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Keywords:

  • generic drugs;
  • border measures;
  • TRIPS;
  • access to medicines

Abstract

  1. Top of page
  2. Abstract
  3. The Cases of Losartan and Abacavir
  4. External Transit Control of Generics under EU Regulation 1383/2003
  5. TRIPS Minimum Standards on Border Measures
  6. The Extraterritoriality Claim
  7. Are There Ceilings to External Transit Control of Medicines?
  8. Free-Trade Provisions as Weak Internal Ceilings
  9. The Limited Role of the Objectives and Principles of the TRIPS in Protecting Public Health
  10. The Doha Declaration on TRIPS and Public Health as a Potential Ceiling
  11. The International Definition of Counterfeit Medicines
  12. International Law on Access to Medicines
  13. Access to Medicines and Intellectual Property Rights in the Context of the Fragmentation of International Law
  14. TRIPS-plus Agreements and Access to Medicines
  15. Conclusions
  16. References
  17. Biography

In 2008, Dutch customs authorities blocked generic medicines in transit in the Dutch territory on suspicion of their being counterfeit. India and Brazil subsequently claimed that external transit control of medicines is inconsistent with the Trade-Related Aspects of Intellectual Property Rights (TRIPS), the Doha Declaration on TRIPS and Public Health and international provisions on access to medicines. This article aims to shed light on the consistency of external transit control of generics with international law, and on the interrelations between issues of intellectual property, free trade and public health at the international level; it shows that TRIPS makes possible a broad extension of IP rights protection while ceilings present some weaknesses.


The Cases of Losartan and Abacavir

  1. Top of page
  2. Abstract
  3. The Cases of Losartan and Abacavir
  4. External Transit Control of Generics under EU Regulation 1383/2003
  5. TRIPS Minimum Standards on Border Measures
  6. The Extraterritoriality Claim
  7. Are There Ceilings to External Transit Control of Medicines?
  8. Free-Trade Provisions as Weak Internal Ceilings
  9. The Limited Role of the Objectives and Principles of the TRIPS in Protecting Public Health
  10. The Doha Declaration on TRIPS and Public Health as a Potential Ceiling
  11. The International Definition of Counterfeit Medicines
  12. International Law on Access to Medicines
  13. Access to Medicines and Intellectual Property Rights in the Context of the Fragmentation of International Law
  14. TRIPS-plus Agreements and Access to Medicines
  15. Conclusions
  16. References
  17. Biography

On 4 December 2008, Dutch customs authorities seized an air shipment of generic medicines exported from India by the Indian Dr. Reddy’ Laboratories, on their way to the Brazilian market, specifically to the Brazilian importer the EMS Sigma Pharma Group. The shipment consisted of 570 kg of Losartan Potassium, an active pharmaceutical ingredient used in the production of medicines for arterial hypertension. Even though these goods were not intended for the European Union (EU) market, and were only passing through the Netherlands, Dutch customs authorities applied Regulation 1383/20031 to block these generics in external transit allegedly on suspicion of their being “counterfeit”. The cargo was held for 36 days and then released, but, instead of following its course to Brazil, it was directed back to India. India protested that the medicines in transit were going to be destroyed, while the EU replied that the Dutch authorities “temporarily detained” them;2 that, if detention had occurred on the basis of an unsubstantiated complaint, the owner of the products was entitled to compensation and that, after the release, the Indian exporter could have continued its journey to Brazil instead of returning to India.3

The case is not isolated however: in 2008, 17 shipments of generics were seized in the Netherlands.4 Similarly, on 4 March 2009, the drug-purchasing mechanism UNITAID5 said that one of its funded shipments had been stopped by Dutch customs authorities at Schiphol airport, also under the claim that it included “counterfeit” goods. The shipment, containing 49 kg of Abacavir sulphate, a second-line HIV/AIDS medication, was not counterfeit according to UNITAID, and it was of fundamental importance for patients awaiting these urgently needed medicines, since interruption in HIV therapy is extremely risky, and can trigger resistance to the medicines.6

Following these events, India and Brazil, supported by several developing countries,7 expressed concern on them at the World Trade Organisation (WTO) General Council8 in February 2009, and then at the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) in March 2009,9 and at the ensuing Councils. Finally, in May 2010, they decided to request consultations with the EU and the Netherlands, the first step to bring the issue to the Dispute Settlement Body (DSB) of the WTO.10 According to these countries, external transit control of medicines is inconsistent with the TRIPS and the Doha Declaration on TRIPS and Public Health, and it represents a grave impediment for access to medicines. Leading international public health advocates have also expressed concern for these events and they called the WTO's and the World Health Organisation's (WHO) Director General to attend to the issue.11 The relevance of the matter is also tied to the fact that the medicines seized qualify as generics, namely, drugs produced after the expiry of the patent or under a compulsory licence, and particularly important for general access to medicines because they cost less than branded and patented drugs. While it is true that these countries could simply change their routes of trade and transit through other countries, such a change would entail redesigning their entire supply chain, and therefore the EU policy critically impacts the ability of these countries to service the healthcare needs of citizens in a timely manner (Mara, 2009).

In October 2010, the Indian Minister of Commerce declared that the EU has promised to “fix” the law that causes generics seizures (Mara, 2010), and it therefore seems unlikely that a WTO panel will be established on the issue. However, the case remains an interesting occasion to evaluate whether TRIPS sufficiently protect public health, or if it implicates an extension of the protection of IP rights without limits; the analysis will show that limits are weak. The present article aims indeed to shed light on the consistency of external transit control of generic medicines with international law: after explaining the contents of EU Regulation 1383/2003, I will focus on whether external transit control of medicines—a so-called “TRIPS-plus” measure—is consistent with TRIPS, and especially whether free trade and access to medicines may be considered as “ceilings”.

External Transit Control of Generics under EU Regulation 1383/2003

  1. Top of page
  2. Abstract
  3. The Cases of Losartan and Abacavir
  4. External Transit Control of Generics under EU Regulation 1383/2003
  5. TRIPS Minimum Standards on Border Measures
  6. The Extraterritoriality Claim
  7. Are There Ceilings to External Transit Control of Medicines?
  8. Free-Trade Provisions as Weak Internal Ceilings
  9. The Limited Role of the Objectives and Principles of the TRIPS in Protecting Public Health
  10. The Doha Declaration on TRIPS and Public Health as a Potential Ceiling
  11. The International Definition of Counterfeit Medicines
  12. International Law on Access to Medicines
  13. Access to Medicines and Intellectual Property Rights in the Context of the Fragmentation of International Law
  14. TRIPS-plus Agreements and Access to Medicines
  15. Conclusions
  16. References
  17. Biography

Border measures are a fundamental tool for IP holders because they are a “safety net” in the event that enforcement at the source has not taken place (Otten and Wager, 1996, p. 405; UNCTAD, ICTSD, 2005, p. 609). The most common case of application is when the IP holder cannot prevent the production of counterfeit abroad (in a territory where his right is not protected) but, at least, he is allowed to ask customs to block these goods before they enter and sold in the territory where the holder's right is protected by national law.12

The EU has established border measures since 1986, and it has exclusive competence over them, since they are part of the Common Commercial Policy.13 The latest revision of the border measures discipline led to Regulation 1383/2003,14 a powerful tool for IP holders, because it has a very broad scope of application in terms of rights protected and customs procedures covered.

The procedure enables customs to suspend the release of goods suspected of infringing IP rights ex officio, or by request of the right holder. First, in terms of rights protected, Regulation 1383/2003 applies to “goods infringing an IP right”, which, according to article 2, means “counterfeit goods”, “pirated goods” and goods infringing patents and other IP rights.15 In the case of Losartan, Dutch customs blocked the goods because of the suspicion of a patent violation of the drugs in transit from India, which is included in the scope of application of the Regulation, though it is not deemed a “counterfeit good”.

Second, Regulation 1383/2003 seems to be applicable not only in the event of import, export and re-export, but also when goods are subject to other customs procedures that do not provide for the goods to be cleared and released for free circulation into the EU territory, since they remain formally outside—for example, when they are placed in a free zone or warehouse—or in the event of external transit.16 This last customs procedure technically refers to goods coming from and directed to a third country, which therefore are not to be released for free circulation within the EU territory (as it is the case under discussion). Nevertheless, European case law on external transit is still controversial. In the case of internal transit (from and to a EU member state), the Court of Justice of the European Union (CJEU) made clear that national legislations cannot allow member states to stop goods in transit within the Union,17 because this would be contrary to the free movement of goods (now article 36 Treaty on the Functioning of the EU). In fact, this main EU pillar is seriously undermined by territorial IP rights, but in certain cases, like this one, free movement of goods prevails. However, the issue is not settled in the case of external transit (concerning goods coming and going to third countries), when Regulation 1383/2003 is applicable.

In Polo Lauren,18 the CJEU stated that the Regulation should be interpreted as granting the possibility for a US company to obtain a decision from Austrian customs offices to suspend release or to detain Polo T-shirts featuring its verbal and pictorial trademarks (suspected of violating its right protected under Austrian law) in external transit. The CJEU also underlined that external transit control makes sense because transit is a legal fiction, by stating that

after all, the external transit of non-Community goods is not completely devoid of effect on the internal market. It is, in fact, based on a legal fiction. Goods placed under this procedure are subject neither to the corresponding import duties nor to the other measures of commercial policy; it is as if they had not entered the Community territory. In reality, they are imported from a non-member country and pass through one or more member states before being exported to another non-member country. This operation is all the more liable to have a direct effect on the internal market as there is a risk that counterfeit goods placed under the external transit procedure may be fraudulently brought on to the Community market, as several Governments pointed out in their written observations and at the hearing.19

On the contrary, after this ruling, the CJEU held in Montex that from the mere risk that the goods in external transit in Germany could fail to reach their destination (Ireland), where the trademark at issue was not protected, and that they could theoretically be marketed fraudulently in Germany, where they would have been counterfeit, it did not follow that transit infringes the essential functions of the trademark in Germany20: in order for the goods to be stopped by customs, the risk of their possible diversion should be manifest. Following this ruling, some authors argued that external transit control in the case of Losartan could have only be justified if there was evidence of the threat of fraudulent diversion of those drugs into the EU market (Grosse Ruse-Khan and Jaeger, 2009, p. 519), while it is clear that this threat was not present concerning Losartan and Abacavir.

It has to be hoped that the CJEU will soon clarify this important matter through the two pending cases.21 On the one hand, the argument brought by some authors supporting control of goods in transit, even within the EU market,22 is that transit has to be controlled even without evidence of diversion: they clearly show that, in a number of disputes in EU member states, traders declared external transit procedure to avoid border measures and therefore, while the risk of diversion is not always manifest, it is still present (Vrins, 2010, pp. 362ff). They also asserted that placing the goods in external transit—in particular for tobacco products and spirits—is a typical means bringing them into the EU so as to be ultimately distributed for sale there (Vrins and Schneider, 2006, p. 95). On the other hand, external transit does not imply import and commercialization in the country of transit and, therefore, in the event of lack of evidence of fraudulent diversion, there should be no legal basis for infringement of IP rights protected in the country of transit, since external transit on the territory should not be sufficient to derogate to the territoriality principle (see paragraph 4 below).23 Furthermore, the right holder who cannot avoid transit may still protect his rights through civil and criminal sanctions when the goods are put into commerce within the market.

In conclusion, in the cases of Losartan and Abacavir, the compliance of Dutch authorities with Regulation 1383/2003 by blocking medicines suspected of infringing Dutch patent rights and in external transit into the European territory, has been questioned referring to Montex but CJEU case law on external transit is not settled yet; and the legitimacy of the Regulation on the basis of fundamental rights, especially the right to health, has so far not been questioned by member states. The fact that the EU is now committed to revising the text of Regulation 1383/2003 in order to “fix” it, would appear to confirm the ambiguity of a matter that could be interpreted in several ways.

