Doshi v. Canada (Attorney General)

Doshi v. Canada (Attorney General)
Court (s) Database
Federal Court Decisions
Date
2018-07-09
Neutral citation
2018 FC 710
File numbers
T-335-17, T-336-17
Notes
Reported Decision
Decision Content
Date: 20180709
Dockets: T-335-17
T-336-17
Citation: 2018 FC 710
Ottawa, Ontario, July 9, 2018
PRESENT: Mr. Justice Grammond
Docket: T-335-17
BETWEEN:
PETER DOSHI
Applicant
and
ATTORNEY GENERAL OF CANADA
Respondent
Docket: T-336-17
AND BETWEEN:
PETER DOSHI
Applicant
and
ATTORNEY GENERAL OF CANADA
Respondent
JUDGMENT AND REASONS
[1] On March 18, 2000, at the age of 15, Vanessa Young died of a heart attack, after taking a prescription drug called Prepulsid. After Vanessa’s death, her father, Terence Young, began investigating the practices of the pharmaceutical industry and wrote a book on the topic. He advocated for stronger measures intended to protect the public against the unintended side effects of drugs. He ran for elected office and was a Member of Parliament for Oakville from 2008 to 2015. He played a major role in the debates leading to the adoption of Bill C-17, which amends the Food and Drugs Act, RSC 1985, c F-27 [the Act]. Bill C-17 is now known as the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), SC 2014, c 24, and I will refer to it simply as Vanessa’s Law. This is the first case in which the courts are called upon to interpret and apply Vanessa’s Law.
[2] Vanessa’s Law added section 21.1(3) to the Act. That section, which I quote in full below, empowers the Minister of Health [Health Canada] to disclose information concerning drugs to certain persons. Dr. Peter Doshi, who is an Assistant Professor at the University of Maryland, applied to Health Canada to obtain unpublished information, including clinical trial reports, concerning certain drugs. Health Canada replied that it would only accede to that request if Dr. Doshi signed a confidentiality agreement that would prevent him from disseminating or publishing the information to be disclosed. Dr. Doshi refused to sign such an agreement, arguing that Health Canada’s request had no basis in law and that signing such an agreement would impede his ability to conduct his research project and to publish its results. Accordingly, Health Canada refused Dr. Doshi’s request.
[3] Dr. Doshi now seeks judicial review of this refusal. I am allowing his application, because Health Canada exercised the discretionary power set forth in section 21.1(3) in a manner that contradicts the purpose of Vanessa’s Law, which is to improve clinical trial transparency. Health Canada also fettered its discretion by adopting a rigid policy requiring a confidentiality undertaking before disclosing information under section 21.1(3). Lastly, I find that Health Canada failed to assess the effects of its decision on Dr. Doshi’s freedom of expression, guaranteed by section 2(b) of the Canadian Charter of Rights and Freedoms [Charter].
I. Background
[4] To understand this case properly, it is necessary to provide some detail about the reasons that led to the enactment of Vanessa’s Law and the legislative environment within which it finds its place. I will then describe Dr. Doshi’s request and its treatment by Health Canada.
A. Legislative Background
(1) Legislative Environment
[5] Broadly speaking, legislation concerning drugs pursues two categories of purposes: protecting the health and safety of the public and promoting the economic interests of pharmaceutical companies. These two objectives may be intertwined to a certain extent, as innovation by pharmaceutical companies may result in new drugs being made available, which in turn may result in better health. It remains useful, however, to view these two purposes as being conceptually separate, in particular because they are given effect by two different legislative regimes.
[6] The Food and Drugs Act is aimed at protecting the health and safety of the Canadian public through, among other things, a mechanism to ensure that new drugs are safe and effective before they are made available to the public. New drugs must receive a notice of compliance [NOC] from Health Canada, which may be obtained through a new drug submission [NDS]. An NDS may be described as follows:
A NDS is comprised of various sections, including pre-clinical, clinical, chemistry and manufacturing sections. The pre-clinical portions thereof will consist of all the information pertaining to the experiments that the innovator has conducted in a laboratory so as to test the action and toxicity of the drug. The clinical portions of a NDS provide information with regard to clinical trials with volunteer subjects and/or patients to test the safety and efficacy of the new drug.
