Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology

Issue 5 - Ninth Report of the Committee

Monday, June 22, 2009

The Standing Senate Committee on Social Affairs, Science and Technology has the honour to present its

NINTH REPORT

Your committee, which was referred Bill C-11, An Act to promote safety and security with respect to human pathogens and toxins has, in obedience to the order of reference of Tuesday, June 2, 2009, examined the said Bill and now reports the same without amendment but with observations, which are appended to this report.

Respectfully submitted,

ART EGGLETON

Chair

OBSERVATIONS OF THE STANDING SENATE COMMITTEE ON SOCIAL AFFAIRS, SCIENCE AND TECHNOLOGY WITH RESPECT TO BILL C-11,
AN ACT TO PROMOTE SAFETY AND SECURITY WITH RESPECT TO HUMAN PATHOGENS AND TOXINS

INTRODUCTION

The Standing Senate Committee on Social Affairs, Science and Technology heard evidence relating to Bill C-11 on the 4th, 10th and 17th of June 2009. The Committee heard from witnesses representing both the scientific and the legal community, some of whom expressed support for the bill and some of whom highlighted concerns with the bill in its current form. While the Committee is both sensitive to and supportive of many of the concerns that were raised, the Committee is at the same time cognizant that amending the bill at this time may lead to unnecessary delay in its implementation. The Committee agrees with the Public Health Agency of Canada [PHAC] that there is an urgent need to have legislation respecting human pathogens and toxins in place, and believes that delaying the bill would be contrary to the public interest.

That being said, the Committee wishes to highlight a number of issues that were raised by witnesses, and emphasizes the need for PHAC to consider these concerns as it turns its attention to developing the regulations that are required to support the bill's implementation.

ISSUE 1: CONSULTATION

A number of witnesses expressed the concern that consultations on Bill C-11 were inadequate. In some cases, consultations were described as ``information sessions,'' and those who attended did not feel that they were provided with an opportunity to participate in a meaningful way. From PHAC's perspective, efforts were made to reach out to the scientific research community to seek its input.

The issue of adequate consultation is directly linked to the concerns raised that, since the details relating to licensing and other aspects of the bill will be addressed through regulations, they will be subject to less public scrutiny. It is feared that stakeholders may be afforded even less of an opportunity to express any apprehensions they might have with respect to the regulations.

The Minister of Health has assured the Committee that PHAC is ``committed to engaging provinces and territories and a broad range of stakeholders in the development of the regulations.'' The Committee wishes to emphasize that, while the engagement with provinces, territories and stakeholders should be done as expeditiously as possible, thorough and open discussions should not be sacrificed as a result of trying to conduct consultations in a compressed timeframe.

One witness suggested that the role of the advisory committee (referred to in clauses 9(4) and 10(3) of the bill) be expanded to include advising the Minister on issues relating to the implementation of the bill. The members of the advisory committee would presumably be in ongoing contact with the university and other scientific research communities, and could serve as another means of providing community feedback to the Minister.

RECOMMENDATION 1

That the Public Health Agency of Canada ensure that the provinces, territories and stakeholders are given the opportunity to participate in the development of Bill C-11 regulations in a meaningful way. Consultations should be carried out as expeditiously as possible, but not at the expense of a thorough and open discussion.

RECOMMENDATION 2

That the role of the advisory committee referred to in clauses 9(4) and 10(3) be expanded to include advising the Minister with respect to the general implementation of the bill.

ISSUE 2: RISK GROUP 2 PATHOGENS

A number of witnesses, particularly witnesses from the scientific research community, sought the removal of Risk Group 2 pathogens from the scope of Bill C-11. PHAC stressed the need to include some oversight of laboratories that handle Risk Group 2 pathogens, as they do pose some risk. PHAC also noted that it has always been the intent that Risk Group 2 pathogens will be treated less stringently than Risk Group 3 or 4 pathogens.

ISSUE 3: THE USE OF THE CRIMINAL LAW POWER

Many witnesses raised concerns with respect to the use of the criminal law power as a means to ensure compliance with Bill C-11. In particular, it was feared that the use of the criminal law power may discourage research and innovation. It was also suggested that resorting to the criminal law power to, in effect, regulate the use of human pathogens and toxins was not an appropriate use of the criminal law power, and that as a result, Bill C-11 encroached on provincial jurisdiction.

PHAC stressed that Bill C-11 meets the requirements established by the Supreme Court of Canada with respect to the use of the federal criminal law power: namely, it contains a prohibition accompanied by a sanction, and the prohibition is based on a legitimate public purpose. PHAC also emphasized that the offences and punishment provisions of Bill C-11 would only be used as a last resort.

ISSUE 4: THE POTENTIAL ADMINISTRATIVE BURDEN

Witnesses were concerned that Bill C-11 regulations would impose an administrative burden on laboratories. PHAC stressed that the intention of Bill C-11 was not to increase the regulatory burden, and suggested that laboratories that already complied with the Laboratory Biosafety Guidelines would be minimally affected by the bill. PHAC also emphasized that part of the consultations on the regulatory process would focus on how to ensure that that the licensing process was as simple and straightforward as possible.

ISSUE 5: POWERS OF INSPECTORS

Some witnesses were concerned that inspectors under the bill had overly-broad powers. PHAC confirmed that the inspection provisions were subject to extensive Charter scrutiny by the Department of Justice, and that the provisions were found to be Charter compliant.

The qualifications and training of inspectors were also flagged as potential areas of concern. PHAC noted that inspectors that verify compliance with the Human Pathogens Importation Regulations are well-qualified, and that inspectors verifying compliance with Bill C-11 will be expected to be equally qualified.

RECOMMENDATION 3

That PHAC expand the role of the advisory committee referred to in clauses 9(4) and 10(3) of Bill C-11 to include providing the Minister with advice in relation to the qualification and training of inspectors.

ISSUE 6: THE DISCLOSURE OF PERSONAL
INFORMATION AND CONFIDENTIAL BUSINESS
INFORMATION

A number of witnesses were concerned that the provisions relating to the Minister's authority to disclose personal information and confidential business information did not provide adequate protection for privacy interests.

The Privacy Commissioner, however, emphasized that after a careful examination of the bill, it, for the most part, ensures that all potential instances of disclosure are compatible with privacy rights, with one exception. This relates to the absence of a written confidentiality agreement that would protect information disclosed under clause 39(1)(b). While clause 39(2) provides that before disclosing personal information and confidential business information, a written confidentiality agreement must be in place, there is an exception for information that is disclosed out of necessity to address a serious and imminent danger to the health or safety of the public. The Privacy Commissioner proposed that the bill be amended to provide that, in the case of information disclosed under clause 39(1)(b), a confidentiality agreement be entered into after that information has been disclosed. The Privacy Commissioner agreed that this could also be addressed in the regulations.

RECOMMENDATION 4

That PHAC ensure that the need to enter into a written confidentiality agreement after information has been disclosed under clause 39(1)(b) is addressed in regulations.