New Zealand Yearbook of International Law
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Nina Khouri*
There is international alarm about a possible pandemic of avian influenza or ‘bird flu’. The H5N1 virus has caused the deaths of hundreds of millions of birds worldwide and has infected at least 366 people. It differs from seasonal influenza in that it follows an unusually aggressive clinical course, commonly involving viral pneumonia and multi-organ failure. So far, about two thirds of the humans infected with the virus have died.[1] The virus has now been detected in birds throughout the world: in Asia, the Middle East, Africa, Western and Eastern Europe, and the United States. The concern is that the virus, known to pass from birds to humans, could mutate and begin to spread from person to person, triggering a repeat of the 1918 Influenza Epidemic which caused the deaths of between 25 and 50 million people worldwide. World Health Organization (WHO) officials have stated that an outbreak of bird flu could kill five to 150 million people and is ‘like a combination of global warming and HIV/Aids 10 times faster than it's running at the moment’.[2] In 2005, when the first international alarm sounded, WHO described the risk of a pandemic as ‘serious’, stating:[3]
Pandemics can cause large surges in the numbers of people requiring or seeking medical or hospital treatment, temporarily overwhelming health services. High rates of worker absenteeism can also interrupt other essential services, such as law enforcement, transportation and communications. Because populations will be fully susceptible to an H5N1-like virus, rates of illness could peak fairly rapidly within a given community. This means that local social and economic disruptions may be temporary. They may, however, be amplified in today's closely interrelated and interdependent systems of trade and commerce. Based on past experience, a second wave of global spread should be anticipated within the year. As all countries are likely to experience emergency conditions during a pandemic, opportunities for inter-country assistance, as seen during natural disasters or localised disease outbreaks, may be curtailed once international spread has begun and governments focus on protecting domestic populations.
At a recent Intergovernmental Meeting on Pandemic Influenza Preparedness in Geneva, the Director-General of WHO repeated the warning:[4]
Vulnerability is universal. A pandemic will, by its nature, reach every corner of the earth, and will do so within a matter of months… Countries need to brace themselves for a situation where up to 25% of the workforce may be ill at a given time. They have to brace themselves for a possible meltdown of basic municipal services and a slowdown of economic activity. And this situation will be occurring globally. There will be no fortunate unaffected parts of the world.
The World Bank initially estimated that a bird flu pandemic lasting a year could cost the global economy up to US$800 billion, but in 2006 revised that estimate to between US$1 trillion and US$2 trillion.[5] The United States has launched a US$7.1 billion national strategy to prepare for a possible flu pandemic,[6] Saudi Arabia has culled more than 3.5 million birds following an outbreak of H5N1 detected on 12 November 2007[7] and countries such as New Zealand have to consider the possibility of sealing their national borders in the event of an outbreak.[8]
Fortunately, there is an anti-viral drug which treats bird flu, called ‘Tamiflu’ (generic name ‘Oseltamivir’). F Hoffmann-La Roche Ltd (Roche), a Swiss pharmaceutical corporation, holds the worldwide licence to manufacture and market the drug, with the patent owned by Gilead Sciences Inc, a United States biotechnology company (Gilead).[9] In 2005, Roche’s manufacturing capacity was insufficient to meet world demand in the event of a serious outbreak of bird flu. According to one WHO official, even if Roche produced Tamiflu at full capacity for the next 10 years and stockpiled the drug, there would only have been enough at the end of that period for 20 percent of the world's population.[10] Roche, however, refused to allow generic manufacturing of the drug and stated that it would not relinquish its exclusive manufacturing rights. The explanation for this was simple: Roche announced in October of that year that sales of Tamiflu had more than doubled in the last financial quarter and expected revenue for 2005 from Tamiflu sales was $925 million, compared to $266 million in 2004.[11] Faced with international political pressure, including pressure from members of the US Congress and an application by Taiwan for a compulsory licence to manufacture Oseltamivir without consent,[12] Roche (and Gilead) eventually agreed to grant sub-licences to other companies to manufacture Tamiflu.[13] Roche now has more than 15 external contractors around the world manufacturing the drug.[14]
This raises the interesting hypothetical: what if Roche and Gilead had refused to do this? States parties to the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)[15] are obliged to respect the intellectual property rights of private individuals and corporations in the form of copyright, trademarks and patents. This brings into stark relief the conflict between protection of Roche and Gilead’s intellectual property rights in the Tamiflu patent and the national security of States which may be affected by bird flu. How absolute are the intellectual property rights over Tamiflu? Under what circumstances could a hypothetical State (‘State X’), a member of the WTO and a signatory to the TRIPS agreement, override a refusal to sub-license the patent to Tamiflu and manufacture it without Roche and Gilead’s consent? This paper suggests that there may be two avenues under international law which would permit State X to manufacture Tamiflu without such consent. The first is the compulsory licensing regime set out in article 31 of TRIPS. The second is the customary international law doctrine of necessity as codified in the International Law Commission’s Draft Articles on State Responsibility. The international legal obligations arising under each approach are potentially quite different.
The first part of this paper outlines the TRIPS regime as it relates to patents, including the primary obligation on States to respect patents and the compulsory licensing procedure under article 31. The second part of the paper explores whether the customary international law doctrine of necessity could operate as a circumstance precluding wrongfulness of any breach of TRIPS in the bird flu situation if State X could not afford to pay the compensation required under the TRIPS compulsory licensing regime. This might be the case if, for example, all of the State’s resources were required to combat the immediate effects of the outbreak.
If both the article 31 compulsory licensing regime and the doctrine of necessity could operate to allow State X to manufacture Tamiflu without Roche and Gilead’s consent, then there is a conflict between these two international legal approaches, in that potentially different compensation obligations arise under each. The third part of the paper examines whether the existing framework of international law, including the lex specialis rule and article 31(3)(c) of the Vienna Convention on the Law of Treaties,[16] determine which legal approach should apply in this situation.
II. THE TRIPS AGREEMENT
The TRIPS agreement is part of the Agreement Establishing the World Trade Organization signed in 1994. It sits alongside the General Agreement on Tariffs and Trade (GATT) and the General Agreement on Trade and Services (GATS) and sets minimum standards for the recognition and protection of intellectual property rights within all member countries of the WTO. Ratification of the TRIPS agreement is a compulsory requirement of WTO membership, so any country seeking to obtain access to the numerous international markets opened by membership of the WTO must enact the strict intellectual property laws mandated by TRIPS.[17] As a WTO-covered agreement, TRIPS is enforceable through the WTO’s powerful dispute settlement mechanism, the WTO Dispute Settlement Understanding,[18] under which the WTO Dispute Settlement Body can authorise, inter alia, trade sanctions and/or countermeasures against non-compliant States.
TRIPS is not the only source of international intellectual property rights and obligations. More stringent intellectual property protection is included in many regional or bilateral trade agreements. However, this paper will concentrate on the rights and obligations contained in the TRIPS Agreement.
The primary obligation to respect patents is found in article 27 of TRIPS, which prescribes that, subject to certain limited exceptions:
Patentable Subject Matter
[P]atents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application… patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.
