Bill C-9: The Complaints of the Generic Drug Manufacturers and the Perspective of Developing Countries

The predecessor to Bill C-9 - An Act to amend the Patent Act and the Food and Drugs Act (Bill C-56), was introduced to the 2^nd session of the 37^th Parliament in the fall of 2003. The current Bill C-9 (the "Bill") is the first proposed legislation to be introduced in the developed world in response to the World Trade Organization (WTO) decision on August 30, 2003 (the "August 30, 2003 WTO Decision") to allow member countries to export generic copies of patented drugs to impoverished countries that have been overwhelmed by HIV/AIDS, malaria and tuberculosis. The decision waives countries' obligations under Article 31(f) of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement which states that compulsory licensing must be predominantly for the domestic market, thereby limiting the ability of countries that cannot make pharmaceutical products themselves from importing cheaper generic versions from countries where such products are patented, and countries that can manufacture such products from exporting them.

Bill C-9 has not been well-received by the Canadian generic drug industry and on February 26, 2004, Canada's generic drug makers proposed a number of amendments which they claimed would be necessary to entice generic pharmaceutical companies into making and exporting pharmaceutical products to developing countries under the Bill ⁱ. However, to date, every analysis of the Bill has examined its contents from the perspective of the interests of the generic and innovator pharmaceutical companies, rather than from the perspective of the developing countries whose health crises the law is being enacted to abate. This paper will provide such an analysis by first outlining the issues highlighted as critical by the generic industry, and then by comparing or contrasting these with the issues which arise from the perspective of developing countries.

Of the five primary criticisms raised by the generic industry, four of them suggest more complex issues that exist for developing countries pursuant to the Bill. As a result, it is unclear whether the Bill in its present form will help to alleviate the health crises caused by HIV/AIDS, malaria and tuberculosis in the developing world at all, even though it is based on the August 30, 2003 WTO Decision.

The Complaints of the Generic Industry

Right of First Refusal (s. 21.04(6) and (7))
Subsection 21.04(6) states that, pursuant to the filing of a notice of intent by a generic producer to provide pharmaceutical products under the legislation, authorization will be granted "unless the patentee provides the Commissioner, within thirty days...a solemn or statutory declaration in the prescribed form stating that the patentee, or an agent of the patentee...will supply the pharmaceutical product". The Canadian generic drug companies have complained that this subsection unfairly allows brand name drug companies to take over contracts they themselves have negotiated, and have stated that they are unlikely to participate in seeking out international contracts under the legislation if this provision remains in place. They note that such a right of first refusal is unnecessary under international trade agreements and duplicative in light of the de facto right of refusal already possessed by such brand name drug companies by virtue of the patents they hold. (ie if these companies were prepared to provide their products to developing countries at reduced prices, the Bill would not be necessary).
Buyer Should not Be Restricted to Foreign Government or its Agent (s. 21.04(2)(f)) / Distribution by Canadian Government as Part of Foreign Aid Allocation Subsection 21.04(1)(f) states that "A person who intends to apply for an authorization...must first file with the Commissioner [of Patents] the contractual terms and conditions of the agreement between the person and the government of the country or the WTO Member, or the agent of that government, under which the pharmaceutical product...is to be manufactured and sold for export". The generic producers have complained that this subsection unnecessarily limits those who may benefit from the initiative by excluding Non-Governmental Organizations (NGOs) who are not agents of a government, and therefore not permitted to enter into contracts with generic companies under the legislation. Because NGOs deliver health care services at the frontline in developing countries experiencing serious health crises, generic producers argue that such NGOs must, themselves, have access to affordable medicines via the right to contract directly with generic producers under the initiative. The generic producers also note that such a restriction is not required under Canada's international trade obligations. They argue that while the August 30, 2003 WTO decision imposes obligations on the "eligible importing Member", nowhere does it require the importing Member or its agent be the buyer; and likewise, while the decision discusses the role of the "exporting Member", there is no requirement that the seller must be the government of Canada or its agent. Generic producers have also suggested that the legislation should be expanded to include a distinct role for the Government of Canada, by which it purchases and distributes Canadian-made generic pharmaceutical products to the developing world as part of its foreign aid spending, and under an automatic compulsory licence. They note that there are no provisions under the TRIPS Agreement, or the August 30, 2003 WTO decision that would prevent this.