(Apotex Inc. v Canada (Health), 2010 FCA 334 at para 12, [2012] 2 FCR 618 [Apotex 2010])
[7] The Patent Act, RSC 1985, c P-4, provides inventors with a monopoly limited in time over their inventions, provided that they publicly disclose the invention (Free World Trust v Électro Santé Inc., 2000 SCC 66 at para 13, [2000] 2 SCR 1024). By doing so, Parliament seeks to provide an economic incentive for innovation. Pharmaceutical companies frequently obtain patents over new drugs they invent. It is recognized that developing new drugs is a long and costly process and that the monopoly associated with a patent affords pharmaceutical companies an opportunity to recoup their development costs.
[8] Not all pharmaceutical companies, however, engage in the development of new or innovative drugs. So-called “generic” drug makers seek to manufacture drugs that are equivalent to those developed by “research” companies and sell them at a lower cost. It is not necessary, for the purposes of this case, to describe in detail the measures adopted by Parliament to balance the interests of “research” and “generic” pharmaceutical companies (see, e.g., Bristol-Myers-Squibb Co. v Canada (Attorney General), 2005 SCC 26 at paras 6-12, [2005] 1 SCR 533).
[9] One aspect of the regulatory framework that is relevant to this case flows from Canada’s desire to comply with its international obligations. Canada is a party to the North American Free Trade Agreement [NAFTA] and the Agreement on Trade-Related Aspects of Intellectual Property Rights [TRIPS]. Article 1711 of NAFTA and Article 39 of TRIPS contain provisions for the protection of data generated by innovator pharmaceutical companies. In order to comply with those provisions, Parliament amended the Food and Drugs Act to empower the government to make regulations to implement Article 1711 of NAFTA and Article 39 of TRIPS. Those regulations, known as the “Data Protection Regulation”, were enacted in 2006. They provide that a manufacturer cannot seek an NOC by relying on a comparison with an “innovative drug,” before the expiry of a period of six years after the NOC for the innovative drug was granted, and Health Canada cannot grant the NOC before the expiry of a period of eight years. The validity of the Data Protection Regulation was upheld by the Federal Court of Appeal in Apotex 2010.
(2) Clinical Trial Transparency
[10] Clinical trials are a crucial component of the new drug development process. Clinical trials, however, have come under closer scrutiny. The materials submitted in support of Dr. Doshi’s application show important concerns with the manner in which clinical trials currently take place. Clinical trials are undertaken by researchers under contract with pharmaceutical companies. Their results are usually kept secret. While those results are provided to regulators such as Health Canada, pharmaceutical companies have insisted that they constitute confidential business information that regulators should not make public.
[11] Yet, publicly disclosing clinical trial results may be beneficial to public health. There are concerns that the conduct of those tests may be biased, or that pharmaceutical companies selectively publish results that favour their interests. Increased public scrutiny of the work of regulatory agencies, such as Health Canada, may uncover regulatory failures. In this regard, Dr. Doshi states in his affidavit:
[…] analyses of regulatory data, such as clinical study reports, can overturn conclusions previously thought to be reliable, altering the risk-benefit assessment that is central to the authorization and use of medicines.
[12] Dr. Doshi also provides an example where independent researchers were able to question the results of published studies and to shed light on the high risks associated with the use of certain drugs:
The conclusions of a highly cited journal article reporting the results of a randomized trial of paroxetine in children and adolescents (Study 329) were contradicted by an independent analysis undertaken by researchers who gained access to previously confidential clinical study reports, electronic individual patient data, and completed case report forms. Based on these data, these researchers re-published the study in The BMJ […], correcting the previous misleading publication. This reanalysis found that paroxetine was not clinically or statistically more effective than placebo but carried significant increases in risk of suicidal ideation and behavior.
[13] For these reasons, many people have advocated for greater clinical trial transparency.
