was thereafter to be limited. This policy required that significant evidence be included in all requests to the SAP before any new sales were authorized. It indicated that [translation] “in view of this decision, it is unlikely that the SAP shall authorize sales of 714-X for new patients.” It provided for a one-year transitional period for the patients currently taking the product. They were to have access to the product on the advice of their physician if they experienced no adverse reaction. Future use of the product was to be submitted to a clinical trial;
2o this is Health Canada’s response to several requests for access to 714-X which were then still on hold.
[2] The respondents explain the scope of this decision in the following terms, that can be found in their memorandum of points and authorities:
[translation]
2. This decision bears on the sales conditions via the Special Access Programme of a drug known as 714-X. Pursuant to a thorough review of the documentation, the Director concluded, on January 23, 2004, that there was no credible evidence establishing the effectiveness or the safety of this drug. The Director decided not to invoke the exceptional discretionary power conferred on him by section C.08.010 of the Food and Drug Regulations, which authorizes the sale of this drug to certain patients. The sale of this drug remains prohibited, in accordance with the Food and Drugs Act (hereinafter referred to as “FDA”) and the Food and Drug Regulations (hereinafter referred to as “FDR”).
. . .
24. On January 23, 2004, Dr. Brian Gillespie, Director of the Senior Medical Advisor Bureau, made a public policy decision regarding access to a new drug, 714-X. Pursuant to this public policy, the Director informed referring physicians that the new 714-X drug would no longer be accessible via the SAP, except for a one-year grace period for those patients whose referring physicians had already received an authorization. Furthermore, this decision was to be applicable to all access requests which had been on hold since August 2003.
. . .
26. The Director, however, did not rule out the possibility that 714-X might eventually be accessible to Canadians. The manufacturer shall be, however, required to request and obtain an authorization prior to undertaking clinical trials. These are obligations that the “FDA” and the “FDR” impose on all manufacturers of new drugs. [Emphasis added.]
[3] The respondents focus on Dr. Gillespie’s January 23, 2004 decision, claiming that said decision and all the issues raised by the applicants are inextricably interrelated;
[4] As to the applicants, their submissions not only bear on Dr. Gillespie’s decision, but also on the SAP’s decision with regard to access requests by each of their referring physicians: they argue that those decisions were made within a reasonable time or that it is unwarranted to deny them access to the drug in issue;
[5] The applicants raise several issues:
1. Want of jurisdiction
They submit that access decisions were the prerogative of the Assistant Deputy Minister of the Food Directorate, Health Products and Food Branch within the Department, who could not delegate that power or, if he could, that the decision in issue was made by the wrong person, or that it should have been made on a case-by-case basis and not applied uniformly, or that a new delegation of powers was required in view of changes within Health Canada’s administrative structure.
2. Excess of jurisdiction
They submit that the SAP based sales authorizations of 714-X on requirements that went beyond the scope of the Regulations in several manners: (1) by requiring from referring physicians additional information on the product’s effectiveness and safety that physicians do not have, (2) by asking for specific information that appeared in science magazines and pertained to the registration process, which is not part of the Regulations, and (3) by adopting a public policy going beyond the limits of its discretionary power;
3. Breach of legitimate expectation
They contend that the SAP’s mandate, as described by Health Canada, includes a commitment to treat every request for access within 24 hours after it is received. Not only was this policy deviated from in several cases, but in the case of two of the applicants, the delay in the response was unreasonable. The applicants also submit that, after 15 years of access, they had a legitimate expectation that their requests for access would be authorized.
4. The scope of the discretionary power
When construed in the light of their object, the Regulations creating the SAP provide for a restricted authorization power, exclusively based on the duties owed of the physician and his patient; there is nothing discretionary about it. The system thus created is that of access on demand.
5. Abusive and patently unreasonable use of discretionary power
The applicants claim that 714-X is not toxic and is effective. In establishing its public policy, Health Canada is said to have ignored evidence from patients, their physicians, Mr. Nassens, as well as the scientific theory that supports 714-X. Furthermore, in its review of the issue of access to 714-X, the SAP acted arbitrarily in the evaluation and application of the evidence.
