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MINUTES OF PROCEEDINGS
 
Meeting No. 11
 
Thursday, April 22, 2004
 

The Standing Committee on Industry, Science and Technology met at 9:04 a.m. this day, in Room 308 West Block, the Chair, Brent St. Denis, presiding.

 

Members of the Committee present: Gérard Binet, Hon. David Collenette, Paul Crête, Hon. Joe Fontana, Marlene Jennings, Hon. Gurbax Malhi, Brian Masse, Grant McNally, James Rajotte, Andy Savoy, Carol Skelton, Brent St. Denis and Hon. Lyle Vanclief.

 

Acting Members present: Gilbert Barrette for Hon. Gurbax Malhi, Murray Calder for Hon. Herb Dhaliwal, Rodger Cuzner for Hon. Herb Dhaliwal, Brian Fitzpatrick for Cheryl Gallant, Roger Gaudet for Jocelyne Girard-Bujold, Raymond Simard for Hon. David Collenette, Diane St-Jacques for Hon. David Collenette and Bryon Wilfert for Hon. David Collenette.

 

In attendance: Library of Parliament: Lalita Acharya, Analyst; Kristen Douglas, Analyst; Dan Shaw, Analyst. House of Commons: Joann Garbig, Legislative Clerk; Jean-Michel Roy, Legislative Clerk.

 

Witnesses: Department of Industry: Susan Bincoletto, Acting Director General, Marketplace Framework Policy Branch; Éric Dagenais, Acting Director, Patent Policy Directorate; Douglas Clark, Acting Senior Project Leader, Patent Policy Directorate. Department of Health: Robert Peterson, Director General, Therapeutic Products Directorate, Health Products and Food Branch; David K. Lee, Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Health Products and Food Branch. Department of Foreign Affairs: Christopher Armstrong, Senior Advisor, HIV/AIDS. Department of International Trade: Suzanne Vinet, Director General, Trade Policy, Services, Investment and Intellectual Property Bureau; John Drummond, Deputy Director, Intellectual Property, Information and Technology Trade Policy Division. Canadian International Development Agency: Sandra Black, Director, Social Development Policies, Policy Branch.

 
Pursuant to the Order of Reference of Thursday, February 12, 2004, the Committee resumed consideration of Bill C-9, An Act to amend the Patent Act and the Food and Drugs Act.
 

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

 

The witnesses answered questions.

 
On Clause 1,
 
The Committee resumed consideration of the amendment of Joe Fontana, — That Bill C-9, in Clause 1, be amended by replacing line 19 on page 4 to line 23 on page 11 with the following:

21.04 (1) Subject to subsection (3), the Commissioner shall, on the application of any person and on the payment of the prescribed fee, authorize the person to make, construct and use a patented invention solely for purposes directly related to the manufacture of the pharmaceutical product named in the application and to sell it for export to a country or WTO Member that is listed in any of Schedules 2 to 4 and that is named in the application.

(2) The application must be in the prescribed form and set out

( a ) the name of the pharmaceutical product to be manufactured and sold for export under the authorization;

( b ) prescribed information in respect of the version of the pharmaceutical product to be manufactured and sold for export under the authorization;

( c ) the maximum quantity of the pharmaceutical product to be manufactured and sold for export under the authorization;

( d ) for each patented invention to which the application relates, the name of the patentee of the invention and the number, as recorded in the Patent Office, of the patent issued in respect of that invention;

( e ) the name of the country or WTO Member to which the pharmaceutical product is to be exported;

( f ) the name of the person or entity to which the product is to be sold, and prescribed information, if any, concerning that person or entity; and

( g ) any other information that may be prescribed.

(3) The Commissioner shall authorize the use of the patented invention only if

( a ) the applicant has complied with the prescribed requirements, if any;

( b ) the Minister of Health has notified the Commissioner that the version of the pharmaceutical product that is named in the application meets the requirements of the Food and Drugs Act and its regulations, including the requirements under those regulations relating to the marking, embossing, labelling and packaging that identify that version of the product as having been manufactured

(i) in Canada as permitted by the General Council Decision, and

(ii) in a manner that distinguishes it from the version of the pharmaceutical product sold in Canada by, or with the consent of, the patentee or patentees, as the case may be;

( c ) the applicant provides the Commissioner with a solemn or statutory declaration in the prescribed form stating that the applicant had, within the prescribed time before filing the application,

(i) sought from the patentee or, if there is more than one, from each of the patentees a licence to manufacture and sell the pharmaceutical product for export to the country or WTO Member named in the application, and

(ii) provided the patentee, or each of the patentees, as the case may be, with information that is in all material respects identical to the information referred to in paragraphs (2)( a ) to ( g ); and

( d ) the applicant also provides the Commissioner with

(i) if the application relates to a WTO Member listed in Schedule 2, a certified copy of the notice in writing that the WTO Member has provided to the TRIPS Council specifying the name of the pharmaceutical product, as defined in paragraph 1( a ) of the General Council Decision, and the quantity of that product, needed by the WTO Member, and

