We are in midst of Pandemic Covid19 which has taken lives of nearly half a million infected more than 7 million as of now this article is written. With the search for a Covid-19 vaccine, enormous attention and funding have been focused on developing and mass production. The rapid spread of Covid19 Novel Coronavirus has led experts to declare that it would continue to spread if a vaccine cannot be found. The outbreak was declared a Public Health Emergency of International Concern on 30 January 2020.[1]
“This outbreak is a test of political, financial and scientific solidarity for the world to fight a common enemy that does not respect borders… what matters now is stopping the outbreak and saving lives.”- Dr Tedros, Director General, WHO
In response to the global race to combat the Covid-19 pandemic, the World Health Organization embraced a proposal to create a voluntary pool to collect patent rights, regulatory test data, and other information that could be shared for developing drugs, vaccines, and diagnostics.
The notion was raised several weeks ago by Costa Rican officials amid mounting concern that some Covid-19 medical products may not be accessible for poorer populations. By establishing a voluntary mechanism under the auspices of the WHO, the goal is to create a pathway that will attract numerous governments, as well as industry, universities and nonprofit organizations.
“We want to create a repository,” said Costa Rican President Carlos Alvarado Quesada in a media briefing Friday that WHO leaders described as a “pre-launch.” He added that “the idea is to make available for everybody around the world the different advances and innovations and put those into service at lower costs to protect people… This is a call for solidarity and a call for action” to defeat the novel coronavirus.
In a race among countries to develop the vaccine, issue of pharmaceutical patent protection has been raised to the heights of the global discussion on future of free trade initiative. It is important for the vaccine community to provide technical support to developing country governments in the creation of IP laws that not only support innovation and respect international law but also safeguard public health access against unmerited patents. Indeed, as has been demonstrated in other disease areas where patents have posed problems to access, creating patent laws with stricter patentability criteria that weed out low quality patents can help remove some of the barriers. It is suggested that improved transparency around patenting of vaccine technologies, stricter patentability criteria suited to local needs and strengthening of IPRs management capabilities where relevant, may be necessary in order to reduce patent related impediments. Greater attention to these issues through technical support in IP management and FTO analyses, monitoring developments in the industry and sustained engagement with stakeholders for systematic need assessment and identifying solutions can help encourage a competitive supplier base for quality vaccines at sustainably low prices.
In a study conducted by Gavi[2], it was found that IPRs, particularly patents or perceptions thereof, can create obstacles for developing country vaccine manufacturers to enter into the vaccine market.
The astronomical costs of research and development involved in bringing new and effective medicines to market and the epidemic levels of current Covid19, HIV/AIDS, tuberculosis, malaria, and other diseases are at the heart of this debate. The line of interests is unfortunately clear, with the developed countries seeking to protect their valuable pharmaceutical industries, and the developing countries struggling to meet the demands of their sick citizenry for more affordable medications. If the question were one of taking from the rich to give to the poor, a simple answer based on morality and social justice would suffice. Unfortunately, the reality is much more complex and potentially tragic.
WTO & TRIPS
The WTO, in its fact sheet[3] relating to pharmaceutical patents, proposes that the philosophy underlying the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement is one that seeks to strike a balance between the long-term social objective of providing incentives for future inventions and creation, and the short-term aim of allowing people to use existing inventions and creations. The interplay of these two, often contradictory, objectives reverberates along lines that divide the developed and developing world and provides the backdrop for understanding a complex problem involving questions ranging from social justice and morality to economic and investment theory.
The TRIPS Agreement covers intellectual property rights in general, and more specifically, subject matter relating to mechanisms of protection such as patents which serve the purpose of preventing others from making, using, or selling a new invention for a limited period of time.[4]
Furthermore, through TRIPS, developing countries agreed to increased standards for Intellectual Property rights protection, while receiving few or no concessions from developed countries to ensure the availability of necessary goods, such as essential medicines. Thus it came as no surprise that conflict quickly arose over the implementation of TRIPS. This conflict was particularly heated in the area of public health. The rise and spread of diseases such as AIDS, tuberculosis and malaria caused many countries to look for a way in which they could protect access to medications, whether through compulsory patent licences, allowing the production of generic forms of medication, or by declaring a national health emergency. This led other countries, particularly those with developed pharmaceutical industries, to argue that TRIPS protected their own domestic patents. Generic medication producers and suppliers in poor countries even their production by disputation that journeys permits for even infringement of patents for the aim of protective public health. However, the extent to which the agreement was supportive of public health became highly controversial, particularly around the time when most of the substantive obligations of the agreement for developing countries came into force in 2000.