[14] One potential avenue to achieve greater transparency is through access to information legislation. Members of the public, including researchers, may request the disclosure of information in the possession of Health Canada, under the Access to Information Act, RSC 1985, c A-1. However, where a request pertains to information submitted to a government agency by a third party, notice must be given to that third party, who may then argue that disclosure is prohibited by section 20 of that Act. Section 20 covers trade secrets, confidential scientific or technical information and information the disclosure of which may result in financial loss, competitive disadvantage or interference with contractual negotiations. Litigation concerning those provisions may be costly and time-consuming, as illustrated by Merck Frosst Canada Ltd. v Canada (Health), 2012 SCC 3, [2012] 1 SCR 23. The information submitted in this application does not show that access to information legislation has been successful in ensuring clinical trial transparency.
(3) Relevant Provisions of Vanessa’s Law
[15] Bill C-17, which became Vanessa’s Law, was introduced in the House of Commons in December 2013. The initial version of the Bill contained provisions empowering the Minister of Health to order the recall or relabelling of therapeutic products (including drugs) and to request information about, and to mandate the assessment of, therapeutic products. It mandated the reporting of serious adverse drug reactions to the Minister. It also empowered the government to make regulations concerning the same subjects. Those provisions are not in issue in this case.
[16] As a result of discussions at second reading and in Committee, which will be reviewed in more detail later in these reasons, the government proposed amendments to the Bill. The provisions that are directly relevant to this case are the following.
[17] First, a definition of “confidential business information” was added:
2 In this Act,
2 Les définitions qui suivent s’appliquent à la présente loi.
confidential business information, in respect of a person to whose business or affairs the information relates, means — subject to the regulations — business information
renseignements commerciaux confidentiels Sous réserve des règlements, renseignements commerciaux qui se rapportent à l’entreprise d’une personne ou à ses activités et, à la fois :
(a) that is not publicly available,
a) qui ne sont pas accessibles au public;
(b) in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available, and
b) à l’égard desquels la personne a pris des mesures raisonnables dans les circonstances pour qu’ils demeurent inaccessibles au public;
(c) that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors; (renseignements commerciaux confidentiels)
c) qui ont une valeur économique réelle ou potentielle pour la personne ou ses concurrents parce qu’ils ne sont pas accessibles au public et que leur divulgation entraînerait une perte financière importante pour elle ou un gain financier important pour ses concurrents. (confidential business information)
[18] Second, provisions were added to empower the Minister to disclose confidential business information in certain circumstances:
21.1 […]
21.1 […]
(2) The Minister may disclose confidential business information about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the Minister believes that the product may present a serious risk of injury to human health.
(2) Le ministre peut communiquer des renseignements commerciaux confidentiels qui se rapportent à l’entreprise d’une personne ou à ses activités sans obtenir son consentement et sans l’aviser si les renseignements concernent un produit thérapeutique qui, de l’avis du ministre, peut présenter un risque grave de préjudice à la santé humaine.
(3) The Minister may disclose confidential business information about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the purpose of the disclosure is related to the protection or promotion of human health or the safety of the public and the disclosure is to
(3) Si l’objet de la communication est relatif à la protection ou à la promotion de la santé humaine ou de la sécurité du public, le ministre peut communiquer des renseignements commerciaux confidentiels qui concernent un produit thérapeutique et qui se rapportent à l’entreprise d’une personne ou à ses activités sans obtenir son consentement et sans l’aviser :
(a) a government;
a) à toute administration;
(b) a person from whom the Minister seeks advice; or
b) à toute personne qu’il consulte;
(c) a person who carries out functions relating to the protection or promotion of human health or the safety of the public.
c) à toute personne exerçant des fonctions relatives à la protection ou à la promotion de la santé humaine ou de la sécurité du public.
[19] Section 21.1(3) is the provision invoked by Dr. Doshi in this case.