(A) a solemn or statutory declaration in the prescribed form by the person filing the application stating that the product to which the application relates is the product specified in the notice and that the product is not patented in that WTO Member, or

(B) a solemn or statutory declaration in the prescribed form by the person filing the application stating that the product to which the application relates is the product specified in the notice and a certified copy of the notice in writing that the WTO Member has provided to the TRIPS Council confirming that the WTO Member has, in accordance with Article 31 of the TRIPS Agreement and the provisions of the General Council Decision, granted or intends to grant a compulsory licence to use the invention pertaining to the product,

(ii) if the application relates to a country listed in Schedule 2 that is not a WTO Member, a certified copy of the notice in writing that the country has provided to the Government of Canada through diplomatic channels specifying the name of the pharmaceutical product, as defined in paragraph 1( a ) of the General Council Decision, and the quantity of that product, needed by the country, and

(A) a solemn or statutory declaration in the prescribed form by the person filing the application stating that the product to which the application relates is the product specified in the notice and that the product is not patented in that country, or

(B) a solemn or statutory declaration in the prescribed form by the person filing the application stating that the product to which the application relates is the product specified in the notice and a certified copy of the notice in writing that the country has provided to the Government of Canada through diplomatic channels confirming that the country has granted or intends to grant a compulsory licence to use the invention pertaining to the product,

(iii) if the application relates to a WTO Member listed in Schedule 3, a certified copy of the notice in writing that the WTO Member has provided to the TRIPS Council specifying the name of the pharmaceutical product, as defined in paragraph 1( a ) of the General Council Decision, and the quantity of that product, needed by the WTO Member, and stating that the WTO Member has insufficient or no pharmaceutical manufacturing capacity for the production of the product to which the application relates, and

(A) a solemn or statutory declaration in the prescribed form by the person filing the application stating that the product to which the application relates is not patented in that WTO Member, or

(B) a certified copy of the notice in writing that the WTO Member has provided to the TRIPS Council confirming that the WTO Member has, in accordance with Article 31 of the TRIPS Agreement and the provisions of the General Council Decision, granted or intends to grant a compulsory licence to use the invention pertaining to the product,

(iv) if the application relates to a WTO Member listed in Schedule 4, a certified copy of the notice in writing that the WTO Member has provided to the TRIPS Council specifying the name of the pharmaceutical product, as defined in paragraph 1( a ) of the General Council Decision, and the quantity of that product, needed by the WTO Member, and stating that the WTO Member is faced with a national emergency or other circumstances of extreme urgency and that it has insufficient or no pharmaceutical manufacturing capacity for the production of the product to which the application relates, and

(A) a solemn or statutory declaration in the prescribed form by the person filing the application stating that the product to which the application relates is not patented in that WTO Member, or

(B) a certified copy of the notice in writing that the WTO Member has provided to the TRIPS Council confirming that the WTO Member has, in accordance with Article 31 of the TRIPS Agreement and the provisions of the General Council Decision, granted or intends to grant a compulsory licence to use the invention pertaining to the product, or

(v) if the application relates to a country listed in Schedule 4 that is not a WTO Member, a certified copy of the notice in writing that the country has provided to the Government of Canada through diplomatic channels specifying the name of the pharmaceutical product, as defined in paragraph 1( a ) of the General Council Decision, and the quantity of that product, needed by the country, and stating that it is faced with a national emergency or other circumstances of extreme urgency, that it has insufficient or no pharmaceutical manufacturing capacity for the production of the product to which the application relates, that it agrees that product will not be used for commercial purposes and that it undertakes to adopt the measures referred to in Article 4 of the General Council Decision, and

(A) a solemn or statutory declaration in the prescribed form by the person filing the application stating that the product to which the application relates is not patented in that country, or

(B) a certified copy of the notice in writing that the country has provided to the Government of Canada through diplomatic channels confirming that the country has granted or intends to grant a compulsory licence to use the invention pertaining to the product.

21.05 (1) The authorization must be in the prescribed form and, subject to subsection (2), contain the prescribed information.

(2) The quantity of the product authorized to be manufactured by an authorization may not be more than the lesser of

( a ) the maximum quantity set out in the application for the authorization, and

( b ) the quantity set out in the notice referred to in any of subparagraphs 21.04(3)( d )(i) to (v), whichever is applicable.

21.06 (1) Before exporting a product manufactured under an authorization, the holder of the authorization must establish a website on which is disclosed the prescribed information respecting the name of the product, the name of the country or WTO Member to which it is to be exported, the quantity that is authorized to be manufactured and sold for export and the distinguishing features of the product, and of its label and packaging, as required by regulations made under the Food and Drugs Act .

(2) The holder must maintain the website during the entire period during which the authorization is valid.

