HESA Committee Meeting

The Standing Committee on Health met at 8:45 a.m. this day, in Room 306, La Promenade Building, the Chair, Ben Lobb, presiding.

Jim Keon, by videoconference, from Brussels, Belgium, Walter Robinson and Nancy Abbey made statements and, with Jody Cox, by videoconference, from Brussels, Belgium, and Keith McIntosh, answered questions.

At 9:45 a.m., the sitting was suspended.

At 9:48 a.m., the sitting resumed.

Linda Wilhelm, by videoconference from Moncton, New Brunswick, Jeff Morrison and Helen Long made statements and, with Barry Power and Carl Carter, answered questions.

At 10:24 a.m., pursuant to Standing Order 115(5), the sitting was suspended.

At 11:09 a.m.,, the sitting resumed.

The Committee commenced its clause-by-clause study of the Bill.

Pursuant to Standing Order 75(1), consideration of the Preamble and Clause 1, Short Title, were postponed.

The Chair called Clause 2.

On Clause 2,

““confidential business information”, in respect of a person to whose business or affairs the information relates, means — subject to the regulations — business information

(a) that is not publicly available,

(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

(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;”

Debate arose thereon.

Libby Davies moved, — That the amendment be amended by adding the words “(d): For greater clarity, “confidential business information” does not include safety and efficacy information, including Phase I to Phase III pre-market trials, all post-market safety assessments, clinical study reports, and periodic safety update reports” after the words “their competitors;”

After debate, the question was put on the subamendment of Libby Davies and it was negatived, by a show of hands: YEAS: 3; NAYS: 6.

The question was put on the amendment of Eve Adams and it was agreed to, by a show of hands: YEAS: 8; NAYS: 0.

The Chair ruled that the following amendment was consequential to the previous amendment and therefore it was also adopted:

“(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.

(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

(a) a government;

(b) a person from whom the Minister seeks advice; or

(c) a person who carries out functions relating to the protection or promotion of human health or the safety of the public.

(4) In this section, “government” means any of the following or their institutions:

(a) the federal government;

(b) a corporation named in Schedule III to the Financial Administration Act;

(c) a provincial government or a public body established under an Act of the legislature of a province;

(d) an aboriginal government as defined in subsection 13(3) of the Access to Information Act;

(e) a government of a foreign state or of a subdivision of a foreign state; or

(f) an international organization of states.”

““injury to health” includes cases in which a drug does not have its intended effect due to mislabelling or mispackaging of the product;”

Debate arose thereon.

Francis Scarpaleggia moved, — That the amendment be amended by replacing the word “drug” with the words “therapeutic product”

After debate, the question was put on the subamendment of Francis Scarpaleggia and it was negatived, by a show of hands: YEAS: 4; NAYS: 5.

The question was put on the amendment of Libby Davies and it was negatived on the following recorded division: YEAS: Libby Davies, Hedy Fry, Élaine Michaud, Dany Morin — 4; NAYS: Eve Adams, Jay Aspin, James Lunney, David Wilks, Terence Young — 5.

“(4) Definition of “prescribed health care institution” shall include hospitals, community health centres, and pharmacies.”

Debate arose thereon.

Dany Morin moved, — That the amendment be amended by adding the words “at least” after the word “shall”

After debate, the question was put on the subamendment of Dany Morin and it was negatived, by a show of hands: YEAS: 4; NAYS: 5.

The question was put on the amendment of Libby Davies and it was negatived, by a show of hands: YEAS: 3; NAYS: 6.

Clause 2, as amended, carried by a show of hands: YEAS: 9; NAYS: 0.

On Clause 3,

(a) by replacing line 27 on page 3 with the following:

“may order the holder of a therapeutic product authorization to”

(b) by replacing line 35 on page 3 with the following:

“require the holder of a therapeutic product authorization to,”

Debate arose thereon.

