Review Article: 2021 Vol: 24 Issue: 2S
Mohamad AyubDar, Aligarh Muslim University
Tran Vang-Phu, Can Tho University
Healthcare, Intellectual Property Rights, International Trade Law, COVID-19
Right to health is a basic human right. This fundamental right and basic right is under assault in India from unrestricted Privatization, MNCs, “usual business approach”, profiteering policy of some hospitals, lack of state interventions and monopolistic tendency of intellectual property. Strong IPR mechanism and access to health care system is inescapable in the present day society. Intellectual property rights might build fencing walls, while accessing the vaccination, treatments, or technological progress to thwart covid-19 pandemic and access to the healthcare system. The present paper analyses the IPR regime from access to health perspective, further, to study the property through human rights perspective. In the present health crisis, the better use of IPR regulations to cope up with global pandemic will be discussed. Stirring efforts taken by World Intellectual Property Organization, World Trade Organization (WTO) and World Health Organization (WHO) through Trade-Related Aspects of Intellectual Property Rights Agreements (TRIPS), Doha Declaration and then the 30 August 2003 Compulsory License Import Export mechanism to prevent the misuse of patent right for acceleration of health over property standards. The innovator companies pertaining to the pharmaceutical sector must realise the coherence between international trade and intellectual property rights. In this paper, content analysis method based on reports, articles, papers and books have been used. This paper highlights how the IPR regime is creating a gated wall community who benefit from the status quo while the masses are suffering due to its application.
To determine the proper normative relationship between intellectual property and right to health, one must first understand how they relate to one another.
Human-rights approach to property emphasis upon the states to safeguard its netzines against the abuse of intellectual property. Human rights connotation of intellectual property does not out rightly disapprove the impact of the medical patents. Respective authoritative Regimes must comprehend the touch of innovations, with introspection of intellectual property shifts (Chapman, 2001). Human rights and intellectual property connection is in the state of perturbation specially in the medication area of pharmaceutical patents.3 Medical patents can adversely affect the availability of medicines in two key ways: Creation of monopolistic tendency related to essential drugs thereby overcharging and secondly profiteering, money making approach strikes badly to developing countries. It downgrades and stagnates the accessibility of fresh drugs to the bulk of population across the globe (Narula & Smita, 2011).
Intellectual creations have a vital role in the community; the need is to establish the framework, which develops innovative atmosphere.
TRIPs provide the decisive legal underpinning for the governance of access to essential medicines. Essential medicines enumerate the satisfactory health care mechanism in place. TRIPS set out the worldwide network of patent granting and enforcing institutions, from national courts, legislatures and patent offices to the dispute settlement mechanisms and negotiating flora of the WTO itself. Intellectual Property (IP) laws have a significant impact upon global welfare. IP regime substantiates the healthcare, treatment, affordability of necessary drugs and availability of medical literature. For example, patents on pharmaceuticals can lead to prices that are unaffordable by affected populations in developing countries, while copyright law may contribute to the inability of affected populations to access treatment information for basic ailments.
The right to health is secure at international, regional, and domestic level, which opens the path of development and communication for rights of society and indispensable IPR regime. Since the earlier times, human rights institutions established a close nexus through their known interpretations and advanced the IPR models (Helfer & Austin, 2011). The Committee on Economic, Social and Cultural Rights; inter-governmental bodies such as the
U.N. Human Rights Council (formerly the Commission on Human Rights) (Commission on Human Rights, 2001); and special procedures and individual office holders such as the U.N. High Commissioner for Human Rights (Commission on Human Rights, 2001), and the U.N. Special Reporters on the rights to health and food played its role. As it entails the necessity of adopting the human rights perspective of property to ensure greater protection.