Drugs Should not be Limited to Those on Listed on a Schedule (Schedule 1) Schedule 1 lists the 46 drugs that qualify for export under the Bill. The list is made up primarily of drugs used to treat HIV/AIDS, certain heart conditions and in chemotherapy, and a variety of antibiotics. The generic producers have complained that the list is unnecessarily restrictive (as any future amendments to it require the approval of Order in Council), is not required by international trade agreements ⁱⁱ, and will inhibit the ability of Canada's generic manufacturers in the future to adapt quickly as conditions and pharmaceutical requirements change.
No Need for Scrutiny of Whether the Product is "Distinguished" (s. 21.05(3)(b)(ii))
Subsection 21.05(3)(b)(ii) states that the Commissioner shall authorize the use of the patented invention only if the Minister of Health has notified the Commissioner that the pharmaceutical product has been manufactured in a manner that distinguishes it from the version of the pharmaceutical product sold in Canada. The generic companies complain that this provision simply provides for regulatory scrutiny in addition to that which is required by the August 30 WTO Decision (which merely requires that compulsory licences granted pursuant to the initiative contain a condition that generic products be clearly identified so as to distinguish them from the relevant brand products). They note that the subsection is also unnecessarily burdensome because they already have every incentive to comply with the terms of compulsory licences granted to them to avoid costly litigation which could otherwise be launched against them by the patentee(s).
Generic Companies Should not be Required to File Information re. the Importing Country
Subsections 21.04(3)(a)-(c) provide lists of the documents that must accompany any notice of intent to apply for authorization to export pharmaceutical products filed by a generic producer. Subsection 21.04(3)(a) applies to WTO member countries listed in Schedule 2 to the Bill ⁱⁱⁱ, and provides that if a notice of intent relates to such countries, the generic producer must provide a copy of the notice in writing that the WTO member has provided the TRIPS Council specifying the name of pharmaceutical product, the amount needed, and a solemn or statutory declaration that the pharmaceutical product is not patented in the WTO member country, or if it is, that the WTO member has, in accordance with Article 31 of the TRIPS Agreement, confirmed that it intends to grant a compulsory licence. Subsection 21.04(3)(b) provides essentially the same provisions as those contained in subsection (a), but in relation to non-WTO member countries listed in Schedule 2 ^iv. In accordance with this provision, the non-WTO member countries must provide the same documentation as is listed in subsection (a) but to the Canadian government through diplomatic channels, instead of to the TRIPS Council. Subsection (c) provides the same provisions as in subsections (a) and (b), but in relation to countries listed in Schedule 3 ^v, all of which are WTO member countries. Because the countries listed in Schedule 3 are not LDCs, pursuant to subsection (c), each must also have stated in writing to the TRIPS Council that they have insufficient or no pharmaceutical manufacturing capacity for the pharmaceutical product to which the notice relates. (Subsection (d) provides the same provisions as subsection (c) but in relation to more developed WTO member countries ^vi each of which must also have stated in writing to the TRIPS Council that it is facing a national emergency or other circumstances of extreme urgency, and has insufficient or no pharmaceutical manufacturing capacity for the pharmaceutical product to which the notice relates). The generic producers note that these subsections place an unnecessary burden on them in light of the fact that Canada is not responsible for ensuring importing countries are in compliance with TRIPS or the August 30 WTO Decision. Instead, they argue, the importing countries bear this obligation under paragraph 2(a) of the August 30 WTO Decision, and so generic producers should simply be required to establish that the applicable tender or contract specifies that the buyer is satisfied that the importing country will comply with its obligations under paragraph 2(a) of the August 30, 2003 WTO Decision.