21.07 Before exporting any quantity of a product manufactured under an authorization, the holder of the authorization must, at least fifteen days before the product is exported, provide to each of the following a notice specifying the quantity to be exported:

( a ) the patentee or each of the patentees, as the case may be;

( b ) the country or WTO Member named in the authorization; and

( c ) the person or entity that purchased the product to which the authorization relates.

21.08 (1) Subject to subsections (3) and (4), on the occurrence of a prescribed event, the holder of an authorization is required to pay to the patentee or each patentee, as the case may be, a royalty determined in the prescribed manner.

(2) In making regulations for the purposes of subsection (1), the Governor in Council must consider the humanitarian and non-commercial reasons underlying the issuance of authorizations under subsection 21.04(1).

(3) The royalties payable under this section must be paid within the prescribed time.

(4) The Federal Court may, in relation to any authorization, make an order providing for the payment of a royalty that is greater than the royalty that would otherwise be required to be paid under subsection (1).

(5) An order may be made only on the application of the patentee, or one of the patentees, as the case may be, and on notice of the application being given by the applicant to the holder of the authorization.

(6) An order may provide for a royalty of a fixed amount or for a royalty to be determined as specified in the order, and the order may be subject to any terms that the Federal Court considers appropriate.

(7) The Federal Court may make an order only if it is satisfied that the royalty otherwise required to be paid is not adequate remuneration for the use of the invention or inventions to which the authorization relates, taking into account

( a ) the economic value of the use of the invention or inventions to the country or WTO Member; and

( b ) the humanitarian and non-commercial reasons underlying the issuance of the authorization.

21.09 An authorization granted under subsection 21.04(1) is valid for a period of two years beginning on the day on which the authorization is granted.

21.1 The use of a patented invention under an authorization is non-exclusive.

21.11 An authorization is non-transferable, other than where the authorization is an asset of a corporation or enterprise and the part of the corporation or enterprise that enjoys the use of the authorization is sold, assigned or otherwise transferred.

21.12 (1) The Commissioner shall, on the application of the person to whom an authorization was granted and on the payment of the prescribed fee, renew the authorization if the person certifies under oath in the renewal application that the quantities of the pharmaceutical product authorized to be exported were not exported before the authorization ceases to be valid and that the person has complied with the terms of the authorization and the requirements of sections 21.06 to 21.08.

(2) An authorization may be renewed only once.

(3) The application for renewal must be made within the 30 days immediately before the authorization ceases to be valid.

(4) An authorization that is renewed is valid for a period of two years beginning on the day immediately following the day of the expiry of the period referred to in section 21.09 in respect of the authorization.

(5) Applications for renewal and renewed authorizations issued under subsection (1) must be in the prescribed form.”

The debate continued.

 

Marlene Jennings moved, — That the amendment be amended in 21.04(2)( f ) by adding between the words “name” and “to which” the following:

“of the governmental person or entity, or the person or entity permitted by the government of the importing country,”

 

After debate, the question was put on the subamendment of Marlene Jennings and it was agreed to.

 

Marlene Jennings moved, — That the amendment be amended in 21.04(3) by adding between the words “Commissioner shall” and “authorize” the following:

“, unless the Commissioner sees good reason not to grant the authorization,”

 

After debate, the question was put on the subamendment of Marlene Jennings and it was negatived.

 

Paul Crête moved, — That the amendment be amended in 21.04(3)( c )(i) by adding between the words “patentees” and “a licence” the following:

“, by certified mail,”

and in 21.04(3)( c )(ii) by adding between the words “may be” and “with the information” the following:

“by certified mail,”

Debate arose thereon.

 

By unanimous consent, it was agreed, — That the words “or registered” be added after the word “certified”.

 

After debate, the question was put on the subamendment of Paul Crête and it was agreed to.

 

Marlene Jennings moved, — That the amendment be amended in 21.04(3)( c )(i) by adding after the words “in the application” the following:

“on reasonable terms and conditions and that such efforts have not been successful”

and in 21.04(3)( c )(ii) by adding between the words “registered mail” and “with the information” the following:

“in the written request for a licence”

 

After debate, the question was put on the subamendment of Marlene Jennings and it was agreed to.

 

Paul Crête moved, — That the amendment be amended in 21.06(1) by adding between the words “packaging” and “as required by” the following:

“including all known participants in the logistical chain from Canada to the importing country,”

 

After debate, the question was put on the subamendment of Paul Crête and it was agreed to.

 

Marlene Jennings moved, — That the amendment be amended by adding after 21.06(2) the following:

“(3) The Commissioner of Patents shall post and maintain on the website of the Canadian Intellectual Property Office a link to each website required to be maintained by the holder of an authorization under subsection (1).”

 

After debate, the question was put on the subamendment of Marlene Jennings and it was agreed to.

 

Marlene Jennings moved, — That the amendment be amended by adding after 21.06(2) the following:

“(4) The Commissioner of Patents shall, within seven days of receipt, post on the website of the Canadian Intellectual Property Office each application for authorization filed under section 21.04(1).”