With the advent of Trade Related Aspects of Intellectual Property Rights (TRIPS), the intellectual property regimes have changed in most World Trade Organization (WTO) countries. TRIPS agreement sought to harmonize IP protection across the world. Previously many articles expressed the concern on this subject matter. Access to healthcare and IPR regulations are also a popular subject matter for IP book authors. The healthcare protection given by WHO, essential medicines availability, flexibilities of TRIPS and Doha declaration are the core discussion area of today’s healthcare and IPR regulations. Intellectual property rights: An overview and implications in pharmaceutical industry-NCBI was a very helpful article. Article of WIPO (perspectives on access to medicines and IP), Trade, Intellectual Property Rights and Access to Medicines- WHO, Promoting Access to Medical Technologies and Innovation. WHO have prior articles where anyone can learn about the effects, efforts of IPR and the situation regarding healthcare. Intellectual Property and Public Health in the Developing World (1,2). TRIPS agreement, Doha declaration, WIPO Handbooks all are the sources where the background, history and detailed knowledge has been given.
Healthcare accessibility has three dimensions
Physical accessibility: Better health facilities to common populace in need are always priority of well standard health system. Availability of robust health technology, equipment’s as per the demand and expectations of the common masses are of utmost significance.
Financial affordability: Considering common masses capacity to pay for health services without any difficulty. To understand cost factor of essential health services, indeed establishing health financing schemes is to realize the pulse of society.
Acceptability: Patients inclination to look up and accept the health services. Acceptability suffers when services are considered very poor and when extroverted, cultural barriers like age, sex, language, religion, and ethnicity unnerve the service seekers.
World presents appalling image of healthcare accessibility. People suffer and bear the brunt of uneven policies, as 40 % of WHO members recounts to possess only 10 doctors per 10, 000 populations. India, which have only 0.7 doctors per 1000 population as against World Health Organization (WHO) requirement to have at least 0.9 doctors per thousand populations. It’s troubling that greater numbers of them are working in major cities. Government spending on health sector (which includes, medicines, diagnostics and hospitals) is a meager 1.5% of GDP, when in fact for most other comparable developing countries in Latin America its average to 7.5% of GDP.
Health is uncompromising and indeed needs primacy and uniform policy to save the humanity from any catastrophe. Diseases, viruses, and illnesses engulfed the humanity since time immemorial, pandemics like Ebola virus, influenza, the corona virus etc shacked the world fraternity. The paradoxical developments of technology deepen the wedges between rich and poor countries. The intellectual property comes up with sustainable policy between human interests, along with the legitimate interests of the patent owner. Descent health care stems from fundamental right to health. The intellectual property incorporates compulsory licensing, TRIPS (the World Trade Organization’s agreement on trade-related aspects of intellectual property rights) flexibilities, extension of transition periods for developing and least developing countries are prioritizing public health. The Doha Declaration focuses upon the serious public health implications posed to both developing and least-developed countries. The efficient use of IPR (Intellectual Property Rights) is necessary to maintain and penetrate to the essential medicine’s vis a vis for proper health care. TRIPS agreement ensures to maintain sustainable progress to encourage R&D into new drugs and to secure affordable, standardized drugs. The WIPO and WTO advocates for compacted relationship for public health and intellectual property policies and for proper implementation of those policies.
Humankind witnessed the worst health conditions since earlier times. The Novel Corona virus (COVID-19) outbreak attained the pandemic shape, issued stronger threats to rich and poor countries. The deadly virus contours some of history’s worst pandemics, from the Antonine Plague to the current COVID-19 event. Globalisation and easing of international trade scenario rapidly increased the pandemic. Accessible pandemic vaccines and necessary medicines are vital for versatile health care and for sustainable development goals.
Access to Essential Medicines and Health
As the global health crisis has embroiled the whole world. The United Nations Covenant on Economic, Social and Cultural Rights (UNCESCR) enunciates the IPR and human rights paradigms, elaborates their relation clearly. To understand the vision of piercing of essential drugs and advancement of technology is crystal clear under its different provisions like the right to health (Article 12) and the right to benefit from scientific progress (Article 15). According to Article 12, healthcare goods, services and facilities - including essential medicines – must be available, acceptable, accessible and of good quality.
