The Limitations of Canada’s Access to Medicines Regime: Lessons from Apotex’s export of essential medicines to Rwanda

by Jenna Himelfarb

INTRODUCTION

Canada’s Access to Medicines Regime (CAMR) is a system under which least-developed and developing countries can import medicines manufactured in Canada that are needed to treat their public health concerns. It has only been used once. Apotex, Inc. (Apotex) exported an anti-retroviral HIV/AIDS medication to Rwanda. This essay will discuss how the high administrative burdens associated with CAMR make it ineffective, thereby discouraging its use by pharmaceutical companies that would otherwise be willing to supply essential medicines to least-developed and developing countries.

CONTEXT – Understanding TRIPS, The Doha Declaration, and CAMR

The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is an international agreement administered by the Word Trade Organization (WTO). Since its adoption in 1994, TRIPS has outlined intellectual property norms to be followed by all WTO Member states. It regulates international trade and the procedure for resolving international intellectual property disputes.[1]

TRIPS also creates conditions for compulsory licensing regimes. Article 31 sets out conditions that apply when a WTO Member’s domestic law allows for compulsory licensing.[2] Of particular controversy is Article 31(f), which says that where there is a compulsory licensing scheme in a Member country, “any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use”.[3] This effectively prevents the export of medicines from developed Member countries with compulsory licensing schemes.

In response, WTO adopted the Doha Declaration on the TRIPS Agreement and Public Health in 2001 (Doha Declaration), which reaffirmed the flexibility of TRIPS. The Doha Declaration recognized that intellectual property protection has effects on the prices of essential medicines, and that these must be considered in evaluating intellectual property protection and its importance for development and innovation.[4] Paragraph 6 of the Doha Declaration recognizes that:

“WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement.”[5]

The WTO instructed the Council for TRIPS[6] to recommend a solution. In 2003, a recommendation was made which waived Article 31(f) of TRIPS for any least-developed country Member of WTO or any Member that has established that it has “insufficient or no manufacturing capacities in the pharmaceutical sector for the product(s) in question”.[7]

In the context of paragraph 6 of the Doha Declaration, developed countries can export pharmaceuticals to those countries with emergent health crises that would not otherwise have access to essential medicines. It was not until 2005 that this amendment to TRIPS was finally approved by WTO Members.[8] However, the changes cannot be formally included in TRIPS until at least two thirds of WTO Members accept the change. To date, the WTO has not met this threshold. The waiver recommended in 2003 remains in effect today, and will likely remain in effect until the changes can be formally adopted.[9]

Although it has not been formally adopted, some WTO Members have passed domestic legislation to implement the 2003 decision. In May 2004, Canada passed An Act to amend the Patent Act and the Food and Drugs Act, known as The Jean Chretien Pledge to Africa Act.[10] The stated purpose of the Act is to “facilitate access to pharmaceutical products to address public health problems affecting many developing and least- developed countries”.[11]

CAMR was implemented in May 2005, shortly after the Act was passed. The goal of CAMR is to “facilitate timely access to generic versions of patented drugs and medical devices, especially those needed by least-developed or developing countries to fight HIV/AIDS… and other diseases”.[12] While CAMR is based on the framework laid out by WTO in 2003, there are features that make the regime unique. The Canadian Government has said that some of the distinctive measures include CAMR’s:

“reliance on pre-approved lists of products eligible for export and countries eligible to import them and making the grant of an export licence contingent upon the health and safety review of the product by the exporting country’s regulatory authority. In addition, whereas many other regimes waive the requirement that a pharmaceutical manufacturer request a voluntary licence from the patent holder(s) prior to applying for a compulsory licence, in cases of a national emergency or circumstances of extreme urgency, CAMR does not”.[13]

As discussed below, these administrative burdens make CAMR more exacting than the regime envisioned by the WTO.[14]

CASE STUDY – The Use of CAMR by Apotex to Ship Pharmaceuticals to Rwanda

Apotex is the largest producer of pharmaceutical drugs in Canada. It produces over 300 generic pharmaceuticals and exports to over 115 countries, with sales exceeding $1 billion every year.[15]

In December 2004, only months after The Jean Chretien Pledge to Africa Act was passed, and before the implementation of CAMR, Apotex agreed to develop a new anti-retroviral drug called Apo-TriAvir, which combined three medicines used in the treatment of HIV/AIDS.[16] An active prototype was developed by April 2005. While all the components of Apo-TriAvir were listed, the new composite drug was not on the list of products eligible for compulsory licensing pursuant to the Patent Act. The Patent Act defines a “pharmaceutical product” as “any patented product listed in Schedule 1” of the Act.[17] If a product is not listed in Schedule 1, it cannot be eligible for export under CAMR. To have the Patent Act amended requires having recommendations from both the Minister of Industry and the Minister of Health to the Governor in Council, who then uses his/her discretion to determine whether an amendment should be made.[18] Schedule 1 was amended to include Apo-TriAvir in September 2005.

It was only after this step was complete that Apotex was able, in December 2005, to submit a request to Health Canada, Canada’s regulatory authority, to manufacture Apo-TriAvir in quantities for export. Under CAMR, manufacturers of pharmaceuticals are required to “submit scientific evidence of a product’s safety, effectiveness and quality… before receiving permission to export it”.[19]

The manufacturer is also required to provide Health Canada with information to demonstrate that the product intended for export will comply with the Food and Drug Regulations. This requires the manufacturer to show that it has incorporated “anti-diversionary” measures meant to ensure that medical products are not sent to unintended markets. For example, there are strict labeling requirements and the colours of pills must be different than the ones sold in Canada. In addition, the manufacturer is required to maintain a website with information about the new drug to be exported.

These regulatory steps are not required under the framework laid out by WTO. They are additional administrative steps required only under CAMR. Health Canada is given twelve months to complete this review process. They approved Apo-TriAvir in June 2006, six months after the application was submitted.[20]

The Jean Chretien Pledge to Africa Act sets out conditions that must be met before a compulsory licence will be granted. It requires that an applicant “sought from the… patentees… a licence to manufacture and sell the pharmaceutical product for export to the country or WTO Member named in the application… and that such efforts have not been successful”.[21] Accordingly, Apotex had to seek voluntary licences from each party that owned patents over the medicines necessary to develop Apo-TriAvir before being able to begin the process of getting a compulsory licence. These negotiations are not required under TRIPS nor are they required under the 2003 decision; they are required only under CAMR.

Apotex began negotiations in July 2007. Each of the major patent holders published press releases signifying that they would be willing to grant the voluntary licences.[22] Despite indications that there would be eventual support for the voluntary licensing of Apo-TriAvir, Apotex went forward and applied for a compulsory licence.[23]

According to Apotex, “GSK and Shire did not oppose the application, but chose not to grant a voluntary licence… Boehringer Ingelheim was also not prepared to freely grant a licence.”[24] Bruce Clark, then the Vice-President, Regulatory and Medical Affairs of Apotex, stated that by not providing any voluntary licences, “the brand side of the industry” forced Apotex to apply for compulsory licences.[25] In September 2007, after negotiations for voluntary licensing had reportedly stalled, Apotex filed an application under CAMR to export Apo-TriAvir.

The application complied with The Jean Chretien Pledge to Africa Act requirement that it be submitted, at earliest, thirty days after voluntary negotiations had begun.[26] The Commissioner of Patents granted this application fifteen days later. The compulsory licence granted Apotex the right to “make, construct and use, the patented inventions… solely for purposes directly related to the manufacturing of [Apo-TriAvir], and to sell it for export”.[27]

In October 2007, Canada informed WTO that it had granted authorization to a company to “make a generic version of a patented medicine for export under special WTO provisions agreed in 2003”.[28]

