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McBeth, A --- "When Nobody Comes to the Party: Why Have no States Used the WTO Scheme for Compulsory Licensing of Essential Medicines?" [2006] NZYbkIntLaw 5; (2006) 3 New Zealand Yearbook of International Law 69

When nobody comes to the party:
Why have no states used the WTO scheme for compulsory licensing of essential medicines?

Adam McBeth[*]

I. Introduction

In its first decade of existence, the World Trade Organization has been consistently pilloried by elements of civil society as undemocratic, indifferent to the needs of the poor and rigged in favour of rich countries. Among the aspects of the WTO most frequently criticised are the perceived lack of transparency in the decision making process and the tolerance of protectionist barriers in sectors that are important to developing countries – particularly agriculture and textiles – while liberalisation of other sectors is mandated. However, the most effective criticism of the WTO’s social effects in its first ten years, in terms of public consciousness and momentum for change, has undoubtedly been the charge that the intellectual property rules mandated by the WTO result in essential, life-saving medicines being denied to impoverished people in areas hit by epidemic disease, particularly AIDS.

The core of the accusation is that the Agreement on Trade Related Aspects of Intellectual Property Rights [‘TRIPs Agreement’] obliges member States to grant patent protection to pharmaceuticals, among other inventions, and to award a monopoly for a minimum of 20 years to the patent holder, thereby artificially inflating the price of the drugs and making them unaffordable to poor individuals and to government health programs in developing countries. To the extent that exceptions were permitted to the original TRIPs requirements, these were said to be unworkable for all but a tiny group of developing countries. The result, according to the WTO critics, is that adherence to WTO rules prevents the effective treatment of epidemics. Rephrased in terms of international law, it is argued that by complying with one branch of international law, namely public international trade law, States are forced to breach their obligations in another branch of law, namely the pursuit of the highest attainable standard of health in accordance with international human rights law.

Perhaps it is the ready imagery of individual suffering, or perhaps the easily comprehended concept of unaffordable drug prices, divorced from the complexities of the global political economy, which have given this issue such traction. Whatever the reason, the issue of affordable access to patent-protected essential medicines has dogged the WTO for most of its first decade, with strong momentum for change building for at least the second half of that period. Indeed, the collective response from WTO members to this issue, encompassing changes to the legal framework of the relevant treaty, has been unprecedented.

The result of that momentum for legal change was enshrined in a formal decision of the General Council of the WTO in August 2003, with permanent textual amendments to follow. Despite the overwhelming demand for reform and the self-congratulatory fanfare with which the 2003 solution was greeted, more than two years after that result, the new system has never been used.

In a volume looking back on the first ten years of the WTO, the progress on the issue of access to essential medicines under the TRIPs Agreement presents an intriguing case study. It represents a microcosm of many of the criticisms and shortcomings of the WTO, particularly on the social front, as well as the capacity and willingness of the member States to reform the Organization’s rules. At the same time, it provides an insight into the problems with proposed solutions to perceived flaws in the WTO system, particularly the pitfalls of an overly legalistic approach to complex social problems – a stark warning to those of us in the international legal commentariat. The issue of access to medicines is also enlightening in relation to the place of the WTO in the broader sphere of international law by raising the question of potentially conflicting state obligations under WTO law and human rights law.

This article begins by examining the criticism of the relevant provisions of the TRIPs Agreement through the framework of international human rights law, highlighting the dilemma that was initially posed by this issue. Part 3 then considers the TRIPs provisions in more detail, including the exceptions that were built into the original text of the agreement and the limitations of those mechanisms in the context of essential medicines. Having identified the framework and the social problem it posed, part 4 examines the solution reached by the member States, tracing its evolution from Doha to the 2003 decision, through to the envisaged amendments to the text of the TRIPs Agreement. Part 5 then poses the question as to why the solution does not appear to be working, considering in the process the lessons that can be gleaned for WTO reform more generally.

II. The Criticism

A. The Character of the TRIPs Agreement in Relation to Human Rights

The TRIPs Agreement forms part of the suite of agreements annexed to the Agreement Establishing the World Trade Organization,[1] which renders its provisions binding on all WTO member States. Like all the agreements in that compilation, the TRIPs Agreement is subject to adjudication by the WTO’s Dispute Settlement Body,[2] thereby making intellectual property disputes justiciable by an authoritative organ of public international law.

However, the TRIPs Agreement is something of an anomaly in the WTO system. Whereas the other WTO Agreements are designed to increase trade flows by reducing regulatory barriers, the TRIPs Agreement actively erects trade-affecting barriers by mandating minimum levels of regulation to protect the rights of intellectual property owners, resulting in reduced trade flows in the covered products due to the enforcement of monopolies.[3] This observation does not imply that there is anything inherently wrong with the emphasis on intellectual property rights, but the character of the TRIPs Agreement as a trade-restricting rather than trade-liberalising agreement certainly runs against the tide of its Uruguay Round sibling agreements. Indeed, the TRIPs Agreement embodies many of the objections that are habitually raised in response to proposals to incorporate recognition of human rights or labour or environmental standards within the WTO system,[4] including the arguments that individual rights are outside the economic mandate of the WTO and that these other issues are already addressed by existing intergovernmental institutions.[5] In justifying regulatory restrictions on trade flows to protect intellectual property, the TRIPs Agreement recognises that certain legal rights can and should prevail over the general principles of trade liberalisation.[6]

Indeed, intellectual property rights can themselves be categorised as human rights. The protection of the “moral and material interests resulting from any scientific, literary or artistic production” are guaranteed to the author under article 27(2) of the Universal Declaration of Human Rights [‘UDHR’][7] and reiterated in article 15 of the International Covenant on Economic, Social and Cultural Rights [‘ICESCR’].[8] In the case of pharmaceutical patents, those rights of authorship invariably rest with corporations. The direct applicability of human rights norms to the patent holders is therefore questionable, depending on whether or not one accepts that juridical persons are capable of holding human rights,[9] although the patent rights are clearly of a similar character and rationale as the parallel norms under human rights law.[10]

The scope of intellectual property rights within international human rights law is clearly limited by other rights, as well as qualifications within the intellectual property provisions themselves. The right of authors and inventors to “the protection of the moral and material interests” resulting from their works is immediately preceded by the right in the same article of both the UDHR and the ICESCR for “everyone to enjoy the benefits of scientific progress and its applications”,[11] with the apparent intention that a public benefit should take priority over intellectual property in the event of a balancing exercise. The limited duration of the patent monopoly and the requirement that the specifications of the invention be publicly disclosed are evidence of the recognition of the overarching priority of public benefit.[12] The scope of intellectual property rights within the human rights regime is also clearly limited to the extent that they are inconsistent with other rights, such as an impediment to realising the right to health if patent protection restricts access to essential medicines. This issue is discussed in detail in 2.2 below.

The United Nations High Commissioner for Human Rights concludes that the concept of intellectual property in human rights law, extrapolated from the full context of Article 15 of the ICESCR, “could be said to bind States to design [intellectual property] systems that strike a balance between promoting general public interests in accessing new knowledge as easily as possible and in protecting the interests of authors and inventors in such knowledge.”[13] While the TRIPs Agreement elevates intellectual property rights above the general drive in the WTO to deregulate and dismantle regulatory barriers to trade, those rights themselves, as manifested in the intellectual property regimes adopted by States in fulfilment of their TRIPs obligations, must be subject to other human rights considerations binding on the WTO member States under international human rights law, both treaty-based and customary.

Indeed, the United Nations Sub-Commission on the Promotion and Protection of Human Rights has reminded States “of the primacy of human rights obligations under international law over economic policies and agreements”,[14] while the High Commissioner for Human Rights has noted that “WTO members have concurrent human rights obligations under international law and should therefore promote and protect human rights during the negotiation and implementation of international rules on trade liberalization”.[15]

In the present context of patent protection of pharmaceuticals, those limitations include the realisation of the right to health.

