| |||||||||||||||||||||||||||||||||||||
|
|
||||||||||||||||||||||||||||||||||||
 |
| ||||||||||||||||||||||||||||||||||||
 |
|||||||||||||||||||||||||||||||||||||
|
Vol. 139, No. 11 — June 1, 2005 RegistrationSOR/2005-143 May 10, 2005 PATENT ACT Use of Patented Products for International Humanitarian Purposes RegulationsP.C. 2005-861 May 10, 2005 Whereas, pursuant to subsection 21.08(2) (see footnote a) of the Patent Act, the Governor in Council has considered the humanitarian and non-commercial reasons underlying the issuance of authorizations under subsection 21.04(1) (see footnote b) of that Act; Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of Industry, pursuant to section 12 (see footnote c) of the Patent Act, hereby makes the annexed Use of Patented Products for International Humanitarian Purposes Regulations. USE OF PATENTED PRODUCTS FOR INTERNATIONAL HUMANITARIAN PURPOSES REGULATIONS INTERPRETATION 1. In these Regulations, "Act" means the Patent Act. COMMUNICATIONS 2. (1) Any correspondence and envelope that relate to an application under section 21.04 of the Act shall clearly indicate this fact. The correspondence shall be written in English or French and shall be addressed, together with the envelope, in English or French to the Commissioner. (2) Correspondence shall be delivered to the Patent Office by hand or by mail and (a) if it is delivered during the ordinary business hours of the Patent Office, it is considered to be received by the Commissioner on the day of the delivery; and (b) if it is delivered outside the ordinary business hours of the Patent Office, it is considered to be received on the next business day. 3. (1) For the purposes of sections 21.01 to 21.2 of the Act, any correspondence to be sent to a patentee shall be sent to its representative in Canada, as shown in the records of the Patent Office or, if no representative has been appointed, to the patentee. (2) Any correspondence sent to the patentee's representative in Canada is deemed to have been received by the patentee. APPLICATION FOR AUTHORIZATION 4. For the purpose of subsection 21.04(2) of the Act, an application for authorization shall be in the form set out in Form 1 of the schedule and shall be signed by the applicant. SOLEMN OR STATUTORY DECLARATIONS 5. (1) The solemn or statutory declaration referred to in paragraph 21.04(3)(c) of the Act shall be in the form set out in Form 2 of the schedule and shall be signed by the applicant. (2) The solemn or statutory declarations referred to in clauses 21.04(3)(d)(i)(A) and (B) and (ii)(A) and (B) of the Act shall be in the form set out in Forms 3, 4, 5 and 6, respectively, of the schedule and shall be signed by the applicant. (3) The solemn or statutory declarations referred to in clauses 21.04(3)(d)(iii)(A), (iv)(A) and (v)(A) of the Act shall be in the form set out in Form 7 of the schedule and shall be signed by the applicant. (4) The solemn or statutory declaration referred to in paragraph 21.16(1)(b) of the Act shall be in the form set out in Form 8 of the schedule and shall be signed by the holder of the authorization. AUTHORIZATION 6. For the purpose of subsection 21.05(1) of the Act, the authorization shall be in the form set out in Form 9 of the schedule. WEBSITE 7. For the purpose of section 21.06 of the Act, the website of the holder of an authorization shall disclose the following information: (a) if the pharmaceutical product named in the application is a drug as defined in section 2 of the Food and Drugs Act, the name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product, or if the pharmaceutical product is a medical device, the name of the medical device; (b) the name of the country or WTO Member named in the application to which the pharmaceutical product is to be exported; (c) if the country or WTO Member referred to in paragraph (b) is not itself the purchaser of the pharmaceutical product, the name of the person or entity — other than a governmental person or entity — referred to in paragraph 21.04(2)(f) of the Act, to which the product is to be sold, together with their postal address; (d) the quantity of the pharmaceutical product that, under section 21.04 of the Act, has been authorized to be manufactured for export to the country or WTO Member referred to in paragraph (b); (e) the distinguishing features of the pharmaceutical product — including its colour if applicable — and of its label and packaging, as required by regulations made under the Food and Drugs Act; (f) the name and postal address of the shipping agent and any other party that, to the knowledge of the holder of the authorization, will be handling the pharmaceutical product while it is in transit from Canada to the country or WTO Member referred to in paragraph (b); (g) if the consignee in the importing country or WTO Member is a person or entity other than the country or WTO Member referred to in paragraph (b), or the person or entity referred to in paragraph (c), as the case may be, the name and postal address of the consignee; (h) the quantity of the pharmaceutical product contained in each shipment; (i) the export tracking number issued by the Minister of Health in respect of each shipment; and (j) the number of the bill of lading for each shipment. ROYALTIES 8. (1) In this section, "Index" means the Human Development Index developed and maintained by the United Nations Development Programme. (2) For the purpose of subsection 21.08(1) of the Act, the events on the occurrence of which a royalty is required to be paid, and the manner of determining the royalty, are as follows: (a) if the total quantity of the pharmaceutical product that is authorized to be manufactured and exported is exported in a single shipment, the amount of the royalty determined in accordance with subsection (4) or (6), as the circumstances require, shall be paid in full within 45 days after the date of the export notice provided under section 21.07 of the Act; and (b) if the quantity of the pharmaceutical product that is authorized to be manufactured and exported is exported in a series of shipments, a royalty shall be paid within 45 days after the date of the export notice provided under section 21.07 of the Act in an amount for a shipment that is the same proportion of the full amount of the royalty determined in accordance with subsection (4) or (6), as the circumstances require, as the quantity of the pharmaceutical product exported in the shipment is of the quantity of the pharmaceutical product that has been authorized to be manufactured and exported. (3) If the name of the country or WTO Member to which an authorization relates appears on the Index, the rate for calculating the royalty that is required to be paid to the patentee or to each of the patentees, as the case may be, in respect of the authorization shall be determined by (a) adding 1 to the total number of countries listed on the Index; (b) subtracting from the sum determined under paragraph (a) the numerical rank on the Index of the country or WTO Member to which the pharmaceutical product is to be exported; (c) dividing the difference determined under paragraph (b) by the total number of countries listed on the Index; and (d) multiplying the quotient determined under paragraph (c) by 0.04. (4) If the name of the country or WTO Member to which an authorization relates appears on the Index, the amount of royalty payable to the patentee or to each of the patentees, as the case may be, shall be determined (a) when there is only one patentee, by multiplying the total monetary value, expressed in Canadian currency, of the agreement pertaining to the pharmaceutical product to be manufactured, sold and exported under the authorization by the royalty rate determined in accordance with subsection (3); and (b) when there is more than one patentee, by dividing the amount determined under paragraph (a) by the number of patentees. (5) If the name of the country or WTO Member to which an authorization relates does not appear on the Index, the rate for calculating the royalty that is required to be paid to the patentee or to each of the patentees, as the case may be, in respect of the applicable authorization shall be determined by (a) adding 1 to the total number of countries listed on the Index; (b) subtracting from the sum determined under paragraph (a) the average (i) in the case of a country or WTO Member