During the time of the negotiations in July 2007, three months prior to the granting of the compulsory licence by Canada, Rwanda became the first country to notify WTO of its intention to import generic drugs under the compulsory licensing scheme adopted in the 2003 decision.[29] Because Rwanda is a least-developed country, it is automatically an “eligible importing member” under paragraph 1(b) of the 2003 decision and it does not have to apply for such status by demonstrating its lack of manufacturing capacity. The government of Rwanda made clear in its notification to WTO that it intended to import 260,000 packs of Apo-TriAvir.[30]

Despite the stated intention to buy the drugs from Apotex in Canada, Rwanda opened a public tender for the supply of Apo-TriAvir in October 2007.[31] Rwandan domestic law requires the issuing of tenders whenever drugs are imported. Dr. Innocent Nyaruhirira, the Rwandan Health State Minister for Aids and other Pandemics at the time, said that no formal deal had been made with Canada and that the importer would be confirmed through the tendering process. He added that if there is “any country that produces such drugs with same quality at a cheap price, we will import from there”.[32] The Rwandan government claimed that it would award the tender based on World Health Organization standards of price and quality.[33]

After overcoming the domestic obstacles imposed by CAMR, Apotex managed to overcome one final international hurdle. In May 2008, eight months after the tender was opened, Apotex announced that it had won and would be supplying Apo-TriAvir to Rwanda.[34] Thereafter, Apotex began manufacturing the drug, which had finally been approved for export. In September 2008, Apotex sent its first shipment of 6,785,000 tablets to Rwanda. One year later, in September 2009, Apotex completed the order by sending a second shipment of 7,628,000 tablets.[35]

Apotex has not participated in the CAMR regime since, nor has any other pharmaceutical company. This shipment to Rwanda remains the only use of CAMR.

THE AFTERMATH – Responses to the Process from Key Players

In 2010, at the WTO TRIPS Council related to the review of the Paragraph 6 system, Canada delivered an intervention about its experience using CAMR. Canada said that the Apotex-Rwanda example “clearly shows that Canada’s Regime and the Waiver are efficient, effective and timely”.[36] Canada stressed the limited role of CAMR in the whole process. Canada was required to issue the compulsory licence. Even including the time spent in negotiations for voluntary licences, the licence was issued in two months. Thereafter, the only role played by Canada was a pre-export inspection. Canada concluded that the “challenges and delays in Apotex’s export of medicines to Rwanda were separate from CAMR”.[37]

In contrast, Apotex has announced that it will not apply for a compulsory licence again under CAMR because of its inherent inefficiencies. The company has emphasized that it took four years to achieve the first shipment of medicines, and has stressed that in its current form, CAMR is overly complex and not workable for either Apotex or for the developing countries it is intended to benefit.[38]

John Hems, then the Director, Regulatory Affairs of Apotex, wrote a letter to Health Canada and Industry Canada in January 2007 expressing some of Apotex’s ongoing policy concerns with the process. Hems requested that there be a clear and transparent process implemented to allow for the addition of products to Schedule 1.[39] Hems also lamented CAMR’s requirement that the importing country’s notification to WTO should be included in an application for a compulsory licence. Eligible countries are clearly listed, and that should be sufficient. He pointed out that this requirement could act as a deterrent for countries that do not want to publicly ask for such an import until the licences are obtained.[40]

Hems went on to criticize the administrative burdens of CAMR. In particular, he expressed concern about the requirement to request voluntary licences before being able to apply for a compulsory licence.[41] This constraint adds potential for abuse and litigation, and undoubtedly increases delays (as there is at least a thirty day negotiation requirement). Finally, Hems stated that the anti-diversionary methods are sufficient and that the requirement that each company maintain a website is an unnecessary burden.[42] It is especially onerous to smaller manufacturers and could act as a deterrent from participation.

After complying with CAMR, Apotex had to comply with Rwanda’s own domestic standards before being able to export Apo-TriAvir. The tender process, as required by Rwandan law, took until eight months after the compulsory licence had been granted. Understandably, Apotex was unwilling to start mass production of the drug until it had assurance that the Apo-TriAvir would be imported by Rwanda.[43] This waiting period was a futile use of time.