TRIPS Minimum Standards on Border Measures

  1. Top of page
  2. Abstract
  3. The Cases of Losartan and Abacavir
  4. External Transit Control of Generics under EU Regulation 1383/2003
  5. TRIPS Minimum Standards on Border Measures
  6. The Extraterritoriality Claim
  7. Are There Ceilings to External Transit Control of Medicines?
  8. Free-Trade Provisions as Weak Internal Ceilings
  9. The Limited Role of the Objectives and Principles of the TRIPS in Protecting Public Health
  10. The Doha Declaration on TRIPS and Public Health as a Potential Ceiling
  11. The International Definition of Counterfeit Medicines
  12. International Law on Access to Medicines
  13. Access to Medicines and Intellectual Property Rights in the Context of the Fragmentation of International Law
  14. TRIPS-plus Agreements and Access to Medicines
  15. Conclusions
  16. References
  17. Biography

As affirmed above, this article will focus on whether external transit (or in-transit) control of generics, as applied by the EU in the case of Losartan, is consistent with international law, specifically with TRIPS and related international norms.

At the international level, TRIPS, concluded in 1994 as an annex of the Agreement Establishing the WTO, is the first agreement to provide for minimum standards on the enforcement of IP rights, and to include provisions on border measures that, at present, are applied by 153 WTO member states. Articles 51–60 TRIPS impose WTO member states to adopt border measures, and they provide certain requirements on the procedure, aimed at safeguarding a balance between the right holder and its competitors. According to the WTO Dispute Settlement Understanding, TRIPS has to be interpreted in accordance with the customary rules of interpretation of public international law and the Appellate Body (AB) has affirmed that articles 31–33 of the Vienna Convention on the Law of the Treaties (VCTL)24 have attained that status. Therefore, according to article 31.1 VCTL:

A treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose.

And according to article 31.3 VCTL:

There shall be taken into account, together with the context:

  1. any subsequent agreement between the parties regarding the interpretation of the treaty or the application of its provisions;
  2. any subsequent practice in the application of the treaty that establishes the agreement of the parties regarding its interpretation;
  3. any relevant rules of international law applicable in the relations between the parties.

In order to understand whether the transit control of Losartan effected by Dutch customs was inconsistent with TRIPS, we therefore must first analyse the ordinary meaning of article 51 of the Agreement. This article, on “suspension of release by customs authorities”, provides that

Members shall, in conformity with the provisions set out below, adopt procedures to enable the right holder, who has valid grounds for suspecting that the importation of counterfeit trademark or pirated copyright goods may take place, to lodge an application in writing with competent authorities, administrative or judicial, for the suspension by the custom authorities of the release into free circulation of such goods.

Footnote 13 on the procedures permissible states that “it is understood that there shall be no obligation to apply such procedures to imports of goods put on the market in another country by or with the consent of the right holder, or to goods in transit”. Literally (and compatibly with the official French and Spanish versions), this means that member states are not obliged to institute national legislation covering the control of goods in transit by TRIPS. Such a statement seems also to imply that control of goods in transit can be applied by the member states, if they consider it opportune, because if external transit control were deemed contrary to TRIPS, this footnote would likely have had a different formulation, and it would not have left members the possibility of providing for these controls.

In the case of Losartan, it appears that the seizure was requested by the companies Merck (a US pharmaceutical company licensee of European patents and Dutch supplementary protection certificates), and DuPont, holding patents that they considered violated by the shipment in question,25 while new evidence confirmed that EU customs acted ex officio.26 Inasmuch as the case at issue concerns patents, it has then to be seen whether transit control in the event of goods suspected to violate a patent is covered by TRIPS since article 51 first sentence only refer to counterfeit trademarks and pirated copyrights goods (see paragraph 9 below). From a general perspective, and at practical level, it is a highly complex task for customs to cross-check patents, as this requires specific technical know-how; moreover, as we will see, the case of medicines involves further complexities. As for TRIPS, article 51 explicitly states in the second part that

Members may enable such an application to be made in respect of goods which involve other infringements of intellectual property rights, provided that the requirements of this section are met.27 Members may also provide for corresponding procedures concerning the suspension by the customs authorities of the release of infringing goods destined for exportation from their territories.

Therefore, it is possible to stop goods on suspicion of patents’ infringements under certain conditions, since articles 51–60 TRIPS requirements (concerning e.g. evidence, the duration of suspension and remedies) have to be fulfilled. However, also in the event of goods infringing a patent destined for exportation, as it is the case of goods in external transit, holders may ask the suspension. In this last case, a WTO panel affirmed recently that since this sentence does not mention the requirements of that section they have not necessarily to be met,28 notwithstanding the fact that this means that members may provide for broader protection for goods destined to export than to those to be released in their markets, and for goods infringing patents than for counterfeit and pirated goods.

In conclusion, external transit of goods suspected of infringing a patent is consistent with article 51 TRIPS but this still has to be analysed in the framework of its context and of the object and purpose of the treaty.

The Extraterritoriality Claim

  1. Top of page
  2. Abstract
  3. The Cases of Losartan and Abacavir
  4. External Transit Control of Generics under EU Regulation 1383/2003
  5. TRIPS Minimum Standards on Border Measures
  6. The Extraterritoriality Claim
  7. Are There Ceilings to External Transit Control of Medicines?
  8. Free-Trade Provisions as Weak Internal Ceilings
  9. The Limited Role of the Objectives and Principles of the TRIPS in Protecting Public Health
  10. The Doha Declaration on TRIPS and Public Health as a Potential Ceiling
  11. The International Definition of Counterfeit Medicines
  12. International Law on Access to Medicines
  13. Access to Medicines and Intellectual Property Rights in the Context of the Fragmentation of International Law
  14. TRIPS-plus Agreements and Access to Medicines
  15. Conclusions
  16. References
  17. Biography

Before analysing article 51 in the light of the object and purpose of TRIPS, it is necessary to focus on the territoriality principle. IP rights are indeed based on this principle: they are granted by a national body and have effect only within national borders; if then an entrepreneur decides to protect their rights in additional countries, he must apply in each country and will be protected according to the respective law of those countries. Furthermore, the validity of an IP right in a given country does not depend on the validity offered in other countries. In the case of Losartan, because not patented, this product is legal in India, where the drugs were manufactured, and in Brazil, where they were to be sold; whereas it could infringe a patent in the EU, where it is patented by DuPont and Merck Sharp & Dohme. Therefore, it is a case of extraterritorial application of Dutch patent rights; controlling goods in external transit implies the possibility to enforce its own law (a state can only assess IP violations under its own law according to the territoriality principle) on goods formally outside its territory. Actually, from a substantive point of view, we saw that external transit can be considered a legal fiction since goods are physically in the country of transit and it makes sense to stop goods that could divert into the national market, but this is contestable in the case of Losartan since there was no evidence of fraudulent diversion of the goods.

The principle of territoriality was already underlying the Paris Convention on Industrial Property of 1883,29 one of the most important treaties on industrial property before TRIPS. That principle is now a main feature in TRIPS. However, already the Paris Convention provided for some provisions that overcame this principle, such as the priority principle, well-known marks provisions and the telle quelle (article 6 quinquies) (Bodenhausen, 1968). The TRIPS incorporates those provisions and, in some cases, such as well-known marks, extends the scope of “extraterritorial” provisions (article 16 TRIPS). Moreover, today the tension between territoriality and market integration is evolving rapidly through the internet,30 and WTO member states provide for “extraterritorial” provisions not listed in those international agreements. In conclusion, territoriality is not an absolute principle but it could be derogated.

In order to analyse these claims, one has also to look at the TRIPS definition of counterfeit and pirated goods according to which they consist in a violation of the trademark and copyright of the owner under the law of the country of importation. The same could therefore be inferred for patent infringements. However, in the case of Losartan, there are no apparent factual doubts on the fact that Dutch customs acted on alleged evidence of patent infringement under the law of the country of transit, thereby going beyond the agreed minimum standards and being against the principle of territoriality. The EU was not enforcing a foreign law, such as the law of the country of destination.

In this regard, it has to be noted that importation and transit cannot be considered the same. Up to now the DSB had not interpreted the term “importation” in article 51 TRIPS but one can look at the General Agreement on Tariffs and Trade (GATT) and at its jurisprudence: GATT 1947 refers to “imported goods” in many provisions, such as article III, but article V referring specifically to “goods in transit” seems to make clear that importation and transit are different custom procedures. Also relevant for the interpretation may be the World Custom Organisation (WCO) treaties, such as the International Convention on the simplification and harmonization of customs procedures (Kyoto Convention), concluded within the WCO, of which Brazil, India and EU are members. In this Convention, import and transit are considered as different categories in the Specific Annexes; customs transit is the “Customs procedure under which goods are transported under Customs control from one Customs office to another”; in the case of transit “goods being carried under Customs transit shall not be subject to the payment of duties and taxes, provided the conditions laid down by the Customs are complied with and that any security required has been furnished”.31

Therefore, considering that the ordinary meaning of article 51 is clearly allowing external transit of goods suspected of patent infringement and that a strict interpretation of the definition of infringements, not allowing violations under the law of the country of transit, could render meaningless footnote 13 of article 51 TRIPS (Kumar, 2010, p. 167), it seems difficult to argue that the principle of territoriality should prevail. It is instead more appropriate to consider it in the framework of article 1.1 TRIPS, analysed below, which could make possible for member states to extend the protection to infringements under the law of the country of transit and beyond territoriality, provided that such protection does not contravene the TRIPS provisions.

Are There Ceilings to External Transit Control of Medicines?

  1. Top of page
  2. Abstract
  3. The Cases of Losartan and Abacavir
  4. External Transit Control of Generics under EU Regulation 1383/2003
  5. TRIPS Minimum Standards on Border Measures
  6. The Extraterritoriality Claim
  7. Are There Ceilings to External Transit Control of Medicines?
  8. Free-Trade Provisions as Weak Internal Ceilings
  9. The Limited Role of the Objectives and Principles of the TRIPS in Protecting Public Health
  10. The Doha Declaration on TRIPS and Public Health as a Potential Ceiling
  11. The International Definition of Counterfeit Medicines
  12. International Law on Access to Medicines
  13. Access to Medicines and Intellectual Property Rights in the Context of the Fragmentation of International Law
  14. TRIPS-plus Agreements and Access to Medicines
  15. Conclusions
  16. References
  17. Biography

From the above analysis of article 51 TRIPS, it clearly emerges that this article does not oblige members, nor provide for, border measures to be applied to goods in external transit suspected of infringing patents, whereas external transit control goes far beyond the minimum standard provided by TRIPS; indeed external transit control implicates a TRIPS-plus legislation, since it allows customs to block goods suspected of violating patents under the law of the country of transit, and goods that are under external transit procedure.

However, according to the VCTL, that interpretation cannot disregard the object and purpose of the treaty. According to the Preamble, one of the main aims of the TRIPS is to reduce distortions and impediments to international trade. Moreover, according to article 7 TRIPS, on “objectives”, the protection and enforcement of IP 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.

We will therefore analyse external transit control in the light of the object and purpose of the treaty, considering that this analysis is strictly related to another element of the context. Indeed article 51 TRIPS has also to be read in the framework of the structure and the context of the Agreement. It is known that TRIPS provides for minimum standards of substantive law and on enforcement procedures (Cottier, 2008, p. 11; Gervais, 2008, pp. 86ff; Lupone, 2004, p. 147) and this was one of the main features of the Agreement, also if one compares it to the former Paris Convention on Industrial Property; these standards are to be read in the context of article 1.1 TRIPS, which states that

Members may, but shall not be obliged to, implement in their law more extensive protection than is required by this Agreement, provided that such protection does not contravene the provisions of this Agreement.

WTO members are therefore allowed to advance broader protection than the minimum standards provided for by article 51.