Dany Morin moved, — That the amendment be amended by adding the words “sellor or the” after the words “may order the” in paragraph (a) and

That the amendment be amended by adding the words “sellor or the” after the words “require the” in paragraph (b)

After debate, the question was put on the subamendment of Dany Morin and it was negatived, by a show of hands: YEAS: 3; NAYS: 5.

The question was put on the amendment of Libby Davies and it was negatived, by a show of hands: YEAS: 3; NAYS: 6.

“(a.1) quarantine the product; or”

After debate, the question was put on the amendment of Libby Davies and it was negatived, by a show of hands: YEAS: 3; NAYS: 6.

“(2.1) For greater certainty, if the Minister makes an order under paragraph (1)(a) in respect of a therapeutic product, that therapeutic product must be withdrawn from the market.”

After debate, the question was put on the amendment of Libby Davies and it was negatived, by a show of hands: YEAS: 3; NAYS: 6.

“(2) The Minister shall ensure that any order made under any of sections 21.1 to 21.3 is publicly available.”

The question was put on the amendment of Eve Adams and it was agreed to, by a show of hands: YEAS: 8; NAYS: 0.

“21.51 (1) All clinical trials and investigational tests involving human subjects must 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 must 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 must 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 must ensure that the following information is posted on the Health Canada's website :

(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;

(c) the decisions respecting the issuance or refusal of issuance of authorizations 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) must not be used to gain an unfair commercial advantage.”

After debate, the question was put on the amendment of Francis Scarpaleggia and it was negatived, by a show of hands: YEAS: 4; NAYS: 5.

“21.61 The Minister must undertake an independent review of all monographs of therapeutic products that the Minister has prepared since the coming into force of this section and must post the results of such reviews on the Department's Internet site.

After debate, the question was put on the amendment of Libby Davies and it was negatived, by a show of hands: YEAS: 4; NAYS: 5.

“21.71 The holder of a therapeutic product authorization referred to in paragraph 30(1.2)(c) shall ensure that prescribed information concerning the clinical trial or investigational test is made public within the prescribed time and in the prescribed manner.”

Libby Davies moved, — That the amendment be amended by replacing the words “prescribed information concerning the elinical trial or investigational test is” with the words “the registration and results, whether positive or negative, from all clinical trials and other investigative tests be”

After debate, the question was put on the subamendment of Libby Davies and it was negatived, by a show of hands: YEAS: 4; NAYS: 5.

The question was put on the amendment of Eve Adams and it was agreed to, by a show of hands: YEAS: 8; NAYS: 0.

The Chair ruled that the following amendment was consequential to the previous amendment and therefore it was also adopted:

“following after section 21.71:”

“(2) It is a condition of every authorization that the Minister be provided with all the results of clinical trials and investigational tests involving human subjects within the specified period.”

After debate, the question was put on the amendment of Libby Davies and it was negatived, by a show of hands: YEAS: 4; NAYS: 5.

Clause 3, as amended, carried by a show of hands: YEAS: 8; NAYS: 0.

At 12:18 p.m., the sitting was suspended.

At 1:02 p.m., the sitting resumed.

On motion of David Wilks, it was agreed, — That the Committee extend its current meeting, suspending at 1:45 p.m. and resuming at 3: 30 p.m., for the purpose of clause-by-clause consideration of Bill C-17; and that the Committee continue sitting until clause-by-clause consideration of Bill C-17 is complete, or 11:59 p.m. whichever comes first.

On Clause 4,

“(2) The Minister shall ensure that any order made under any of sections 21.1 to 21.32 is publicly available.”

The question was put on the amendment of David Wilks and it was agreed to, by a show of hands: YEAS: 8; NAYS: 0.

Clause 4, as amended, carried by a show of hands: YEAS: 9; NAYS: 0.

Clause 5, as amended, carried by a show of hands: YEAS: 5; NAYS: 0.

