Sequence Bioinformatics Inc., Dr. Gerald Mugford v. Dr. Michael Phillips, 2019 NLSC 21

court crest IN THE SUPREME COURT OF NEWFOUNDLAND AND LABRADOR GENERAL DIVISION Citation : Sequence Bioinformatics Inc. v. Health Research Ethics Authority for Newfoundland and Labrador , 2019 NLSC 21 Date : January 31, 2019 Docket : 201801G1948 Between: Sequence Bioinformatics Inc., Dr. Gerald Mugford and Dr. Michael Phillips Applicants And: Health Research Ethics Authority for Newfoundland and Labrador First Respondent And: Health Research Ethics Board Second Respondent Before: Justice Vikas Khaladkar Place of Hearing: St. John’s, Newfoundland and Labrador Date of Hearing: December 17, 2018

Summary: The Applicants request a declaration concerning the

interpretation of section 9(4) of the Health Research Ethics Authority Act owing to their contention that the Health Research Ethics Board was delinquent in its duty to consider, and adjudicate, a proposal made by the Applicants within the time periods contained in section 9(4) .

The Applicants have, under the legislation, the right to ask the Health Research Ethics Board to reconsider their Application. TheApplicants have the further right to appeal a decision of the Health Research Ethics Board to an independent Appeal Panel establishedunder the Health Research Ethics Authority Act. A final appeal lies to this Court. However, while an appeal lies with respect to thedecision of the Health Research Ethics Board, there is no right to appeal the procedure employed by the Health Research Ethics Board:namely, its timeliness in arriving at its decision.

For those reasons, I am prepared to make a declaration concerning section 9(4) of the Health Research Ethics Authority Act. By doingso, proponents of medical research involving human subjects will have some certainty with respect to how they can expect theirproposals to be dealt with by the Health Research Ethics Board, and judicial resources will be saved in the future because the groundrules will be clear for all involved.

Inasmuch as this Court is the final appellate body in accordance with the legislation, I do not feel that I am usurping the Health ResearchEthics Board’s authority to interpret its own legislation. If the matter were to be appealed here in the ordinary course, this Court wouldhave to interpret the legislation, review the record and finally determine whether or not the ethical concerns generated by the proposalwere being appropriately met. Appearances: J. Alexander Templeton Appearing on behalf of the Applicants Jonathan D.

Dale Appearing on behalf of the Respondents Authorities Cited: CASES CONSIDERED: Sequence Bioinformatics Inc. v. Health Research Ethics Authority for Newfoundland and Labrador, 2018NLSC 129; Ewart v. Canada, 2018 SCC 30; Harelkin v. University of Regina, (SCC), [1979] 2 S.C.R. 561; Friesen v.Hammell, 1999 BCCA 23; LIUNA, Local 1208 v. Transport and Allied Workers (TC, Local 855), 2014 NLCA 45; British ColumbiaTelephone Co. v. T.W.U. of B.C. (1985), (BC CA), 65 B.C.L.R. 145, 20 D.L.R. (4th) 719 (C.A.); British ColumbiaTelephone Co. v. T.W.U. of B.C., (SCC), [1988] 2 S.C.R. 564; Quigley v.

Torbay (Town), 2010 NLCA 3; Dunsmuir v.New Brunswick, 2008 SCC 9; Canada (Human Rights Commission) v. Canada (Attorney General), 2018 SCC 31 STATUTES CONSIDERED: Health Research Ethics Authority Act, S.N.L. 2006, c. H-1.2 REASONS FOR JUDGMENT Khaladkar, J.: INTRODUCTION [1] In an earlier decision reported as Sequence Bioinformatics Inc. v. Health Research Ethics Authority for Newfoundland andLabrador, 2018 NLSC 129, I ruled that the Applicants had standing to prosecute an Application for a declaration concerning thestatutory

interpretation of section 9(4) of the Health Research Ethics Authority Act, S.N.L. 2006, c. H-1.2 (the “Act”). [2] There are two issues that I must consider: 1. Will I exercise my discretion to grant a declaration in this matter?

