The team from Oxford University presented the opposition case that waiving patents was not a solution to the mutually agreed problem of ART distribution in the developing world, and went further to argue that waiving patents could be detrimental to the efforts against HIV/AIDS.
Intellectual property rights exist for several purposes, not least of which is to ensure monetary reward for the owner of the patent. Pharmaceutical companies are often characterized as profiteering, more interested in their own gain than in the benefit of the end-users of their products, patients. This characterization is not only accurate but quite appropriate; every company is beholden to its share-holders, and moreover an unprofitable company will simply cease to be. In the case of the pharmaceutical industry, where development and manufacturing are both necessarily highly costly and highly specialized, reducing profitability is potentially harmful to all. To develop pharmaceutical products is to invest millions into an enormously high-risk venture, relying upon the product to pass scrupulous safety and efficacy testing, carried out at great expense to the developer - estimates of overall cost vary from 500 million to over 2,000 million dollars [10]. What does this mean in the context of ARTs?
Drug development for diseases that predominantly affect the developing world is already a precarious business. We see in the case of orphan drugs [11], incentivizing companies to invest in research and development (R&D) for rare or unprofitable diseases is expensive and costly in diplomatic reserve on the part of governments or organisations involved and is rarely successful. Consistently it is apparent that pharmaceutical companies will only invest into R&D for diseases which are considered profitable. To waive patents for ARTs in the developing world would be to wave a banner saying investing in HIV in the developing world is to pour money down the drain- worse, to pour money into your rivals' pockets. It can be argued that the developing world represents an insignificant fraction of the market for ARTs, and that the profit from patents in the developed world would continue to support research and development. There are two problems with this analysis: firstly, the numbers do not hold up. Sub-Saharan Africa alone has over 22.5 million patients infected with HIV compared to 860,000 in the whole of Western Europe [3] - even with poor access to ART, the developing world represents an incredibly significant fraction of the market. Further, only approximately 5.3 million people out of a possible 14.6 million (36%) eligible patients in low and middle income countries received ART in 2009 [12]. This compares to approximately 50,300 out of a possible 64,600 (78%) eligible patients receiving treatment in the UK in the same year [13]. Clearly, the developing world currently represents the largest potential marketplace for ARTs.
This brings us to the second problem: as we have already seen in the guise of heat-resistance, problems exist in many developing countries that do not in the developed world. To chip away at profit in the developing world is to disincentivise those best placed to tackle these problems from attempting to do so. Finally, a patent waiver would send the message that treatments which primarily benefit developing nations can never be profitable - hence undermining efforts to encourage investment in this sector. Waiving patents in these countries could be a devastatingly short-termist approach to the problem, in the long-term harming those it is intended to help. There is direct evidence of the harm that can be wrought by a patent waiver - in 2007 Abbott (the world's 10th biggest pharmaceutical company) were so angered by Thailand's decision to ignore patents that they did not apply for licenses to sell their latest products there, one of which was a new heat-resistant formula, which would have been particularly helpful for the hot South East Asian climate.
In the long-term, then, money certainly seems to be the primary problem. But is it the case, as it has been contended, that the cost of ARTs is the greatest barrier to their effective distribution? And are patents to blame for this? There is evidence to suggest that the answer to both of these questions is no.
The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement between World Trade Organisation (WTO) member countries was the first international agreement on intellectual property law. Among other outcomes, TRIPS stipulated that member states respect patent law. Although all provisions apply equally to all members, developing countries were given a transition period, until 2016, before changes to their domestic laws regarding pharmaceutical patents need to be put in place [9], and many countries made use of the transition period. We thus have a model within which to examine the effects of a system whereby patents are enforced in the developed world but not in the developing world. One study examined the patent-status and accessibility of 15 different ARTs in 53 African countries in 2002 and found that the drugs were patented in very few of those countries (median 3; mode 0)[14]. The accessibility of ARTs did not correlate with patent coverage. This suggests that, while the "Big Pharma" giants offer an appealing scapegoat for a global tragedy, the situation is far more complex than it first appears and indeed waiving patents may not be as effective as proposed. The barriers to ART in the developing world are many, and while drug cost is certainly an enormous issue, some developing countries have shown that gains can be made without the drastic and potentially harmful course suggested by the proposition.
This brings us finally to some of the alternative targets for intervention. One of the many difficulties in successful ART is the risk of resistance to first-line therapy developing. Resistance develops most rapidly in the context of unplanned interruptions of treatment, often a consequence of poorly managed procurement strategies in developing countries [15]. Malawi provides us with an excellent model [16] for coping with this problem: developing a nationwide standardized program of therapy simplifies the process of matching supply to demand and of eventual distribution. Another advantage of this system is that it reduces the need for medically trained staff, who face an overwhelming patient to staff ratio in many developing countries. Lay staff can relieve this burden and provide effective care in regions with limited medical resources.
Improving access to ARTs in the developing world is an indisputably important goal. However, to target patents is to miss many of the true barriers to ART access and, in the long-term, may be seriously detrimental. While less intuitively attractive, the application of many smaller, fine-tuned changes such as those to national HIV/AIDS strategies has been a more effective and practical alternative.