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Access to Medicine: Moral Imperative and a New Consciousness
- Jenik Radon, Adjunct Professor of International and Public Affairs, Columbia School of International and Public Affairs
- Maree Newson, Research Associate, Vale Columbia Center for Sustainable International Investment, Columbia University

This series of five articles will address the main issues of the seemingly unending debate, beginning with an introduction of the key concepts and the international agreements that establish, or seek to establish, access to medicine as a human right, and, in the last article, offering a way forward.

The phrase “access to medicine” has become a catch-all, a mantra and a demand. Supporters want it to become a human right, taking its place along with freedom of speech and freedom from genocide. But it is not clear what the right of access to medicine exactly means or how it can be implemented.

Access to medicine has become a headline phrase ever since 1998 when the South African Pharmaceutical Manufacturers Association (PMA) and 39 pharma companies sued the government of South Africa (The Pharmaceutical Manufacturers’ Association of South Africa, et al. v. South Africa, in the High Court of South Africa, Case Number 4138/98). These companies challenged the validity of a South African law that aimed to control South Africa’s AIDS epidemic by importing generic versions of AIDS medicines without the consent of the patent holders.

The pharma companies vowed a worldwide legal fight to keep sole control of their intellectual property rights related to these medicines; and they lobbied the US government to support their commercial and legal position. But ultimately, after three years, they retreated under what had become unrelenting negative publicity.

Although access to medicine had been pragmatically codified earlier in 1994 in the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS), the phrase had not yet evolved into a clearly-defined legal concept at the time the pharma companies instituted their lawsuit. Moreover, despite the continued notoriety of this expression and its frequent invocation, there is still no generally accepted agreement to its meaning or scope and it continues to elicit heated debate. The term raises a host of conceptual, commercial and practical questions, as well as, of course, ethical questions.

Access to Medicine: What Does it Really Mean?
Does access to medicine mean that every person has a right to be treated by a doctor, to be admitted to a hospital, and, the focus of this series of articles, to receive the necessary drugs? Does this apply irrespective of the cost thereof? Are all persons entitled to the same standard of care and receipt of the same medicine, irrespective of income or citizenship? Pharma companies, which have been the primary focus of access to medicine campaigns by NGOs throughout the world, dedicate their business to a very basic and fundamental human concern, namely health. Does this focus give rise to a special societal obligation, or does even impose a burden, to provide their drugs to those in need, no matter where in the world, even if at below cost?

There is also the related question of how does one calculate the cost of any drug, especially if it based in part on the work of publicly funded research? If so, exactly why do pharma companies have this burden and manufacturers of other lifesaving necessities such as ambulances do not? Moreover, do states and their governments have any public obligations to provide necessary drugs to their citizens? And if so, how and at what cost? Does an economically developed country such as the US have an obligation to help a poorer state secure access to medicine for that state’s citizens?

In order for pharma companies to remain profitable and continue their drug research, should citizens of developed nations, especially the US and EU nations, pay more than citizens of developing nations for new and innovative drugs protected by a pharma company’s patents? Specifically, is access to AIDS medicines a somewhat special situation, as those, afflicted by AIDS would surely die without such medicine? If access to AIDS medicine is the standard by which all other cases are judged, how should arthritis, a disease perceived to be “only” debilitating, be addressed?

An endless number of practical and ethical questions continue to be raised. And the answers to these questions cannot easily be separated from the emotions they evoke. But they must be openly addressed.

Underlying the above questions is a growing consensus that a moral imperative exists to provide appropriate medical drugs to the people of developing nations, as well as of course to poor or poorer people of developed nations. Of course, even that consensus demands that fundamental questions be addressed and answered:
1) Do all drugs have to be provided;
2) Do the drugs have to maintain the same quality or efficacy as those provided in developed countries;
3) At what prices can or should such drugs be provided;
4) Does the pricing have to be uniform or can it be differentiated; in other words, can a system be developed that standardises different pricing for different countries and perhaps even within countries; and
5) Perhaps most challenging of all, who pays for the development of new drugs?

After all, the development, production and provision of drugs, especially new and innovative ones, impose a significant cost that must be borne by someone. Some of these concerns could potentially be addressed by structuring an appropriate worldwide incentive system to encourage expenditures on continuous drug R&D, manufacturing challenges and costs, and regulatory requirements, which are all necessary parts of developing new, improved drugs. However, this ideal incentive structure remains elusive in practice and is often addressed in terms of rhetoric rather than data.

A viable business model requires the price of any new drug to compensate the research organisations, including pharma companies, for all the costs of their research and development, including research on other products that did not yield marketable products.

