PATENTS AND BIOTECHNOLOGY: FROM A SATELLITE LOOKING DOWN AT OUR USE OF PATENTS IN THE GREAT PLANETARY SCHEME OF THINGS
Patents, by Providing more Research and Development, Benefit the People of the World. Well, except for…
Patents allow inventors to have unique access to a market for a set period of time, giving the inventors monopoly control and/or market exclusivity on the sale of their innovation. The monopoly control provided by patents not only provides for a return on the relatively high cost of research and development that went into the innovation, but also provides rather high profits as a result of the monopoly and its duration. Excess profits serve to attract capital investors, who then create jobs in the biotechnology industry, increase the rate of research, and cause new innovations in drug treatments, tests and therapies to be undertaken, subsequently benefiting the people of the world. Well, except for… except for the people who comprise the majority of the world’s population, that is, the socially and economically underprivileged people of the world, who live for the most part in less-developed countries. Because of this, the challenging question was raised by Solomon Benatar in an article addressing human rights and biotechnology: “If drugs for malaria, tuberculosis, many tropical diseases and HIV/AIDS have not been made available to billions in poor countries is it likely that the poor will benefit from advances in biotechnology?”.
Where in the World is the Pharmaceutical/Biotechnology Industry? The Transnational Operation of the Industry.
Pharmaceutical/biotechnology companies cannot be pinpointed to one location as they function as any transnational corporation would; globally. As with any corporation that is transnational in scope, operations are carried out depending on where labor is cheapest, raw materials are the least expensive, where taxes can be most easily evaded, as well as where market regulations are the least strict. As Bodenheimer describes “…a pharmaceutical company might have its corporate headquarters in the United States, produce its drugs in Ireland, assemble its capsules in Brazil, and sell the products in Bolivia” . In his description, the “core” are the regions of capital accumulation, mainly in the more developed countries, and are where the majority of research and development occurs. The “periphery” are described as the exploited regions of the world, the less-developed countries, whose main functions are production and assembly. Institutions such as the World Bank and the International Monetary Fund (IMF) support these corporations by lending billions of dollars to third world elites, who in turn, because of their large debts, support the profit-making of corporations. Unfortunately, profits from these corporate organizations are achieved through decision-making about policies without public consultation that have historically been achieved by introducing policies that harm human-rights, labor rights and the environment, especially in third world countries . The other concerns regarding this set-up are the same as those for any transnational corporation: the mobility of the pharmaceutical industry compared to the relative immobility of governments means that because the industry is seeking out the cheapest labor and the lowest taxes, governments have few means of maintaining stable employment and collecting required taxes .
Not only is the pharmaceutical industry difficult to locate in any single place around the world, it is also difficult to isolate from other transnational capital, a characteristic of its world-wide pervasiveness and strength. Interlocks, mergers and acquisitions, serve to make the industry a force indistinguishable from other transnational capital such as that of oil companies, Coca-Cola, and even the New York Times [2,3]. In this sense, the transnational pharmaceutical industry is, overall, difficult to discuss tangibly and as a separate and distinguishable entity, requiring it instead to be addressed along with other transnational capital. Although it is referred to here as the pharmaceutical industry, it is important to keep in mind this lack of disctinction to better understand how the industry operates.
Patents and Social Responsibility…
The Corporate Struggle to Prevent Antiretroviral Accessibility During an HIV/AIDS Crisis in South Africa.