The strict obligation to respect patents is qualified by article 31, which provides:
Other Use Without Authorization of the Right Holder
Where the law of a Member allows for other use of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorised by the government, the following provisions shall be respected:
(a) authorization of such use shall be considered on its individual merits;
(b) such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly;
(c) the scope and duration of such use shall be limited to the purpose for which it was authorised, and in the case of semi-conductor technology shall only be for public non-commercial use or to remedy a practice determined after judicial or administrative process to be anti-competitive;
(d) such use shall be non-exclusive;
(e) such use shall be non-assignable, except with that part of the enterprise or goodwill which enjoys such use;
(f) any such use shall be authorised predominantly for the supply of the domestic market of the Member authorising such use;
(g) authorization for such use shall be liable, subject to adequate protection of the legitimate interests of the persons so authorised, to be terminated if and when the circumstances which led to it cease to exist and are unlikely to recur. The competent authority shall have the authority to review, upon motivated request, the continued existence of these circumstances;
(h) the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization;
(i) the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;
(j) any decision relating to the remuneration provided in respect of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member;
(k) Members are not obliged to apply the conditions set forth in subparagraphs (b) and (f) where such use is permitted to remedy a practice determined after judicial or administrative process to be anti-competitive. The need to correct anti-competitive practices may be taken into account in determining the amount of remuneration in such cases. Competent authorities shall have the authority to refuse termination of authorization if and when the conditions which led to such authorization are likely to recur;
(l) where such use is authorised to permit the exploitation of a patent (‘the second patent’) which cannot be exploited without infringing another patent (‘the first patent’), the following additional conditions shall apply:
(i) the invention claimed in the second patent shall involve an important technical advance of considerable economic significance in relation to the invention claimed in the first patent;
(ii) the owner of the first patent shall be entitled to a cross-licence on reasonable terms to use the invention claimed in the second patent; and
(iii) the use authorised in respect of the first patent shall be non-assignable except with the assignment of the second patent.
Compulsory licensing under article 31 functions as a ‘safety valve’,[19] providing flexibility for governments to modify the protection granted to patent holders in order to meet public policy goals. It allows exceptions to patent holders’ rights in circumstances such as national emergencies or where the patent holder is engaging in anti-competitive practices, provided certain conditions designed to protect the legitimate interests of the patent holder are met.[20] The Ministerial Declaration on the TRIPS Agreement and Public Health, adopted by the Ministerial Conference of the WTO on 14 November 2001 at Doha, Qatar (Doha Declaration) affirms that TRIPS ‘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.’[21]
Were State X to issue a compulsory licence to manufacture Tamiflu, the most important conditions to consider would be the obligation to make efforts to negotiate a voluntary licence (article 31(b)), the domestic market limitation (article 31(f)) and the obligation to pay adequate remuneration (article 31(h)).
The obligation to make efforts to negotiate a voluntary licence on reasonable commercial terms and conditions does not apply during national emergencies or other circumstances of extreme urgency or in cases of public non-commercial use. In such circumstances the State would simply have to notify the patent holder as soon as reasonably practicable. The Doha Declaration affirmed the right of governments to determine what constitutes a national emergency or other circumstances of extreme urgency and indicated that HIV/AIDS, tuberculosis, malaria and other epidemics can fall within this category.[22] The threat of a bird flu outbreak which could quickly spread globally presumably would also fall within this category.
Article 31 provides that any compulsory licensing must be predominantly for the supply of the domestic market of the authorising government. This restriction reflected concerns about generically produced drugs flooding the markets of industrialised countries and undercutting profits. It caused problems for those nations lacking the infrastructure and technical capabilities to manufacture pharmaceutical products, since it prevented them from importing generically produced drugs.[23]
Paragraph 6 of the Doha Declaration instructed the WTO Council to find an ‘expeditious solution to this problem’[24] and in August 2003 the WTO Council issued a decision which established the ‘paragraph 6 system’, making it easier for countries to import generic drugs made under compulsory licensing provided certain conditions aimed at preventing the medicines from being diverted to the wrong markets or undermining patent systems in developed countries are met.[25] On 6 December 2005 WTO Members approved an amendment to TRIPS to incorporate this decision.[26] The amendment, the first change to any of the WTO agreements, will be formally incorporated into TRIPS once two thirds of the WTO’s members have ratified the change. The deadline for ratification, originally 1 December 2007, has now been extended to 31 December 2009.[27]
On 4 October 2007, Canada became the first country to grant a compulsory licence under article 31. It has authorised the production of TriAvir, an AIDS drug, by a Canadian company Apotex, Inc for export to Rwanda.[28]
This amendment (proposed article 31bis) would permit State X (assuming it were otherwise permitted to manufacture Oseltamivir under article 31) to export the drug to a neighbouring country in desperate need of the drug. This is particularly useful in the bird flu situation where inhibiting the spread of the virus in a neighbouring country may be as important to State X as inhibiting the spread of the virus within State X, given the virus’ lack of respect for national borders. It might also allow it to import it from a country that had already decided to issue a compulsory licence.
The final condition that a government issuing a compulsory licence must observe is the payment of ‘adequate remuneration’ to the patent holder. This adequate remuneration is determined in the circumstances of each case, ‘taking into account the economic value of the authorization’.[29] The ‘paragraph 6 system’ incorporated into article 31bis of the proposed amendment to TRIPS does not change the requirement that ‘adequate remuneration’ be paid to the patent holder. It does, however, excuse an importing country from paying it where it has already been paid by the exporting country.[30]
No guidelines for calculating adequate remuneration are provided under TRIPS. Countries retain broad authority to set royalties for use of patents according to their own choosing, subject to the requirement under article 31(j) that ‘any decision relating to the remuneration provided… shall be subject to judicial review or other independent review by a distinct higher authority in that Member’.
What is ‘adequate’ will depend on the facts and circumstances of each case,[31] but the general rule is that the ‘economic value of the authorization’ is what such a licence would normally cost if available from the patent owner.[32] Where possible, it should be based on actual examples of licence agreements voluntarily entered into by the patent holder, so long as the inventions licensed are comparable in nature to the invention in respect of which a compulsory licence is to be granted.[33] Thus, adequate remuneration will generally take into account the profits that the patent holder would have made had a licence been granted voluntarily.