It has to be noted that some authors assume that article 1.1 does not apply to enforcement provisions: according to Carvalho (2005, pp. 36–7), Part III of TRIPS includes articles that are phrased in a way that leaves WTO members no alternative to the measures established therein, and consequently the enforcement provisions would not be minimum but “mandatory” standards, to which article 1.1 does not apply. Nevertheless, other authors assert that enforcement provisions are minimum standards, given the open-ended language in which they are cast (Reichmann, 2008, p. 71; UNCTAD, ICTSD, 2005, pp. 575–6), an assumption recently confirmed by the panel China-Measures affecting the protection and enforcement of intellectual property rights.32

Consequently, I will consider article 1.1 as applicable to TRIPS enforcement provisions, and will assess whether transit control is allowed by this article. In fact, article 1.1 does not allow extending IP protection in an unlimited way: the more extensive protection granted should not “contravene” the provisions of TRIPS. We will see in the next paragraphs whether the EU legislation “contravenes” those provisions, with particular regard to the balance between IP and free trade, as well as IP and access to medicines and we will see that limits are weak.

Since international IP law currently seems to enjoy limitless extension both at national level and through TRIPS-plus agreements, it has become increasingly urgent to circumscribe its scope of action: border measures covering the external transit procedure are a good example of this problem inasmuch as they may negatively affect public health. Many authors already underlined the opportunity to provide not only for minimum standards, as TRIPS does already, but also for “substantiva maxima” (Dinwoodie, 2006, p. 214) or “ceiling rules” (Kur and Grosse Ruse-Khan, 2008, pp. 5ff). In this regard, article 1.1 TRIPS is therefore a sort of “internal ceiling”, which aims to guarantee exclusive rights to the IP holder in the short term, so as to facilitate the public benefit of the results, and of the innovation in the long term, in order to safeguard the intrinsic IP balance. Nonetheless, given the weakness of some internal ceilings, external ceilings, such as international human rights rules, are becoming more and more relevant, although in the case at issue they are weak as well.

In order to evaluate whether there is a ceiling on national provisions broader than TRIPS minimum standard or, in other terms, whether a national legislation allowing control of goods in transit extends IP protection to the extent of “contravening” the provisions of TRIPS, we should refer to several relevant provisions: article 41, which provides for the general obligations of Part III TRIPS on enforcement procedures, as well as the general provisions and basic principles of the Agreement enshrined in the Preamble, and principally in articles 7 and 8.

Free-Trade Provisions as Weak Internal Ceilings

  1. Top of page
  2. Abstract
  3. The Cases of Losartan and Abacavir
  4. External Transit Control of Generics under EU Regulation 1383/2003
  5. TRIPS Minimum Standards on Border Measures
  6. The Extraterritoriality Claim
  7. Are There Ceilings to External Transit Control of Medicines?
  8. Free-Trade Provisions as Weak Internal Ceilings
  9. The Limited Role of the Objectives and Principles of the TRIPS in Protecting Public Health
  10. The Doha Declaration on TRIPS and Public Health as a Potential Ceiling
  11. The International Definition of Counterfeit Medicines
  12. International Law on Access to Medicines
  13. Access to Medicines and Intellectual Property Rights in the Context of the Fragmentation of International Law
  14. TRIPS-plus Agreements and Access to Medicines
  15. Conclusions
  16. References
  17. Biography

Concerning the balance between IP and free trade, article 41.1 TRIPS states that

members shall ensure that enforcement procedures, as specified in this Part, are available under their law so as to permit effective action against any act of infringement of intellectual property rights covered by this Agreement, including expeditious remedies to prevent infringements and remedies which constitute a deterrent to further infringements. These procedures shall be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse.

Moreover, article 8.2 TRIPS states that

appropriate measures, provided that they are consistent with the provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.

And, overall, TRIPS provisions are to be read in the context of one of the main aims of the Agreement, which is to reduce distortions and impediments to international trade, as stated in the Preamble of TRIPS, and in the context of the WTO Agreements in general, and therefore of the GATT, which focuses on liberalizing international trade.

The control of goods in transit is effectively a barrier to free trade (as well as measures on goods imported), because the goods are temporarily blocked by customs, thereby hindering trade while not precluding it altogether. However, the obligation to avoid barriers to “legitimate” trade in applying border measures (article 41) does not seem necessarily in conflict with measures aimed at curbing trade that is not legitimate (or suspected to be illegitimate) according to national law and justifiable (as required by a WTO panel33) on the basis of the protection of private IP rights. Trade of Losartan from India to Brazil is fully legitimate but in the event of EU legislation providing for external transit control of goods suspected of violating IP, even without evidence of fraudulent diversion (as it was in Polo Lauren), a potential WTO panel could defer the meaning of “legitimate” and the underlying justifiable interest to national law and jurisprudence. Again, article 8 refers to practices that restrain trade “unreasonably”, whereas preventing the trade of goods infringing IP can be seen as part of public policy geared to protecting property rights. However, in the specific case of medicines, it will be shown that external transit control of this type of good suspected of infringing patents cannot be justified according to health provisions.

Border measures on external transit are a powerful tool for IP holders, and they could negatively affect free trade but, overall, the above interpretations of articles 41 and 8 are consistent with the context of TRIPS, which aims—as do the other WTO agreements—at reducing impediments to free trade, but, at the same time, one should consider that IP is not anymore subordinated to free trade and therefore transit control should be limited but not prohibited as such. Indeed the ratio underlying TRIPS is that IP protection is a condition for free trade, since only if IP is secured can enterprises compete fairly.34 In fact, this Agreement changed the perspective on the relation between IP and free trade compared to the GATT, whereby IP was an exception to free trade. The new balance is also confirmed by the fact that issues crucial for free trade, such as exhaustion and anti-competitive practices, are left at the discretion of members and are not regulated by the Agreement: if free trade is subordinated to a violation of IP rights (parallel import goods are not counterfeit), the same could apply for goods in external transit suspected of infringing a patent. This implies that border measures extended to the transit procedure are not forbidden as such, since they do not contravene TRIPS provisions on free trade, but only if there are no safeguards on the procedure for preventing abuses by IP holders towards their competitors, and legitimate international trade is not obstructed. In particular, it is important that customs make sure there is sufficient evidence on the suspect of counterfeiting presented by the holder; provisional35 and ex officio border measures, which involve harassing possibly legitimate merchants where granted in response to spurious requests by competitors, should be adequately curbed (articles 50.3 and 50.7 TRIPS); procedures shall be fair and equitable, and shall not entail unreasonable time limits or unwarranted delays (article 41.2, article 55 TRIPS); the judicial authorities shall have the authority to order a party at whose request measures were taken, and who is proven to have abused enforcement procedures, to subsequently provide a party wrongfully enjoined or restrained with adequate compensation for the injury suffered resulting from such abuse (article 48 TRIPS).

This interpretation seems also to fit with the fact that object and purpose of a treaty cannot be used to alter the clear meaning of a term of a treaty (Gardiner, 2008, p. 198), referring to article 51 TRIPS’ interpretation, and that, on the other hand, the AB “appears to suggest that the ordinary meaning of the text in its context needs to be consistent with the object and purpose of all other contextual elements; or at least not to seriously subvert their object and purpose” (Van Damme, 2009, p. 259).

However, any assessment of the consistency of external transit control with free-trade provisions entails also analysing the GATT, especially article V, which guarantees freedom of transit. The GATT and the related case-law are relevant for the interpretation of the TRIPS, as affirmed by article II of the Marrakesh Agreement Establishing the WTO, which makes clear that TRIPS belongs in a coherent and consistent general set of agreements that are in turn integral parts of the WTO agreement. Furthermore, the application of TRIPS must not exclude the application of GATT.36 External transit control could violate GATT since freedom of transit “shall not be subject to unnecessary delays or restrictions” (article V.3 GATT). A WTO panel could consider the above-mentioned balance between IP and free trade also by interpreting article V GATT, therefore coming to the previous conclusion that external transit control is not a violation as such, except when the procedure is abused; at the same time, it could be harder to demonstrate that external transit control is “necessary”. Similarly, in the event that the panel considered external transit as unnecessary, the EU could argue that this violation is justified according to article XX.d GATT, which states that GATT provisions

shall not be construed to prevent the adoption or enforcement of measures … d) necessary to secure compliance with laws or regulations, which are not inconsistent with the provisions of this Agreement, including those relating to customs enforcement, … the protection of patents trademarks and copyrights.

In this regard, while it cannot be contested that external transit control aims at protecting patents and trademarks, it could be difficult for the EU to demonstrate that these measures are “necessary” for protecting IP rights: following the panel report Colombia—Ports of entry37 a potential panel on the case of Losartan could argue that IP holders can make use also of civil and criminal measures in the event of counterfeiting, although transit control is better from the viewpoint of the IP holder since it is pre-emptive; and the EU should bring evidence of the contribution of external transit control to the realization of the objective of protecting IP rights.38

In conclusion, it has to be seen how such a panel would reconcile the two potentially opposite conclusions deriving from a combined TRIPS and GATT interpretation. However, the fact that the more TRIPS specific a provision is, the more panels treat TRIPS as a lex specialis (Frankel 2010, p. 23), may bring to the conclusion that an unambiguous interpretation of article 51 TRIPS could prevail.39

The Limited Role of the Objectives and Principles of the TRIPS in Protecting Public Health

  1. Top of page
  2. Abstract
  3. The Cases of Losartan and Abacavir
  4. External Transit Control of Generics under EU Regulation 1383/2003
  5. TRIPS Minimum Standards on Border Measures
  6. The Extraterritoriality Claim
  7. Are There Ceilings to External Transit Control of Medicines?
  8. Free-Trade Provisions as Weak Internal Ceilings
  9. The Limited Role of the Objectives and Principles of the TRIPS in Protecting Public Health
  10. The Doha Declaration on TRIPS and Public Health as a Potential Ceiling
  11. The International Definition of Counterfeit Medicines
  12. International Law on Access to Medicines
  13. Access to Medicines and Intellectual Property Rights in the Context of the Fragmentation of International Law
  14. TRIPS-plus Agreements and Access to Medicines
  15. Conclusions
  16. References
  17. Biography

Evaluating whether the extension of the minimum standards by WTO members in the case at issue “contravenes” TRIPS provisions, according to article 1.1 TRIPS, concerns also the principles and objectives of TRIPS and the Doha Declaration on TRIPS and Public Health,40 adopted by the WTO Ministerial Conference on 14 November 2001. Article 7 of the agreement states that enforcement of IP rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology “in a manner conducive to social and economic welfare”, whereas article 8 upholds members’ rights “to protect public health and nutrition”.41

As for the object and purpose of TRIPS, as enshrined in articles 7 and 8, these have been interpreted by the WTO panel Canada—Patent Protection of Pharmaceutical Products in 2000. The panel clarified that those articles cannot be used to renegotiate the Agreement, since the settlement has already been achieved in the text of the Agreement when it was negotiated. This means that panels cannot, making reference to those articles, reach a balance that is not consistent with the text of the Agreement.42 Moreover, it is not possible here to analyse the panel itself in depth, but, according to some authors, it did not take sufficiently into account the object and purpose of the Agreement in the interpretation of TRIPS provisions.43 At any event, previous panels are not binding for future panels,44 and, after that, and also in reaction to that, the Doha Declaration on TRIPS and Public Health has reaffirmed that each provision of the TRIPS shall be read in the light of the objectives and principles of the Agreement (which were proposed by developing countries during the Uruguay round). In this context, at the TRIPS Council in March 2009, Brazil recalled that the protection of public health and the promotion of public interest are still part of the fundamental principles of TRIPS. Moreover, although “the acceptance of this fundamental principle … is regarded as an extreme example of generosity of developed countries” (Shanker, 2002, p. 762), the Doha Declaration reiterates a rule of interpretation that was applicable also previously: since article 3.2 of the Dispute Settlement Understanding prescribes that WTO agreements must be interpreted in accordance with “customary rules of interpretation of public international law”, the DSB should comply with article 31.3 of the VCLT, which already provides that treaties have to be interpreted “in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its objects and purpose”. Therefore, it has now to be hoped that a potential panel for the Losartan case would have taken these into account.