6. Violation of sections 7 and 15 of the Canadian Charter of Rights and Freedoms (the Charter)
[6] In my view, several of the issues raised by the applicants are essentially issues of statutory interpretation. The modern approach was reiterated by Mr. Justice Gonthier in Barrie Public Utilities v. Canadian Cable Television Assn. [2003] 1 R.C.S., who quoted the following excerpt from E.A. Driedger in his work, Construction of Statutes (2nd ed. 1983, p.87):
Today there is only one principle or approach, namely, the words of an Act are to be read in their entire context and in their grammatical and ordinary sense harmoniously with the scheme of the Act, the object of the Act, and the intention of Parliament. [Emphasis added.]
[7] Only two sections of the Regulations, captioned “sale of new drug for emergency treatment,” relate to the SAP:
C.08.010. (1) The Director may issue a letter of authorization authorizing the sale of a quantity of a new drug for human or veterinary use to a practitioner named in the letter of authorization for use in the emergency treatment of a patient under the care of that practitioner, if
(a) the practitioner has supplied to the Director information concerning
(i) the medical emergency for which the drug is required,
(ii) the data in the possession of the practitioner with respect to the use, safety and efficacy of that drug,
(iii) the names of all institutions in which the drug is to be used, and
(iv) such other data as the Director may require; and
(b) the practitioner has agreed to
(i) report to the manufacturer of the new drug and to the Director on the results of the use of the drug in the medical emergency, including information respecting any adverse reactions encountered, and
(ii) account to the Director on request for all quantities of the drug received by him.
(2) The Director shall, in any letter of authorization issued pursuant to subsection (1), state
(a) the name of the practitioner to whom the new drug may be sold;
(b ) the medical emergency in respect of which the new drug may be sold; and
(c) the quantity of the new drug that may be sold to that practitioner for that emergency.
C.08.011. (1) Notwithstanding section C.08.002, a manufacturer may sell to a practitioner named in a letter of authorization issued pursuant to section C.08.010, a quantity of the new drug named in that letter that does not exceed the quantity specified in the letter.
(2) A sale of a new drug made in accordance with subsection (1) is exempt from the provisions of the Act and these Regulations. [Emphasis added.]
C.08.010. (1) Le Directeur général peut fournir une lettre d'autorisation permettant la vente d'une certaine quantité d'une drogue nouvelle d'usage humaine ou vétérinaire à un praticien nommé dans la lettre d'autorisation pour le traitement d'urgence d'un malade traité par ledit praticien, si
a) le praticien a fourni au Directeur général des renseignements concernant
(i) l'état pathologique urgent pour lequel la drogue est requise,
(ii) les données que possède le praticien à propos de l'usage, de l'innocuité et de l'efficacité de ladite drogue,
(iii) le nom de tous les établissements où la drogue doit être utilisée, et
(iv) les autres renseignements que le Directeur général pourrait lui demander; et
b) le praticien a consenti à
(i) faire part au fabricant de la drogue nouvelle et au Directeur général des résultats de l'usage de la drogue au cours de l'urgence, y compris les renseignements se rapportant à toute réaction défavorable qu'il aura observée, et
(ii) rendre compte au Directeur général, sur demande, de toutes les quantités de la drogue qu'il aura reçues.
(2) Le Directeur général doit, dans toute lettre d'autorisation fournie conformément au paragraphe (1), spécifier
a) le nom du praticien auquel la drogue nouvelle peut être vendue;
b) l'état pathologique urgent pour lequel la drogue nouvelle peut être vendue; et
c) la quantité de la drogue nouvelle qui peut être vendue audit praticien pour ledit cas urgent.
C.08.011. (1) Nonobstant l'article C.08.002, un fabricant peut vendre à un praticien mentionné dans une lettre d'autorisation fournie conformément à l'article C.08.010, une quantité de la drogue nouvelle nommée dans ladite lettre qui n'excède pas la quantité spécifiée dans la lettre.
(2) La vente d'une drogue nouvelle faite en conformité du paragraphe (1) n'est pas soumise aux dispositions de la Loi et du présent règlement.
[8] The sale of a new drug via the SAP is not subject to the requirements of section C.08.002 of the Regulations.
[9] According to subsection C.08.002(1), it is forbidden to sell or advertise a new drug unless, upon request from the manufacturer, the Minister issues a notice of compliance. However, subsection 30(1)(j) of the Act authorizes the Governor in Council to exempt a drug from any or all provisions of the Act and to prescribe the conditions of exemption;
[10] In order to enable the Minister to assess the safety and effectiveness of a new drug, the information demanded under subsection C.08.002(4) of the Regulations in support of such a request includes: 1) details of the tests to be applied to control the potency, purity, stability and safety of the new drug; 2) detailed reports of the tests made to establish the safety of the new drug for the purpose and under the conditions of use recommended; and 3) substantial evidence of the clinical effectiveness of the new drug for the purposes and under the conditions of use recommended.
