Written By: Vanshika Mehra
The purpose of this research paper is to understand how public health and patenting operate, and some pertinent aspects. A good public health aids and prolongs life, which in turn is one of the essentialities for a good economic and social development. Health complications, minor or major, rely on the pharmaceutical industry. Patent Regimes like The Agreement on Trade- Related Aspects of Intellectual Property Rights (TRIPS) have a major impact on pharmaceutical industry and the lives that depend on it. Application of this intellectual property right affects the accessibility, availability and affordability of medical innovations, in both developed and developing countries. Patents grant exclusive right to the inventor to use their invention and this reinforces novel innovations. However, in the medical world, the patent regimes obstruct the alleviation of sufferings of the diseased people because of difficult access to medicines, and hence, the humans’ right to health gets violated. Both, Right to Health and Patent Right, are globally recognised rights. The paper intends to study the scope of both the rights and how these can be simultaneously protected in future. The magnitude of crisis was huge during the era of HIV/AIDS when death consumed so many people because of unaffordablity or unavailability of existing medicines. Even in today’s times, the treatment of diseases like cancer, Hepatitis, Tuberculosis, etc is posed a challenge because of the expensive and unprocurable medicines. Currently, the whole world is struggling amidst the wreaking pandemic of Covid-19, a malignant disease that doesn’t have a combat treatment presently. After some useful medical invention in future, strict patent policies will hinder the easy obtainability of drugs, vaccines, etc for treating Covid-19. So, the paper also aims to highlight the tense relation between patents and prevention and/ or cure of fatal diseases. This research study can further be useful to scholars, researchers, students, medical practitioners, legal experts, academicians, etc.
Keywords: Patents, TRIPS, Public Health, Medicines, Right to Health, Covid-19.
REVIEW OF LITERATURE
- Shubra Khanna (2016) has very comprehensively and illustratively discussed about pharmaceutical patents and healthcare of the people, with special reference to poor, in India. She has highlighted the evolution of TRIPS using several case laws. It has been concluded that people’s concerns regarding affordability and accessibility of pharmaceutical products requires the adjustments within the IPR regimes. The Right to Health and Patent Right cannot be equated but balanced and hence, necessary tools must be used at both national and international levels to protect the public interest, especially of the underdeveloped and developing countries which already lack resources.
- Emmanuel Kolawole Oke (2013) has emphasized that incorporation of right to health perspective plays an important role in improving the access to medicines. In addition to the effective implementation of the international law, a prudent interpretation of the patent law while the adjudication of different relatable disputes by the domestic courts is crucial.
- Robin A. Weiss (2003) has discussed about HIV and AIDS in relation to other pandemics. The article explains the story of the battle against HIV/AIDS and nothing but an efficacious vaccine and development of therapy as the biggest factors behind its eradication. Education also plays an important role in avoiding its transmission.
- Enrico Bonadio and Andrea Baldini (2020) have highlighted the necessity to strike a balance between protection of public health and propriety rights. The article elucidates the criticism of Chinese Institute for placing more importance to earning profits through patent right. They have concluded that IPR regimes need to be adjusted during the times when public interests need to be protected.
- OECD (2020) has in its article, ‘Treatments and a vaccine for Covid-19: The need for co-ordinating policies on R&D, manufacturing and access’, discussed about the various policies which need to be formulated to ensure an equitable access to the medical products amidst Covid-19. Looking at the pace at which Covid-19 is spreading, the article stresses upon sufficiently enough production of vaccine, whenever it gets discovered.
- Anjula Gurto and Rahul Patil (2020) have highlighted the concern regarding availability and affordability level of Covid-19 vaccine once it gets discovered. It has illustratively explicated the efforts being taken up by governments, philanthropists and international organizations and various deals being made between the countries. The Intellectual Property Rights shouldn’t limit the process of essential innovation and import and export of the medical products.