However, looking at the specific content of articles 7 and 8, it emerges that they have a limited role in ensuring health protection. As for article 7, as mentioned above this is a general obligation for WTO members but it can be interpreted in several ways; at any event, it is not automatically sufficient to affirm that control of goods in transit is inconsistent with TRIPS.45 As for article 8, it may allow members to adopt legislation to protect public health but it does not actually oblige them to do so, and therefore could not be seen as an obligation for the EU to forbid external transit control of medicines; article 8 is mainly a basis for the adoption of internal (and “necessary”) measures aiming at protecting public health, while it is less clear whether a WTO member can claim a violation of article 8 concerning national legislation of another Member.46 It is true though that external transit control of generics reduces the flexibility of Brazil and India in applying article 8 and in adopting public health measures. However, it has not to be taken for granted that flexibility per se could be considered a ceiling. TRIPS was conceived as a flexible Agreement that leaves members discretion on many measures, as articles 51 and 8 show. According to article 1.1 TRIPS, members may benefit from this flexibility, since they are free to determine implementation methods, and they are not obliged to implement more extensive protection in their own laws. The Agreement also refers to the need for flexibilities in order to create a viable technological base in the Preamble, but this applies only to least developed countries (LDCs) and seems to refer to article 66.1, which says that, in view of this need, members agree to postpone the entry into force of the Agreement for the LDCs. Finally, in the Doha Declaration, members reaffirm the right of WTO members to fully implement TRIPS provisions that provide flexibility for the purpose of protecting public health and access to medicines.47 In this context, on the one hand the fact that the EU exercises its own flexibility, extending border measures’ scope of application (where this does not “contravene” the agreement or other rules of international law), is consistent with the Agreement. At the same time, being extraterritorial, this measure has negative effects on the capability of another country, in this case Brazil and India, developing countries, to take advantage of the TRIPS flexibilities and safeguard health and access to medicines.48 Therefore, these countries could claim that external transit control of medicines contravenes their right to use flexibilities as mentioned in the Doha Declaration since, for example, control could apply on generics made under compulsory licences; however, as it will be shown in the next paragraph, the legal status of the Doha Declaration is controversial.

The Doha Declaration on TRIPS and Public Health as a Potential Ceiling

  1. Top of page
  2. Abstract
  3. The Cases of Losartan and Abacavir
  4. External Transit Control of Generics under EU Regulation 1383/2003
  5. TRIPS Minimum Standards on Border Measures
  6. The Extraterritoriality Claim
  7. Are There Ceilings to External Transit Control of Medicines?
  8. Free-Trade Provisions as Weak Internal Ceilings
  9. The Limited Role of the Objectives and Principles of the TRIPS in Protecting Public Health
  10. The Doha Declaration on TRIPS and Public Health as a Potential Ceiling
  11. The International Definition of Counterfeit Medicines
  12. International Law on Access to Medicines
  13. Access to Medicines and Intellectual Property Rights in the Context of the Fragmentation of International Law
  14. TRIPS-plus Agreements and Access to Medicines
  15. Conclusions
  16. References
  17. Biography

Given the specific and sensitive nature of the product at issue, it has also to be analysed the consistency of external transit control of medicines with the Doha Declaration on TRIPS and Public Health.49 Through the adoption of the Doha Declaration, WTO member states agreed that TRIPS does not and should not prevent Members from taking measures to safeguard public health, and that TRIPS

can and should50 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.51

In Brazil's view, since enforcement provisions have to be interpreted according to the Doha Declaration, external transit control of medicines consist of an extension of protection that “contravenes” the Declaration according to article 1.1 TRIPS.

The Declaration has not to be interpreted assuming that TRIPS provisions would not stand in the way of measures taken to protect the public health and that, therefore, the interpretation and implementation of the Agreement in the light of public health needs could allow the violation of TRIPS. At the same time, the Declaration should be relevant for the interpretation of TRIPS provisions that allow flexibility (Abbott, 2002b) and the other provisions analysed above.

However, the legal status of the Declaration is controversial and the Declaration seems to have more political effects than legal ones. The Declaration is not an authoritative interpretation ex article IX.2 of the Agreement establishing the WTO since it is not a decision, as article IX.2 requires; and it does not refer to article IX.52 Therefore, if a WTO panel were to be set up in the present case, it may not automatically follow the line of the Doha Declaration. Moreover, according to the EU and United States, the Declaration is not a binding instrument53 and the mainstream is divided over whether the Declaration has binding status.54 This would also imply that the Declaration could not be considered an “agreement” because is not binding (Gardiner, 2008, pp. 217–22), and therefore cannot be used as a “subsequent agreement” for the interpretation of TRIPS provisions.55 Indeed according to article 31.3.a VCLT, “There shall be taken into account, together with the context: (a) any subsequent agreement between the parties regarding the interpretation of the treaty or the application of its provisions”. In this case, the AB would likely use a Ministerial Declaration as a supplementary means of interpretation of the Agreement (article 32.1 VCTL) (Abbott, 2002a, p. 46) and therefore, the AB might also find other substantial evidence, such as state practice, with a higher priority in the interpretative hierarchy than the supplementary means.56

Nevertheless, it is also true that the Declaration carries a strong political weight, and therefore the DSB is likely to take this into account as a subsequent agreement under article 31.3.a VCTL. By this, the DSB should interpret TRIPS in order “to promote access to medicines for all”, fostering an interpretation of articles 51–52 TRIPS, of the free-trade provisions, and of members’ right to make use of the flexibility provisions analysed above, which could set ceilings in the case of medicines. If a panel were to be set up in this case, the DSB might conclude that external transit control of generic medicines, thereby preventing other members from using TRIPS flexibilities to protect public health or posing an unreasonable barrier to legitimate trade of medicines, is inconsistent with the TRIPS and the Doha Declaration. The Declaration could therefore be a ceiling for this TRIPS-plus measure but the conclusions of an interpretation consistent with access to medicines are strictly related to the contents of international instruments protecting access to medicines and to the international notion of counterfeit medicines. It is therefore necessary at this point to deepen the international law rules on counterfeit drugs and access to medicines.

The International Definition of Counterfeit Medicines

  1. Top of page
  2. Abstract
  3. The Cases of Losartan and Abacavir
  4. External Transit Control of Generics under EU Regulation 1383/2003
  5. TRIPS Minimum Standards on Border Measures
  6. The Extraterritoriality Claim
  7. Are There Ceilings to External Transit Control of Medicines?
  8. Free-Trade Provisions as Weak Internal Ceilings
  9. The Limited Role of the Objectives and Principles of the TRIPS in Protecting Public Health
  10. The Doha Declaration on TRIPS and Public Health as a Potential Ceiling
  11. The International Definition of Counterfeit Medicines
  12. International Law on Access to Medicines
  13. Access to Medicines and Intellectual Property Rights in the Context of the Fragmentation of International Law
  14. TRIPS-plus Agreements and Access to Medicines
  15. Conclusions
  16. References
  17. Biography

Since we are referring to medicines, it is important to make clear that, from the IP point of view, the notion of counterfeiting has to be distinguished from that of health.

From an IP standpoint, we will refer to the notion provided for in TRIPS: according to footnote 14 of article 51

“counterfeit trademark goods” shall mean any goods, including packaging, bearing without authorization a trademark which is identical to the trademark validly registered in respect of such goods, or which cannot be distinguished in its essential aspects from such a trademark, and which thereby infringes the rights of the owner of the trademark in question under the law of the country of importation; “pirated copyright goods” shall mean any goods which are copies made without the consent of the right holder or person duly authorized by the right holder in the country of production and which are made directly or indirectly from an article where the making of that copy would have constituted and infringement of a copyright or a related right under the law of the country of importation.

By contrast, the case of Losartan refers to a patent violation, which consists of an infringement of IP rights, and not of counterfeiting. Moreover, it is important to underline that counterfeiting and infringements depend on the law of the country the case is subject to: an authentic medicine produced in a country where its patent is not protected could infringe a patent in another country where the right holder can prevent the goods to be sold and imported.

From the point of view of public health, a definition of counterfeit medicines was initially endorsed in 1992 (WHO, 2008, paragraph 8) by a large group of WHO member states, INTERPOL, the WCO,57 the International Narcotics Control Board, the International Federation of Pharmaceutical Manufacturers’ Associations, the International Organisation of Consumer Unions and the International Pharmaceutical Federation. According to this group, “counterfeit medicine” signifies

a pharmaceutical product which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit pharmaceutical products, and may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.

Subsequently, work continued in order to refine the 1992 definition and to properly address the growing phenomenon of counterfeit medicines. Recently, one of the main international forums dealing with those issues is the International Medical Products Anti-Counterfeiting Taskforce (IMPACT)58: based on the IMPACT's work, the WHO issued a report and a draft resolution59 urging member states to establish and enforce legislation and regulations that prevent counterfeit medical products from being manufactured, exported, imported or traded in international transactions and the regulated distribution system. The Taskforce put forward that counterfeiting also entailed IP violations: initially the draft resolution included “violation about intellectual property rights”, while a corrigendum of the draft resolution stated that “violations or disputes about patents are not to be confused with counterfeiting” (WHO, 2008). Consequently, patent infringements were excluded, but trademarks and other rights violations were included in the notion of counterfeit medicines.

In this regard, it has to be noted that IP rights infringements do not always entail counterfeiting of medical products; violations concerning patents and trademark may—or may not—be related to medicines of poor quality or mislabelled and hence dangerous for the end user. According to a study by Outterson, generic medicines can infringe a patent in a country where the same type has been patented, but this does not regard the quality of the medicine and, in the case of patents, a link between IP infringements and poor quality is unlikely (Outterson, 2009, p. 9). At the same time, a trademark infringement may—though not necessarily—lead to a false representation of the source and identity confusing patients and therefore have a negative effect for public health,60 but, in the case of trademarks, the probability that infringements imply heightened safety risks is very high (Outterson, 2009, pp. 9–10).

Therefore, the IMPACT definition failed in a general perspective, since it is desirable to make a clear distinction between IP and public health concerns. According to the WHO (WHO, 2008, paragraph 12), many member states do not have satisfactory legal instruments for combating counterfeit medical products, because current legal instruments related to IP rights have a broad scope, and are not focused on the protection of public health. The IP rights approach identifies the right holder as the main victim of counterfeiters; whereas, in the case of medical products, the real victim is the patient. Legislation should therefore enable patients and health authorities to undertake appropriate procedures, regardless of the action of IP holders. In this regard, certain public health advocates underline that Resolution WHA41.16 gave the mandate to the WHO to initiate programmes not only on counterfeit products, but also those falsely labelled (wrong information on the label with regard to the content, date and manufacture, place of manufacture, date of expiry), or spurious (products that, despite the labelling, contain no active ingredient or wrong active ingredient or an insufficient amount of active ingredient), or substandard drugs (low-quality drugs conditioned by poor manufacturing practices, poor transportation techniques or poor storage facilities); but these have been sidelined, and the draft resolution title refers solely to “counterfeit” medical products. They also underline that besides making a clear distinction between IP rights infringements and counterfeiting of medical products, it is advisable to avoid the confusing “counterfeit” term both for violations of IP rights and for medicines dangerous for patients, and instead distinguish counterfeit from mislabelled and poor quality medicines (Third World Network, 2009).