Issues from the Perspective of Developing Countries

The Burden Created by Subsections 21.04(3)(a) - (c) of the Bill
As noted above at paragraph 5, the generic industry has objected to these subsections of the Bill on the grounds that they place an unnecessary burden on them to ensure the required information has been submitted to the appropriate authorities by each of the countries listed in the various schedules (Schedule 2 lists LDCs some of which are members of the WTO and some of which are not, Schedule 3 lists developing countries, all of which are WTO members, and Schedule 4 lists more developed countries and Newly Industrialized Countries, all of whom are WTO members). However, from the perspective of the developing world, the more important issue seems to be the burden that the contents of the Bill place on the LDCs listed in Schedule 2, and even some of those developing countries listed in Schedule 3. However, from the perspective of developing countries, and in particular LDCs, the basic problem with the requirements of these subsections of the Bill is that they are too onerous given the lack of infrastructural development in such countries (Schedule 2 includes the majority of Africa's countries, including its poorest and most in need of the help the Bill was designed to provide). These subsections require that all of the countries listed in Schedule 2 must not only certify that any pharmaceutical products they wish to purchase pursuant to the Bill are not patented within their own borders, and if they are, must also grant a compulsory licences to the Canadian generic producers who will be supplying them. It is difficult to see how LDCs who do not even maintain their own intellectual property offices will be able to do this on a regular basis. For example, 19 of the 48 LDCs listed in Schedule 2 are African countries which, even though they are members of the Patent Co-operation Treaty ^vii, do not even maintain national intellectual property offices through which National Phase Applications under the Treaty may be completed. Instead, patent applicants wishing to obtain domestic patents in these countries must file applications through the African Regional Industrial Property Organization (ARIPO) in Zimbabwe ^viii. No analysts of the Bill have yet offered any guidance as to how the necessary domestic patent searches are to be conducted by LDCs, or how they are to issue the compulsory licences required of them by subsection 21.04(3)(a)(ii). In countries that are members of the Patent Co-operation Treaty and thus already must have at least a regional office in place to receive National/Regional Phase Patent Applications, it is not clear whether this obligation under the Bill will be a responsibility delegated to the respective regional offices, and if so under what jurisdiction or authority this would occur. Perhaps more importantly, it is not clear exactly why the LDCs listed in Schedule 2 that are also WTO members are not simply exempted completely from these provisions on the basis of the June 27, 2002 decision of the WTO council responsible for intellectual property (which formalized part of paragraph 7 of the Declaration on the TRIPs Agreement and Public Health, that WTO ministers adopted on November 14, 2001 in Doha), which extended until 2016 the transition period during which LDCs are exempt from providing any patent protection at all for pharmaceuticals ^ix. What could possibly be the point of making LDCs take stock of the patents they have issued in relation to pharmaceutical products and also issue compulsory licences in relation to them when no such patents need be granted by LDCs pursuant to the June 27, 2002 decision of the WTO? As noted above, only 19 of the 48 countries listed at Schedule 2 are even members of the Patent Co-operation Treaty, and are thus even remotely likely to have issued such patents for pharmaceutical products. Also, pursuant to section 21.17 of the Bill, the Minister of Health must complete a review of sections 21.01 through 21.16 of the Bill three years after it comes into force, and thus it is unlikely that any of the LDCs listed in Schedule 2 will have issued any patents for the products enumerated in Schedule 1 by the time the Bill is reviewed.
The Inadequacy of the List of Drugs Contained in Schedule 1
The complaint of the generic industry in this regard is certainly one that could be made by developing countries as well, especially LDCs in sub-Saharan Africa. However, the generic industry argument that Schedule 1 should be removed from the Bill altogether, in favour of an ongoing determination to be made by the importing countries themselves is completely incompatible with subsection 21.05(3)(b) under which the Minister of Health must certify that each pharmaceutical product for which an authorization is issued under the Bill, meets the requirements of the Canadian Food and Drugs Act. While the generic industry has also called for the removal of subsection 21.05(3), it seems to have been placed in the Bill not to prevent developing countries from getting particular drugs they may need to treat health crises, but to limit the drugs exported under the Bill to those which have been proven to be safe and efficacious under Canada's Food and Drugs Act and its accompanying Regulations. Query the legal and moral implications of Canadian generic manufacturers exporting to needy individuals in developing countries experimental drugs whose safety and effectiveness is uncertain. A Schedule of drugs approved for export under the Bill seems to be the only way to ensure that drugs not approved for use in Canada are not exported to developing countries whether on benevolent grounds, or on grounds of self-interest (e.g. to conduct ad hoc clinical trials on desperately sick individuals in the developing world).