 

After debate, the question was put on the subamendment of Marlene Jennings and it was agreed to.

 

Marlene Jennings moved, — That the amendment be amended in 21.07 by

(a) replacing the word “exporting” with the words “each shipment of ”

(b) replacing the words “at least” with the word “within”

(c) adding between the words “notice” and “specifying” the following:

“, by certified or registered mail,”

(d) adding after the words “quantity to be exported” the following:

“, and identifying every known party in the distribution chain from Canada to the final country of import”

 

After debate, the question was put on the subamendment of Marlene Jennings and it was agreed to.

 

At 9:44 a.m., the sitting was suspended.

At 9:54 a.m., the sitting resumed.

 

Brian Masse moved, — That the amendment be amended in 21.04(2) by deleting paragraph (g).

 

After debate, the question was put on the subamendment of Brian Masse and it was negatived, by a show of hands: YEAS: 1; NAYS: 2.

 

Brian Masse moved, — That the amendment be amended in 21.04(3)( c ) by adding between the words “had” and “before” the following:

“within thirty days”

 

After debate, the question was put on the subamendment of Brian Masse and it was agreed to.

 

Brian Masse moved, — That the amendment be amended by adding after 21.04(3) the following:

“(4) Section 21.04 (3) (c)(i) and (ii) does not apply if the application relates to a country that is not a WTO Member, or in the case of a country that is a WTO Member, if the Commissioner receives a certified copy of a written statement, provided by the WTO Member confirming that:

(i)In the case of a WTO Member listed in Schedule 2 or 3, the pharmaceutical product named in the notice

i.Is to be used for addressing a national emergency or other circumstance of extreme urgency, or

ii.Is for public, non-commercial, use;

(ii)In the case of a WTO Member listed in Schedule 4, the pharmaceutical product named in the notice is to be used for addressing a national emergency or other circumstance of extreme urgency; or

(iii)In the case of any WTO Member, that the importation and distribution in the WTO Member of the pharmaceutical product named in the notice has been permitted in the WTO Member to remedy a practice by the patentee that has been determined by the appropriate judicial or administrative process in that WTO Member to be anti-competitive.

(5) If the requirements set out in subsection (4) have been met, the Commissioner shall, without delay, send to each patentee named in the application, by registered mail, a copy of the application and, in the case of an application that relates to a country that is a WTO Member, a copy of the written statement.”

 

After debate, by unanimous consent, the subamendment was withdrawn.

 

Brian Masse moved, — That the amendment be amended in 21.08(1) by adding after the words “prescribed manner” the following:

“, not to exceed 4% of the value of the pharmaceutical products exported under the authorization”

 

After debate, the question was put on the subamendment of Brian Masse and it was negatived.

 

Brian Masse moved, — That the amendment be amended in 21.08(4) by adding between the words “greater” and “than the royalty” the following:

“or lesser”

 

After debate, the question was put on the subamendment of Brian Masse and it was negatived.

 

Brian Masse moved, — That the amendment be amended in 21.08(7) by reordering and renumbering 21.07(a) and (b) as follows:

“( a ) the humanitarian and non-commercial reasons underlying the issuance of the authorization; and

( b ) the economic value of the use of the invention or inventions to the country or WTO Member.”

 

After debate, the question was put on the subamendment of Brian Masse and it was agreed to.

 

Brian Masse moved, — That the amendment be amended by replacing 21.09 with the following:

21.09 An authorization granted under subsection 21.04(1) is valid until the date of the first of the following:

(a)the length of the contract referred to in the application; or

(b)the date that the pharmaceutical product authorized for export is removed from the Patent List.”

 

After debate, the question was put on the subamendment of Brian Masse and it was negatived.

 

After debate, the question was put on the amendment of Joe Fontana, as amended, and it was agreed to.

 
Joe Fontana moved, — That Bill C-9, in Clause 1, be amended

(a) by replacing lines 25 to 28 on page 11 with the following:

“rization ceases to be valid on the earliest of

( a ) the expiry of the period referred to in section 21.09 in respect of the authorization, or the expiry of the period referred to in subsection 21.12(4) if the authorization has been renewed, as the case may be,”

(b) by replacing line 35 on page 11 with the following:

“ referred to in paragraph 21.04(3)( b ) has”

(c) by replacing line 42 on page 11 with the following:

“ ( d ) thirty days after the day on which”

 

After debate, the question was put on the amendment of Joe Fontana and it was agreed to.

 

By unanimous consent, it was agreed, — That departmental officials be requested to submit draft regulations to the Committee as soon as they are posted in the Canada Gazette.