Moreover, although not affecting the cases of Losartan and Abacavir (concerning patents), it should be stressed that the inclusion of trademarks and other IP rights by IMPACT could still be considered as an impediment for trade in generics: as noted earlier, trademark infringements on medicines likely imply medicines “fraudulently mislabelled with respect to identity and/or source”; however, this is not automatically the case, since a medicine branded with a generic name could infringe a trademark, but it is not for that reason mislabelled. Therefore, a definition including trademarks could again have been an impediment for legitimate trade of generic drugs, taking into account that, after the expiry of a patent, pharmaceutical companies tend to maintain their monopolies through trademarks.61

Against this background, the WHO General Assembly in May 2010 made a positive step forward: following the critics of many developing countries on IMPACT's work and legitimacy, the Assembly decided to establish a new working group on substandard/spurious/falsely-labelled/falsified/counterfeit medical products, which will be open to all member states, and will examine the WHO's role in the prevention and control of medical products of compromised quality, safety and efficacy from a public health perspective, while excluding trade and IP considerations.62 It is now highly desirable that the WHO adopts a stance on the crucial notion of counterfeit medicines as soon as possible; a clear definition agreed within the WHO, and the separation of drugs counterfeiting from the IP issue, and from the health point of view, would strongly support the interpretation of the Doha Declaration as ceiling.

International Law on Access to Medicines

  1. Top of page
  2. Abstract
  3. The Cases of Losartan and Abacavir
  4. External Transit Control of Generics under EU Regulation 1383/2003
  5. TRIPS Minimum Standards on Border Measures
  6. The Extraterritoriality Claim
  7. Are There Ceilings to External Transit Control of Medicines?
  8. Free-Trade Provisions as Weak Internal Ceilings
  9. The Limited Role of the Objectives and Principles of the TRIPS in Protecting Public Health
  10. The Doha Declaration on TRIPS and Public Health as a Potential Ceiling
  11. The International Definition of Counterfeit Medicines
  12. International Law on Access to Medicines
  13. Access to Medicines and Intellectual Property Rights in the Context of the Fragmentation of International Law
  14. TRIPS-plus Agreements and Access to Medicines
  15. Conclusions
  16. References
  17. Biography

Access to medicines refers in the first place to the universal right to health, which is protected by the International Covenant on Economic, Social and Cultural Rights (ICESCR, article 12),63 whereby equitable access to safe and affordable medicines is vital to the attainment of the highest possible standard of health by all. It can no longer be argued that the content of the right to health is unduly vague (Yamin, 2003, p. 336) and the scope of article 12 ICESCR has been clarified by the Committee on Economic, Social and Cultural Rights (CESCR) through General Comment no. 14 on the right to health.64 According to that, access to medicines refers only to essential drugs,65 namely “those that satisfy the priority health care needs of the population”, and which are listed by the WHO in broad terms: examples are drugs dealing with HIV, malaria and tuberculosis, such as Abacavir, but also anti-hypertensive medicines (even though Losartan is not specifically included in the list).66 Furthermore, access to medicines contains four elements: (1) the availability of medication in sufficient quantity; (2) the accessibility of medication to everybody (where access means physical, economic, without discrimination and information access); (3) the acceptability of the treatment with respect to the culture and ethics of the individual; (4) an appropriate quality of medication. States parties of the ICESCR have the obligation to “respect”67 the right to health, and therefore they have to refrain from denying or limiting equal access to essential medicine and from action that interferes with access to medicines; to “protect”, that is to prevent third parties from interfering with the right and, for example, to avoid abuses by IP holders; and to “fulfil”, which requires appropriate measures, including legislative, administrative and budgetary ones, which ensure the full realization of the right.

Besides the ICESCR there are other instruments regarding the right to health, such as Resolution 2002/31 of the Commission on Human Rights on the right to enjoy the highest standards of physical and mental health.68 Moreover, as some international public health advocates said,69 TRIPS-plus measures agreed by the EU can be considered in conflict with WHO resolution on “the global strategy and plan of action on public health, innovation and intellectual property”,70 which states that “international negotiation on issues related to intellectual property rights and health should be coherent in their approaches to the promotion of public health”, and calls upon member states to “take into account, where appropriate, the impact on public health when considering adopting or implementing more extensive intellectual property protection than is required by TRIPS” (article 20). This notwithstanding, WHO resolutions are not legally binding.71 Moreover, on the Losartan issue, WHO made a cautious statement72: it recalled the resolution on the global strategy that, among other important objectives, expressed member states’ commitment to improving the delivery of and access to all health products and medical devices by effectively overcoming barriers to access; and it said that the Organization is continuing to follow developments and consulting with member states and relevant international intergovernmental organizations on this matter.

Referring to the ICESCR for the main international binding provisions on access to medicines, it is possible to conclude that an impediment to ICESCR may be justified only when it is intended to guarantee the proper quality of medicines in transit. Since “quality” refers to whether the medicine could harm a patient, while patent violations do not perforce entail that medicines are dangerous for consumers’ health, and considering that patent violations are not, at the moment, included in the international definition of counterfeit medicines, this means that in the present case it can be inferred (though a statement by the CESCR on this would clarify the issue) that the ICESCR may be interpreted to mean that external transit control of medicines suspected of infringing a patent—at least regarding essential medicines listed by the WHO—is not consistent with the Covenant's provisions on health. Therefore, a State effecting the inspection of medicines in transit because suspected of infringing a patent would be committing a violation of the obligation to respect and to protect access to medicines. Indeed such a provision represents a barrier for authentic medicines and therefore a limitation of access to medicines in terms of their availability, as India and Brazil argue. Whereas the argument brought by the EU at the TRIPS Council,73 whereby the Dutch authorities claimed their action was also to check for poor quality so as to prevent possible health hazards (in Europe, where medicines might be illegally resold, or in Brazil, where they were directed), cannot be defended, since medicines suspected of violating a patent would not cover poor-quality medicines.

On the contrary, measures aimed at combating counterfeit from the health standpoint are fully consistent with ICESCR, because they focus on the quality of medicines, and are therefore to be promoted in light of the rise in counterfeit drugs.74 For example, according to the WHO guidelines for the development of measures to combat counterfeit drugs (WHO, 76, pp. 19ff), member states should establish and empower regulatory bodies to ensure the enforcement of appropriate drug laws and regulations, and improve inspection procedures when pharmaceutical products are suspected to be counterfeit. As for such action within the EU, the European Medicines Agency (EMEA) has a major role to play, and the EU recently put forward a proposal75 for preventing the entry into the legal supply chain any medicinal products that carry misleading data on their identity, history or source; such a measure calls for strengthened import requirements on active pharmaceutical ingredients from third countries (if it cannot be established that the regulatory framework within the respective third country ensures reliable safety levels for products exported to the EU). In this regard, it is also worth noting that in the case of Abacavir, the medicines traded by UNITAID were pre-qualified by the WHO, and consequently there was no concern whatever about their quality.

Access to Medicines and Intellectual Property Rights in the Context of the Fragmentation of International Law

  1. Top of page
  2. Abstract
  3. The Cases of Losartan and Abacavir
  4. External Transit Control of Generics under EU Regulation 1383/2003
  5. TRIPS Minimum Standards on Border Measures
  6. The Extraterritoriality Claim
  7. Are There Ceilings to External Transit Control of Medicines?
  8. Free-Trade Provisions as Weak Internal Ceilings
  9. The Limited Role of the Objectives and Principles of the TRIPS in Protecting Public Health
  10. The Doha Declaration on TRIPS and Public Health as a Potential Ceiling
  11. The International Definition of Counterfeit Medicines
  12. International Law on Access to Medicines
  13. Access to Medicines and Intellectual Property Rights in the Context of the Fragmentation of International Law
  14. TRIPS-plus Agreements and Access to Medicines
  15. Conclusions
  16. References
  17. Biography

From the interpretation given in the previous section, it is clear that any form of external transit control of medicines suspected of patent infringements is not consistent with the ICESCR. Consequently, by holding up medicines in transit suspected of infringing patents, the EU—or at least the Netherlands76—violate the ICESCR obligation to respect and protect the enjoyment of accessibility and affordability of basic medications. This contravention could legitimate countermeasures by Brazil and India for a violation of access to medicines according to general state responsibility of international law.

This conclusion presumes that access to medicines prevails on IP rights in international law. According to the CESCR General Comment no. 17,77 access to medicines is a human right, while IP rights are mainly economic rights (with the exception of copyright), and therefore human rights would prevail over IP. Nevertheless, this debate is by no means over yet,78 and in some European countries the idea is spreading that IP rights are fundamental rights, as the right to property, a trend confirmed by the European Court of Human Rights (ECHR) in recent judgements,79 and by the Charter of Fundamental Rights of the EU (article 17).

However, if it is rightly arguable that, at international level, IP rights cannot yet be considered as human rights, one should consider the de facto hierarchy of international law rules in the context of the fragmentation of international law:

a factual hierarchy of regimes, a hierarchy that, even though completely independent from the normative hierarchy is still real: some regimes boast strong enforcement mechanisms with possibility of sanctions, other are enforced by shaming states into compliance, other do not have enforcement/adjudication mechanisms at all (Hestermeyer, 2007, p. 196).

TRIPS is more enforceable than human rights’ agreements, in particular as regards economic and social rights, although they are more and more considered justiciable (Hestermeyer, 2007, pp. 89–94; Steiner et al., 2007, pp. 318–57; Yamin, 2003, p. 368–9). Therefore, Brazil and India could apply countermeasures for ICESCR violation but the fact that the WTO DSB would be able to take into account access to medicines, and to affirm that external transit control of medicines suspected of patent infringements is inconsistent with TRIPS, would be a much stronger tool for those countries.

In this regard, it is necessary to assess whether a potential WTO panel could take into account the international definition of counterfeit medicines and ICESCR provisions so as to consider them as external ceilings, able to overcome the weak effect of internal ceilings I analysed above. The DSB could take into account access to medicines also referring to the right to life, which is protected by article 6 of the International Covenant on Civil and Political Rights (ICCPR), since in this case customary law would apply; but the scope of the right to life is narrower than that of the ICESCR concerning access to life-saving medicines in national emergences, such as HIV, malaria (Hestermeyer, 2007, p. 116; Yamin, 2003, p. 331) and, in any case, it is not ius cogens (Picone and Ligustro, 2002, pp. 631–2).80

First, looking at the WTO case law, it emerges that the AB affirmed that WTO law cannot be understood in “clinical isolation from public international law”81 and that the DSB took into account international provisions of other treaties in several cases82 but, mainly, as limited interpretative instruments. And recently, the DSB chose a narrow interpretation of article 31.3.c VCTL as referring to relevant rules applicable between “all” parties of a treaty,83 which could lead to an alarming risk of isolation of the so-called “self-contained regime”, and has been criticized by many authors (including Marceau, 2002, p. 781; and McGrady, 2008, p. 616). Therefore, even though it is not possible to deepen here the issue of the extent to which the WTO case law render the organization a self-contained regime, it cannot be taken for granted that, although ICESCR is binding, it would be applicable since, for example, the United States signed but did not ratify it. In this context, the Doha Declaration, mentioned above, referring to an interpretation promoting access to medicines, should also favour an interpretation of VCLT rules that “open” the regime to international health provisions. At the same time, the role of the Declaration is limited to the extent it only allows an interpretation of TRIPS measures and does not imply the need to strike a balance between IP rights protected in TRIPS and the right to health protected in ICESCR. In the case at issue, if ICESCR would be deemed to apply and if an international definition of counterfeit medicines, excluding patent violations, would be formally agreed by WHO, to which all WTO member participate, a panel could rely on these provisions to interpret article 41 TRIPS, on the need to apply enforcement procedures avoiding the creation of barriers to legitimate trade, and article 8.2 TRIPS, preventing practices that unreasonably restrain trade. Of course, the panel could conclude that external transit control of medicines on suspicion of patent violations consist of a barrier to legitimate trade and unreasonably restrain trade since from a public health perspective it is not justified but this implies that the panel would give prevalence to health than to IP rights protection.

TRIPS-plus Agreements and Access to Medicines

  1. Top of page
  2. Abstract
  3. The Cases of Losartan and Abacavir
  4. External Transit Control of Generics under EU Regulation 1383/2003
  5. TRIPS Minimum Standards on Border Measures
  6. The Extraterritoriality Claim
  7. Are There Ceilings to External Transit Control of Medicines?
  8. Free-Trade Provisions as Weak Internal Ceilings
  9. The Limited Role of the Objectives and Principles of the TRIPS in Protecting Public Health
  10. The Doha Declaration on TRIPS and Public Health as a Potential Ceiling
  11. The International Definition of Counterfeit Medicines
  12. International Law on Access to Medicines
  13. Access to Medicines and Intellectual Property Rights in the Context of the Fragmentation of International Law
  14. TRIPS-plus Agreements and Access to Medicines
  15. Conclusions
  16. References
  17. Biography

Before drawing conclusions, it is also worth mentioning the TRIPS-plus phenomenon in reference to bilateral agreements. If considering international provisions on access to medicines may bring to an interpretation according to which external transit of medicines suspected of infringing a patent is inconsistent with TRIPS, it has to be taken into account the so-called TRIPS-plus phenomenon, which could bring to an opposing interpretation.

Given the principle of territoriality of IP, the only way to protect European enterprises abroad for the EU is to conclude bilateral and multilateral agreements that set sufficient standards of protection, especially with developing countries that have lower standards of protection.

At the moment, developed countries—concerned about the high levels of piracy and counterfeiting,84 and the consequent losses of revenue of their enterprises—are concentrating international efforts on the fight against counterfeiting, and therefore on the enhancement of border measures, as well as civil and criminal measures (Reboul et al., 2004, p. 14). At the WTO level, the EU, supported by other developed countries (United States, Japan, Switzerland), proposed at the TRIPS Council, since 2005, to amend Part III TRIPS by extending article 51's scope of application to include all IP rights, as well as to transit and transhipment.85 However, the issue has been contested by developing countries (Micara, 2007), and at the meeting of the Council in June 2008, the issue was not presented again by these members (nor it is included in the Doha Agenda); developing countries pointed out their need to benefit from IP and to take advantage of the TRIPS flexibilities. More recently, given the WTO deadlock, the EU started to address this issue in other international forums, implementing the forum-shifting strategy (Helfer, 2004, pp. 1–84), and at bilateral level. The control of goods in transit has been proposed at the WCO,86 where Provisional Standards Employed by Customs for Uniform Rights Enforcement (SECURE) (WCO, 2007) were discussed.87 Moreover, since October 2007 the EU, United States, Japan and other developed, and some developing, countries, started to negotiate an Anti-Counterfeiting Trade Agreement (ACTA), which should provide a new international framework aimed at enhancing the enforcement of IP rights (according to the last draft released, Parties may provide procedures for suspect goods in transit88 and the right holder is required to provide evidence that there is prima facie infringement of the right holder's IP right under the law of the Party providing the procedures). Finally, at the bilateral level, TRIPS-plus is nowadays a widespread phenomenon. Given the difficulties in achieving a multilateral agreement, as the Doha round shows, the EU, as well as the United States and other developed countries, are trying to tighten TRIPS minimum standards through bilateral agreements with developing countries. Recently the EU concluded an agreement with CARICOM, in the context of the Economic Partnership Agreement negotiations, which includes detailed provisions on enforcement, and it extends the application of border measures to goods in transit.89

According to some developing countries,90 efforts to enshrine new, maximalist TRIPS-plus provisions in other forums will seriously undermine the delicate balance in TRIPS between IP holders and public policy goals (e.g. prejudicing members flexibilities), and they raise systemic issues.91 In the case of TRIPS-plus agreements, whether bilateral or multilateral, that impose transit control of goods suspected to infringe patents, one could envisage a conflict92 between the provision of the agreement and the State's obligation to access to medicines in ICESCR concerning essential medicines. Therefore, here too, the problem of fragmentation of international law would emerge, as well as the fact that this implies a de facto hierarchy of norms of international law. The outcome would mainly depend on the enforcement mechanisms and the openness to international health provisions of those bilateral agreements and of ACTA. Moreover, the more they are widespread the more they could eventually be taken into account by the WTO as “subsequent agreements” according to article 31.3.a VCTL or “relevant rules of international law” according to article 31.3.c VCTL.

International organizations dealing with health issues should address this point, also because the failure of a state to take into account its legal obligations regarding the right to health when entering into bilateral or multilateral agreements with other states, international organizations and other entities, is a violation of the duty to respect the right to health. The CESCR already expressed concern in some cases on the TRIPS-plus phenomenon, as evidence by the report on Morocco on the conclusion of the bilateral agreement between United States and Morocco, which limited the flexibility provided for in the Doha Declaration regarding parallel import and access to medicines (through an extension of the length of the patent rights).93 However, here the CESCR does not have binding powers, but can only invite members to evaluate the impact of the bilateral agreements in the light of the obligations of the ICESCR. More recently, the UN Special Rapporteur on the right to health, Mr. Anand Grover, warned that the EU-India draft free-trade agreement could prevent millions of people gaining access to necessary, life-saving and life-prolonging medicines and it referred especially to the fact that “border seizures of non-infringing goods in Europe over the past few years have demonstrated how such provisions have delayed access to medicines for patients in other developing countries”.

In conclusion, TRIPS-plus agreements are extending IP protection while reducing the flexibilities incorporated in TRIPS (and the ability to further change TRIPS94). Overall, they indicate that international law on the enforcement of IP rights is being enhanced, whereas limits to these rights and, especially access to medicines provisions, could be less enforceable.

Conclusions

  1. Top of page
  2. Abstract
  3. The Cases of Losartan and Abacavir
  4. External Transit Control of Generics under EU Regulation 1383/2003
  5. TRIPS Minimum Standards on Border Measures
  6. The Extraterritoriality Claim
  7. Are There Ceilings to External Transit Control of Medicines?
  8. Free-Trade Provisions as Weak Internal Ceilings
  9. The Limited Role of the Objectives and Principles of the TRIPS in Protecting Public Health
  10. The Doha Declaration on TRIPS and Public Health as a Potential Ceiling
  11. The International Definition of Counterfeit Medicines
  12. International Law on Access to Medicines
  13. Access to Medicines and Intellectual Property Rights in the Context of the Fragmentation of International Law
  14. TRIPS-plus Agreements and Access to Medicines
  15. Conclusions
  16. References
  17. Biography

The analysed cases of transit control of generic medicines by the EU show mainly the need to define ceilings for border measures covering external transit and, in general, for the phenomenon of the extension of TRIPS provisions at the unilateral, bilateral and multilateral level. This would take into consideration that the TRIPS mirrors the balance achieved by developed and developing countries at the international level on IP issues.

TRIPS’ internal ceilings are weak concerning the extension of border measures to transit of medicines. The new balance between IP and free trade makes uncertain that control of goods in transit is inconsistent with free-trade provisions and the content of articles 7 and 8 of TRIPS has limited relevance in safeguarding public health. The Doha Declaration on TRIPS and Public Health could hopefully foster an interpretation of TRIPS provisions that would protect public health, providing a ceiling in the case at issue. Whereas, regarding external ceilings to apply, specifically the right to health, access to medicines may be considered a ceiling, but it is not certain whether the WTO “self-contained regime” will take this into account and a WHO agreed definition of counterfeit medicines would be necessary.

In order to promote the legitimate trade of generics and access to medicines, Brazil and India, apart from raising the dispute at WTO (since exporters could not go before the CJEU to ask for the implementation of TRIPS95) should put forward a unitary position at the multilateral forums that influence these matters: their action within the 2010 World Health Assembly concerning IMPACT indicates a positive step forward. It is also desirable that WHO, CESCR and other relevant bodies, take a clear position on external transit control of generics, also considering TRIPS-plus bilateral and multilateral agreements in this field.

Notes
  1. 1

    Regulation 1383/2003 of 22 July 2003 concerning customs action against goods suspected of infringing certain intellectual property (IP) rights and the measures to be taken against goods found to have infringed such rights , OJ [2003] L 196.

  2. 2

    EC intervention (any other business) at the WTO General Council, 3 February 2009.

  3. 3

    Intervention by India on agenda item M other business—public health dimension of TRIPS at the TRIPS Council, 3–4 March 2009, paragraph 2.

  4. 4

    See also WTO, TRIPS Council meeting 8–9 June 2009, minutes of the meeting, IP/C/M/60, paragraph 127.

  5. 5

    UNITAID is an international drug purchase facility, established in 2006 to provide long-term, sustainable and predictable funding to increase access and reduce prices of quality drugs and diagnostics for the treatment of HIV/AIDS, malaria and tuberculosis in developing countries.

  6. 6

    See UNITAID statement on Dutch confiscation of medicines shipment. Available at <http://www.unitaid.eu/en/resources/news/156-unitaid-statement-on-dutch-confiscation-of-medicines-shipment.html> [Accessed October 2011].

  7. 7

    At the WTO General Council, in addition to Brazil and India, those voicing concerns about access to medicines and customs were as follows: Argentina, Bolivia, Burkina Faso, China, Costa Rica, Cuba, Ecuador, Egypt, Indonesia, Israel, Nigeria, Pakistan, Paraguay, Peru, South Africa, Thailand and Venezuela.

  8. 8

    Intervention by India at the WTO General Council, 3–4 February 2009; Intervention by Brazil at the WTO General Council, 3–4 February 2009.

  9. 9

    Intervention by Brazil on agenda item M other business—public health dimension of TRIPS at the TRIPS Council, 3–4 March 2009; intervention by India at the TRIPS Council, 3–4 March 2009 supra note 3.

  10. 10

    WTO, European Union and a member state: Seizure of generic drugs in transit—Request of consultation by India (19 May 2010) WT/DS408/1; WTO, European Union and a member state: Seizure of generic drugs in transit—Request of consultation by Brazil (19 May 2010) WT/DS409/1.

  11. 11

    Letter from public health advocates (the 16 groups are BUKO Pharma-Kampagne, Consumers International, Consumers Union, Essential Action, Health Action International, Health GAP, IQSensato, Knowledge Ecology International, Medico International, Oxfam International, Third World Network, US PIRG) to the heads of WTO and of the WHO on seizures of medicines as goods in transit to developing countries, available at the Knowledge Ecology International website. See also the NGO open letter over WHO's involvement in “Counterfeit Medical Products” and in the IMPACT addressed to the WHO Director General Chan on 11 May 2010.

  12. 12

    Lack of protection in the third country may be due to different factors: on the one hand because some countries do not have a legislation covering certain forms of IP rights or providing a more limited content of the exclusive right. Therefore, given the principle of territoriality, the IP holder cannot exercise exclusive rights and stop the production of counterfeit and pirated goods in those countries. The fact that national law does not protect certain aspects of IP may be a way to leave national enterprises to use counterfeit as a commercial strategy, but it also may be due to political choices aimed at fostering economic development, especially in developing countries. Moreover, IP holders may not be able to enjoy protection in a given country because someone else is already holder of that right in that country (a type of conflict that emerges keenly with ongoing globalization). In conclusion, while the intricacies of the notion of counterfeit are outside the scope of this article, the lack of protection is not always due to “inadequate” protection by third countries.

  13. 13

    CJEU Opinion 1/94, Competence of the Community to conclude international agreements concerning services and the protection of intellectual property [1994] ECR I-5267, paragraph 55.

  14. 14

    See supra note 1, articles 1–2.