On new Clause 5.1,

“5.1 The Act is amended by adding the following after section 29.2:

NO LIABILITY

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 was put on the amendment of Libby Davies and it was negatived on the following recorded division: YEAS: Libby Davies, Élaine Michaud, Dany Morin, Francis Scarpaleggia — 4; NAYS: Jay Aspin, James Lunney, Rick Norlock, David Wilks, Terence Young — 5.

On Clause 6,

“manufacture, reprocessing, preparation, preservation”

After debate, the question was put on the amendment of Francis Scarpaleggia and it was negatived, by a show of hands: YEAS: 4; NAYS: 5.

“(a.1) respecting the refusal of issuance of an authorization if the person did not register the clinical trials and investigational tests involving human subjects under paragraph (c.1);”

After debate, the question was put on the amendment of Libby Davies and it was negatived, by a show of hands: YEAS: 4; NAYS: 5.

“(b.1) requiring the Minister to ensure that decisions with regard to the issuance, amendment, suspension and revocation of authorizations referred to in paragraph (a), and to the imposition and amendment of terms and conditions referred to in paragraph (b), along with the reasons for those decisions, are publicly available;”

Debate arose thereon.

Libby Davies moved, — That the amendment be amended by adding the words “(b.2) The Minister must ensure the status of post-market studies are disclosed to the public on an annual basis” after the words “publicly available;”

After debate, the question was put on the subamendment of Libby Davies and it was negatived, by a show of hands: YEAS: 4; NAYS: 5.

The question was put on the amendment of David Wilks and it was agreed to, by a show of hands: YEAS: 9; NAYS: 0.

“(c.1) defining “clinical trial” and “investigational test” for the purposes of this Act;”

The question was put on the amendment of David Wilks and it was agreed to, by a show of hands: YEAS: 8; NAYS: 0.

“(c.1) respecting the registration of clinical trials and investigational tests involving human subjects and specifying the period within which the results of those clinical trials and investigational tests must be provided to the Minister;”

After debate, the question was put on the amendment of Libby Davies and it was negatived, by a show of hands: YEAS: 3; NAYS: 5.

“(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.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),

(i) is not confidential business information, or

(ii) has ceased to be confidential business information;”

The question was put on the amendment of David Wilks and it was agreed to, by a show of hands: YEAS: 9; NAYS: 0.

“(d.1) respecting the information that the Minister must make available to the public, including

(i) all clinical trials and investigational tests involving human subjects registered under paragraph (c.1),

(ii) results of clinical trials and investigational tests involving human subjects,

(iii) information received about any serious adverse drug reaction that involved a therapeutic product,

(iv) decisions respecting the issuance or refusal of issuance of authorizations and the reasons for them,

(v) terms and conditions imposed on an authorization and any amendment to them,

(vi) decisions respecting the suspensions and revocations of authorizations and the reasons for them, and

(vii) recalls of a therapeutic product and the reasons for them;”

After debate, the question was put on the amendment of Libby Davies and it was negatived, by a show of hands: YEAS: 4; NAYS: 5.

“(e.1) respecting the establishment of best practices, the promotion of standards of practice and the communication of information relating to the risk, safety and effectiveness of therapeutic products;”

After debate, the question was put on the amendment of Libby Davies and it was negatived, by a show of hands: YEAS: 3; NAYS: 5.

“(f.1) respecting the procedures for disclosing gifts or other advantages offered to or accepted from the holder of a therapeutic product authorization or the manufacturer of a drug or device, for limiting the value of such gifts or other advantages and for addressing any conflicts of interest involving the holders of a therapeutic product authorization or the manufacturers of a drug or device.”

After debate, the question was put on the amendment of Libby Davies and it was negatived, by a show of hands: YEAS: 3; NAYS: 5.

At 1:37 p.m., the sitting was suspended.

At 3:30 p.m., the sitting resumed in Room 253-D, Centre Block.

