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In this Comment, the author traces the relevant legislative history pertaining to compulsory licensing of patented pharmaceuticals from the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement of 1994 to the 2003 waiver to, and later proposed amendment of, article 31, which enables poor countries to obtain needed medicines from other countries that possess manufacturing capacity. The Comment then evaluates recent, controversial uses of the relevant legislative machinery as viewed from different critical perspectives. The Comment shows how developing countries seeking access to essential medicines can collaborate in ways that would avoid undermining incentives to innovation and other social costs attributed to compulsory licensing. It ends by defending the legality of recent measures taken to promote public health in developing countries, and by reminding developed countries that unilateral retaliation against such measures is demonstratably illegal under WTO foundational law and jurisprudence.

Developing countries, particularly the BRIC countries of Brazil, Russia, India, and China, should accommodate their national systems of innovation to the worldwide intellectual property (IP) regime emerging after the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in a way that maximizes global economic welfare in the foreseeable future. As many developed countries' experience demonstrates, badly configured, over-protectionist IP regimes stifle innovation by making inputs to future innovation too costly and too cumbersome to sustain over time. More carefully considered IP regimes, however, are an important way to protect innovative small- and medium-sized firms from predatory, larger competitors. The challenge is for emerging economies to capture the benefits of IP without importing the serious problems that developed countries have themselves failed to solve. Emerging economies can attain this balance by pursuing a policy of counter-harmonization in which they take advantage of existing exemptions in international agreements governing IP to establish regional, local, and international practices that promote more innovative, flexible uses of IP. Such practices include a research exemption for experimental uses of IP, government imposed nonexclusive licensing, anti-blocking provisions, an essential facilities doctrine, and compulsory licenses. Additional tools include an ex ante regime of compensatory liability rules for small scale innovation and sensible exceptions, particularly for science as well as general fair use provisions, to the exclusive rights of domestic copyright laws. Emerging economies will have to overcome strong economic pressure to accept more restrictive IP regimes as part of free trade agreements as well as a lack of technical expertise and internal government coordination. However, emerging economies have already accrued enough experience to be aware of the strengths and weaknesses of various IP schemes and their own ability to tailor IP to local ...

ABSTRACT
The COVID-19 pandemic has brought into stark relief the gaps in global preparedness to address widespread outbreaks of deadly viral infections. This article proposes legal mechanisms for addressing critical issues facing the international community in terms of providing equitable access to vaccines, treatments, diagnostics, and medical equipment. On the supply side, the authors propose the establishment of mandatory patent pools ('Licensing Facilities') on a global or regional, or even national basis, depending upon the degree of cooperation that may be achieved. The authors also discuss the importance of creating shared production facilities. On the demand side, the authors propose the establishment of Regional Pharmaceutical Supply Centers (RPSCs) for the collective procurement of products, and the need to coordinate the issuance of necessary compulsory licenses for production and/or importation, depending on relevant circumstances. The authors envisage that centralized coordination by RPSCs should assist in overcoming difficulties individual countries may encounter in addressing administrative and technical issues in procuring supplies, as well as creating improved bargaining leverage with potential suppliers. The authors finally address the problem created by the decision of various high-income countries to 'opt out' as eligible importing countries under the World Trade Organization TRIPS Agreement Article 31bis amendment that addresses the predominant export of pharmaceutical products under compulsory licenses.

This entry into force of the World Trade Organization (WTO) TRIPS Agreement in 1995 transformed the international intellectual property system. The harmonization of basic intellectual property standards has operated to protect investment in innovation, limiting risks from unjustified 'free riding.' Yet these same harmonized IP standards sharply curtailed the traditional capacity of suppliers of public goods, such as health care and nutrition, to address the priority needs of less affluent members of society, particularly in (but not limited to) developing countries. In the Doha Declaration, the Waiver Decision of 30 August 2003 and the Article 31bis Protocol of Amendment, stakeholders concerned with re-opening policy space for the supply of newer pharmaceutical products pushed back against the restrictive elements of the TRIPS Agreement. Governments around the world are in the process of deciding whether to ratify and accept the Article 31bis Amendment. Based on their Study for the International Trade Committee of the European Parliament, the authors argue that acceptance of the Amendment will provide a 'net benefit' for countries seeking to improve access to medicines. At the insistence of WTO delegations acting on behalf of the originator pharmaceutical industry lobby, Article 31bis regrettably is saddled with unnecessary administrative hurdles. Nonetheless, through skillful lawyering, political determination and coordinated planning, the system can be made to work. Among other options, expeditious back-to-back compulsory licensing linked with pooled procurement strategies may effectively achieve economies of scale in production and distribution of medicines. The authors doubt that the international political environment would support renegotiation of an 'improved' solution. They express concern that failure to bring the Amendment into force will open the door to a campaign to undermine the Waiver Decision. Recent events in Brazil and Thailand illustrate both the opportunities and risks associated with implementing TRIPS exception mechanisms, and help to inform views on the negotiating environment. Specific proposals for regional cooperation in implementing the Amendment are laid out, and the authors emphasize the importance of pursuing concrete transfer of technology measures in support of developing country pharmaceutical manufacturing. Over-reliance on private market mechanisms for the supply of public health goods leaves the international community with an unresolved collective action problem on a large scale.