[20] Third, the regulation-making powers of the government were enlarged to encompass the following:
30(1.2) Without limiting the power conferred by any other subsection of this section, the Governor in Council may make regulations […]
30(1.2) Sans que soit limité le pouvoir conféré par les autres paragraphes du présent article, le gouverneur en conseil peut prendre des règlements : […]
(c.1) defining clinical trial and investigational test for the purposes of this Act; […]
c.1) définissant essai clinique et essai expérimental pour l’application de la présente loi; […]
(d.1) specifying the business information obtained under this Act in relation to an authorization under paragraph (a) that is not confidential business information, or the circumstances in which business information obtained under this Act in relation to such an authorization ceases to be confidential business information;
d.1) précisant les renseignements commerciaux obtenus en vertu de la présente loi relativement à une autorisation visée à l’alinéa a) qui ne sont pas des renseignements commerciaux confidentiels ou précisant les circonstances dans lesquelles des renseignements commerciaux ainsi obtenus relativement à une telle autorisation cessent d’être des renseignements commerciaux confidentiels;
(d.2) authorizing the Minister to disclose, without notifying the person to whose business or affairs the information relates or obtaining their consent, business information that, under regulations made under paragraph (d.1),
d.2) autorisant le ministre à communiquer des renseignements commerciaux qui se rapportent à l’entreprise d’une personne ou à ses activités sans obtenir son consentement et sans l’aviser si, selon le cas :
(i) is not confidential business information, or
(i) un règlement pris en vertu de l’alinéa d.1) précise que ces renseignements ne sont pas des renseignements commerciaux confidentiels,
(ii) has ceased to be confidential business information;
(ii) ces renseignements ont cessé d’être des renseignements commerciaux confidentiels en application d’un règlement pris en vertu de cet alinéa;
(4) Proposed Regulations
[21] As of the date of this judgment, the government has not made regulations pursuant to section 30(1.2). On December 9, 2017, however, the proposed Regulations Amending the Food and Drugs Regulations (Public Release of Clinical Information) were published in the Canada Gazette. Subject to certain exceptions, information regarding clinical trials would cease to be considered as confidential business information when an NOC is issued or an NDS withdrawn or refused. Health Canada would be empowered to disclose such information publicly. Of interest, the context and justification of this regulatory proposal are described as follows:
Health Canada typically treats most clinical information provided by manufacturers in drug submissions and medical device applications as confidential business information (CBI). The Department does not have a formal policy or guidance on the identification of CBI in drug submissions and medical device applications. Consequently, the established practice is not to publicly release detailed clinical data in drug submissions and medical device applications, except where the information has entered the public domain or consent has been granted by the sponsor.
Without access to detailed clinical data, health professionals and researchers are unable to perform independent analyses of the evidence underlying published research findings and Health Canada’s regulatory reviews. This approach limits transparency and misses opportunities to promote greater confidence in the oversight of drugs and medical devices. It is also out of step with Health Canada’s key regulatory partners, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration, which have increased clinical data transparency over the past 10 years.
B. Dr. Doshi’s Application
[22] Soon after the coming into force of Vanessa’s Law, Dr. Doshi communicated with Health Canada to express his interest in obtaining information pursuant to section 21.1(3). After an exchange of correspondence, Dr. Doshi filed two requests with Health Canada on January 16, 2016. The first request pertained to three HPV vaccines, Gardasil, Gardasil 9 and Cervarix. The second request pertained to two neuraminidase inhibitors, Tamiflu and Relenza. In both cases, Dr. Doshi sought “complete copies of all sections of all clinical study reports.” He also asked for “all electronic datasets from these same trials, including participant level datasets.” Dr. Doshi stated that he would use the data for two distinct projects. First, he would conduct a “systematic review” of regulatory data (also known as a “Cochrane review”), which he describes as a “well-established methodology for exhaustively and critically reviewing all randomized controlled trials and research studies.” Second, he proposed to undertake a “methodology project,” “focused on improving the methodology of evidence synthesis and appraisal of regulatory documents.”
C. Health Canada’s Decision
[23] Early in the discussion with Dr. Doshi, Health Canada made it clear that it would only disclose the data if Dr. Doshi signed a confidentiality agreement. This, in fact, was consistent with a “Draft Guidance Document” regarding section 21.1(3)(c) prepared by Health Canada on March 10, 2016. Initially, Dr. Doshi indicated that he would consider the terms of a proposed confidentiality agreement. Subsequently, he revised his position and objected to any form of a confidentiality agreement.