Intellectual Property refers to set of legal rights that are a result of the owner’s intellectual activity in the field of literature, art, science and industry. In the absence of such protection, the inventors will be hesitant to go public with their innovations as they would know that their work wouldn’t be credited. Generally, patents, copyright, trademarks, geographical indication and trade secrets are covered within the ambit of IPR. The research of this paper revolves around Patents and Public Health.
In the context of patents, the legal patentee monopolises over the invention and makes profits by putting the invention to commercial usage. For an invention to be patented, it is very important for it to contain an inventive step. Inventive step refers to advancement in the technology in a particular field as compared to the existing knowledge, and/ or an economic significance attached to the invention, which suggests the non-obviousness. Patents do not protect ideas but the subject matter exhibited in the form of new product or new method to manufacture an existing product. One of the requirements of patent system is the disclosure of information of the invention to the public. This enlightens and serves the common man, and also encourages the running of innovation cycle as the third parties can use the invention in further development.
Every person is entitled to right to live a dignified life and right to health is one of its strands. As envisaged in World Health Organization’s Constitution (1946), it is the fundamental right of every human being to have the highest attainable standard of health. It is every state’s legal obligation to ensure the accessibility and affordability of health to everyone. It equally entitles every person to enjoy the resources dedicated to maintaining a good public health.
Healthcare includes all the goods and services which help to ensure a good physical and mental well being of the people. Improving healthcare becomes a challenge when there is scarcity of resources and humungous demand for healthcare. The medical drugs, equipments, vaccines, etc come with intellectual property rights attached to them. Right to health encompasses spectrum of rights within it and the aforementioned international conventions try equating IPRs with other forms of human rights such as right to health. Development of new technology and medicines is an important part of this right because it helps in catering to healthcare needs of individuals. There are certain flexibilities which are included with the IPR laws in order to ensure that the purpose of public health isn’t impeded and efforts are directed towards balancing the rights related to patent and health. It is very important to prudently adjust the regimes, especially during the unprecedented challenges posed by the health issues. Such situations demand the prioritization of public health concerns and ignorance of potential profits out of the medical discoveries.
The research of the paper is absolutely secondary in nature. The help of several online articles, research papers, blogs, etc has been taken to study the top in an exhaustive manner. It highlights the historical background of the laws pertinent to Patents and Public health in both Indian and International context.
The research paper aims to discuss the following:
- The scope of Right to Health and Patent Right.
- Impact of patents on increasing incidents of fatal diseases.
RELEVANT BACKGROUND FACTS AND LAWS
The concept of Intellectual Property Rights isn’t new, but it was in 500 BC when the kings started making efforts to preserve and protect the rights of the owners of the intellectual property. It was in the Greek state, Sybaris, that any new refinement in luxury was recognized as intellectual property right in the nature of patent. Statute of Monopolies, passed in Britain in 1623, was a remarkable step as the statute extended ownership right of any new invention to the creator themselves rather than guilds. Statute of Anne was yet another notable legislation in Britain, for the protection of copyrights.
Over the years, the importance of IPR has gained importance in Public International Law (PIL). Paris Convention of 1883 and Berne Convention of 1886 form the substantive part of IPR in PIL. However, these conventions do not manage to create homogeneity among the countries. Trade Related Aspects of International Law Agreement (TRIPS) of 1995, a comprehensive multilateral agreement, between the member nations of World Trade Organization (WTO) addresses the loopholes of Paris Convention and Berne Convention. It specifies minimum standards of protection of IPR, enforcement procedures, remedies and dispute resolution procedures. According to Article 1 of the Agreement, the members can determine the appropriate method of implementing provisions of the Agreement, provided that the protection laws provided by them aren’t in contravention with what is laid in TRIPS. Members can legislate according to their suitability, provided they abide by the principles as enshrined in Article 8 of TRIPS. Members may adopt the measures which are essential to protect public health, promote public interest in vital sectors and ensure socio- economic and technological development provided the laws and regulations aren’t in contravention to the provisions of TRIPS and prevent the abuse of IPR. By having such kind of flexibility the government can simultaneously focus on achieving the social goals. For developing and propagating new intellectual property rights, World Intellectual Property Organization (WIPO) formed two new treaties i.e. WIPO Copyrights Treaty 1996 and WIPO Performances and Phonograms Treaty 1996.
