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Annals of Bioethics & Clinical Applications Research Article 52 min read

Study on Protection of the Right to Health, Access to Medicines and the Construction of the Rule of Law for Medicine Patents

Yang W, Hai Y* and Haitian M*
* Corresponding author
ISSN: 2691-5774  10.23880/abca-16000245  Received: October 12, 2022  Published: October 27, 2022
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Keywords
Access to Medicines Right to Health Medicine Management Law Medicine Patents Patents Law
Abstract

The Access to Medicines is related to the basic rights of people's rights to life and health. It has been widely recognized by international conventions and has become a basic duty of the state to ensure and improve the level of citizens' access to medicines. At the same time, in the face of increasingly widespread uncertainties in modern society, building a fair and efficient legal system for medicines access is a necessary measure to promote citizens' trust in the government and maintain the legitimacy of power. In the conditions of 1.3 billion population and an unbalanced and inadequate economic development, China strives to ensure that its citizens’ medicines are economically affordable through continuous improvement of the legal system and arrangements, and to encourage local pharmaceutical companies to develop and manufacture better-quality medicines. On the premise of respecting the status of market players and property rights of pharmaceutical companies, China comprehensively uses diversified tools such as information, standards, market access, and competition law enforcement to establish a legal system for medicines accessibility from two channels: supply guarantee and price control. Particular attention is paid to the adjustment of the medical and social insurance and essential medicines systems. In recent years, China has focused on improving the pharmaceutical patent system, promoting the balanced development of local original research medicines and generic medicines, as well as the overall optimization and upgrading of the pharmaceutical industry through the protection of patent rights and appropriate restrictions. Driven by the economic and trade agreement reached between China and the United States in 2020, China's Patent Law will introduce a drug patent term extension system and a drug patent linkage system, and further improve the legal mechanism to encourage innovative activities of pharmaceutical companies.

Introduction

Medicines derived from the natural needs of humans to prevent diseases and protect health. Medicines are also indispensable to the survival and development of human individuals and communities. Health rights protection is a logical starting point for exploring the accessibility of medicines from a legal perspective. Accessibility of medicines is both a challenge that humanity needs to face together and country specific. On the one hand, humanity is faced with an epidemic that threatens public health and the sustainable development of society. The desire for healthiness is over- boundaries and races. Individuals should have the right to access medicines to prevent and treat diseases, and any international level of system coordination should reflect the universal value of humanism and fairness care. On the other hand, specific to each country level, each country is obliged to improve the level of medicine accessibility as its basic legal and policy goal. However, countries are at different stages of development of the social economy, pharmaceutical industry, and healthcare system, which means it is necessary to ensure the feasibility of legal systems and policies should base on national conditions and sustainability.

China is the largest developing country with the largest population. How to meet the medicines demand of 1.3 billion people has become a major challenge and task for the government: to ensure that the citizens have equal access to the essential medicines within their accountability, also to activate the research and development ability of domestic pharmaceutical companies, so that to provide medicines with wider indications and better efficacy. China implements a socialist market economic system and governing the country according to law. The production and operation of pharmaceuticals are dominated by corporate market entities. At the same time, the country has a wealth of toolkits to intervene in the pharmaceutical market to achieve public welfare goals. However, the exercise of government power must also prevent abuse of power and avoid disruption of the pharmaceutical market order. As a result, how to properly intervene in pharmaceutical production and operation activities under the constraints of the rule of law, especially the use of private legal tools to adjust patent rights, to balance the public interest and the interests of pharmaceutical companies. In addition, in 2020, the epidemic of the new coronavirus (COVID-19) that swept the world caused the most serious loss of life and economy since this century. In the face of the epidemic, there is no distinction among countries and political systems. The epidemic tests the country’s basic ability to protect citizens’ rights to life and health. The key lies in how the state promotes the development of therapeutic medicines and vaccines in the most efficient way through institutionalized interventions, and also guarantees the fairness and justice of market supply and citizen access. The construction of the rule of law on the accessibility of medicines has become a key capacity of a country to deal with uncertain risks.

This article intends to analyze the conceptual connotation and national mission of medicines accessibility from the basic standpoint of China’s treatment of medicine accessibility and its relationship with human rights. It is further summarized as to what constitutional and legal institutional arrangements China has undertaken to achieve the goals of ensuring and improving access to medicines, and how to balance the interests of pharmaceutical companies and the public through appropriate market interventions. At the same time, in recent years, one of the reform directions of China’s medicine accessibility system is to improve the medicine patent system. China’s practice in this regard reflects the efforts and difficulties faced by developing countries in protecting the basic rights of their citizens and protecting and incentivizing the private rights of market entities.