to which the pharmaceutical product is to be exported and whose name appears
in Schedule 2 or 3 to the Act, of the numerical ranks on the Index of
all of the countries and WTO Members whose names appear both on the Index
and in the same Schedule to the Act as the country or WTO Member to which
the pharmaceutical product is to be exported,
(ii) in the case of a country — other than a WTO Member — to which the pharmaceutical product is to be exported and whose name appears in Schedule 4 to the Act, of the numerical ranks on the Index of all of the WTO Members whose names appear both on the Index and in Schedule 3 to the Act, and (iii) in the case of a WTO Member to which the pharmaceutical product is to be exported and whose name appears in Schedule 4 to the Act, of the numerical ranks on the Index of all of the WTO Members whose names appear both on the Index and in Schedule 4 to the Act; (c) dividing the difference determined under paragraph (b) by the total number of countries listed on the Index; and (d) multiplying the quotient determined under paragraph (c) by 0.04. (6) If the name of the country or WTO Member to which an authorization relates does not appear on the Index, the amount of royalty payable to the patentee or to each of the patentees, as the case may be, shall be determined (a) when there is only one patentee, by multiplying the total monetary value, expressed in Canadian currency, of the agreement pertaining to the pharmaceutical product to be manufactured, sold and exported under the authorization by the royalty rate determined in accordance with subsection (5); and (b) when there is more than one patentee, by dividing the amount determined under paragraph (a) by the number of patentees. RENEWAL APPLICATION 9. For the purpose of section 21.12 of the Act, an application for the renewal of an authorization shall be in the form set out in Form 10 of the schedule and shall be signed by the holder of the authorization. RENEWAL OF AUTHORIZATION 10. The renewal of an authorization by the Commissioner under section 21.12 of the Act shall be in the form set out in Form 11 of the schedule. PRODUCT PRICE PUBLICATIONS 11. For the purpose of paragraph (b) of the definition "average price" in subsection 21.17(6) of the Act, the publications reporting the prices in Canada of pharmaceutical products sold by or with the consent of the patentee that are equivalent to the pharmaceutical product to which an authorization under section 21.04 of the Act relates are the following: (a) the Ontario Drug Benefit Formulary, as amended from time to time; (b) the Drug Formulary published by the Régie de l'assurance maladie du Québec, as amended from time to time; and (c) the PPS( Pharma Publication published by Total Pricing Systems Inc., as amended from time to time. COMING INTO FORCE 12. These Regulations come into force on the day on which An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), being chapter 23 of the Statutes of Canada, 2004, comes into force. SCHEDULE FORM 1 APPLICATION FOR AUTHORIZATION UNDER SECTION 21.04 OF THE PATENT ACT 1. The undersigned hereby applies for an authorization under section 21.04 of the Act. 2. The pharmaceutical product that the undersigned intends to manufacture and sell for export under the authorization is (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act: ______________ (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or (b) if the pharmaceutical product is a medical device: ____________ (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations). 3. The maximum quantity of the pharmaceutical product that the undersigned intends to manufacture and sell for export under the authorization is _________________________. 4. For each patented invention to which the application relates, the name(s) of the patentee(s) of the invention, the name(s) and postal address(es) of the representative(s) of the patentee(s) or, if no representative has been appointed, the postal address(es) of the patentee(s), and the patent number(s) issued in respect of the invention are as follows:
5. The name of the WTO Member or country that has notified, respectively, the TRIPS Council or the Government of Canada in writing of its requirement for the pharmaceutical product named in the application, and to which the pharmaceutical product is to be exported, is _______________________________________________________________. 6. The name, postal address and telephone number of the person or entity referred to in paragraph 21.04(2)(f) of the Act, to which the pharmaceutical product is to be sold, are as follows: _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ 7. For the purpose of subsection 21.06(1) of the Act, the website address of the undersigned is _____________. 8. The name, postal address and telephone number of the undersigned are as follows: _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ Dated at ________________ the ____________ day of ________ , ________ __________________ FORM 2 SOLEMN OR STATUTORY DECLARATION UNDER PARAGRAPH 21.04(3)(c) OF THE PATENT ACT In the matter of an application by__________________ (name of applicant) for export to _______________ (name of country or WTO Member) of the following pharmaceutical product: (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act: _____________ (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or (b) if the pharmaceutical product is a medical device: _____________ (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations); 1. The undersigned _____________ (name of applicant) hereby declares, in accordance with paragraph 21.04(3)(c) of the Act, that on ____________ (date), being at least 30 days before the date of filing of the application for an authorization under section 21.04 of the Act, the undersigned (a) sought from the patentee or, if there is more than one, from each of the patentees, namely, ________________ (name(s) of the patentee(s)), by certified or registered mail addressed to ______________ (name(s) and postal address(es) of the patentee(s) or the representative(s) of the patentee(s), if any), a licence to manufacture and sell the pharmaceutical product for export to the country or WTO Member named in the application on reasonable terms and conditions and that such efforts have not been successful; and (b) provided the patentee, or each of the patentees, as the case may be, by certified or registered mail, in the written request for a licence, with the information that is in all material respects identical to the information required under paragraphs 21.04(2)(a) to (g) of the Act. 2. The name, postal address and telephone number of the undersigned are as follows: _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ Dated at ________________ the ____________ day of ________ , ________ __________________ FORM 3 SOLEMN OR STATUTORY DECLARATION UNDER CLAUSE 21.04(3)(d)(i)(A) OF THE PATENT ACT In the matter of an application by _______________ (name of applicant) for export to _____________ (name of WTO Member) of the following pharmaceutical product: (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act: _____________ (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or (b) if the pharmaceutical product is a medical device: ___________ (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations); 1. The undersigned ___________ (name of applicant) hereby declares, in accordance with clause 21.04(3)(d)(i)(A) of the Act, that the pharmaceutical product to which the application relates (a) is the pharmaceutical product specified in the notice in writing that the WTO Member has provided to the TRIPS Council; and (b) is not patented in that WTO Member. 