In many cases, governments themselves may be acting on behalf of the pharmaceutical industry. In the United States during the 1997 to 1998 election campaigns, the pharmaceutical industry spent almost $12 million in soft money, Political Action Committee and individual pharmaceutical company campaign contributions, according to the Centre for Responsible Politics . These large contributions came at a time when the U.S. government was supporting the pharmaceutical firms in abolishing the health initiatives of the South African government that made the antiretroviral drugs more accessible to South Africa’s population. Antiretroviral drugs are drugs that target HIV, have the possibility of prolonging infected people’s lives indefinitely and as well, have been shown to drastically reduce the transmission of HIV from mother to child. Drugs that fight HIV/AIDS, although being physically close to the many millions of people living with HIV/AIDS in South Africa (the subsidiaries of international pharmaceutical firms produce these drugs in South Africa), are far from being accessible financially to infected people and their families. This is still true now despite the fact that in April 2001 the 39 pharmaceutical firms suing the South African government for patent violations, finally dropped their case . Bond has published a report and analysis on the situation in South Africa from 1996 to 1999 in the International Journal of Health Services and his report is discussed in this section to highlight the role of globalization on the health of poor people . The “Medicines Act,” established in 1996 in South Africa, included an Essential Drug List, based on 90-95% of the most common and detrimental conditions, and contained a clause allowing the importation of generic substitutes for the essential drugs specified. This clause included allowing the importation of some of the antiretroviral drugs, for example AZT, ddI and ddC, that had been developed by the U.S. National Institute of Health, and were produced by some of the large pharmaceutical firms. The clause allowing the importation of these generic substitutes was legal according to the World Trade Organization (WTO) Trade in Intellectual Property Rights (TRIPS) rules, and similar measures have often been used by European nations and the U.S. to attempt to import generic substitutes at times of health emergencies, for example during the potential Anthrax threat in the U.S. . This is due to every government’s entitlement to compulsory licenses and parallel imports during times of need. Compulsory licenses allow a product to be manufactured without the inventor’s consent and parallel imports allow it to be bought wherever it is sold the cheapest.
Yet at a time when 25.1 million people out of a total 36.1 million living with HIV/AIDS worldwide lived in Sub-Saharan Africa, with at least 2.9 million living with HIV/AIDS in South Africa in 1997, a lawsuit claiming intellectual property rights violation was issued by the pharmaceutical firms, backed by the U.S. government. This lawsuit tied up the law in South African High Court between mid-1997 and April 2001, and impeded South African peoples’ access to the drugs during this time. In April 2001, finally, a deteriorating public image, in an industry that spends more money on marketing than on research and development [2,4], and international criticism and protest, finally prompted the firms to drop the case . Yet on top of lawsuits, threats of trade sanctions and trade constraints were used against the South African government as the government attempted to install WTO-legal imports of generic HIV/AIDS drugs .
Although funds for research and development were cited by the industry as the reasons they pushed for their monopoly patents, Sanjaya Lall’s studies inform us that where there is inelastic demand for a drug, as would be the situation in this case for a drug involved in a life-threatening virus with soaring new infection rates, the profits earned are so great as to be extremely socially irresponsible . To add to the injustice, the funding for the development of some of the drugs implicated came from the U.S. National Institute of Health, and so from the U.S. population’s tax dollars.
Is This An Isolated Incident?
The evidence tells us otherwise: previously, there had been similar U.S. government threats of foreign aid cuts to Bangladesh in the early 1980’s when Bangladesh attempted to prohibit import of non-essential drugs; then there were trade pressures on Thailand when they attempted to provide affordable antiretrovirals for people with HIV/AIDS . It is obvious that trade pressure and threats of foreign aid cuts by developed countries on less developed ones, make it difficult for governments of less developed countries to implement policies that would make necessary drugs affordable to populations.
To Consume More Than We Need vs. Balancing Health Resources – How Patents and Marketing Measures Work In Partnership
Drug “dumping,” exporting harmful drugs into countries that lack strict drug enforcement, and the excessive marketing of unnecessary or damaging drugs have been heavily documented [4,5] and prompted the World Health Organization to release its list of essential drugs. As the case study of South Africa has shown, it can be nearly impossible for governments to make drugs accessible to their population as a results of patents. While “drug dumping” has been clearly problematic in less developed countries, closer to home, marketing can create a similarly dangerous and/or unnecessary problems of drug over-consumption.
The decision makers in drug purchases are often doctors and not the consumers themselves, so marketing can produce a lack of reliable information or as Lall has put it, “promotion creates powerful monopoly positions, confuses the flow of correct information, may induce inappropriate prescribing and generally leads to considerable social waste” . The reason it is so important that a person’s income not be wasted on unnecessary or expensive drugs is that ill people are more likely to be poor, and expensive medications detracts income from food, adequate housing and other such important expenses. Lall has noted that in the countries where there is a governmental health system (i.e. Canada), the consumer’s identity may also be separate from the purchaser, the state. In this situation, the best interests of society, to balance health expenditures among pharmaceuticals, testing, screening, hospitals, care staff, and other social expenditures coincides with the interests of the biotechnology industry, which is conversely driven by market forces that call for the maximum usage of commodities that will profit them.