 
Marlene Jennings moved, — That Bill C-9, in Clause 1 be amended to delete the word “and” at the end of line 6 page 12, and add at line 8 page 12:

“(f) the day on which the licensee receives notice from the importing country that the importation of the product into the country or WTO Member to which the pharmaceutical product was, or is to be, exported, is illegal, or infringes patents in the country of import; and

(g) the day on which the contract between the licensee and the person or entity in the importing country has ceased to exist.”

 

The question was put on the amendment of Marlene Jennings and it was negatived.

 
Joe Fontana moved, — That Bill C-9, in Clause 1, be amended by replacing lines 16 to 34 on page 12 with the following:

“ or any of the documents provided to the Commissioner in relation to the application contained any material information that is inaccurate;

( b ) the holder of the authorization has failed to establish a website as required by section 21.06, has failed to disclose on that website the information required to be disclosed by that section or has failed to maintain the website as required by that section;

( c ) the holder of the authorization has failed to provide a notice required to be given under section 21.07;

( d ) the holder of the authorization has failed to pay, within the required time, any royalty required to be paid as a result of the authorization;

( e ) the holder of the authorization has failed to comply with subsection 21.16(2);

( f ) the product exported to the country or WTO Member, as the case may be, under the authorization has been, with the knowledge of the holder of the authorization, re-exported in a manner that is contrary to the General Council Decision and in quantities that are significant, considering the quantities exported;

( g ) the product was exported, other than in the normal course of transit, to a country or WTO Member other than the country or WTO Member named in the authorization;

( h ) the product was exported in a quantity greater than the quantity authorized to be manufactured; or

( i ) if the product was exported to a country that is not a WTO Member, the country has permitted the product to be used for commercial purposes or has failed to adopt the measures referred to in Article 4 of the General Council Decision.”

Debate arose thereon.

 

Marlene Jennings moved, — That the amendment be amended in 21.14( f ) by deleting the following:

“and in quantities that are significant, considering the quantities exported”

 

After debate, the question was put on the subamendment of Marlene Jennings and it was agreed to.

 

After debate, the question was put on the amendment of Joe Fontana, as amended, and it was agreed to.

 
Marlene Jennings moved, — That Bill C-9, in Clause 1, be amended, by adding after line 39 on page 12:

“Every person commits an offence who

(a) exports a patented product that is the subject of an authorization where the person knows or should know that it will be re-exported; or

(b) submits an application containing false or misleading information;

is guilty of an offence punishable on summary conviction and liable to a fine.”

 

After debate, the question was put on the amendment of Marlene Jennings and it was negatived.

 

At 11:35 a.m., the sitting was suspended.

At 12:19 p.m., the sitting resumed.

 
Marlene Jennings moved, — That Bill C-9, in Clause 1, be amended, at page 12, by adding after section 21.15:

“The grant of an authorization under subsection 21.04 affects the patentee's rights in Canada only to the extent necessary to permit the holder of the authorization to manufacture and export the patented product according to the terms and conditions prescribed by legislation and/or as set in the authorization.”

 

After debate, the question was put on the amendment of Marlene Jennings and it was negatived.

 
Joe Fontana moved, — That Bill C-9, in Clause 1, be amended by replacing lines 40 to 44 on page 12 and lines 1 and 2 on page 13 with the following:

21.16 (1) Within fifteen days after the later of the day on which the authorization was granted and the day on which the agreement for the sale of the product to which the authorization relates was entered into, the holder of an authorization must provide the Commissioner and the patentee, or each patentee, as the case may be, with

( a ) a copy of the agreement; and

( b ) a solemn or statutory declaration in the prescribed form setting out

(i) the total monetary value of the agreement, expressed in Canadian currency, and

(ii) the number of units of the product to be sold under the terms of the agreement.

(2) The holder of an authorization may not export any product to which the authorization relates until after the holder has complied with subsection (1).

21.17 (1) If the average price of the product to be manufactured under an authorization is equal to or greater than 25 percent of the average price in Canada of the equivalent product sold by or with the consent of the patentee, the patentee may, on notice given by the patentee to the person to whom an authorization was granted, apply to the Federal Court for an order under subsection (3) on the grounds that the essence of the agreement under which the product is to be sold is commercial in nature.

(2) In determining whether the agreement is commercial in nature, the Federal Court must take into account

( a ) the need for the holder of the authorization to make a reasonable return sufficient to sustain a continued participation in humanitarian initiatives;

( b ) the ordinary levels of profitability, in Canada, of commercial agreements involving pharmaceutical products, as defined in paragraph 1( a ) of the General Council Decision; and

( c ) international trends in prices as reported by the United Nations for the supply of such products for humanitarian purposes.

(3) If the Federal Court determines that the agreement is commercial in nature, it may make an order, on any terms that it considers appropriate,

( a ) terminating the authorization; or

( b ) requiring the holder to pay, in addition to the royalty otherwise required to be paid, an amount that the Federal Court considers adequate to compensate the patentee for the commercial use of the patent.