B. The Right to Health and Access to Essential Medicines

Article 12 of the ICESCR sets out, “the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.” The provision stipulates that the realisation of the right to health requires, inter alia, “the prevention, treatment and control of epidemic, endemic, occupational and other diseases;”[16] and “the creation of conditions which would assure to all medical service and medical attention in the event of sickness.”[17] The Committee on Economic, Social and Cultural Rights has elaborated on the content of the latter paragraph, making it clear that the right to health includes “the provision of essential drugs”.[18] The right to health is also intertwined with the right to life, which includes an obligation “to take all possible measures to reduce infant mortality and to increase life expectancy, especially in adopting measures to eliminate malnutrition and epidemics”.[19]

The World Health Organization [‘WHO’] has confirmed that “[a]ccess to essential drugs is part of the human right to health.”[20] Given that people in developing countries very often have to pay for their own health care, drug pricing has an enormous impact on access to health care in those countries.[21] The WHO further notes that patent protection of pharmaceuticals increases drug prices, which is a standard and recognised mechanism for recouping outlays for research and development, but also recognises that the poor “cannot afford patent-protected prices.”[22]

The obligations of States with regard to the right to health include, as a minimum standard and core obligation, providing access to essential drugs[23] and a duty to prevent third parties from interfering with such provision.[24] They also include obligations “to respect the enjoyment of health in other countries” and “facilitate access to essential health facilities, goods and services in other countries,”[25] including access to medicines, while “[r]estrictions on such goods [adequate medicines and medical equipment] should never be used as an instrument of political and economic pressure.”[26] Economic and diplomatic pressure exercised in an effort to discourage compulsory licensing of essential medicines, discussed in 3.2 below, could arguably breach those elements of the right to health, as could a state that yields to such coercion in the face of an epidemic, given that violations of the right to health: [27]

…include the formal repeal or suspension of legislation necessary for the continued enjoyment of the right to health or the adoption of legislation or policies which are manifestly incompatible with pre-existing domestic or international legal obligations in relation to the right to health.

If we accept that WTO member States are obliged to implement their obligations under the TRIPs Agreement in a manner that is consistent with their concurrent and overarching obligations under international human rights law, including an obligation to design legal structures that ensure access to essential medicines as broadly as possible, it is then necessary to ask what effect the enforcement of pharmaceutical patents has on access to essential medicines.

The application of patents to pharmaceuticals is not unequivocally negative for access to medicines. Cullet notes that “patents have the potential both to improve access, by providing incentives for the development of new drugs, and to restrict access, because of the comparatively higher prices of patented drugs.”[28] However, numerous studies have sought to disprove the link between patent protection and innovation in essential medicines that particularly affect poorer countries, noting that research and development activity tends to correlate more closely with profitability than with medical need. For example, Roffe et al report that between 1975 and 1999, “90% of investment into health-R&D has focused on concerns that only affect 10% of the global population”,[29] while Joseph notes the disproportionate amount of research investment into “chronic, ongoing conditions, like heart disease or high cholesterol,” with their potential for ongoing financial returns, as well as “lucrative problems like obesity, cellulite, and impotence.”[30]

While the positive link between patent protection and research and development into new drugs that would benefit the poor is debatable, there is general agreement that enforced patent monopolies lead to increased drug prices, including by the WTO itself.[31] Indeed, the exclusive right to exploit a patented product or process is designed to provide an economic incentive to innovators by excluding competitors – along with downward pressure on prices – from the market for the duration of the protection period.

Against this background of concurrent international legal obligations regarding access to medicines and the protection of intellectual property, and the inevitable price rises that flow from patent protection, I turn now to the specific provisions of the TRIPs Agreement and the effectiveness of its safeguards for medicinal access.

III. Patent Protection Obligations and Compulsory Licences

A. Patent Protection Obligations under the TRIPs Agreement

Article 27 of the TRIPs Agreement requires member countries to make patents available upon application for products or processes that are new or involve an inventive step and are capable of industrial application.[32] A prospective patent holder must apply for a patent separately in each country where patent protection is desired. Whilst medical treatment techniques are explicitly excluded from the list of inventions for which States must ensure patent protection under the TRIPs Agreement,[33] drugs and pharmaceutical products are not.

The introduction of TRIPs was especially significant for those countries that had previously chosen to exclude pharmaceuticals from patentability, which according to the WTO numbered more than 40 at the commencement of the TRIPs negotiations and more than 20 by their conclusion.[34] According to Roffe et al, “[t]he rationale for this exclusion was founded on public or social considerations related in most cases to the need for ensuring access to medicines at a lower cost to the population.”[35] While the TRIPs Agreement allowed States to exclude certain products from patentability on health grounds as a way of preventing their commercial distribution within that country,[36] that option is not available to enable increased distribution of positive products, such as essential medicines. With the advent of the TRIPs Agreement, any state that wished to become a member of the nascent WTO therefore had to accord patent protection to pharmaceuticals, either immediately or by the extended deadline for developing and least-developed countries.

Article 28 of the TRIPs Agreement compels member States to confer monopoly protection upon the holder of a patent for a minimum of 20 years.[37] During that period, the patent holder has the exclusive right to make, use, sell or import the patented product, or a product derived from a patented process, subject to the exceptions contained elsewhere in the TRIPs Agreement.[38] These obligations are now in force for all but the 32 designated least-developed countries,[39] which have until 2016 to implement the obligations fully in relation to pharmaceutical products.[40] The transitional period for other developing countries ended on 31 December 2004.[41]

Furthermore, a number of countries have come under pressure to implement more stringent protection for longer periods as part of so-called ‘TRIPs-plus’ provisions contained in regional and bilateral trade agreements, particularly from the United States.[42]

The TRIPs Agreement includes a number of exceptions to the exclusivity of patent rights. Article 30 provides:

Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.

When read in conjunction with article 8, which is headed “principles” and authorises States to “adopt measures necessary to protect public health … and to promote the public interest in sectors of vital importance to their socio-economic … development, provided that such measures are consistent with the provisions of this Agreement”,[43] it would seem that some degree of flexibility would be permitted in relation to the treatment of pharmaceutical patents in developing countries in order to improve access to essential medicines. However, article 30 has never been expressly used in this way.

Instead, the focus in the debate on pharmaceutical patents has been on two other exceptions: the so-called “exhaustion” flexibility in article 6, and most prominently, the provision for compulsory licences in article 31. It was the tweaking of the compulsory licence rules that formed the centrepiece of the trumpeted solution to the problem of access to essential medicines which is examined in the remainder of this article.

B. Compulsory Licences and Generic Medicines

Article 31 of the TRIPs Agreement allows governments to authorise entities other than the patent holder to use a patent, for instance by manufacturing a patented product, without the patent holder’s permission, provided that twelve conditions are satisfied. Such an authorisation is known as a compulsory licence, which breaks the patent holder’s monopoly. The rationale for compulsory licences is explained by Roffe et al: “The patent itself is a concession from a government in favour of a particular person that gives that person certain exclusive rights. The compulsory licence acts to restrain the exercise of those private rights in the public interest.”[44]

In the context of patented drugs, a compulsory licence enables a government to grant permission to anyone within its jurisdiction to manufacture and distribute generic copies of a patented drug, provided the conditions in article 31 of the TRIPs Agreement are complied with. Because the generic manufacturer has conducted no research and development into the drug, it should be able to offer the drug significantly cheaper than a patent holder with significant research and development investment to recoup.

Among the conditions on compulsory licences under Article 31 are that the licence be non-exclusive[45] and non-assignable,[46] that the scope and duration of the licence be limited and clearly specified,[47] that each decision to grant a licence be made on its own merits[48] and be subject to judicial review,[49] and that the licence be subject to termination when the conditions that led to its grant have ceased.[50] Three other conditions posed more of a problem for developing countries seeking to secure access to cheaper patented drugs, namely the requirement that negotiations for a voluntary licence on commercial terms be attempted before a compulsory licence can be granted, the requirement that royalties be paid to the patent holder and the territorial restrictions on the licence.