Patents and promotion have a common vision – that of establishing and maintaining a secure position of monopoly control. Technological innovations and monopoly patents have provided a way, during periods of economic crisis, which occur after as a result of economic overproduction and stagnation, to render the pharmaceutical industry, what MacKinlay has termed, “almost crisis proof” . Marketing measures serve to establish a monopoly position long after the patent has expired. Periods of low consumer demand in the world economy are dealt with through promotions and patents to insure that the industry remains profitable and suffers minimal setbacks throughout a crisis.
Overall, Lall has also found that the pharmaceutical industry faces little risk in research and development when compared with other industries, yet its pricing policies are based on the monopolistic principles of “what the market can bear” rather than on the socially responsible one of lowering prices after recovering research costs . The fact remains that patents reduce competition. For example, smaller firms that cannot afford the high cost and time-consuming process of litigation will simply sell their innovations to the giant firms for a set amount. This reduces competition and so works in turn to keep the price of drugs and therapies high. As far as health goes, pharmaceuticals and biotechnology really only fit into a continuum of health needs, ranging from good nutrition, adequate housing, clean air and water, to education, and qualified health care workers. Just as a person with limited resources may have to divert income for expensive drugs from that spent on food, lifestyle and other social spending, or else go without medication, the state has an allocated budget for social spending and health care and must divert from other necessary endeavors to fund pricey biotechnology. Either way, as a result of the high prices brought on by patents, impoverished people will not receive necessary medication, or will become more impoverished, or else governments will go further into debt and into economic control of unaccountable organizations such as the International Monetary Fund and the World Bank .
The Ontario government has so far ignored Myriad Genetics Laboratory’s demands regarding breast cancer genetic susceptibility tests. They involve demanding screening for genes only in Myriad’s own labs in the U.S. at about five times the current price; in doing so the Canadian government has thereby “taken steps toward charting a path that balances societal and commercial interests in the area of genomics” . It is important to grasp then, that although for society’s sake high-costing patented biotechnology should be balanced among many other health and social factors, without continual resistance, resources will be allocated in an unbalanced way to biotechnology.
Where are Innovations in Health Headed? North, East, South, West…? The Compass Guiding Scientific Research is Pointing Towards Profit.
“Scientific knowledge emerges from a process that in intensely human, a process indelibly shaped by human virtues, values and limitations… Science is a social enterprise… [and] takes place within a broad social and historical context, which gives substance, direction, and ultimately meaning to the work of individual scientists…”
– National Academy of Science, National Academy of Engineering, Institute of Medicine .
What is driving research endeavors if not the collective needs of people? An economic and political compass is guiding scientific research, driven by the “logic of capitalist expansion” , where instead of accountability to society, research is steered towards earning profits for shareholders. In this way, the research endeavors undertaken by scientists are likely to be determined by market forces rather than real human need. This ideology coincides with the ideology of benefiting society, only at opportune times, or as Mckinlay has termed it: “There is only a ‘coincidental relationship’ between the production of goods and services in accordance with the logic of capitalism and any resulting improvements in the health and general welfare of mankind.” Such forces embedded in the direction of scientific research are exemplified in that: “Sixty six percent of the USA Government’s expenditure on research and development is on military research . Ninety percent of global expenditure on medical research is on diseases causing 10% of global burden of diseases,  and of 1233 new drugs developed between 1975-1997 only 13 were for the tropical diseases” . Not only is most of the revenue spent on research not for the majority of people’s health problems, a large portion of the research is also not even spent on drugs that are new or innovative in the sense that they are useful to society. These drugs, as a result of molecule manipulation, allow patents to be obtained for drugs of no value to society, what Thomas Bodenheimer has dubbed the “me too” drugs . This type of research is uneconomical and wasteful as there is much research needed in other areas of healthcare and social expenditure.