In the context of Indian IPR Law, Patents Act of 1856 was the first one to be introduced. Following this, other specific IPR laws were made. In order to be in compliance with TRIPS, several amendments were made to Indian IPR Laws and the first amendment was made in 1999 with the objective of including pharmaceutical invention. The second amendment in 2002 extended the term of patents to 20 years. The 2005 Amendment was major step which enabled the granting of patents in all the fields of technology including drugs, chemicals, food, etc. The addition of Section 3(d) introduced the pharmaceutical product patents for the first time in India. Changes to other IPRs have also been made at different points of time. But, India is still in the transition period and has yet to absolutely comply with TRIPS.
Section 5 of TRIPS is dedicated towards Patents. Within it, the articles state and explain several aspects of patent right, for instance, Article 27 is about the patentable subject matter, Article 28 is about the rights conferred, etc. Currently, The Patents (Amendment) Act 2005 is used in India. According to it, pharmaceutical products” means any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address public health problems and shall be inclusive of ingredients necessary for their manufacture and diagnostic kits required for their use. A pharmaceutical product applied for patentability must have substantial efficacy and serve public health.
FINDINGS AND ANALYSIS
- The Scope of Right to Health and Patent Right.
Patent Right: Patent is an exclusive right for the protection and exploitation of the original, novel and innovative invention by the patentee (owner), and it generally extends up to 20 years. The patent right pays off the time and effort of the inventor by helping it create a strong position and positive image in the market and earn high returns on the investment made. This acknowledgement and financial reward, followed by the invention, reinforces creativity and innovations. The patentee also has the right to decide if they want to exclusively exploit the patent or to grant license their right and put the patented subject matter to commercial use by the licensee. If they license it, they can earn in the form of royalty. This in turn enlightens and serves the public and encourages third parties to contribute in further development. In case of infringement of the patent right of the owner, Section 108 of the law provides for remedies in the form of interim injunction, damages on account of profits or permanent injunction.
Right to Health: Every individual is free to control their health and body, without any kind of unwelcomed or non-consensual interference, and is entitled to lead a life consisting of highest attainable health. International Conventions namely, Universal Declaration of Human Rights (1948), Convention on the Elimination of all forms of Discrimination against Women (1979), The Convention on Rights of the Child (1989), International Covenant on Economic, Social and Cultural Rights (1966), and International Covenant on Civil and Political Rights (1966) recognize the right to health of the individuals and obligates the states to ensure the protection of the same. In 2015, United Nations General Assembly adopted a new developmental agenda, Transforming Our World: The 2030 Agenda for Sustainable Development, which is going to have major implications on the health sector because health is centrally positioned within Sustainable Development Goal 3: Ensure healthy lives and promote well being for all at all ages. It focuses on realization of importance of achieving this goal as a good health for all is an intrinsic approach towards inclusive growth of human personality.
Under Part III of Indian Constitution, Article 21 (The Fundamental Right to Life and Personal Liberty) of India Constitution is interpreted to include right to health within its ambit as it ensures a dignified life. Under Part IV of Indian Constitution, there are Directive Principles of State Policy concerned with the state’s obligation to ensure a good health condition of the people. Article 38 states the responsibility of the state to promote welfare of the people by maintaining an effective social order. Article 39(e) is related to the health of workers. Article 41 provides for the state’s obligation to provide public assistance for old, sick and disabled people. Article 43 directs the state to ensure a decent standard of life of workers. So, Right to Health is considerably covered within the Constitution of India and hence lives up to the spirits of mandates International Organizations.
