Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 21 - Minutes of Proceedings - October 9, 2014
OTTAWA, Thursday, October 9, 2014
(47)
[English]
The Standing Senate Committee on Social Affairs, Science and Technology met this day at 10:29 a.m., in room 2, Victoria Building, the chair, Honourable Kelvin Kenneth Ogilvie, presiding.
Members of the committee present: The Honourable Senators Chaput, Cordy, Eggleton, P.C., Nancy Ruth, Ngo, Ogilvie, Oh, Seidman, Seth, Smith, P.C. (Cobourg), Stewart Olsen and Wells (12).
In attendance: Sonya Norris, Analyst, Parliamentary Information and Research Service.
Also in attendance: The official reporters of the Senate.
Pursuant to the order of reference adopted by the Senate on Thursday, September 18, 2014, the committee continued its study of Bill C-17, An Act to amend the Food and Drugs Act. (For complete text of the order of reference, see proceedings of the committee, Issue No. 19.)
The chair made a statement.
It was agreed that the committee proceed to clause-by-clause consideration of Bill C-17, An Act to amend the Food and Drugs Act.
It was agreed that the title stand postponed.
It was agreed that the preamble stand postponed.
It was agreed that clause 1, which contains the short title, stand postponed.
It was agreed that clause 2 shall carry.
The chair asked whether clause 3 shall carry.
The Honourable Senator Eggleton, P.C., moved that Bill C-17 be amended in clause 3,
(a) on page 3,
(i) by replacing line 28 with the following:
''of injury to human health, the Minister shall'',
(ii) by replacing lines 30 and 31 with the following:
''information that is in the person's control if the Minister believes it is necessary to'', and
(iii) by adding after line 40 the following:
''(2.1) If the Minister believes that a therapeutic product may present a serious risk of injury to human health, the Minister shall make public any information about the product that is in the interest of public health and safety.'';
(b) on page 4,
(i) by replacing line 25 with the following:
''21.2 The Minister shall, if he or she believes'', and
(ii) by replacing line 34 with the following:
''shall order a person who sells the product to''; and
(c) on page 6, by adding after line 8 the following:
''21.51 (1) All clinical trials and investigational tests involving human subjects shall be registered with the Minister.
(2) The Minister may not issue a therapeutic product authorization unless the applicant has complied with subsection (1).
(3) The results of all clinical trials and investigational tests shall be provided to the Minister no later than one year after the completion of the trial or test.
(4) It is a condition of every authorization that the Minister be provided with the results of all clinical trials and investigational tests involving human subjects within the specified period.
(5) If no therapeutic product authorization is issued, the applicant shall still provide to the Minister the results of all clinical trials and investigational tests no later than six months after the Minister's decision not to issue the authorization.
21.52 (1) The Minister shall make the following information publicly available on the Department's Internet site:
(a) all clinical trials and investigational tests involving human subjects registered under subsection 21.51(1);
(b) the results of clinical trials and investigational tests involving human subjects referred to in paragraph (a);
(c) the decisions respecting the issuance or refusal of issuance of authorizations by the Minister and the reasons for them;
(d) the terms and conditions imposed on an authorization and any amendment to them;
(e) the decisions respecting the suspensions and revocations of authorizations and the reasons for them;
(f) the recalls of a therapeutic product and the reasons for them; and
(g) all information received about any serious adverse drug reaction that involved a therapeutic product.
(2) The information posted under subsection (1) shall not be used to gain an unfair commercial advantage.''.
After debate, the question being put on the motion, it was negatived on the following vote:
YEAS
The Honourable Senators
Chaput, Cordy, Eggleton, Smith (Cobourg) — 4
NAYS
The Honourable Senators
Nancy Ruth, Ngo, Oh, Seidman, Seth, Stewart Olsen, Wells — 7
It was agreed that clause 3 shall carry.
It was agreed that clause 4 shall carry.
The chair asked whether clause 5 shall carry.
The Honourable Senator Eggleton, P.C., moved that Bill C-17 be amended in clause 5, on page 7, by adding after line 16 the following:
''5.1 The Act is amended by adding the following after section 29.2:
Immunity
29.3 Despite any other Act of Parliament, no civil or criminal proceedings lie against the Minister or any person acting on behalf of, or under the direction of, the Minister for anything done or omitted to be done in good faith in the exercise or performance of any powers, duties or functions that under this Act are intended or authorized to be exercised or performed.''.