There is no single accepted approach to the calculation of royalties. Some countries have issued royalty guidelines for the calculation of the remuneration payable under compulsory licences. For example, the 1998 Japanese Patent Office guidelines for licences of government-owned patents prescribe royalties ranging from zero to six percent of net sales of the licensed product. The royalty payable is calculated according to a complex formula which takes into account factors such as expected profits from the licensed product, the novelty of the invention and public interest concerns.[34]
A different approach is taken in Canada. In 2005 the Jean Chrétien Pledge to Africa Act, which implemented the ‘paragraph 6 system’, set royalty guidelines for the export of generic pharmaceuticals under compulsory licence. These guidelines prescribe a formula for calculating royalties according to the importing country’s standing on the United Nations Human Development Index. Royalties can vary from a fraction of a percent to four percent of the generic sales price.[35]
In 2001 the United Nations Development Programme recommended that developing countries adopt royalty guidelines to promote predictability and ease of administration, citing Germany’s approach of two to 10 percent royalties and Canada’s (pre-2005) approach of a fixed four percent as models. It suggested that developing countries could increase the fixed amount by up to two percent for products of particular therapeutic value and decrease it by the same amount where government funds had been used to develop the product. [36]
These schemes all base royalty rates on the cost of the generic product, with no reference to the ability of the country issuing the compulsory licence to pay. For example, as identified by WHO in a critique of these regimes, royalties for the same generic drug will not vary between Denmark and Uganda (while there will be some variance under the Canadian model, this will not match the variance between national wealth).[37]
In summary, the TRIPS regime imposes a strict obligation to respect the intellectual property rights of patent holders. Article 31 allows governments flexibility to issue compulsory licences in furtherance of public policy interests, but this ‘safety valve’ is subject to a number of conditions, the most important for present purposes being the payment of ‘adequate remuneration’. What would happen if a State could satisfy all of the conditions of article 31 except the obligation to pay this compensation because, for example, all of its financial resources were required to actually manufacture Tamiflu, or to combat bird flu in other respects? Is that State obliged to breach international intellectual property law in order to provide the required medicine to its citizenry? The next part of this paper explores whether the customary international law doctrine of necessity might provide an alternative ‘safety valve’ to the strict obligation to respect patents.
The customary international law doctrine of necessity is a circumstance precluding wrongfulness in international law. It provides a shield for a State against an otherwise well-founded claim for breach of an international obligation. The doctrine is codified in the International Law Commission's Articles on Responsibility of States for Internationally Wrongful Acts (Articles on State Responsibility),[38] adopted by the General Assembly on 12 December 2001.[39] Article 25 provides:
Necessity
Necessity may not be invoked by a State as a ground for precluding the wrongfulness of an act not in conformity with an international obligation of that State unless the act:
Is the only way for the State to safeguard an essential interest against a grave and imminent peril; and
Does not seriously impair an essential interest of the State or States towards which the obligation exists, or of the international community as a whole.
In any case, necessity may not be invoked by a State as a ground for precluding wrongfulness if:
(a) The international obligation in question excludes the possibility of invoking necessity; or
(b) The State has contributed to the situation of necessity.
Article 25 was accepted by the International Court of Justice as reflecting customary international law in the Gabcíkovo-Nagymaros Project case.[40] It applies to any internationally wrongful act, whether it involves the breach by a State of an obligation arising under a rule of general international law, a treaty, a unilateral act or from any other source. The irrelevance of the source of the international legal obligation breached is confirmed in article 12 of the Articles on State Responsibility, which provides:
Existence of a breach of an international obligation
There is a breach of an international obligation by a State when an act of that State is not in conformity with what is required of it by that obligation, regardless of its origin or character.
The availability of the doctrine of necessity as a circumstance precluding wrongfulness of the breach of a treaty obligation was accepted in principle by the International Court of Justice in the Gabcíkovo-Nagymaros Project case, considering a treaty between Hungary and Czechoslovakia for a cross-border barrage system.[41] It was also accepted by an International Centre for Settlement of Investment Disputes (ICSID) arbitral tribunal in CMS Gas Transmission Company v Argentine Republic,[42] considering Argentina’s obligations under a 1991 Argentine-United States bilateral investment treaty in the wake of Argentina’s 2001-2002 financial crisis.
Could the customary international law doctrine of necessity preclude the wrongfulness of a breach by State X of its obligation under article 27 of TRIPS to respect Roche and Gilead’s intellectual property rights, should State X decide to manufacture Tamiflu? Each of the elements of the plea of necessity must be examined in turn.
In the Anglo-Portuguese dispute of 1832, in which the Portuguese government appropriated British-owned property, advice to the British Government expressed this requirement in the following way: the Treaty obligations between Britain and Portugal were not such that[43]
the stipulation ought to be so strictly adhered to, as to deprive the Government of Portugal of the right of using those means, which may be absolutely and indispensably necessary to the safety, and even to the very existence of the State.
Similarly, in the Russian Indemnity case of 1912, the arbitral tribunal accepted the principle that the obligation for a State to execute treaties may be weakened ‘if the very existence of the State is endangered, if observation of the international treaty is… self-destructive’.[44] More recently, the ICSID tribunal in CMS considered that ‘the need to prevent a major breakdown, with all its social and political implications’ could entail an essential interest of a State.[45] It also accepted that the peril posed by Argentina’s financial crisis was sufficiently grave and imminent ‘to justify the government taking action to prevent a worsening of the situation and the danger of total economic collapse’.[46]
The extent to which a given interest is ‘essential’ depends on all the circumstances and cannot be prejudged. It extends to particular interests of the State and its people, as well as the international community as a whole.[47] In contrast to the discretion to determine the existence of a national emergency conferred upon States under article 31 of TRIPS, the peril must be objectively established and not merely apprehended as possible.
It would seem relatively clear that the public health of a State is an essential interest of that State. Without healthy citizens, nothing can function. Indeed, it could be said that the very purpose of the State's existence is to provide for the well-being of its citizens. The interests of the international community as a whole are arguably also engaged, given the fact that an outbreak of bird flu would not respect national borders.
The more pertinent question is whether the risk of a bird flu outbreak is sufficiently grave and imminent to justify breaching the obligation under TRIPS. To date, there have been no confirmed cases of human-to-human transmission of the virus. The total number of people killed from the virus is estimated as less than 400 on the last official count.[48] However, by definition, in cases of necessity the peril will not yet have occurred. The very nature of the plea is anticipatory. The International Court of Justice in the Gabcíkovo-Nagymaros Project case stated that[49]
a ‘peril’ appearing in the long-term might be held to be ‘imminent’ as soon as it is established, at the relevant point in time, that the realisation of that peril, however far off it might be, is not thereby any less certain and inevitable.
Thus, the fact that a bird flu epidemic has not yet occurred is not an obstacle to the plea of necessity. The key question is the gravity of the risk. Relevant here is the WHO estimation that bird flu could kill up to 150 million people worldwide and is like ‘a combination of global warming and HIV/Aids 10 times faster than it's running at the moment’.[50] The United Kingdom’s national framework for pandemic flu estimates that up to half of Britain’s population could be infected within 15 weeks of a pandemic, and 2.5% of these would die.[51] This equates to about 750,000 deaths. The economic ramifications of a bird flu epidemic are also relevant. The World Bank has estimated that a bird flu pandemic could cost the global economy up to US$2 trillion.[52] However, these figures are not uncontested. For example, the WHO has since estimated the potential death toll as between two million and 7.4 million, acknowledging that there is confusion over the figures.[53]
Obviously, it is impossible to engage in a calculation of how many millions of people would have to die before the risk was considered sufficiently high. Such a calculation is unnecessary because the International Court of Justice has stated that a measure of uncertainty about the future does not necessarily disqualify a State from invoking necessity. What is important is that the peril is clearly established on the basis of currently available evidence.[54] The worldwide alarm, the statements of public health officials, and the actions taken by States to prepare for a bird flu epidemic, all suggest that the requirement that an essential interest of the State be in grave and imminent peril would be satisfied in this situation.
