This article has been written by Ms. Aarshiya Punera, a second-year student at Law Centre-II, Faculty of Law, University of Delhi.
ABSTRACT
The visible debate around IPR in the Pharmaceutical industries is mainly about finding a balance between rewarding the Intellectual Property owners and securing the larger general interest of society. This article reiterates the concept of Essential medicines as given by the World Health Organization (WHO) and aims to examine and understand the role of non-governmental organizations (NGOs) in this IPR debate concerning the accessibility of drugs to all.
Keywords: Intellectual Property, Essential Medicines, Access to Medicines, Pharmaceutical Industry, Pharmaceutical Patents, NGOs
ACCESSIBILITY OF MEDICINES
The World Health Organization (WHO) defines Essential medicine as medicines that are fundamental for treatment, are effective and trusted, and are available at all times, in adequate amounts in the nearest healthcare facility. These medicines are procured at affordable prices by the individuals of a particular community.
Post the acceptance of the concept of “Essential Medicines” at the Alma-Ata Declaration in 1977, each member state was to roll out a list of Essential Medicines. These Essential medicines lists (EMLs) are specific to the community. They are specifically tailor-made to fight the disease prevalent in the community. They are tested for their efficacy and are cost-effective. BCG vaccines, anti-rabies, Hepatitis B vaccine, oral rehydration salts, etc are some of the medicines notified by the Ministry of Health and Family Welfare in the National List of Essential Medicines (NLEMs) 2022.
Heath, today is a holistic concept. It is not merely the absence of a disease but the complete mental, physical, and social well-being of an individual. The dynamic aspect of health and well-being involves availability, affordability, and accessibility to efficient and appropriate healthcare. One of the fundamental ingredients of healthcare is medicines and essential life-saving drugs.
Despite India being one of the largest exporters of generic drugs and low-cost effective vaccines, 50-80% of the Indian population does not have access to medicines.2 Basic medicines like paracetamol, antibiotics, anti-snake venom, and anti-rabies are hardly present in adequate quantities in Primary Health care facilities.2
The various factors leading to the inadequacy of drug availability are discussed below.
CHALLENGES IN ACCESS TO MEDICINES
One of the fastest and most economical remedies to ensure large-scale makeover in the healthcare of a country is to ensure accessibility of medicines to everyone. The major challenges that developing countries including India’s face concerning drug accessibility are the limited production compared to the overwhelming population that depends on the production, the presence of fake medicines, inefficient drug-delivery and drug-procurement systems, and a limited pool of patented medicines.
The common challenges to access to medicines are discussed under:
Insufficient investments and engagement in R&D: Many diseases that do not affect a large population and do not occur frequently do not get to be the subject of research and development. The incentive for pharmaceutical companies is to make a profit by the production and commercialization of efficient drugs. Such “Neglected Diseases” are not profitable enough for the pharma companies because of the limited number of people they affect, thus creating a limited pool of drugs available for the treatment of such diseases (if it is available at all). Mostly Tropical diseases and rare immune-deficient diseases fall under this category.
Supply chain management: The production of medicines in one thing and its adequate supply to the targeted population in another. Limited production of medicines may still be less harmful if the supply chain management is efficient, fast, transparent, and accountable. The subsidized medicines available at public facilities operate at the grassroots level and boost “access to medicine” in the real sense as these public facilities are the first point of contact for the patient.
Rampant corruption and heavy regulatory and legal compliance may sometimes impair the ability of the state to make available essential drugs and other generic drugs at all times in healthcare facilities.
It is common to see Primary Healthcare facilities running out of basic medicines and necessary life-saving drugs. Despite government efforts like Ayushman Cards and Jan Aushadhi Kendra, the non-availability of certain essential and life-saving drugs at these centres forces the common man to buy medicines from expensive private facilities, thus hindering access to medicines.
High cost of patented drugs: The most inevitable challenge in the present debate is the high cost of patented drugs.
To produce a new drug requires investment in the form of both, working and fixed capital. Above this, the final product is patented by the companies to prohibit its competitors from making, using, or selling the same formulation in the market. Filing for a patent is in itself monetarily exhausting. In addition to this adequate standard test are conducted to make the medicine ready for human use. The Pharma companies thus seek to recoup this cost.
The most immutable challenge still present is to balance the interest of the pharmaceutical companies against the right to health of the society.
Presence of Fake and inefficient drugs: Accessibility of medicines is not the only problem. The bigger challenge is the presence of fake counterfeit, substandard drugs in the market. The patented drugs are costly due to which a significant portion of the population is forced to buy cheaper drugs through different channels which are sometimes illegal.
Most of the medical practitioners are doubtful of generic drugs. They bypass the otherwise genuine and low-cost generic drugs and may recommend the branded drug to the patients which sometimes also pressurizes the patients to look for a cheaper second route.
The role of Quacks and Pharmacists in recommending drugs to patients cannot be ignored. Many times, pharmacists bypass the prescriptions of the doctors. In order to attract customers, they may sell the cheapest, substandard replacement of the drug to the patient.
ROLE OF NON-GOVERNMENTAL ORGANIZATIONS
Acting as Pressure Groups: The main argument of the majority of NGOs is to bring down the high cost of medicines as a result of them being patented and increasing research and development in the production sector apart from profit-making being the only incentive. They demand localization of drug production to bring down the costs of drug production. By bringing out these demands, NGOs act as a pressure group and put pressure on the stakeholders including the government to shape their policies in a way as to promote generic drugs and increase drug production.