2. What is the proper

interpretation to be accorded to section 9(4) of the Act ? IS DECLARATORY RELIEF WARRANTED? [ 3 ] The Health Research Ethics Board (the “Board”) has already taken a position with respect to the

interpretation of section 9(4) of the Act , which states: The research ethics board or a research ethics body approved by the authority under

section 8 shall consider the application referred to it under subsection (3) within 30 days of receiving it and may (

a) approve the application; (

b) approve the application subject to the changes the board or other body may require; or (

c) refuse to approve the application. [ 4 ] The Board’s

interpretation of this

section is that it is only required to consider the Application within 30 days. However, in its estimation, it is not required to approve, approve with changes, or refuse within 30 days. [ 5 ] The Applicants, on the other hand, take the view that the legislation requires the Board to not only consider within 30 days but, as well, to adjudicate the matter within that time. THE APPLICANTS ARGUE [ 6 ] The Applicants say, and I agree, that there is no way for them to counter the Board’s

interpretation of the

section without resort to the Courts. It is important to the Applicants to have this matter settled because they already have two applications before the Board and are planning to bring forward two more. THE RESPONDENTS ARGUE [ 7 ] The Respondents say that, at times, the Board has as many as seven or eight proposals to consider in one meeting. The Applicant’s Application in this matter was 950 pages in length. If a significant number of the applications are as lengthy, the Board says it would not be able to consider and give decisions within 30 days. ANALYSIS [ 8 ] The Act is clear, in

section 15, that appeals lie from a decision of the Board. The decision that is so impugned can only be a decision made pursuant to section 9(4) – which is a decision in relation to the substantive elements of the application put forward by a research proponent. [ 9 ] The term “research” is not defined in the Act , but

section 2 (

d) defines “health research involving human subjects” as being activities whose primary goal is to generate knowledge in relation to human health, health care systems and that involve human beings as research subjects, or that pertain to health care information respecting human beings or relate to human biological material. “Research” would, therefore, be circumscribed by these parameters. [ 10 ] Under section 9(1) of the Act , applicants are not allowed to engage in health research involving human subjects without first obtaining approval for the research from the Board or an ethics body approved under the Act . [ 11 ] Under section 9(2) of the Act , researchers are required to submit an application. [ 12 ] Under section 9(3) of the Act , the Health Research Ethics Authority for Newfoundland and Labrador (the “Authority”) is required to submit an application under section 9(2) to the Board or approved ethics body within two business days. [ 13 ] Under section 9(4) of the Act , the Board or approved ethics body is required to consider the application referred to it by the Act within 30 days of receiving it. [ 14 ] Subsections (

a) to (

c) of section 9(4) of the Act gives the Board or approved ethics body the range of dispositions that are possible subsequent to the consideration of the application – approval, approval subject to changes, or rejection. [ 15 ] It follows, therefore, that the application will always be one dealing with the manner in which ethical considerations concerning human subjects are to be handled. No application can be brought forward concerning the timeliness of the Board’s decision. Under the statute, therefore, there is no way of challenging the Board’s

interpretation of the contents of section 9(4) of the Act . [ 16 ] While some applications might be undertaken for academic, esoteric purposes, many will be undertaken for commercial reasons. In those cases, time will be of the essence – not only because of the costs associated with the prosecution of these applications, but also because the proponent will want to maintain a competitive advantage over others in the field.

[ 17 ] The Honourable Tom Osbourne, Minister of Health, on November 20, 2006, when this legislation was being debated by the House of Assembly, made reference to the increasing commercialization of health research and, particularly, genetic research as giving the impetus to put this legislation in place. He made specific reference to the Skanes [1] report that had recommended the legislation [2] . [ 18 ] Dr.

Verna Skanes, in her report and recommendations dated February, 2000, indicated that the Authority set up by the legislation she was recommending “must have sufficient resources to provide prompt review ”, and that “it have adequate resources to function efficiently”. [Emphasis added] [ 19 ] In January, 2003 the Honourable Minister’s department funded and received a further report from Dr.

Daryl Pullman [3] , an associate professor in the field of medical ethics with Memorial University, who wrote as follows: The central challenge in this regard is to present a model for regulating commercially sponsored genetic research that ensures that both the health and economic burdens and benefits that accrue as a result of this work are fairly distributed among all relevant stakeholders. An acceptable model for regulating commercial human genetic research must pass the test of ethical, legal, and socio-political acceptability without sacrificing the commercial viability of the research. [ 20 ] Dr.

Pullman further stated: It is important to recognize that commercial research enterprises need to conduct their activities under stable conditions. So far as the regulatory environment is concerned, commercial sponsors need to know at the outset what the costs of doing business in Newfoundland and Labrador will be . Furthermore, they have a right to expect that the rules that govern their research and business activities will not be subject to continual and arbitrary change.

Hence it is important that the model adopted provide such stability. [Emphasis added] [ 21 ] It is with this backdrop that the legislation was passed into law in 2006.

