Date: 20040531
Docket: T-698-04
Citation: 2004 FC 788
Ottawa, Ontario, May 31, 2004
Present: The Honourable Madam Justice Danièle Tremblay-Lamer
BETWEEN:
LÉOPOLD DELISLE
Applicant
and
ATTORNEY GENERAL OF CANADA
and
DEPARTMENT OF HEALTH (HEALTH CANADA)
and
DIRECTOR GENERAL THERAPEUTIC PRODUCTS
DIRECTORATE (HEALTH CANADA)
Respondents
REASONS FOR ORDER AND ORDER
[1] This is a motion seeking an interlocutory order that the respondents accept the requests for special access (request for access) to the drug 714-X made by physicians, without further requirements or conditions, within 24 hours of receipt of such requests for access, irrespective of whether the patients who are covered have previously been so authorized. The applicant is also asking the Court that the respondents notify by mail those physicians who have prescribed or requested authorization for the use of 714-X of the possibility of obtaining this product upon request to the Special Access Program (SAP).
[2] The respondent Health Canada established the SAP to enable physicians and patients to gain access to some drugs that are not approved in Canada for the treatment of serious or life-threatening illnesses when conventional treatments fail or are inappropriate.
[3] The drug 714-X has been accessible through the SAP or its predecessor, the Emergency Drug Program, since 1989. Between December 18, 1989 and March 23, 2004, 1,499 Canadian physicians received 10,981 access authorizations for the use of 714-X, thereby benefiting 4,051 Canadian patients.
[4] In 1989, the applicant was diagnosed with a disease of the immune system called mastocytosis, a rare disease for which there is as yet no medication.
[5] He began a treatment with 714-X on July 23, 1997. He has continued this treatment to this day. He has observed no side effects and notes an improvement in his physical condition.
[6] It seems that since last year the respondents have been refusing some requests for access to 714-X and that there have been some abnormal and unjustified delays in the processing of these requests. Furthermore, the respondents now require that physicians making requests for access provide credible proof as to the effectiveness and harmlessness of 714-X.
[7] On January 29, 2004, the applicant filed a class action seeking both a review of decisions in response to access requests and the payment of damages. Following the filing of this action, the parties agree to suspend the class action proceedings in order to decide first the aspect concerning the review of the respondents' decisions, through an application for judicial review filed on April 2, 2004.
[8] The present motion, filed on April 7, 2004, seeks an interlocutory order providing access to the drug 714-X for the applicant and the patients who are awaiting a reply to their requests for access, pending the conclusion of the proceedings.
[9] Assuming, but without deciding the question, that the applicant has the requisite interest to act in this case, I am of the opinion that the relief that is sought cannot be granted.
[10] As I indicated above, the drug 714-X is a "new drug" within the meaning of the Food and Drug Regulations, C.R.C. c. 870 (the Regulations), the sale of which is not approved in Canada. However, under the SAP, the Director General of the Therapeutic Products Directorate (the Director General) may issue a letter of authorization authorizing the sale of a quantity of the drug under certain conditions to the practitioner named in the letter.
[11] The Director General exercises his discretion pursuant to section 8.010 of the Regulations, which reads as follows:
| Sale of New Drug for Emergency Treatment |
|
Vente d'une drogue nouvelle pour un traitement d'urgence |
| 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 |
|
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) the practitioner has supplied to the Director information concerning |
|
a) le praticien a fourni au Directeur général des renseignements concernant
|
| (i) the medical emergency for which the drug is required, |
|
(i) l'état pathologique urgent pour lequel la drogue est requise, |
| (ii) the data in the possession of the practitioner with respect to the use, safety and efficacy of that drug, |
|
(ii) les données que possède le praticien à propos de l'usage, de l'innocuité et de l'efficacité de ladite drogue, |
| (iii) the names of all institutions in which the drug is to be used, and |
|
(iii) le nom de tous les établissements où la drogue doit être utilisée, et |
| (iv) such other data as the Director may require; and |
|
(iv) les autres renseignements que le Directeur général pourrait lui demander; et
|
| (b) the practitioner has agreed to |
|
b) le praticien a consenti à
|
| (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 |
|
(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) account to the Director on request for all quantities of the drug received by him. |
|
(ii) rendre compte au Directeur général, sur demande, de toutes les quantités de la drogue qu'il aura reçues.
|
| (2) The Director shall, in any letter of authorization issued pursuant to subsection (1), state |
|
(2) Le Directeur général doit, dans toute lettre d'autorisation fournie conformément au paragraphe (1), spécifier
|
| (a) the name of the practitioner to whom the new drug may be sold; |
|
a) le nom du praticien auquel la drogue nouvelle peut être vendue;
|
| (b) the medical emergency in respect of which the new drug may be sold; and |
|
b) l'état pathologique urgent pour lequel la drogue nouvelle peut être vendue; et
|
| (c) the quantity of the new drug that may be sold to that practitioner for that emergency. |
|
c) la quantité de la drogue nouvelle qui peut être vendue audit praticien pour ledit cas urgent. |
[12] Thus, section 8.010 of the Regulations creates a discretionary authority, and not an obligation, to issue authorizations for special access. In the case at bar, the applicant is asking that the Court order the respondents to issue authorizations for special access. It is obvious that the relief sought by the applicant is a mandamus. But the case law on this point is well established. The Court may, in the context of an application for mandamus, order the performance of a public duty but it cannot dictate the appropriate result when the authority conferred by the enabling provision is discretionary (Apotex Inc. v. Canada (Attorney General), [1994] 1 F.C. 742 (F.C.A.), aff'd [1994] 3 S.C.R. 1100; see, to the same effect, Martinoff v. Canada, [1994] 2 F.C. 33 (C.A.); Kahlon v. Canada (Minister of Employment and Immigration), [1986] 3 F.C. 386 (C.A.)).
[13] Furthermore, this is a motion for an interlocutory order of mandamus. Here again, the case law is determinative in this regard. The issuance of a writ of mandamus is not possible in such circumstances, for it would constitute in fact an interim declaration of right (Paquette v. Canada (Attorney General) (2001), 211 F.T.R. 179 (F.C.T.D.); Brissette v. Canada (Department of Citizenship and Immigration) (2002), 228 F.T.R. 314 (F.C.T.D.)).
[14] Finally, this Court cannot order the respondents to accept requests for access to 714-X "[translation] without further requirements or conditions". Such an order would be illegal, since it would be in violation of the provisions of the Regulations, which stipulate certain conditions that must be met by a physician requesting access before the Director General can exercise his discretion.
[15] For these reasons, the motion is dismissed with costs.
ORDER
THIS COURT ORDERS that the motion be dismissed with costs.
"Danièle Tremblay-Lamer"
Judge
Certified true translation
Suzanne Gauthier, C.Tr., LL.L.
FEDERAL COURT
SOLICITORS OF RECORD
DOCKET: T-698-04
STYLE: Léopold Delisle
v.
Attorney General of Canada and Department of Health (Health Canada) and Director General Therapeutic Products Directorate (Health Canada)
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: May 25, 2004
REASONS FOR ORDER
AND ORDER: Madam Justice Danièle Tremblay-Lamer
DATED: May 31, 2004
APPEARANCES:
Michel Bélanger FOR THE APPLICANT
Yves Lauzon
Carmela Maiorino FOR THE RESPONDENT
SOLICITORS OF RECORD:
Lauzon Bélanger Avocats FOR THE APPLICANT
Montréal, QC
Morris Rosenberg FOR THE RESPONDENT
Deputy Attorney General of Canada
Montréal, QC