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Access to Medicine: Moral Imperative and a New Consciousness Part 3
- 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

This series of articles has explained how the HIV/ AIDS epidemic brought “access to medicine” to the forefront of public debate, what the “human right to health” means, and how we might begin to identify the illnesses that trigger this right.

Now we ask, which medicines can we identify as “essential”? Are there some medicines that are not “lifesaving” as such, but that nevertheless should be accessible by everyone? For example, should we also provide access to medicines that help to relieve chronic pain and suffering, some of which may over years shorten a lifespan? Who gets to decide when the “new and improved” version of a patented drug should become the standard for all? Defining “essential medicines” is clearly a challenge as this also requires a multiple of decisions, including a judgment on what illnesses are to be prioritised in treatment.

In that regard we will also discuss how our societies as well as economies could be improved if medicines to address a broader range of conditions were available to all. From a purely utilitarian perspective, healthy workers are simply more productive.

Defining Essential Medicines
Although one can persuasively, and morally, argue that all people have the right to receive the same medical services throughout the world, it is not feasible --- and it costs. For example, medicines for a given illness can have different levels of quality, efficacy and safety, terms that are not simply words in the abstract but have clearly defined clinical meaning. Does every person have the right to the newest or best version of a particular medicine? Ideally yes, but pragmatically it is not possible.

Moreover, advances in drugs, even minor ones, in any of those areas for which companies invariably seek patent protection, is costly and often demands extensive research. Insurance companies argue that they should not have to pay for the added cost of marginally improved drugs and may well not list them in drugs approved for insurance coverage and payment. Providing all desired medicines to all patients is a worthy goal, but unfortunately not a realistic approach or objective to access to medicine.

Rather, specific medicines must be identified that set the floor for what should be provided to all patients, no matter in what country they live in. The World Health Organization has established a list of drugs that are essential to the basic health needs of most people, the “Model List of Essential Medicines. These medicines were selected on the basis of four criteria – (i) the prevalence of the disease which they treat, (ii) evidence of the efficacy of the drug, (iii) evidence of its safety, and (iv) the drug’s comparative cost-effectiveness.

The Model List includes very few patentedprotected drugs, other than a number of AIDS drugs. Some organisations have challenged the contents of such a list and claim that the fourth criteria has excluded the most innovative or patented protected drugs from making the Model List.

Further, other than national life span tables and the disability-adjusted life expectancy measurement discussed below, there is no objective measurement of what constitutes such essential needs from a quality of, or productive, life approach. There appears, however, to be a consensus that the pressing or priority health needs of poorer nations at this stage of their development can, barring an emergency, be satisfied by generic drugs and drugs that address neglected diseases, which are neglected for the simple reason that they on the whole affect people in nations which cannot afford the cost of discovering medicines that cure such illnesses. It is important to note, however, that research into drugs to treat neglected diseases, and, accordingly, the availability of those drugs is not sufficient as it is still too charity- or aid-dependent. Such an approach has shown itself in practice as not a sustainable form of funding over time.

Such nations as Thailand and Brazil, which are viewed as middle income nations, do not agree with the standards set by WHO’s essential medicine list and demand a higher level of medical or drug care for their citizens. This contrary view underscores the fact that there is no consensus on what constitutes sufficient basic medical care that satisfies a nation’s human rights commitment.

Brazil has used the threat of compulsory licensing in its negotiations with pharma companies for access to patented medicines (although so far it has issued only one compulsory license). Thailand has been more active. As discussed by Jamie Feldman in a 2009 article, in 2007 Thailand controversially issued a compulsory license for Plavix, a blood thinner used to treat heart disease that was patented by Sanofi-Aventis and Bristol-Meyers Squibb.

In 2008, Thailand also issued compulsory licenses for cancer medications, Sanofi’s Taxotere, Roche/Genentech’s Tarceva, Novartis’ Femara, and Glivec/Gleevec, as discussed in Nicholas Zamiska’s 2008 article in the Wall Street Journal.

Heart disease and cancer do not share the same characteristics as other diseases such as AIDS more typically considered appropriate for compulsory licensing. Specifically, although heart disease and cancer can result in death, they are not contagious. Thailand had stepped outside of the type of diseases and essential medicines usually at the center of the access to medicine debate.