The course of action taken must be the only way for the State to safeguard the essential interest. The plea is excluded where there are other (otherwise lawful) means available, even if they are more costly or less convenient.[55] For example, the International Court of Justice found in 2004 that the construction of a wall in the Occupied Palestinian Territories, including in and around East Jerusalem, was not the only means to safeguard Israel’s essential security interests against terrorist attacks.[56] Assuming that distribution of an anti-viral drug such as Tamiflu is an essential and effective element of a bird flu prevention strategy and it is possible to manufacture it,[57] the key question is whether there are alternatives to simply overriding Roche and Gilead’s intellectual property rights to produce Tamiflu.
In our hypothetical scenario State X cannot simply purchase Tamiflu because there is no Tamiflu for sale. World demand exceeds supply and Roche and Gilead are refusing to allow others to manufacture it. This is the problem of scarcity. Nor can State X wait for Roche to manufacture more Tamiflu – the demand is more urgent than that because of imminent risk of an outbreak and the speed with which the virus could spread globally. The obvious alternative is to issue a compulsory licence under article 31 of TRIPS. However, as discussed above, this course of action would require State X to pay Roche (and Gilead, presumably) ‘adequate remuneration’. What if State X could not afford to pay such compensation because, for example, it is already heavily in debt with no access to further finance or it must apply what financial resources it has to combating bird flu in other respects? Compulsory licensing under TRIPS article 31 would be an option if the only problem were that the patent holder was not producing enough Tamiflu to meet world demand. It is not a viable option where the scarcity of the drug and the urgency of demand are combined with poverty on the part of the affected State. In this situation, it would seem that overriding Roche and Gilead’s intellectual property rights is the only way to safeguard against an outbreak.
This limitation also means that the State may only take such steps as are reasonably necessary to safeguard its essential interests. It could not, for example, use necessity as an excuse to begin manufacturing Tamiflu for profit. It should take all reasonably practicable steps to minimise the damage to the patent holder.
It is important to note here that it is the combination of factors which justifies the plea of necessity in this case. It is not my argument that financial difficulties alone would justify overriding the patent rights. Such an argument would venture into the debate about access to AIDS drugs in developing countries, which is beyond the scope of this article.
The interest relied on must outweigh all other considerations, not merely from the point of view of the acting State, but on a reasonable assessment of the competing interests, whether these are individual or collective.[58] In this case, the interests competing with that of State X in manufacturing the drug would be the interests of Roche and Gilead in the protection of their rights as well as the interests of the international community as a whole in promoting the development and diffusion of new scientific technologies through the protection of intellectual property rights.[59] The policy objectives of the TRIPS regime are set out in article 7 of TRIPS, which provides:
Objectives
The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.
The protection of intellectual property rights gives companies such as Roche and Gilead the incentive to invent new drugs such as Tamiflu, meaning that it may be counterproductive in the long term to override the patent rights.[60] This element of the plea of necessity demands a balancing exercise between the immediate need to provide drugs to treat an existing health crisis and the longer term need to encourage the development of drugs for future health crises. Striking the correct balance between these two interests involves making a substantive value-judgment which will inevitably engage the decision-maker’s subjective preferences. However, given the value of human life and health recognised in articles 3 and 25 of the Universal Declaration of Human Rights,[61] article 6 of the International Covenant on Civil and Political Rights[62] and article 12 of the International Covenant on Economic, Social and Cultural Rights,[63] and the fact that the predicted global scale of an outbreak of bird flu could be serious enough as to amount to a threat to international peace and security (caused by, for example, international flows of people fleeing the virus; destabilisation of societies whose populations were decimated by the virus, as predicted by the WHO; or even riots protesting the intellectual property protection enjoyed by the exclusive manufacturer[64]), it is clearly arguable that the immediate need to provide drugs to prevent an outbreak should prevail.
Article 25(2)(a) prescribes that necessity may not be invoked by a State as a ground for precluding wrongfulness if the international obligation in question excludes the possibility of invoking necessity, either explicitly or implicitly. Where a treaty is clearly intended to apply in abnormal situations of peril for the responsible State and plainly engages its essential interests, the non-availability of the plea of necessity may be apparent from the object and purpose of the rule.[65]
The primary obligation under article 27 of TRIPS to respect patents does not make any explicit exclusion of the plea of necessity. However, the question is whether article 31 of TRIPS is so clearly intended to apply in abnormal situations of peril such as the bird flu scenario so as to preclude any plea of necessity. On one hand, article 31 could be said to preclude the plea of necessity because it functions as a ‘safety valve’ with respect to the primary obligation to respect patents. It provides member governments discretion to issue compulsory licences in pursuit of their public health policies, for example, to provide cheaper drugs to their citizens, or to combat anti-competitive behaviour on the part of patent holders. It makes national emergencies an excuse for member governments not to make bona fide attempts to negotiate a voluntary licence but not an excuse for non-payment of compensation. The subsequent Doha Declaration and proposed amendments to TRIPS increases global access to medicines, but the article 31(h) requirement for the payment of adequate remuneration has not changed. Does this mean that article 31 can be said to contemplate an inability to pay and nonetheless makes the obligation absolute? Such an interpretation would have drastic consequences. A more realistic interpretation would be that the scope of article 31 is more limited. Its function is, to adopt the terminology developed by Calabresi and Melamed,[66] to convert the intellectual property rights of a patent holder from an entitlement protected by a property rule to an entitlement protected by a liability rule. An entitlement protected by a liability rule is one which someone may appropriate for himself without the consent of the entitlement holder if he is willing to pay an objectively determined value for it.[67] As such, article 31 does not contemplate the possibility that a State may be unable to pay for the intellectual property rights.
It is accepted that article 31 would preclude a plea of necessity if the bird flu scenario simply involved a worldwide shortage of Tamiflu (scarcity) and an urgent need for the drug. However, article 31 does not address the possibility that these two elements may be combined with an inability to comply with the financial requirements of article 31(h) due to poverty on the part of a member government. As such, it is arguable that the TRIPS regime does not exclude the plea of necessity in this narrow set of circumstances.
The contribution must be sufficiently substantial and not merely incidental or peripheral.[68] In the CMS case, the ICSID arbitral tribunal found that Argentina had substantially contributed to its financial crisis through its own governmental policies, thus excluding the plea of necessity.[69] In the bird flu context, examples of contribution which may preclude a plea of necessity might include failure to comply with WHO influenza prevention guidelines or failure to take appropriate steps to minimise the risk of an outbreak in ways other than through pharmaceuticals, such as by restricting the import of contaminated birds. Assuming that State X had taken such measures (to the best of its ability, given its financial constraints) this element would be satisfied.
In summary, there is an arguable case for the plea of necessity on behalf of State X in the hypothetical bird flu situation, where State X cannot afford to pursue the avenue of compulsory licensing under article 31 of TRIPS.
What follows from this? Even if all the elements of necessity are satisfied, article 27 of the International Law Commission’s Articles on State Responsibility prescribes two important limitations:
Consequences of invoking a circumstance precluding wrongfulness
The invocation of a circumstance precluding wrongfulness in accordance with this chapter is without prejudice to:
a) Compliance with the obligation in question, if and to the extent that the circumstance precluding wrongfulness no longer exists;
b) The question of compensation for any material loss caused by the act in question.