Since the market revolves around research on commodities that can be bought and sold, the importance of research into non-profitable aspects of health, such as long-term environmental and lifestyle studies and measures, have remained minimal [2,11,12]. This may produce genetic screening and gene-based therapies that are marketed as “magic bullet” solutions to disease and used, at best, excessively, and, at worst, marketed and used as replacements for other measures. As Willison and Macleod have noted: “…modifiable behavioural factors, such as obesity, inactivity and smoking account for over 70% of the cases of stroke and colon cancer, over 80% of coronary artery disease and over 90% of adult-onset diabetes”, so that ignoring the importance of these areas in healthcare would be both costly and inefficient in addressing the majority of health problems . Market forces and the success of shareholders being the determinants of research focus instead of societal health needs, results in a heavily promoted approach to diseases as drug and biotechnology-oriented when evidence suggests socioeconomic factors simply cannot be ignored.
Research Process – Effects of the Biotechnology Industry
As stated above, the market may have a profound effect on the focus of research, but what are the effects on the research process itself? Donald Willison and Stuart MacLeod have looked at whether or not patents are benefiting society by first outlining how research and patent use should be carried out, with benefits to society: “By granting time-limited market exclusivity, patents create the potential for inventors to generate high returns on successful innovations. In exchange, the inventor provides a complete description of the invention so that others may build on the technology to create improvements or other breakthrough discoveries.” . Yet as government research funding through grants becomes more scarce, researchers are forced to turn to the private sector, thereby creating a lack of objective scientific knowledge, or what Baird has termed a lack of, “a body of independent scientists without commercial affiliation who can provide more objective input and opinion when society has to deal with choices posed by developing technologies” .
The few high profile cases in the past of physicians or scientists covering-up undesired results or even forging results, has been connected to the large financial motive present, or as Bodenheimer states, “Science is supposed to be objective, but when money is at stake, subjectivity may certainly come to the fore” . To demonstrate how the market can affect the research process, Willison and Macleod  cite a survey of 100 Universities in the U.S. with the greatest amount of funding from the National Institute of Health (i.e. public funding) in 1998 : “In a survey of over 2100 life scientists, about 20% of respondents reported delays in publication of 6 months or more to allow for patent application, to protect their scientific lead, to slow dissemination of undesired results, to allow time for patent negotiation or to resolve disputes over the ownership of intellectual property.” They have also cited a survey that concentrated on geneticists in 50 U.S. Universities with the maximum government funding : “47% of geneticists who asked other faculty for additional information, data or materials regarding published research reported denial of at least 1 request in the preceding 3 years. In 28% of cases, respondents were unable to replicate published research as a direct result of this refusal to share information. The rate of denial of requests for data was equivalent to that reported by non-geneticists. However, geneticists were more likely to report that the withholding of data impeded progress of their research (58% v. 38% respectively).” These findings were especially prevalent where there was more academic-industry research partnerships and commercialization of university research. Since secrecy and lack of educational dispersal throughout academia is not the way to improve on an innovation or to find new and ground-breaking discoveries, these effects of industry on scientific research can be viewed as paralyzing at worst, or at best dulling, to reaching societal benefits. As Baird has pointed out: “The opinions of academic researchers with investments in biotechnology firms, or with appointments on their boards or as consultants, cannot be accepted as objective, but this is not often taken into account” .
Patent Scope: Can They Put a Patent on Someone’s Brain? What is Deemed Worthy of Patents is Consistently Tested Under the Law, with Repercussions on Research.
For now, human beings cannot be patented for ethical reasons. It could be speculated though, that in the future, when such technology is developed, some human organs created and developed in the laboratory would be eligible for patent protection. Could these organs include the entire human brain – or would that be going too far? How far patent protection can go is partly based on ethical issues and public consensus and partly on the many legal interpretations of current laws. Regarding laws, we have section 2 of the Patent Act of Canada, which says that an “invention” comprises, “any new and useful art, process, machine, manufacture, or composition of matter” . The dynamic relationship between the theory of what a patent is meant to include and this interpretation by law is elucidated by Willison and MacLeod: “To qualify for a patent, the invention must be deemed useful, novel and not obvious. The utility criterion requires that a clear application is known. Novelty means that the invention has not been described before in the literature. The criterion of non-obviousness demands creativity on the part of the inventor” . They have noted that where these criteria came into consideration was, for example, when Pfizer, a company that patented Viagra, a drug used for erectile dysfunction, was denied a patent on the entire class of phosphodiesterase-5 inhibitors for erectile dysfunction on the grounds of “obviousness,” since the knowledge for this class of drugs already existed in the literature.