Protection of the Right to Health and Access to Medicines

Access to Medicines and the Right to Health as a Basic Human Right

The right to health, as a basic human right, has been widely spread and recognized throughout the world, mainly from many important international legal documents after World War II. Reflecting on the two world wars and envisioning the future development of human society, the United Nations (UN), the World Health Organization (WHO) and other international organizations have incorporated the right to health into a series of important international legal documents. The preamble of the 1946 Constitution of the World Health Organization emphasizes the equality of the right to health: “THE STATES Parties to this Constitution declare, in conformity with the Charter of the United Nations, that the following principles are basic to the happiness, harmonious relations and security of all peoples: Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.” Article 25 of the 1948 United Nations Universal Declaration of Human Rights clearly stipulated that the right to health is a basic human right enjoyed by everyone and should be guaranteed by law. In addition, some international conventions also listed and regulated the right to health as a basic human right, such like Article 5 of the International Convention on the Elimination of All Forms of Racial Discrimination in 1965, Articles 11 and 12 of the 1979 Convention on the Elimination of All Forms of Discrimination against Women, Article 24 of the 1989 Convention on the Rights of the Child, and Article 25 of the Convention on the Rights of Persons with Disabilities. As a party to the conventions and a responsible developing country, China has always been committed to implementing the provisions of the international conventions on the right to health. China takes the improvement of citizens’ health as an important human rights cause, focusing on the construction of public health infrastructure and the development of medical and health industries. In addition, the right to health is regarded as an element of the concept of a community of human destiny [1]. Through multilateral and bilateral forums, Government and non-governmental levels, China has participated in international public health affairs in a comprehensive manner and fulfill national obligations to promote global health such as financial support, disaster relief assistance, and information exchange. The realization of the right to health is closely related to medicines and their accessibility. From the perspective of the connotation of the right to health, Article 12 of the UN International Covenant on Economic, Social and Cultural Rights in 1966 includes the right to health, including the right to receive proper medical care, use of medicines, medical facilities, and services when sick. The United Nations Economic, Social and Cultural Council pointed out that the right to health contains a number of interrelated elements: (1) Availability, which means that in order to protect citizens’ right to health, the state should provide adequate and effective operations, including but not limited to professional medical personnel and essential medicines that are compatible with their level of development; (2) Accessibility, which means that the state provides the above facilities, goods or services It should be non-discriminatory, geographically accessible, and reasonable prices; (3) Acceptability means that the country should respect medical ethics and cultural appropriateness when providing these facilities, goods or services, such as respecting the culture of ethnic minorities, gender equality, confidentiality of medical information; (4) Quality requirements, including skilled medical staff, safe and effective medicines and medical equipment, etc. [2]. The “availability”, “accessibility” and “quality requirements” of the right to health are all directly related to the accessibility of medicines, and ensuring and improving the level of accessibility of medicines is the main way to protect and realize the right to health.

Access to medicine is one of the basic method to prevent disease and protect human health, so it takes a social nature that is different from that of general commodities, and social regulations are required. On the one hand, medicines have the trading value and use value of general commodities, and are used to prevent, treat, and diagnose human diseases, and purposely regulate human physiological functions. On the other hand, medicines have a profound social nature, and the quality, quantity, and convenience of public access to medicines directly affect the realization of the right to health. The lack of effective medicines supply leads that quality of life and health is not guaranteed, individual rights cannot be realized, and the development of groups and society is stalled or even retrogressed, so the public lives in poverty and fear. In view of this understanding, China has adopted special legislation to set up a relatively independent professional agency to manage the production, circulation, and payment of medicines The basic goal of such legislation is to ensure the safety, effectiveness, and accessibility of medicines, and promote the health of citizens of individuals and society. This is reflected in the Article 3 of the Pharmaceutical Administration Law (Amended in 2019):

Pharmaceutical Administration should be centered on people’s health, adhere to the principles of risk management, overall control, and social co-governance, establish scientific and strict supervision and administration system, and comprehensively improve the quality of medicines and ensure the safety, effectiveness, and accessibility of medicines.