It is from within the framework of the TRIPS Agreement that the issue of international pharmaceutical patent protection should be discovered. From the balance that TRIPS attempts to strike between the pharmaceutical companies who seek to protect their investments in research and development and the undeniable need for affordable drugs in the developing world, to the incorporation of numerous exceptions as to government’s obligations under TRIPS, the application of the multilateral agreement’s provisions has been filled with contention and controversy.[5] The central role of TRIPS in the debate about the future of free trade was evinced most recently in the November 2001 WTO ministerial meeting in Doha, Qatar, where discussions on the topic resulted in a separate ministerial declaration on the TRIPS Agreement and public health.
Exceptions to the TRIPS Agreement
As described previously, the balance sought by the WTO in the TRIPS Agreement is underpinned by a philosophy that holds that member nations must be given the flexibility they need in enacting intellectual property laws so as to make the process politically and socially viable. This flexibility, as reflected in the mechanisms and exceptions described below, is the result of the efforts of the developing and least developed countries to incorporate their concerns into the debate following the creation of the WTO and about the growth of free trade initiatives. From the contention that requiring countries to strictly enforce pharmaceutical patents enables drug companies in the developed world to charge exorbitant prices that the poor cannot afford, follows the push for flexibility in enacting intellectual property laws. The following is a description of the language in the TRIPS Agreement, which creates exceptions to the provisions requiring patent protection.
Under Article 27 of the TRIPS Agreement dealing with patentable subject matter, member governments can refuse to grant patents for three reasons. Article 27(2) states that members “may exclude from patentability inventions, [when] prevention within their territory [for] commercial exploitation … is necessary to protect ordre public or morality, including to protect human, animal, or plant life, or health or to avoid serious prejudice to the environment [.]” Similarly, a government can refuse patents under Article 27.3 (a) and (b) for diagnostic, therapeutic and surgical methods for the treatment of humans or animals, and for plant and animal inventions excluding those dealing with micro- organisms.
The notion that the public good may, under certain circumstances, outweigh the right to have one’s innovation and creation protected is further developed in Article 8 of the TRIPS Agreement. Article 8 of TRIPS reads as follows:
- Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.
- Appropriate measures, provided that they are consistent with the provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices, which unreasonably restrain trade or adversely affect the international transfer of technology.
Soon after its adoption, the content of Article 8 gave rise to a practice whereby countries began to invoke TRIPS as the basis for the argument that their domestic health crises necessitated the amending of their laws regarding intellectual property rights (or their immediate non-enforcement) in order to protect the public interest.39 In relation to Article 8, it is important to note that this section of the TRIPS Agreement holds another major concession made to the developing nations in its adoption. The developing countries had argued for a form of research “piggy-backing,” which would allow for the further development of pharmaceutical products during the patent term. The theory for allowing this type of research on patented product was that the balance, which the TRIPS Agreement sought in principle, is better approached by allowing a form of forced collaboration between pharmaceutical companies, while simultaneously seeking to protect the patent through the minimum twenty year term. This concession to the developing countries is adopted in Article 8(2) and is commonly referred to as the “regulatory” or “Bolar” exception. Under this exception, some countries allow manufacturers of generic drugs to use the patented invention for research and development as they work their way through the pharmaceutical drug-approval process, without the patent owner’s permission and before the patent protection expires. The idea behind this exception is that it speeds up the process of bringing generics to the local market after the patent term has expired.
This practice has been upheld by the World Trade Organisation’s dispute resolution body in a decision where a Canadian law allowing this exception was held to be in conformity with the TRIPS Agreement.[6]
Another concession to the TRIPS signatories from the developing world is Article 31, which encompasses what is described as “other use without authorization of the right holder.” This provision of the TRIPS Agreement grants member governments the right to legitimize compulsory licensing. This form of licensing allows a non-patent holder to produce the patented product or process absent the consent of the patent’s rightful owner. Article 31 tries to limit the circumstances under which compulsory licensing can be utilized. Article 31(b) requires that under most circumstances, “the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions, and that such efforts have not been successful within a reasonable period of time.”