Sustainable Development Goal (SDG) 3 propagates meticulously importance of essential medicines and advocates for common action plan for members and stakeholders to accomplish widespread health care inclusive of “access to safe, effective, quality and affordable essential medicines and vaccines for all”. To assure supportable access of medicines, its necessary to focus on relevant SDG goal: so as to “promote research, development, innovation and increase access to medicines, vaccines, diagnostics and related health technologies to improve the health and wellbeing of all”(Medical report, 2016).
Access to essential medicines, as defined by the WHO, is a core, non-derogable duty of all member states, as is providing progressively improving health services and other measures to prevent, treat and control epidemic and endemic diseases.
'Essential medicines precede and slake the basic health care necessities of the society. Extremely important drugs are supposed to be available, serviceable, tolerable, accessible, and also to maintain the quality standards along with all the relevant information. The implementation tool of emergency drugs is deliberated on the flexibility and adoptive to various situations, as a regard to fulfil state responsibility (Rasmussen & Onarhein, 2016).
The World Health Organization explained the concept of essential medicines as “that the priority health care needs of the population”, and “access to medicines depends on four factors: rational selection, affordable prices, sustainable financing and reliable health systems”.
Accessibility, availability, acceptability of healthcare equipment, medicines and better treatment is indispensable for common people. Acceptability pertains to following of medical ethics and serious concern of medical norms related to individuality. Medication should be acquirable on urgent basis rather than on pricing scale. In cases where international trade accords impact health, right of way must be provided to realize the facets of health. For example, plane offers of making all drugs free from import tariffs can adversely affect the particular country. Those states which wholly depend upon the import, such as Bhutan or Maldives, are likely to fetch down the available price rate. To look from other perspective when there are small scale domestic industries as for e.g., in “Nepal”, then it will damage local production of low-cost generics and ultimately will lead to the import of more costly medicines.
“Millions of people are still unable to access medicines and health technologies that can ensure their health and wellbeing. Failure to reduce the costs of patented medicines is resulting in millions of people being denied access to lifesaving treatments for Communicable diseases like HIV, TB, Malaria, and viral hepatitis, non-communicable diseases (NCDs) and rare diseases. This failure is affecting governments and individuals in all low-, middle and high-income countries, where budgets are being stretched to capacity by treatment costs.” (UNDP HIV/AIDS Group, 2016). Without going into the detail of legal position of health, the AIDS exigency compelled policy analysts, policy drafters, commentators, and activists to contemplate over the healthcare crisis in least developed countries. As on April 27, 2015, the Royal Society of Medicine held a conference in London and stated in the report that five billion people do not have access to safe, affordable, “surgical and anesthesia care”, during the critical situations (Mcneil, 2015). Worst was observed in the very low-income and lower-middle-income countries, where nine of ten people cannot access basic surgical care (John, 2015).
Drug producing corporations increase the prices, which affect the whole society to bear the brunt of patent abuse, which need to be examined in detail (USA Today, 2016). In case of Association for Molecular Pathology V. Myriad Genetics the case was heard by US Supreme Court in 2013 is an example of how the High corporations abused the patent laws in maintaining a monopoly and keeping high costs for the treatment. The patent was held by Myriad over two genes BRCA1 and BRCA2, the mutation in these genes would indicate the increased risk of breast and ovarian cancer. The patent forced companies offering BRCA testing to stop stopped sharing BRCA data hampering research. Although the Supreme Court’s decision offered some leniencies but Myriad still holds a monopoly of the testing of these genes hampering access to Healthcare.
