Patent Laws and the Benefits of Medication - Essay Example

Patent Laws and the Benefits of Medication The laws pertaining to pharmaceutical patents restrain the people living in the developing nations from procuring the benefits of medication. Patents are very important for protecting innovation. They ensure legitimate incentives to the producers of innovative products. In the field of medicine, patents play a major role; and a compulsory licensing system is indispensable for increasing access to medicines. Patents result in a number of socio – economic problems. The grant of monopolistic patent rights, in respect of essential medicines, has serious repercussions on sociological and economic development of the country that grants such patents (Kuanpoth 2008: 15). Patents provide exclusive rights to companies to market their products. In general, the pharmaceutical companies exploit this statutory exclusivity, to demand exorbitant prices for their products. In addition, these companies ensure that their essential drugs are always in short supply, as this increases market share and leads to overpricing. Accessibility to medicines is hindered by patents, and the poor nations cannot obtain the essential but expensive medicines. Many poor nations in Asia lack accessibility to life saving drugs, due to the fact that most of these drugs have been patented by the pharmaceutical companies of the developed world (Kuanpoth 2008: 15). Several health problems faced by the populace of the developing countries, are on account of the non – availability of life saving drugs in those countries. This unhappy situation is a direct result of the patent law. The multinational companies enjoy protection under the patent law, and ruthlessly exploit it to increase the cost of their medicines. It is usual for these multinational drug companies to charge exorbitant prices for their products, by relying on monopolistic market policies (Bird 2009, 209). People living in the impoverished nations of Asia and Africa, do not have access to life saving drugs. These countries have a high number of people with HIV infection, and their number is constantly on the increase. In order to survive, these people need access to essential medicines. The drugs used in the treatment of HIV are patented by the companies of the developed world, and are therefore difficult to procure (Shantharam 2005: 49 – 50). This issue has assumed global significance, and there have been innumerable discussions, regarding the relationship between patent laws and access to drugs that are required in the treatment of ailments, like tuberculosis, HIV/AIDS, and malaria. The attitude of the developing countries towards this inequitable and inhuman patent regime is that they would prefer to circumvent these unjust laws, in order to obtain life saving drugs for their suffering populace (Shantharam 2005: 49 – 50). In Australia, the 1990 Patents Act protects the interests of patent owners. It provides exclusive right to the owner of a patent to commercially exploit his invention, during the pendency of the patent. Under this Act invention refers to any device, substance, method or process that is new, inventive and useful for the purposes intended (Australian law and agencies, 2008). In order to enforce their monopoly, and in order to maximise profits, the United States and other developed nations moved in a concerted manner to establish international patent laws and to compel the poor nations to obey these laws. Accordingly the developed world, under the assumption that such international laws were indispensable to safeguarding the interests of their drug companies, ensured extended protection to their products. The result was the strict enforcement, from the 1 January 1995, of the Trade – Related Aspects of Intellectual Property Rights (TRIPS) Agreement (Shantharam 2005: 49 – 50). The TRIPS agreement requires all the WTO member states to implement the measures, specified by this agreement, so as to protect intellectual property in their territories. Under the provisions of this Agreement, member states will be forced to implement patent protection for 20 years. This protection has to be provided for products that were patented in the other member states of the WTO. The TRIPS provides two important safeguards, namely compulsory licensing and parallel importing, which prevent undesirable outcomes (Shantharam 2005: 49 – 50). The impoverished nations are beset with disease and poverty, and living conditions are significantly inferior to those in the developed nations. However, some improvement in this dismal situation has transpired, chiefly due to the provision of some financial assistance by international entities and NGOs. Inter alia, awareness regarding public health has increased to a considerable extent (Whobrey 2007: 623). Moreover, income levels have improved, on account of globalisation. All the same, living conditions in the poor countries have not improved in proportion to these developments. The problem of HIV/AIDS defies a solution in these nations. This disease has no cure; nevertheless, it is possible to prolong the lifespan and improve the quality of life of the patient by adopting the antiretroviral therapy (Whobrey 2007: 623). The governments in these regions had undertaken various measures to stem the proliferation of HIV/AIDS. These efforts were met with a degree of success, in the initial stages. Later on, it was noticed that the number of people, afflicted with this disease was not reducing. In 2005, there was a sudden increase in the number of HIV/AIDS patients, by five million (Whobrey 2007: 624). Sub – Saharan Africa was home to most of the new cases of HIV/AIDS infection. This area is among the poorest in the world, and its people, desperately need access to life saving drugs. Such access is denied by the pharmaceutical majors, who are more concerned about maximising their profits. The issue of providing access to medical products to the people living in developing and poor nations has always been controversial (Whobrey 2007: 624). It is essential for the international community to realise that the provision of access to life saving drugs is very important for improving healthcare in the less developed and least developed countries. Moreover, it is necessary for the major pharmaceutical companies to understand that their patented products are essential in improving public health in these countries (Whobrey 2007: 624). Furthermore, these companies have to recognise the fact that they have a responsibility towards humanity, in addition to making profits on their products. Consequently, it is incumbent upon them to maintain a balance between profit – making and their social responsibility, whilst implementing their business practices. Therefore, it is the bounden duty of these companies to allow easy access to persons in need of essential drugs (Whobrey 2007: 624). The pharmaceutical industry has continually made efforts to establish stronger intellectual property rights for its products, at the international level. This industry has called for more stringent patent laws. Under the aegis of such laws, these companies hope to enjoy monopoly, in the production of new drugs. By enforcing stricter patent laws, the pharmaceutical majors can effectively prevent the poorer nations from conducting research to find new drugs or cheaper alternatives. The proponents of more stringent laws, contend that such laws would increase the profits of the patent owning companies and thereby provide better returns on the investment of their shareholders (Whobrey 2007: 624 – 625). However, the opponents to a stricter patent regime argued that such strong protection to intellectual property, would promote a monopolistic approach by the companies. In addition, such protection would favour the property rights of companies, to the detriment of the welfare of those living in the least developed nations. On account of strict patent laws, pharmaceutical companies can drastically increase the cost of their drugs. Such high cost drugs would be beyond the reach of the people, living in the least developed countries. Ultimately, this situation further deteriorates living conditions in those nations (Whobrey 2007: 625). The majority of the poorer countries were apprehensive of the TRIPS, and the perceived effect of this Agreement on public health. Many poor nations found it difficult to meet the enforcement deadlines, for protecting intellectual property. In 2001, the WTO issued a statement, during the Doha Conference; which came to be known as the Doha Declaration. It served to make clear the objectives of the TRIPS agreement, and specified the means to achieve them (Whobrey 2007: 635). The Doha Declaration made it amply clear that the provisions of TRIPS were to be interpreted from the point of view of protecting public health in the member states. These provisions have to be implemented in such a manner that they provide better access to essential medicines to all (Whobrey 2007: 636). The deadline for the implementation of the TRIPS, with regard to medicines was extended till the year 2016. Every member of the WTO agreed to extend the deadline, with a view to help the poorer nations to make the necessary arrangements (Whobrey 2007: 636). These impoverished countries will have to develop new intellectual property regulations and establish enforcement mechanisms for the implementation of these laws. Specifically, the 2003 Decision waived the duties laid down by Article 31(f) of the TRIPS agreement. This initiative enabled a member state to export generic drugs, manufactured under compulsory licensing, to any country that was in need of these medicines. The importing country was required to inform the TRIPS Council about the name and the quantity of the drug that was imported. This simple requirement was deemed to be sufficient to receive the imports. The exporting was permitted to export only as much of the required drugs, as had been intimated by the importing country to the TRIPS Council (Whobrey 2007: 636 – 637). Strong laws buttress monopolies, and the pharmaceutical companies increase the price of their products, in order to receive the maximum profits from these drugs. The people in the least developed countries cannot afford to buy these highly prices drugs, despite their being essential for their life. The pharmaceutical companies have made it very clear that they are not willing to reduce the price of their patented products. The usual reason proffered by these companies is that they had spent vast amounts on research and development of these products(Bird 2009, 209). They also contend that if they reduce prices, the countries that import these drugs would sell them in a clandestine manner, in the profitable markets of the developed world. The compulsory licensing system provides a right to the developing