Before a compulsory licence under article 31 can be granted, a prospective licensee is required to have “made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions”, but “such efforts have not been successful within a reasonable period of time.”[51] The requirement of prior commercial negotiation can be waived “in the case of a national emergency or other cases of extreme urgency or in cases of public non-commercial use.”[52] The text of the TRIPs Agreement gives no indication of the circumstances that qualify as a national emergency or “other case of extreme urgency”. The status of epidemics such as AIDS as national emergencies became a topic of fierce debate in the period between the TRIPs Agreement coming into force in 1995 and the Fourth Ministerial Conference of the WTO in Doha in 2001. During that time, moves by South Africa and Thailand to investigate compulsory licences for patented AIDS drugs were met by threats of trade sanctions from the United States, despite South Africa and Thailand arguing that their actions were consistent with the TRIPs Agreement. Similar moves in Brazil led the United States to lodge a dispute with the WTO, although the dispute was ultimately dropped, while political pressure also forced the United States to amend its position in relation to AIDS drugs in South Africa.[53] The debate on the status of public health crises in relation to the condition in Article 31(b) was finally settled at the Doha conference, discussed in 4.1 below.

The requirement to pay royalties to the patent holder has also proven problematic in the context of essential medicines. Article 31(h) stipulates that “the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization.” Again, there is no indication in the text of the TRIPs Agreement as to what will constitute “adequate remuneration”. Weissman points out that the “economic value” must be the value to the licensee, since payment of the full value to the patent holder would defeat the purpose of compulsory licensing, and suggests that royalty payments should be linked to the licensee’s profit margins or gross sales.[54] If the purpose of granting a compulsory licence in respect of a patented drug is to facilitate broader access by slashing the cost of the drugs, achieved by harnessing the generic producer’s much lower expenses and therefore much lower profit margins, a mandated payment to the patent holder reintroduces a layer of expense, increasing the cost of the generic drug and thereby reducing accessibility. This obstacle survives the 2003 breakthrough and may well be one of the keys as to why the new notification system has still not been used.

The final condition on compulsory licences that I wish to highlight is the territorial restriction in article 31(f). That paragraph dictates that a compulsory licence “shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use.” Prima facie, this restriction would prove fatal to any scheme to gain access to cheaper generic drugs in any country that lacked pharmaceutical manufacturing capacity or the economy of scale to make generic drugs for domestic consumption. Of the poorest countries most in need of access to cheaper medicines, all but a handful fit that description. For that reason, the restriction in article 31(f) was a primary focus of the reform efforts from 2001 onwards.

C. Import and Export Problems

Writing in 1996, soon after the inception of the TRIPs Agreement, Weissman foresaw the difficulties posed to small developing countries by the restriction in article 31(f): [55]

Generic manufacturers can lower their marginal costs by expanding their demand pool, that is, by selling in other countries. And a rationally configured compulsory licensing scheme in many regions of the Third World might rely heavily on a common market approach, so that the countries of, for instance, East Africa would develop an integrated compulsory licensing and generic drug manufacturing and marketing approach. Provision (f)’s requirement that use be ‘predominantly’ for domestic use seems to preclude the full elaboration of such an approach.

As the United States has observed of the consensus view leading to the 2003 General Council decision, “all members recognized that if countries could not produce drugs for themselves, they could not in that special circumstance effectively use the compulsory licensing flexibilities.”[56]

For developing countries other than the handful with the capacity to manufacture their own generic drugs on an economically viable scale, a solution needed to be found that would allow them to import cheaper drugs manufactured elsewhere. If the patent holder would not supply the patented drugs at an affordable level, it would be necessary to import generic copies manufactured under a compulsory licence in another country.

From the perspective of the importing state, there is no prohibition on importing goods that enjoy patent protection in the exporting state or a third state, nor is there any prohibition on importing goods produced under a compulsory licence. However, if the imported goods are the subject of a patent application in the importing state, the text of the TRIPs Agreement requires that they be granted the same protection that would apply as if they were produced locally or imported from the patent holder rather than from a compulsory licensee.[57] In other words, the compulsory licence granted by the exporting state does not have extraterritorial effect to exempt the products so produced and exported from patent protection in the importing state. For example, if Brazilian manufacturers were to produce generic versions of patented drugs under a compulsory licence and export some of those drugs to Bolivia, where the drugs were also patented, the Brazilian compulsory licence would not exempt Bolivia from its obligation to enforce the patent holder’s monopoly within Bolivia.

In order to combat that problem, an importing state may authorise a compulsory licence for the importation of cheaper products lawfully produced in another state.[58] Following the previous example, Bolivia could authorise a compulsory licence for the importation of generic drugs from Brazil, which have been lawfully produced under the Brazilian compulsory licence. That scenario therefore requires the grant of two separate compulsory licences – one in Brazil to manufacture the generic drugs and one in Bolivia to import them.

However, under the original text of the TRIPs Agreement, the proportion of drugs produced in the foregoing scenario that were exported to Bolivia would probably have to be merely incidental to domestic Brazilian consumption, due to the requirement that the drugs manufactured under the compulsory licence must be “predominantly for the supply of the domestic market of the Member authorizing such use”,[59] namely Brazil. It would not be permissible for Brazil to issue a compulsory licence specifically to manufacture a quantity of generic drugs requested by Bolivia. In addition, the need for two compulsory licences would, on a strict reading of article 31(h), require two sets of royalty payments.

Without amending the territorial restriction in article 31(f), the use of compulsory licences to produce cheaper generic drugs was simply not feasible for the overwhelming majority of developing countries. At the same time, countries with significant pharmaceutical industries feared that their economic interests would be undermined if large quantities of generic copies of their patented drugs were released onto the international market. In particular, these countries feared that cheap generic drugs produced for export would then be re-exported to developed countries, where they would undercut the more expensive patent-protected versions. This impasse was the focus of an unprecedented movement within the WTO for reform of its rules, commencing in Doha in 2001.

IV. The response

A. Doha Declaration on the TRIPs Agreement and Public Health

At the WTO’s Fourth Ministerial Conference in Doha in November 2001, the legitimacy of using exceptions to the patent protection regime, such as compulsory licensing and parallel importing, was affirmed in the context of a threat to public health. The Doha Declaration on the TRIPs Agreement and Public Health [‘Doha TRIPs Declaration’],[60] separate from the customary all-encompassing Ministerial Declaration arising from every Ministerial Conference, was significant for its very existence, as the perceived need for a secondary Ministerial Declaration dedicated solely to the issue was evidence of the seriousness with which WTO members viewed the issue.

Paragraph 4 of the Doha TRIPs Declaration stated:

We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.

The Doha TRIPs Declaration then proceeded to approve of the right of member States to grant compulsory licences[61] and to establish their own “regime for exhaustion of intellectual property rights”,[62] which could legitimately permit parallel importing of patented products without the patent-holder’s permission. Furthermore, in relation to the existence of a national emergency, which would avoid the need for an unsuccessful attempt to obtain a licence on commercial terms before a compulsory licence could be granted,[63] the Doha TRIPs Declaration confirmed: [64]

Each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.

The Ministerial Conference therefore confirmed beyond doubt the ability of member States to grant compulsory licences for patented essential medicines for domestic consumption in a public health crisis. However, the problem of importing and exporting medicines produced under a compulsory licence remained unresolved. The Doha TRIPs Declaration acknowledged that problem and directed the TRIPs Council “to find an expeditious solution to this problem” and report to the General Council by the end of 2002.[65]

A draft of the Doha TRIPs Declaration proposed by a group of developing countries had attempted to put the ability to export compulsorily licensed goods beyond doubt by including the following paragraph: [66]

A compulsory licence issued by a Member may be given effect by another Member. Such other Member may authorize a supplier within its territory to make and export the product covered by the licence predominantly for the supply of the domestic market of the Member granting the licence. Production and export under these conditions do not infringe the rights of the patent holder.