Additionally, Article 31(h) requires that after a compulsory license is issued without the consent of the patent’s holder, “the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization.” As revealed by the language used in outlining the circumstances under which “other use without the authorization of the right holder” is permitted, the protection of patent rights is open to significant challenges even in countries agreeing to the provisions of the TRIPS Agreement in general.
The requirement is that “efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time” is uptight with ambiguity and is highly problematic from the perspective of the patent right holder who, in all likelihood, cringes at the sight of the word “reasonable” appearing twice in one sentence. Because of the ambiguity contained in the Article, it has been central to the debate about the enforcement of patent rights in the developing world, where arguably the level of infections from dis- eases like HIV and AIDS have created a “national emergency or other circumstances of extreme urgency” in many signatory countries. The implications of this argument will be discussed further following this section on exceptions to patent protection.
The TRIPS Agreement does not oblige member countries to introduce penal sanctions for patent rights violations either. A country may leave it to the patentees to enforce their rights through civil remedies. A large multinational pharmaceutical company would probably be more reluctant to pur sue its claim on patent protection if it had to go through a civil law suit rather than have the state prosecutor do the job. In many cases, developing countries have difficulty mustering the legal and technical expertise necessary to take advantage of the flexibility provided by the TRIPS Agreement. Moreover, the sheer complexity of setting up a patent protection scheme could prevent a country with inadequate resources from effectively using the flexibilities built into the TRIPS Agreement. Technical assistance is thus needed to ensure that policy-makers are aware of the options available to them when they are amend
Side-effects of Enforcement of IPR under the TRIPs Agreement
The TRIPS Agreement sets out the only comprehensive multilateral framework to enforce intellectual property rights. It contains a set of minimum standards that protect intellectual property rights while avoiding barriers to legitimate trade.[7] These standards include civil court procedures and remedies that should be made available, such as injunctions, damages and orders for the disposal of goods that are infringing trademarks. These remedies must be available for all the intellectual property rights covered by the TRIPS Agreement, including patents, test data protection, trademarks and copyright.48 Administrative procedures, such as actions before administrative authorities, are optional and have to conform to the principles applicable to civil procedures. A wider range of procedures, including customs measures and criminal procedures, must be available for counterfeit trademark goods, as defined in the TRIPS Agreement, including medical products, and for pirated copyright goods.50 The TRIPS Agreement also includes certain general obligations or performance standards which provide that WTO members must ensure that these specific enforcement procedures permit effective action, including expeditious remedies to prevent and deter infringement. The TRIPS Agreement clarified that WTO members are not under any obligation with respect to the distribution of resources between the enforcement of intellectual property rights and general law enforcement. The TRIPS Agreement also gives members powers to adopt procedures to enable a rights holder, who has valid grounds for suspecting that the importation of counterfeit trademark or pirated copyright goods may take place, to lodge an application in writing with competent administrative or judicial authorities for the suspension by the customs authorities of the release into free circulation of such goods.[8] Members may also provide for corresponding procedures concerning the suspension by the customs authorities of the release of infringing goods destined for exportation from their territories. It is understood that there shall be no obligation to apply such procedures to imports of goods put on the market in another country by or with the consent of the rights holder, or to goods in transit.