nations to utilise patents. Under this right, a patent granted by the government of one country can be used by the government of another country, without seeking the permission of the owner of the patent. Such compulsory licenses are the consequence of a patent owner’s refusal to distribute the patent or reduce the cost of his patented products to affordable levels (Bird 2009, 209). As such, compulsory licenses are introduced; if the public of a developing country find it very difficult to access essential drugs. Under such circumstances, the government may declare the patented drug open for manufacture by any domestic company, and thereby effectively nullify the exploitative patent. In this manner, the government of a poor country may issue a license to some state owned or private company, to manufacture what was once a patented drug (Bird 2009, 209). The nation that issues a compulsory license may provide reasonable compensation to the patent owner. During the existence of the compulsory license, the patent will be suspended and any firm can manufacture the patented drug and sell it without having to obtain the express permission of the original patent holder. For this reason and due to the various advantages that it provides, several developing nations issue compulsory licenses within their territories; and encourage private and public sector firms to produce essential medicines at affordable prices (Bird 2009, 210). Compulsory licensing removes the barrier constructed by the avaricious multinational companies, which prevent access to essential drugs. This system of compulsory licensing has saved the life of many residents of the least developed nations. This mechanism, born of desperation, has successfully garnered the support of innumerable scholars, activists and NGOs (Bird 2009, 210). However, a compulsory licence does not inundate a poor nation with life saving drugs, at affordable prices. Such licenses have to be managed very carefully; otherwise, they would fail to benefit the majority of the populace. On several occasions it had been noticed that some of the developing nations had failed to take this aspect into account, while issuing compulsory licenses. These nations had failed to envisage the ramifications of compulsory licensing. If a government fails to provide adequate protection to intellectual property, then foreign direct investments could be adversely affected (Bird 2009, 210). Furthermore, compulsory licensing discourages multinational companies from investing in those countries. Any multinational company dealing in pharmaceuticals requires a legal environment that is business friendly. Many patent owners have launched legal battles against compulsory licensing systems, at the international and national levels. Moreover, the industrialised nations have attempted to protect their companies from being subjected to compulsory licensing. (Bird 2009, 210). As part of this battle, these developed nations are imposing economic and political sanctions against the developing nations that issue compulsory licenses. Seldom have the developing countries announced the discovery of a new drug. This is on account of the fact that the cost entailed in conducting research to find new drugs cannot be defrayed by the companies of the developing countries. Such research is monopolised by the pharmaceutical companies of the industrialised world. Not surprisingly, the majority of the patents belong to the drug companies of the developed world. In fact, a mere 10% of the patents relating to drugs have been registered by the developing world (Gontijo, 2005). It is beyond the capability of the developing nations to invent or discover new drugs. The discovery and development of new drugs entails vast investments, infrastructure, and scientific and technical capabilities. In general, these resources are absent in the developing and poor countries. The multinational corporations of the wealthy and industrially developed countries develop drugs for diseases. More than 90% of the total patents in the world, for new drugs, are owned by these pharmaceutical giants. The developing and poor countries do not encourage their domestic companies to develop medicines (Gontijo, 2005) . Consequently, their policies encourage foreign companies and multinational corporations to conduct their activities on their soil. It is obvious that patents prevent companies, in developing nations from conducting research on patented drugs. In addition, patents promote monopolistic trade policies, and patent holders enjoy undisputed market domination. By taking advantage of this position, they can set the cost price of their patented products at very high levels, which cannot be accessed by the denizens of the poor and developing nations. Patents effectively prevent further research on patented drugs, and bring innovation to a standstill. Moreover, patent holders can maintain secrecy about their products and inventions. The pharmaceutical majors of the West have developed extremely effective drugs, such as the protease inhibitors. These drugs have established their efficacy in addressing the AIDS problem. Furthermore, these companies are chiefly based in the US, where they produce high quality essential and life saving drugs and make them available to the patients in the US. This has not been extended to Thailand, where the cost of the drugs used in AIDS treatment has proved to be very expensive (Curti 2001, 469). In the US, a course of treatment for the disease AIDS, involves expenditure that is in excess of $20,000 per year. This is unaffordable for most of the persons of the developing or poor nations. Unfortunately, the developed nations of the West have adopted a callous attitude, and are not coming forward to help the developing and poor countries in their fight against HIV/AIDS (Curti 2001, 469). For instance, Thailand is a developing nation with a large number of AIDS patients. Moreover, the number of AIDS patients in Thailand, is on the increase. The AIDS problem in Thailand came to the fore in the mid- 1980s, and it had assumed epidemic proportions by the 1990s. Thailand’s patent laws protect the interests and intellectual rights of the Western pharmaceutical companies. These companies are the major producers of the drugs that are needed in the treatment of this epidemic (Curti 2001, 469). Every year, more than ten million people succumb to treatable infectious diseases. Nearly ninety percent of these people hail from the developing countries. Diseases such as HIV/AIDS, respiratory infections, malaria and tuberculosis are the major causes for these deaths, which transpire chiefly in the countries of Africa, Asia and South America. The cause for most of these deaths can be attributed to restricted access to drugs that are indispensable in curing these diseases and assuaging the suffering caused by them. It is essential to take cognisance of the fact that nearly 8,000 people die every day, due to AIDS, in the developing and poor countries (Hoen, 2002). Access to essential drugs for those who live in the poor and developing countries has been prevented in many ways. One of these is the high cost of the drugs, which effectively disallows access, as these individuals cannot afford the high cost. Thus, the price factor proves to be an effective barrier to treating diseases and saving lives. Another, measure that prevents access, is strong intellectual property protection, which gives rise to restrictive and monopolistic trade policies. The situation is made worse by the fact that the government of a developing nation cannot make bold to impose restrictions on the cost of drugs, manufactured by the multinational drug companies. These governments desist from any attempt to do so, because they fear that any such attempt would infuriate the pharmaceutical majors and the governments that support them (Hoen, 2002). An absence of access to essential drugs can take place, due to various reasons. One of these is a difficulty in the supply and storage of drugs, which creates a scarcity for these drugs. In addition, there may be factors, like the quality of the drug being inferior or substandard, selection of the drug being inappropriate, the use to which the drug was put could have been inappropriate, inadequacy of production, and overpricing (Hoen, 2002). A large number of children and adults succumb, every year, to disease. Many of these diseases can be cured by using existing medicines. For instance, malaria causes the death of 40% of the five million people that it infects, every year. Minor diseases such as diphtheria, measles, tetanus and syphilis, routinely claim thousands of lives, annually. Most of these deaths are on account of these people being unable to access the drugs, necessary to cure their illness (Bird 2009, 209). It is to be emphasised that these diseases can be cured by employing medicines that are available. This is the situation in the poor countries, where millions of people are dying annually, on account of diseases that can be cured. What is truly disheartening about this state of affairs is that access to essential medicines could have saved millions of lives. To all intents and purposes, drug companies in developing countries, do not possess, the necessary infrastructure to conduct research for developing new drugs. The developing countries are at a disadvantage, due to the monopolies generated by the extant patent laws. Most of the patents relating to medicines belong to the developed world; therefore, the developing countries do not obtain the benefit of medication. List of References Caslon Analytics intellectual property (2008) Australian law and agencies [online] available from < http://www.caslon.com.au/ipguide3.htm > [31October 2009]. Bird, R. C. (2009) ‘Developing Nations and the Compulsory License: Maximizing Access to Essential Medicines While Minimizing Investment Side Effects’. Journal of Law, Medicine & Ethics 37(2), 209 –210. Curti, A. M. (2001) ‘The WTO Dispute Settlement Understanding: An Unlikely Weapon in the Fight Against AIDS’. American Journal of Law & Medicine 27, 469 – 470. Gontijo, C (2005) Changing the Patent System (Chapter Two) [online] available from [31 October 2009]. Hoen, E (2002) TRIPS, pharmaceutical patents, and access to essential medicines: A long way from Seattle to Doha [online] available from [31 October 2009]. Kuanpoth, J. (2008) ‘Give the poor patients a chance: Enhancing access to essential medicines through compulsory licensing’. Journal of Generic Medicines 6(1), 15 – 28. Shantharam, Y. (2005) ‘The Cost of Life: Patent laws, the WTO and the HIV/AIDS pandemic’. Undercurrent 2(2), 48 – 56. Whobrey, B. (2007) ‘International Patent Law and Public Health: Analyzing Trips' Effect on Access to Pharmaceuticals in Developing Countries’. The University of Louisville Brandeis Law Journal 45(1), 623 – 642. Read More