  15. 15

    According to article 2: For the purposes of this Regulation, “goods infringing an intellectual property right” means: (1) “counterfeit goods”, namely (a) goods, including packaging, bearing without authorization a trademark identical to the trademark validly registered in respect of the same type of goods, or which cannot be distinguished in its essential aspects from such a trademark, and which thereby infringes the trademark holder's rights under Community law, as provided for by Council Regulation (EC) No. 40/94 of 20 December 1993 on the Community trademark or the law of the Member State in which the application for action by the customs authorities is made; …; (2) “pirated goods”, namely goods that are or contain copies made without the consent of the holder of a copyright or related right or design right, regardless of whether it is registered in national law, or of a person authorized by the right holder in the country of production in cases where the making of those copies would constitute an infringement of that right under Council Regulation (EC) No. 6/2002 of 12 December 2001 on Community designs or the law of the Member State in which the application for customs action is made; (c) goods that, in the Member State in which the application for customs action is made, infringe (a) a patent under that Member State's law; (b) a supplementary protection certificate of the kind provided for in Council Regulation (EEC) No. 1768/92(7) or Regulation (EC) No. 1610/96 of the European Parliament and of the Council (8); … On EU law on IP see Tritton (2002); on the definition of counterfeiting see also Van Hezewijk (2008).

  16. 16

    According to article 1 of the Regulation, this is applicable … (b) when they are found during checks on goods entering or leaving the Community customs territory in accordance with articles 37 and 183 of Regulation (EEC) No. 2913/92, placed under a suspensive procedure within the meaning of article 84(1)(a) of that Regulation, in the process of being re-exported subject to notification under article 182(2) of that Regulation or placed in a free zone or free warehouse within the meaning of article 166 of that Regulation”. In this regard, article 84(1)(a) is understood as applying, in the case of non-Community goods, to external transit, custom warehousing, inward processing in the form of a system of suspension, processing under custom control and temporary importation.

  17. 17

    Case C-23/99, Commission v France, [2000] ECR I-7653, paragraph 49. See also case C-115/02, Administration des douanes et droits indirect v Rioglass and Transremar [2003] ECR I-12705, paragraph 30.

  18. 18

    Case C-383/98, The Polo/Lauren Company LP and PT. Dwidua Langgeng Pratama International Freight Forwarders, [2000] ECR 2519, paragraphs 26–7 concerning the applicability of EC Regulation 3295/94 (then amended by Regulation 1383/2003).

  19. 19

    Ibid., paragraph 34.

  20. 20

    See Case C-281/05, Montex Holdings Ltd v Diesel SpA, [2006] ECR I-10881, paragraph 24.

  21. 21

    See Case C-495/09, Nokia OJ C 37 (13.2.2010); and case C-446/09, Phillips OJ C 24 (30.1.2010).

  22. 22

    Some authors argue that if EU member states cannot implement transit control of goods in the state where they are counterfeit according to national law, the IP holder cannot rely on detention by customs (pre-emptive) but “only” on civil and criminal remedies (if during transit the goods are put into commerce) that are different in each member state (Vrins and Schneider, 2008); and transit control would be a powerful tool to deal with the fact that there may be customs less efficient that do not stop infringing goods that can then freely circulate in the whole market (Fatiguso, 2007, p. 97). On the other hand, the internal market would be seriously undermined if transit control would be allowed and internal remedies, partially harmonized, should be sufficient to face counterfeiting.

  23. 23

    Although a thorough analysis of this matter goes outside of the scope of this article, it would also be interesting to do some considerations on the applicable law of such a case since this situation reminds to the remarks on the eventuality to combine the lex protectionis (the basic rule for choice of law in IP matters grounded on the territoriality principle) with a market impact rule. See Kur (2005, pp. 971ff). On these issues, see also Boschiero (2009, pp. 468ff), Fentiman (2005, p. 140).

  24. 24

    Vienna Convention on the Law of the Treaties (adopted 23 May 1969, entered into force 27 January 1980) 1155 UNTS 331.

  25. 25

    Intervention by Brazil at the WTO General Council, supra note 9, paragraph 2.

  26. 26

    TRIPS Council, 25 May 2009, minutes of the meeting, IP/C/M/59, paragraph 125.

  27. 27

    WTO, China: Measures affecting the protection and enforcement of intellectual property rights—Report of the panel (26 January 2009) WT/DS362, 7.223ff. According to the panel, “may” indicates that this is an optional extension to “other infringements of intellectual property rights”. Moreover, this is a reference both to goods that infringe trademarks and copyright without constituting counterfeit trademark goods or pirated copyright goods as well as to goods that infringe other categories of IP rights such as patents.

  28. 28

    WTO, China: Measures affecting the protection and enforcement of intellectual property rights, 7.224.

  29. 29

    See Paris Convention for the Protection of Industrial Property, 20 March 1883.

  30. 30

    On this topic see Dinwoodie (2004, p. 889) (quoting US Courts of Appeal, Forth Circuit, 19 May 2003, International Bancorp LLC v Société de bains de mer et du cercle des étrangers à Monaco, 329F 3d 359 on use in commerce of trademarks through internet) and WIPO Joint recommendation concerning provisions on the protection of marks, and other industrial property rights in signs on the internet (with explanatory notes), adopted by the WIPO General Assembly in 24 September to 3 October 2001; commented by Kongolo (2008, pp. 105–8).

  31. 31

    Kyoto Convention Annexure E chapter 1 on Customs Transit.

  32. 32

    WTO, China: Measures affecting the protection and enforcement of intellectual property rights, supra note 27, paragraph 7.241: one of the major reasons for the conclusion of TRIPS was the desire to set out a minimum set of procedures and remedies that judicial, border and other competent authorities must have available to them.

  33. 33

    See WTO, Canada: Patent Protection of Pharmaceutical Products—Report of the panel (17 March 2000) WT/DS114/R, paragraphs 7.68–.69: the panel, interpreting “legitimate interest” underlined that “legitimate” is commonly defined as follows: (1) comfortable to, sanctioned or authorized by, law or principle: lawful; justifiable; proper; (2) normal; regular, conformable to a recognized standard type, the term must be defined as a normative claim calling for protection of interests that are “justifiable” in the sense that they are supported by relevant public policies or other social norms.

  34. 34

    On the link of IP and international trade in TRIPS see Reichmann (1989, pp. 827ff), Gadbaw (1989, pp. 223ff); communication from India to the Negotiating Group on TRIPS, Including Trade in Counterfeit Goods, Standards and Principles Concerning the Availability, Scope and Use of Trade-Related IP Rights, 10 July 1989, MTN.GNG/NG11/W/37, paragraph 2; Helfer (2004, pp. 18–24).

  35. 35

    In this regard, the CJEU affirmed that “with a view to preventing the abuse of provisional measures prescribed before the defendant being heard, art. 50.4 TRIPS provides that, where the defendant has not been heard, he is entitled to request an immediate review of the provisional measures ordered”. Case C-89/99, Schieving Nijstad and others and Robert Groeneveld, [1999] ECR I-5851, paragraphs 40–1.

  36. 36

    There are no conflict norms in the WTO agreement but there is some case law on the relation between GATT and GATS. On this see Pauwelyn (2003, pp. 399ff), Davey and Zdouc (2003, pp. 58ff), Dordi (2004, pp. 83–5). Specifically, on the cumulative nature of WTO obligations in interpreting article V GATT in the case at issue see Seuba (2009, p. 7).

  37. 37

    WTO, Colombia: Indicative prices and restrictions on ports of entry—Report of the panel (27 April 2009) WT/DS366. According to paragraphs 7.549 and 7.550, a measure cannot be considered necessary if there is an alternative measure that a member could reasonably employ; and the panel should consider the relative importance of the common interests or values that the law or regulation to be enforced is intended to protect, the extent to which the measures contribute to the realization of the end pursued and the restrictive impact of the measure on imported goods.

  38. 38

    It has also to be noted that, concerning the claim that external transit control violates the international principle of freedom of transit, the DSB would likely interpret this principle as it is referred to in article V GATT.

  39. 39

    To support this view it is also possible to quote WTO, India: Patent Protection for Pharmaceutical and Agricultural and Chemical Products—Report of the panel, DS50, paragraph 7.19: We must bear in mind that the TRIPS, the entire text of which was newly negotiated in the Uruguay round and occupies a relatively self-contained, sui generis status in the WTO Agreement, nevertheless is an integral part of the WTO system, which itself builds upon the experience of over nearly half a century under the GATT 1947. … Since the TRIPS is one of the Multilateral Trade Agreements, we must be guided by the jurisprudence established under GATT 47 in interpreting the provisions of the TRIPS unless there is a contrary provision.

  40. 40

    Doha Declaration on the TRIPS Agreement and Public Health adopted on 14 November 2001 by the fourth WTO Ministerial Conference, Doha, WT/MIN(01)/DEC/W/2.

  41. 41

    Intervention by Brazil at the TRIPS Council supra note 9, paragraph 14.

  42. 42

    WTO, Canada: Patent Protection supra note 33, paragraph 7.26. In the panel's view, the negotiators of the Agreement did not intend article 30 TRIPS (on the exception of exclusive rights on patents) to bring about what would be equivalent to a renegotiation of the basic balance of the Agreement since this balance was already set during negotiations and, therefore, the scope of the article depends on the specific meaning, articles 7 and 8 are to be taken into account but they cannot change the terms of the provisions [this was also the opinion of developed countries at the Special discussion on IP and Access to Medicines (a TRIPS Council Special Session, IP/C/M/31) while developing countries argued that public policy objectives should have prevailed over IP protection]. On this panel, see Shanker (2002, pp. 736ff), Biagdleng (2008, pp. 102–4), Howse (2000, pp. 494ff).

  43. 43

    In WTO, Canada: Patent Protection supra note 33, the panel argued in paragraph 7.92 that “to the extent that the prohibition of discrimination does limit the ability to target certain products in dealing with certain important national policies referred to in article 7 and 8.1, that fact may well constitute a deliberate limitation rather than a frustration of purpose”. According to Shanker, this amounted at an ignorance of the rules of the VCLT (Shanker, 2002, p. 742). In the same sense, about the interpretation of the words “limited” see Howse (2000, pp. 496ff).

  44. 44

    WTO, Japan: Taxes on Alcoholic Beverages—Report of the Appellate Body (4 October 1996), WT/DS8/AB/R, WT/DS10/AB/R, WT/DS11/AB/R, p. 14.

  45. 45

    According to Law (2009, p. 53), the practical effect of article 7 will be limited to its use as reinforcement for an action taken and permitted in other provisions.

  46. 46

    See the project “IP in transition” quoted in Kur and Grosse Ruse-Khan (2008, p. 31). See also Gervais (1998, p. 68): according to the author, article 8 does not allow broader exceptions but it is a policy statement that underlines the rationale for measures taken under articles 30, 31 and 40.

  47. 47

    Doha Declaration on the TRIPS Agreement and Public Health supra note 40, paragraph 4.

  48. 48

    In this regard, see also paragraph 10.

  49. 49

    Doha Declaration on the TRIPS Agreement and Public Health, supra note 40, paragraph 4. On the Declaration see Abbott (2002b, pp. 8ff), Roffe et al. (2006, pp. 9–27), Law (2009, pp. 156ff).

  50. 50

    It has to be noted that the choice of the word “should” in the context of rules and regulations indicates a mandatory obligations (Webster's Third New International Dictionary quoted by Law, 2009, pp. 51–2).

  51. 51

    Doha Declaration on the TRIPS Agreement and Public Health supra note 40, paragraph 4. See also Acconci (2006, p. 139).

  52. 52

    While, for example, the decision on the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (adopted by the General Council on 30 August 2003) makes reference to article IX.1, 3 and 4.

  53. 53

    According to European Commission (2001), “a Member of which the legislation, in particular in the area of patents, is being challenged by another Member because of alleged incompatibility with the TRIPS, can refer to the contents of this Declaration. Panellists are likely to take account of the provisions of the TRIPS themselves as well as of this complementary Declaration, which, although it was not meant to affect Members’ rights and obligations, expresses the Members’ views and intentions. Hence, the Declaration is part of the context of the TRIPS, which, according to the rules of treaty interpretation, has to be taken into account when interpreting the Agreement”. See also USTR Fact Sheet summarizing results from WTO Doha meeting 15 November 2001. Available at <http://www.usembassy.it/file2001_11/alia/a1111516.htm> [Accessed May 2011].