That passage was, however, omitted from the final text of the declaration. While the consensus at Doha in relation to the legitimacy of using exceptions to patent rules to facilitate affordable access to essential medicines represented a significant breakthrough in the dynamics of the debate within the WTO, the practicalities of the problem, particularly in relation to the import/export restrictions, remained unsolved.

B. The 2003 General Council Decision and the new Notification System

Following the mandate from the Doha Ministerial Conference to find a solution to the impasse on the issue of importing and exporting compulsorily licensed medicines, an unofficial ‘mini-Ministerial’ meeting in Sydney in November 2002 and a meeting of the TRIPs Council in December 2002 canvassed options that focused on waivers of the exportation restrictions in Article 31(f) and the compensation requirement in article 31(h) of the TRIPs Agreement. While there was broad support from member States at both meetings,[67] no consensus emerged, prompting sharp criticism of the United States, the European Union, Switzerland and Canada,[68] whose inertia was widely blamed for the stalemate.

Following further protracted negotiations, the WTO General Council finally exercised its power under article IX of the Marrakesh Agreement to issue a decision in August 2003 [‘General Council decision’] to waive the restrictions in article 31(f) and (h) for pharmaceuticals to a limited extent in certain circumstances.[69] The General Council decision is intended to be an interim measure to operate until a formal amendment to the text of the TRIPs Agreement towards the same ends is concluded.[70]

The waivers in the General Council decision apply only to pharmaceuticals needed to address epidemics;[71] the pre-existing provisions of the TRIPs Agreement remain applicable to all other products and processes. The decision further stipulates that only the least-developed countries, plus other countries that have made notifications to the TRIPs Council as to their lack of pharmaceutical manufacturing capacity, may use the new system as importers. To that end, 33 developed country WTO members have agreed not to use the system as importers,[72] and a further 11 countries have agreed only to use it in situations of national emergency or circumstances of extreme urgency.[73]

As a precondition for waiving the restriction in article 31(f), the General Council decision requires both the prospective importing country and the manufacturing and exporting country to make a detailed notification to the TRIPs Council. The importer’s notification must specify the name and expected quantities of the products needed, a confirmation that the country has insufficient pharmaceutical manufacturing capacity for that requirement, and a confirmation that a compulsory licence has been granted under that country’s law.[74] The exporter’s notification must include a confirmation that a compulsory licence has been granted and must specify the conditions attached to that licence, as well as the name and address of the licensee, the name of the products, the quantity authorised under the licence and the destination country.[75] Furthermore, the compulsory licence granted by the exporting country must contain conditions designed to prevent the diversion of the imported drugs away from the intended recipients and into another country’s market.[76] These include limiting production under the compulsory licence to the amount required by the prospective importing country and differentiating the compulsorily licensed drugs from the patented version in terms of appearance and packaging.[77]

Article 31(h) of the TRIPs Agreement, which requires adequate compensation to be paid to the patent-holder when its product is the subject of a compulsory licence, is only waived under the General Council decision in respect of the importing country; it is still necessary for compensation to be paid in respect of the manufacturing and exporting country.[78] The effect of this partial waiver is therefore merely to prevent double-payment of royalties because multiple States are involved in the compulsory licensing process. In this way, the partial waiver of article 31(h) is not really a source of relief for an importing country, but merely puts it in the same position it would have been in, so far as compensation is concerned, if it had manufactured the drugs domestically.

Under this new system, it is therefore still necessary for a developing country wishing to import generic drugs to convince another country to issue a compulsory licence to enable the generic drugs to be manufactured and exported (which would require legislative reform in most countries with pharmaceutical manufacturing capacity[79]), to ensure compensation is paid to the patent holder and to find a manufacturer willing to produce and export the drugs required. These significant hurdles are in addition to the regulatory obligation imposed upon the importing state to take reasonable measures to minimise the risk that the generic drugs will be re-exported.[80] Similar obstacles in the so-called “Sydney compromise”, which was the precursor to the General Council decision, were the subject of vehement criticism from non-government organisations engaged on this issue.[81]

Nevertheless, the General Council decision was lauded by many as a breakthrough, demonstrating that the WTO could in fact succeed in balancing human rights considerations with its agenda of trade liberalisation. The interim decision and the mandate for a permanent textual amendment that accompanied it was also held out as evidence that the WTO was flexible and responsive to social and developmental needs.[82]

C. Towards a Permanent Amendment

The 2003 General Council decision expressly anticipates an amendment to the text of the TRIPs Agreement, to be based on the decision.[83] True to WTO form, the deadlines of mid-2004 and then March 2005 have been missed.[84] At the time of writing, the status of the amendment seems to be that of a work in progress without a specific deadline.

The African Group, representing the countries most ravaged by diseases such as AIDS and tuberculosis which are at the heart of this issue, presented a proposed text for a permanent amendment to the TRIPs Council in December 2004.[85] The African Group proposal focused on inserting a new paragraph 31(2) into the TRIPs Agreement, which purported to be a mere simplification of the General Council decision, eliminating only those provisions that “would be redundant in the context of an amendment or where their purpose would otherwise be served by other provisions of the TRIPS Agreement”.[86]

However, a number of provisions that were inserted in the General Council decision at the insistence of pharmaceutical manufacturing countries are conspicuously absent from the African proposal. “Most notably, the African amendment proposal cuts out all references to ‘trade diversion’ and, with the exception of a paragraph on distinctive packaging, to measures that Members using the system must take to avoid it.”[87] A number of other obligations on the importing country are also omitted from the African Group’s proposal, including the detailed notification requirements set out in the General Council decision.[88]

The fact that many developing countries support the African Group’s proposal, while most developed countries, especially those with significant pharmaceutical industries, oppose it,[89] may provide some hint as to why the utilisation of the 2003 General Council decision has so far failed to live up to expectations. If prospective medicine importing countries are unable or unwilling to meet the substantial regulatory obligations under the General Council decision, the system will do little to overcome the barriers imposed by the TRIPs Agreement to the flow of affordable medicines. On the other hand, if the countries with the most developed pharmaceutical manufacturing capacity refuse to engage with prospective importing countries under less onerous obligations, or to move towards a formal amendment incorporating lesser obligations, the necessary medicines may prove unobtainable. The remainder of this article considers this chasm in political will, along with other possible explanations for the non-utilisation of the new system.

V. Why isn’t it Working?

The 2003 General Council decision and its new notification system was the result of an enormous amount of diplomatic, academic and NGO agitation and debate on the supposedly urgent and impenetrable problem posed by article 31 of the TRIPs Agreement. The WTO has lauded the decision as historic and a breakthrough. In the words of then WTO Director-General Supachai Panitchpakdi: [90]

The final piece of the jigsaw has fallen into place, allowing poorer countries to make full use of the flexibilities in the WTO’s intellectual property rules in order to deal with the diseases that ravage their people. It proves once and for all that the organization can handle humanitarian as well as trade concerns.

Despite such assertions as to the monumental nature of the decision and its effects for developing countries, the number of notifications at the time of writing – more than two years after the decision – stands at zero.[91] Why isn’t this system working? This article does not pretend to have the answer to that question. Instead, it explores a number of possible factors with a view to informing more productive responses to future dilemmas.

A. This Issue Was Never the Main Problem

The most obvious explanation for the lack of movement is that the ability to import and export drugs produced under compulsory licence was never a significant practical issue. Rather, the restriction in article 31(f) happened to be one obstacle that could be overcome by reform to the legal framework, and therefore became the focus of legally-focused academics and other critics of the WTO.

If WTO member States are to remain obliged to accord monopoly protection to patent holders in respect of pharmaceuticals, an alternative system must be found to introduce the patented drugs into the territory of a disease-ravaged state in sufficient quantity and for a sufficiently low price as to make them accessible and affordable for the people who need them. Generic production under compulsory licence may be part of the solution if the licensee is able to offer the generic drugs for a significantly lower price than the patent holder, given that there will be no research and development costs to recoup. To the extent that allowing generic drugs produced under compulsory licence to be exported would create economies of scale to improve the feasibility of generic production at a much lower price, that may also be part of the solution. Obviously, allowing such drugs to move across borders is essential for those States that do not have the capacity to produce their own and would otherwise have no access to generic drugs at all.