[11] Léopold Delisle currently has access to 714-X via the SAP. In his application for judicial review, filed April 2, 2004, Mr. Delisle seeks to:
[translation]
5. Purpose of application for judicial review: The application for judicial review relates to the decisions of the respondent Health Canada, and more specifically, of the Director General of the Therapeutic Products Directorate, who refused requests from physicians on behalf of their patients to make the 714-X product available through the Special Access Programme (hereinafter referred to as “the SAP”) administered by the respondents. The application also seeks to order the respondents to allow the physicians’ requests, without any further requirements and conditions within 24 hours of receiving these requests, whether the patients concerned have been granted or not in the past a similar authorization for access to the 714-X product; [Emphasis added.]
[12] Although his physician has been requesting it since August 2003, Daniel Grandmont was never treated with 714-X. His application for judicial review, filed on December 1st, 2004, seeks to have the following order issued against Health Canada:
[translation]
(a) Not to deny access requests to 714-X made by his physician through the Special Access Programme ((hereinafter referred to as the “SAP”) on grounds of insufficient information regarding the effectiveness or toxicity of 714-X;
(b) To allow the applicant to have access to 714-X upon request from his physician through the SAP, beyond January 2005 and for as long as his physician deems it necessary; [emphasis added.]
[13] Laurent Légère, who currently has access to the 714-X via the SAP, is seeking the following relief in his application for judicial review, filed on December 1st, 2004:
[translation]
12. Relief sought
12.1 The application for judicial review seeks to have the following order made against respondent Health Canada:
(a) To respond to special access requests within twenty-fours and to avoid any unreasonable delay, such as the applicant has suffered, in processing requests for access;
(b) Not to deny any requests for access to 714-X made by his physician through the Special Access Programme (hereinafter referred to as the “SAP”) on grounds of insufficient information regarding the effectiveness or the toxicity of 714-X;
(c) To allow the applicant to have access to 714-X upon request from his physician pursuant to the SAP, after January 2005 and for as long as his physician deems it necessary; [emphasis added.]
12.2 . . .
[14] Dany Laforest was treated with 714-X, but no longer has access to it. Her application for judicial review, filed on December 1st, 2004, seeks to have the following orders made against Health Canada:
[translation]
(a) To allow her request for access to 714- X, which the respondent has omitted or refused to do within a twenty-four-hour deadline;
(b) Where applicable, not to request that her physician submit any further information on the effectiveness or toxicity of 714-X than that provided in response to prior requests;
(c) To enable the applicant to have access to 714-X, upon request from her physician in compliance with the SAP, after January 2005 and for as long as her physician deems it necessary; [Emphasis added.]
[15] In the alternative, assuming that Health Canada has complied with the enabling legislation, each applicant is seeking that the Court declare that sections C.08.010 and C.08.011 violate sections 7 and 15 of the Charter, in that they allow the responsible authorities to deny and delay treatment in an unreasonable manner, or to reject in an abusive and arbitrary manner and without reasonable grounds the requests submitted by physicians for access to 714-X, thus resulting in a deprivation of the liberty and security of the person under section 7, or discrimination under section 15.
II. The SAP
[16] The SAP is a programme instituted by Health Canada to facilitate emergency access to unapproved experimental drugs for serious illnesses when conventional therapies have failed, are unsuitable, or unavailable. The programme started in 1966 under a different name. The Department describes as follows the SAP’s mandate in its request for special access Guideline (applicants’ brief, volume 1, page 62):
The Special Access Programme (the SAP) provides access to nonmarketed drugs for practitioners treating patients with serious or life‑threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP authorizes a manufacturer to sell a drug that cannot otherwise be sold or distributed in Canada. Drugs considered for release by the SAP include pharmaceutical, biologic, and radiopharmaceutical products not approved for sale in Canada.
The SAP does not authorize the use or administration of a drug ‑ this authority falls within the practice of medicine, which is regulated at the provincial level. The SAP authorization does not constitute an opinion or statement that a drug is safe, efficacious or of high quality. The SAP does not conduct a comprehensive evaluation to ensure the validity of drug information or attestations of the manufacturer respecting safety, efficacy and quality. These are important factors for practitioners to consider when recommending the use of a drug and in making an appropriate risk/benefit decision in the best interests of the patient. The SAP strongly encourages practitioners treating individuals with drugs obtained through the SAP to seek informed consent before treatment.
