11 August 2006

Noises Off At The Patent Law Medicine Show

By Rusty Rockets

For years now we have been bombarded with gloomy HIV/AIDS statistics coming out of developing regions like Sub-Saharan Africa, where, according to the World Health Organization (WHO), 60 percent of all HIV/AIDS sufferers in the world are located. The big question here is why the drugs used to control HIV/AIDS in developed nations have not trickled down to help treat the swelling ranks of HIV infected people in poorer countries. It's a serious issue that is easy to explain but seemingly difficult to resolve, as it involves the volatile interface between Intellectual Property (IP) laws, globalization and global health.

It seems that the pharmaceutical industry and governments can get away with paying lip service to demands for a fairer system that will ensure that poor countries have access to affordable drugs, while at the same time continue to expand global trade agreements and strengthen patent laws. Increasingly, health care professionals, academics and scientists are drawing attention to a change in the way that pharmaceutical companies are doing business globally, claiming that the focus is now on the marketing and distribution of standard products rather than developing new ones. It's the bottom line that counts, say critics. The losers in this new global health care environment are those countries that cannot afford or manufacture enough drugs to combat serious health problems that plague their countries. This is despite pharmaceutical companies and governments arguing that patent law amendments now provide for developing nations facing health emergencies by allowing them to legally use generic drugs. But either due to bureaucratic red tape or the threat of a lawsuit these provisions are difficult to access. Now, two researchers are calling foul in a new policy paper, published in the August edition of PloS Medicine, entitled: "How Do Intellectual Property Law and International Trade Agreements Affect Access to Antiretroviral Therapy?"

Doctors Michael Westerhaus, of Brigham and Women's Hospital, and Arachu Castro, from Harvard Medical School, show that little has changed, and that international patent laws and US-negotiated trade agreements continue to impede access to the HIV treatment known as antiretroviral therapy (ART). "Multinational pharmaceutical companies, World Trade Organization members, US and European Union trade representatives, and health-care activists have clashed over provision of ART to people living with AIDS in developing countries," say Westerhaus and Castro. They also add that these agreements have: "conditioned liberalized trade upon the expansion of IP law for multinational pharmaceutical companies holding patents for ARVs (antiretrovirals), among other essential medicines. Specifically, these agreements extend the protection of patents beyond the 20-year period, freeze generic manufacturing of ARVs, protect the manufacturers' drug testing data for five years (a practice known as data exclusivity), and limit options for compulsory licensing."

Both Westerhaus and Castro have previously been involved in various initiatives to bring greater equality to global health care. As a medical anthropologist, Castro works with infectious diseases such as AIDS, tuberculosis and dengue fever, in addition to reproductive health. The author and co-author of a number of books, Castro will see her Medical Anthropology: Regional Perspectives and Shared Concerns released later this year.

As a master's student in medical anthropology in 2005, at Harvard Graduate School of Arts and Sciences, Cambridge, MA, Westerhaus wrote about his visit to war ravaged Northern Uganda, where AIDS and tuberculosis are rife. Published in the British Medical Journal, Westerhaus' harrowing account revealed a disproportionately high rate of HIV/AIDS in Northern Uganda (12 percent) - predominantly due to institutionalized war - compared with the rest of the country (4 percent). It's an observation that correlates sharply with the WHO's own extensive research, which concludes: "Just as it is inaccurate to speak of a single 'African' AIDS epidemic, national-level HIV prevalence data can sometimes prompt incomplete pictures of the actual state of affairs." Westerhaus noted with dismay the way that tuberculosis and HIV/AIDS treatments in regions such as this were based on a cost-outcome basis, which, says Westerhaus, is a: "sentiment that originates in the formulation of global public health strategies that deem treatment of tuberculosis drug resistance beyond the limits of cost effectiveness." With disdain, Westerhaus argued in 2005 that the neglect shown by rich nations in the face of declining health conditions in certain parts of Africa has become normalized.

As Professor David Henry, Department of Clinical Pharmacology, University of Newcastle, Australia, stated in the Lancet back in 2002: "The international pharmaceutical industry manufactures and distributes many good drugs, displays generosity in its philanthropic activities, and has an important role in maintenance of manufacturing standards. However, evidence shows that companies have shifted their core activities from discovery and development of innovative drugs to marketing of products that keep profit to a maximum in high-income countries."