Thus, the most fundamental question concerning access to medicine arises: What are the principles that should guide pharma companies and the rest of society in balancing the competing demands of drug innovation, profit making, and the moral imperative underlying access to medicine?

Will such balance, at least in part, be anchored in modern-day self-interested utilitarianism? After all, unhealthy people and nations do not have the strength to develop good governing structures and have limited capability to prevent the spread of diseases.

These articles seek to establish the foundation for such principles by examining the evolution of “access to medicine” since the PMA v. South Africa lawsuit. This discussion will move closer to determining what “access to medicine” means and how it can be put into practice.

International Agreements and a Landmark Lawsuit
Current international agreements for intellectual property help to define the parameters of what access to medicine can or should be guaranteed. During the Uruguay Round of the General Agreement of Trades and Tariffs in 1994, TRIPS was created to guide international enforcement of patent rights, including those applicable to drugs. Article 7 of TRIPS states that protection of intellectual property rights should promote innovation "in a manner conducive to social and economic welfare, and to a balance of rights and obligations.” Article 8 allows for the possibility of suspending intellectual property rights to protect public health and to promote interest in sectors of socio-economic need.

The 1994 TRIPS agreement, however, has been vigorously opposed in many sectors on the basis that it is not in keeping with international human rights norms. The agreement created many ambiguities as to when and how the World Trade Organization (WTO) members could suspend intellectual property rights to gain access to needed drugs for their nations. In 1998, these ambiguities were tested under a glaring global spotlight. South Africa, the country at the time with the largest population of individuals living with HIV/AIDS in the world, passed the Medicines and Related Substances Control Act in 1997. The Medicines Act was designed to create access to AIDS medicines at prices lower than those the pharma companies’ had set.

Necessary medicine for treating AIDS, including drugs to prevent mother-tochild transmission, antiretroviral therapy, and important antifungal and antibacterial drugs, were all under patent protection and sold at prices that developed nations could pay but were too high for the South African healthcare system.

Section 15 of the Medicines Act gave the Minister of Health the power to allow lower cost versions of these medicines to be imported from other countries, either through compulsory licensing or through parallel importing. Parallel importing is particularly important when a country lacks the capability of producing the medicines itself.

The pharmaceutical industry plaintiffs brought the PMA lawsuit in 1998, which claimed that the Medicines Act violated the TRIPS agreement to enforce patent rights. In this specific instance, the pharmaceutical industry had little to lose financially because they would not have made a profit selling medicine in South Africa regardless. But as a general rule, patent protection is a core principle of the industry, and modern commercial life. The South African law risked setting a precedent that weakened patent protection for new medicines globally.

The High Court of South Africa granted the advocacy group Treatment Advocacy Campaign (TAC)’s petition to file a friend-of-the-court brief. Among other arguments in its brief, TAC demanded information about the cost of producing the medicines in order to better debate whether the industry would be able to make a reasonable profit despite South Africa’s law.

At the same time, the pharmaceutical industry plaintiffs, who were mostly headquartered in Switzerland, UK and the US, continued to receive extremely negative publicity. The plaintiffs were portrayed as greedy corporations from rich nations withholding medicine from dying poor patients. Eventually, the companies began offering their medicines at lower prices, lessening the need for parallel imports or compulsory licensing. Ultimately, in April 2001, the plaintiffs withdrew their complaint.

In November 2001, during the wake of the PMA case and growing concern about access to medicine as a counterbalance to protecting intellectual property rights, the Declaration on the TRIPS Agreement and Public Health was adopted in Doha by the member nations of the WTO (Doha Declaration). The Doha Declaration emphasises countries’ rights under TRIPS to take measures to protect public health and to determine the grounds upon which to grant compulsory licenses and to declare a health related emergency.

In 2005, TRIPS was amended to allow a country that cannot manufacture its own drugs to grant a compulsory license to import drugs from another WTO member country that has the necessary manufacturing capacity. Over the years, TRIPS has focused on trying to balance access to medicine while simultaneously protecting intellectual property rights.

What is clear is that, although legal agreements and cases might define rights or provide principles, applying those rules is very difficult and challenging in practice. In the next issue, we explore one of the most important issues that must be addressed if “access to medicine” is to become a reality and a right: Which illnesses demand a universal response, and when is the right to access triggered?

Later in the series, we’ll also be looking at the costs and distribution of medicines, the pioneering and humanistic decisions of the Indian Supreme Court, and how the pharmaceutical industry can live up to its standard-bearer responsibilities as a universal medical professional, a doctor, literally for the world, in all but name.