(4) If the Federal Court makes an order terminating the authorization, the Federal Court may also, if it considers it appropriate to do so, make an order, on any terms that it considers appropriate,

( a ) requiring the holder to deliver to the patentee any of the product to which the authorization relates remaining in the holder's possession as though the holder had been determined to have been infringing a patent; or

( b ) with the consent of the patentee, requiring the holder to export any of the product to which the authorization relates remaining in the holder's possession to the country or WTO Member named in the authorization.

(5) The Federal Court may not make an order under subsection (3) if, under the protection of a confidentiality order made by the Court, the holder of the authorization submits to a Court-supervised audit and that audit establishes that the average price of the product manufactured under the authorization does not exceed an amount equal to the direct supply cost of the product plus 15 per cent of that direct supply cost.

(6) The following definitions apply in this section.

"average price" means

( a ) in relation to a product to be manufactured under an authorization, the total monetary value of the agreement under which the product is to be sold, expressed in Canadian currency, divided by the number of units of the product to be sold under the terms of the agreement; and

( b ) in relation to an equivalent product sold by or with the consent of the patentee, the average of the prices in Canada of that product as those prices are reported in prescribed publications on the day on which the application for the authorization was filed.

"direct supply cost", in relation to a product to be manufactured under an authorization, means the cost of the materials and of the labour, and any other manufacturing costs, directly related to the production of the quantity of the product that is to be manufactured under the authorization.

"unit", in relation to any product, means a single tablet, capsule or other individual dosage form of the product, and if applicable, in a particular strength.

21.18 The Minister and the Minister of Health may establish an advisory committee to advise them on the recommendations that they may make to the Governor in Council respecting the amendment of Schedule 1.

21.19 The person designated by the Governor in Council for the purpose of this section must maintain a website on which is set out a copy of every notice referred to in subparagraphs 21.04(3)( d )(ii) and (v) that is provided to the Government of Canada through diplomatic channels by a country that is not a WTO Member. The copy must be added to the website as soon as possible after the notice has been provided to the Government of Canada.

21.2 (1) A review of sections 21.01 to 21.19 and their application must be completed”

 

Marlene Jennings moved, — That the amendment be amended

(a) in 21.16(1) by adding between the words: “provide” and “the Commissioner” the following:

“by certified or registered mail,”

(b) in 21.16(1)(a) by adding the following:

“it has reached with the person or entity referred to in 21.04(2) ( f ) for the supply of the product authorized to be manufactured and sold incorporating information that is in all material respects identical to the information referred to in paragraph (2)( a ) ( b ), ( e ) and ( f );”

(c) in 21.16(1)( b )(i) by adding between the words: “agreement” and “expressed” the following:

“as it relates to the product authorized to be manufactured and sold”

 

After debate, the question was put on the subamendment of Marlene Jennings and it was agreed to.

 

Marlene Jennings moved, — That the amendment be amended in 21.17(1) by adding

(a) before the words: “If the average” the following:

“Subject to subsection (5),”

(b) between the words “consent of the patentee” and “the patentee may” the following:

“the essence of the agreement is deemed to be commercial, and”

 

The question was put on the subamendment of Marlene Jennings and it was negatived.

 

Brian Masse moved, — That the amendment be amended in 21.18 by replacing the words “may establish” with the words “shall establish, within three years,”.

 

After debate, the question was put on the subamendment of Brian Masse and it was agreed to.

 

Marlene Jennings moved, — That the amendment be amended in 21.19 by adding after the words “WTO Member” the following:

“by which the country seeks supply of a particular product in a particular quantity.”

 

After debate, by unanimous consent, the subamendment was withdrawn.

 

After debate, the question was put on the amendment of Joe Fontana, as amended, and it was agreed to.

 
James Rajotte moved, — That Bill C-9, in Clause 1, be amended by adding after line 44 on page 12 the following:

“(2) The standing committee of the House of Commons that normally considers matters related to industry shall assess all candidates for appointment to the advisory committee and make recommendations to the Minister on the eligibility and qualifications of those candidates.”

 

After debate, the question was put on the amendment of James Rajotte and it was agreed to.

 
James Rajotte moved, — That Bill C-9, in Clause 1, be amended by replacing line 3 on page 13 with the following:

“by the Minister two years after this section”

 

After debate, the question was put on the amendment of James Rajotte and it was agreed to.

 
By unanimous consent, the Committee reverted to the consideration of the amendment of Joe Fontana previously stood which read as follows: That Bill C-9, in Clause 1, be amended by replacing line 7 on page 1 with the following:

21.2 is to give effect to Jean Chrétien's pledge to Africa by facilitating access to pharmaceutical”

 

Marlene Jennings moved, — That the amendment be amended by adding before the words “Jean Chretien's pledge ” the following: “Canada and”.

 

After debate, the question was put on the subamendment of Marlene Jennings and it was agreed to.

 

The question was put on the amendment of Joe Fontana, as amended, and it was agreed to.

 

Clause 1, as amended, carried.