[24] On February 7, 2017, Health Canada issued its decision regarding Dr. Doshi’s requests. First, Health Canada accepted that Dr. Doshi, given his credentials and current position, is “a person who carries out functions relating to the protection or promotion of human health or the safety of the public.” With respect to the systematic review project, Health Canada also accepted that the proposed disclosure would be “related to the protection or promotion of human health or the safety of the public.” With respect to the methodology project, however, Health Canada determined that Dr. Doshi had not provided enough information to allow it to reach a conclusion.
[25] Nevertheless, because Dr. Doshi had refused to sign a confidentiality agreement, Health Canada denied his request. Health Canada also noted that Dr. Doshi had failed to provide a signed declaration of conflict of interest.
D. Dr. Doshi’s Application for Judicial Review
[26] Dr. Doshi now seeks judicial review of Health Canada’s rejection of his requests. Two separate applications for judicial review have been filed. File no. T-335-17 relates to Gardasil, Gardasil 9 and Cervarix. File no. T-336-17 relates to Tamiflu and Relenza. The evidence and the submissions in both files are identical. These reasons apply to both.
[27] For the purposes of these applications, both parties agree that the information sought by Mr. Doshi constitutes confidential business information within the meaning of section 21.1(3) and I am prepared to accept this. This is without prejudice to Dr. Doshi’s more general assertion that clinical trial results should usually not be considered as such. In this connection, I observe that the proposed regulations would provide that clinical trial results cease to be confidential business information when a decision is made on an NDS. They would also authorize Health Canada to disclose such information. However, until such regulations are made, section 21.1(3) applies only to confidential business information. Thus, if Dr. Doshi were to argue that clinical trial results are not confidential, this would undercut his position that this information is covered by section 21.1(3).
[28] Dr. Doshi also agrees that Health Canada rightly requires him to sign a declaration of conflict of interest. As he is prepared to sign such a declaration if the application is allowed, I need not delve further into this issue and I will make my order conditional on Dr. Doshi providing such a declaration to Health Canada.
II. Analysis
[29] As I mentioned above, I find that Health Canada’s decision was unreasonable. To explain why, I must first lay out certain principles of administrative law regarding the exercise of discretionary powers. I will then examine the text, structure and history of Vanessa’s Law to discern its purpose. I will then be in a position to analyse Health Canada’s decision.
A. Reviewing the Exercise of Discretionary Powers
[30] Administrative decision-makers who are granted discretionary powers enjoy a considerable margin of appreciation with respect to the manner in which they exercise their powers and the considerations they take into account (Mount Sinai Hospital Center v Quebec (Minister of Health and Social Services), 2001 SCC 41 at para 58, [2001] 2 SCR 281). Nevertheless, since at least Roncarelli v Duplessis, [1959] SCR 121 [Roncarelli], it is recognized that discretionary powers are never absolute. Administrative law now comprises several principles guiding the exercise of discretionary power. These principles may act independently, but they may also reinforce each other in particular cases. Three such principles are invoked in this case. I will review them briefly before turning to an examination of the purposes of Vanessa’s Law and, finally, the analysis of Health Canada’s decision in this case.
(1) Compatibility with Statutory Purposes
[31] The first relevant administrative law principle is that a discretionary power must be exercised in a manner compatible with the purposes of the statute that grants the power. It is a matter of fidelity to legislative intent.
[32] This principle was indeed outlined in Roncarelli, where Justice Martland said that the power to revoke Mr. Roncarelli’s liquor licence could not be exercised “for reasons which are unrelated to the carrying into effect of the intent and purpose of the Act” (at 156). Likewise, in Shell Canada Products Ltd. v Vancouver (City), [1994] 1 SCR 231, the Supreme Court of Canada stated that a municipality must exercise its powers for “municipal purposes,” that is, purposes which are contemplated by the legislation creating the municipality (at 278).
[33] This principle is sometimes expressed using slightly different language or from a slightly different perspective. For example, in Delta Air Lines Inc. v Lukács, 2018 SCC 2 at para 20 [Delta Air Lines], it was said that a discretionary power must not be exercised in a manner “contrary to the scheme of the Act.” In Montréal (City) v Montreal Port Authority, 2010 SCC 14 at para 47, [2010] 1 SCR 427, the Supreme Court required administrative decisions to be consistent with the “principles governing the application” of the legislation and with “Parliament’s intention.”
