TRIPS-Plus, Public Health and Performance-Based Rewards Schemes Options and Supplements for Policy Formation in Developing and Least Developed Countries

I. INTRODUCTIONThe debate surrounding the creation of a balanced patent protection regime in countries is not new. For decades, policy makers experimented with the levels of protection.3 For example, the Netherlands abolished patents in the field of chemistry for decades between 1869 and 1910, in order to catch up with other European countries such as Germany.4 Similarly, between 1960 and 1980 a number of Asian economies-often referred to as the Tiger economies-adopted a systematic national policy of reverse engineering and imitation.5 When South Korea introduced patent protection in 1961, the protection term was limited to only twelve years and protection did not extend to foodstuffs, pharmaceuticals, or chemicals.6 Similarly, many of the developed nations adopted a relaxed protection regime during their initial stages of development, utilizing their preferred intellectual property regime only after reaching a certain level of advancement.7This debate remains as relevant as ever.8 A 2013 report published in Australia sums up the dilemma facing many governments in the area of public health, noting:Thus the question of how much patent protection to offer is crucial. Pharmaceutical patent rights that run for too long or that are defined too expansively will deprive people of drugs because purchasers, including Governments, cannot afford them. They can also constrain follow on innovation: too weak a patent system means patients will suffer because the industry has inadequate incentives to develop new drugs.9On March 31, 2015, the Harper Report, triggered by major concerns about the current regime, requested that the Australian government should direct the Productivity Commission to conduct a twelve-month overarching review of the intellectual property regime in the country.10Many factors affect the intellectual property regime in any country.11 This also means that the responsiveness of intellectual property protection itself to any reform will vary depending on these factors. Therefore, it is baseless to advocate that stronger economic growth in any given country would be triggered by strengthened intellectual property protection.12 The World Bank, in a 2005 report, concluded that "[e]vidence is inconclusive about the responsiveness of Foreign Direct Investment ("FDI") to intellectual property regimes."13Home grown factors, including a country's level of development and progress, its national priorities, and standards of living are often important factors in shaping the debate. Yet in more recent times, external factors became more visible-and even more influential to that effect-in the formation of such a process. Following the creation of the World Trade Organisation ("WTO") and its Agreement on Trade-Related Aspects of Intellectual Property Rights ("TRIPS Agreement") in 1994, an upward trend in the regulation and enforcement of intellectual property rights in general was noticeable.14 More recently, TRIPS-Plus rules were included under various bilateral, regional, and multilateral arrangements and forums resulting in strengthened levels of intellectual property protection and enforcement in many parts of the world.15More crucial than any other branch of intellectual property in today's global debate is the issue of patent protection and its relation to the accessibility and affordability of medicines. The TRIPS Agreement made it obligatory for the first time in history for all member states to provide patent protection for pharmaceutical products and processes.16 This meant that many developing-and developed-countries are no longer capable of making drugs cheaper and affordable for their citizens, due to the need to pay royalties to the pharmaceutical producers originating from the developed countries.17 With the support of the major pharmaceutical producers, these developed countries incorporated the protection of intellectual property in their international trade agenda under the auspices of free trade, resulting in, and subjecting developing countries into accepting, higher TRIPS-Plus levels of intellectual property protection under their national legal regimes. …