Practitioners are encouraged to contact individual manufacturers to confirm the availability of a drug as well as to obtain the most up‑to‑date drug information such as prescribing information and other data supporting the use of the drug. In all cases, the manufacturer has the final word on whether the drug will be supplied. The manufacturer also has the right to impose certain restrictions or conditions on the release of the drug to ensure that it is used in accordance with the latest information available. For instance, they may restrict the amount of drug released, request further patient information, etc. Inquiries concerning the shipping, cost and/or payment should be directed to individual manufacturers.
In seeking and receiving access to a drug through the SAP, the practitioner agrees to provide both the SAP and the manufacturer with a report on the use of the drug, including information on adverse reactions and, on request, account for all quantities of drug received. [Emphasis added.]
[17] The patient’s referring physician is the one who requests access to 714-X (or any other new drug) by completing a Health Canada form. In addition to giving information on the medication, the patient and the exact medical condition he wishes to receive for this medication, since 2002, the physician must: (1) provide a clinical rationale, including about the patient's medical history, prognosis, other treatments attempted or ruled out; (2) justify why this drug is the best choice for the patient, for example it is a drug of choice, he is undergoing a first or second line therapy, there are no product alternatives; and (3) reference any sources of information available, such as specific medical literature, product monograph, etc., with respect to the use, safety and effectiveness of the medication he is ordering.
[18] The practitioner’s consent on the form is as follows:
I, the practitioner, am accessing this non-marketed drug for use in the emergency treatment of a patient under my care in accordance with the Food and Drug Regulations (C.08.010).
I, the practitioner, am aware that by accessing this drug through the SAP, the sale of the drug is exempt from all aspects of the Food and Drugs Regulations including those respecting the safety, efficacy and quality.
I, the practitioner, agree to provide a report on the results of the use of the drug including information on Adverse Drug Reactions and, on request, to account for quantities of the drug received. [Emphasis added.]
[19] In its guidelines, Health Canada requests that the forms be faxed to the SAP and indicates that a complete form does not guarantee that a request will be authorized, as “additional information may be required during the review process.” Health Canada states that “every effort is made to process requests within 24 hours of receipt” but warns that “given the mandate of the Programme and the volume of requests received, the SAP adopts a triage system to ensure that requests for drugs for life-threatening conditions take precedence over other less urgent matters” and that “if a drug is new to the Programme, the total processing time may be extended” (applicants’ brief, at page 64).
[20] Another Health Canada document (applicants’ brief, at page 70) defines the SAP’s objective:
The Special Access programme (the SAP) allows practitioners to request access to drugs that are unavailable for sale in Canada. This access is limited to patients with serious or life‑threatening conditions on a compassionate or emergency basis when conventional therapies have failed, are unsuitable, or are unavailable. [Emphasis added.]
[21] In the same document, Health Canada responds as follows to the question: “Can the SAP be considered a fast-track approval process for medications?”:
No. The SAP is not intended to be a mechanism to promote or encourage the early use of drugs or to circumvent the clinical trials review and approval process or the new drug approval process, but rather to provide compassionate access to drugs on a patient by patient basis. [My emphasis.]
[22] In 1997, the House of Commons Standing Committee on Health (“Standing Committee”) reviewed the operation of the Emergency Drug Release Program (“EDRP”), the SAP’s precursor.
[23] In its report, the Standing Committee addressed the right of catastrophically-ill patients:
The concept of catastrophic rights holds that: “a catastrophically‑ill patient has the right to be free from any paternalistic interference in electing, in consultation with his physician, any therapy whatsoever that does not cause direct harm to others.” (2) This concept is rooted in the principle of freedom. [Emphasis added.]
[24] This Committee acknowledged, however, that “the catastrophic right to try to save one’s own life is, unfortunately, neither straightforward nor simple in its application for this is a “positive” right, meaning that its fulfilment requires the participation of others,” in other words, it “imposes a corresponding duty on those who have drugs or on those who manufacture drugs.”