Access to Medicines and it’s State Duties

Connotation of Access to Medicines: Access to medicines refers to the objective state and level for patients to obtain medicines to meet the prevention and treatment of diseases, recovery, and maintenance of health. As far as the constituent elements are concerned, the access to medicines should be a combination of accessibility and affordability based on availability, safety, and effectiveness: Usability: Usability means that the medicine has the efficacy of treating diseases. Within a certain range of indications, the usability of the medicine is supported and evaluated by safety and effectiveness. Safety requires medicines to play a role in curing diseases but must not cause unnecessary damage to the human body, and toxic and side effects should be controlled within a certain range. Efficacy requires that under the prescribed indications, usage and dosage conditions, the medicine can meet the cure of human diseases and purposely adjust the physiological functions of humans. The so called medicines that do not meet the standards of usability, safety, or effectiveness, such as “counterfeit medicines” and “inferior medicines” as prescribed in Article 98 of China’s “Pharmaceutical Administration Law”, not only fail to prevent diseases, but may also harm the lives and health of patients. Therefore, usability, safety and effectiveness are the requirements for the “quality” of medicines. Without the “quality” of medicines, it is impossible to talk about the access to medicines. Accessibility: In technical means, medicines for disease prevention and treatment can be produced at the technical level and can be obtained by the public in a timely manner geographically. Affordability: Affordability is economic accessibility, which means that citizens (patients) have the ability to pay for medicines to cure their diseases. Only when a medicine is purchased and used at a consumer terminal can its exchange value be realized as a commodity, and the overall social affordability or affordability of a medicine also determines the motivation for medicines innovation and production.

Constitutional Origins and State Duties of the Access to Medicines: Taking medicines as an intermediary, the state protects citizens’ right to health by formulating and implementing laws and policies that guarantee the accessibility of medicines, which is its international law and constitutional duty to respect and protect human rights. The transformation from human rights to the fundamental rights of citizens in the Constitution is an important symbol of the realization of the right to health. The constitutional rights to health correspond to the state’s duty to realize, guarantee, and promote human rights. The “Constitution of the People’s Republic of China” (hereinafter referred to as the “Constitution”) known as the “Mother Law” has the function of deriving legislation and establishing national policies. The main norms in the Constitution to stipulating the rights to health include: (1) Article 33 (para. 3), The state shall respect and protect human rights. Article 36 (para.3), concerning the inviolability of citizens’ health. The state shall protect normal religious activities. No one shall use religion to engage in activities that disrupt public order, impair the health of citizens or interfere with the state’s education system. (2) Article 45 (para.1), Citizens have the right to material assistance from the state and society when they are aged, ill or have lost the capacity to work. The state shall develop the social insurance, social relief, and medical and health services which is necessary for citizens to enjoy this right. (3) Article 21, Article 26 (para.1), the state shall develop medical and health services, sports, and protect life and the ecological environment. Among them, the first paragraph of Article 21 provides that to protect the people’s health, the state shall develop medical and health care, develop modern medicine and traditional Chinese medicine”. Since the establishment of the Constitution in 1982, this provision has constituted the direct constitutional basis for China to promote the construction of the rule of law in medicine based on the accessibility of medicines to protect citizens’ right to health.

During the implement of reform and opening policy for more than 40 years, China’s pharmaceutical industry has made great progress, and legislated Promotion of Basic Medical and Health Care Law, Pharmaceutical Administration Law, Law on Prevention and Treatment of Infectious Diseases, Traditional Chinese Medicine Law, Vaccine Administration Law, etc. Through regulating the medical system and pharmaceutical management, the state develops and protect citizens’ right to life and health. To protect such rights and to improve the availability of medicines, the Promotion of Basic Medical and Health Care Law implemented in 2020 provides a comprehensive institutional framework by providing organizations, human resources and funds with all-round system construction guidelines. The first paragraph of Article 4 clearly stipulates: “The state and society shall respect and protect citizens’ right to health”; Chapter 5 Guarantee for Supply of Medicines stipulates goals of “guaranteeing the safety, effectiveness and accessibility of medicines” Comprehensively improve the accessibility of medicines in terms of essential medicine system, medicine review and approval system, quality, price, market supply. However, for a relatively long period of time in the future, China must continue to promote the regulations in pharmaceutical affairs in order to improve the accessibility of medicines. This is an important part of the construction of China’s human rights protection system [3].

The state’s duty based on the availability of medicines is essentially to establish a sound legal system aimed at protecting and promoting citizens’ health. China is establishing a complete legal system, which is based on the market-oriented production and circulation of medicines and comprehensive state intervention. Through the implementation of the law, it provides a medical service system, medical social insurance and payment system, and intervenes and regulates the pharmaceutical market. The accessibility of medicines involves the producers, sellers, medical service institutions and payers of medicines. The payers include patients and social insurance institutions. The producers and patients at the two market terminals of production and consumption of medicines are the key roles of the accessibility of medicines. In a market economy, the production and pricing right of medicines are largely in the hands of pharmaceutical companies, so the availability of medicines requires the establishment of a legal system that regulates the production of medicines. State duties based on the availability of medicines involve the exercise of a wide range of government functions, which is centered on Medicine Products Administration under the Administration for Market Regulation. Intellectual Property Administration, Anti-monopoly Bureau and the health administrative agency have corresponding administrative law enforcement powers.