Taking into account the Hansard transcription of the Minister’s comments and the reports on which those comments were based, it is abundantly clear that the House of Assembly intended to put in place a streamlined regime that would be sensitive to the needs of entrepreneurs in the field of human health research. [ 22 ] Prior to this legislation, the only constraints on the ethical aspects of human research were what existed through the policies of institutions such as the Memorial University of Newfoundland and Labrador and the various Health Authorities. [ 23 ] But for the legitimate commercial interests of application proponents, there would have been no need to put time limits on when the Authority would have to forward applications, or when the Board would have to consider them.

If there was no urgency, the legislation could have simply remained silent on the timing. It did not remain silent. I will deal with this in my discussion of legislative intent. [ 24 ] There is no privative clause in the legislation that would prevent this Court from granting an application for a declaration. The Court has the inherent right to do so provided that the judge hearing the matter chooses to exercise her/his discretion in that regard. [ 25 ] The dispute concerning the time within which the Board must render a decision is not illusory, it is real.

It has come up in the context of this Applicant’s Application and, undoubtedly, will come up again in the future unless there is some direction by which all interested parties are bound. Providing certainty would be in keeping with Dr. Pullman’s call for stability and Dr. Skanes’ recommendation for prompt reviews. [ 26 ] Both parties to this Application have an interest in the resolution of the issue – albeit their

interpretation of statutory provision is materially different. [ 27 ] The Supreme Court of Canada, in Ewart v. Canada , 2018 SCC 30 stated that declarations should, normally, be declined at paragraph 83: 83. … where there exists an adequate alternative statutory mechanism to resolve the dispute or to protect the rights in question… [ 28 ] The legislation provides no means for the Applicants to have the issue of the timelines appropriate for the review of their Application resolved. They could satisfy themselves with the Respondent’s

interpretation, but that would not resolve the disagreement. [ 29 ] A declaration would settle the difference of opinion between the parties and, additionally, would provide guidance to all other proponents of projects involving health research with human subjects. To that extent, it is desirable that the Court undertake the requested analysis of section 9(4) of the Act and make a declaration as to its scope and application. [ 30 ] The declaration will affect only those who seek to obtain a ruling concerning the ethical propriety of the project upon which they wish to embark.

Additionally, it will affect the Board since the Board will be bound by the Court’s declaration. The declaration does not have any wider ambit than that. [ 31 ] The statutory scheme contained in the Act does not provide a procedure for the resolution of this particular dispute. While, at the appellate levels, the Appeal Board and this Court are authorized to conduct appeals, such appeals are limited to the subject matter of the application. It seems to me that an appellant would be hard pressed to argue that it is appealing from the Board’s

interpretation of the process (concerning timelines for decision) that it ought to follow. [ 32 ] The declaration sought from the Court is limited to the matter in dispute between the parties – whether a decision must be rendered within 30 days or whether the matter only need be considered within 30 days – with a decision to follow at some future, indeterminate, time. That is the lis between the parties. To that extent the Court’s declaration would not be tantamount to the offering of advisory or legal opinions.

It would, rather, be a ruling to settle the matter in controversy. [ 33 ] It is the Court’s function, in construing legislative enactments, to give effect to the entire purpose and scheme of the Act – not

simply to mechanically define words in an exercise that is blind to the context of the passage of the legislation. [ 34 ] Here we have a piece of legislation that was trail-breaking in the Country. Newfoundland and Labrador was the first Canadian province to legislate in an area that cried for legislative intervention. And, before so doing, the Province considered its options for at least six years and sought the counsel of experts in the field.

The legislation strives to strike a balance between the rights of individuals and the ability of researchers – both for profit and not for profit – to embark on studies that involve human subjects. [ 35 ] The goal of the legislation is varied: 1. It seeks to regulate research activities so that they are carried out in an ethical manner; 2. It seeks to strike a balance between the rights of individuals who might become test subjects and the ability of researchers to involve those individuals in their research; 3.

It incorporates, by reference, the policy statement of the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada and the Social Sciences and Humanities Research Council of Canada concerning ethical conduct for research involving humans (called the Tri-Council Policy Statement); 4.

It recognizes that significant commercial interests can be involved in conducting health research with human subjects, and that industry needs stability and a handle on the costs that will be involved in conducting research in Newfoundland and Labrador. [ 36 ] The parties have provided the Court with sufficient facts to enable it to have the factual foundation necessary to make a declaration.

The declaration requested is quite narrow – it only involves the determination whether the permissive “may” in section 9(4) of the Act is logically connected to the imperative “shall” in the same section, or whether it operates independently as a mere statement of the various options available to the Board. In other words, does the

section say that the Board has 30 days to consider a proposal including its eventual decision, or does the

section say that the Board has 30 days within which to look at a proposal, but then may take whatever time it requires to make its eventual decision? [ 37 ] There is no compelling reason why the Court should defer to the Board in making this determination. It has nothing to do with testing human subjects or the intricacies involved in determining whether such testing satisfies ethical considerations.