(a) adding after line 11 on page 7 the following:

“(g) prescribing anything that is to be prescribed under section 21.71”

(b) replacing line 14 on page 7 with the following:

“of paragraph (f) and by adding the following”

(c) replacing line 16 on page 7 with the following:

“(f.1) respecting assessments referred to in ”

(d) replacing lines 18 and 19 on page 7 with the following:

“of the assessments to the Minister;

(f.2) requiring the Minister to ensure that decisions with regard to the making of orders under section 21.31, along with the reasons for those decisions, are publicly available;

(f.3) respecting the compilation of informa-”

(e) replacing line 24 on page 7 with the following:

“referred to in paragraph 21.32(b); and ”

(f) replacing lines 27 to 29 on page 7 with the following:

“of paragraph (f) and by adding the following after paragraph (g):

(h) defining “serious adverse drug reaction””

(g) replacing line 32 on page 7 with the following:

“(i) respecting the provision by health care”

(h) replacing line 36 on page 7 with the following:

“(j) prescribing anything that is to be pre-”

(i) replacing line 42 on page 7 with the following:

“paragraph (1.2)(i) or (j), the Minister shall take”

The question was put on the amendment of David Wilks and it was agreed to, by a show of hands: YEAS: 4; NAYS: 3.

“(1.4) Results of clinical trials and investigational tests involving human subjects are not business proprietary information for the purposes of this Act.”

After debate, the question was put on the amendment of Libby Davies and it was negatived, by a show of hands: YEAS: 2; NAYS: 5.

After debate, the question was put on the amendment of Libby Davies and it was negatived, by a show of hands: YEAS: 3; NAYS: 6.

Clause 6, as amended, carried by a show of hands: YEAS: 9; NAYS: 0.

By unanimous consent, Clauses 7 to 13 inclusive carried severally.

On new Clause 13.1,

“INDEPENDENT REVIEW

13.1 (1) Within two years after this section comes into force, the Minister shall cause an independent review of the provisions and operation of this Act to be undertaken.

(2) The Minister shall cause a report on the review to be laid before each House of Parliament within one year after the review is completed.”

After debate, the question was put on the amendment of Libby Davies and it was negatived, by a show of hands: YEAS: 3; NAYS: 5.

On Clause 14,

“before subsection 6(3), then the English version of subsection 6(3) is amended by replacing “paragraph (f)” with “paragraph (f.3)”.

(2) If subsection 6(3) comes into force before subsection 6(2), then the English version of subsection 6(2) is amended by

(a) striking out “striking out “and” at the end of paragraph (f) and by”; and

(b) striking out “and” at the end of the paragraph (f.3) of the Food and Drugs Act that it enacts.”

The question was put on the amendment of David Wilks and it was agreed to, by a show of hands: YEAS: 9; NAYS: 0.

Clause 14, as amended, carried by a show of hands: YEAS: 9; NAYS: 0.

Clause 15 carried by a show of hands: YEAS: 9; NAYS: 0.

Clause 1, Short Title, carried by a show of hands: YEAS: 8; NAYS: 0.

The Preamble carried by a show of hands: YEAS: 7; NAYS: 0.

The Title carried by a show of hands: YEAS: 9; NAYS: 0.

The Bill, as amended, carried by a show of hands: YEAS: 9; NAYS: 0.

ORDERED, — That the Chair report the Bill, as amended, to the House.

ORDERED, — That Bill C-17, as amended, be reprinted for the use of the House at report stage.

At 3:48 p.m., the sitting was suspended.

At 3:50 p.m., the sitting resumed in camera.

It was agreed, — That the Standing Committee on Health be granted an operational budget of $16,200 for its study of Bill C-17, An Act to amend the Food and Drugs Act.

It was agreed, — That the Standing Committee on Health be granted an operational budget of $6,600 for its study of C-442, An Act respecting a National Lyme Disease Strategy.

At 3:51 p.m., the Committee adjourned to the call of the Chair.