2. The name, postal address and telephone number of the undersigned are as follows: _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ Dated at ________________ the ____________ day of ________ , ________ __________________ FORM 4 SOLEMN OR STATUTORY DECLARATION UNDER CLAUSE 21.04(3)(d)(i)(B) OF THE PATENT ACT In the matter of an application by ____________ (name of applicant) for export to ___________ (name of WTO Member) of the following pharmaceutical product: (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act: _____________ (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or (b) if the pharmaceutical product is a medical device: ____________ (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations); 1. The undersigned __________ (name of applicant) hereby declares, in accordance with clause 21.04(3)(d)(i)(B) of the Act, that the pharmaceutical product to which the application relates is the pharmaceutical product that is specified in the notice in writing that the WTO Member has provided to the TRIPS Council. 2. The name, postal address and telephone number of the undersigned are as follows: _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ Dated at ________________ the ____________ day of ________ , ________ __________________ FORM 5 SOLEMN OR STATUTORY DECLARATION UNDER CLAUSE 21.04(3)(d)(ii)(A) OF THE PATENT ACT In the matter of an application by ______________ (name of applicant) for export to ______________ (name of country) of the following pharmaceutical product: (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act: ______________ (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or (b) if the pharmaceutical product is a medical device: _____________ (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations); 1. The undersigned ____________ (name of applicant) hereby declares, in accordance with clause 21.04(3)(d)(ii)(A) of the Act, that the pharmaceutical product to which the application relates (a) is the pharmaceutical product specified in the notice in writing that the country has provided to the Government of Canada; and (b) is not patented in that country. 2. The name, postal address and telephone number of the undersigned are as follows: _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ Dated at ________________ the ____________ day of ________ , ________ __________________ FORM 6 SOLEMN OR STATUTORY DECLARATION UNDER CLAUSE 21.04(3)(d)(ii)(B) OF THE PATENT ACT In the matter of an application by __________ (name of applicant) for export to _____________ (name of country) of the following pharmaceutical product: (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act: ___________ (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or (b) if the pharmaceutical product is a medical device: ___________ (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations); 1. The undersigned _________ (name of applicant) declares, in accordance with clause 21.04(3)(d)(ii)(B) of the Act, that the pharmaceutical product to which the application relates is the pharmaceutical product that is specified in the notice in writing that the country has provided to the Government of Canada. 2. The name, postal address and telephone number of the undersigned are as follows: _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ Dated at ________________ the ____________ day of ________ , ________ __________________ FORM 7 SOLEMN OR STATUTORY DECLARATION UNDER CLAUSE 21.04(3)(d)(iii)(A), (iv)(A) AND (v)(A) OF THE PATENT ACT In the matter of an application by ___________ (name of applicant) for export to ____________ (name of country or WTO Member) of the following pharmaceutical product: (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act: _____________ (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or (b) if the pharmaceutical product is a medical device: _____________ (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations); 1. The undersigned ___________ (name of applicant) hereby declares, in accordance with clause 21.04(3)(d)(iii)(A), (iv)(A) or (v)(A) of the Act, as the case may be, that the pharmaceutical product to which the application relates is not patented in the country or WTO Member. 2. The name, postal address and telephone number of the undersigned are as follows: _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ Dated at ________________ the ____________ day of ________ , ________ __________________ FORM 8 SOLEMN OR STATUTORY DECLARATION UNDER PARAGRAPH 21.16(1)(b) OF THE PATENT ACT In the matter of authorization number ___________ granted on __________ (date) to _________ (name of holder of authorization) for export to ___________ (name of country or WTO Member) of the following pharmaceutical product: (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act: _____________ (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or (b) if the pharmaceutical product is a medical device: ______________ (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations); 1. The undersigned ____________ (name of holder of authorization) hereby declares, in accordance with paragraph 21.16(1)(b) of the Act, that (a) the total monetary value of the agreement, expressed in Canadian currency, as it relates to the pharmaceutical product authorized to be manufactured and sold is $ ________ ; and (b) the number of units of the pharmaceutical product to be sold under the terms of the agreement is ____________. 2. The name, postal address and telephone number of the undersigned are as follows: _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ _______________________________________________________________ Dated at ________________ the ____________ day of ________ , ________ _____________________________ FORM 9 AUTHORIZATION UNDER SECTION 21.04 OF THE PATENT ACT In the matter of application for authorization number ________ by _________ (name of applicant) for export to ___________ (name of country or WTO Member) of the following pharmaceutical product: (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act: ____________ (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or (b) if the pharmaceutical product is a medical device: ____________ (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations); 1. I hereby authorize ____________ (name of applicant), whose postal address is _____________, to make, construct and use, the patented invention(s) identified in patent number(s) ___________ solely for purposes directly related to the manufacture of the above-mentioned pharmaceutical product, and to sell it for export to the above-mentioned country or WTO Member. 2. The quantity of the pharmaceutical product authorized to be manufactured by this authorization is _________. 3. In accordance with section 21.09 of the Act, this authorization is valid for a period of two years beginning on the date shown below. Granted at ______________ the ___________ day of ________ , ________ ______________________________ FORM 10 APPLICATION FOR RENEWAL OF AUTHORIZATION UNDER SECTION 21.12 OF THE PATENT ACT In the matter of an application for renewal of authorization by ___________ (name of applicant) for export to ________ (name of country or WTO Member) of the following pharmaceutical product: (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act: _________ (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or (b) if the pharmaceutical product is a medical device: ___________ (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations); 1. The undersigned, whose postal address and telephone number are _________, hereby applies for a renewal of authorization number __________ that was granted on ________ (date) authorizing the making, construction and use of the patented invention(s) identified in the patent numbers below, solely for purposes directly related to the manufacture of __________ (unexported quantity) of the above-mentioned pharmaceutical product and its sale for export to the above-mentioned country or WTO Member. 2. For each patented invention to which the application for renewal relates, the name(s) of the patentee(s) of the invention, the name(s) and postal address(es) of the representative(s) of the patentee(s) or, if no representative has been appointed, the postal address(es) of the patentee(s), and the patent number(s) issued in respect of the invention are as follows:
3. The undersigned hereby certifies that (a) the quantities of the pharmaceutical product that were authorized under authorization number __________ to be manufactured and sold for export under section 21.04 of the Act were not or will not be exported before the authorization ceases to be valid; and (b) the undersigned has complied with the terms of the authorization and the requirements of sections 21.06 to 21.08 of the Act. Dated at ________________ the ____________ day of ________ , ________ __________________ Sworn before me this ________ day of ________ , ___________________ ______________________________ FORM 11 RENEWAL OF AUTHORIZATION UNDER SECTION 21.12 OF THE PATENT ACT In the matter of an application for a renewal of an authorization by __________ (name of applicant) for export to ___________ (name of country or WTO Member) of the following pharmaceutical product: (a) if the pharmaceutical product is a drug as defined in section 2 of the Food and Drugs Act: ___________ (name of the pharmaceutical product as set out in Schedule 1 to the Act and, if applicable, the strength, dosage form and route of administration of the pharmaceutical product); or (b) if the pharmaceutical product is a medical device: ___________ (name of the pharmaceutical product as set out in Schedule 1 to the Act, its class, and its identifier within the meaning of section 1 of the Medical Devices Regulations); And in the matter of authorization number ___________ that was granted in accordance with section 21.04 of the Act on __________ (date) to make, construct and use the patented invention(s) identified in patent number(s) ___________ solely for purposes directly related to the manufacture of the quantity remaining to be shipped _________ (quantity) of the above-mentioned pharmaceutical product, and to sell it for export to __________ (name of country or WTO Member); And whereas the applicant has not yet manufactured and exported the above-noted quantity of the pharmaceutical product on the date of its application for renewal; I hereby renew the above-mentioned authorization in accordance with section 21.12 of the Act. Dated at ________________ the ____________ day of ________ , ________ __________________________ REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Description The Use of Patented Products for International Humanitarian Purposes Regulations are made pursuant to recent amendments to the Patent Act (the "Act") introduced by Bill C-9, S.C. 2004, c. 23, An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa). Bill C-9, which received Royal Assent on May 14, 2004, is intended to implement an August 30th, 2003 decision of the General Council of the World Trade Organization (WTO). By that decision, WTO Members agreed to waive certain obligations in the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) which were thought to be a potential barrier to effective responses to health emergencies. The regulations prescribe the forms and other supplementary administrative rules that Parliament considered necessary to complement the amendments brought to the Act by Bill C-9. The TRIPS obligations WTO Members agreed to waive relate to the terms and conditions under which Members can authorize the use of a patented invention without the consent of the patent holder. Formerly, such use could only be authorized "predominantly for the supply of the domestic market". This had the effect of preventing developed countries that are WTO Members, such as Canada, from authorizing the production of low-cost versions of patented medicines solely for export to least developed and developing countries unable to manufacture their own. With the waiver of the domestic supply requirement, developed countries that are WTO Members are now free to authorize exports of this nature. However, to do so, these countries must first implement the waiver by making the necessary changes to their relevant domestic legislation. It is up to each individual country to decide whether, and to what extent, it will give effect to the August 30th decision. With the passage of Bill C-9, Canada is one of the first countries to have amended its legislation accordingly. The amendments contained in the Bill thus establish a legislative framework for a regime which will allow Canadian pharmaceutical manufacturers (typically generic drug companies) to obtain compulsory licences authorizing the manufacture of eligible patented pharmaceutical products for export to eligible importing countries. The eligible pharmaceutical products and importing countries are as they appear in Schedules 1 through 4 of Bill C-9. These schedules can be readily amended by the Governor in Council in order to remain current with international developments. These Regulations and the companion regulations made under the Food and Drugs Act come into force on the day on which Bill C-9 comes into force. Background In 1994, following the Uruguay Round of Multilateral Trade Negotiations under the General Agreement on Tariffs and Trade (GATT), Canada entered into the Agreement Establishing the World Trade Organization. This Agreement included a number of annexed agreements relating to more specialized aspects of the rules governing the international trading environment. One of these, the TRIPS Agreement, sets out the minimum standards of intellectual property protection that must be conferred on rights holders by the national patent and other intellectual property laws of each Member. The amendments implementing TRIPS came into force in Canada in 1996. While the TRIPS provisions pertaining to patents are centred on the exclusive rights and privileges which must be accorded to inventors, they also impose restrictions on a Member's capacity to limit or interfere with those rights. Thus, a Member that wishes to use a patented invention, or authorize the use of that invention by a third party, without the patentee's consent, may only do so to the extent permitted by TRIPS. These restrictions do not amount to a complete prohibition, and until recently had been considered by the WTO to be sufficiently flexible to allow Members to use a patented invention for the purposes of promoting the public interest in matters of vital importance, such as the protection of public health. However, in recent years critics of TRIPS have observed that while the flexibility to authorize non-consensual use of a patent is of potential benefit to developed countries with domestic manufacturing capacity in a particular field of technology, it is of limited succour to countries with insufficient or no such capacity. This is particularly problematic in the pharmaceutical field as it prevents such countries from using TRIPS to address their often very substantial public health problems. As mentioned, this problem is compounded by the fact that TRIPS also requires that any non-consensual use of a patented invention be predominantly for the supply of the domestic market of the country granting the licence. This puts an obvious limit on the ability of countries with manufacturing capacity in the pharmaceutical sector to authorize the manufacture of patented pharmaceutical products for export to countries