The TRIPs Agreement defines ‘counterfeit’ in relation to trademarks in a general manner, not specific to the public health sector, and thus subject to abuse, and further provides members with powers to enable a rights holder, who has valid grounds for suspecting that the importation of counterfeit trademark or pirated copyright goods may take place, to lodge an application in writing with competent authorities, administrative or judicial, for the suspension by the customs authorities of the release into free circulation of such goods. Such provision in the TRIPS Agreement has been a basis for abuse by patent holders.[9]
Conclusion
Health is a fundamental human right; indispensable for the exercise of many other rights, in particular the right to development, and necessary for living a life in dignity. The realization of the right to health is also a fundamental goal of state policies and programmes, regardless of their economic, social, cultural, religious or political background.[10] Nevertheless, for millions of people around the world, the full enjoyment of the right to health remains an illusive goal, which is partly due to the obstacles in accessing affordable medicines of good quality, and in a timely fashion, mostly in the LDCs (Least Developing Countries). This constitutes a challenge to human dignity, the basis of all human rights, including the rights to life, health and development of all persons. From a human rights perspective, access to medicines is intrinsically linked with the principles of equality and non-discrimination, transparency, participation and accountability.[11] It is therefore important that gains under Doha Declaration are maintained and not lost. This is only possible if the issue of access to medicines at risk is addressed. Addressing this means that the TRIPS Agreement goes a step further and provides safeguards against the abuse of the enforcement provisions. The WHO also needs to play a stronger role and create a regional treaty for LDCs that will promote research and development of neglected tropical diseases that affect LDCs. This will strike a balance between the production of low cost generic drugs and the promotion of research and development of neglected tropical diseases for LDCs thus leading to their securing access to medicines.
Access to essential medicines has gradually come to be recognized as part of the human right to health, enforceable under both international and national laws.[12] Access is defined as having medicines continuously available and affordable at public or private health facilities or medicine outlets that are within one hour’s walk from the homes of the population. The UN Committee on Economic, Social and Cultural Rights (CESCR), authoritatively recognized access to medicines as a means of fulfilling the right to health in General Comment 14. Paragraph 43 of General Comment 14 stated clearly, for the first time, that state parties are obliged ‘to provide essential drugs, as from time to time defined under the WHO Action Programme on Essential Drugs’ and ‘to ensure equitable distribution of all health facilities, goods and services’.
Delay in distributing vaccines where they are needed most has a devastating human cost. Many of the reasons offered for the disparity in vaccine distribution between rich and poorer countries can now be challenged with new evidence and better understanding of the underlying problems Wider global availability of affordable vaccines can be achieved through building local or regional clinical trial and vaccine production capacity Implementation research, by directly demonstrating the benefits of vaccination, can spur country-level leadership.
Since the current environment of free trade agreements may further heighten IP barriers, patents may play a bigger role in the future in influencing manufacturers’ decisions to develop innovative vaccines in a timely manner. As more patents are filed they may become an obstacle (whether granted or not) simply by creating a level of uncertainty that is not a feasible risk to some manufacturers. Increased filing of patent applications with broad claims or which are not merited because they are not new or lack inventiveness could also deter companies or governments from supporting innovative vaccine development. The latter may have other negative consequences, such as creating mistrust among governments in developing countries on collaborative vaccine development projects.
References:-
[1] https://www.who.int/emergencies/diseases/novel-coronavirus-2019/
[2] Chandrasekharan, S., Amin, T., Kim, J., Furrer, E., Matterson, A., Schwalbe, N., et al. (2015). Intellectual property rights and challenges for development of affordable human papillomavirus, rotavirus and pneumococcal vaccines: Patent landscaping and perspectives of developing country vaccine manufacturers. Vaccine, 33(46), 6366-6370. doi:http://dx.doi.org/10.1016/j.vaccine.2015.08.063
[3] https://www.wto.org/english/tratop_e/trips_e/factsheet_pharm00_e.htm
[4] World Trade Organization, TRIPS and Pharmaceutical Patents WTO OMC Fact Sheet (Apr. 2001), available at http://www.wto.org/english/tratop_e/trips_e/ trips_e.htm.
[5] World Trade Organization, Governments Share Interpretations on TRIPS and Public Health (June 20, 2001), available at http://www.wto.org/english/news_e/ news01_e/trips_drugs_010620_e.htm
[6] World Trade Organization, Canada – Patent Protection of Pharmaceutical Products (Mar. 17, 2000), at http://www.wto.org/english/tratop_e/dispu_e/distabase_ wto_membersl_e.htm
[7] Part III: Agreement on Trade Related Aspects of Intellectual Property Rights.
[8] Article 51 of the TRIPS Agreement.
[9] Article 51(2) of the TRIPS Agreement.
[10] http://www.ohchr.org/EN/Issues/Development/Pages/AccessToMedicines. aspx.
[11] ibid
[12] Hogerzeil, H.V. and Mirza, Z., 2012, ‘The World Medicines Situation 2011: Access to Essential Medicines as Part of the Right to Health’, Geneva: World Health Organization, pp.1–12
