Dallas Buyers Club

This article deals with the politics and the various debates involved in the field of pharmaceutical industry in reference to the lifesaving medicines and treatments. It is hardly a contested fact that there is something wrong in the way the Food and Drugs Administration (FDA) and the pharmaceutical industry works; keeping in mind that the prime objective of both the institutions is a moral one, one that involves the lives of many, i.e. insuring proper health and access to life saving drugs. Let us now take a glimpse at the story of Ron Woodroof, also shown in the Oscar winning movie, Dallas Buyers’ Club (2013), to have a basic understanding of the topic.
Ron Woodroof was confronted with his mortality after he was diagnosed with AIDS. AIDS

is almost 100% terminal if left untreated but antiretroviral drugs (ARVs’) and treatment may convert it into a chronic, yet controllable disease that would be more like diabetes or blood pressure.

Ron Woodroof then went to the hospital for his treatment but found out that the medicines he was administered were deteriorating his health even further. He then had almost no faith in the hospital staff and in the medicines he was administered and then he decided to make his own way. He started smuggling and taking illegal drugs from all around the world and found out that he was responding very well to the drugs he was administrating himself. He says that the government and the pharmaceutical companies are trying to make money by limiting the number of AIDS medicines in the market and thereby playing with the peoples’ health. He then started Dallas Buyers’ Club, a club that provides illegal medicines to people suffering with AIDS. The Dallas Buyers’ Club has smuggled as many as 112 drugs that are illegal in the United States. During Ron Woodroofs’ time, the drug called AZT which was once considered illegal in the United States itself was administered to him. But Ron Woodroof and thousands of his customers preferred taking a drug called dideoxycytidine (DDC) instead of AZT. Later, years after Ron Woodroofs’ death, AZT was found to cause nerve damage and the doses of AZT was gradually

lowered down. Also, the use of DDC in the treatment of AIDS was allowed. So, in a sense, Ron Woodroof was right in his actions, in his smuggling the then illegal drugs, as it saved the lives of many people suffering from AIDS. This story raises a number of issues. Why did the FDA not take such a step before? Was it because of the fact that the big pharmaceutical companies (also referred to as the “Big Pharma” was not able to make money out of DDC then? Why did the government and the Big Pharma not listen to the buyers’ club? One thing is for sure that many lives were risked and many deaths were caused because of the time the government took in legalizing DDC. This presents before us the first debate, the government v. the buyer’s club. Ron Woodroof always had this discontent in his mind that the government lacks in taking action when it is most needed of them to take. But why did the government keep quiet when it was most needed of them to respond. It is also to be noted that no clarifications or even a simple apology was not given by the government for their inaction. There is clearly something fishy in the way the government and the pharmaceutical industry work.
THE DEBATE OF LIMITS OF PATENT RIGHTS
The second debate is the debate of limits of patent rights. ARVs (anti-retro viral), for example, are needed to cure cancer. These ARV drugs, which need to be taken for life, have been widely available in the United States, but have been, because of the cost, "out of reach for most of those living with HIV/AIDS around the world.” "In 2000, the average worldwide price for patented ARVs was more than $10,000 per patient per year." Today, the same medicine sold in generic form costs as little as $168 per patient per year. For example, because the ARV medicines have not been patented in Guatemala yet, generic competition has decreased the prices of ARV medicines, enabling better access to essential medicines. The generic drugs cost $216 per person per year, while the brand-name drugs cost $4,818 per person per year. However, as developing countries enter free trade agreements that include intellectual property protections, access to these life-saving generic drugs may be obstructed, increasing the number of HIV/ AIDS related deaths. According to humanitarian organizations such as Oxfam and MSF, strict intellectual property rights will prevent developing countries from gaining access to generic drugs for their poorer patients. To address the public health crisis, availability of affordable antiretroviral medications in developing countries is necessary. But with more stringent intellectual property policies in bilateral agreements, prices of these medicines will increase enormously. Supporters of access to generic medicines argue that "essential drugs are not just another consumer product but a human right, and that patients are injured by patents.”
The Agreement on Trade-Related Aspects of Intellectual Property Rights ("TRIPS") gives member countries some flexibility for patent protection. However, with the latest implementation of the Dominican Republic-Central America Free Trade Agreement ("CAFTA"), drug companies face a barrier in manufacturing generic drugs. These intellectual property protections will probably prevent access to affordable, generic drugs necessary for patients in the participating developing countries.

THE TRIPS v. CAFTA DEBATE

To understand the limits of patent debate it is also important to understand the TRIPS v. CAFTA debate. In developing the TRIPS agreement, the drafters' focus was to create universal standards for patents on pharmaceutical products. However, CAFTA may disturb this international uniformity of patent protection for pharmaceutical products because it sets different, narrower standards.
Because of the pressure from developing countries and non-governmental organizations, in November 2001, the WTO convened in Doha, Qatar to address the public health initiatives." The WTO Members adopted a separate interpretative statement called the Declaration on the TRIPS Agreement and Public Health ("Doha Declaration"), where public health commitments were solidified. The Declaration stated that the "TRIPS Agreement does not and should not prevent members from taking measures to protect public health.” The Declaration also gives the developing nations the "right to protect public health and, in particular, to promote access to medicines for all.” In addition, the Declaration benefits the developing countries by extending the deadline for enacting the TRIPS provisions. Thus, TRIPS, as modified by the Doha Declaration, now provides safeguards for generic drug manufacturers to produce cheaper and accessible medicines. However, the latest CAFTA Agreement provides for stricter intellectual property provisions that would limit the public health commitments set forth in the Doha Declaration and foster the HIV/AIDS epidemic in Central America and the Dominican Republic.
On the other hand, proponents of CAFTA also have something interesting to say.

Terry McGraw, Chairman, President and CEO of The McGraw- Hill Companies, testified before the Full Committee of the House of Ways and Means that CAFTA will benefit the U.S. markets and advance the competitiveness of the CAFTA signatories' industries and the development of a stronger, more stable hemisphere. He further stated that CAFTA is the next logical step to promote stability and democracy in the Central American region and is a symbol of U.S. support and engagement in open international markets. McGraw also testified that CAFTA's strong intellectual property rules are critical to promote innovation and new research. Though the CAFTA Agreement may promote better research and development in the pharmaceutical industry, the consequences are detrimental to the participating nations' public

health.
Specifically in the pharmaceutical industry, CAFTA proponents support the free trade agreement for many reasons. The major pharmaceutical companies (commonly known as Pharma) believe that they should be rewarded for innovation and the risk-taking efforts in researching and developing the essential medicines because the research is quite expensive and very time-consuming. Furthermore, drug companies believe that patent protections are necessary for the company to recoup the cost of investment for the innovation of new drugs.
CAFTA proponents put forward the argument that the generic drug companies getting a free ride are detrimental in many levels. Because they cannot provide the upfront expenditures for research and development, generic drug manufacturers "piggy back" on Pharma companies by relying on Pharma's costly test data. As a result, the generic drug companies do not have to repeat the expensive and time-consuming research in developing the essential drugs. Thus, these manufacturers could produce the same drugs at a lower cost for patients in need.
But proponents of CAFTA claim that it would be unfair to allow generic drug companies to obtain a free ride and use the pharmaceutical companies' test data in developing cheaper medicines. Moreover, if generic drug companies can easily copy the products of drug research, the economic incentive to conduct new drug research is greatly diminished.
Essential drugs are not just another consumer product but a human right, and that patients are injured by patents. After comparing the provisions of the CAFTA and TRIPS
Agreement, one sees that CAFTA would extend the monopoly rights of pharmaceutical companies, delaying or limiting the introduction of generic competition. "According to medical humanitarian groups such as Oxfam and MSF, CAFTA's intellectual property protections will give monopoly-like status to high-priced, brand-name drugs in poor markets, potentially killing off generics" in Central America and the Dominican Republic. Patent protection is supposed to reward innovation, but stricter intellectual property protections can oust other competitors and eventually reduce innovation, which contradicts the core purpose for intellectual property protections in the first place. Additionally, there may be enough incentives already for drug research and development that CAFTA is just excessive. The government may offer research grants, tax benefits, public-funded research, etc. At least these big drug companies should consider these incentives for research and development. Patent protections through the strict CAFTA provisions should not be the only alternative to fund their expensive research and development. Even if drug companies do not overstate the need for more rewards, society should accept less innovation to distribute drugs to poor people. Also, to protect the big pharmaceutical companies, five years of market exclusivity may be reasonable to compensate for their data testing. Better quality drugs and research of the essential medicines are necessary. But once a drug is approved and protected for at least five years, the drug testing data should be made available for the generic drug companies to develop affordable drugs for the poor.

CONTINUING ON THE LIMITS OF PATENT RIGHTS

The moral justification of the patent rights comes from two primarily claims:
(1). The first argument is the fairness or justice argument which says that those who spend time and money on developing a particular product or an expression of an idea deserves a chance to receive compensation if their product is useful and beneficial to others who are willing to pay for it.
(2). the second part of the argument is based on consequences. It states that unless developers are allowed a period during which to recoup their investment and make a profit, the incentive to produce new products beneficial to the society will be greatly reduced.
Both these arguments serve as the manifold arguments of the pharmaceutical industry and are mainly used by them against their critics. These arguments do have weight in them, but what they lack is a proper dialect with their critics.
Taking one step further, the industry then make and use laws to protect their interest and serve them with profit so that they can develop new medicines. Thus they defend their techniques to extend the time before which generic drugs can be introduced, to extend patent protection on an international level through institutions such as the WTO, to produce me-too drugs or drugs which are only marginally different from the existing drugs rather than concentrating on the breakthrough drugs. Along with all these, the industry also conducts give away programs so as to appear moral and ethical.
On the other hand, the moral analysts argue on the point that access to health care and life saving treatments and medicines is the basic moral duty of the pharmaceutical industry and the industry is not able to serve that. This lack of dialogue between the two sides results in extremists in both the sides which weakens each of their claims. The lack of communication arises because both the sides speak different languages. The moral analysts speak in terms of morality and ethics. On the other hand, the industry speaks the language of law and economics. What is needed is a proper dialogue, a moral justification. The giveaway programs are just the social responsibility of the pharmaceutical industry; it cannot be the moral backbone of their actions. Also, it is difficult for any government to represent both the consumer and the industry, and the public’s trust in the government is already weakened when that industry is pharmaceutical industry, which is alleged to be the biggest lobbying group in any country.