However, that is not to say that Schedule 1, in its present form is satisfactory from the perspective of developing countries. Firstly, by limiting the Bill's focus to "HIV/AIDS, tuberculosis, malaria and other epidemics" in the introductory subsection 21.03(1)(a), treatments for a number of key diseases which occur primarily in LDCs have been left off the list. For example, common and effective treatments for African trypanosomiasis, or sleeping sickness ^x, leprosy ^xi, leishmaniasis ^xii, blinding trachoma ^xiii and malaria ^xiv (which is actually one of the acknowledged "public health problems" in the introductory subsection 21.03(1)(a)), have all been left off Schedule 1. As these diseases are endemic only in the developing world there is no reason for leaving them off the list other than the desire of brand name companies to market them for other uses in the developed world. Secondly, and more importantly, the list comprising Schedule 1 is not even comprehensive enough to allow for the export of effective treatments for the primary diseases listed in the introductory subsection 21.03(1)(a). The primary reason for this is that the restrictive list of drugs provided by Schedule 1 allows for the exportation of only some of the drugs which comprise the most effective combinational therapies for tuberculosis and HIV/AIDS. For tuberculosis, and the now more prevalent multi-drug resistant tuberculosis (also known as MDR-TB), this fact is particularly troubling. Active pulmonary tuberculosis often contains a billion or more bacteria, and thus any one drug given alone leaves behind thousands of organisms totally resistant to it. Therefore, at least two drugs (although preferably more) with totally different mechanisms, should be given in order to kill off all the bacteria ^xv. While a number of antibiotics (including azithromycin, ceftazidine, ceftriaxone, ciprofloxacin, erythromycin, levofloxacin, metronidazole and nitrofurantoin) are included on Schedule 1, the most effective drugs for treating tuberculosis (isoniazid, rifampin, pyrazinamide, streptomycin and ethambutol) are not included. Additionally, the World Health Organization defines MDR-TB as any form of active tuberculosis caused by bacilli that are resistant to at least isoniazid and rifampicin, the two most powerful anti-tuberculosis drugs available ^xvi. Clearly, if all antibiotics used in the treatment of tuberculosis are not listed in Schedule 1 to the Bill, combinational therapies will not be accessible to those receiving drugs pursuant to the Bill and the acknowledged health crises caused by the primary focus diseases listed in subsection 21.03(1)(a) will go untreated. The same is true of HIV/AIDS, which is arguably the greatest health crisis in recent human history, and obviously a powerful force behind the Doha Declaration, the August 30 WTO Decision, and Bill C-9 itself. A total of 9 antiretroviral drugs are listed on Schedule 1, and most of them can be administered as independent therapies. However, one of the key drugs listed - zidovudine, is usually administered as part of a combinational therapy, the other components of which are not listed in Schedule 1. Zidovudine is usually administered along with abacavir sulfate and/or with lamivudine in a combinational therapies called Trizivir or Combivir which are both sold in Canada by GlaxoSmithKline; however, neither of these drugs is listed in Schedule 1. As the majority of HIV/AIDS patients in the developed world are treated with highly complex combinational therapies (which include drugs to attack fungal and viral infections, diarrhea, intestinal and parasitic infections, nausea and vomitting, tuberculosis, eating disorders and related disorders such as AZT-induced anaemia and Kaposi's sarcoma), there are countless other drugs that, by having been left off of Schedule 1, prevent the administration of effective combinational therapies for patients in the developing world. If all of the necessary drugs are not included, the treatments made available as a result of the Bill can hardly be effective.