unable to produce their own. At the 2001 Doha Ministerial meetings, the WTO recognized these problems and issued the Declaration on the TRIPS agreement and public health instructing the Council for TRIPS to find an expeditious solution. In August 2003, TRIPS Council recommended to the WTO General Council that it waive the application of the treaty rules that were preventing Members with insufficient or no manufacturing capacity in the pharmaceutical sector from making effective, public health focussed use of the flexibility said to be inherent in the compulsory licensing provisions of the TRIPS Agreement. In its decision of August 30th, the General Council endorsed the TRIPS Council's recommendation and waived the application of the rules in question. The decision thus allows Members with pharmaceutical manufacturing capability to amend their patent laws to permit the non-consensual use of patented inventions to manufacture and export the pharmaceutical products required by other Members to respond to their public health problems, especially those resulting from HIV/AIDS, malaria, tuberculosis, and other epidemics. The decision also partly waives the TRIPS requirements relating to the payment of compensation to the patentee for the non-consensual use of the patented invention, directing instead that adequate remuneration be paid taking into account the economic value to the importing country of the use that has been authorized in the exporting country. As noted above, the amendments to the Act set forth in Bill C-9 are designed to give effect to the WTO decision in Canada by permitting the grant of "export-only" compulsory licences to Canadian pharmaceutical manufacturers who wish to supply countries having inadequate or no pharmaceutical manufacturing capabilities with lower cost versions of patented pharmaceutical products. Outline of the International and Domestic Compulsory Licensing Scheme The new provisions of the Act establish the procedure to be followed by domestic pharmaceutical manufacturers when applying for a compulsory licence to manufacture a specified quantity of an eligible patented pharmaceutical product for export to an eligible importing country. The WTO – international scheme Both the WTO decision and the new provisions of the Act anticipate that the procedure for applying for an export licence is to be initiated internationally by an "eligible importer" – a requesting Member – posting a notice on a dedicated WTO website. That notice must identify the name and the quantity of the required product and, if the product is protected by a domestic patent, indicate the Member's intention to issue a compulsory licence authorizing imports of the product in question. Unless the importing Member is a least developed country, the notice must also contain a declaration by that Member that it has no or insufficient capacity to manufacture the required product. As an agreement between Member countries of the WTO, the August 30th decision does not apply to countries not party to that organization. Nevertheless, Canada has chosen to implement the decision in a manner that enables both developing and least developed non-WTO Member countries to participate as importers of eligible patented pharmaceutical products. While this technically exceeds the boundaries of TRIPS and the WTO General Council's August 30th decision, Parliament was of the view that, insofar as least developed countries are concerned, the moral imperative of assisting them outweighs the risk of any trade challenge that may arise as a result. These countries have therefore already been listed as eligible importers under Schedule 2 of Bill C-9. As for the less vulnerable non-WTO Member developing countries, they are not automatically eligible to import but can be individually added to Schedule 4, on request, following an assessment by the Governor in Council. However, only those countries that are eligible for official development assistance according to the Organization for Economic Co-operation and Development (OECD) may qualify for consideration. Given that non-Member countries are not accountable to the WTO, alternative means of ensuring their adherence to the principles set down by the August 30th decision were considered necessary. Accordingly, further criteria were developed which reflect the essence of the obligations WTO Members must subscribe to in seeking to import licenced versions of patented pharmaceutical products under the terms of the August 30th decision. In the case of a least developed country, failure to adhere to these criteria would constitute grounds for removing it from Schedule 2 and for terminating any outstanding licence operating to that country's benefit. In the case of a developing country, agreeing to these criteria would be a condition precedent for being added to Schedule 4 and, once added, would likewise constitute grounds for removing it from the Schedule and terminating a licence in the event of non-compliance. Just as WTO Members seeking to import eligible pharmaceutical products are expected to initiate that process by notifying the WTO, the Bill C-9 amendments require non-WTO countries to do so by providing written notice to the Government of Canada through diplomatic channels. A copy of any such notice received by the Government will be posted on a website maintained by the Minister of Foreign Affairs. The domestic scheme – application for licence A Canadian pharmaceutical manufacturer that wishes to supply a low cost version of a patented pharmaceutical product to an eligible importing country must file an application for an "export-only" compulsory licence with the Commissioner of Patents ("Commissioner"). The application must indicate, inter alia, the pharmaceutical product for which a licence is sought, the quantity to be manufactured, the patents which protect it, the country to which it is to be exported and the identity of the purchaser. The application must also include a declaration that the applicant had, at least 30 days prior to applying for the compulsory licence, unsuccessfully sought a voluntary licence from the patentee and, in doing so, provided the latter with information that is substantially the same as the information appearing in the application. This declaration must be accompanied by, in the case of a WTO Member, a copy of that country's notification to the WTO of its intention to import the product to which the application relates and, in the case of a non-WTO Member, a copy of the country's notice to the Government of Canada of its intention to import that product. In either case, the applicant must also provide the Commissioner with a declaration setting out the patent status of the product in the importing country. The manner in which the above information is communicated to the Commissioner is prescribed by the regulations. Form 1 of the regulations sets out the information which must appear in the application itself. Form 2 sets out the information which must appear in the applicant's declaration that it unsuccessfully sought a voluntary licence from the patentee at least 30 days prior to the date of the application. Forms 3 to 7 set out the information which must appear in the applicant's declaration as to the identity of the pharmaceutical product and its patent status in the importing country. Whichever of Forms 3 to 7 applies in the circumstances will depend on the Schedule on which the importing country appears and the patent status of the product in that country. If the application meets the content requirements described above, specifies an eligible product on Schedule 1 which the Minister of Health has notified is compliant with the Food and Drugs Act as being safe, efficacious, of good quality and distinctive from the innovator's version of the product sold in Canada, and names a country on any one of the Schedules of eligible importers in Bill