This article reflects the limitations on the plea of necessity as set out in cases such as the Rainbow Warrior arbitration[70] and the Gabcíkovo-Nagymaros Project case.[71] First, the plea is temporary.[72] Necessity would only excuse State X’s non-compliance with TRIPS for so long as the bird flu crisis persists. Secondly, the plea of necessity is ‘without prejudice’ to the question of compensation for any material loss caused by the act in question. This wording reflects an ambiguity in international law as to the compensation payable in circumstances of necessity. It does not confer any rights to compensation, being only a reservation in general terms. As noted by the ICSID ad hoc annulment committee in CMS Gas Transmission Co v Argentine Republic, article 27 does not attempt to specify the circumstances in which compensation could be due, notwithstanding the state of necessity.[73] Indeed the International Law Commission states in its Commentaries to article 27 that ‘it is not possible to specify in general terms when compensation is payable’.[74] In the Gabcíkovo-Nagymaros Project case,[75] the International Court of Justice accepted that compensation might sometimes be payable in circumstances of necessity but did not order it in that case. Some commentators suggest that it is conceptually flawed to speak of compensation at all, given the fact that the existence of a state of necessity precludes the wrongfulness of the international act in the first place.[76] The Commentaries to article 27 state only that ‘the reference to “material loss” is narrower than the concept of damage elsewhere in the Articles: Article 27 concerns only the adjustment of losses that may occur when a party relies on a circumstance covered by Chapter V’[77] (which includes the plea of necessity), reflecting the idea that it would be unconscionable to shift the entire burden of the situation of necessity onto the innocent party.[78] Article 27 stands in contrast to article 36 of the Articles on State Responsibility, which states:
Compensation
a) The state responsible for an internationally wrongful act is under an obligation to compensate for the damage caused thereby, insofar as such damage is not made good by restitution.
b) The compensation shall cover any financially accessible damage including loss of profits, insofar as it is established.
The key difference between the two provisions for compensation is that article 36 provides for compensation for loss of profits, whereas article 27 is limited to ‘material loss’. Thus, even if it were accepted that compensation is payable in a circumstance of necessity (which is far from certain), such compensation would be limited to material loss. Applying this to the bird flu situation, State X may not be obliged to compensate Roche and Gilead at all if it made out a successful plea of necessity. If compensation were payable, it would be limited to Roche and Gilead's material loss. While the distinction between ‘material loss’ and lost profits will be somewhat blurred in the case of intellectual property, given that the value of informational goods such as patents depends on their exclusivity, compensation for material loss might be limited to, for example, the research and development costs incurred in anticipation of sale on the market in State X. This can be contrasted with the obligation under article 31(h) of TRIPS to pay ‘adequate remuneration… taking into account the economic value of the authorization’, which would have to take into account the terms upon which Roche and Gilead would have granted a voluntary licence.
At this point it becomes apparent that there are two possible approaches under international law which might justify State X manufacturing Tamiflu without the consent of Roche and Gilead, each with different compensation obligations. Which one is correct? The next part of the paper will examine whether the existing framework of international law can reconcile the two approaches and clarify the legal obligations of State X.
As a WTO-covered agreement, the TRIPS treaty regime is part of the body of general public international law.[79] It follows that the obligation under TRIPS to respect patents is a primary rule of international law. The customary international law doctrine of necessity, as codified in the International Law Commission’s Articles on State Responsibility, is a secondary rule of international law in that it is part of that body of law which specifies the consequences of a breach of a primary obligation of international law. Neither rule is inherently superior to the other. They both derive from State consent and are in principle equal in value.[80] This is the ‘flat’ structure of international law. This flat structure, combined with the increasing complexity of international law as a result of the proliferation of treaties in such diverse areas as international trade, international environmental protection and international human rights has led to concern about the ‘fragmentation’ of international law. The concern is that this fragmentation will result in conflicting judgments, forum-shopping, uncertainty and unpredictability in the law.[81] It has led the International Law Commission to include the topic of fragmentation in its programme of work and establish a Study Group to consider ways in which conflicting rules of international law may be harmonised. The 2005 report of the International Law Commission[82] sets out various existing ‘conflict rules of international law’ which can be used in this way. These include:
a) The maxim of lex specialis derogat legi generali;
b) The rule in article 30 of the Vienna Convention on the Law of Treaties (VCLT) relating to successive treaties;[83]
c) The rule in Article 31(3)(c) of the VCLT relating to treaty interpretation;
d) The rule in article 41 of the VCLT relating to modification of multilateral treaties;
e) The concepts of jus cogens and obligations erga omnes; and
f) Article 103 of the Charter of the United Nations, which provides that obligations under the Chapter shall prevail over obligations under any other international agreement.
Of these rules, article 31(3)(c) and the maxim of lex specialis are the most relevant to the conflict between the TRIPS treaty regime and the customary international law doctrine of necessity.
The doctrine of lex specialis derogat legi generali is a traditional and widely accepted maxim of legal interpretation which seeks to resolve conflicts between norms by establishing relationships of priority between them.[84] It provides that a more specific law will have priority over a more general law. When there is a conflict between primary rules of obligation (such as the TRIPS obligation to respect patents) and secondary rules (such as the rules on State responsibility, including the doctrine of necessity) it will always be possible to say that the primary rules are more specific. Indeed, the operation of lex specialis is built into these secondary rules, both in article 25(2)(a) of the Articles on State Responsibility which contemplates a treaty obligation excluding the operation of the doctrine of necessity and, more generally, in article 55 of the Articles on State Responsibility, which provides:
Lex specialis
These Articles do not apply where and to the extent that the conditions for the existence of an internationally wrongful act or the content or implementation of the international responsibility of a State are governed by special rules of international law.
As such, if the fact situation which might otherwise give rise to the plea of necessity is contemplated by the primary obligation and an alternative legal treatment is provided, this alternative will prevail. This brings us back to the question whether the TRIPS regime contemplates the combination of the urgency of the threat of bird flu, the scarcity of Tamiflu, and the inability of State X to afford the full profit-based compensation required for a compulsory licence under article 31, and whether it prescribes a legal result inconsistent with a plea of necessity. As we have seen from the analysis of article 25(2)(a) above,[85] on one hand, it could be said that the fact that the existence of a national emergency is specified as an excuse for not consulting with a patent holder before issuing a compulsory licence and not as an excuse for non-payment of adequate remuneration implies that the obligation to pay adequate remuneration is absolute, regardless of any extenuating circumstances. If one accepts this argument then, according to the lex specialis maxim, this TRIPS rule would take priority over and displace the doctrine of necessity because it specifically contemplates situations involving public health and pharmaceuticals. However, on the other hand, it is also arguable that article 31 is simply a device to allow governments to shape their own public health policies by converting the protection of the intellectual property entitlement from a property rule to a liability rule and that the type of national emergency contemplated by article 31 is not one in which an urgent need for a scarce drug are combined with an inability to pay the adequate remuneration required by article 31(h). If one accepts this second argument, then in the narrow fact pattern faced by our hypothetical State X there is no conflict between the TRIPS regime and the doctrine of necessity. It is possible to read the two together. How is one to decide between these two alternative approaches?
Article 31(3)(c) of the VCLT provides that, in interpreting a treaty provision:
There shall be taken into account, together with the context:
…(c) any relevant rules of international law applicable in the relations between the parties.
Article 31(3)(c) is a principle of systemic integration — it aims to integrate the treaty obligation in question into the general rules of international law. Unlike the lex specialis maxim, it is a rule of interpretation, not of hierarchy. It is of no assistance if there is an irreconcilable conflict between two norms.[86] The principle was applied recently by the International Court of Justice in the Oil Platforms case[87] and was accepted by the WTO Appellate Body as applicable in the interpretation of the WTO-covered agreements in the Shrimp-Turtle case.[88] Article 3(2) of the WTO Dispute Settlement Understanding requires interpretation of the WTO agreements, including TRIPS, ‘in accordance with customary rules of interpretation of public international law’.[89]
In applying article 31(3)(c) of the VCLT the question is whether there is a way to interpret the TRIPS agreement (including both the primary obligation to respect patents and the compulsory licensing regime) in the context of other rules of international law so as to resolve the apparent conflict between TRIPS and the doctrine of necessity. What are the relevant rules of international law applicable between State X and Roche and Gilead? As non-State actors, Roche and Gilead are not traditional subjects of international law. Indeed, any legal action against State X for breach of TRIPS, for example, in the WTO dispute settlement system, would have to be mediated through Switzerland or the United States, their respective countries of incorporation. However, this does not mean that interaction between the parties is not governed by international law.
The doctrine of necessity is itself one rule of international law applicable between the parties. Is it possible to interpret TRIPS to accommodate this doctrine? A complication is that deference to an inconsistent treaty provision is built into the necessity doctrine in article 27(2)(a). This makes the interpretation exercise circular — the question remains whether the TRIPS agreement is in fact inconsistent.
The predicted global scale of an outbreak of bird flu means that other relevant rules of international law will include treaties recognising the value of human life and health, such as article 6 of the International Covenant on Civil and Political Rights[90] and article 12 of the International Covenant on Economic, Social and Cultural Rights.[91] They will also include rules emphasising the fundamental importance of international peace and security, such as those enshrined in the Charter of the United Nations,[92] as discussed above.[93] Returning to the two possible interpretations of TRIPS identified in the preceding section, the first approach (in which the obligation to pay adequate remuneration is absolute) would require the impoverished State X to refrain from producing and distributing Tamiflu without Roche and Gilead’s consent, even if this entailed the decimation of its population by bird flu and the destabilisation of its society. Such an interpretation is inconsistent with rules recognising the value of human life and the potential destabilisation of international society that could accompany a serious global outbreak. The second interpretative approach (in which the obligations under TRIPS are interpreted as being subject to the doctrine of necessity in the narrowly defined circumstances where urgency and scarcity of the drug is combined with poverty) would be consistent with these other rules of international law applicable between the parties. As such, an application of article 31(3)(c) would suggest that this interpretation is to be preferred.
There is a real threat of a global outbreak of bird flu. While there is disagreement about the precise extent of the threat, there is consensus that an outbreak would have devastating public health and economic consequences. The scarcity of anti-viral drugs to treat bird flu gives rise to a conflict between the private intellectual property rights of the patent holder and the manufacturer and the public national security interest of States faced with the threat of bird flu. The aim of this paper has been to suggest that, in the narrowly defined circumstances faced by the hypothetical State X where the urgent threat of bird flu and the scarcity of anti-viral drugs is combined with an inability to pay the adequate remuneration required by the TRIPS compulsory licensing scheme, the customary international law doctrine of necessity might operate to preclude the wrongfulness of a breach of the TRIPS agreement.
Why is international law not clear on the point? The flat structure of international law means that there is no inherent hierarchy between the TRIPS treaty regime and the customary international law doctrine of necessity. The existing ‘harmonising’ rules do not resolve the matter – they can be applied in different ways with different results. Resolution of the conflicting norms returns inevitably to a balancing exercise between competing values: the immediate need to provide drugs to treat an existing health crisis and the longer-term need to encourage the development of drugs for future health crises through the incentives provided by intellectual property rules.
The balancing exercise can also be viewed more broadly as between fundamentally conflicting values within the globalisation debate itself: the tension between, on the one hand, promotion of international trade and development with increased rights for corporate actors and, on the other hand, respect for State sovereignty, particularly of States obliged to accede to the TRIPS agreement in order to gain membership of the WTO, and the right to value human life above all else. Striking a balance between these two interests involves making a value-judgment. This element of subjectivity is inconsistent with the idea that international law should provide certain and predictable answers to questions of law and clearly pronounce the legal obligations of international actors.
The uncertainty highlighted by the arguments in this paper is partly a result of the increasing complexity of modern international law and may be remedied to a certain extent by the International Law Commission’s work to develop harmonising rules of international law. However, harmonising rules cannot resolve the tension where it arises from the fundamentally incompatible values embedded in conflicting norms of international law. The tensions are conceptual and will continue to give rise to contestation in international legal argumentative discourse, no matter how many harmonising rules are developed. In the meantime, the necessity argument should be explored by any impoverished State facing the bird flu threat.
* Nina Khouri, BA/LLB(Hons) (Auckland), LLM (NYU). The author gratefully acknowledges the support and encouragement of Professor Benedict Kingsbury of the New York University School of Law in the preparation of this article.
1 World Health Organization, ‘Cumulative Number of Confirmed Cases of Avian Influenza A/(H5N1) Reported to WHO’ (22 February 2008), online: <http://www.who.int/csr/
disease/avian_influenza/country/cases_table_2008_02_22/en/index.html> at 26 February 2008 (“WHO estimates”).
[2] ‘Bird flu could kill 150m people’, BBC News Online, 30 September 2005, online: <http://news.bbc.co.uk/1/hi/world/asia-pacific/4292426.stm> at 26 November 2007.
[3] World Health Organization, ‘World Health Organization Avian Influenza Frequently Asked Questions’ under ‘Why are pandemics such dreaded events?’ online: <http://www.who.int/csr/disease/avian_influenza/avian_faqs/en/index.html#vaccine> at 27 November 2007 (“WHO Frequently Asked Questions”).
[4] Dr Margaret Chan, ‘Sharing of influenza viruses and access to vaccines and other benefits’ (Opening remarks at the Intergovernmental Meeting on Pandemic Influenza Preparedness, Geneva, 20 November 2007).
[5] ‘Bird flu Could Cost Global Economy $800b’ New Zealand Herald Online, 8 November 2005, online: <http://www.nzherald.co.nz/section/story.cfm?c_id=2 & ObjectID=10354179> at 26 November 2007; Christian Nordqvist, ‘Avian Flu Pandemic Could Cost World 2 Trillion Dollars’ Medical News Today, 18 September 2006, online: <http://www.medicalnewstoday.com/articles/52126.php> at 29 November 2007.
[6] ‘Bush Unveils $7.1 Billion Plan to Prepare for Flu Pandemic’, CNN.com, 2 November 2005, <http://www.cnn.com/2005/HEALTH/conditions/11/01/us.flu.plan/> at 26 November 2007.