 

Clause 2 carried.

 

Clause 3 carried.

 

Clause 4 carried.

 

On Schedule 1,

Brian Masse moved, — That Bill C-9, in Schedule 1, be amended by deleting, if applicable, in respect of each patented product listed in Schedule 1, the dosage form, the strength and the route of administration specified in that Schedule in relation to the product.

 

After debate, the question was put on the amendment of Brian Masse and it was negatived.

 
Joe Fontana moved, — That Bill C-9, in Schedule 1, be amended by adding the following in alphabetical order:

“abacavir (ABC): tablet, 300 mg (as sulfate); oral solution, 100 mg (as sulfate)/5 mL

abacavir + lamivudine + zidovudine: tablet, 300 mg (as sulfate) + 150 mg + 300 mg

amprenavir: capsule, 50 mg or 150 mg; oral solution, 15 mg/mL

delavirdine: tablet, 100 mg (as mesylate)

didanosine (ddI): buffered chewable, dispersible tablet, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg; buffered powder for oral solution, 100 mg, 167 mg, 250 mg, packets; unbuffered enteric coated capsule, 125 mg, 200 mg, 250 mg, 400 mg

lamivudine (3TC): tablet, 150 mg; oral solution 50, mg/5 mL

lamivudine + zidovudine: tablet, 150 mg + 300 mg

nevirapine (NVP): tablet, 200 mg; oral suspension, 50 mg/5 mL

zalcitabine: tablet, 0.375 mg or 0.750 mg”

Debate arose thereon.

 

Brian Masse moved, — That the amendment be amended by adding to the listing of amprenavir the following:

“amprenavir tablet, 150 mg”

 

After debate, by unanimous consent, the subamendment was withdrawn.

 

After debate, the question was put on the amendment of Joe Fontana and it was agreed to.

 

By unanimous consent, it was agreed, — That departmental officials would provide Brian Masse and the Committee with a list of medication and dosage for possible use at report stage.

 

Schedule 1, as amended, carried.

 

On Schedule 2,

Brian Masse moved, — That Bill C-9, in Schedule 2, be amended by adding the following, in alphabetical order:

“East Timor

Timor-Oriental

 

After debate, the question was put on the amendment of Brian Masse and it was negatived.

 
On motion of Joe Fontana, it was agreed, — That Bill C-9, in Schedule 2, be amended by adding the following in alphabetical order:

“Myanmar

Myanmar

 

Schedule 2, as amended, carried.

 

On Schedule 3,

Brian Masse moved, — That Bill C-9 be amended by deleting Schedule 3.

 

The Chair ruled the proposed amendment inadmissible because, in order to delete a schedule, all that is required is to vote against its adoption.

 
Paul Crête moved, — That Bill C-9, in Schedule 3, be amended by adding the following in alphabetical order:

“Algeria

Algérie

 

The question was put on the amendment of Paul Crête and it was negatived.

 
Brian Masse moved, — That Bill C-9, in Schedule 3, be amended by adding the following, in alphabetical order:

“Anguilla

Anguilla

 

The question was put on the amendment of Brian Masse and it was negatived.

 
Brian Masse moved, — That Bill C-9, in Schedule 3, be amended by adding the following, in alphabetical order:

“Aruba

Aruba

 

The question was put on the amendment of Brian Masse and it was negatived.

 
Paul Crête moved, — That Bill C-9, in Schedule 3, be amended by adding the following in alphabetical order:

“Azerbaijan

Azerbaïdjan

 

The question was put on the amendment of Paul Crête and it was negatived.

 
Roger Gaudet moved, — That Bill C-9, in Schedule 3, be amended by adding the following in alphabetical order:

“Bosnia-Herzegovina

Bosnie-Herzégovine

 

The question was put on the amendment of Roger Gaudet and it was negatived.

 
Brian Masse moved, — That Bill C-9, in Schedule 3, be amended by adding the following, in alphabetical order:

“Cook Islands

Îles Cook

 

The question was put on the amendment of Brian Masse and it was negatived.

 
Paul Crête moved, — That Bill C-9, in Schedule 3, be amended by adding the following in alphabetical order:

“East Timor

Timor-Oriental

 

The question was put on the amendment of Paul Crête and it was negatived.

 
Brian Masse moved, — That Bill C-9, in Schedule 3, be amended by adding the following, in alphabetical order:

“French Polynesia

Polynésie française

 

The question was put on the amendment of Brian Masse and it was negatived.

 
Brian Masse moved, — That Bill C-9, in Schedule 3, be amended by adding the following, in alphabetical order:

“Gibraltar

Gibraltar

 

The question was put on the amendment of Brian Masse and it was negatived.

 
Paul Crête moved, — That Bill C-9, in Schedule 3, be amended by adding the following in alphabetical order:

“Iran

Iran

 

The question was put on the amendment of Paul Crête and it was negatived.