C-9, the Commissioner is required to grant the applicant an authorization (i.e., a compulsory licence) to manufacture and export the product in question. The actual content of the licence issued by the Commissioner is set out at Form 9 of the regulations. The domestic scheme – renewal An export licence is valid for a maximum period of two years and can be renewed only once for an equal period, on application by the licencee. An applicant seeking renewal of a licence must certify that the quantity of the product that had been authorized to be made and exported had not been fully exported within the initial two year term and that the applicant has otherwise complied with the terms of the licence and its statutory obligations to establish a website disclosing the particulars of the authorized transaction and to pay the patentee the required royalty. Where these conditions are sworn to by the licencee in Form 10 of the regulations, the Commissioner will issue the renewed licence, as it appears in Form 11. Duty to maintain website Before a pharmaceutical product subject to a licence may be exported, the licencee must establish a website on which is set out information about the name of the licenced product, its distinguishing characteristics, the identity of the importing country, the amount to be manufactured and sold for export, as well as information identifying every known party that will be handling the product while it is in transit from Canada to the eligible importing country. The regulations prescribe the particulars of the information which must be disclosed in this context, including, for example:
The duty to maintain the website by disclosing these particulars remains ongoing throughout the validity period of the licence. Duty to pay royalties Paragraph 3 of the August 30th WTO decision calls for "adequate remuneration" to be paid to the patentee on a case-by-case basis, taking into account the economic value to the importing country of the use that has been authorized by the exporting country. The provisions in Bill C-9 which implement this obligation require that the royalty payable by the licencee to the patentee be determined in accordance with a formula to be prescribed by regulation. This regulatory formula must take into account the humanitarian and non-commercial reasons underlying the issuance of an export licence. The regulatory formula calculates the royalty by multiplying the monetary value of the supply agreement between the licencee and the importing country by an amount which fluctuates on the basis of that country's standing on the United Nations Human Development Index (UNHDI). The formula to determine the royalty rate is: 1, plus the number of countries on the UNHDI, minus the importing country's rank on the UNHDI, divided by the number of countries on the UNHDI, multiplied by 0.04. For example, in 2004 Nigeria was ranked number 151 of the 177 countries listed on the UNHDI. Therefore, the royalty rate that would be applicable to exports of pharmaceutical products to Nigeria would be [(1+177-151)/177] x 0.04 = 0.0061 or 0.61 percent. According to this formula, the royalty payable in respect of the lowest eligible country which currently appears on the UNHDI would be 0.02 percent, and the highest 3.5 percent. Mathematically, the regulatory formula cannot result in a royalty rate in excess of 4 percent, a ceiling which is considered consistent with the humanitarian and non-commercial considerations which gave rise to the August 30th decision and the Bill C-9 regime. In the rare instance where a country is not listed on the UNHDI, the royalty is to be calculated by substituting the individual country's rank in the formula with the average rank of all countries appearing on the same Schedule. However, an exception to this rule has been made in the case of non-WTO Member developing countries that are unranked. Although these countries are individually eligible for listing on Schedule 4, their individual rank in the formula will be replaced by the average rank of all countries appearing on Schedule 3, as the latter is thought to better reflect the level of development of the countries in question. Bill C-9 also provides that a licencee is required to pay royalties within the prescribed time, on the occurrence of a prescribed event. The regulations make the royalty due and payable in full within 45 days of the export notice which Bill C-9 requires the licencee provide to the patentee at least 15 days before the product is exported. Where there is more than one shipment of the product, the amount of payment that becomes due would be in proportion to the total quantity of product to be exported. The good faith clause According to the WTO, the August 30th decision was adopted by the General Council in light of the General Council Chairperson's statement stipulating that it must be used in good faith in order to deal with public health problems and not for commercial policy objectives. Bill C-9 contains a "good faith clause" intended to give effect to Canada's obligation to implement the August 30th decision in keeping with the Chairperson's statement. It does this by providing patentees with the right to challenge a licence in Court where there is good cause to believe it is commercial, as opposed to humanitarian, in nature. Under that clause, a patentee who believes a licence is commercial in nature can make an application to the Federal Court for a number of legal remedies. To do so, the patentee must first establish that the average price of the licenced drug is 25 percent or more of the average price of the equivalent patented brand name drug in Canada. If this test is met, the Court will look to the merits of the application and determine, based on a number of statutory considerations, whether the licence is commercial in nature and, if so, what remedies apply. To allow for the determination of the average price of the licenced drug, Bill C-9 requires that the licencee provide the Commissioner and the patentee with a copy of its supply agreement with the importing country and indicate its total monetary value and the number of units of pharmaceutical product sold. This information must be filled out in Form 8 of the regulations. The regulations also prescribe the price publications which must be taken into account when determining the average price of the equivalent patented brand name drug in Canada for the purposes of the good faith clause. The first two publications indicate the prices paid by the Provincial governments of Ontario and Québec in reimbursing the pharmaceutical expenditures of certain classes of residents covered by Provincial health insurance programs. These were selected because they represent the two largest public reimbursement programs in Canada and are consistent with the prices paid by other public insurers across the country. The third publication is a private formulary maintained by PPS Pharma which reproduces the price lists provided by Canadian pharmaceutical manufacturers to private purchasers. It should be noted that these latter prices do not depart significantly from those appearing in public formularies and should not have an appreciable impact on the determination of average price. Alternatives The regulations are necessary in order to render Bill C-9 operational. As noted above, Parliament contemplated that its statutory scheme, although quite detailed in some respects, would nevertheless need to be supplemented by regulations respecting administrative matters, the forms to be completed and some of the information to be disclosed in the course of seeking a licence to use a patented invention without the consent of the patentee for the humanitarian purposes which underscore the amendments to the Act resulting from Bill C-9. Since Parliament itself contemplates that these complementary administrative regulations are necessary to make its legislative