Doha Declaration 2001 in the Wake of Concerns Pertaining to Public Health Protection: During the end of 20th century and beginning of 21st century, the developing countries started having concerns about the obstacles they had to face in accessing the affordable medicines to protect public health, especially while controlling serious diseases like HIV, Tuberculosis, Malaria, etc. In response to this, 2001 Doha Declaration on TRIPS and Public Health was adopted. The Doha Declaration affirms that “the TRIPS Agreement does not and should not prevent members from taking measures to protect public health”. While adopting this separate declaration on TRIPS and Public Health, it was stressed that TRIPS needs to be interpreted and implemented in a way that public health is supported both by access to existing medicines and creation of new one.
Not only this, Doha declaration also stressed upon other flexibilities and reinforced them. Compulsory licensing enables the government of a country to grant the licence to use the patented invention to a third party or a government agency without considering the consent of the patent holder. This is done in order to address a situation of extreme urgency like national emergency. In addition to the possible grounds of granting compulsory licence stated in the Agreement, the Declaration states that each member has the right to the freedom to determine the other grounds upon which such licences are granted. Further, practices related to parallel importation cannot be challenged under WTO’s dispute settlement system. Parallel importation is the importation of the patented product, without the consent of the patent holder, marketed in another country either by the patent holder or with the patent- holder’s consent.
Ineffective Implementation: Despite the provision of the flexible norms and reaffirmation by Doha Declaration 2001, the developing countries haven’t been able to implement them beneficially, because of the pressure from industrialized countries. It is doubtful that if a country takes an extreme measure in its patent regime; such as excluding a pharmaceutical product from patent protection; this may lead to imposition of trade sanctions by other countries owing to the non-compliance to TRIPS Agreement. Articles 7, 8, 30 and 31 of the Indian Patent Act reflect that the efforts have been made to ascertain the promotion of innovative development in the pharmaceutical industry and to realise the objective of achieving the social and economic welfare. Even though, through the evolution of IPR related laws aimed at equating and balancing the patent right and the right to health, it hasn’t been absolutely successful.
The Unequable Rights: Right to health is a fundamental human right and thus it is unalienable, timeless and universal in nature. On the other hand, Intellectual Property Right is instrumental and temporary in nature and can be licensed, revoked or assigned to someone else. The international conventions like ICESCR and UDHR recognize both these rights but they don’t equate them and it will be erroneous to do so. It is the state’s obligation to ascertain that people’s right to health is shielded. In an Indian case of People’s Union of Democratic Rights v. Union of India it was held that it is the state’s constitutional obligation to make sure that the fundamental rights of any person aren’t violated. So, there is the government’s responsibility to see that social welfare measures are practiced. When there comes a tension between the two rights, dignity and health must be prioritized over the intellectual property right.
The Other Side of the Coin: It is important to attach a right to health perspective to the patent right, however the ultimate resolution of the conflict between the two rights doesn’t always have to be the same. Sometimes, it might be possible that patent right doesn’t fails the purpose of right to health and the patentee’s right needs to be regarded. in the South African case of Aventis v. Cipla,the South African Supreme Court of Appeal granted an injunction to restrain the infringement of the patent on a drug (Docetaxel) after having satisfied itself that the injunction would not necessarily impede access to the drug in question as the patentee (Aventis) was already supplying the patented drug to the South African government at a price cheaper than that of the defendant’s (Cipla) generic version.
- Impact of patents on increasing incidents of fatal diseases
According to Merriam- Webster, a fatal disease is the disease that takes away or is capable of taking away the lives of humans. Cancer, Tumours, Tuberculosis, Cirrhosis, Alzheimer, etc are various deadly diseases. Other than these, there have been a lot of outbreak, epidemic and pandemic situations in the world, leaving devastating impacts. The current corona virus pandemic has crossed the bounds of continents and has lead to a huge death toll. There have been such major wrecking occurrences in the history as well, for instance, Polio Epidemic (1900), Sixth Cholera (1910- 1911), Hong Kong Flu (1968), HIV/AIDS (1981- present), etc. These excruciating incidents have majorly affected the ones living in the developing or underdeveloped countries of the world.