 
Roger Gaudet moved, — That Bill C-9, in Schedule 3, be amended by adding the following in alphabetical order:

“Iraq

Irak

 

The question was put on the amendment of Roger Gaudet and it was negatived.

 
Paul Crête moved, — That Bill C-9, in Schedule 3, be amended by adding the following in alphabetical order:

“Kazakhstan

Kazakhstan

 

The question was put on the amendment of Paul Crête and it was negatived.

 
Paul Crête moved, — That Bill C-9, in Schedule 3, be amended by adding the following in alphabetical order:

“Lebanon

Liban

 

The question was put on the amendment of Paul Crête and it was negatived.

 
Brian Masse moved, — That Bill C-9, in Schedule 3, be amended by adding the following, in alphabetical order:

“Libya

Libye

 

The question was put on the amendment of Brian Masse and it was negatived.

 
Brian Masse moved, — That Bill C-9, in Schedule 3, be amended by adding the following, in alphabetical order:

“Marshall Islands

Îles Marshall

 

The question was put on the amendment of Brian Masse and it was negatived.

 
Brian Masse moved, — That Bill C-9, in Schedule 3, be amended by adding the following, in alphabetical order:

“Micronesia (Federated States of)

Micronésie (États fédérés de)

 

The question was put on the amendment of Brian Masse and it was negatived.

 
Brian Masse moved, — That Bill C-9, in Schedule 3, be amended by adding the following, in alphabetical order:

“Myanmar

Myanmar

 

The question was put on the amendment of Brian Masse and it was negatived.

 
Brian Masse moved, — That Bill C-9, in Schedule 3, be amended by adding the following, in alphabetical order:

“Nauru

Nauru

 

The question was put on the amendment of Brian Masse and it was negatived.

 
Brian Masse moved, — That Bill C-9, in Schedule 3, be amended by adding the following, in alphabetical order:

“New Caledonia

Nouvelle-Calédonie

 

The question was put on the amendment of Brian Masse and it was negatived.

 
Brian Masse moved, — That Bill C-9, in Schedule 3, be amended by adding the following, in alphabetical order:

“Niue

Nioué

 

The question was put on the amendment of Brian Masse and it was negatived.

 
Paul Crête moved, — That Bill C-9, in Schedule 3, be amended by adding the following in alphabetical order:

“North Korea

Corée du Nord

 

The question was put on the amendment of Paul Crête and it was negatived.

 
Brian Masse moved, — That Bill C-9, in Schedule 3, be amended by adding the following, in alphabetical order:

“Palau (Republic of)

Palaos (République des)

 

The question was put on the amendment of Brian Masse and it was negatived.

 
Paul Crête moved, — That Bill C-9, in Schedule 3, be amended by adding the following in alphabetical order:

“Serbia-Montenegro

Serbie-Monténégro

 

The question was put on the amendment of Paul Crête and it was negatived.

 
Paul Crête moved, — That Bill C-9, in Schedule 3, be amended by adding the following in alphabetical order:

“Syria

Syrie

 

The question was put on the amendment of Paul Crête and it was negatived.

 
Brian Masse moved, — That Bill C-9, in Schedule 3, be amended by adding the following, in alphabetical order:

“Tajikistan

Tadjikistan

 

The question was put on the amendment of Brian Masse and it was negatived.

 
Brian Masse moved, — That Bill C-9, in Schedule 3, be amended by adding the following, in alphabetical order:

“Tonga

Tonga

 

The question was put on the amendment of Brian Masse and it was negatived.

 
Roger Gaudet moved, — That Bill C-9, in Schedule 3, be amended by adding the following in alphabetical order:

“Turkmenistan

Turkménistan

 

The question was put on the amendment of Roger Gaudet and it was negatived.

 
Paul Crête moved, — That Bill C-9, in Schedule 3, be amended by adding the following in alphabetical order:

“Ukraine

Ukraine

 

The question was put on the amendment of Paul Crête and it was negatived.

 
Paul Crête moved, — That Bill C-9, in Schedule 3, be amended by adding the following in alphabetical order:

“Uzbekistan

Ouzbékistan

 

The question was put on the amendment of Paul Crête and it was negatived.

 
Paul Crête moved, — That Bill C-9, in Schedule 3, be amended by adding the following in alphabetical order:

“Vietnam

Vietnam

 

The question was put on the amendment of Paul Crête and it was negatived.

 

Schedule 3 carried.

 

Schedule 4 carried on division.

 

On Title,

Joe Fontana moved, — That the long title of Bill C-9 be replaced by the following:

“An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa)”

 

The Title, as amended, carried.

 

The Bill, as amended, carried.

 

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

 

ORDERED, — That Bill C-9, as amended, be reprinted for the use of the House at report stage.

 

At 2:10 p.m., the Committee adjourned to the call of the Chair.

 



Louise M. Thibault
Clerk of the Committee

 
 
2004/06/08 10:20 a.m.