AIPPI INTERNATIONAL ASSOCIATION FOR THE PROTECTION OF INTELLECTUAL PROPERTY SPECIAL COMMITTEE Q94 QUESTIONNAIRE NO. 4 on the IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON TRIPS AND PUBLIC HEALTH Answer of the Canadian National Group 1
1. QUESTION 1 Steps to implement the WTO decision In the preamble to the WTO General Council decision, reference is made to the instruction of the Ministerial Conference in Doha, 2001 that an expeditious solution is to be found for the difficulties in some WTO member countries in regard to access to pharmaceutical products. 1.1 Are you aware of any actual or impending legislative amendments in your country, including, statements of intention to introduce amendments, consultation processes with a view to legislative amendments, proposals for new or amended legislation already enacted legislation with a view to implementing any or all of the features of the WTO Council decision? X Yes If yes, please provide details such as Government Act, Regulation, Proclamation or Bill no. Proposal or Policy Paper details Website information for text Other details The following federal Canadian legislation pertains to Canada s implementation of the WTO Council decision August 30, 2003: Bill C-9, An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), 3 rd Sess., 37 th Parl., 2004, (assented to 14 May 2004), S.C. 2004, c. 23. [the Act ]. The purpose of the Act is to amend the Patent Act, R.S.C. 1985, c. P-4 and the Food and Drugs Act, R.S.C. 1985, c. F-27 to allow the Commissioner of Patents to authorize the production, sale and export of patented medicines in accordance with the WTO Council decision. Website Information for text: pdf. version available at http://www.parl.gc.ca/pdf/37/3/parlbus/chambus/house/bills/governme nt/c-9_4.pdf Information on Bill C-9 at http://www.cptech.org/ip/health/c/canada/c9.html 2
The Act has been enacted but has not yet come into force (as of November 8, 2004). Coming into force will require a proclamation by the Government of Canada. On October 2, 2004 proposed regulations under the amendments to the Patent Act and Food and Drugs Act were published. There is a 75-day period to make representations regarding the regulations; this ends December 17, 2004. The representations will be considered and a final version of the regulations will be published, with the Act being proclaimed into force a short time later. Presently, Canadian government officials have indicated that they anticipate the Act being proclaimed in the February/March 2005 time frame. 1.2 Has your country made any changes to your laws to provide for importation licences in respect of pharmaceutical products? If so, please provide details. Yes Act / Regulation / Proclamation no. Website information for text Other details Canada has not made any changes to provide for importation licences. Regarding importation, Canada has opted out of the system set out in the WTO General Council decision of August 30, 2003. 1.3 Has your country made any changes to your laws to provide for exportation licences in respect of pharmaceutical products? If so, please provide details. X Yes Act / Regulation / Proclamation no. Website information for text Other details Bill C-9, which is referenced in question 1.1 above, contains provisions that permit the Commissioner of Patents to authorize production of patented medicines for sale and export. Any such export licences will be subject to the conditions as set out in s. 1 of the Act. 3
2. QUESTION 2 Identification of eligible importing countries Clause 2(a) of the WTO decision requires eligible importing Member countries to make a notification to the TRIPS Council recording certain information. (Note: the countries specified in Note 3 of the decision have already indicated that they will not use the compulsory licensing system as importing countries). 2.1 Are you aware - Whether your own country has filed a notification as an eligible importing Member country, and if so, when? Yes Date: Canada is a Member country listed in Note 3 of the decision indicating they will not use the compulsory licensing system as an importing country. 2.2 Whether any other country/countries have filed such a notification, and if so, which countries? Countries and dates: We are not aware of any specific notices to the TRIPS Council that contain the information required under clause 2(a) of the WTO decision. However, Bill C-9 does recognize this requirement, specifically, the amendment to the Patent Act to include s. 21.04(3)(d). This section requires compliance with all of the terms in clause 2(a) before the Commissioner of Patents can authorize use of the patented invention. Bill C-9 also contains, in Schedules 2, 3 and 4, lists of eligible importing countries. To be listed in a Schedule a country must fulfil the requirements of s. 1 of the Act. Section 1 provides for the addition of s. 21.03 to the Patent Act. Before being added to a Schedule, a WTO Member country must have provided the TRIPS Council with a notice in writing stating that the country intends to import, in accordance with the General Council Decision, pharmaceutical products, as defined in paragraph 1(a) of that decision. Schedule 2, 3 and 4 the Act can be found at the website in answer 1.1. 4