scheme operational, no alternative measures were considered. Benefits and Costs The benefits of the regulations are the standardization and simplification of the procedures to be followed in the course of seeking an authorization – an "export only" compulsory licence – to use a patented invention without the consent of the patentee. As one of the first countries to implement the August 30th decision, Canada is acting as a leader in this important humanitarian initiative and will encourage other similarly fortunate countries to follow suit. The regulatory requirements have been kept to a minimum and, as just noted, are designed to simplify the procedure for obtaining an "export only" compulsory licence. They should not therefore impose a serious burden on potential applicants. In keeping with the non-commercial nature of Bill C-9, the Government will cover the administrative costs of the regulatory scheme by reimbursing the Commissioner for expenditures ordinarily incurred in processing an application for a licence or a renewal of same. Consultation The Government held informal consultations with the brand name and generic pharmaceutical manufacturing industries and with a number of non-governmental organizations (NGO) prior to the pre-publication of the proposed Regulations in the Canada Gazette, Part I, on October 2, 2004. Following pre-publication, interested persons were given 75 days to formally comment on the proposed new rules. Eight submissions were received from a variety of sources representing either the brand name or generic pharmaceutical industries and NGOs. In general, the submissions were supportive of the Government's proposed regulations. However commentators did suggest a number of changes which they believed would increase transparency, minimize diversion and improve the overall effectiveness of the regime. The most salient of these are summarized below. Suggested changes which have been incorporated into the final text of the regulations are noted and a short rationale given for those that have not. Buying groups/Regional trade organizations One commentator expressed concern that Bill C-9 and its regulations do not anticipate the possibility that buying groups or regional trade associations may wish to purchase pharmaceutical products on behalf of several eligible importing countries at a time. To address this, it was suggested that the formula for calculating royalty payments in such cases be changed to take into account the UNHDI ranking of each individual country in a buying group. It was also suggested that the regulations include a provision clarifying who has standing to apply for a compulsory licence. The Government recognizes that the August 30th decision endorses bloc buying by regional trade organizations as a means of harnessing economies of scale and enhancing the purchasing power of countries suffering from the same health problems. Bill C-9 contemplates this to the extent that it allows the re-exportation of licenced products from one eligible importing country to another, provided it is in a manner not contrary to the August 30th decision. Although no provision is made in the regulations for the calculation of a royalty rate which takes into account the UNHDI rank of each individual country in a particular buying group, such groups tend to be composed of countries having substantially the same development status. In any event, and as explained above, the royalty rate remains a marginal one even for the highest ranked countries and therefore failure to consider the individual rank of composite countries in a buying group should not make a meaningful difference in terms of the overall purchase price of a particular pharmaceutical product. However, should Bill C-9 eventually prove uncompromising on this front, this is an issue which can be revisited in the context of the statutorily mandated review of the legislation to take place two years from its coming into force. Website A number of comments were received regarding the duty of a licence holder to establish a website disclosing certain information about the product to which the licence relates. Several commentators noted that while subsection 21.06(2) of Bill C-9 requires the licence holder to "maintain" a website, it does not specify how current the posted information must be. To make this obligation more meaningful, it was suggested that the regulations assign specific time lines for the posting of various information. For example, one commentator requested that information relating to product shipments be posted no later than 15 days from the date of shipment. In terms of the request to specify precisely what is meant by "maintain" in this context, the Government is concerned that imposing strict deadlines for the performance of certain acts could lead to the termination of a licence on relatively trivial grounds. It is sufficient that the licence holder comply with its existing obligation under section 21.06 of Bill C-9 to establish a website disclosing the prescribed information prior to exporting a licenced product. As for the disclosure of shipment details, section 21.07 of the Bill already requires the licence holder to provide the patentee, the Commissioner and the importing country with shipment information within 15 days before export. Patentees thus have the ability to track all amounts shipped under a compulsory licence. Requiring the public posting of this information within a specified period of time would impose an additional and largely redundant burden on the licence holder. Lastly, one commentator requested that the "distinguishing physical features" a licence holder is obligated to post on its website in accordance with paragraph 7(e) of the Regulations also include a photograph of the product and its label and specify its precise colour. The Government agrees that specifying the distinctive colour of the licenced product will improve the overall transparency of the regime and has amended the regulations accordingly. The Government would also encourage licence holders to include photos of product on their websites, where feasible, but is reluctant to impose such a requirement in the absence of any specific legal obligation to do so under the terms of the August 30th decision. Voluntary Licence Paragraph 21.04(3)(c) of Bill C-9 requires that an applicant for a compulsory licence provide a solemn or statutory declaration stating that at least 30 days prior to applying for the compulsory licence, it had unsuccessfully sought a voluntary licence from the patentee on "reasonable terms and conditions". One commentator suggested that "reasonable terms and conditions" should be defined in the regulations because any ambiguity in this regard might prompt a patentee to contest the validity of a licence on the ground that the terms suggested by the licence holder were unreasonable. The duty to seek a voluntary licence from the patentee prior to applying for a compulsory licence originates with article 31(b) of the TRIPS Agreement. Thus the meaning to be attributed to the term "reasonable" in both instruments is the same, subject of course to the humanitarian considerations which gave rise to the August 30th Decision and which underlie a request for a voluntary licence in this context. However, any attempt to define what constitutes "reasonable terms and conditions" is fraught with difficulty as this may vary considerably with the circumstances of each application. Indeed, use of the term "reasonable" as a qualifier in statutory language is often necessary where a definition would be too rigid, as is the case here. Calculation of Royalty Fee One commentator requested clarification of the term "total monetary value" as it is used in paragraphs 8(4)(a) and 8(6)(a) of the regulations for the purpose of calculating the royalty payments the licence holder must pay to the patentee. As pre-published, the