Restriction of Buyers to Governments or Their Agents / Distribution Through Foreign Aid Channels
While the generic industry likely makes these points from the perspective of expanding its potential market for pharmaceutical products to be exported under the Bill, this point is also one that is relevant from the perspective of the LDCs listed in Schedule 2, or more particularly the sick and poor individuals living therein. One of the biggest concerns with pharmaceutical products being exported under the Bill is obviously the market for re-export, and the likelihood that governments and agents purchasing the pharmaceutical products will be able to resist selling them on at a profit. This concern has been addressed in the form of subsections 21.05(3)(i) and (ii) which require that all pharmaceutical products exported under the Bill be distinguished from the equivalent products sold in Canada, and subsection 21.14(d) which allows a patentee who can establish that such products are being re-exported with the knowledge of the generic manufacturer to apply to the Federal Court for an Order terminating its authorization to export. However, these provisions do not address what is probably the largest barrier to the exported medicines actually getting to the individuals for whom they are intended - corruption in the governments of countries purchasing or receiving the pharmaceutical products pursuant to the Bill. Only 16 of the 48 LDCs listed in Schedule 2 are included in the 2003 Corruption Perceptions Index published by Transparency International, but all of these countries fall in the lowest 40% of the Index ^xvii. Even though the index measures only "perceived" corruption, it is clear that if any countries which receive pharmaceutical products pursuant to the Bill are likely to suffer from the problem of diversion to re-exportation, it is going to be the LDCs whose bureaucratic, legal and administrative systems are the "least developed" and arguably the most corrupt. It is unclear whether exporting pharmaceutical products directly to NGOs working on the so-called "frontline" of delivering health care services would alleviate the problem of diversion to re-exportation by corrupt government and bureaucratic employees. This would depend on exactly how "direct" such exportation turns out to be under the Bill. Many NGOs working in developing countries also have difficulty in dealing with corrupt governments while attempting to do their work, and the level of corruption in the policy environment in which such NGOs operate has been shown to strongly influence the effectiveness of their work ^xviii. Thus, unless the exportation of pharmaceutical products were to somehow bypass conventional shipping routes through government channels in such countries, it is difficult to see how this proposal could help the potential problem of re-exportation. The second proposal, that the Canadian government simply purchase the pharmaceutical products directly from the generic producers and include their distribution as part of its foreign aid budget is also not likely to address concerns over the potential for re-exportation unless such exports were somehow able to bypass LDC governments completely. This is because while the drugs themselves may be less liquid than foreign currency, they still have value if re-exported, or even sold privately by corrupt government officials. Canada also has a particularly dismal aid allocation system that is based historical precedent rooted in political goals, rather than aid effectiveness criteria ^xix. This means that Canada actually gives more of its bilateral development aid to countries perceived to be highly corrupt than to those which are perceived to be less corrupt. Of the top 25 recipients of Canadian bilateral aid between 1994-99 (by cumulative dollar amounts), 24 are included in the 2003 Corruption Index published by Transparency International. Of these 24 countries, 21 fall in the lower 50% of the Index, including four countries appearing in the lowest 10%. Clearly, if Canada continues to provide large amounts of aid to highly corrupt governments based on historical precedent, any pharmaceutical products it includes as part of such packages will be more vulnerable to re-exportation by corrupt government officials and, as a result, may continue to be ineffective at alleviating the health crises faced by the countries eligible to receive such products under the Bill.