[7] Agence France-Presse, ‘Saudi Arabia: Bird Flu Outbreak’ New York Times, 22 November 2007), online: <http://www.nytimes.com/2007/11/22/world/middleeast/22briefs-birdflu.
html?ex=1353474000&en=e778bb99fc2d65d1&ei=5088&partner=rssnyt&emc=rss> at 29 November 2007.
[8] ‘Closing Borders an Option in Fight Against Bird Flu’ (Press Release, New Zealand Herald Online, 16 November 2005), online: <http://www.nzherald.co.nz/location/
story.cfm?l_id=3&objectid=10355535> at 26 November 2007.
[9] Roche, ‘Tamiflu Factsheet’ (15 December 2005), online: <http://www.roche.com/
med_mbfstamiflu.pdf> at 26 November 2007.
[10] Keith Bradsher, ‘Pressure Rises on Producer of a Flu Drug’, New York Times, 11 October 2005, C12.
[11]Unmesh Kher, ‘Why Roche Released Tamiflu’, Time Online Edition, 19 October 2005), online: <http://www.time.com/time/business/article/0,8599,1120533,00. html> at 26 November 2007.
[12] Jenny Hsu, ‘DOH Submits Application for Tamiflu License’ (Press Release, Taiwan News, 1 November 2005), online: <http://english.www.gov.tw/e-Gov/pda_index.jsp?categid=217 & recordid=87883> at 26 November 2007.
[13] David Fidler, ‘The Continuing Global Spread of Avian Influenza A (H5N1) and Its Implications for International Law, ASIL Insight (7 November 2005).
[14] Roche, above n 9.
[15] Agreement on Trade-Related Aspects of Intellectual Property Rights, Annex 1C, WTO Agreement: Marrakesh Agreement Establishing the World Trade Organization, opened for signature 15 April 1994, 1867 UNTS 154, 33 ILM 1144 (1994) (entered into force) (TRIPS Agreement).
[16] Vienna Convention on the Law of Treaties, opened for signature 23 May 1969, 1155 UNTS 331 (entered into force 27 January 1980) (Vienna Convention).
[17] The TRIPS Agreement contains transitional provisions allowing time for developing and least developed countries to implement the Agreement, including the obligations regarding protection of pharmaceutical patents. It is assumed for the purposes of this discussion that State X has met its TRIPS obligations in this respect.
[18] Marrakesh Agreement Establishing the World Trade Organization, opened for signature 15 April 1994, 1867 UNTS 3 (entered into force 1 January 1995), annex 2 ‘Understanding on Rules and Procedures Governing the Settlement of Disputes’, 1869 UNTS 401, art 3(2).
[19] Anupam Chander, ‘The Fight Over Patent Protection for Pharmaceuticals’, FindLaw Legal News and Commentary (6 March 2003), online: <http://writ.findlaw.com/
commentary/20030306_chander.html> at 26 November 2007.
[20] World Trade Organization, ‘Fact Sheet: TRIPS and pharmaceutical patents’ (2 September 2003), online: <http://www.wto.org/english/tratop_e/trips_e/ tripsfactsheet_pharma_e.pdf> at 26 November 2007 (WTO Fact Sheet).
[21] World Trade Organization, ‘Ministerial Declaration on the TRIPS Agreement and Public Health’ (14 November 2001), WT/MIN/(01)/DEC/2, online: <http://www.wto.org/english/
thewto_e/minist_e/min01_e/mindecl_e.htm> at 6 February 2008) (Doha Declaration), para 4 (emphasis added).
[22] Ibid, para 5.
[23] FM Scherer and Jayashree Watal, ‘Post-TRIPS Options for Access to Patented Medicines in Developing Nations’ (2002) 5 Journal of International Economic Law 913, 925.
[24] Doha Declaration, above n 21, para 6.
[25] World Trade Organization, ‘Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health’, WT/L/540, WT/L/540 (30 August 2003), online: <http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm> at 6 February 2008.
[26] World Trade Organization, ‘Amendment of the TRIPS Agreement’, WT/L/641 (6 December 2005), online: <http://www.wto.org/english/tratop_e/trips_e/wtl641_e.htm> at 6 February 2008.
[27] World Trade Organization, ‘Amendment of the TRIPS agreement – Extension of the period for the acceptance by Members of the protocol amending the TRIPS Agreement’, W/L/711 (18 December 2007), online: <http://docsonline.wto.org/DDFDocuments/t/WT/L/
711.doc> at 6 February 2008.
[28] World Trade Organization News Items, ‘Canada is first to notify compulsory licence to export generic drug’ (4 October 2007), online: <http://www.wto.org/english/news_e/
news07_e/trips_health_notif_oct07_e.htm> at 20 January 2008.
[29] TRIPS Agreement, above n 15, art 31(h).
[30] ‘Amendment of the TRIPS Agreement’, above n 26, art 31bis(2).
[31] MB Rao and Manjula Guru, Understanding TRIPS: Managing Knowledge in Developing Countries (2003) 183.
[32] Daniel Gervais, The TRIPS Agreement: Drafting History And Analysis (1998) 166.
[33] Ibid.
[34] James Love, Remuneration Guidelines for non-voluntary use of a patent on medical technologies (WHO, 2005), TCM Series No 18, WHO/TCM/2005.1, online: <http://www.who.int/medicines/areas/technical_cooperation/WHOTCM2005.1_ OMS.pdf> at on 23 February 2008), 68-71 (WHO remuneration guidelines).
[35] Canadian Intellectual Property Office, ‘Use of Patents for International Humanitarian Purposes to Address Public Health Problems: Pay Royalties (Canada's Access to Medicines Regime)’, online: <http://www.ic.gc.ca/sc_mrksv/cipo/jcpa/p3-e.html> at 23 February 2008.
[36] United Nations Development Programme, Human Development Report 2001: Making New Technologies Work for Human Development (2001) 108, online: <http://hdr.undp.org/en/media/completenew1.pdf> at on 23 February 2008); cited in WHO remuneration guidelines, above n 34, 68.
[37] WHO remuneration guidelines, above n 34, 73.
[38] The text of the Articles on State Responsibility and the commentaries thereto (International Law Commission Commentaries) are reproduced in Report of the International Law Commission to the General Assembly, UN GAOR, 56 Supp (No 10), UN Doc A/56/10 (2001). These are reprinted in James Crawford, The International Law Commission’s Articles On State Responsibility (2002) (Crawford).
[39] GA Res 56/83, Resolution of the United Nations General Assembly on the Responsibility of States for Internationally Wrongful Acts, UN GAOR, 56th sess, UN Doc A/Res/56/83 (12 December 2001).
[40] Case concerning the Gabcíkovo-Nagymaros Project (Hungary v Slovakia) [1997] ICJ Rep 7.
[41] Ibid.
[42] CMS Gas Transmission Company v Argentine Republic, ICSID Case No ARB/01/8, Award of 12 May 2005 (CMS).
[43] AD McNair (ed), International Law Opinions, Vol II (1956), 232, cited in Crawford, above n 38, 179 (emphasis added).