regulations proposed a formula which calculates royalty payments by multiplying "the total monetary value of the pharmaceutical products to be manufactured and exported" under the compulsory licence by the royalty rate. Stated in this way, it could be construed that royalty payments are to be calculated as a function of the value these products would have on the Canadian market. This was not the intended meaning of the provisions in question. As explained in the original Regulatory Impact Analysis Statement (RIAS) which accompanied the regulations upon pre-publication, the Government intended that royalty payments be calculated by "multiplying the monetary value of the supply agreement between the licencee and the importing country" by the royalty rate. To confirm that royalties are to be calculated on the basis of the value of the agreement between the licence holder and the importing country, and not the value of the products in Canada, the phrase "total monetary value of the pharmaceutical products" has been deleted from paragraphs 8(4)(a) and 8(6)(a) and replaced with "total monetary value... of the agreement". Medicinal Ingredient Two commentators suggested that the licence holder should be required to indicate the active medicinal ingredient in the pharmaceutical product, in addition to its dosage form, strength and route of administration, as part of the information to be posted on its website and on Forms 2 to 11 as this would better identify the pharmaceutical product that is subject to the compulsory licence. The Regulations have thus been amended to require the licence holder to post the name of the pharmaceutical product "as set out in Schedule 1...". Schedule 1, it will be recalled, identifies the eligible pharmaceutical products by their generic constituent but also specifies, where applicable, the particular form (e.g., salt, hydrate, solvate) of the constituent which appears in the product. Application Number Two commentators observed that under the proposed system, the Minister of Health assigns a tracking number to each drug approval application and the Commissioner assigns a number to each application for a compulsory licence. In order to be able to cross-reference the particulars of the compulsory licence application with those of the corresponding product under review by the Minister, it was suggested that these two numbers be linked or, alternatively, that the licence holder be required to post the application number assigned by the Commissioner on its website. In response to these comments, Health Canada and the Canadian Intellectual Property Office have agreed to generate one tracking number for both the compulsory licence application and the application for regulatory approval to export. This will be the same number that, as required by the companion amendments to the Food and Drug Regulations, the licence holder must include on all its product labels. Renewal of authorization Two commentators suggested that Forms 10 and 11 be amended to include language indicating that a renewal of a licence pertains only to the balance remaining of the quantity originally authorized for export and, further, that this amount be specified on those forms. These comments appear to reflect a concern that a licence holder will use a renewed licence to export more product than was originally authorized. From section 21.12 of Bill C-9 it is clear that a renewal applies only to the remainder of the quantity originally authorized for export that has not yet been shipped at the time the licence ceases to be valid. Restating this fact on the renewal form would not make the law any more binding in this regard. Furthermore, as explained above, patentees already have the ability to track all amounts shipped under a licence pursuant to section 21.07 of the Bill which requires a licence holder to provide the patentee with an export notice indicating the amount to be exported within 15 days before each shipment. However, specifying the remaining quantity to be exported upon applying for a renewal is in no way onerous on the licence holder and, for greater certainty, a requirement to do so will appear on the forms in question. Good faith clause Another commentator took issue with language in the RIAS describing the relationship between the good faith clause in Bill C-9 and the WTO General Council Chairperson's statement in light of which the August 30th decision was adopted. It will be recalled that the Chairperson's statement reflects a shared understanding by WTO members that the August 30th decision is to be used in good faith in order to deal with public health problems and not for commercial policy objectives. Specifically, the commentator objected to the statement in the RIAS that the good faith clause "is intended to give effect to Canada's obligation to implement the August 30th decision in keeping with the Chairperson's statement". This statement was objected to because, in the commentator's view, it suggests that the Government regards the good faith clause as specifically required in order to ensure Bill C-9's compliance with the August 30th decision. This is not the case. As explained, the Government has the discretion to determine how best to implement the various obligations attendant to the August 30th decision and, insofar as the obligation to ensure that the decision not be used for commercial policy objectives is concerned, chose this particular policy instrument by which to do so. This is not to say, however, that alternative measures could not be conceived which would implement this obligation in an equally compliant manner. On this same question, the commentator also opined that by circumscribing the commercial behaviour of licence holders, the good faith clause goes beyond the obligations identified in the Chairperson's statement which are binding only on WTO Members (i.e., governments) not private sector entities. However, given that the Government is, by definition, not a commercial actor, the commercial character of its policies can only be assessed in terms of their impact on the market behaviour of private sector interests. For example, if the Government introduced measures designed to facilitate and promote lucrative commercial transactions which would otherwise constitute illegal or infringing acts it would, in that instance, be pursuing a commercial policy objective. In the present context, the good faith clause ensures that Bill C-9 cannot be used in this manner and can thus be said to "give effect" to the Chairperson's statement. Amending Schedule 1 Finally, one commentator suggested that the regulations should prescribe the process by which the list of eligible pharmaceutical products in Schedule 1 may be amended. Section 21.18 of Bill C-9 stipulates that an advisory committee will be established by the Minister of Industry and the Minister of Health within three years of the coming into force of the regime. The advisory committee will advise both Ministers on the recommendations they may make to the Governor in Council respecting the amendment of Schedule 1. The Government intends to establish the advisory committee as soon as possible after Bill C-9 and the present regulations come into force, at which point it will elucidate on the process envisaged for amending Schedule 1. Compliance and Enforcement The "export only" compulsory licensing scheme is centred on amendments to the Act and so the regulations are to be administered under the supervision of the Commissioner. Enforcement mechanisms are set out in Bill C-9. The Federal Court is granted the jurisdiction to terminate a compulsory licence for non-compliance with the provisions of Bill C-9 or the regulations. Contact Susan Bincoletto S.C. 2004, c. 23, s. 1 S.C. 2004, c. 23, s. 1 S.C. 1993, c. 15, s. 29 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
NOTICE:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