Countries Other than Canada are Better Positioned to Supply such Generic Drugs to Developing Countries
Perhaps the most important concern of developing countries with respect to the Bill, is whether or not it will actually lead to better access to affordable medications over and above the access they have now. It does not seem that even if all of the concerns of the Canadian generic industry were to be addressed, and the Bill were to become law immediately, that developing countries would be in any better a position than they presently find themselves. This is due to the fact that subsection 21.05(3)(b) of the Bill places burdens on Canada's generic drug manufacturers that comparable companies in countries such as Brazil and India (which are known for their large and thriving generic pharmaceutical industries and for their comparable advantage as imitators in the field) do not face. Such companies are also already exporting such drugs to the countries the Bill is designed to help, and thus already have the know-how and manufacturing capability to do so. Under subsection 21.05(3)(b), before an authorization will be granted to a generic manufacturer, the Minister of Health must notify the Commissioner of Patents that the pharmaceutical product in question meets the requirements of the Food and Drugs Act and its Regulations. This Act provides extensive provisions governing what must be done in order to sell or even advertise a new drug in compliance with the Act. Before patented or generic medicines may be sold in Canada, the manufacturer must obtain a Notice of Compliance ("NOC") from the Minister of Health ^xxi. This document signifies that the drug is both safe and efficacious in treating the diseases or conditions for which it is indicated. In order to obtain this document for a drug that is new to the market, the manufacturer must submit a New Drug Submission in which testing and clinical trials prove that the drug is safe and efficacious. Completing this approval process is a long and expensive task. While generic manufacturers do not have to conduct all of the same testing to show safety and efficacy over again, they must still submit an Abbreviated New Drug Submission in which they state which approved (and usually patented) product they would like to reference and include proof that their generic product is "bioequivalent" to the reference product (usually by submitting the results of bioavailability, pharmacodynamic or clinical studies which prove that their product will deliver the required amounts of the active ingredient in an acceptable way to the patients who take it) ^xxii. It is not clear from the Bill whether generic manufacturers will actually have to obtain an NOC from the Minister of Health to be in compliance with the requirements of the Food and Drugs Act, but nowhere in the Bill is it stated that they will not have to. Under the current system, generic manufacturers, before they can obtain NOCs, must also comply with the provisions of the Patented Medicines (Notice of Compliance) Regulations, a process which usually entails 24-month long application proceedings conducted between the patentee and generic drug company to address the issue of patent infringement. While it would make no sense under the Bill to require generic manufacturers to have completed these proceedings and obtained an NOC (because at that point, if there was no patent granted in the developing country for the pharmaceutical product they could export it anyway), there is also no provision in the Bill which expressly removes generic manufacturers from this obligation. In addition to this potential burden, section 21.14 of the Bill provides the patentee with the right to bring an application for the termination of any authorizations already granted under the Bill where the generic manufacturer has (a) submitted an application for authorization containing inaccurate information, (b) has failed to establish a website in accordance with section 21.07, (c) failed to pay any royalties owed, or (d) knowledge that the pharmaceutical product it has exported has been re-exported in a manner that is contrary to the August 30, 2003 WTO Decision. While it is obvious that Canada must uphold high standards of safety and efficacy in allowing generic pharmaceutical products to be exported abroad, the requirements contained in the current draft of the Bill are still much more onerous than the laws and regulations to which generic companies in countries such as India and Brazil are subjected. Large generic manufacturers such as Cristalia of Brazil and Ranbaxy Laboratories and Mumbai-based Cipla of India have already been supplying many of the drugs listed in Schedule 1 of the Bill to LDCs for years. While these countries are obliged by 2005 to give product patent protection, in addition to process patent protection (effectively preventing them from continuing the reverse engineering techniques that have led their generic manufacturing industries to such enormous growth) ^xxiii, they will undoubtedly also pass laws similar to Canada's proposed Bill pursuant to the August 30, 2003 WTO Decision, thereby ensuring that their generic companies may still export to LDCs. Because of the experience generic manufacturers in countries such as India and Brazil have gained in exporting drugs such as anti-retrovirals ("ARVs") to LDCs, any such legislation put in place in this regard in these countries, unlike Canada's Bill, will likely be drafted to accommodate generic companies from the start. Because countries such as India and Brazil do not have such a large presence and lobby from innovator pharmaceutical companies as Canada, these countries will not need to balance the interests of the two opposed sides in drafting such legislation, and will be able to favour generic companies and their interests. For example, Ranbaxy Laboratories and Cipla Limited of India each have research initiatives in place to develop "fixed-dose" combination ARV therapies that are designed to be taken by those living in conditions of deep poverty. These combinations contain three drugs in a pill that need only be taken twice a day (ie in the morning and evening). The combination contains lamivudine, stavudine and nevirapine, which are patented by GlaxoSmithKline, Bristol-Myers Squibb and Boehringer Ingelheim, respectively ^xxiv. It is worth noting, that of these three medications, only one - stavudine, is listed on Schedule 1 of Canada's Bill C-9. Such development initiatives, and more broadly drafted legislation, would surely give foreign generics the edge over Canadian generics in supplying medications to treat illnesses which afflict LDCs.
