The World AIDS Day was first observed 25 years ago on 1 December to raise awareness for this then-fatal disease. Since its discovery, HIV/AIDS has cost the lives of 25 million people worldwide. Another 30 million adults and 2.5 million children have been infected. If we count family members, loved ones and the numerous professionals and volunteers who have cared for the infected, HIV/AIDS has disturbed the lives of an incalculable number of individuals and communities from around the world.
Although reports about HIV/AIDS, especially those concerning the lack of access to antiretrovirals, tend to be depressing, recent years have seen some promising developments. This post will take stock of both the good and the bad in our continuous fight against HIV/AIDS. It will also draw key lessons from this fight and apply them to other global public health problems.
Let’s start with the good. This June, the poorest members of the World Trade Organization (WTO) successfully lobbied for an eight-year extension of the transition period for implementing the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). This extension is important from a public health standpoint, because it delays the introduction of the protection for pharmaceutical patents and undisclosed clinical trial data until July 1, 2021. Previously, the Doha Declaration, which the WTO adopted in 2001, allowed for such delay until only 2016.
Earlier this year, the highest courts on both sides of the Pacific also handed down two very important decisions intersecting intellectual property and public health. In April, the Indian Supreme Court rejected Novartis’ challenge of section 3(d) of the Indian Patents (Amendment) Act of 2005, which prevents patent protection from being granted to ‘the mere discovery of a new form of a known substance which does not result in increased efficacy of that substance’. Novartis’ challenge was mounted following the rejection of its patent application on the anti-cancer drug Glivec.
Two months later, the US Supreme Court decided Association for Molecular Pathology v Myriad Genetics, Inc., which concerned the patentability of claims covering two isolated human genes associated with breast and ovarian cancers. In this case, the Court held that ‘a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated’. Although the decision was narrowly written, it likely will have a significant impact on the development of biotechnology, biologics and diagnostic kits.
As if these developments were not promising enough, the public intellectual property debate has changed considerably in the past few years. Although AIDS activists have been leading protests against excessive patent protection, they are now joined by people who are concerned about other problems in the intellectual property system. Last year, for example, the protests against the Anti-Counterfeiting Trade Agreement led hundreds of thousands of European protesters to march on the streets of multiple cities in the middle of winter. The protests against proposed US internet legislation also resulted in a massive service blackout involving Wikipedia, Reddit, WordPress and other Internet companies.
Finally, the HIV/AIDS debate has seen new players emerging at both the state and non-state levels. The arrival of the BRICS countries (Brazil, Russia, India, China and South Africa) and the African Group has greatly increased the leverage of the developing world in recalibrating the balance in the international intellectual property system. Private foundations such as the Bill and Melinda Gates Foundation have also ushered in exciting new initiatives in vaccine development and global health research.
With the good of course comes the bad. The biggest threat of the year has to be the secret negotiation of the Trans-Pacific Partnership (TPP) Agreement between the United States and 11 like-minded countries in the Asia Pacific region. As shown in a recently-leaked text, the agreement’s intellectual property chapter includes highly controversial provisions, such as those concerning the extension of the patent term due to administrative delay, the protection of clinical trial data for biologics and the allowance for patent claims in medical and surgical procedures.
In addition, the proposed agreement calls for much higher levels of enforcement than is required by the TRIPS Agreement. By shifting costs and burdens from private rights holders to national governments, the TPP enforcement provisions also threaten to divert scarce public resources from other important needs. Even though the agreement has paid lip service to the Doha Declaration, it likely would make it more difficult for countries to promote public health, nutrition, education, development and the environment.
Even worse, the TPP Agreement includes an investment chapter that would allow private rights holders to file complaints directly against the host state. Although intellectual property rights holders have not actively used investor-state arbitrations, the landscape changed recently when Philip Morris used bilateral investment agreements to challenge restrictions on the packaging of cigarette products in Australia and Uruguay. Following the Canadian courts’ invalidation of its drug patents, Eli Lily also announced its intention to seek $100 million of damages under the North American Free Trade Agreement (NAFTA).
Finally, despite its existence for more than eight years and three repeated deadline extensions, the only amendment to the TRIPS Agreement has still not entered into effect. Under this amendment, a new article 31bis will be added to the TRIPS Agreement to enable countries with insufficient or no manufacturing capacity to import generic versions of patented pharmaceuticals. Thus far, the world is still short of ratifications from more than a third of the WTO member states, including many target countries in Sub-Saharan Africa. Given the resistance, one cannot help but wonder how much benefit the amendment will actually provide to those it claims to protect.
Although news about HIV/AIDS continues to surface from time to time, and the issue remains highly important, much of the public attention has now focused on communicable diseases. Examples of these diseases are H5N1 (bird flu virus), H1N1 (swine flu virus), H7N9 (another bird flu virus) and MERS (Middle East Respiratory Syndrome). This growing focus, to some extent, reminds us of the scare caused by the outbreak of SARS (Severe Acute Respiratory Syndrome) a decade ago.
As I noted in a recent article, if there is anything we can learn from both HIV/AIDS and SARS, it is that communicable diseases create a much bigger and more global problem than non-communicable diseases. What happens in the developing world could easily spill over into the developed world. A SARS-stricken doctor from mainland China staying at a hotel in Hong Kong, for example, can spread a respiratory disease to Canada, Hong Kong, Singapore, Vietnam and other parts of the world.
Notwithstanding the danger of communicable diseases, many developed countries remain reluctant to provide public health assistance to countries that constitute the ‘weakest link’ in our global public health system. Their reluctance is understandable from a political standpoint. Developing and stockpiling vaccines to take care of local citizens have always been more popular than addressing problems in the global public health system.
What these politicians and their constituents have yet to realize, however, is that their short-sighted views will eventually come back to haunt them. It is no coincidence that influenza and other infectious diseases often break out in poor countries. After all, these countries are the least likely to have the resources, expertise and personnel needed to provide quick and effective responses.
When a communicable disease fails to be detected and properly contained, it will spread to major cities abroad. Although SARS has taken hundreds of lives and infected thousands more, these figures are in no comparison with the millions of people dying annually of AIDS, malaria, tuberculosis, pneumonia or even infectious diarrhea. What makes SARS especially frightening is its tens of billions of dollars of damages and the months of fear, panic and disruption the disease and the resulting quarantines have sparked.
In the wake of the SARS outbreak, contagious diseases have finally become a more frequent subject of Hollywood movies. While Contagion paints a grim picture where a mysterious disease travels quickly from Macau, China to other parts of the world, World War Z shows the global threat created by a virus that can transform humans into zombies. In both movies, the quick and wide spread of contagious diseases has led to quarantines, deaths, emotional distress, crimes and ultimately mass panic.
Although both movies have been heavily dramatized, their important point that a failure to prevent and control a highly contagious disease can take a heavy toll on society or humanity is not lost on the audience. The inclusion of scenes from different parts of the world also drives home the point that viruses can spread quickly from one country to another.
If we can learn only one thing from two and a half decades of observing the World AIDS Day, it has to be that a global problem requires global action. We have learned important lessons from the fight against HIV/AIDS. It is time we apply these lessons to other global public health problems.
Peter K. Yu holds the Kern Family Chair in Intellectual Property Law and is the founding director of the Intellectual Property Law Center at Drake University Law School. With Obijiofor Aginam (UNU) and John Harrington (Cardiff), he co-edited The Global Governance of HIV/AIDS: Intellectual Property and Access to Essential Medicines, published by Edward Elgar earlier this year [download the introduction for free]. He is also the editor of the Elgar Intellectual Property and Global Development Series and the Elgar Law, Technology and Society Series.