WHO promoted the concept of a national Essential Medicines List (EM). The first Model List of Essential Medicines (later Essential Medicines List, EML) in 1977 has been described as “a peaceful revolution in global health”. Development of EML model list assisted in incorporating a universal settlement regarding accessibility of medicines which meets the necessary health requirements of the maximum number of people. Despite making eloquent international efforts for improving the accessibility, but still essential medicines remained inapproachable for number of people around the globe. For example, the mean availability of existing important medicines in 27 low- and middle-income countries where data is available has been measured at 38.4% in public facilities, and 64.2% in private facility. The movie named as, “Fire in the Blood”, highlighted the plight of AIDS patients, it uncovered the reality of non-availability of AIDS drugs which affected the people badly. Every day 8000 people were dying because of AIDS. There is very grave issue in production of new essential medicines; they mostly cover the people of High-Income Countries (HICS) as per research 85-90% of medicine production forwarded since 1990s have small amount of or no therapeutic value when equated with present available. Treatment options (Rasmussen & Onarhein, 2016). “Pharmaceutical companies” generate huge profit on shooting of special medication and vaccination of deadly diseases. Pricing scale remains high, which can hardly be borne by affected community, but the manufacturer justifies the conundrum, on the basis of difficulty to produce. In 2013, for example, “industry giant Gilead Sciences launched Sovaldi, a hepatitis C drug, at $1,000 per pill (Knox, 2013) or $84,000 (Twomey, 2019) per treatment, which could last 12 to 24 weeks” (Info help, 2016). Thereafter 18-month investigation was carried to examine the cost effect, wherein it the Senate Finance Committee found that Gilead developed the marketing and pricing strategy designed to “maximize revenue with little concern for access or affordability.” (U.S. Senate Committee on Finance, 2015).
Moving towards 2035, if proper policies are not adopted to enforce substantial framework for healthcare, people from all around the globe will face serious problem pertaining to access. The governments will face two main hardships, while guaranteeing the delivery of health care services to respective society. First, surging rate of diseases and global viruses in whole world will definitely demand drugs for greater period of time covering considerable number of people. The cost factor overburden’s the long-suffering populace in Low- And Middle-Income Countries (LMICs). It is important to protect health care access as major challenge. The non-availability of essential medicines such as, “Direct-Acting Antiviral” (DAAs) (for hepatitis C), “insulin” (for diabetes), and “epinephrine” (for anaphylaxis) deplores the common people, shows pathetic attitude of world community. Secondly, changing levels of economic prosperity, along with increased interconnectedness in respective financial systems, will adversely affect and impact on access (Rasmussen & Onarhein, 2016).
Research and Development Vis a Vis Health
“We have no model which would meet the need for new drugs in a sustainable way. You can’t expect for-profit organizations to do this in a large scale. If you want to establish a system where companies systematically invest in this kind of area [low-cost medicines for developing-countries], you need a different system.” –
Former Novartis CEO, Daniel Wasilla, in the Financial Times, September 2006 Developing health technologies requires wise use of intellectual creation. New research in an area of health and IP can ensure the better implementation of health. The human rights measure furthers very significant legal and policy outlook, concern for health and drug-based problems (WHO, 2012).
In the recent past, the United States and India, Germany and China, Japan and Mexico became conscious, so have upgraded their IP rights and protections. In the modern study, the proper nexus got established in IP legislations and enhancing R&D of leading industries (Manap et al., 2016). It is important to make investment in health-related development projects, so that posterior generations should get the best health related solutions.
The R&D establishes proper order, formulates, and reshapes ideas as well as discoveries into need-based health production. The universal aim of health should be to ensure accessibility, affordability for the desired community. Robust R&D mechanism equipped with modern health advancements is indispensable so as to boost the available health worldwide health sector. Despite making global efforts, people are still dying by infectious diseases each year. To further and face the future prospects in the health arena drug mechanism, vaccination continuously need to be explored as well as developed. Health related research has multiple benefits, it not only improves, saves lives, but also creates cost savings, steers economic growth and enhances global security.
The scientific experiment of antiviral medicine remdesivir triumphed in prevention of disease in rhesus macaques infected with, “Middle East respiratory syndrome corona virus” (MERS-CoV), as per latest examination study performed by the US National Institutes of Health and supported by the Biomedical Advanced Research and Development Authority. Remdesivir helped from spreading the infection after application of injective dose and ameliorated the community situation of the macaques, despite the involvement of animal infection. MERS-CoV is closely related to COVID-19, which emerged in Wuhan, China in December 2019 and has led volatile health emergency in every nook and corner of the world. The promising results of this study support the case for fresh clinical trial of remdesivirto treat COVID-19. Gilead Sciences developer of remdesivir and collaborates further to promote the research (Kahn, 2020).