Consequently, the United States added Thailand to, and has maintained it on, the US “Priority Watch List,” a ranking of serial violators of intellectual property, which also covers patented pharmaceuticals. In turn, the United States has been criticised by non-profit organisations such as Medecins Sans Frontiers for penalising Thailand in this way.

Chronic and Debilitating Diseases and National Stability
The WHO list seeks to set a floor for essential medicines, but is a universal list of medicines the standard to judge whether a government has fulfilled its human rights obligations under Article 12 of the Social Covenant? Should medicine to treat chronic, debilitating diseases that are not deadly also be regarded as part of a government’s human rights obligations? Chronic diseases, such as arthritis, are prevalent in developed countries as well as in developing nations. With their physically debilitating effects, they sap a population’s energy and a person’s ability to work productively and to function as a participating citizen.

In the view of many human rights activists, medicines to treat chronic debilitating diseases should also be included in any essential medicines list. Many of the drugs for these diseases are still subject to patent protection, and access might well require the imposition of compulsory licensing.

Addressing these debilitating, but not deadly diseases, may be necessary for a country to alleviate its poverty issues, to aid its development and spur and grow its economy. Klaus M Leisinger, the recently retired chair of the Novartis Foundation for Sustainable Development, made the following statement in a 2008 article, “Corporate Responsibilities for Access to Medecines”:

Poor health is not only a consequence of poverty but also a cause…An individual’s state of health determines their ability to work, his or her labor productivity, and therefore earnings…For poor people, the health of their bodies and minds is a critically important asset – often their only asset. And vice versa: People’s abilities to manage their own lives, to develop their assets, and to learn and make use of their skills and knowledge all depend heavily on their state of health.”

An economic argument can be made that access to medicine for debilitating diseases is necessary at every level of the value chain. David Barnard, Professor of Palliative Care and Medical Ethics at the University of Pittsburgh explains in an article, it is essential “to preserve a healthy labor force for the extraction of natural resources and manufacture of products for purchase by the developed nations, to preserve economically viable markets for the export of the developed nations’ goods, and to protect the populations of developed nations from the spread of dangerous infectious diseases.” Moreover an economically viable nation is normally a more stable and peaceful country. Through this rationale, developed countries as well as companies outside of the pharmaceutical industry have an economic and commercial stake in providing access to medicine in least developed countries.

This basic principle also might contribute to understanding why access to medicine has been recognised in the least controversial instances, such as the push to treat AIDS. The AIDS epidemic created all of the problems mentioned above – unhealthy labor force, economically unviable markets, and the spread of disease. In contrast, cancer and heart disease, for which compulsory licensing was highly controversial, typically do not. This justification for access to medicine does not require that a disease be deadly to demand treatment.

Keeping a country healthy helps that country develop economically and politically. If a country can reduce its poverty level, the poverty-related causes of disease will also be reduced. Supporting development and reducing the real causes of disease, as opposed to simply providing medicine, will also invariably increase investment and trade because a healthy country is a potential growth market. This growth will benefit other countries that would wish to trade with that country, reduce aid, or that rely on the country’s workforce.

This logic of enlightened self-interest could motivate developed countries and international corporations to recognise that it is commercially necessary to provide access to medicine for chronic or debilitating diseases that affect large portions of a developing country’s population.

Moreover, it is of note that 12 of the 20 nations heading the list of states in the Fund for Peace Failed States Index are also among nations that have the lowest health-adjusted life expectancies (HALE). The HALE is a disability-adjusted measurement where years of life are weighted by health status, and it is commonly used by the WHO. Although not a perfect correlation, one can conclude that populations in nations afflicted with poor health do not have the energy to establish and maintain good governance institutions in their countries. Although not all poor health states are necessarily threats to international peace, it should be of concern that a fair number, including such now well known conflict-torn nations as Afghanistan, Somalia, Sudan and Yemen, are. Accordingly, international political self-interest should also motivate the US and other developed nations to significantly improve the health situation in such nations. But the connection between health and international security is still a little studied or understood concept.

Thus far, we have discussed what medicines a country should provide in order to satisfy its human rights obligations. In the next issue, we turn to the question of who should or will pay for these necessary drugs.