These criteria are only guides though in the highly contentious fields of biology and ethics where the distinction between life forms that constitute property, such as molecules, micro-organisms or non-human animals, are still highly debatable and controversial among the public. A case in 1980 in the U.S. where the U.S. Supreme Court rules in a 5-4 split decision that “the genetic modification of a bacterium to break down oil spills was consistent with ‘a new composition of matter,’” set the precedence for the majority of the rational behind today’s patent decisions; that is because components of an organism, its DNA sequences and genes, may well be patented if a whole organism (the bacteria) can. Canada, although having issued patents for certain yeasts and moulds, has drawn the line at so-called higher life-forms such as seeds, plants and non-human animals, although in the U.S., Europe and Japan, such patents have already been issued . A federal Court of appeal ruled earlier this year that the Harvard Oncomouse, a mouse susceptible to cancer and so used in cancer research, fit the criteria of “non-obviousness” and was described by a justice Marshall Rothstein as “a new and useful ‘composition of matter’” and so an “invention” according to the patent act . The decision of the Court of Appeal has been appealed to the Supreme Court and is currently under review.
In the general distinction between discoveries, “upstream discoveries” are very broad discoveries, for example on the H2-receptor responsible for gastric acid secretion, and “down stream” applications are, for example, the development of H2-receptor antagonists, which work on these receptors. Before 1980, the discoveries eligible for patents were only the specific tests or therapies that made use of the “upstream discoveries” . For the purposes of research and the goals of maintaining useful and innovative new inventions, it has been noted by Willison and Macleod that, “An excessively broad patent – particularly on an upstream discovery – might block or place severe constraints on the ability of others to develop new tests or therapies that build on the patented invention” . If companies are able to place very broad patents, for example on higher life-forms or “upstream discoveries,” more lawsuits and time-consuming court appeals from possible intellectual property rights violations would result. Many researchers who lack the funds to deal with the litigation may decide not to research in a greater number of areas, and so such broad-patents may very well discourage and impede important research endeavors.
Moving From Our Satellite To The Ground: How Do We Go From Observing These Problems In Patent Use From Our Satellite to Making Real Changes On The Ground?
1) Targeting Patents in Canada:
As discussed, some of the “upstream” patents and litigation hassles from large multinationals can cause barriers to research endeavours and technological accessibility. Willison and Macleod have outlined reforms proposed here in Canada by the Ontario government regarding Canada’s Patent Act:
– Narrow the scope of gene patents;
– Create clear exemptions for experimental and noncommercial clinical use of a patented invention;
– Introduce a morality clause, the basis on which a patent may be challenged;
– Make provision for a separate ethics review panel;
– Create a faster, less expensive dispute-resolution mechanism’ and
– Permit compulsory licensing of genetic diagnostic and screening tests, giving government authority to require the patent holder to license the test to another firm, under reasonable conditions.
2) Targeting Research:
As one measure to reduce the number of clinically similar functioning drugs (“me-too” drugs) on the market, Marcia Angell proposes policies to force new drugs to be tested against older treatments already on the market for the same condition, rather than just testing against placebos .
3) Drug Marketing:
Marketing restrictions on the pharmaceutical industry are needed to ensure information patients and health professionals receive about drugs are guided by independent research rather than corporate-sponsored information. A greater reliance on independent consumer information on medicines is therefore required. A summary of non-brand sources of drug therapy information is available online at http://www.ti.ubc.ca.
4) Increasing Corporate Transparency:
A second important reform widely accepted by both those who think research should be done as a public utility and those who think research should be market-led is a greater transparency in the business operations of the pharmaceutical sector.