Since 2008, a generic pharmaceutical company in India has been able to provide the medicine to Rwanda at the same price charged by Apotex, but without triggering the cumbersome requirements of any waiver.[44] That Rwanda has turned elsewhere to import the medicine demonstrates that CAMR is not essential to the provision of essential medicines to least-developed and developing countries.

CRITICAL ANALYSIS – CAMR Provides Economic Disincentive to Companies

Inherent in Apotex’s criticisms of CAMR is the idea that it is not an economically viable regime, because it is not cost-effective to produce medicines for only one importing country at a time. Under CAMR, a compulsory licence cannot be granted unless an eligible importing country has indicated its need to WTO. Furthermore, Canada has imposed a maximum term of two years for its compulsory licences.[45] Therefore, if an eligible country other than Rwanda presently indicated to WTO its need for a drug like Apo-TriAvir, Apotex’s compulsory licence would no longer be valid and it, or any other manufacturer would have to start the licensing process from the beginning.

It follows that for CAMR to be effective, multiple eligible countries would have to indicate to WTO their need to import essential medicines at the same time, so that a manufacturer would be able to produce the medicine en masse. Practical barriers make this unlikely. Various countries notifying WTO concurrently of a common need is an improbable event. Furthermore, as discussed above, countries are often not willing to make their need known until their applications have been approved. The two-year limit imposed by CAMR is consequently one of the regime’s most problematic elements.

It is not economically rational for manufacturers to invest in the development, production, scheduling, and approval of a new drug if that drug can only be exported to one country for only two years, after which all prior efforts and investment expire. Jack Kay, president of Apotex, said that the company “invested millions in the research and development of the product, legal costs in negotiating with the brand companies and made no profits in the process”.[46] Apotex has pledged to continue to develop anti-retroviral HIV medications only once CAMR has been simplified.

When Apotex entered into negotiations for voluntary licences and subsequently applied for a compulsory licence, it made clear its intention to sell the medicine for no profit. The company has stated that it invested $2 million developing the product and that the components of Apo-TriAvir are sold for approximately $4.50 per tablet in Canada. Because of the human rights implications, Apotex was willing to supply the drug to Rwanda at their cost of $0.39 per tablet.[47]

Ultimately, Apotex supplied the drug to Rwanda for $0.195 per tablet.[48] Apotex complied with the bureaucratic requirements of CAMR having not guarantee that it would eventual be able to export the medicine. It is widely believed that Apotex lowered the price to remain competitive in the bidding process with other countries that do not have similarly stringent patent requirements.[49] Having to halve their price certainly cost Apotex money, and this likely underlies its adamant opposition to ever using CAMR, in its current form, again. In 2008, Rwanda wanted to double its order. However, Apotex refused because they were restricted “by the structure of the legislation”.[50] Despite Apotex’s refusal to continue exporting under CAMR, Rwanda was readily able to purchase the medicines, at the same price, from an Indian pharmaceutical company.[51] CAMR fails to account for the domestic legislation of importing countries. It is likely that such requirements will always cause further delays in an already time-consuming process.

If Apotex, amongst the world’s largest generic pharmaceutical companies, has no economic incentive to use CAMR, it can be assumed that the regime is similarly too costly for other pharmaceutical companies in the developed world. It was concluded at a hearing of the European Parliament, after consideration of the system, that it is doubtful that any company in Europe would make use of CAMR.[52] For a compulsory licensing regime to be effective at incentivizing pharmaceutical manufacturers to focus on health concerns prevalent in the developing world, the regime has to be economically rational.

CONCLUSION

It took close to four years from the time of the development of Apo-TriAvir until its final shipment to Rwanda. The delays were caused in large part by the high administrative burdens of CAMR. These burdens have proved so costly that they have acted as a disincentive and prevented other pharmaceutical companies from exporting essential medicines under a compulsory licence.

Nevertheless, the case shows that it is possible for companies in the developed world to export medicines to those who lack the necessary infrastructure to develop the drugs themselves. That the process required so much time and investment demonstrates that the regime is in need of major reform in order to make it a worthwhile venture for companies in the developed world. Yet, it also demonstrates that these reforms can be worthwhile. Ultimately, Apotex was able to ship enough medication to treat 21,000 patients for two years in Rwanda.[53] If there is a regime that will improve human rights by providing rapid access to medicines in a costly and efficient manner, that is a regime worth pursuing.