After debate, the question being put on the motion, it was negatived on the following vote:
YEAS
The Honourable Senators
Chaput, Cordy, Eggleton, Smith (Cobourg), Nancy Ruth — 5
NAYS
The Honourable Senators
Ngo, Oh, Seidman, Seth, Stewart Olsen, Wells — 6
It was agreed that clause 5 shall carry.
It was agreed that clause 6 shall carry.
It was agreed that clause 7 shall carry.
It was agreed that clause 8 shall carry.
It was agreed that clause 9 shall carry.
It was agreed that clause 10 shall carry.
It was agreed that clause 11 shall carry.
It was agreed that clause 12 shall carry.
It was agreed that clause 13 shall carry.
It was agreed that clause 14 shall carry.
It was agreed that clause 15 shall carry.
It was agreed that clause 1 carry.
It was agreed that the preamble, carry.
It was agreed that the title carry.
It was agreed that the bill carry.
The chair asked whether the committee wished to append observations to the report.
The Honourable Senator Eggleton, P.C., moved that following observation be appended to the report:
That the regulations for Bill C-17 be expedited and presented to the Senate Standing Committee on Social Affairs, Science and Technology for a brief review and comment before they are proclaimed and implemented.
After debate, the question being put on the motion, it was negatived on the following vote:
YEAS
The Honourable Senators
Chaput, Cordy, Eggleton, Smith (Cobourg), Nancy Ruth — 5
NAYS
The Honourable Senators
Ngo, Oh, Seidman, Seth, Stewart Olsen, Wells — 6
The Honourable Senator Eggleton, P.C. moved that following observation be appended to the report:
That in the preparation of regulations, openness and transparency of information to the public, health-care professionals and researchers be maximized for both pre- and post-approval studies and reviews. This is an issue that can be found throughout the Senate Standing Committee on Social Affairs, Science and Technology's four reports on our review of prescription pharmaceuticals in Canada, tabled between 2012 and 2014. The extent of openness and transparency should be no less than is what is publicly available from the Federal Drug Administration in the United States and the European Medical Agency in the European Union.
After debate, the question being put on the motion, it was negatived on the following vote:
YEAS
The Honourable Senators
Chaput, Cordy, Eggleton, Smith (Cobourg), Nancy Ruth — 5
NAYS
The Honourable Senators
Ngo, Oh, Seidman, Seth, Stewart Olsen, Wells — 6
The Honourable Senator Eggleton, P.C. moved that following observation be appended to the report:
That the Government of Canada ensure that the necessary funding be provided to Health Canada to fully implement Bill C-17 as soon as the regulations are proclaimed in effect. We draw attention to recommendation 4 found in the Senate Standing Committee's report Prescription Pharmaceuticals in Canada: Post-Approval Monitoring of Safety and Effectiveness. It states:
The committee therefore recommends that the Minister of Health work to achieve equal funding for both pre- and post-approval drug regulatory activities and ensure that post-approval resources are adequate for implementation of a comprehensive life-cycle approach to drug management.
After debate, the question being put on the motion, it was negatived on the following vote:
YEAS
The Honourable Senators
Chaput, Cordy, Eggleton, Smith (Cobourg), Nancy Ruth — 5
NAYS
The Honourable Senators
Ngo, Oh, Seidman, Seth, Stewart Olsen, Wells — 6
The Honourable Senator Eggleton, P.C. moved that following observation be appended to the report:
That where the Minister, pursuant to new section 21.31 and 21.32 of the Act, instructs the holder of a therapeutic product to: (1) conduct an assessment of the therapeutic product to which the authorizations relates, and provide the Minister with the results of the assessment; and (2) compile information, conduct tests or studies or monitor experience in respect of the therapeutic product; that the Drug Safety and Effectiveness Network, or an alternative arms-length entity, provide oversight to ensure the proper conduct and accuracy of results of the investigation.
After debate, the question being put on the motion, it was negatived on the following vote:
YEAS
The Honourable Senators
Chaput, Cordy, Eggleton, Nancy Ruth — 4
NAYS
The Honourable Senators
Ngo, Oh, Seidman, Seth, Stewart Olsen, Wells — 6
It was agreed that the chair report Bill C-17 to the Senate.
At 11:42 a.m., the committee adjourned to the call of the chair.
ATTEST:
Jessica Richardson
Clerk of the Committee