Global Health Technology Coalition, (GHTC) has joined civil society in urging G20 policymakers to rejuvenate research and development so as to cope up with pressing demands, which includes achieving Universal Health Coverage (UHC), against Antimicrobial Resistance (AMR) and health related obstacles. GHTC director Jamie Bay Nishi delivered remarks on advancing R&D for AMR, the face-to-face meeting with G20 officials, and the coalition provided input on broader civil society recommendations.
GHTC Focused that sustainable financing to address urgent R&D loopholes is the need of hour. G20 nations should finance the global health research projects to overcome the pandemic crisis and other emerging threats, including funding R&D for new diagnostics, treatments, vaccines, and other innovations. This should include support for multilateral institutions including the Coalition for Epidemic Preparedness Innovations 27 .
Three months ago, the World Health Organization (WHO) prequalified rVSV- ZEBOV- GP, (Ebola Vaccine) and announced that the vaccine met quality, safety, and efficiency standards - paving the way for African countries to start their own regulatory processes. RVSV- ZEBOV-GP was first used in the 2015 Ebola outbreak and later in the current on going outbreak under a “compassionate use” research protocol, where it was found to be more than 97 percent effective (Global Health Technologies Coalition, 2020).
The World Health Organization (WHO) has announced it will launch a multi-arm, multi- country clinical trial, known as the SOLIDARITY trial, for potential coronavirus therapies. A continuous effort is needed to accelerate and maintain the coherence in the Intellectual discoveries and health based human right.
The Doha Declaration
Adoption of special declaration on TRIPS agreement and public health at the WTO ministerial conference of 2001 in Doha on November 14, 2001. The member countries must be able to use medicines, vaccines, to combat on going epidemics, illnesses, or sudden threats. The primary purpose of the declaration is clarifying of unambiguousness between the fundamentals of public health and the TRIPS agreement. Medical patents were apprehended, that probably it may bypass the inventive medications, vaccination, and other necessary health discovery drugs. All such worrisome questions were taken up for consideration in the Fourth WTO Ministerial Conference, held in 2001 in Doha, Qatar, where in it embraced the watershed development in the IPR regime in the form of Declaration on TRIPS and Public Health. The agreement focused upon the adaptable nature of TRIPS, for the membership countries in dodging of drug patents for the high quality, accessibility of imperative medication. The cardinal principle of holding this special session was to delineate intimate nexus in the IPR regime and essential medication access vision through the most controversial TRIPS agreement. The Declaration affirmed the dominant power of governance in maintaining the equilibrium between the health and trade agenda of the state, to ensure safeguarded community health mechanism. It transformed stereotyped image of medical patents and championed the balanced approach of IP for overall benefit of society, rather than through commercial perspectives only. The Declaration placed great impact on national and international policies of under developed member states, emphasized upon grant of compulsory permission for use and manufacturing of generic drugs as well as their import policies, thereby to effectuate the government use provisions, and/or utilise the non- enforcement patents rules. Number of countries employed the TRIPS flexibilities as leverage in cost-based give and take up process with patent-based medicine industries. The Doha Declaration acknowledged the possible effect of drug patents. Thereby it enlarged the available transition time duration from 2006-2016 for least developed countries, which is significant move of understanding health related TRIPS obligations.
The Doha Declaration explicates that "the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health". On that basis, the Doha Declaration promotes TRIPS fundamentals, WHO openly proposed and stressed upon over the years on the vested right of WTO member states for proper and possible use of protected provisions of TRIPS Agreement in order to enhance public health protection and improve the medicine access of indigent states (Doha Declaration, 2001).