However, drugs manufactured under a compulsory licence are not free. While research, development and marketing costs are a very substantial portion of the price built into pharmaceutical products, the setup costs, ingredients, labour costs, ongoing maintenance and so on still need to be covered in a generic manufacturing operation. In addition, article 31(h) of the TRIPs Agreement, even after the partial waiver in the General Council decision, obliges the licensee to pay royalties “taking into account the economic value of the authorization”.[92]

In 2001, more than 20% of the world’s people were living on less than the equivalent of one US dollar per day, with that figure approaching half the population in Sub-Saharan Africa and trending upwards,[93] and exceeding 70% in some countries.[94] Meanwhile, over 7% of the population of Sub-Saharan Africa is infected with HIV,[95] approaching 40% in the worst affected countries,[96] while infection rates of malaria exceed half the population in the hardest hit countries.[97] The mammoth scale of these epidemics and the meagre resources of the affected populations mean that a reduction in the cost of medicines – even if very substantial – will be meaningless if the reduced price continues to exceed the income of the patients. The reality for the poorest people affected by epidemic disease is that access to essential medicines can only be delivered by way of aid, either from their own governments, from charities or from international aid agencies.

These monumental problems cannot be solved by amending international legal instruments. The enthusiasm that accompanied the push for reform and the progress of the 2003 General Council decision may be a symptom of the human tendency to focus on things we can control while ignoring those we cannot. It is understandable that trade diplomats and legal academics focused on the obstacles that were within their power to remove, although the fervour devoted to that effort may have obscured much more significant obstacles which cannot be removed with the stroke of a pen.

The General Council decision and the TRIPs amendment that will ultimately follow undoubtedly represent progress. Further changes could be made to improve the feasibility of the new notification system, including making the conditions relating to trade diversion less onerous and waiving or at least minimising the obligation to pay royalties under article 31(h). However, there are clearly other and more significant obstacles to widespread access to essential medicines in the developing world.

B. Problem of Political Will Remains

Leaving aside the more significant issues beyond the bounds of the TRIPs framework and focusing solely on the new notification system, it is still the case that the changes encompassed in the General Council decision and the forthcoming amendment merely facilitate States’ ability to take action. The political will for States to make the necessary legislative changes and commence manufacturing or importing generic drugs, as the case may be, is still required.

If indeed the underutilisation of the new notification system is partly due to a lack of political will, it would certainly be consistent with a number of other criticisms of the WTO system on social or environmental grounds. While there is a plethora of literature advocating a human rights or environmental approach to interpretation of WTO agreements, for instance through a broad reading of the exception allowing the protection of human life or health in article XX(b) of the General Agreement on Tariffs and Trade, States have been almost universally unwilling to argue such an approach in a WTO dispute settlement case. Without the political will of States to put forward the broader interpretation, it is impossible to say whether the criticisms of the legal framework are justified. In the same way, the main cause for the new notification system remaining unused may be the unwillingness of States to use it.

The United States has all but pleaded for developing countries to use the new system: [98]

If some Members encounter difficulties in implementing or utilizing the solution, the United States would be pleased to discuss the need for technical assistance. … If Members feel that they need to make immediate use of the solution, they need not and should not wait for the amendment process to run its course before doing so.

In the WTO General Council meeting in May 2005, following the second, extended deadline for a permanent amendment to the TRIPs Agreement being missed, Switzerland expressed dismay that developing countries were haggling over the wording of a permanent amendment while the temporary system sat dormant:[99]

At this stage of the discussion, and after so much discussion, Members were discussing a number of formal issues, whereas the real way to solve the actual medical and other problems that had been mentioned so many times would be to ensure that the distribution of medicines that were already available … took place in an orderly and fair way for the countries concerned. The present kind of debate was for [the Swiss representative] somewhat surrealistic and was not one which, in his view, brought much honour for the Members.

As Joseph observed before the 2003 General Council decision, inaction from governments in some of the disease-ravaged countries is a very real problem, “Any blame attributed to Big Pharma for its failure to lower prices cannot absolve complacent, incompetent, and/or corrupt governments of their complete failure to take appropriate measures to combat HIV/AIDS.”[100]

On the other hand, developing countries may fear recriminations on other issues if they were to make extensive use of the compulsory licensing system. The pressure exerted on developing countries by the United States not to manufacture pharmaceuticals under compulsory licence for domestic consumption was discussed in III(B) above. Since it is not known what pressure is being applied behind the scenes, conceivably linked to aid delivery or further trade reforms in economically vital areas to developing countries such as access to agricultural markets, it is difficult to ascertain just how much of the inaction is attributable to political or diplomatic considerations.

C. Lack of Commercial Interest

For compulsory licences under the notification system to be effective in improving access to essential medicines in the worst affected countries, generic pharmaceutical manufacturers must be found to produce the drugs for export. That means that there must be some financial incentive to generate commercial interest from prospective manufacturers.

Manufacturers of generic drugs under a compulsory licence granted under the notification scheme face the usual production costs, plus an obligation to pay royalties “taking into account the economic value of the authorization”,[101] plus the costs of implementing the measures in the General Council decision designed to prevent trade diversion, such as special colouring or shaping of the drugs to differentiate them from the patent holder’s version.[102] The generic drugs need to be affordable to the generally impoverished patients after taking those costs into account, as well as the costs of export and distribution, leaving little if any room for a profit margin to provide an incentive for a pharmaceutical manufacturer to become a licensee under this system.

Given the calamitous financial situation of such a large proportion of the populations of those countries, as briefly canvassed in V(A) above, the reality for many is that the drugs need to be provided free of charge in order for them to be truly accessible. When the overwhelming infection rates in those countries for epidemics like HIV, malaria and tuberculosis are taken into account, the provision of access to essential medicines on more than a perfunctory basis is likely to be beyond the resources of the worst affected countries.

The combination of these factors results in a yawning gap between the cost of producing the compulsorily licensed drugs at a commercially attractive profit and the capacity of end users or their governments to pay. While the ability to bypass the patent holder’s monopoly might reduce that gap from a canyon to a mere chasm, the difference is academic and both gaps are equally impassable without an intervening party providing a bridge.

One suggestion is for pharmaceutical companies to provide essential medicines free of charge or at heavily discounted prices to the governments of poor and epidemic-affected countries, offset by the large profits generated by their pharmaceutical sales in the developed world. This is already occurring on an ad hoc basis on a small scale, particularly in relation to AIDS drugs. Another suggestion is to co-ordinate the work of international non-government organisations focused on public health, along with government-funded research institutions. Again, this is already happening on a small scale at the research and development stage with the Drugs for Neglected Diseases Initiative.[103]

Perhaps the most promising suggestion would be for developed countries to use their aid budgets to purchase generic drugs from a licensee under this scheme, thereby achieving a higher volume of medicines for their finite budgets than purchasing from the patent holder. If the compulsory licensee is also located in the developing world, perhaps in Brazil, South Africa or India, the use of aid budgets in this way would have the added bonus of contributing to employment, industry and development in those countries, as well as reducing transport and associated costs. In the context of a program such as this, the notification system established by the General Council decision would effectively be a budget-cutting – or alternatively, impact-boosting – measure for the aid budgets of developed countries. Perhaps this is the context in which the issue needs to be framed to win the enthusiastic support of developed countries. Without their assistance, it is difficult to see how pharmaceutical manufacturers can have any commercial incentive to produce generic drugs for export under this scheme, nor to see how patients in the poorest countries could realistically obtain access to them.