Principles and Tools of the Rule of Law for Access to Medicines

Promoting the Reform of the Patent System for the Availability of Medicines

Affordable Availability of Medicines and Patent Limitations

The other side of medicine patents is to directly lead to high medicine prices and reduce patients’ affordable accessibility to medicines. Patents grant original research medicine companies monopolistic operating benefits during their validity period, and medicine patents are the most important reason for high medicine prices. A horizontal comparison of international medicine prices shows that the price gap between patented and non-patented medicines is dozens as large. After the expiration of the medicine patent period and the generic medicines appearing in market, the competition will lead the price of medicines with the same curative effect to drop by 80% [11].

The high price of original research medicines also indirectly affects the technical availability of medicines. Driven by the interests of patent monopoly, the primary goal of R&D investment in the pharmaceutical industry is the disease field with the greatest profit return. One of the important metrics is the patient’s ability to pay. Most pharmaceutical companies focus on projects with high return rates and are likely to target R&D groups and targets in the wealthy class in developed countries that often suffer from diseases. On the other hand, only less than 5% of the world’s medicine R&D funds are used to develop medicines for the treatment of diseases that seriously affect developing countries [12]. The WHO Consultative Expert Working Group on Financing and Coordination of R&D pointed out in the 2012 research report, whether in the public or private sector, current incentive system failed to generate enough new medicine research and development to meet the health needs of developing countries [13].

Pharmaceutical patents in the sense of purely private rights reduce the affordable accessibility of medicines and can only promote technical accessibility within a limited range of medicines and groups, resulting in a reduction in the level of accessibility of medicines to citizens of a country or global humans as a whole. It violates the value goal of patents in promoting public interest. In fact, from its beginning to its globalization, the patent law has always emphasized its goals of enhancing public interest. As far as system functions are concerned, the monopoly of knowledge is not the purpose of patent pursuit. As far as system functions are concerned, the monopoly of knowledge is not the purpose of patent pursuit. Monopoly is only to encourage more inventions and creations, promote knowledge dissemination, technological progress, consumer welfare and social and economic development, etc. The promotion of overall social welfare is patent’s ultimate value goal. For example, Article 1 of China’s Patent Law stipulates that this law is enacted for the purpose of protecting the legitimate rights and interests of patentees, encouraging inventions, giving an impetus to the application of inventions, improving the innovative capabilities, and promoting scientific and technological progress as well as the economic and social development. The patent law needs to take into account the interests of patentees, users of patented technology and the public so as to achieve the best social benefits of the patent system.

Conclusion

The availability of medicines is a common proposition facing human survival and development. Based on the most fundamental human rights of life and health protection, the state needs to formulate corresponding policies and laws according to its own economic and social development. Influenced by the traditional Confucian political ethics “respect for nature and protect the people”, China’s authorities have always regarded the protection of people’s lives and health as one of the main sources of political legitimacy, and it continues to the goal of protecting people’s livelihood in today’s China’s strategy of ruling the country according to law, which is also reflected in the construction of the legal system regarding the availability of medicines. After more than 40 years of reform and opening policy and the construction of a socialist market economy with Chinese characteristics, China has gradually established a legal system for the availability of medicines based on market operation with the government intervening in all aspects of medicine supply, competition environment, and payment guarantee, and with the essential medicine system and the medical social insurance system as the cores. Facing the goals of high-quality development of the pharmaceutical industry, building an innovative country, and realizing a higher level of citizen medicine accessibility, China will focus on improving and constructing a medicine patent system in the future to realize the balance between the industrial economic benefits and the public benefits of medicine accessibility.

Acknowledgment

1. Construction of the Rule of Law in Fair Competition Review under the Background of a Unified Large Market, Key Construction Discipline Projects, L22ZD060. 2. Research on the Transformation of Government-led Industry Self-regulation in the New Era, 2022 Liaoning Provincial Social Science Planning Fund Project, L22CFx001.

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@article{yang2022,
  title   = {Study on Protection of the Right to Health, Access to Medicines and the Construction of the Rule of Law for Medicine Patents},
  author  = {Yang W, Hai Y* and Haitian M},
  journal = {Annals of Bioethics & Clinical Applications},
  year    = {2022},
  volume  = {5},
  number  = {4},
  doi     = {10.23880/abca-16000245}
}
Yang W, Hai Y* and Haitian M (2022). Study on Protection of the Right to Health, Access to Medicines and the Construction of the Rule of Law for Medicine Patents. Annals of Bioethics & Clinical Applications, 5(4). https://doi.org/10.23880/abca-16000245
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AU  - Yang W, Hai Y* and Haitian M
JO  - Annals of Bioethics & Clinical Applications
PY  - 2022
VL  - 5
IS  - 4
DO  - 10.23880/abca-16000245
ER  -