[25] In the Committee’s opinion, “the Act attempts to safeguard the health of Canadians by prohibiting the sale of drugs of unproven safety and efficacy.” It stated:
As such, the Act would disallow an individual's catastrophic right to an unproven therapy were it not for sections C.08.010 and C.08.011 of the Act's Regulations. These provisions establish the conditions for the Emergency Drug Release Program (EDRP); whereby, the Health Protection Branch (HPB) of Health Canada may authorize a pharmaceutical manufacturer to sell a drug, not approved for sale in Canada, to a physician for the emergency treatment of a specific patient. The program covers two therapeutic categories: investigational drugs and drugs approved in foreign countries. When the EDRP was established in 1966, it was largely used for this latter function; however, since the emergence of the AIDS epidemic approximately 15 years ago, the focus of the EDRP has shifted to the point where the authorization of experimental drugs for people who are catastrophically ill is the program's major function. While catastrophic rights do not have the force of legal recognition in Canada, the government’s action to facilitate the provision of unapproved medications “implicitly recognizes that critically‑ill persons should be allowed to take much greater risks than would otherwise be acceptable.” [Emphasis added.]
[26] It cautioned, however:
Round Table participants identified a number of problems associated with compassionate access; however, its potential to slow the drug regulatory process was probably the greatest concern. There was strong concurrence that nothing must interfere with the rapidity of drug development, which brings the best treatment to the most people, and is therefore of paramount importance. The availability of compassionate access may lead to high drop‑out rates from trials in progress or it may slow or limit recruitment to controlled trials . . . Not only did this slow the achievement of knowledge, but some volunteers were on drugs for three years without any evidence of a superior arm. There was considerable agreement that if compassionate access is to occur in parallel to clinical trials then creative solutions must be developed to protect the drug development process; but, it was also stressed that greater flexibility within the drug regulatory process is required in order to respond to the urgent need for drugs to treat immediately life‑threatening conditions. [Emphasis added.]
[27] At page 10 of its report, the Standing Committee stated a consensus on the need for
compassionate access:
From the briefs, presentations and five days of Round Table discussions, it appears that the provision of compassionate access to investigational therapies can and does have an impact on the drug development and evaluation process in Canada. In spite of this impact, however, not a single Round Table participant suggested that compassionate access programs should be curtailed in any fashion or that attempts to further liberalize the process should be avoided. . . . [Emphasis added.]
[28] Under the heading “Ethical aspect, overarching considerations,” at page 18, it was stated:
The five National Round Table sessions were characterized by a high level of agreement. Indeed, there was no stated disagreement to the concept of a catastrophic right. It was pointed out, however, that this right is only operational when the physician agrees with the choice of therapy; that is to say, an individual's right to an unmarketed therapy does not override the physician's equal right “to do no harm.” This ethical obligation, to do no harm, goes to the heart of the question of when it becomes appropriate to consider an unproven therapy as a possible candidate for compassionate access. Although a few participants held that there should be no risk limitations on access to experimental drugs, the majority opinion held that release of a therapy should only be considered when “an acceptable balance between efficacy and toxicity” has been demonstrated. (43) Further, it was firmly held that the rights of those with catastrophic illness have defined limits. On this point, Neill Iscoe of the Canadian Cancer Society stated that “the society believes in the right to self‑determination but does not believe this right permits one person to exercise that right to the disadvantage or detriment of another individual.”(44) Specifically, it was felt that compassionate access, while necessary, should not be allowed to impede rapid drug development. [Emphasis added.]
III. 714-X
[29] The inventor of the 714-X product is a biologist, Gaston Naessens. He submitted an affidavit in support of each application for judicial review and was not cross-examined. 714-X was developed in 1975 and is sold by its manufacturer, CERBE Distribution Inc. (“CERBE”). Mr. Naessens is the owner. This product enhances the natural defenses and the immune system when it is introduced directly into the lymphatic system.
[30] 714-X has been accessible to the SAP since December 18, 1989. Gaston Naessens stated that, between that date and March 30, 2004, 1,499 Canadian physicians received 20 985 authorizations from Health Canada for 714-X, which is the equivalent of 440,685 injections and 30,513 treatments by inhalation provided for 4,051 Canadian patients.
[31] According to section C.08.001 of the Regulations, 714-X is a new drug because it has not been sold for a sufficient time and in sufficient quantity in Canada to establish its safety and effectiveness, a finding which is challenged herein.
[32] However, CERBE made no request for a notice of compliance in connection with this product. It should be noted that, until now, 714-X has not been subjected to any clinical trials. Based on the evidence submitted, this product is not authorized in the United States, or anywhere else.