D. Amending Domestic Legislation is Causing Delay

The ability of a state with pharmaceutical manufacturing capacity to issue compulsory licences for the manufacture and export of patented medicines under the conditions envisaged in the 2003 General Council decision requires domestic legislative amendment in most cases. Norway and Canada have advised the TRIPs Council that they have amended their legislation to enable them to fill a request under the new system,[104] while the European Union and Switzerland are in the process of amending their legislation.[105] The amount of time required to complete the legislative process is one simple explanation for the notification system remaining unused for so long.

Both Norway and the European Union include more onerous labelling and trade diversion safeguards in their legislation than those mandated by the General Council decision.[106] Those additional hurdles might also act as disincentives for using the system.

E. Maybe It Is Working!

The absence of any notifications under the new system does not necessarily mean that the General Council decision has failed to make essential medicines more affordable. It is possible that the existence of the system has forced pharmaceutical companies to offer their products more cheaply to developing country governments or risk being undercut by lawful generic imports.

The UN High Commissioner for Human Rights has noted that the Brazilian government managed to negotiate significant price discounts from pharmaceutical companies in relation to two HIV drugs by passing a law in 1997 to allow compulsory licensing and by taking the initial steps towards manufacturing the drugs locally under a compulsory licence, without reaching the point where the compulsory licence actually had to be granted.[107] It therefore appears that the ability to undercut the companies’ commercial position through a lawful compulsory licence significantly strengthened the Brazilian government’s bargaining position, resulting in access to essential medicines from the patent holder on a more affordable basis.

It may well be the case that the new notification system arising from the 2003 General Council decision has brought a similar increase in bargaining power for developing countries that lack domestic pharmaceutical manufacturing capacity. By creating the potential for patented medicines to be imported lawfully under a compulsory licence, the decision may have changed the dynamics of negotiations between those governments and pharmaceutical companies, such that a patent holder is faced with the prospect of receiving only minimal compensation for its product under the TRIPs Agreement[108] if it will not conclude a commercial arrangement that is affordable and acceptable to the purchasing government. Indeed, it has been suggested by some writers that the availability of the new import system has already led to more fruitful negotiations on supply arrangements with pharmaceutical patent holders,[109] although concrete examples of these success stories are difficult to identify.

Practical progress in affordable access to essential medicines achieved through negotiation from a strengthened bargaining position will of course not be evident from the public register of notifications under the new system, even if the system’s existence was the decisive factor in shifting the balance of negotiating power in the purchasing country’s favour. In the absence of publicised success stories, it is difficult to know whether the existence of the new system is leading to improved access to essential medicines, notwithstanding that the system itself is not being utilised.

VI. Conclusion

Although the controversy surrounding access to essential medicines in the context of the TRIPs Agreement represents only a tiny segment of the WTO’s activity in its first decade, it provides a compact case study of some of the criticisms typically directed at the WTO, as well as the prospects for achieving substantive change to the trade agreements and the elusiveness of universally effective solutions.

Much of the initial criticism on the issue of access to patent-protected medicines focused on the tendency of the WTO to operate in a vacuum, oblivious to the overarching international legal responsibilities of its member States, including obligations under international human rights law. The consensus among member States from 2001 onwards that some degree of balance with public health obligations had to be reflected in WTO rules arguably represented a shift towards a more holistic approach to international law, although the WTO secretariat and member States have not expressed it in those terms, perhaps deliberately.

The fact that an incompatibility between WTO rules and particular social goals was recognised by the WTO, and that legal change, however slow and cumbersome, was eventually forthcoming, should provide hope to optimists for reform of the WTO in favour of the world’s poor. The agreement to amend the TRIPs text to reflect the 2003 General Council decision, which itself aimed to address criticisms highlighted by developing countries and civil society critics, is unprecedented and proves that change is indeed possible.

At the same time, the fact that the notification system arising from the General Council decision remains unused more than two years after it was put in place should be food for thought for those who advocate legal or institutional changes in the WTO as a panacea for problems in global trade. Indeed, overly legalistic approaches to entrenched social, political and economic problems, which are the hallmark of many academics and international lawyers, may be a significant cause for the purported solution so far failing to fulfil its promise.

On the other hand, the legal changes to the TRIPs regime examined in this article could be seen as a vital step in addressing the problem of access to essential medicines. The changes may assist in facilitating more efficient international aid programs for the provision of medicines, and they may already be having an impact on behind the scenes negotiations between governments and pharmaceutical companies.

Whichever view is taken of the success or failure of these changes, the issue provides an insight into both the shortcomings of the WTO and the potential for positive reform as the WTO enters its second decade.


On 6 December 2005, the WTO General Council agreed on a permanent amendment to the TRIPs Agreement, creating a new article 31 bis and an Annex to the Agreement.[110] Between them, article 31 bis and the Annex replicate the substance of the 2003 General Council decision exactly, effectively defeating the proposal of the African Group discussed in IV(C) above. The protocol of amendment is intended to come into effect on

1 December 2007.[111]

While the amendment is significant as the first ever amendment to the text of a core WTO agreement, its effectiveness in improving access to essential medicines remains uncertain. As at 31 March 2006, the number of notifications remains nil.

[*] BA, LLB(Hons). Lecturer, Faculty of Law, Monash University. This article is part of an Australian Research Council grant on the WTO and human rights awarded to the law faculty at Monash University. The ideas on which this article is based were presented to the annual conference of the Australian and New Zealand Society of International Law at the Australian National University, Canberra, in June 2005. The author wishes to thank the participants of that conference, Johanna von Braun of the International Centre for Trade and Sustainable Development and Nicola Charwat for their feedback in developing this article.

[1] Marrakesh Agreement Establishing the World Trade Organization, opened for signature 15 April 1994, 1867 UNTS 154 (entered into force 1 January 1995). The TRIPs Agreement comprises Annex 1C: 1869 UNTS 299.

[2] TRIPs Agreement, ibid, art 64.

[3] See Robert Weissman, ‘A Long, Strange TRIPS: The Pharmaceutical Industry Drive to Harmonize Global Intellectual Property Rules, and the Remaining WTO Legal Alternatives Available to Third World Countries’ (1996) 17 University of Pennsylvania Journal of International Economic Law 1069, who was perhaps the first to remark on this anomaly, noting at 1069 that “[b]y definition, protecting intellectual property is about restricting trade in certain goods”.

[4] See, for example, Martin Wolf, ‘What the World Needs from the Multilateral Trading System’, in Gary Sampson (ed), The Role of the World Trade Organization in Global Governance (United Nations University Press, 2001); see also the critique of Wolf and others in David Kinley and Adam McBeth, ‘Human Rights, Trade and Multinational Corporations’, in Rory Sullivan (ed), Business and Human Rights (Greenleaf, 2003) 53-56.

[5] An intergovernmental organisation, the World Intellectual Property Organization, already existed to oversee international intellectual property rights before the commencement of the Uruguay Round of trade negotiations which begat the TRIPs Agreement.

[6] The contrary argument often made is that the TRIPs Agreement facilitates free trade by harmonising intellectual property rules that were previously disparate and “a source of tension in international economic relations”: World Trade Organization, ‘Intellectual Property: Protection and Enforcement’, online: <

thewto_e/whatis_e/tif_e/agrm7_e.htm> (last accessed 22 November 2005). Nevertheless, even if the rules are less restrictive than previously, intellectual property protection is undeniably a fetter on goods moving lawfully across borders.

[7] GA Res 217A(III), Universal Declaration of Human Rights, UN GAOR, 3rd sess, 183rd plen mtg, UN Doc A/RES/217 (1948).

[8] International Covenant on Economic, Social and Cultural Rights, opened for signature 16 December 1966, 993 UNTS 3 (entered into force 3 January 1976), art 15(1)(c).