I might add that, even if it did, this Court is the final arbiter of any dispute in accordance with the legislation. [ 38 ] The Respondents argue that the Applicants must avail themselves of alternate remedies before asking the Court to exercise its discretion to grant a declaratory remedy. The legislation does not countenance appeals that are based upon some deficit in process. As I explained earlier in this decision, only appeals on the substantive merits of the application are capable of being taken to the next level. [ 39 ]

Section 14 of the Act is clear: An appeal lies from a decision of the research ethics board or a research ethics body approved by the authority under

section 8 or from a decision on reconsideration by it to an appeal board. [ 40 ] Whether or not the Board renders its decision within 30 days is not subject to appeal since the timeliness of the decision- making cannot really be considered a “decision of the research ethics board…”. Decisions in this sense are the response to the substantive content of the application that is submitted and do not have anything to do with the timeliness of the consideration that is required. [ 41 ] In Ewert v.

Canada , at paragraph 81 , the Court said: A court may, in its discretion, grant a declaration where it has jurisdiction to hear the issue, where the dispute before the court is real and not theoretical, where the party raising the issue has a genuine interest in its resolution, and where the respondent has an interest in opposing the declaration sought: … [ 42 ] These criteria are met here. The appeal process outlined in the Act is not appropriate for solving this issue. What is the proper

interpretation to be accorded to section 9(4) of the Act ? [ 43 ] The intention of the House of Assembly in passing this Act can be gleaned from the words of the Minister and the writings of those subject matter experts whose opinions were sought when considering the legislation. [ 44 ] The time periods imposed on the Authority and the Board can only be meant to be present in order to convey the sense of urgency with which applications need to be dispatched. Otherwise, there is no reason to impose a time restriction on the number of days allowed to refer an application to the Board.

There is no reason to legislate that the Board must consider the application within a certain number of days, namely 30, if it is not also the intention of the House of Assembly that the application be finally dealt with in that period of time. [ 45 ] I agree with the submissions of counsel for the Applicants that the House of Assembly intended that within 30 days of receipt of an application, the Board must approve the application, reject the application or approve the application subject to conditions.

[46] If the number of applications received by the Board makes it difficult for the Board to assess them within the required timelimits, then some, or all, of the following needs to happen: 1. Additional resources need to be made available to the Board so that there are an appropriate number of skilled staff membersavailable to review the applications and provide the decision-makers on the Board a list of issues that must be dealt with. It makes littlesense to have Board members individually reading 950-page applications when much of the background work can be done on theirbehalf. 2.

If additional resources are not going to be made available, then the House of Assembly needs to amend the legislation so that moretime is made available to the Board to do its job. However, the danger in adopting this route will be the possibility that researchproponents will be thwarted and, potentially, lose their competitive advantage.

Fewer studies translates into fewer potential benefitsdown the road for the citizens of this Province – since health research involving human subjects should have, as one of its main aims, theamelioration of health conditions for the population being studied. [47] In this case, Board approval was requested on August 23, 2017. On September 28, 2017 the Applicants were advised that as aresult of a conflict that had arisen on the Board, additional expertise would be required to assess the Application. The review waspostponed to October 19, 2017.

The 30-day limit for consideration was already breached. [48] On October 19, 2017 the Board met. On November 3, 2017 the Applicants were given a list of 37 questions to answer. Theanswers were provided before November 8, 2017. [49] On November 21, 2017 the Applicants were advised that their Application had not been reviewed in full and the review wouldbe continued at a future, unspecified date. [50] On November 30, 2017 the Board requested the assistance of an ad hoc advisor. [51] On December 8, 2017 the Applicants were asked to respond to the ad hoc advisor’s comments.

The response was necessary byDecember 12, 2017 to put it before the December 14, 2017 meeting of the Board. The Applicants were unable to respond before January3, 2018. [52] The Applicants were advised that the Board continued their review of the Application on January 11, 2018 and January 25,2018, but did not finish and would continue on February 8, 2018.

The Board refused the Applicants’ request for feedback. [53] On February 16, 2018 the Board’s Ethics Director informed the Applicants that the review was complete but they could not beinformed of the decision until the Board’s minutes were finalized. [54] On February 28, 2018 the Applicants were informed that the letter was taking longer than anticipated and no timeline could begiven as to when they might see a response. [55] On March 13, 2018 the Applicants started this proceeding.