The notice for inclusion in a Schedule is a general notice and not the specific notice called for in both clause 2(a) of the WTO decision and s. 21.04(3)(d) to be added to the Patent Act. 2.3 If your answer to 2.1 is Yes, are you aware of any compulsory licences granted in your country for the importation of pharmaceutical products, and if so, do you have any details as regard licensor, licensee, products covered, etc? Yes N/A 3. QUESTION 3 Granting, notification and information of export licences Clause 2(b) of the WTO decision deals with compulsory licences granted in exporting Member countries for the exportation of pharmaceutical products in terms of the waiver of TRIPS Art 31(f). 3.1 Are you aware of any compulsory licences which have been granted in your country for the exportation of pharmaceutical products to eligible importing member countries? If so, please provide details of which you are aware, such as licensor, licensee, products covered, etc. Yes No compulsory licences have been granted under the new legislation discussed in Question 1.1 above as the legislation has not yet been proclaimed into force. 3.2 Clause 2(c) of the WTO decision requires notification to the TRIPS Council by an exporting member country of the grant of any such compulsory licences. Are you aware of such a notification having been made, and if so, when? Yes Date(s): 5
The legislation in Canada is not yet in force. Therefore, there have been no opportunities to provide such notification. The Act does not include a specific requirement for notice to the TRIPS Council as called for in subparagraph 2(c) of the WTO General Council decision. 3.3 Clause 2(b) requires a licensee under such a compulsory licence to post certain information on a website. Are you aware of any such website? and if so, please provide details. Yes We are not aware of any such website and to-date none are required because there have been no compulsory licences issued. The Act in s. 1 amends the Patent Act to include s. 21.06 which requires a website to be created and the appropriate information posted before any exports can take place under an authorization granted by the Commissioner of Patents. 4. QUESTION 4 Prevention of re-exportation/diversion of imported products Clauses 4 and 5 of the WTO decision deal with the need to prevent reexportation of products imported into eligible importing countries under the licensing system. Are you aware 4.1 Whether special measures (in laws or otherwise) have been introduced in your country to prevent re-exportation of products? If so, please provide details, such as Government Act, Proclamation, export restriction, etc X Yes We are not aware of any special measures regarding re-export from Canada. Given that Canada is a non-importing country, such measures are not necessary in Canada itself. However, the Act amends the Patent Act to include s. 21.14(f) and s. 21.04(3)(b) which both act to prevent reexportation of products produced in Canada. Section 21.14(f) will allow the Federal Court, on application by the patentee, to terminate authorization where: 6
21.14(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. Section 21.04(3)(b) requires notification by the Minister of Health that the product meets the requirements of the Food and Drugs Act and its regulations, including: the requirements under those regulations relating to the marketing, embossing, labeling and packaging that identify that version of the product as having been manufactured (i) in Canada as permitted by the General Council Decision (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 4.2 Whether any technical or financial cooperation or assistance has been provided to developing or least-developed countries to prevent trade diversion and re-exploitation? If so, please provide details, such as type of assistance, receiving country, etc. Yes We are not aware of any such assistance at this time. 5. QUESTION 5 Waiver of TRIPS Art 31(f): domestic market supply Clause 6 provides for the waiver of TRIPS Art 31(f), ie the restriction to use predominantly for the supply of the domestic market, in respect of developing and least-developed member countries which are parties to a regional trade agreement, to permit exportation to other parties of the regional trade agreement of products imported or manufactured under compulsory licences. Are you aware 7
5.1 In the event that your country falls within the provisions of Clause 6, whether use has been made of the exportation provisions of Clause 6? If so, please provide details. Yes N/A. Canada does not fall within the provisions of Clause 6. 5.2 In the event of exportation from your country in terms of a compulsory licence to a country/countries falling within the provisions of Clause 6, whether use has been made of the exportation provisions of Clause 6? If so, please provide details. Yes N/A 6. QUESTION 6 Technology transfer and capacity building Clause 7 provides for the promotion of technology transfer and capacity building in the pharmaceutical sector by using the compulsory licensing system of the WTO decision. Are you aware of any such technology transfer or capacity building initiatives, in your own country or elsewhere? If so, please provide details. Yes We are not aware of any such technology transfer or capacity building initiatives in Canada or elsewhere. Submitted on behalf of the Canadian Group by Steven B. Garland November 8, 2004 8