The shift that Professor Henry described in 2002 has been exacerbated further by the expansion of international trade laws that standardized IP law among World Trade Organization (WTO) members, called The Trade-Related Aspects of Intellectual Property Rights (TRIPS). As a result, say Westerhaus and Castro, public health in low to middle income countries would be considerably constrained, where: "the cost of these treatments far exceeds personal and national budgets, and the development of more affordable generic alternatives is proscribed." After some none too flattering press, and concerns raised by the WTO, it looked as though pharmaceutical companies had no choice but to enter into negotiations that would make some provision for low to middle income nations, where out of the 50 least-developed countries, 32 are WTO members.

Under TRIPS, governments and the pharmaceutical industry have ensured that pharmaceutical companies have a monopoly on the manufacture and distribution of life-saving drugs. So it is a sad indictment that pressure of any sort is needed before pharma companies bear their humanitarian responsibilities. Henry, again in the 2002 Lancet article, stated that while some companies try and ameliorate the inherent inequalities in the new trade systems most have to be forced to the negotiating table to come up with long-term global health strategies. "These moves largely seem to have been in response to external pressures, especially bad publicity and generic competition, rather than initiatives of the companies themselves. Restoration of true market forces and fair pricing of drugs is a better long term solution to shortages than 'ad hoc' donations," explained Henry.

Despite making the right noises, pharma companies in conjunction with the US government have again managed to stymie attempts at a fair deal for low-income countries. Westerhaus and Castro found that while TRIPS eventually made provision for countries to break patents and manufacture their own generic drugs under compulsory licensing (the granting of a license to another producer to manufacture, use, and distribute generic versions of patented inventions without the consent of the patent holder but in exchange for a remuneration to compensate for the reduction of the potential market for the branded sale of the drugs) during public health emergencies, it left those countries unable to produce their own generic drugs vulnerable. The inability of certain countries to produce generic drugs led the WTO to request that the council for TRIPS come up with another solution. The end result was a waiver that would allow such countries to either manufacture their own generic drugs or legally import generic drugs from other drug companies.

The waiver was only ever intended to be a temporary amendment while a permanent amendment was being hammered out. Most of the debate that followed centered on developing the waiver into a more substantial form, but both the African Group and Médecins Sans Frontiļæ½res could foresee significant problems with the waiver, as it involved time-consuming procedural obstacles and had never been tested under real world conditions. Westerhaus says that despite these reservations, "WTO members agreed in early December 2005... to make the temporary waiver permanent if at least two-thirds of the 148 WTO members ratified the amendment by December 1, 2007." The negotiations between the WTO and the pharma industry subsequently ended up looking like a good-cop-bad-cop routine. But despite low-income countries again being the losers in this bureaucratic nightmare, the US government and the Pharmaceutical Research and Manufacturers of America (PhRMA) proclaimed the amendment a coup in regard to ensuring the health and well being of developing and least-developed countries.

But Westerhaus and Castro are yet to find a country that has made use of the provisions added to the temporary waiver, in spite of the fact that many low and middle-income countries are currently facing health emergencies. Why? Some may claim that the governments of these countries are too corrupt to care about their suffering populations, but this would be to ignore the successes of Brazil, Cuba and Thailand, say Westerhaus and Castro. As it happens, the African Group seem to have been right in their assessment of the temporary waiver, when they claimed that the WTO rules are too laden with red tape and too difficult for poorer countries to navigate to be beneficial. Westerhaus and Castro argue that: "When viewed in this light, the humanitarian motives pled by pharmaceutical companies and economically powerful governments can be seen as empty lip service, functioning only to counter growing calls for social justice in global health."

The $64,000 question is: If governments want to free up global trade, then why back trade agreements and an expansion of IP laws that will allow pharma companies to further monopolize the market; especially when it is such a crucial market. Where's that free-trade spirit? Where's the competition? It's a naïve question, of course, especially in light of the response provided by the pharma companies themselves. The main reason that pharma companies give when pressed as to why patents are necessary in regard to life-saving drugs is that without them innovation and the development of new drugs would be severely limited. Westerhaus and Castro say that there is scant reason to believe this line, stating: "there is little evidence that current IP law creates incentives for the development of new drugs. An analysis of a small sample of pharmaceutical inventive activity before and after compulsory licensing showed no uniform decline in scientific innovation, challenging the assumption that patent protection is necessary to foster the development of new drugs."

The new direction in global health is an unfortunate and ugly one, which monopolizes drug markets, yet marginalizes the sick. But both Westerhaus and Castro believe that through: "interdisciplinary efforts, the strengthening of IP law can be effectively challenged in the interests of promoting global health equity." Let's hope that they're right.

AIDS Epidemic Update: December 2005 (UNAIDS & WHO)

"How Do Intellectual Property Law and International Trade Agreements Affect Access to Antiretroviral Therapy?"