[34] It is also said that a discretionary power must not be exercised for irrelevant or extraneous considerations: City of Prince George v Payne, [1978] 1 SCR 458. Likewise, a decision-maker must not overlook relevant factors: CUPE v Ontario (Minister of Labour), 2003 SCC 29 at paras 172-176, [2003] 1 SCR 539. What is relevant or irrelevant is delineated according to the legislation’s purpose.
[35] In Chamberlain v Surrey School District No. 36, 2002 SCC 86, [2002] 4 SCR 710, the Supreme Court held that certain statements of principles in British Columbia’s school legislation prevented a school board from making decisions based on certain motives. While the majority of the Court did not resort to the concept of statutory purpose, it is clear that it considered that the school board’s decision not to approve pedagogical materials that depicted families with same-sex parents was contrary to the legislation’s declared purpose of having a “strictly secular” school system. That decision “was unreasonable in the context of the educational scheme mandated by the legislature” (at para 59). In his concurring opinion, Justice LeBel wrote that the legislation’s statements of purposes imposed limits on the discretion of the school board (at paras 207, 215).
[36] This principle of administrative law is aptly summarized by Justice Wilson in Reference re Bill 30, an Act to Amend the Education Act (Ont.), [1987] 1 SCR 1148 at 1191:
It is, however, well established today that a statutory power to make regulations is not unfettered. It is constrained by the policies and objectives inherent in the enabling statute. […] It cannot be used to frustrate the very legislative scheme under which the power is conferred.
(2) Compatibility with Charter
[37] As the Constitution is the supreme law of the land, discretionary powers must be exercised in a manner compatible with the Constitution, which includes the Charter. In Doré v Barreau du Québec, 2012 SCC 12, [2012] 1 SCR 395 [Doré], the Supreme Court of Canada established a framework for the review of the exercise of discretionary powers that impinge upon Charter rights or values. This framework was summarized in a later decision, Loyola High School v Quebec (Attorney General), 2015 SCC 12, [2015] 1 SCR 613, at para 4:
Under Doré, where a discretionary administrative decision engages the protections enumerated in the Charter — both the Charter’s guarantees and the foundational values they reflect — the discretionary decision-maker is required to proportionately balance the Charter protections to ensure that they are limited no more than is necessary given the applicable statutory objectives that she or he is obliged to pursue.
(3) No “Fettering” of Discretion
[38] It is generally accepted that decision-makers may issue guidelines indicating the factors they will take into consideration when exercising their discretionary powers. However, those guidelines do not become law themselves. Decision-makers must still examine all relevant factors, whether mentioned in their guidelines or not. If they treat their guidelines as binding, they are “fettering” their discretion and their decisions may become unreasonable (see, for example, Maple Lodge Farms v Government of Canada, [1982] 2 SCR 2 at 5-6; Kanthasamy v Canada (Citizenship and Immigration), 2015 SCC 61 at para 32, [2015] 3 SCR 909; Delta Air Lines at para 18; Stemijon Investments Ltd. v Canada (Attorney General), 2011 FCA 299).
B. Purposes of Vanessa’s Law
[39] The first two principles described above require me to ascertain the purpose of Vanessa’s Law and, in particular, of section 21.1(3).
[40] In R v Moriarity, 2015 SCC 55, [2015] 3 SCR 485, and R v Safarzadeh-Markhali, 2016 SCC 14, [2016] 1 SCR 180 [Safarzadeh-Markhali], the Supreme Court of Canada outlined a method for determining the purpose of a statute. While that method was developed in the context of a constitutional challenge to the statute in question, it is equally applicable in this case. Purpose must not be confused with the means employed by the statute. It must be articulated at an appropriate degree of generality, which is neither a general social value nor a mere rephrasing of the provision. It must focus on the provision that is at issue. To ascertain statutory purpose, “courts look to (1) statements of purpose in the legislation, if any; (2) the text, context, and scheme of the legislation; and (3) extrinsic evidence such as legislative history and evolution” (Safarzadeh-Markhali at para 31).