 

Jenna Himelfarb

QMJIP Guest Editor

Toronto Law School

 

[1] WTO, Intellectual property: protection and enforcement, online: <http://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm&gt;.

[2] For more information about compulsory licensing, see: Deli Yang, “Compulsory Licensing: For Better of For Worse, the Done Deal Lies in the Balance” (2012) 17 Journal of Intellectual Property Rights 76-81.

[3] WTO, Agreement on Trade-Related Aspects of Intellectual Property Rights, Marrakesh: WTO, 1994, 5th Sess, online: <http://www.wto.org/english/docs_e/legal_e/27-trips_04c_e.htm>.

[4] WTO, Declaration on the TRIPS agreement and public health, WTO/MIN(01)/Dec/2, 4th Sess at para 4 online: <http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.pdf&gt;.

[5] Ibid at para 6.

[6] See: WTO, Work of the Trips Council, online: <http://www.wto.org/english/tratop_e/trips_e/intel6_e.htm&gt;.

[7] Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health, WT Decision L/540 of 30 August 2003, online: <http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm&gt;.

[8] WTO, Press Release, 426, “Members OK amendment to make health flexibility permanent” (6 December 2005) online: <http://www.wto.org/english/news_e/pres05_e/pr426_e.htm&gt;. >

[9] The waiver will likely stay in place “temporarily” as the WTO has continuously pushed back the deadline for formally approving the changes; See: <http://www.wto.org/english/tratop_e/trips_e/amendment_e.html>.

[10] An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), SC 2004, c 23.

[11] Ibid at summary.

[12] Government of Canada, Background, online: Canada’s Access to Medicines Regime <http://www.camr-rcam.gc.ca/intro/context-eng.php&gt;.

[13] Canada, Report on the Statutory Review of Section 21.01 to 21.19 of the Patent Act, (Ottawa: Industry Canada, 2007) at 29.

[14] For a list of some of the other unique requirements, see: <http://www.camr-rcam.gc.ca/intro/regime-eng.php>.

[15] “About Apotex”, online: Apotex <http://www.apotex.com/global/about/default.asp&gt;.

[16] Matthew Rimmer, “Race Against Time: The export of essential medicines to Rwanda” (2008) 2 Public Health Ethics at 11.

[17] An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), supra note 10 at s 21.02.

[18] Ibid at s 21.03(1).

[19] Government of Canada, Canada’s Drug and Medical Devices Review Process, online: Canada’s Access to Medicines Regime <http://www.camr-rcam.gc.ca/countr-pays/elig-admis/process-eng.php&gt;.

[20] “Canada’s Intervention to TRIPS Council: Experience using the System (Apotex-Rwanda Case)” (27 October 2010) online: Knowledge Ecology International <http://keionline.org/node/1000&gt;.

[21] An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), supra note 10 at s 21.04(3)(c)(i).

[22] For relevant press releases, see: Boehringer Ingelheim (Canada) Ltd, Press Release, “Boehringer Ingelheim Offers a Licence to Apotex to Export BI’s patented product nevirapine to Developing Countries with terms better than that required by Canadian Legislation” (22 August 2007) online: <http://www.boehringer-ingelheim.ca/en/news/press_releases/2007/22_august_2007.html>; GlaxoSmithKline plc, Press Release, “GSK gives consent under Canada’s Access to Medicines Regime for generic version of HIV/AIDS medicine for use in Rwanda” (8 August 2007) online: <http://www.gsk.com/media/press-releases/2007/gsk-gives-consent-under-canadas-access-to-medicines-regime-for-generic-version-of-hivaids-medicine-for-use-in-rwanda.html>; Shire BioChem Inc, Press Release, “Shire supports Canada’s Access to Medicines Regime” (15 August 2007) online: <http://www.shire.com/shireplc/uploads/press/CAMR_15Aug07.pdf>.