[9] This question is a significant debate in itself. Some jurisdictions have recognised a corporation’s ability to take advantage of domestically or regionally guaranteed human rights in relation to freedom of speech, privacy and rights in a criminal prosecution. The broader international law position is considered, inter alia, by: Stephen Bottomley, ‘Corporations and Human Rights’, in Stephen Bottomley and David Kinley (eds), Commercial Law and Human Rights (Ashgate Publishing, 2002) 61-65; Michael Addo, ‘The Corporation as a Victim of Human Rights Violations’, in Michael Addo (ed), Human Rights Standards and the Responsibility of Transnational Corporations ( Kluwer, 1999) 189-196; and Janet Dine, Companies, International Trade and Human Rights (Cambridge University Press, 2005) 205. In the context of corporations holding human rights to intellectual property, Ricketson concludes that “[i]t is difficult to conceive that the obligations [in the UDHR and ICESCR] could be intended to extend any further than the initial human creator of the subject-matter in question”: see Sam Ricketson, ‘Intellectual Property and Human Rights’, in Bottomley and Kinley (eds), 192. My own view concurs with that of Ricketson, as does Sarah Joseph, ‘Pharmaceutical Corporations and Access to Drugs: The ‘Fourth Wave’ of Corporate Human Rights Scrutiny’ (2003) 25 Human Rights Quarterly 425, 430.

[10] Ricketson, above n 9, 187, 194, 201-202 and 207-209.

[11] UDHR, above n 7, art 27(1); ICESCR, above n 8, art 15(1)(b).

[12] Philippe Cullet, ‘Patents and Medicines: The Relationship Between TRIPS and the Human Right to Health’ (2003) 79 International Affairs 139, 140.

[13] United Nations High Commissioner for Human Rights, The Impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights on Human Rights, UN Doc E/CN.4/Sub.2/2001/13 (2001), 10.

[14] United Nations Sub-Commission on the Promotion and Protection of Human Rights, Resolution 2001/21, Intellectual Property and Human Rights, UN Doc E/CN.4/Sub.2/Res/2001/21 (2001), para 3.

[15] United Nations High Commissioner for Human Rights, Liberalization of Trade in Services and Human Rights, UN Doc E/CN.4/Sub.2/2002/9 (2002), para 5.

[16] ICESCR, above n 8, art 12(2)(c).

[17] Ibid, art 12(2)(d).

[18] Committee on Economic, Social and Cultural Rights, General Comment 14: The right to the highest attainable standard of health, 22nd sess, UN Doc E/C.12/2000/4 (2000), para 17.

[19] Human Rights Committee, General Comment 6: The Right to Life, 16th sess, UN Doc HRI\GEN\1\Rev.1 (1994), para 5.

[20] World Health Organization, WHO Policy Perspectives on Medicines – Globalization, TRIPS and Access to Pharmaceuticals, 2001, online: <

WHO_EDM_2001.2.pdf> (last accessed 18 October 2005), 5.

[21] Ibid. See also Cullet, above n 12, 143.

[22] World Health Organization Commission on Macroeconomics and Health, Macroeconomics and Health: Investing in Health for Economic Development, 2001, online: <,cmh,cmh_report&

language=English> (last accessed 18/10/2005), 87.

[23] CESCR General Comment 14, above n 18, para 43(d).

[24] Ibid, para 33.

[25] Ibid, para 39.

[26] Ibid, para 41.

[27] Ibid, para 48.

[28] Cullet, above n 12, 143.

[29] Peter Roffe, Christoph Spennemann and Johanna von Braun, ‘From Paris to Doha: The World Trade Organization Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health’, in Roffe, Tansey and Vivas-Eugui (eds), Negotiating Health. Intellectual Property and Access to Medicines (Earthscan Publishing, 2005) 9-26.

[30] Joseph, above n 9, 435. Statistical data supporting similar assertions to those of Joseph and Roffe et al are set out in Ellen ‘t Hoen, Médecins Sans Frontières, ‘Presentation to European Parliament Committee on International Trade Hearing on TRIPS and Access to Essential Medicines’, 18 January 2005, and at Médecins Sans Frontières’ Access to Essential Medicines Campaign website, online: <> (last accessed on 11 October 2005).

[31] World Trade Organization and World Health Organization, WTO Agreements and Public Health: A Joint Study by the WHO and the WTO Secretariat, 2002, <

english/ res_e/booksp_e/who_wto_e.pdf> (last accessed on 11 October 2005), para 175.

[32] TRIPs Agreement, above n 1, art 27(1).

[33] Ibid, art 27(3)(a).

[34] World Trade Organization and World Health Organization, above n 31, para 52.

[35] Roffe, Spennemann and von Braun, above n 29.

[36] TRIPs Agreement, above n 1, art 27(2).

[37] The duration of patent protection is stipulated in art 33 of the TRIPs Agreement.

[38] TRIPs Agreement, above n 1, art 28. Footnote 6 to the text of the TRIPs Agreement, contained in art 28, expressly notes that the exclusive right to import patented products is subject to the exhaustion provisions in art 6.

[39] As at October 2005, 50 States are designated Least Developed Countries by the United Nations, 32 of which are current WTO members. Eight more States from the UN list are currently in accession negotiations with the WTO, while two others have observer status in the WTO. See, World Trade Organization, Least Developed Countries, online: <> (last accessed on

11 October 2005).

[40] Art 66(1) of the TRIPs Agreement originally required compliance by least-developed countries by 2006, but that period was extended by ten years in relation to pharmaceutical patents and the protection of undisclosed commercial information in relation to pharmaceutical products by para 7 of the Declaration on the TRIPS Agreement and Public Health, Doha, 14 November 2001, WTO Doc WT/MIN(01)/DEC/2 (2001) (Fourth Ministerial Conference of the WTO).

[41] Art 65, paras (2) and (3) of the TRIPs Agreement grant developing and transitional countries four years on top of the year granted to all WTO members before the TRIPs obligations (excluding national treatment and MFN) must be implemented (expiring on 1 January 2000). Art 65(4) grants developing countries a further five years (expiring on 1 January 2005) to implement patent protection obligations for subject matter that was not patentable in those countries when the WTO Agreement came into force on 1 January 1995. Some developing countries therefore only recently became bound by patent protection obligations with regard to certain subject matter, notably India in the case of pharmaceuticals. The TRIPs Agreement is now generally in force for all countries except least developed countries.

[42] Pedro Roffe, Bilateral Agreements and a TRIPS-Plus World: The Chile-USA Free Trade Agreement (Quaker International Affairs Program, 2004), online: <> (last accessed on 11 October 2005), 5, notes that since the conclusion of TRIPs and the North American Free Trade Agreement, the United States has concluded free trade agreements with Jordan, Laos and Vietnam, all of which contain “extensive TRIPS-plus provisions”.

[43] TRIPs Agreement, above n 1, art 8(1).

[44] Roffe, Spennemann and von Braun, above n 29.

[45] TRIPs Agreement, above n 1, art 31(d).

[46] Ibid, art 31(e).

[47] Ibid, art 31(c).

[48] Ibid, art 31(a).

[49] Ibid, art 31(i).

[50] Ibid, art 31(g).

[51] Ibid, art 31(b).

[52] Ibid, art 31(b).

[53] For a summary of these cases, see Srividhya Ragavan, ‘The Jekyll and Hyde Story of International Trade: The Supreme Court in PHRMA v Walsh and the TRIPS Agreement’ (2004) 38 University of Richmond Law Review 777, 789-793.

[54] Weissman, above n 3, 1114.

[55] Ibid.

[56] Comments on Implementation of the 30 August 2003 Agreement (Solution) on the TRIPS Agreement and Public Health, WTO Doc IP/C/W/444 (2005), Communication from the United States.

[57] TRIPs Agreement, above n 1, art 27(1), which provides that patent protection must be applied “without discrimination as to the place of invention… and whether the products are imported or locally produced”.

[58] European Communities, submission to the Council for Trade-Related Aspects of Intellectual Property Rights on “Para. 6 of the Doha Declaration on the TRIPS Agreement and Public Health”, TRIPS Council Doc IP/C/W339 (2002), para 6.

[59] TRIPs Agreement, above n 1, art 31(f).