[44] Russian Indemnity Case (Turkey v Russia) (1912) 11 United Nations Reports of International Arbitral Awards 431, 443 (emphasis added).
[45] CMS, above n 42, para 319.
[46] Ibid, para 321. These findings were not criticised by the ICSID ad hoc annulment committee: CMS Gas Transmission Company v Argentina Republic, ICSID Case No ARB/01/8 (Annulment Proceeding), Decision of the Ad Hoc Committee on the Application for Annulment of the Argentine Republic of 25 September 2007 (CMS annulment decision).
[47] International Law Commission Commentaries in Crawford, above n 38, 183.
[48] WHO estimates, above n 1, at 22 February 2008.
[49] Case concerning the Gabcíkovo-Nagymaros Project (Hungary v Slovakia) [1997] ICJ Rep 7, para 54.
[50] ‘Bird flu 'could kill 150m people’, above n 2.
[51] ‘Pandemic flu: your questions answered’ (Press Release, Guardian Unlimited, 22 November 2007), online: <http://www.guardian.co.uk/society/2007/nov/22/health.birdflu> at 27 November 2007.
[52] ‘Avian Flu Pandemic Could Cost World 2 Trillion Dollars’, above n 5.
[53] ‘Bird flu 'could kill 150m people’, above n 2.
[54] International Law Commission Commentaries in Crawford, above n 38, 184.
[55] Case concerning the Gabcíkovo-Nagymaros Project (Hungary v Slovakia) [1997] ICJ Rep 7, para 55; CMS , above n 42, para 323.
[56] Legal Consequences of the Construction of a Wall in the Occupied Palestinian Territory (Advisory Opinion) (2004) ICJ LEXIS 20, para 140.
[57] There is some controversy over whether it is physically possible to manufacture Tamiflu in sufficient quantities. A key ingredient, star anise, is in increasingly short supply. Researchers at the University of Michigan claim to have found a substitute: Andrew Pollack, ‘Is a Bird Flu Drug Really So Vexing?’ New York Times, 5 November 2005, C1; as do researchers at Harvard University: Debora MacKenzie, ‘Way to mass produce key bird flu drug revealed’ NewScientist.com, 4 May 2006, online: <http://www.newscientist.com/channel/health/bird-flu/dn9107-way-to-mass-produce-key-bird-flu-drug-revealed.html> at 27 November 2006. There is also concern that the virus might develop resistance to the drug: Bradsher, above n 10. For the purposes of this legal analysis, however, it is assumed that it is possible to produce the drug, that the drug would be effective against bird flu, and that proper risk-minimization measures, such as controlled distribution through authorised health centres, would be taken.
[58] International Law Commission Commentaries in Crawford, above n 38, 184.
[59] Gervais, above n 32, 65-66.
[60] This is, in fact, a contestable assumption. There is wide disagreement over whether an information policy based on exclusive proprietary rights is in fact the best model for promoting innovation. See, for example, Yochai Benkler, Wealth of Networks (2006), ch 9; and William W Fisher III, Promises To Keep: Technology, Law, and the Future of Entertainment (2004).
[61] GA Res 217A (III), Universal Declaration of Human Rights, UN GAOR, UN Doc A/810 (1948).
[62] International Covenant on Civil and Political Rights, opened for signature 16 December 1966, 999 UNTS 171 (entered into force 23 March 1976).
[63] International Covenant on Economic, Social and Cultural Rights, opened for signature 16 December 1966, 999 UNTS 3 (entered into force 3 January 1976).
[64] Consider, for example, the December 2001 riots in Argentina caused by outrage at the financial crisis and, in part, by the perceived preferential treatment of foreign corporate interests.
[65] International Law Commission Commentaries in Crawford, above n 38, 185.
[66] G Calabresi and A D Melamed, ‘Property Rules, Liability Rules, and Inalienability: One View of the Cathedral’ (1972) 85 Harvard Law Review 1089.
[67] Ibid, 1092.
[68] International Law Commission Commentaries in Crawford, above n 38, 185.
[69] CMS, above n 42, para 329. This finding was not criticised in the CMS annulment decision, above n 46.
[70] Rainbow Warrior (New Zealand v France) (1990) 20 United Nations Reports of International Arbitral Awards 217.
[71] Case concerning the Gabcíkovo-Nagymaros Project (Hungary v Slovakia) [1997] ICJ Rep 7, 42-43.
[72] CMS, above n 42, paras 379-380.
[73] CMS annulment decision, above n 46, para 147.
[74] International Law Commission Commentaries in Crawford, above n 38, 190.
[75] Case concerning the Gabcíkovo-Nagymaros Project (Hungary v Slovakia) [1997] ICJ Rep 7.
[76] See, for example, Stephan Wittich, ‘The International Law Commission’s Articles on the Responsibility of States for Internationally Wrongful Acts Adopted on Second Reading’ (2002) 15 Leiden Journal of International Law 891.
[77] International Law Commission Commentaries in Crawford, above n 38, 190.
[78] James Crawford, Second Report on State Responsibility, UN Doc A/CN/4/498 and Add. 1-4 (1999), para 339.
[79] Joost Pauwelyn, ‘The Role of Public International Law in the WTO: How Far Can We Go?’ (2001) 95 American Journal of International Law 535, 538.
[80] Ibid, 536.
[81] Martti Koskenniemi, ‘Global Legal Pluralism: Multiple Regimes and Multiple Modes of Thought’ (Speech delivered at Harvard University, Cambridge, Massachusetts, 5 March 2005), online: <http://www.helsinki.fi/eci/Publications/MKPluralism-Harvard-05d%5B1%5D.pdf> at 27 November 2007.
[82] Report of the International Law Commission on the work of its fifty-seventh session, UN GAOR, 60th sess, Supp No 10, UN Doc A/60/10 (2 May-3 June; 11 July–5 August 2005).
[83] Vienna Convention, above n 16.
[84] Report of the Study Group on Fragmentation of International Law: Difficulties arising from the diversification and expansion of international law, UN Doc A/CN.4/L.663/Rev.1 (28 July 2004), 4-5.
[85] Text accompanying footnote above n 65.
[86] Campbell McLachlan, ‘The Principle of Systemic Integration and Article 31(3)(c) of the Vienna Convention’ (2005) 54(2) International and Comparative Law Quarterly 279, 318.
[87] Case concerning Oil Platforms (Iran v United States of America) 42 ILM 1334 (2003), para 41.
[88] United States - Import Prohibition of Certain Shrimp and Shrimp Products, WT/DS58/A/R (12 October 1998), 38 ILM 118 (1999) (Report of the WTO Appellate Body).
[89] Annex 2 ‘Understanding on Rules and Procedures Governing the Settlement of Disputes’, above n 18, art 3(2).
[90] International Covenant on Civil and Political Rights, opened for signature 16 December 1966, 999 UNTS 171 (entered into force 23 March 1976).
[91] International Covenant on Economic, Social and Cultural Rights, opened for signature 16 December 1966, 999 UNTS 3 (entered into force 3 January 1976).
[92] See, for example, Preamble to the Charter of the United Nations, opened for signature 26 June 1945 (entered into force 24 October 1945).
[93] Text accompanying above n 61.
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