Health and TRIPS flexibilities: An Overview
Nobel laureate Joseph Stieglitz propounded that international pharmaceutical patents law, WTO agreement on TRIPS, was formulated to prejudice the least developing and developed countries. But the flexibilities were introduced so that dissidents would not undergo in the deprivation. The agreement on TRIPS adopted in 1994 is landmark legislation in IPR regime. TRIPS explored and developed prominent place of intellectual property rights, accelerated the course of advancement. Countries should incorporate reservation policies of IPR regulation mechanism with sum total of adoptable TRIPS declaration and utilize the policy frame work of Article 27 of the TRIPS “by adopting and applying rigorous definitions of invention and patentability that are in the best interests of the public health of the country,” to take up the abuse of medical patents of most important medicines and while awarding of drug patents interests of the people should be taken care of. Authorities should facilitate and enforce the process of compulsory licenses, “An important factor behind the incoherence between human rights, trade, intellectual property and public health lies in the diverse accountability mechanisms and transparency levels of these different but overlapping spheres”.
Refusal of complying with TRIPS obligations embraces the hard dispute settlement mechanism of WTO body, the panel rules of WTO and Appellate body can impose the trade sanctions. The viable TRIPS provisions, further expounded in the special Declaration on TRIPS and Public Health (the Doha Declaration) (Intellectual Property Watch, 2016),supports the claim of member nations to integrate in their respective IPR regime the provisions pertaining to patent application and usage without seeking prior permission from patent holder, as prescribed in Article 31. “Compulsory licensing” is usually inscribed in local regime so that to execute term Article 31, TRIPS do provide minimum safeguards while applying the respective legislations. In the critical crisis the enabling provisions of IPR legislation are softened to prevent the commercial use of, relieve the competitiveness conduct of pharmacy in national emergencies and other appalling circumstances. Article 5 of the Doha Declaration proposes the liberal policy of WTO Member States so as to lay down the different modes for compulsory licensing and that public health crises, it also deals with the epidemics, “Human Immunodeficiency Virus” (HIV) infectious diseases like tuberculosis, malaria, epidemics and other communicable sickness, which presents dangerous complications or other circumstances of extreme necessity (United Nations report, 2016).
The TRIPS “flexibilities” that enable member states to employ national intellectual property law, competition law, medical regulations and procurement laws to fulfil their human rights and public health obligations Flexibilities help the nation in health emergencies to cope up sudden outbreak of infections, viruses etc.
The administrative authorities may provide concession; non-voluntary licence in the patents while acting as quasi-judicial or in judicial capacity to third party on disbursement of compensation for proper utilization of patented invention even without any assent of patent holder (UNAIDS report, 2013).
Members may enact suitable provisions to control or avoid the anti-competitive practices allied with intellectual property, which encompasses the compulsory licenses granted on the pattern of anti-competitive conduct and control of anti-competitive licensing. Despite of clear provisions, the grant of compulsory licences enshrined in the TRIPS, enumerates certain difficulties, encounters trouble of revenge from government and corporations against the countries who adopted the TRIPS procedure of flexibilities. The respective battle of controversies pressed and weakened the negotiation of WTO members pertaining to use of compulsory licences. Further it restricted the innovative field of governments and corporations belonging to process of making and distributing of medical technology. One such example is, “Thailand’s 2006 decision to import generic versions of the antiretroviral medicine “efavirenz” from India under compulsory license, Thailand’s subsequent decision to issue two further compulsory licenses in 2007 for lopinavir/ritonavir and clopidogrel also resulted in retaliatory measures” (United Nations report, 2016).
Prolonging of transition periods – sought of flexible provisions under the TRIPS – is in accordance with the United Nations General Assembly 2011 Political Declaration on HIV/AIDS which persuades international organizations, especially UNDP and the WTO, to provide “assistance for the efforts of developing country Governments to increase access to HIV medicines and treatment”. Least developed countries should guarantee and strategize their policy framework to reduce the healthcare burden. The Article 66 of TRIPS agreement encourages the possible time durations enhancement to unfold the use of modern technology (UNAIDS REPORT, 2013).