[60] Above n 40.

[61] Ibid, para 5(b).

[62] Ibid, para 5(d).

[63] TRIPs Agreement, above n 1, art 31(b): see infra at III(B).

[64] Doha TRIPs Declaration, above n 40, para 5(c).

[65] Ibid, para 6.

[66] African Group in the WTO, et al, Proposed Ministerial Declaration on the TRIPS Agreement and Public Health, TRIPS Council Doc IP/C/W312 (2001), General Council Doc WT/GC/W/450 (2001), para 5. The proposal was on behalf of the African Group, Bangladesh, Barbados, Bolivia, Brazil, Cuba, Dominican Republic, Ecuador, Haiti, Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay, Philippines, Peru, Sri Lanka, Thailand and Venezuela.

[67] World Trade Organization, Trips and public health: the situation before Cancún, online: <> (last accessed on

10 May 2005).

[68] Oxfam International, Oxfam condemns deadlock on access to medicines negotiations (Press Release, 21 December 2002). For a particular criticism of the United States position, see Brook Baker, ‘Arthritic Flexibilities for Accessing Medicines: Analysis of WTO Action Regarding Para. 6 of the Doha Declaration on the TRIPS Agreement and Public Health’ (2004) 14 Indiana International and Comparative Law Review 613 at 630-633.

[69] Implementation of para. 6 of the Doha Declaration on the TRIPS Agreement and Public Health, WTO Doc WT/L/540 (2003) (Decision of the General Council).

[70] Ibid, para 11.

[71] Ibid, para 1(a).

[72] Ibid, para 1(b) and note 3. The original countries in this category were Australia, Canada, Iceland, Japan, New Zealand, Norway, Switzerland, the United States and the member states of the European Union. The ten States that were awaiting accession to the European Union as at 30 August 2003 (the Czech Republic, Cyprus, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, the Slovak Republic and Slovenia) agreed initially to use the system as importers only in cases of national emergency or other cases of extreme urgency, and to opt out of using the system as importers altogether upon their accession to the European Union: General Council Chairperson’s Statement WTO Doc WT/GC/M/82 (2003) (Minutes of meeting), para 4.

[73] General Council Chairperson’s Statement, above n 72, para 4. The 11 countries are Israel, Korea, Kuwait, Mexico, Qatar, Singapore, Turkey, the United Arab Emirates, the Chinese Special Administrative Regions of Hong Kong and Macau (each a separate country for WTO purposes) and the Separate Customs Territory of Taiwan, Penghu, Kimmen and Matsu.

[74] General Council decision, above n 69, para 2(a).

[75] Ibid, para 2(c).

[76] The intention behind the conditions is evident from the subsequent statements in paras 4 and 5 of the General Council decision, above n 69.

[77] General Council decision, above n 69, para 2(b).

[78] Ibid, para 3.

[79] Jennifer Rogers, ‘The TRIPS Council’s Solution to the Para. 6 Problem: Toward Compulsory Licensing Viability for Developing Countries’ (2004) 13 Minnesota Journal of Global Trade 443, 469.

[80] General Council decision, above n 69, para 4.

[81] Oxfam and Médicins Sans Frontières, Sydney Summit a step back for access to medicines, but it is not the end of the story (Press Release, 15 November 2002).

[82] WTO Press Release, Decision removes final patent obstacle to cheap drug imports, WTO Doc Press/350/Rev.1 (2003).

[83] General Council decision, above n 69, para 11.

[84] The original deadline was “within six months” of the TRIPs Council initiating work on a permanent amendment “by the end of 2003”: General Council decision, above n 69, para 11. In June 2004, the TRIPs Council extended the deadline to 31 March 2005: Annual Review of the Decision on the Implementation of Para. 6 of the Doha Declaration on the TRIPS Agreement and Public Health, WTO Doc IP/C/33, 8 (2004) (Report to the General Council), para 8.

[85] Implementation of Para. 11 of the 30 August 2003 Decision, WTO Doc IP/C/W/437/Rev.1 (2005) – Communication from Nigeria on behalf of the African Group (as revised).

[86] Ibid, para 3.

[87] International Centre for Trade and Sustainable Development, ‘Africa Calls for Action on Public Health’ (2004) 8(10) Bridges 1, 2.

[88] Ibid.

[89] International Centre for Trade and Sustainable Development, ‘No Solution Yet on Access to Medicines’ (2005) 9(4) Bridges 10.

[90] World Trade Organization, Press Release, above n 82.

[91] The WTO’s webpage dedicated to notifications under the General Council decision is online: <> (last accessed on 31 March 2006).

[92] TRIPs Agreement, above n 1, art 31(h).

[93] United Nations Development Program, Human Development Report 2005: International Cooperation at a Crossroads: Aid, Trade and Security in an Unequal World (Oxford University Press, 2005), 34.

[94] Ibid, 229. On the most recent figures, 72.3% of the population of Mali had an income below the equivalent of US$1 per day, along with 70.2% of Nigerians.

[95] Ibid, 249. The aggregate figure for HIV prevalence in the Sub-Saharan African population aged between 15 and 49 years old in 2004 was 7.3%.

[96] Ibid, 248. The rate of HIV prevalence in the population aged between 15 and 49 years old in 2003 in Swaziland was 38.8% and was 37.3% in Botswana.

[97] Ibid, 248-9. The number of malaria cases reported to the WHO in 2000 in Guinea was 75,386 per 100,000 of population. In Burundi the figure was 48,098; in Botswana it was 48,704. The UNDP notes that the data “may represent only a fraction of the true number” of cases in a given country, since they reflect only cases reported to the WHO.

[98] Comments on Implementation of the 30 August 2003 Agreement (Solution) on the TRIPS Agreement and Public Health, WTO Doc IP/C/W/444 (2005) (Communication from the United States), paras 5 and 6.

[99] Minutes of General Council Meeting, 26 May 2005, WTO Doc WT/GC/M/95 (2005), para 118.

[100] Joseph, above n 9, at 451.

[101] TRIPs Agreement, above n 1, art 31(h).

[102] General Council decision, above n 69, para 2(b)(ii) contains the obligation to distinguish the drugs “through specific labelling or marking”. That obligation is augmented by the “Best Practice Guidelines”, annexed to the General Council Chairman’s Statement, above n 72, which contains the examples given here.

[103] See, Drugs for Neglected Diseases Initiative, online: <> (last accessed on 17 October 2005).

[104] Implementation of Para. 6 of the Doha Declaration on the TRIPS Agreement and Public Health, WTO Doc IP/C/W/427 (2004) (Communication from Norway); Annual Review of the Decision on the Implementation of Para. 6 of the Doha Declaration on the TRIPS Agreement and Public Health, WTO Doc IP/C/33 (2004) (Report to the General Council), para 5 in relation to Canada.

[105] International Centre for Trade and Sustainable Development, Africa Calls for Action on Public Health, above n 87, 2. The General Council of the WTO noted the report from Switzerland that the relevant legislation had been drafted and was before the parliament at the time of the 26 May 2005 General Council meeting: World Trade Organization, Minutes of General Council Meeting, above n 99, para 118.

[106] Implementation of Para. 6 of the Doha Declaration on the TRIPS Agreement and Public Health (Communication from Norway), above n 104, 2; International Centre for Trade and Sustainable Development, ‘EU Seeks to Implement WTO Decision on Access to Medicines’ (2004) 8(10) Bridges 21.

[107] United Nations High Commissioner for Human Rights, above n 13, para 56.

[108] Art 31(h) of the TRIPs Agreement requires payment of “adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization”, which is likely to be significantly lower than the profit that would be made by the patent holder in normal commercial circumstances: see infra at III(B).

[109] Rogers, above n 79, 468.

[110] Amendment of the TRIPS Agreement, WTO Doc WT/L/641 (2005) (Decision of the General Council).

[111] WTO Press Release, Members OK Amendment to Make Health Flexibility Permanent, WTO Doc Press/426 (2005).

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