IV. The challenged decision and related decisions
[33] On January 23, 2004, Dr. Gillespie wrote to several physicians to respond to their requests for access to 714-X and notified them of changes in the administration of the programme which would affect the processing of future requests for the product. He recalled that the SAP’s mandate is to offer access to non commercial drugs to physicians who treat patients with serious or life-threatening conditions when conventional therapies have failed or have proven to be unsuitable. (I also note that Dr. Gillespie had sent a similar letter to a smaller number of physicians on January 19, 2004.)
[34] He cautions, however, that, as an emergency mechanism, [translation] “the SAP is not designed to circumvent the clinical trial process or the review process of new medications, nor to promote or encourage the marketing or early use of drugs before their safety and effectiveness has clearly been shown.” [Emphasis added.]
[35] He lists Health Canada’s efforts since 2001 to improve the SAP’s operations. He mentions two initiatives:
[...]The first, a drug audit process, was implemented to monitor all drugs on the programme and identify those for which there are identified concerns of safety, efficacy or quality and/or there is limited data to support widespread access. The second, a quality initiative, was implemented to review the administration of the programme to preserve its use as an emergency mechanism in accordance with the SAP provisions of the Food and Drugs Regulations. [Emphasis added.]
[36] As to 714-X, Dr. Gillespie advises that this product [translation] “has been identified from the start of the medication verification process as a product with limited data to support widespread access or long-term use, and with limited prospects.”
[37] Therefore, at the time, [translation] “it was assigned some priority and it was added on to a list of products requiring sequential testing in an order of priority.” Shortly thereafter, a new form was introduced in connection with the Health Canada initiative on the quality of the programme. [translation] “The most important change is the requirement that practitioners provide a clinical rationale for its use . . . and the sources of scientific information supporting this rationale.”
[38] He concluded by announcing:
In the months after these procedures were introduced, the SAP received many 714-X requests that did not reference scientific data supporting the use, safety and efficacy of this product. The SAP responded to these apparent deficiencies through a routine fax-back procedure for incomplete requests. This process is used to identify specific request deficiencies, reference additional sources of programme information, . . . and outlines our minimal request standards. In addition, it offers practitioners an opportunity to consider a deficiency in light of the minimal requirements of the Food and Drug Regulations and resubmit a request, with additional information, for further consideration. Despite these efforts, the SAP continued to receive a large volume of 714-X requests with little or no data.
Based on a further review of evidence now available with respect to the use, safety and efficacy of this drug, as they relate to the emergency uses for which this drug has been requested, it has been determined that significant new evidence would have to be included in any SAP request before any further sales of 714-X could be authorized pursuant to requests made under section C.08.010 of the Food and Drug Regulations. Given this determination, it is unlikely that the SAP will authorize the sale of 714-X for new patients. During an interim period of one year, the SAP will take account of the special considerations relating to patients currently receiving the drug, who in the opinion of the practitioner have not experienced adverse effects from their ongoing treatment, and may continue to authorize requests made for such patients. The SAP then will revisit the merits of any such continued authorizations on the basis of reports filed on the previous use of the product, including any adverse events, in accordance with subparagraph C.01.010 (b)(i) [n’existe pas] of the Food and Drug Regulations.
The determination that has been made by Health Canada in this matter is consistent with that made by the U.S. National Cancer Institute (NCI) concluded that there have been no clinical studies (e.g. clinical trials, case series or case reviews) reported in peer-reviewed, scientific journals to support the safety or the efficacy of 714-X and it did not recommend the use of 714-X outside the context of well designed clinical trials. If you wish to pursue the use of 714-X, I recommend that you work with a manufacturer to develop and sponsor a clinical trial. A clinical trial would provide an opportunity to better understand the safety and efficacy of 714-X for specific indications and conditions. The regulatory review of the clinical trial would ensure that formal scientific and medical scrutiny is applied to the method of manufacturer of 714-X and the protocol and data supporting the use of 714-X in the proposed treatment. Most importantly, a clinical trial would ensure that the best interests of patients are protected through the required involvement of research ethics boards. [Emphasis added.]
V. The SAP’s evaluation of each applicant’s file
[39] Following is a history of each applicant’s treatment with 714-X and the progress of their physicians’ request for access underlying the application brought before the Court. None of the applicants was cross-examined on the affidavit that they submitted in support of their application for judicial review.