[23] Ann Silversides, “Not a Single Pill”, Ottawa Citizen (13 August 2006), online: <http://www2.canada.com/ottawacitizen/features/aids/story.html?id=33dd04aa-52b6-437e-b4d1-d4c8d59010a4>.

[24] Apotex, Press Release, “Life Saving AIDS Drug for Africa Gets Final Clearance” (20 September 2007) online: <http://www.apotex.com/ca/en/about/press/20070920.asp&gt;.

[25] Parliament, Proceedings of the Standing Senate Committee on
Banking, Trade and Commerce, 40th Sess, Issue 11 (22 October 2009).

[26] An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), supra note 10 at s 21.04(3)(c).

[27] WTO, Notification Under Paragraph 2(c) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, IP/N/10/CAN/1 (2007), online: <http://www.wto.org/english/tratop_e/trips_e/ta_docs_e/3_ipn10can1_e.pdf&gt;.

[28] WTO, News Item, “Canada is first to notify compulsory licence to export generic drug” (4 October 2007) online: <http://www.wto.org/english/news_e/news07_e/trips_health_notif_oct07_e.htm&gt;.

[29] WTO, Notification Under Paragraph 2(a) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, IP/N/9/RWA/1 (2007), online: <http://www.wto.org/english/tratop_e/trips_e/ta_docs_e/3_ipn9rwa1_e.pdf&gt;.

[30] Ibid.

[31] “Canada’s Intervention to TRIPS Council: Experience using the System (Apotex-Rwanda Case)”, supra note 20.

[32] Innocent Gahigana, “No Deal Yet on Aids Drug”, The New Times: Rwanda’s First Daily, online: <http://www.newtimes.co.rw/news/views/article_print.php?1259&a=258&icon=Print&gt;.

[33] International Centre for Trade and Sustainable Development, “Canadian WTO Notification Clears Path For Rwanda To Import Generic HIV/AIDS Drug”, Bridges Weekly Trade News Digest (10 October 2007) online: <http://ictsd.org/i/news/bridgesweekly/6568/>. See also: <http://politicswatch.com/drugs-september26-2007.htm&gt;.

[34] Apotex, Press Release, “Canadian Company Receives Final Tender Approval From Rwanda For Vital AIDS Drug” (7 May 2008) online: <http://www.apotex.com/ca/en/about/press/20080507.asp&gt;.

[35] “Canada’s Intervention to TRIPS Council: Experience using the System (Apotex-Rwanda Case)”, supra note 20.

[36] Ibid.

[37] Ibid.

[38] Apotex, Press Release, “CAMR Federal Law Needs to be Fixed if Life-Saving Drugs for Children are to be Developed” (14 May 2009) online: <http://www.apotex.com/global/about/press/20090514.asp&gt;.

[39] Letter from John Hems (23 January 2007) re: CAMR Consultation Paper, online: <http://www.camr-rcam.gc.ca/review-reviser/camr_rcam_apotex_18-eng.pdf>.

[40] Ibid.

[41] Ibid.

[42] Ibid.

[43] International Centre for Trade and Sustainable Development, “Rwanda Should Receive Cut-Price HIV/Aids Drugs In September, Five Years After 30 August Decision”, Bridges Weekly Trade News Digest (14 May 2008) online: <http://ictsd.org/i/news/bridgesweekly/11081/&gt;.

[44] Cynthia Ho, “Complicated Compulsory Licences: The Waiver/Article 31BIS ‘Solution’” (2011) 32 Oxford University Press at 217.

[45] An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), supra note 10 at s 21.09.

[46] Apotex, supra note 38.

[47] Parliament, Standing Committee on Industry, Science and Technology, 39th Parl, 1st Sess, No 055 (23 April 2007).

[48] Canadian HIV/AIDS Legal Network, News Release, “Canada’s Law on Compulsory Licensing for Export” (3 December 2009) online: <http://www.aidslaw.ca/publications/interfaces/downloadFile.php?ref=1585&gt;.

[49] In particular, Indian companies were able to undercut the 39¢ price, See: Amir Attaran, “Why CAMR Can Never Succeed” (2010) 60 UNB Law Journal 150-160 at 153.

[50] Proceedings of the Standing Senate Committee on
Banking, Trade and Commerce, supra note 25.

[51] For more information on India’s compulsory licensing scheme, see: http://ipindia.nic.in/ipr/patent/eVersion_ActRules/sections/ps92.html (s 92A); For a comparative analysis with CAMR, see: Emily Ng & Jillian Kohler, “Finding Flaws: The Limitations of Compulsory Licensing for Improving Access to Medicines – An International Comparison” (2008) 16 Health Law Journal 143 at 166.

[52] Holger Hestermeyer, “Canadian-made Drugs for Rwanda: The First Application of the WTO Waiver on Patents and Medicines” Insights (10 December 2007), online: The American Society of International Law <http://www.asil.org/insights/volume/11/issue/28/canadian-made-drugs-rwanda-first-application-wto-waiver-patents-and#_edn1&gt;.

[53] Proceedings of the Standing Senate Committee on
Banking, Trade and Commerce, supra note 25.

BIBLIOGRAPHY

Legislation

An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), SC 2004, c 23.

Patent Act, RSC 1985, c P-4.

Secondary Sources

“About Apotex”, online: Apotex <http://www.apotex.com/global/about/default.asp&gt;.

“Canada’s Intervention to TRIPS Council: Experience using the System (Apotex-Rwanda Case)” (27 October 2010) online: Knowledge Ecology International <http://keionline.org/node/1000&gt;.

Amir Attaran, “Why CAMR Can Never Succeed” (2010) 60 UNB Law Journal 150-160.

Ann Silversides, “Not a Single Pill”, Ottawa Citizen (13 August 2006), online: <http://www2.canada.com/ottawacitizen/features/aids/story.html?id=33dd04aa-52b6-437e-b4d1-d4c8d59010a4>.

Apotex, Press Release, “CAMR Federal Law Needs to be Fixed if Life-Saving Drugs for Children are to be Developed” (14 May 2009) online: <http://www.apotex.com/global/about/press/20090514.asp&gt;.

Apotex, Press Release, “Canadian Company Receives Final Tender Approval From Rwanda For Vital AIDS Drug” (7 May 2008) online: <http://www.apotex.com/ca/en/about/press/20080507.asp&gt;.

Apotex, Press Release, “Life Saving AIDS Drug for Africa Gets Final Clearance” (20 September 2007) online: <http://www.apotex.com/ca/en/about/press/20070920.asp&gt;.

Boehringer Ingelheim (Canada) Ltd, Press Release, “Boehringer Ingelheim Offers a Licence to Apotex to Export BI’s patented product nevirapine to Developing Countries with terms better than that required by Canadian Legislation” (22 August 2007) online: <http://www.boehringer-ingelheim.ca/en/news/press_releases/2007/22_august_2007.html>.

Canada, Report on the Statutory Review of Section 21.01 to 21.19 of the Patent Act, (Ottawa: Industry Canada, 2007).

Canadian HIV/AIDS Legal Network, News Release, “Canada’s Law on Compulsory Licensing for Export” (3 December 2009) online: <http://www.aidslaw.ca/publications/interfaces/downloadFile.php?ref=1585&gt;.

Cynthia Ho, “Complicated Compulsory Licences: The Waiver/Article 31BIS ‘Solution’” (2011) 32 Oxford University Press.

Deli Yang, “Compulsory Licensing: For Better of For Worse, the Done Deal Lies in the Balance” (2012) 17 Journal of Intellectual Property Rights 76-81.

Emily Ng & Jillian Kohler, “Finding Flaws: The Limitations of Compulsory Licensing for Improving Access to Medicines – An International Comparison” (2008) 16 Health Law Journal 143.

Government of Canada, Background, online: Canada’s Access to Medicines Regime <http://www.camr-rcam.gc.ca/intro/context-eng.php&gt;.

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