Marcia Angell describes why drug companies should open their books as well as why the industry should be regarded as a public utility :
“Drug companies reveal very little about the most crucial aspects of their business. We know next to nothing about how much they spend to bring each drug to market or what they spend it on. (We know that it is not $802 million, as some industry apologists have recently claimed.) Nor do we know what their gigantic “marketing and administration” budgets cover. We don’t even know the prices they charge their various customers. Perhaps most important, we do not know the results of the clinical trials they sponsor—only those they choose to make public, which tend to be the most favorable findings. (The FDA is not allowed to reveal the results it has.) The industry claims all of this is “proprietary” information. Yet, unlike other businesses, drug companies are dependent on the public for a host of special favors—including the rights to NIH-funded research, long periods of market monopoly, and multiple tax breaks that almost guarantee a profit. Because of these special favors and the importance of its products to public health, as well as the fact that the government is a major purchaser of its products, the pharmaceutical industry should be regarded much as a public utility.”
5) Organizing Locally for Global Change:
Consumer organizations representing public interests in pharmaceutical policy can be an important way for people to start projects or help work on campaigns that address some of the global and local problems described in this article. An organization called Health Action International Europe , for example, is one such organization that has members from Europe, North America and beyond.
As in the case of South Africa discussed in this article, some very vital work was done by organizations working right out of the U.S. to help bring about changes for South Africans. An AIDS organization called Act Up New York  and James Love and Ralph Nader’s Consumer Project on Technology  helped catalyze the wider public dissent that pushed for the topic of AIDS/HIV drug accessibility to become a major issue in the 2000 presidential election campaign. Combined with work from a network of progressive public health practitioners, concerned organizations and scholars in South Africa and around the world, this world-wide organizing helped fuel the public outcry that forced the 39 pharmaceuticals to drop their case against South African government in April 2001. Yet as Toby Kasper, coordinator of the Access to Essential Medicines Campaign for Médecins Sans Frontières South Africa, has pointed out: “[T]he decision to drop the South African court case, and some recent announcements of price reductions on antiretrovirals can be seen as attempts by the pharmaceutical industry to avoid having HIV/AIDS catalyze an international movement seeking to address the problems in the TRIPS Agreement. The companies seem to be increasingly willing to sacrifice the (already marginal) sales generated on HIV drugs in Africa in an attempt to forestall the development of a larger social movement that might ultimately lead to the TRIPS Agreement being significantly altered or even removed from the WTO” . There are many organizations and online resources which take a critical look at global issues such as the TRIPS agreement, with links to other resources withing each of them [24, 25].
6) Political Will and Commitment Necessary:
As opposed to charitable gestures by the pharmaceutical industry, more systemic changes are needed to ensure that quality drugs can access people in developing countries in a sustainable manner. Thrupp has evaluated regional-level cooperative scheme of the Caribbean counties (CARICOM) and compared it with the national-level policy of Cuba to perhaps find applications for other developing countries . She found that the limitations of CARICOM consisted of its voluntary nature and lack of enforcement mechanisms for its member countries. Although the national-level policy of Cuba may not be adaptable in its entirety to other countries, due to the specific context of Cuba’s 1959 revolution and its framework of socialism and structural transformation, some of its policies may well be adapted to other regions of the world.
It is worth noting that Cuba’s conditions resembled that of other Latin American countries before the 1959 revolution. These conditions consisted of “high morbidity and infant mortality rates, very high incidence of communicable diseases, extreme maldistribution and inadequate health care services and doctors, and gross misuse of government health funds for private purposes.” Due to its systemic changes Cuba was able to implement the following changes: the bulk purchasing of drugs instead of finished packaging (a direct foreign exchange savings of over 30 percent), development of its own domestic production, thus reducing external drug dependence, and the building of a solid research and development capability so as to increase technological self-reliance. Cuba has further taken measures to eliminate commercial brands of drugs wherever possible and maintain well-trained professionals and technicians all along the distribution chain, including in remote regions. The improvements Cuba has made in the health and pharmaceutical sector have been dramatic. They included a reduction of infectious and parasitic diseases and those caused by malnutrition to insignificant levels and an almost complete eradication of poliomyelitis, diphtheria, tuberculosis and tetanus through measures such as vaccination programs. It must be emphasized that the dramatic improvements in Cuba came about as a result of broad-based social change and restructuring. A strong political will and commitment to both implement and enforce these changes was a prerequisite.
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