A. Léopold Delisle
[40] Mr. Delisle’s evidence is not limited to his own particular case. He studied the cases of several other patients who used the product or wished to have access to it. He obtained access to other documents by submitting a request pursuant to the Access to Information Act;
[41] The applicant, Léopold Delisle, was diagnosed in 1989 with an immune system illness — mastocytosis. He stated that neither traditional medicine nor international research has found any medication to cure this disease. Between May 1994 and June 1997, he was treated with experimental medication, not only unsuccessfully, but with adverse results. On July 23, 1997, he was given access to 714-X. Paragraphs 38 to 40 of his affidavit read as follows:
[translation]
38. On October 21, 1997, my medical specialist noticed that my condition had improved, with a weight gain, a decrease in these signs and symptoms, the disappearance of a right-side inguinal hernia, which had been present since December 1995, and a significant decrease in my medication;
39. Since July 1997, I have administered myself several 714-X injections; in addition, I have received more than 714-X 100 treatments by inhalation in conjunction with these injections;
40. During this entire period, I observed no secondary side effects, except some painless redness on the site of the injections. The effects of 714-X have given me much more energy, fewer signs and symptoms of the illness, and have enabled me to substantially reduce my medication.. Furthermore, it has helped stabilize my immune system and, as such, has enabled me to have a better quality of life;
[42] He was authorized by an order of the Court to file a further affidavit in order to explain how the SAP reviewed his September 3, 2004 request for access, a request made, I emphasize, following Dr. Brian Gillespie’s January 23, 2004 decision and following the filing of evidence contained in the first affidavit from Ian MacKay, Director of the SAP. The chronology of events is as follows:
(1) on September 9, 2004, his physician received a letter from the SAP [translation] “rejecting my request on the grounds that the form is incomplete in that it lacks information.” (Indeed, his physician’s answer to question 3 on the clinical rationale was “documentation;" however, this question was asking for the available reference materials with regard to the safety and effectiveness of 714‑X.)
(2) in anticipation of a possible decision to extend access to the SAP for 2005, on December 1st, 2004, his physician received a letter from Dr. Gillespie asking him if he had scientific information establishing the effectiveness and safety of 714-X and more particularly, reminding him that his incomplete September 9, 2004 request for access remained unanswered;
(3) on December 14, 2004, his physician submitted a new request for access;
(4) on December 15, 2004, his physician responded to Dr Gillespie’s December 1st, 2004 letter:
[translation]
With respect to 714-X and the scientific data, I should tell you that my patient . . . submitted to me in December 2004, a letter from Dr Arthur B. Pardee of the Dana-Farber Cancer Institute, which confirmed scientifically what I had been observing for many years about 714-X. Notwithstanding the fact that there are no clinical trials on 714-X, it is very evident to me that this product has specific characteristics that are very beneficial to the immune system. Dr. Pardee’s report clarifies the clinical observations I had made.
As to the September 2004 request on behalf of my patient L.D., your rejection and the further information required were irrelevant and unjustified, considering that in May 2004, you had authorized my request, which set forth facts identical to the ones submitted in September 2004. Furthermore, my patient has been using 714-X for several years and this medication is of great help to him. I support him in his wish to maintain its use.
Encl.: Dr Pardee’s letter [Emphasis added.]
(5) on December 15, 2004, Mr. Delisle’s request for access to the SAP was granted.
[43] The enclosure is a letter dated August 9, 1999 from Dr. Pardee. It plays an important role in both parties’ arguments, and shall be analysed further down.
B. Laurent Légère
[44] Laurent Légère’s situation is analogous to Léopold Delisle’s. He currently has access to
714-X. He complained about the delay incurred in the processing of his most recent request, the one submitted by his physician on November 13, 2003, and rejected, it appears, in December 2003 for insufficient information, but authorized in February 2004 following an exchange from his physician.
[45] In October 1994, after he was diagnosed with a carcinoma-type stomach cancer, his survival prognosis was six to eighteen months, and there was no conventional treatment for that type of cancer.
[46] His physician, who knew about 714-X, requested access to the SAP. The access was authorized. At the end of October 1994, he received treatments for eleven cycles, amounting to 231 consecutive injections. After nine months of treatment, he returned to work, [translation] “to his physician’s surprise” and discontinued using it for almost three years. In 1998, his physician obtained two cycles of treatment, and later, in 2001,