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Access to Medicine: Moral Imperative and a New Consciousness Part 2
- Jenik Radon, Adjunct Professor of International and Public Affairs, Columbia School of International and Public Affairs
- Maree Newson, Associate (NZ Qualified) Radon Law Offices, New York

What would it take for every person to have access to life-saving, life-improving drugs when they needed them, at a price they could truly afford? This series of articles explores the issues around making “access to medicine” and in particular, access to medication, a reality.

In Part 1, we introduced the concept of “access to medicine” as a human right, and discussed some of the key international agreements and decisions that have helped to bring the debate into the public eye. In this issue, we start to address one of the practical issues for realising those rights: what illnesses trigger, or should trigger, the obligation to provide access to medicine?

In relation to certain diseases, over the past decade, there has been a major change in the way the pharmaceutical industry regards access to medicine.

Many agree that the pharmaceutical industry should provide access to critical medicine, but which medicines should be the focus of such efforts? Society is still in the midst of an intense debate on this issue for a number of reasons, in particular it raises the issue of how to finance the high cost of innovation, and a broad consensus is needed for any workable answer.

Rather than proposing an answer, this article focuses on the most important questions that arise, which need to be addressed to build this consensus.

AIDS and HIV in Developing Countries
There has been a significant shift since the South African PMA lawsuit in 1998, discussed in our previous article, to the public and private resources available today to buy AIDS medicine. The Global Fund for AIDS and the President’s Emergency Programme for AIDS Relief are two examples of new initiatives to finance research into AIDS medicine and subsidise the cost of AIDS medicine. In fact, the pharmaceutical industry itself is now developing programmes to deliver medicine to low-income countries and patients that could not otherwise afford life-saving drugs. The shift in the pharma industry’s perspective on this issue demonstrates that this disease is one instance in which the “access to medicine” campaign has gained traction. But why? What characteristics of the AIDS epidemic led to the public’s rejection of the PMA plaintiff’s claims and to the widespread acknowledgement that there is a moral imperative to supply these drugs?

The best clue to what characteristics of the AIDS disease requires access to medicine can be found in the brief submitted by the Treatment Action Campaign (TAC) in the PMA lawsuit. In its Replying Affidavit, TAC repeatedly emphasizes the extent of the HIV/AIDS epidemic and the life-threatening nature of HIV, citing its “epidemic proportions and catastrophic effects.” Although TAC “denies any suggestion that the constitutionality of government measures to make essential medicines more affordable depends on the number of people whose rights to dignity, life, and health care are thereby protected. In any event… in the realm of HIV/AIDS, these numbers are vast.” Indeed, although a right to health care may not hinge on how many people are affected by a particular ailment, the size and extent of the AIDS epidemic doubtlessly played a role in the world’s recognition of the importance of this health issue.

Looking beyond the contours of the TAC brief, there are other clear reasons why combating AIDS is a concern for people around the world. AIDS affects people universally, in both developing and developed countries. According to the WHO’s 2011 report, around 34 million people are estimated to be living with the disease. Of that number, more than 97 per cent are in low- and middle-income countries. 69 per cent of people living with HIV in the world live in Sub-Saharan Africa.

Importantly, AIDS is capable of crossing political borders and, although transmission can be controlled behaviorally, it continues to spread. In many countries, as was the case in South Africa in 1997, the number of people affected by AIDS was large enough that the disease had a destabilising effect on the economy and hindered development. People who were sick could not get treatment because patented drugs were too expensive for South Africa’s health care system, and South Africa’s economic situation was unlikely to improve without a healthy work force. The characteristics of AIDS that create a moral imperative to ensure access to medicine may be summed up as: AIDS is deadly; it crosses borders and can cross borders freely; it affects a very large group of people; and these people cannot afford to pay for the medicine.

Anthrax Scare in the United States
Treating AIDS in the developing world seems to be the most universally accepted instance in which there is a moral imperative to provide access to medicine. But these same arguments for access permeate pharmaceutical sales related to many other diseases and other markets as well.

A 2001 dispute over compulsory licensing in the United States demonstrates that the wealth of the country may not always be an important consideration. In October 2001, the United States faced a potential anthrax attack. Ciprofloxacin (Cipro), the antibiotic drug prescribed for treating patients suffering from anthrax, was under patent until 2003 and was owned by the German drug company, Bayer. As documented by Kavaljit Singh in a 2002 article, the retail price for two months’ treatment of Cipro in the United States was over USD 700. Bayer also reported that, at most, it would be able to make 200 million pills in two months, much less than the 1.2 billion pills requested by the United States. As a result, some people in the US would not be able to afford Cipro at this price; other people who could afford the medicine might not have had access because of the limited supply. Senator Charles Schumer and health activists including Ralph Nader and James Love (who was cited in TAC’s brief in The Pharmaceutical Manufacturers’ Association of South Africa, et al. v. South Africa, in the High Court of South Africa, Case Number 4138/98) called for the United States to begin compulsory licensing of Cipro. Although the Bush Administration refused to suspend Bayer’s patent rights, this push for compulsory licensing may have been that hidden hand that contributed to negotiations with Bayer that ultimately resulted in a reduced price for Cipro.

A widespread anthrax outbreak shares certain characteristics with AIDS that may similarly raise it to an emergency level – it is deadly, hard to contain, and potentially destabilising. The controversy over whether the United States should respect and enforce Bayer’s patent rights, demonstrates that compulsory licensing is not a tool reserved solely for the least developed countries. Rather, wealthy nations can also face health emergencies that could require suspending patent rights. The second lesson drawn from this episode is that, although rarely applied, compulsory licensing is often used as a negotiating tool to reduce the price of patented drugs. The success of using the threat of compulsory licensing to lower drug prices seems to depend on how politically powerful the country wielding the threat is. Unfortunately, as a negotiating chip, compulsory licensing would then make more of a difference for wealthy countries than for poor countries that lack significant international political power or influence.

As evidenced by the Cipro example, a government will use compulsory licensing directly, or indirectly as a negotiation tool with private pharmaceutical companies, in situations where there is a perceived national medical emergency. Even the United States, which traditionally relies on economic market mechanisms to resolve problems and has a culture of respecting laws and the written word, is not able to always resist the pressures to apply the threat of compulsory licensing to patented products. However, if a national moral imperative for acquiring access to medicine at affordable prices is limited to crisis situations, then the extensive medical needs of non-developed nations can never be adequately addressed. So the lingering question is: Should access to medicine be more than a medical emergency response?

In the next issue, we look at medical access for those suffering from nonterminal conditions, and the positive social and economic, and even security, impacts that this could bring. Later in the series, we also discuss different models for funding access to essential medicines, and the opportunities that arise from the unique role and responsibility of pharmaceutical companies, doctors in all but name.