Given these factors, and the fact that Canada's patent laws have to strike a balance between the interests of the so-called "innovator" and "imitator" companies which each have a share of the market, it seems unlikely that Canada's generic manufacturers will ever serve a meaningful role in supplying LDCs with generic medications. If Bill C-9 passes in its current form, Canada's generic manufacturers will never be able to compete with countries whose pharmaceutical markets are dominated by generic manufacturers and their specialties.

Conclusion

When the proposed Bill is viewed from the perspective of developing countries themselves, in particular LDCs, it is not clear that if it were to pass in its current form (or any form compatible with Canada's other related legislation), it would improve the position of such countries in obtaining the medicines they need to treat the health crises they are facing. Many deeper problems exist for such countries, and it seems that no unilaterally structured effort will solve these problems. Additionally, Canadian generic drug manufacturers, because they are based in a market the governing body of which must balance their interests against those of innovator companies, will always be at a disadvantage in supplying generic drug products vis-Ã -vis comparable companies operating in imitation-based markets. While it is commendable to see Canada taking the initiative to implement legislation to further such benevolent goals, it is not clear whether Canada is really properly positioned to play such a role.

Endnotes

Editor's Note: On April 20, 2004, another set of proposed general amendments relating to the right of first refusal contained in subsections 21.04(6) and (7), the drugs listed in Schedule 1 and the limitations on who may buy drugs pursuant to subsection 21.04(f) were approved. However, a version of the Bill with the exact wording of these proposed amendments has yet to be produced, and thus this paper is based on the text of the Bill as proposed prior to April 20, 2004.
The August 30 WTO Decision defines "pharmaceutical product" to include "any" patented product "needed to address the public health problems as recognized in paragraph 1 of the [Doha] Declaration", which itself specifically allows the importing members to determine what drugs are needed and to notify Council for TRIPS under paragraph 2(a)(i), with the final decision to be made by the WTO Secretariat.
Angola, Bangladesh, Benin, Burkina Faso, Burundi, Central African Republic, Chad, Democratic Republic of Congo, Djibouti, Gambia, Guinea, Guinea-Bissau, Haiti, Lesotho, Madagascar, Malawi, Maldives, Mali, Mauritania, Mozambique, Niger, Rwanda, Senegal, Sierra Leone, Solomon Islands, Tanzania, Togo, Uganda and Zambia
Afghanistan, Bhutan, Cambodia, Cape Verde, Comoros, Equatorial Guinea, Eritrea, Ethiopia, Kiribati, Lao People's Democratic Republic, Liberia, Nepal, Samoa, Sao Tome and Principe, Somalia, Sudan, Tuvalu, Vanuatu and Yemen
Albania, Antigua and Barbuda, Argentina, Armenia, Bahrain, Barbados, Belize, Bolivia, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cameroon, Chile, China, Colombia, Congo, Costa Rica, Cote d'Ivoire, Croatia, Cuba, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Fiji, Former Yugoslav Republic of Macedonia, Gabon, Georgia, Ghana, Grenada, Guatemala, Guyana, Honduras, India, Indonesia, Jamaica, Jordan, Kenya, Kyrgyz Republic, Liechtenstein, Malaysia, Mauritius, Moldova, Mongolia, Morocco, Namibia, Nicaragua, Nigeria, Oman, Pakistan, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Romania, St. Kitts and Nevis, St. Lucia, St. Vincent and the Grenadines, South Africa, Sri Lanka, Surinam, Swaziland, Thailand, Trinidad and Tobago, Tunisia, Uruguay, Venezuela and Zimbabwe
Cyprus, Czech Republic, Estonia, Hong Kong, Hungary, Israel, Korea, Kuwait, Latvia, Lithuania, Macao, Malta, Mexico, Poland, Qatar, Singapore, Slovak Republic, Slovenia, Chinese Taipei, Turkey and United Arab Emirates
These are Benin, Central African Republic, Chad, Equatorial Guinea, Gambia, Guinea, Guinea-Bissau, Madagascar, Malawi, Mali, Mauritania, Mozambique, Niger, Senegal, Sudan, Tanzania, Togo, Uganda and Zambia
Please See: Guidance Document published by the African Regional Industrial Property Organization (ARIPO). Available at http://www.aripo.org/pct_route.html.