Watch Dogs against Corporations: Many NGOs monitor the use and misuse of the IPR law by big corporate offices and Multinational companies to ensure a transparency and level playing field for low-income and developing countries so that the developed countries do not bypass any regulatory or legal compliance.
International NGOs like Oxfam International advocate for compliance with the TRIPS agreement by pharmaceutical companies. Local Drug-Accessibility advocacy groups, consumer protection groups, and other watchdogs also ensure a uniform application of globally applicable Intellectual Property laws, specifically Patent laws to discourage and prohibit the developed countries from tweaking their national policies to gain an edge over the competition.
Research and Analyses: The majority of NGOs are also involved in extensive research and analyses of the present IP laws and how they impact various aspects of healthcare situations globally. The different national patent laws and their impact on drug accessibility are specifically analysed to notice their effect on policymaking. The impact of the IPR regimes under TRIPS on developing countries and their effect on policymaking is also analysed.
Awareness and Local Participation: Another role played by the NGOs is to educate the general public about various Intellectual Property laws and various regulatory and legal compliances that are to be adhered to. On some occasions, the NGOs are also engaged in imparting basic training and knowledge regarding the working of the various patent systems globally and the different Patent filing routes.
INTERNATIONAL EFFORTS TO BOOST ACCESS TO MEDICINES
Alma-Ata Declaration: The Alma Ata Declaration of WHO in 1977 defined the landmark concept of “Essential drugs”. The need for medicines as an important tool to promote public health was realized and the WHO reiterated medicines to be one of the most important tools to achieve public health. This declaration made Primary healthcare a responsibility of the government. The member states committed to include primary healthcare in their national policy.
Flexibilities under the TRIPS Agreement: The general rule under trips to provide a minimum level of protection for intellectual property rights is given flexibility under Article 31 of the TRIPS. Compulsory licensing empowers the government to allow the manufacturing of a generic version of the patented drug by someone other than the patent owner, including itself. The patent owner is in return paid the compensation for the number of drugs produced.
Article 30 includes “Bolar provisions” which allow generic drug manufacturers to use the patented product to get market approval to speed up the rate at which the drug enters the market. Another flexibility is that of Parallel Importation mentioned in Article 6 of the TRIPS agreement.
Parallel importation allows the government to obtain the same patented drug from abroad at a cheaper price than the domestic price in its own country, without the permission of the Patent owner.
The Doha Declaration of 2001 recognized the power of the governments to protect public health even at the cost of patent rights. It reiterates that TRIPS should be “interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all. (ref- Doha Declaration)
Global Funds: Global funds are a new phenomenon taking place in the international arena. They are aimed at achieving a joint effort by various stakeholders like the government, pharmaceutical companies, the general public, and civil organizations. Philanthropist organizations like the Clinton Foundation and The Gates Foundation are two internationally recognized foundations working to fund research and improve access to medicines in lower and middle-income countries. The NGOs are engaged in heavily scrutinizing the actions of such foundations.
EFFORTS BY THE INDIAN GOVERNMENT
Accessibility of drugs has always been a debatable point between the ruling party and the opposition. Ever since the compliance of the TRIPS Agreement by India, the case of a major chunk of the poor population being cut off from using patented high-priced drugs has taken centre stage in political debates targeting healthcare.
The Indian government runs various schemes like the National Health Mission, Pradhan Mantri Jan Aushadhi Yojana (PMJAY), and Ayushman Bharat Mission Relief which aims at providing efficient cheaper medicines to the general public at various public healthcare facilities.
The Ministry of Health and Family Welfare releases a list of National Essential Medicines List (NEMLs) which are to be present at all times to ensure accessibility of certain basic drugs to the poor. The Drug Pricing Control Orders (DPCO) are released by the government to set a ceiling price of various medicines so that they are available at a reasonable price to the general public.
CONCLUSION
Ensuring the health of the population is the duty of the state. The Indian constitution calls for equality in status and opportunities. Article 21 of the Constitution guarantees life and personal liberty. The right to health is a fundamental right implied under Article 21.
Despite Government efforts to check the prices of drugs and put a ceiling on them, factors like inefficient supply chain management, rampant corruption in Primary Healthcare centres, the presence of cheap fake drugs, and distrust of the medical fraternity in generic drugs continue to add up to the problem of lack of access to drugs.
NGOs and other consumer protection forums ensure transparency by keeping a regular check on various transactions occurring among the different stakeholders. They also put pressure on regional and international organizations to ensure compliance with the standards. Highlighting the lack of research and development on Neglected diseases is also one of the remarkable works undergone by the NGOs.
REFERENCES:
This article was originally written by Ariane La fortune and published on the Centre for Applied Studies in International Negotiations website. The link for the same is herein:
Non Governmental Organisations and Intellectual Property Rights
This article was originally written by Rituparna Maiti, Vikas Bhatia, Biswa Mohan Padhy, and Debasish Hota and published on the Indian Journal of Community Medicine website. The link for the same is herein:
Essential Medicines: An Indian Perspective – PMC.
This article was originally written by Philippe Cullet and published on the ielrc.org website. The link for the same is herein:
The Doha Declaration of the WTO and Access to Medicines
This article was originally written by Nazim Akbar and published on Dehradun Law Review website. The link for the same is herein: