The Dilemma of Intellectual Property Rights with Special Reference to Pharmaceutical Patents


Intellectual property rights are a collection of rights granted to the true and original owner of work, thereby rewarding his intellectual hard work. Intellectual Property Rights play a pivotal role in maximizing the innovation in distinct fields; however; many times it has been employed by the developed nations for their profit maximization. They achieve this by influencing the regimes that play a great role in shaping the policies regarding IPR. To counter such bias, the developing countries, like India and Brazil have taken the forefront in advocating the equitable IPR regime for the third world as well.


The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is one such regime that focuses on maintaining homogeneity among the treatment of IPRs in different nations of the globe.[1]This too forces the developing nations to tailor their IP regimes in accordance with that of the developed nations, because at the end of the day; they are the ones who influence the policies of these IPR regimes.


The paper focuses on one such IP Right, namely patent in the pharmaceutical sector; that aims at increasing the innovation and cater to the needs of both the developed and the third world nations. With the increase in technology and developments in the field of science, the pharmaceutical industry has been revitalized under the TRIPS regime. However, despite a modernized regime; the third world has been unable to avail of the benefits of cheap medicines and other assistance as ensured by the TRIPS regime.[2]Also, the disregard with respect to the research and development of the diseases that are more prevalent in the developing countries, or in other words; the neglected diseases, also reflects the shortcomings in the policies of TRIPS concerning the pharmaceutical sector.[3]In the initial stages of the strengthening the IPR regime in developing countries, the objective was to increase research and development in the third world; but scholars in the later stages asserted that these steps neither provided them with the novel pharmaceutical products nor do they facilitated the process of development in the field of health.[4]


Accessibility of pharmaceutical products to the third world

The provisions of the pharmaceutical patents got a complete makeover when the same was harmonized with the provisions and policies of the TRIPS agreement. In the pre TRIPS era, the third world excluded pharmaceutical products from being protected under the patent regime. Likewise in India, the medicines for deadly diseases like HIV AIDS, malaria and tuberculosis were not granted patents before the year 2005 so as to facilitate the manufacturing of generic drugs and easy access of the medicines to the nationals of the third world.[5]Although, after complying with the World Trade Organisation regime, it began granting patents to the pharmaceutical products as well, which the developed countries asserted was necessary for further research and development of the health sector.[6]This increased the monopoly over the drugs that were patented by the major manufacturers of these products, i.e. the developed nations; thereby curtailing the access to generic and cheap drugs to the third world as well as a fall in the patentability standards.[7]


Moreover, the concept of data exclusivity advocated by the developed nations has been detrimental to the interests of the third world. However, the TRIPS provision in this regard does not make it mandatory for the signatory nations to comply with the same. This practice is employed by the leading drug manufacturers to prevent the generic drug companies from using the clinical trial data which is availed by them to prove the quality of the drug by a regulatory authority.[8]Through this, the manufacturer company gets a period of exclusivity for a duration of about four to ten years in which any other generic drug manufacturer is barred from entering the market, thereby making the affordability of cheap medicines an almost impossible task for the third world.[9]Similar case was observed in the year 2016 when the United States vehemently opposed Section 3 (D) of the Indian Patent Act that does not allow patent protection to new inventions unless they possess a certain level of efficacy.[10]In other words, the Indian patent act bars the Evergreening of patents as this practice gives undue advantage to the developed nations in securing and extending the already patented pharmaceutical products without employing any major additions and efficacy to the drug.[11]The provision was being rejected because the US wanted exclusivity in the market with respect to pharmaceutical drugs, thereby maintaining its monopoly over the drug market. On the contrary, the United Nations, in its report on Access to Medication; advocated for the generic drug manufacturers as it eases access to cheap medicines to the poor people residing in third world nations.[12]It further included an insightful dialogue by Dr. Amit Sengupta who is an Associate Coordinator of People’s Health Movement, India; where he rejected the oppressive TRIPS regime that is detrimental to the interests of the third world and further pressed for more and more use of generic drugs so as to eradicate the problem of access of medicines to the third world countries.[13]Data exclusivity, therefore, is an evil for the developing nations that are against their public interest forcing them to purchase patented drugs by placing a barrier to access to cheap medicines.


TRIPS, which governs the patents in the case of pharmaceutical products is flexible as far as the provisions for data exclusivity are concerned, even then this regime is against the third world countries. This is sole because of the reason that the major objective of the TRIPS is to facilitate the free flow of trade in goods and services rather than promoting and developing access to knowledge and health.[14]The above instances are evidence of the fact that the regime for the protection of patents is inclined much towards the developed nations, thereby jeopardizing the interests of the third world. Therefore, the son- affordability of cheap pharmaceutical products to the third world due to the Evergreening of patents and data exclusivity by the developed nations indicates the unbalanced IPR regime prevalent on the globe.


R&D on Neglected Diseases by the developed countries

Developing countries suffer a double burden over themselves as they have to cater to the needs of pharmaceutical products for diseases that are highly communicable and caused due to the lack of proper nutrition in their country.[15]For being able to achieve this, a proper mechanism of research and development should be available in these countries. Unfortunately, the situation is contrary as the pharmaceutical companies invest more in Type I diseases which are prevalent more in the developed nations rather than in the third world nations.[16]This could be derived from the statement made by the Marijn Dekkers, the CEO of German pharmaceutical company Bayer; “that their company developed the cancer drug for the Western nations who are capable of bearing the cost of such drugs rather than the Indian market.”[17]Likewise, the British Swedish company AstraZeneca stalled the R &D of the neglected diseases that majorly affect the developing nations and started developing the drugs for the diseases dominant in the developing nations.[18]This treatment with the third world is evident in the fact that the pharmaceutical companies only function for their commercial benefits, and to cater to the needs of the developed nations. Diseases like cancer and diabetes that are prevalent in the developed nations are huge money churners for these pharmaceutical companies in contradiction to diseases like malaria that affect the poor in the third world.[19]The patented drugs that cost a lot of money are affordable by the developed nations, as a result, to fulfill their commercial needs; these pharmaceutical companies develop those drugs that affect the developed nations completely disregarding the health needs of the developing nations. Owing to this factor, the developing countries, even after constituting 80% of the total population of the world is responsible for only 10% of the global sale of pharmaceutical products.[20]This was also pointed out by the European Parliament Report in 2005 when it asserted that the third world is countering a lack of research and development in the diseases that affect majorly their nationals, thereby creating an acute deficiency in the availability of drugs that would cater to their needs.[21]The pharmaceutical giants refrain from investing in the research and development of the drugs for these developing nations due to the inability of the poor nationals of these countries in affording the costly drugs. The pharmaceutical industry witnessed the aforementioned indifference when between the years 1975 and 2004, mere 21 drug molecules out of a total of 1556 all over the globe, were sold for the neglected diseases.[22]The pharmaceutical industry also treats the third world indifferently due to the fact that the low-income countries spend a meager amount of money on drugs as compared to the developed ones, for instance; the sub-Saharan Africa spend less than the US $6 when placed in juxtaposition with the nations of the Organisation for Economic Cooperation and Development who spend an approximate amount of US $240.[23]In simpler words, the health needs of the developing nations are getting jeopardized due to their lesser purchasing power as well as owing to the profit motive with which the major pharmaceutical companies function.


The aforementioned facts are evidence of the failure of the IPR regime that was constituted with the aim of harmonizing the interests of the developed as well as the developing nations. TRIPS regime was one such agreement whose provisions governed the pharmaceutical patents and focused on maintaining a level ground among all the IPR regimes. There is a need to establish more pharmaceutical industries other than in the developed nations so as to cater to the needs of the third world and their citizens, otherwise, the developing nations would keep on facing the indifferent attitude of the R&D of the major pharmaceutical giants.[24]


However, the state of affairs has changed with the multinational drug companies beginning their research and development in the sphere of neglected diseases as well. Earlier, they refrained from the same as the third world was not able to afford the costly medicines manufactured by these major giants and it was detrimental to their commercial motives. Now, however, the pharmaceutical giants claim that they are centered on the interests of the third world and catering to their health needs rather than the earlier objective of fulfilling their business motives.[25]They asserted that the short term business profits that they earlier aimed at have now been replaced with long term considerations that included the basic intention of corporate social responsibility towards the third world.[26]However, the third world which is on the receiving ends of all these agendas of the developed nations, such as countering attacks on their reputation due to their negligent attitude to address the needs of the developing nations and, strategies to approach the highly-skilled, low-cost scientists and researchers for the R&D needs to be cautious with regards to the interest of their nationals.[27]


The developed nations by catering to the needs of the third world and providing pharmaceutical products on lesser costs, up to some extent have showcased the move as an ethical consideration; however, after analyzing the factors responsible for such an activity, it is evident that the ultimate objective is more or less the achievement of commercial benefits in the long run.[28]


Provisions of Technology Transfer and the Third World

The period after the TRIPS agreement witnessed the developing nations in a state of inadequate technology to cater to the needs of their citizens. Also, for the manufacturing of pharmaceutical products, the third world lacked the adequate infrastructure to achieve the same. For all these needs, the developing nations had to depend upon the R&D of the developed nations which was evidence of their lack of self-sufficiency in manufacturing the pharmaceutical drugs.[29]However, the state of affairs in the pre-TRIPS era was altogether different as there were no restrictions on the countries in drafting the provisions with regards to the protection of IP which helped them in framing the regimes that fostered the technological growth.[30]


Therefore, to support the third world in technological endeavors and further promoting them in the research and development of the same; the TRIPS Agreement has mandated the developed countries to transfer their technology and assist the aforementioned by providing them with incentives for the same.[31] However, the mandate of the TRIPS that was framed for the betterment of the third world seems to be failing on practical grounds when Cambodia, on behalf of the Least Developed countries (LDCs) expressed its concern over the problems and loopholes existing in the provision of technology transfer.[32]The document presented by them contained the issues with regard to the lack of implementation of the provision and gaps in the interpretation of the term ‘incentives’ contained therein.[33]Further, the TRIPS provision regarding the technology transfer fails to assist the third world also because of the lack of proper interpretation of the phrase ‘technology transfer’ itself.[34]The lack of consensus among the developed nations in deciding what the term actually denotes is one of the major factors responsible for the gap in achieving the objective set up by the TRIPS agreement.[35]Further, the irresponsible behavior and negligent attitude of the developed countries with regard to the needs of the third world is also responsible for the failure of the provision.[36]This was also observed by Suerie Moon in a study, which analyzed the actual implementation of the technology transfer on the third world countries between the years 1999 and 2007; it ascertained that merely 22% of a total of 292 proposed programs by the developed nations actually focused on the agenda of technology transfer of the Least Developed Countries who were members of the World Trade Organisation (WTO).[37]To conclude on the basis of the above analysis and surveys, it can be stated that the developed nations have failed on a practical ground in implementing the technology transfer provision of the TRIPS, thereby jeopardizing the interests of the third world.


Conclusion

The above analysis of the pharmaceutical industry examined the implementation of the TRIPS in catering to the interests of the third world and examined the challenges that the developing countries face therein. The major pharmaceutical industries refrain from investing in the third world due to their low purchasing capability and the high cost of medicines. The developing nation has to rely on the developed nation due to the lack of adequate research facilities and structures needed for the innovation of such technology. To counter this issue, a model of research catering to the needs of the third world has to be set up as the developing nations have the most skilled researchers and a lot of traditional pharmaceutical knowledge as compared to the globe. Also, focusing on the position of India, it has emerged as the world’s third-biggest exporter of pharmaceutical drugs and also boasts of exporting generic drugs in the largest number with 20% of the drugs being exported solely by India on the whole globe.[38]For defeating the dominance of the developed nations in the pharmaceutical sector, the third world needs to employ its traditional systems of pharmaceuticals thereby harmonizing them with the present established Intellectual Property Rights Regimes. This would increase the efficiency and make the developing nation's self-sufficient in research, development and innovation of the pharmaceutical products; consequently defeating the monopoly of the developed nations and industries that they have achieved through patenting of the pharmaceutical drugs


References:

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Submitted by,

Vasunhara Singh, LL.M.,

The West Bengal National University of Juridical Sciences.


(Image used for representational purpose only)

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