  54. 54

    According to Law (2009, pp. 162ff), Sykes (2002), the Declaration is not binding. For the opposing point of view, according to which the Doha Declaration has not only political value but it has legal effects, see Musungu (2008, p. 448), Correa (2002, pp. 44–5).

  55. 55

    While according to Correa, the binding nature of the Declaration would bring to the conclusion that the Declaration should be considered as a subsequent agreement according to article 31.3.a VCTL (Correa, 2002). In this sense also Frankel (2005). For the opposing view: Law (2009, pp. 162ff). To deepen the analysis on the potential interpretive value of the Declaration, see also Gathii (2002).

  56. 56

    For national praxis of WTO members see Blakeney (2001). However, the conduct has to be concordant and requires all parties of the agreement to practice or agree on something (Gardiner, 2008, p. 227).

  57. 57

    At the time known as the Customs Cooperation Council.

  58. 58

    It is a taskforce of anti-counterfeiting stakeholders, including pharmaceutical industry associations and drug regulatory authorities, international agencies and non-governmental agencies and enforcement bodies.

  59. 59

    Draft resolution attached to WHO (2008).

  60. 60

    That is the patients confuse a medicine for another one because it is written that there is one component, and then there is another one or it should have a name but it has another one or misleading statement about the manufacturer and country of manufacture.

  61. 61

    On this topic see, among others, Blanchard et al. (2007, pp. 65ff).

  62. 62

    WHO, Sixty-third World General Assembly, Substandard/spurious/falsely-labelled/falsified/counterfeit medical products, 21 May 2010, WHA63(10).

  63. 63

    International Covenant on Economic, Social and Cultural Rights (adopted 16 December 1966, entered into force 3 January 1976), 993 UNTS 3.

  64. 64

    Committee on Economic, Social and Cultural Rights, General Comment no. 14 on the right to highest attainable standard of health, E/C.12/2000/4, 4 July 2000.

  65. 65

    Ibid., article 43 lett. d.

  66. 66

    These medicines are selected with due regard to public health relevance, evidence on efficacy and safety and comparative cost effectiveness. The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations; exactly which medicines are regarded as essential remains a national responsibility. See WHO essential drugs and medicines policy. The WHO Model Lists of Essential Medicines has been updated every 2 years since 1977. The current version, the 15th list, dates from March 2007. Available at <http://www.who.int/medicines/publications/08_ENGLISH_indexFINAL_EML15.pdf> [accessed October 2011]. From October 2007, there is also a version of essential medicines for children.

  67. 67

    General Comment n. 14 supra note 64, paragraph 34; on this see also Yamin (2003, pp. 352ff).

  68. 68

    Mentioned by India in Intervention by India at the TRIPS Council supra note 3. Also other Resolutions may be relevant, such as Commission on Human Rights resolution 2003/29, Access to medication in the context of pandemics such as HIV/AIDS, tuberculosis and malaria, which call for Members to ensure access, non-discrimination and good quality of HIV medicines.

  69. 69

    Letter from public health advocates to the head of the WHO Margaret Chan supra note 11.

  70. 70

    The global strategy and plan of action on public health, innovation and IP, WHA61.21, May 2008. Moreover, there are other paragraphs that could be relevant: the elements of the strategy will improve “delivery of and access to all health products by effectively overcoming barriers to access” (paragraph 14 f); among the actions to be taken “encourage and support the application and management of IP in a manner that maximizes health-related innovation and promotes access to health products and that is consistent with the provisions in the TRIPS and other WTO instruments related to that agreement and meets the specific R&D needs of developing countries” [paragraph 36 (5.1a)]; and “providing as appropriate, upon request, in collaboration with other competent international organizations technical support including, where appropriate, to policy processes, to countries that intend to make use of the provisions contained in TRIPS, including the flexibilities recognized by the Doha Declaration in order to promote access to pharmaceutical products” paragraph (5.2); and “consider, where necessary, and provided that they are consistent with the provisions of TRIPS, taking appropriate measures to prevent the abuse of IP rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology, in the field of health products” (paragraph 39, 6.3f).

  71. 71

    See article 23 of the WHO Constitution.

  72. 72

    WHO, Statement on Access to Medicines, 13 March 2009.

  73. 73

    EU countered that it is important to allow customs authorities to control goods in transit suspected of infringing IP rights since this was the only way to stop traffic of potentially dangerous products, such as fake medicines, also taking into account the significant and worrying level of counterfeit medicines, which is higher in poor countries (and even that safeguarding health justified an impediment to free trade as collateral damage). See TRIPS Council, 3 March 2009, minutes of the meeting, IP/C/M/58, paragraph 149.

  74. 74

    Counterfeit of medicines is becoming a wide-spreading phenomenon. It is estimated that up to 25% of the medicines consumed in poor countries are counterfeit or substandard, representing a major threat to public health (see WHO Fact Sheet no. 275, November 2003. Available at <http://www.who.int/mediacentre/factsheets/2003/fs275/en/> [accessed October 2011]. On the countries of source of these counterfeit medicines inside and outside Europe, see Reboul et al. (2004, pp. 39ff).

  75. 75

    See Proposal for a directive amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products that are falsified in relation to their identity, history or source, COM (2008) 668.

  76. 76

    It is outside of this article to analyse the problem of the binding nature of ICESCR for the EU.

  77. 77

    Committee on Economic, Social and Cultural Rights, General Comment no. 17 on the right of everyone to benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he or she is the author (article 15, paragraph 1 (c), of the Covenant), E/C.12/GC/17, 2005.

  78. 78

    On the relation between IP and human rights at international level see WIPO, OHCHR (1998), Haugen (2007, pp. 53–69), Drahos (1996), Yu (2007, pp. 1039–149).

  79. 79

    Anheuser Busch Inc. v Portugal (App. no. 73049/01) ECHR (Grand Chamber), 11 January 2007.

  80. 80

    See also Marceau (2002, p. 795) on the possibility that the DSB will face a conflict between WTO and human rights law.

  81. 81

    WTO, US: Standards for Reformulated and Conventional Gasoline—Report of the AB (29 April 1996) WT/DS2/AB/R, p. 16.

  82. 82

    WTO, US: Import prohibition of certain Shrimp and Shrimp Products—Report of the Appellate Body (12 October 1998) WT/DS58, 131 (the AB used the United Nations Convention on the Law of the Sea to interpret the meaning of “exhaustible natural resources” in article XX.g GATT, even though one of the parties did not belong to the relevant treaty, justifying that on the basis of the principle of effectiveness); WTO, EC: Custom Classification of Certain Computer Equipment—Report of the panel (5 February 1998) WT/DS62, 95; WTO, EC: Custom Classification of Frozen Boneless Chicken Cuts—Report of the Appellate Body (12 September 2005), DS269, 199.

  83. 83

    WTO, EC: Approval and Marketing of Biotech Products—Report of the panel (21 November 2006) WT/DS/291/R, WT/DS/292/R, WT/DS/293/R, paragraph 7.70 Taking account of the fact that article 31(3)(c) mandates consideration of other applicable rules of international law, and that such consideration may prompt a treaty interpreter to adopt one interpretation rather than another, we think it makes sense to interpret article 31(3)(c) as requiring consideration of those rules of international law that are applicable in the relations between all parties to the treaty that is being interpreted. Requiring that a treaty be interpreted in the light of other rules of international law that bind the States parties to the treaty ensures or enhances the consistency of the rules of international law applicable to these States and thus contributes to avoiding conflicts between the relevant rules.

  84. 84

    On the phenomenon of counterfeiting see OECD (2007, p. 3); Blakeney (2006, pp. 3ff).

  85. 85

    See, among others, Communication from the European Communities, Enforcement of intellectual property rights: border measures, IP/C/W/471, 9 June 2006, pp. 1–2.

  86. 86

    WCO Model Law on border measures elaborated in collaboration with WIPO adopted on 20 February 2003. It is not binding for WCO members but it contains a set of principles that are TRIPS-plus.

  87. 87

    Although last reports seem to show that the proposal is controversial and blocked.

  88. 88

    See Anti-Counterfeiting Trade Agreement, 3 December 2010. Available at <http://europa.eu> [accessed October 2011], pp. 9ff (article 16–17). In the previous draft of 1 July 2010, the EU proposal was that each party shall provide procedures for in-transit shipments for goods suspected of infringing any IP right.

  89. 89

    Economic Partnership Agreement between the CARIFORUM States, of the one part, and the European Community and its Member States, of the other part, OJ [30 October 2008] L 289, article 163. It has also to be noted that, after the entry into force of the Lisbon Treaty, the European Parliament is now more involved in the Common Commercial Policy, see Cronin (2010).

  90. 90

    Intervention by India at the WTO General Council, supra note 3. On this issue, see also UNCTAD, ICTSD (2005, p. 25).

  91. 91

    To face this situation, developing countries are proposing measures to defend their interests such as the protection of traditional knowledge and the protection of biodiversity, the right to health and the right to food. Moreover, they put enforcement in the WIPO Development Agenda and argued that if enforcement will be enhanced, at least it should take into account economic and social implications since beside enforcement, also competition and human rights such as health have to be considered. The last of these recommendations deals precisely with IP rights enforcement as it underlines the need to “approach intellectual property enforcement in the context of broader societal interests and especially development oriented concerns” in accordance with article 7 of TRIPS.

  92. 92

    According to Karl (1984), a conflict arises when two (or more) treaty instruments contain obligations that cannot be complied with simultaneously. On this point see Pauwelyn (2003).

  93. 93

    Economic and Social Council, Committee on Economic, Social and Cultural Rights, 36th session, 1–19 May 2006, Consideration of reports submitted by States parties under articles 16 and 17 of the Covenant, Concluding observations of the Committee on Economic, Social and Cultural Rights, Morocco, point 29: the Committee is concerned at the possible adverse effects of free-trade agreements that entered into force in 2006. It appears that these agreements, which raise the costs of medical supplies and drugs, could impinge on the rights enshrined in the Covenant, particularly the right to health. See also Economic and Social Council, E/C.12/CRI/CO/4, 4 January 2008, Consideration of reports submitted by States parties under articles 16 and 17 of the Covenant, Costa Rica, Draft concluding observations of the Committee on Economic, Social and Cultural Rights, paragraph 27: The Committee notes with concern the potential impact of the entry into force of the Central American Free Trade Agreement (CAFTA) on the State party's obligations under the Covenant and, in particular, on traditional agriculture, labour rights, access to health, social security and the IP regimes protecting, inter alia, access to generic medicines, biodiversity, water and the right of indigenous communities associated to these resources.

  94. 94

    This is why it would be useful to include a clause that goes beyond the non-derogation clauses used so far and lets the TRIPS provisions and future developments override the FTA provisions, according to Hestermeyer (2007, p. 290).

  95. 95

    TRIPS does not have direct effect on the EU law. See Case C-300/98 and C-392/98, Parfums Dior SA v Tuk Consultancy BV and Assco Geruste Gmbh v Layher BV, paragraph 41-9. On this see, among others, Puissochet (2005).

References

  1. Top of page
  2. Abstract
  3. The Cases of Losartan and Abacavir
  4. External Transit Control of Generics under EU Regulation 1383/2003
  5. TRIPS Minimum Standards on Border Measures
  6. The Extraterritoriality Claim
  7. Are There Ceilings to External Transit Control of Medicines?
  8. Free-Trade Provisions as Weak Internal Ceilings
  9. The Limited Role of the Objectives and Principles of the TRIPS in Protecting Public Health
  10. The Doha Declaration on TRIPS and Public Health as a Potential Ceiling
  11. The International Definition of Counterfeit Medicines
  12. International Law on Access to Medicines
  13. Access to Medicines and Intellectual Property Rights in the Context of the Fragmentation of International Law
  14. TRIPS-plus Agreements and Access to Medicines
  15. Conclusions
  16. References
  17. Biography
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