In the year 2016, “the Ministry of Health of Columbia adopted resolution 2475”, promulgated that access to imantib, a medicine that show up in the WHO Essential Medicines List, was of “public interest” to cure the leukaemia. The decision opened the gateways of the protected compulsory license. The letters chronicle attempted through various domestic and foreign parties to dissuade the Colombian government from issuing a compulsory license as provided for by the TRIPS Agreement and the Doha Declaration (Ruggie, 2009).
Intellectual property rights have never been as much in news as they are in today. Several controversies have arisen e: g drug companies have been accused of taking benefit of patent and manipulating common man’s right by charging exorbitant prices for essential medicines such as AIDS drugs. Indigenous peoples and advocacy groups supporting their rights condemn corporate bio pirates for making money out of their knowledge acquired from tribal healers. Many developing countries complain about the pressure for imposition of western model of IPR regulations in an era of rapid technology.
National IPR regimes are becoming important, harmonizing minimum standards of protection. Doha declaration, TRIPS agreement all is made to simplify the process of IP protection and also to reduce the paranoia between public health service and availability of health care. The research article focuses on whether IPR regulations furnished the purpose. Amid the pandemic access to healthcare is the basic and fundamental right which cannot be put forth.
Despite all odds and difficulties, remarkable efforts are being made, but access to health care crisis looms large over least developing countries. In this pandemic situation people should get best available health care, all the obstacles should be removed. The current Covid-19 crisis engulfed the entire world, so it becomes necessary in such critical times to prioritize the health of the common people. IPR regime substantiates and subscribes the basic human rights approach, which can never be postponed and altered. TRIPS and Doha Declaration flexibilities should be fully utilized to ensure the unbridled human right. Marginalised and destitute people should not suffer at the behest of IPR development related to patents. Drug industries are becoming billionaires after preparation of new generic medicine, while rendering medicine to most neglected community of the society and for severe, deadly diseases. WHO as pivotal of health right in collaboration with human rights core bodies should look up and create new path of uninterrupted accessibility, thereby to establish sustainable healthcare development. Member States should come up with suitable and coherent mechanism with IPR to ensure the affordable and popular health care policy. Least developed and developing countries are still lagging in the enforcement mechanism of IPR regime where it is most needed, that needs to be addressed the most. It is pertinent for advancement of nation’s property, to accelerate the research in IPR related rights to meet the global health crisis. The unexplored roads of IPR, through the human rights perspective need to be studied in detail. Patientrealistic framework accountability of important drug manufacturers is the main necessity. Without enforcing liability on the large-scale drug industries by IPR rules, the health care access is likely to get affected. Henceforth, there is dire need of articulating the local policies founded on society-based examination and challenges, in consonance with international IPR regime. WHO should guide, inform the member states on the recent developments in the sector of IPR world and accordingly modify the drug regime so as to mitigate the adverse impact of intellectual creation on the human development.
World must learn from the ongoing covid-19 pandemic which devastated the normalisation of the Universe. Research oriented creations and universal health projects should be initiated, so as to understand the challenge of posterity. Intellectual advancement is a key for progress of nation but that should not be at the peril of the health. Research reshapes the health sector and furthers economic aspect of the country. IPR as a subject requires visionary approach to enlighten and enhance the standards of future. States must implement their policies in a right direction to encompass future health prospects and epidemics, collective efforts need to be taken to establish the better health care sector.
Sheremeta, L., & Knoppers, B.M. (2009). Beyond the rhetoric: Population genetics and benefit-sharing. 11 Health Law Journal, 89.
Chapman, A.R. (2001). Approaching intellectual property as a human right (obligations related to Article 15(1)(c )). 35 Copyright Bull. 4, 14–17, 28–29, 30
Helfer, L.R., & Austin, G.W. (2011). Human rights and intellectual property mapping the global interface 90. New York: Cambridge University Press.
Narula, S. (2011). The rights-based approach to intellectual property and access to medicine: Parameters and Pitfalls1.
Helfer, L.R., & Austin, G.W. (2011). Human rights and intellectual property mapping the global interface 53. (New York: Cambridge University Press.
