Alvarez puts his TRIPs apology thus: ‘By bringing intellectual property protections into their trade regimes, WTO members de-legitimized the piracy of intellectual property.’23 This, of course, is a highly partisan position. If one were to substitute ‘obstructed the access to knowledge of the most needy’ for Alvarez’s ‘de-legitimized the piracy of
intellectual property’, one would paint the picture of the TRIPs effect as many developing countries, especially the least-developed of them, see it. As Cullet argues far more
cogently, the TRIPs ‘constitutes one of the most significant changes in law for developing-country WTO members’.24
By becoming signatories to the TRIPs and adopting its legal standards and demands, developing countries have accepted the creation of an important statutory obligation that regulates the formation of agreements in areas not related to trade issues. This Agreement is as legally binding on members as is any other treaty-status agreement in WTO’s legal framework. Indeed, as Charnovitz points out:
The success of adding intellectual property rights during the Uruguay Round (1986-1994) has led many analysts to view TRIPs as a template for incorporating other issues loosely linked to trade into the WTO.25
The TRIPs imposed a new global legal order on the governments of all signatory countries. That this is so is evidenced by the fact that TRIPs imposed an obligation to create a statutory body that implements, administers and monitors its standards. This
22 Again in Chapter 4.
23 Alvarez, JE, ‘The WTO as linkage machine’, vol. 96, no.1, The American Journal of International Law,
January 2002, p. 148.
24 Cullet, Philippe, ‘Human Rights and Intellectual Property Protection in the TRIPs Era’ vol. 29,
no. 2,’Human Rights Quarterly, 2007, pp. 403-404.
makes the TRIPs far more demanding than the usual WTO agreement that does no more than prohibit certain acts and practices.26 Although it is true that the TRIPs has
encroached also on the legal systems of developed countries, feeling is nevertheless strong in developing countries about its encroachment on their legal systems.
More than any other, the TRIPs provisions concerning the compulsory licensing of patent pharmaceuticals have attracted severe condemnation. Pursuant to Article 31, members may, in accordance with specified rights and obligations, set the grounds for compulsory licensing in their national legislation. Paragraphs (a) - (k) of this Article outline the rules concerning acquisition of the licensing rights, the duration of these rights, and the remuneration due to the patent holder. At the 2005 Hong Kong ministerial conference, the WTO adopted an amendment of the TRIPS agreement that formalised the waiver of Article 31(f) that had been passed two years earlier, permitting the compulsory licensing of essential medicines (including treatments for HIV/AIDS).
Compulsory licensing allows a country facing a health emergency to produce the needed drugs. If no local pharmaceutical industry exists in the afflicted country, its government can import these drugs from another country, which may also be producing them under compulsory licensing. One the face of it, the ‘compulsory licensing’ exception seems to address the public health interests of developing countries. In practice, however, there are a number of serious problems with it: In the event of a public health emergency, it may take too much time to activate the compulsory licensing privilege. Even if the solution to
26 Levy, CS, ‘Implementing TRIPs – a Test of Political Will’, vol. 31, no.3, Law and Policy in International Business, 2000, p.792.
the emergency were to be in the importation of the needed drugs, the problem would arise of identifying a country that manufactures those drugs under compulsory licence, unless the manufacturing country is also dealing with a similar emergency. Such a coincidence is highly unlikely.
Also, the developing country interested in implementing the ‘compulsory licensing’ exception must first seek the approval of the patent holder, unless a serious emergency exists. The exception is time limited, and applicable to domestic emergencies only. Upon implementation of the exception, adequate remuneration must be paid to the patent holder, and, in the event of dispute as to the amount of that remuneration, the matter becomes subject to judicial review. On top of this, the exemption is only applicable to specific drugs and not to an entire classes of drugs.27 Not without reason, therefore, compulsory licensing is perceived to be extremely impractical, and even unworkable.28
Another problem is that developing countries do not have a sufficient understanding of the technical and legal nature of exemptions granted to them under various WTO agreements such as the TRIPs, TRIMs and GATS: A recent study showed that even the Brazilian government failed to make effective use of exemptions under the TRIPs. The main factors to blame were the lack of adequate understanding of the legal framework of the agreement, not only in the government bureaucracies, but also among health care enterprises in the private sector. If this is the case in a large developing country with a
27 Cullet, note 24, pp. 143-144.
28 Abbott, FM, ‘The WTO medicines decision: World Pharmaceutical trade and the protection of public
relatively sophisticated legal system, the situation is more likely to be worse in smaller developing countries.29
The TRIPs mandates the protection of patentable agricultural subject matter by means of Article 27, of which ss.3(b)(7) obliges the patent-protection of micro-organisms and microbiological processes, but leaves countries free to exclude plants and animals from this protection, so long as they attach intellectual-property titles to plant varieties, either through patents or through an effective sui generis system. The TRIPs provides for mandatory Geographical Indicators (GIs) for wines and spirits by means of Articles 22- 24.
At the 6th Ministerial Conference in Hong Kong in December 2006, India and Brazil, holders of many genetic resources with a traditional-knowledge content, led the effort to procure an amendment of TRIPs rules regarding genetic plant materials and traditional (cultural) knowledge. They urged that patent holders be required to disclose the origin of their patents. And, where those patents associate with genetic plant materials or
traditional/cultural knowledge, they be required to seek the source country’ permission for its continued use, and to share the economic benefits of their use with the source countries. The American Bio-industry Alliance opposed this demand strenuously, arguing that mandatory patent-disclosure obligations will discourage industry from investing in biotechnology source countries (usually developed and least-developed countries). Not even an undertaking for formal negotiation in this matter emerged. Curiously, such an
29Chaves, GC and Oliveira, MA, ‘A proposal for measuring the degree of public health-sensitivity of
patent legislation in the context of the WTO TRIPs Agreement’, vol. 85, no.1, Bulletin of the World Health
undertaking was easily obtained by the delegates pressing for a global register of GIs for wines and spirits.30 Not unexpectedly, developing countries view this as callous WTO disregard for the piracy of their genetic materials and indigenous knowledge.
Many commentators, among them Oliveira et al.,31 have pointed out the provisions of the TRIPs that seriously inhibit the transfer to developing countries of innovative technology. This holds up development, especially in the least-developed countries. As their study shows, the lack of technical knowledge and the absence of an adequate legislative framework impede these countries’ ability to exploit even the opportunities the TRIPs offers. Stiglitz et al.,32 inter alia, comment on the inertness of the compulsory-licensing provisions of the TRIPs that purport to enable developing countries to produce drugs domestically, noting that only a handful of countries, the powerful block of developing countries: India, China, Brazil and Egypt, have established pharmaceutical industries that can benefit from these provisions.