[41] The parties have put forward different characterizations of the purpose of Vanessa’s Law. Dr. Doshi says that it is to improve transparency. The Attorney General says that Vanessa’s Law cannot be considered in isolation from the Food and Drugs Act that it amends. She then characterizes the purpose of that Act as the promotion of public health through the reconciliation and balancing of several competing objectives, in particular the need to foster the development of new drugs and the need to ensure greater public scrutiny of the practices of pharmaceutical companies. In my view, both characterizations are unhelpful. Dr. Doshi’s characterization is too broad, while the Attorney General’s is too vague.
[42] Indeed, as Professor Ruth Sullivan notes, “[t]he legislature never pursues a goal single-mindedly, without qualification, and at all costs” (Statutory Interpretation, 3rd ed. (Toronto: Irwin Law, 2016) at 186). Thus, a purpose cannot be entirely divorced from the actual means that are deployed to pursue it. Indeed, the fact that the legislature goes only so far in the pursuit of a purpose is often due to the presence of competing values or needs that must be balanced with the legislation’s purpose. But this does not mean that the balancing becomes the purpose itself. Nevertheless, those competing values or needs are helpful in contextualizing the statutory purpose.
[43] With this in mind, I propose to describe the purpose of Vanessa’s Law by analyzing the factors identified by the Supreme Court in Safarzadeh-Markhali.
(1) Statements of Purpose
[44] The Food and Drugs Act does not contain a preamble or a purpose section. Vanessa’s Law, in contrast, includes a preamble, which reads as follows:
Whereas the safety of drugs and medical devices is a key concern for Canadians;
Attendu :
And whereas new measures are required to further protect Canadians from the risks related to drugs and medical devices, other than natural health products;
que l’innocuité des drogues et des instruments médicaux est une préoccupation fondamentale des Canadiens;
[BLANK]
que de nouvelles mesures s’imposent pour protéger davantage les Canadiens contre les risques liés aux drogues et aux instruments médicaux, à l’exclusion des produits de santé naturels,
[45] This preamble suggests, with little specificity, that Vanessa’s Law is intended to afford greater protection against “risks related to drugs.” The implication is that it provides for stricter regulation of the pharmaceutical industry. There is nothing in this preamble that supports the Attorney General’s assertion that the purpose of Vanessa’s Law can be described as the balancing of competing objectives. Nor can it be said that the measure was adopted with the purpose of fostering the development of new drugs.
[46] This conclusion is reinforced by Vanessa’s Law “alternative title,” set forth in section 1: the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law). The “mischief” towards which Vanessa’s Law is geared is clearly identified – unsafe drugs.
[47] A “summary” is also provided when bills are tabled in Parliament. This summary does not form part of the Act. However, it is akin to marginal notes, which may be given some weight in the interpretive process, according to all the circumstances: Ruth Sullivan, Sullivan on the Construction of Statutes, 6th ed. (Toronto: LexisNexis Canada, 2014) at 439-440. It reads as follows:
This enactment amends the Food and Drugs Act regarding therapeutic products in order to improve safety by introducing measures to, among other things,
Le texte modifie la Loi sur les aliments et drogues relativement aux produits thérapeutiques afin d’améliorer la sécurité en introduisant des mesures pour notamment :
(a) strengthen safety oversight of therapeutic products throughout their life cycle;
a) renforcer la surveillance de l’innocuité de tels produits au cours de leur cycle de vie;
(b) improve reporting by certain health care institutions of serious adverse drug reactions and medical device incidents that involve therapeutic products; and
b) améliorer la déclaration, par certains établissements de soins de santé, des réactions indésirables graves aux drogues et des incidents liés à des instruments médicaux et mettant en cause de tels produits;
(c) promote greater confidence in the oversight of therapeutic products by increasing transparency.
c) favoriser une confiance accrue dans la surveillance des produits thérapeutiques en augmentant la transparence.