Please see: Council approves LDC decision with additional waiver, the June 28, 2002 press release of the World Trade Organization. Available at http://www.wto.org/english/news_e/pres02_e/pr301_e.htm
Such as surimin (in Canada, brand name Germanin made by Bayer) and nifurtimox (in Canada, brand name Lampit, also made by Bayer). Please see: Compendium of Pharmaceuticals and Specialties, Canadian Pharmacists Association, 2003.
Such as dapsone (in Canada, brand name Lapdap made by GlaxoSmithKline), rifampin (in Canada, brand name Rifadin made by Aventis, or Rofact made by ICN Pharmaceuticals), or clarithromycin (in Canada, brand name Biaxin made by Abbott Pharmaceuticals), idem.
Such as pentamidine (in Canada, brand names Pentostam by GlaxoSmithKline, Pentacarinat by Aventis Pharmaceuticals, or Pentamidine Isethionate by Faulding (Canada) Inc.), idem.
Such as erythromycin in the transdermal or ocular form. The active ingredient is included on Schedule 1, but only in capsule, tablet, powder for oral suspension and powder for injection in vial forms, idem.
Such as artemesinine (in Canada, brand name Coartem by Novartis), chlorproguanil hydrochloride-dapsone (in Canada, brand name Lapdap by GlaxoSmithKline), chloroquine (diphosphate) (in Canada, brand name Aralen by Sanofi-Synthelabo), or the more popular for chloroquine-resistant regions mefloquine (in Canada, Lariam by Roche), idem.
Dr. Robert Berkow. The Merck Manual of Medical Information. (New York: Pocket Books, 1997), at p. 972.
Please see: Fact Sheet No. 104: Tuberculosis published by the World Health Organization. Available at http://www.who.int.mediacentre/factsheets/fs104/en.
Of 133 countries ranked, these countries are as follows: Senegal - 76, Mali - 81, Malawi - 84, Mozambique - 86, Madagascar - 89, Yemen - 91, Ethiopia - 94, Gambia - 95, Zambia - 99, Sudan - 110, Congo, Republic of - 113, Sierra Leone - 116, Uganda - 117, Angola - 124, Haiti - 131 and Bangladesh - 133. The ranking of the LDCs listed in Schedule 2, as a group, also actually contrasts directly with the ranking of the developing countries listed in Schedule 3. While the LDCs are all found in the final 40% of the list, the developing countries listed in Schedule 3 are found throughout it with rankings as high as 26 (Oman) and 27 (Bahrain), and as low as 130 (Paraguay) and 132 (Nigeria). Please see: 2003 Corruption Perceptions Index available at: http://www.globalcorruptionreport.org/download/gcr2004/12_Corruption_research_I.pdf
World Bank. World Development Report 2000/2001 (Washington, D.C.: World Bank, 2001), p. 200.
Danielle Goldfarb. "Who Gets CIDA Grants? Recipient Corruption and the Effectiveness of Development Aid", Backgrounder for C.D. Howe Institute, November 29, 2001.
Ibid, notes 17 and 19. For example, Bangladesh which is third on the list of top recipients of Canadian bilateral aid, ranks dead last on the corruption index at number 133. Haiti, which is fourth as an aid recipient, is number 131 on the corruption index. Indonesia, which is fifth as a recipient, is 122 on the corruption index. And Cameroon which is the tenth highest recipient of aid is number 126 on the corruption index.
Food and Drugs Act, R.S.C. 1985, c. F-27, section C.08.002.
Regulations under the Food and Drugs Act, subsections C.08.002.1(2) and (3)
Doug Alexander, "Canada's New Plan for Generic-Drug Sales". Christian Science Monitor, March 25, 2004.
Please see: WHO Approves 3 New AIDS Triple Combination Generic Medications. Available at http://www.hivandheptitis.com/recent/developing/120303_a.html.

Contact Heather Watts for more information on Bill C-9.

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