The Battle against Poliovirus Epidemic: Over the years, with development in pharmaceutical industries, the fatal diseases have been fought with. Poliovirus epidemic, which originated in 1875, contagiously spread across the countries and had began to affect the digestive system and nervous system. Where the surging up number of polio affected people wasn’t coming to a halt, now it has been eliminated from all over the world, leaving some. At the end of 2017, polio remained endemic in only three countries: Afganistan, Nigeria, and Pakistan. Although the risk of getting caused remains in a few countries, the massive vaccination efforts by the pharmaceutical industries of countries like USA, India and European Countries have enormously eradicated the disease. Albert Sabin and Jonas Salk made the contributions in coming up with the vaccines, but neither of them patented their discoveries and the vaccines were donated for serving the mankind. Oral polio vaccines are widely provided to children around the world because they are cheap. This has especially alleviated the sufferings of under-developed nations because the occurrences of crippled children has mitigated and has almost got eliminated.
HIV/AIDS and Doha Declaration: Discussing about the major pandemic situations, HIV/AIDS is a chronic and life-threatening condition which claimed lives of around 50 million people of the world. Human Immunodeficiency Virus (HIV), causing Acquired Immunodeficiency Syndrome (AIDS), originated from West Africa and got transferred to humans from chimpanzees. As of 2019, 38 million people were globally living with this disease.
When HIV was becoming a pandemic and there were crises of accessibility of medicines, at the same time, WTO was also created and global standards for protection of IPR were laid through TRIPS Agreement in 1996. In 1996 itself, Highly Active Antiretroviral Therapy was discovered to fight the battle against HIV/AIDS and make the lethal disease a manageable chronic one. HAART isn’t sufficient enough to rid the person off the disease. Once the therapy discontinues, the virus load rebounds to the previous level. Hence, it requires life-long use, but, because of the high prices of live- saving drugs, the poor access was resulting into staggering loss of lives.
Back then, India was in a transition period, so it was offering the generic version of Antiretroviral drugs for importation in other countries, however other countries raised several controversies against this. Where health groups, treatment activists and health professionals demanded greater ﬂexibility in the application of patent law , there, in 1998, a group of 39 pharmaceutical companies along with the Pharmaceutical Manufacturers Association of South Africa sued the South African government over its medicines act, which included provisions to increase access to lower-priced medicines.
As a direct response to the countries’ struggle with AIDS, Doha Declaration was adopted which signaled a vast change in patents and medicines by allowing countries to give primacy to protection of public health. In 2002, the WHO encompassed several HIV medicines to Essential Medicines List. In addition, Global Fund to fight AIDS, Malaria and Tuberculosis was created and the ‘3 by 5’ campaign was initiated by the WHO. Some companies, considering the gravity of the illness, voluntarily licensed their medicines. UNITAID created the Medicines Patent Pool (MPP) for HIV medicines to ensure licenses related to patents needed to produce WHO recommended ARVs were available to generic producers.
Covid-19, The Unprecedented Challenge: In the wake of Covid-19, various countries, companies and universities have begun co-operating in order to put an end to the ruination. The ‘open COVID pledge’ was signed by many universities and companies for encouraging the development of treatments and cures, and assuring researchers the access to technology which enables the mass production of masks, diagnostic kits, medicines and ventilators, etc.
In the times of crises like this, it is very important to make the IP system flexible and allow for the licensing of the medical products. In the early 2020, Wuhan Institute of Virology was criticized for its decision to seek patent for Remdesivir, a drug that was originally researched and produced by Gilead Sciences. To let go the enforcement of its patent right on the drug, it put a condition asking for the collaboration of Gilead in helping the Chinese Authorities fight that Covid-19 Pandemic. Being a signatory to WTO, it could have invoked compulsory licensing of the drug, but it gave an upper edge to earn profits rather than showing concern towards the public health of people living in China.
Compulsory licensing reduces the price of the drugs. Considering the current situation, Israel had issued a compulsory license for Kaletra, an HIV drug which was being tested for effectiveness to inhibit COVID-19, to an Indian Drugmaker named Hetero to manufacture the generic version of the drug. Countries like Chile, Ecudor, Canada, Germany, etc have been making efforts to involve the policies which can ensure the affordability and accessibility during such crucial times. Countries have been showing a great deal of co-operation during pandemic. For instance, French Pharmaceutical Company Sanofi has declared that it would deliver the first shipment of any vaccine, which it would develop, to US because of high-risk early investments made by America. The international organizations, World Health Organization and European Union have been in dialogue and exploring ways to create a patent pool and buy the medicinal rights over Covid-19 medicines and vaccines.
Russia’s Gameleya Institute of Epidemology and Microbiology has come up with the first vaccine, Sputnik, against Covid-19 and is prepared to share the technology with world. Most under-developed and developing countries are relied on leading pharmaceutical firms for the cure to the malignant disease. The IPR Laws cannot be given the opportunity to create financial barriers in solving difficulties posed by the current global health crises. There are many companies which have transparent in sharing the medication based information and the helpful treatments. Where the companies with remarkable research and development adeptness desire to monopolize, the prices of the vaccines, medicines, etc will have to be kept close to the cost that goes in their production.
The findings of the research reflect that the discoveries alone in the field of pharmacy aren’t enough to overcome the adversities of the health issues. But, the IPR Laws also influence the procedure. Following are the suggestions/ recommendations which can be taken into consideration while grappling with the health issues:
- If patent right encourages innovations and novelty, it also leads to increase in the prices of the products. During the times of crises, it is very important to contain such prices in order to ensure affordability and accessibility. So, the government should take steps to make the IPR laws flexible during such times. The Doha Declaration 2001 has also stressed upon the interpretation of TRIPS Agreement in a way to give paramount importance to public health. It has also clarified the rights of the countries to grant Compulsory Licenses. Compulsory Licenses do not entail the permission of the patent holder to be a pre-requisite.
- Companies can use the mechanism of Voluntary Licensing as well. Although it involves various disagreements but it is very helpful when one research depends on another.
- Open Innovation is a brilliant way of managing IPR related management. Open innovation is basically expand the research by not just relying on the research at personal level, but also buying or licensing processes or innovations from other firms or companies. It also encompasses creativity presented by the customers. The initiative promotes broad and equitable access to the innovations. Universities like Hravard and Standford have adopted this initiative amidst Covid-19.
- Patent Pool is yet another tool to deal with the IPR crises. It is an arrangement which allows two or more patent holders of technologies to license them as bundles to third parties. Licensing technologies that require simultaneous use of several technologies reduces the transaction cost. There are different rules of different patent pools. The Medicine Patent Pool (MPP), UN backed public health organization, has also extended its mandate to be able to play such a role for COVID-19 related vaccines or medicines.
- Considering the Covid-19 scenario, advance agreements on how to co-operate and manage the medical supplies is a suggested way through which things involving IPR can be made certain along with protecting right to health of the people. For example, New Zealand and Singapore have signed New Declaration on Trade in Essential Goods for Combating the Covid-19 Pandemic. It is an open plurilateral initiative which can enable other countries to join at any point of time.
- Encouraging public pharmaceutical manufacturing facilities can also prove to be effective as it would tackle the affordability issues and also enhance domestic innovation.
On the basis of the historical background and further findings, it can be concluded that the IPR related regimes, in particular patents, must be managed and implemented with due care and caution. It is paramount to attach to right to health perspective with the patent laws, because it is a key factor for addressing and protecting people’s concerns towards health. During the times of outbreaks, epidemic and pandemic, the public relies on the system for affordability and accessibility of the life- saving drugs against the malignant diseases. It is the companies’ and government’s willingness to occasionally set aside the financial considerations in the wake of moral and ethical concerns rose during unprecedented times, that the public interests can be shielded. So, it is important that efforts are made to strike a balance between patent rights and right to health, and ensure that patent regimes don’t detriment the process of mitigating or eliminating a particular disease and ameliorating the condition of people trapped in associated hardships.
 KPMSOL, NMIMS, Mumbai
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 Supra Note 2
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 Supra note 27
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