[48] It should be noted that the third paragraph was added after the Bill was amended in Committee. It thus reflects the purpose of the amendments made in Committee, in particular sections 21.1(3) and 30(1.2). This summary thus confirms that the general goal of the Bill is to “improve safety.” It provides some precision as to the means through which this will be achieved. It confirms that “transparency” was a goal pursued by Parliament. But transparency of what, and to what extent? That remains to be seen.
(2) Text, Context and Scheme of Legislation
[49] There is no doubt that Vanessa’s Law is aimed at improving the safety of drugs. It does not do so, however, in an all-encompassing manner, but rather through a set of targeted measures. For example, it empowers Health Canada to recall certain drugs or to mandate further testing of drugs, but it does not deal with the process Health Canada is using when approving new drugs.
[50] Closer attention to the provisions at issue and to their relationship with other components of the normative environment provides some insight as to their purpose.
[51] What is striking about the “transparency amendments” adopted in committee, and that became sections 21.1(3) and 30(1.2), is that they resort to a two-track approach. Section 21.1(3) empowers Health Canada to disclose “confidential business information.” On the other hand, section 30(1.2) empowers the government to define what is, what is not and what ceases to be “confidential business information,” and to make public what is not or no longer confidential. Thus, the structure of Vanessa’s Law suggests that Parliament intended some information to become public and some other information to remain confidential, and empowered the government to draw the line between the two categories.
[52] This two-track approach to transparency parallels the provisions of Article 1711 of NAFTA and Article 39 of TRIPS, to which I have alluded earlier and which may now be examined more closely. These provisions deal separately with what they call “trade secrets” and what could be called regulatory data. Let me illustrate this with NAFTA first. The first paragraph of Article 1711 is worded as follows:
1. Each Party shall provide the legal means for any person to prevent trade secrets from being disclosed to, acquired by, or used by others without the consent of the person lawfully in control of the information in a manner contrary to honest commercial practices, in so far as:
1. Chacune des Parties assurera à toute personne les moyens juridiques d'empêcher que des secrets commerciaux ne soient divulgués à des tiers, acquis ou utilisés par eux, sans le consentement de la personne licitement en possession de ces renseignements et d'une manière contraire aux pratiques commerciales honnêtes, dans la mesure où :
(a) the information is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons that normally deal with the kind of information in question;
a) les renseignements sont secrets, en ce sens que, dans leur globalité ou dans la configuration et l'assemblage exacts de leurs éléments, ils ne sont pas généralement connus de personnes appartenant aux milieux qui s'occupent normalement du genre de renseignements en question ou ne leur sont pas aisément accessibles;
(b) the information has actual or potential commercial value because it is secret; and
b) les renseignements ont une valeur commerciale, réelle ou potentielle, du fait qu'ils sont secrets; et
(c) the person lawfully in control of the information has taken reasonable steps under the circumstances to keep it secret.
c) la personne licitement en possession de ces renseignements a pris des dispositions raisonnables, compte tenu des circonstances, en vue de les garder secrets.
[53] It will be appreciated that the definition of trade secret in NAFTA closely parallels the definition of confidential information in Vanessa’s Law.
[54] However, Article 1711 deals separately with regulatory data, which apparently includes clinical trial reports. The fifth and sixth paragraphs of that provision read as follows:
5. If a Party requires, as a condition for approving the marketing of pharmaceutical or agricultural chemical products that utilize new chemical entities, the submission of undisclosed test or other data necessary to determine whether the use of such products is safe and effective, the Party shall protect against disclosure of the data of persons making such submissions, where the origination of such data involves considerable effort, except where the disclosure is necessary to protect the public or unless steps are taken to ensure that the data is protected against unfair commercial use.
5. Lorsqu'une Partie subordonne l'approbation de la commercialisation de produits pharmaceutiques ou de produits chimiques pour l'agriculture qui comportent des éléments chimiques nouveaux, à la communication de données non divulguées résultant d'essais ou d'autres données non divulguées nécessaires pour déterminer si l'utilisation de ces produits est sans danger et efficace, cette Partie protégera ces données contre toute divulgation, lorsque l'établissement de ces données demande un effort considérable, sauf si la divulgation est nécessaire pour protéger le public, ou à moins que des mesures ne soient prises pour s'assurer que les données sont protégées contre toute explo