Committee on economic, social & cultural rights, General Comment No. 17:
Commission on human rights, Res. 2001/33, U.N. Doc. E/CN.4/RES/2001/33 (Apr. 23, 2001]
Commission on human rights, Report of the High Commissioner on the Impact of the Agreement on Trade-Related Aspects of intellectual property rights on human rights, U.N. Doc. E/CN.4/Sub.2/2001/13 (June 27, 2001)
ACCESS to Medicine Report 2016
General Comment 14 paras 43(d) & 44(c).
Anna, R.R., & HusøyOnarheim, K. (2016). Towards realising access to essential medicines for all: A Vision for 2035. The Lancet Youth Commission on Essential Medicines Policies.
General Comment 14 para 12(b).
United nations development programme and the joint united nations development programme on hiv and aids, Terms of Reference: The united nations secretary-general’s high-level panel on access to medicines (New York: UNDP HIV/AIDS Group, 2016), 2.
Donald, M.N. (2015). Routine operations could save millions of lives. New York Times, April 27.
John, M. (2015). Global Surgery 2030: Evidence and Solutions for Achieving Health, Welfare, And Economic Development. The Lancet, 574.
The Editorial Board (2019). “How big pharma plays games with drug patents and how to combat it,” USA Today,
Association for molecular pathology et al. v. Myriad Genetic, Inc., et al. 133 s. ct. 2107 ( June 13, 2013)
Rasmussen, A.R., & HusøyOnarheim, K. (2016).Towards realising access to essential medicines for all: A Vision for 2035. The Lancet Youth Commission on Essential Medicines Policies.
Richard, K. (2013). $1,000 Pill for Hepatitis C Spurs Debate Over Drug Prices.
Twomey, M. (2019). Comprehensive reform to lower prescription drug prices. Center for american progress.
Infohep. (2016). Hepatitis C treatment factsheet: Sofosbuvir (Sovaldi).
U.S. Senate Committee on Finance (2015), Wyden-Grassley Sovaldi Investigation Finds Revenue-Driven Pricing Strategy Behind $84,000 Hepatitis Drug.
Rasmussen, A.R., & HusøyOnarheim, K. (2016). Towards realising access to essential medicines for all: A vision for 2035. The lancet youth commission on essential medicines policies.
World Health Organization, World intellectual property organization and world trade organization (2012). Public health Policy, promoting access to medical technologies and innovation: intersections between public health, intellectual property and trade. Geneva: World Health Organization, World intellectual property organization and world trade organization (2013).
Manap, N.A., & at el. (2016). Protecting R & D inventions through intellectual property. Journal of Intellectual Property Rights, 21, 110-116.
Ansley, K. (2020). Research Roundup: Ebola outbreak wanes, remdesivir prevents MERS corona virus disease in monkeys, and Trump's budget would cut global health programs, GHTC.
Ansley, K. (2020). Research Roundup: Ebola vaccine licensed in five African countries, Sanofi & HHS to develop COVID-19 vaccine, and digital AMR platform in Zambia, GHTC, Feb 24, 2020
Doha Declaration on the TRIPS Agreement and Public Health, WT/MIN(01)/DEC/W/2, November 14, 2001 Intellectual Property Watch, Un high-level panel on access to medicines issues “Landmark” Report 14/09/2016
World Trade Organization [Internet]. Doha ministerial declaration on the TRIPS agreement and public health, WT/MIN(01)/DEC/1: adopted in Doha on 14 November 2001. Geneva: WTO; 2013.
Dianne, N., & Olasupo, O. (2013). Using TRIPS flexibilities to facilitate access to medicines, Bull World Health Organanization, 91(7), 533–539.
Report of the United Nations secretary-general’s high-level panel on access to medicines, September 2016.
UNAIDS Report on TRIPS transition period extensions for least-developed countries, 2013
Ruggie, J. (2009).Report of the Special Representative of the Secretary-General of the United Nations on the issue of human rights and transnational corporations and other business enterprises, A/HRC/11/13/Add.1.