In June, the Hudson Institute released a research report that analyzes several positions taken by the United Nations (UN) High Level Panel on Access to Medicines (HLP) on the impact of patents on global access to medicines.  The report, entitled "The Patent Truth About Health, Innovation and Access," focuses on several assertions of the HLP, which was launched in 2015 by UN Secretary-General Ban Ki-moon with the goal of reviewing and assessing proposals and recommending solutions for "remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies."  In particular, the Hudson Institute report addresses the following premises of the HLP:

1. Millions of poor people in low- and middle-income countries have been denied access to ARVs and other medicines;

2. Patents are the main cause of higher costs of medicines for poor people in low- and middle-income countries;

3. The intellectual property system, including patents and voluntary licenses, limits research and disadvantages local producers in low- and middle- income countries.

The report concludes that "[t]hese basic assumptions . . . are not supported by global health research."

Before addressing each of the HLP's premises, the report first discusses the role of intellectual property in the global economy, stating that "intellectual property (IP) is a fundamental driver of human progress, fueling innovation, creative thinking and economic growth," and adding that "[t]he security of private intellectual property rights for inventors and investors is fundamentally important to a public good: the sharing and flow of information and ideas, which in turn generate new inventions and innovations that drive technological advancements, economic development and economic growth."  Asserting that "the inventors of tomorrow's life-changing products face challenges in protecting their IP rights," the report describes three such challenges: the costs for developing new technologies (particularly in the pharmaceutical industry, where the report notes that the research and development of new pharmaceuticals requires an average of ten years and billions of dollars); the time, effort, and cost required to secure a patent; and the protection of intellectual property rights both within and across borders (the report notes that approximately 95% of the world's population, or potential customer base, lives outside the U.S.).  In discussing a fourth challenge, the report states that:

[I]ntellectual property rights have been, and continue to be, under systematic assault.  The intentional erosion of IP rights occurs passively, by failure to police piracy and counterfeiting, and actively, through advocacy against IP protections in trade agreements and multilateral bodies by NGOs, activist groups and many governments seeking to challenge the legal and moral underpinnings of intellectual property rights.  Paradoxically, the transfers of high technology and advanced medicine these groups seek to promote are undermined as the incentives for innovation and information sharing are also undermined with weakened IP protections.

Turning to the HLP's premises, the report begins by pointing out that a study in the American Economic Review (Cockburn et al., "Patents and the Global Diffusion of New Drugs," American Economic Review 106(1): 136-64 (2016)) has shown that "strengthening IP has resulted in better access to medicines in developing countries" (emphasis in original).  The report includes a table (shown below) that provides evidence of "the extraordinary progress that has been made against death and disease in poor countries."

The report also notes that "[c]ommunicable diseases are no longer the major cause of death in developing countries since people are living long enough to develop non-communicable diseases like cancer, cardiovascular disease, and stroke," pointing out that the World Health Organization (WHO) determined in 2012 that "the top two causes of death in lower middle income countries were ischemic heart disease and stroke, the same as high-income countries."  With respect to the HLP's first premise, the report concludes that if the HLP "had looked at the track record of affordable life-saving medicines and technologies available to the developing world, they would have seen that the most important problems impeding access to medicines and better health for poor people are not patents and prices."

Moving on to the HLP's second premise, the report cites an article by Attaran and Gillespie-White ("Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa," JAMA 286(15): 1886-92 (2001)), which examined the patent status of fifteen drugs for treating HIV in 53 African countries and found that patents were not a barrier to HIV treatment.  The report notes that a follow-up paper from 2004 (Attaran, "How Do Patents and Economic Policies Affect Access to Essential Medicines in Developing Countries," Health Affairs 23(3): 155-66 (2004)) concluded that "[p]atents are an infrequent determinant of access to essential medicines."  According to the report, the authors of the 2001 paper determined that poverty, weak healthcare systems, taxes, and poor supply systems had more of an impact on access to medicines in developing countries than patents.

Examining the prices of patented and non-patented (or "copy") ARV (antiretroviral) drugs that were available for treating HIV in 2004, the report notes that only one of thirteen drugs was significantly higher-priced than its copy, and that other than this outlier, "the copy drugs were even more expensive than the patented [drugs]."  The report also notes that while patient coverage nearly tripled from 2010 to 2014 in the world's largest AIDS treatment program (the President's Emergency Plan for AIDS Relief (PEPFAR)), overall treatment prices for patients significantly decreased.  With respect to the HLP's second premise, the report concludes that "[h]ad the HLP considered the most important factors behind access to medicines and had it properly consulted with UN member states, their panel might have pursued more meaningful solutions than eliminating the intellectual property system."

As for the HLP's third premise, the report argues that the HLP's assertion "blatantly ignores the lifesaving drugs and vaccines that have dramatically reduced infant mortality and increased life expectancy in low-income countries."  The report contends that "nowhere is the importance of innovation and drug development for the poor more clear than in the case of HIV/AIDS over the last 35 years," stating that:

In the history of therapeutic medicine, there has not been a comparable period during which so much innovation resulted in so many new products—which principally benefited the poor in markets far away from those of the manufacturers.  In the United States, between 600,000 and 900,000 people were living with HIV in 1989, while approximately 5-10 million people were living with HIV around the world, most in lower income countries.  In just over ten years, the number of people living with HIV around the world had grown to approximately 37 million while the number in the United States was just under one million people.

Declaring that "the current intellectual property system has not denied millions of poor people access to ARVs and other medicines," and that "[p]atents have not been a cause of high cost drugs for the poor, or led to limited drug research, or disadvantaged local producers," the report concludes that "[o]n the contrary, . . . the intellectual property system has encouraged innovation that has saved millions of lives by providing the poor with access to lifesaving therapies" (emphasis in original).  According to the report, the main barriers to access to medicines in developing countries are "not patents and prices," but rather are "lack of good governance, poor physical infrastructure and distribution systems, a shortage of healthcare facilities and providers, insufficient public health spending, corruption, taxes and tariffs on medicines, and the lack of policies that promote economic growth and incentives for individuals and businesses to develop new technologies so their countries can grow and prosper."  Although the report concedes that "improvements can still be made in global health policy to increase access to medicines and better healthcare," the report argues that "the achievements to date have been remarkable."