On March 14, 2018 the Board informed the Applicants that theirApplication had been rejected. [56] This chronology illustrates the problem. There appears to be insufficient staff hired to perform a detailed analysis of theApplication for the Board’s consideration. Surely 10 volunteer Board members ought not to have the burden of reviewing in detail eachand every proposal placed on their shoulders? To my mind the Board should be conducting a high level review to ensure that theproposed research meets acceptable ethical guidelines.

The Board should not be involving itself in the nitty gritty of reading hundreds ofpages and performing its own detailed analysis. [57] The problem is compounded if multiple applications are being considered in the same Board meeting. [58] I have already alluded to the fact that only substantive decisions of the Board are capable of being appealed. The Applicants inthis case would not have been able to assert a delay in coming to a conclusion as a ground of appeal at any level authorized by the Act. [59] The Respondents cited Harelkin v.

University of Regina, (SCC), [1979] 2 S.C.R. 561 in support of theproposition that the Applicants should have exhausted their rights to appeal before requesting declaratory relief from the Court. However, that case is distinguishable in that Mr. Harelkin had statutory rights to appeal to the University’s Senate Committee after theUniversity had refused to give him a hearing. Here, there was no ability to appeal the question that is in controversy. [60] The Respondents cited Friesen v. Hammell, 1999 BCCA 23.

However, that case can also be distinguished on the basis that theimpugned legislation was a code and circumscribed the role of the Courts in granting declaratory relief. The Act is not a code andcontains no circumscription of the authority of the Courts to grant a prerogative remedy. [61] The Respondents cited LIUNA, Local 1208 v. Transport and Allied Workers (TC, Local 855), 2014 NLCA 45 for theproposition that where alternate remedies exist, a proper basis for judicial review is not established.

I find that the case is distinguishablesince, here, there is no alternate remedy to determine the correctness of the Board’s

interpretation of section 9(4) of the Act. [62] In the LIUNA case, Harrington, J.A. of the Newfoundland and Labrador Court of Appeal, quoted with approval the followingpassage from Justice Lambert’s dissent in the decision of the British Columbia Court of Appeal in British Columbia Telephone Co. v.T.W.U. of B.C. (1985), (BC CA), 65 B.C.L.R. 145, 20 D.L.R. (4th) 719 (C.A.): … A statutory tribunal should follow its own previous decisions and, for that reason, ought to be required to be right in its

interpretationof general public enactments and general legal principles, and ought to arrive at its decisions, even on matters particularly within its

special expertise and function, on the basis of a demonstrably rational process. … [63] The Supreme Court of Canada adopted Justice Lambert’s dissent in British Columbia Telephone Co. v. T.W.U. of B.C., (SCC), [1988] 2 S.C.R. 564. [64] Our Court of Appeal, in Quigley v. Torbay (Town), 2010 NLCA 3 stated, at paragraph 15, that: … The burden is upon the person who seeks one of the prerogative remedies – discretionary remedies of last resort – to satisfy the courtthat there is no adequate alternative remedy. … [65] In Dunsmuir v.

New Brunswick, 2008 SCC 9, the Supreme Court of Canada stated that when an administrative body interpretsits home statute, the reasonableness standard applies. [66] In Canada (Human Rights Commission) v. Canada (Attorney General), 2018 SCC 31 the Supreme Court of Canada said, atparagraph 40: … In matters of statutory

interpretation where there is only one reasonable answer, this Court has shown that the reasonableness standardstill allows the reviewing court to properly deal with the principles of the rule of law and legislative supremacy that remain at the core ofthe judicial review analysis … [67] When one considers the legislative history of the legislation, its aims and objectives, and the fact that the House of Assemblysaw fit to give the Authority only two days to transmit an application to the Board, and the Board only 30 days to consider theapplication, I cannot glean any reasonable

interpretation from section 9(4) other than that proposed by the Applicants: that the onlyreasonable

interpretation of the

section is that the Board must consider the application and give one of the three possible outcomesauthorized by the Act within that time. [68] Had the House of Assembly intended that the Board would have an unlimited amount of time to consider and render itsdecisions, it could have easily refrained from putting any time limits in the section. I cannot render nonsensical the clear wording of thestatute. [69] The Application is granted.

There shall be a declaration that the Board shall consider applications under the Act and render itsdecisions within 30 days of receipt of the application. [70] I thank counsel for their able submissions. [71] Each party shall bear its own costs of the Application. _________________________ VIKAS KHALADKAR Justice [3] Dr. Daryl Pullman, “Policy Implications of Commercial Human Genetic Research in Newfoundland and Labrador”, a reportprepared for the Newfoundland and Labrador Department of Health and Community Services (January, 2003)