Journal of Law and Health Studies

Abstract Background and purpose: Perhaps the most important part of health is medicine. A access to Pharmaceutical Products is considered one of the pillars of human rights. This directly affects the right to health and the right to life. Considering that high-cost and highly effective pharmaceutical products account for a huge share of household expenses, in order to ensure relative justice in access, appropriate price determination and optimal price control methods are required.
Research Method: This article has been written using the paper and e-books and articles available in real and virtual libraries in descriptive-explanatory method.
Findings: Determining the price ceiling is the first step in controlling the price of pharmaceutical products, which is determined based on considerations such as cost, benefits, risks of using drugs, or market conditions. Sometimes governments do not consider any of these requirements in order to follow the free market policy. According to the nature of drugs, these controls are carried out in three categories: brand, generic and imported drugs, although some drugs may be included in the combined category. Due to the high cost and the importance of innovation, price control of brand products is more important and complicated.
Conclusion: Determining the price ceiling and fighting against overselling in order to support production and innovation with the aim of supporting the consumer are necessary as ways to determine and control drug prices. For this purpose, the fight against price gouging regarding imported products is done in support of domestic production. Compulsory licensing is also another good way to control the price of branded pharmaceutical products.

Abstract Background and Objective: economic access to medicine and treatment is one of the most important dimensions of the right to health, which is considered one of the goals of national development in addition to international human rights. Achieving this important goal is possible by using correct and specific strategies such as pricing and compensation of costs through insurance.
Methods: First, the literature of the article was reviewed using e-books, and articles, then the qualitative data was analyzed through content analysis and a practical model was presented.
Results: Price control is done in two ways, direct and indirect. Determining the price and correcting it, it is the direct type, and compensation of costs through insurance is considered the indirect type. As the first control step, pricing strategies are followed based on two basic principles: 1- Value-based pricing, which is related to drug effects and drug cost, and includes the same requirements. 2- Price Classification based on the type and nature of the drug, including generic, under patent and imported.
Conclusion: Since Iran has recently abandoned the Cost Plus method (determining the prices based on a percentage more than the total cost), it is necessary to constantly regulated the prices according to the current conditions, needs and the existence of similar drugs, but This action dose not seems correct in any situation and the necessary considerations regarding single-prescription drugs have not been taken into account. While advanced countries such as France and England include all drugs in the insurance coverage list based on their medicinal nature without special requirements and prerequisites, the budget of countries such as Iran does not allow such a thing.

Abstract This article examines the state of pharmaceutical regulations in the developing world by constructing international indices derived from World Health Organization data. The past two decades have been marked by profound changes in the pharmaceutical sector, including a complete overhaul of intellectual property systems at the behest of the World Trade Organization and the consolidation of global active pharmaceutical ingredient suppliers in China and India. Although drug ownership laws have been regulated and implemented globally, we surprisingly have little information about how national market entry standards and the regulation of pharmaceutical products have changed.

Abstract Background and objective: Cosmetovigilance is a recent concept. The term itself has just been indexed. It is a form of health public surveillance with a public health objective; it therefore differs from the surveillance carried out by industrialists, who aim at the safety of the product for commercial purposes, and differs from peer surveillance whose purpose is medical. Cosmetovigilance concerns cosmetic products. The 2006 European resolution has laid the ground work for a cosmetovigillance system based on case notifications. As of 2013, the new European regulation requires that serious undesirable effects reported to the competent authority should be transmitted to the competent authorities of the other Member States and to the person responsible for the cosmetic product. Two problems are yet to be solved: causality assessment and reporting categories.
 
Result and discussion: Cosmetovigilance systems are genuine means of obtaining information on the safety of cosmetic products and their ingredients. They can be used by Europe to check that new directives ensure a high level of safety. Cosmetovigilance makes it possible to rule out or control potentially hazardous ingredients and can thus set our minds at ease about the products placed on the market.  Until now, there is no act to design and establish local cosmetovigillance system from the side of official authority in IRAN

Abstract Background and Aims: One of the most important ethical issues related to health law is related to organ transplantation. In this regard, the strategies for increasing the transplanted organ and the ethical considerations related to the fair collection and distribution of the tissues and body parts of the deceased are of special importance, which we discuss in this article. First, the various strategies available in the world to increase the donation rate from the deceased as the most appropriate source of transplant organ procurement are discussed from an ethical point of view, and then the general ethical considerations of this field and the way of fair distribution of organs based on different criteria, priorities and philosophical theories are discussed. has been.   Material & methods:  This article was written using the books and articles available in real and virtual libraries in a descriptive-explanatory way. Results: The most important policies to increase the donation rate from the deceased that are examined in this article are: 1- Mandatory selection 2- Presumed consent 3- Required request and common research 4- Voluntary artificial respiration 5- Donation to a third party 6- Use of prisoners. In this article, along with a brief description of each of these policies, an analysis is provided for each of them from an ethical point of view. Conclusion: Each of the methods of removal and fair distribution of transplantable organs and tissues have advantages and disadvantages from the philosophical, ethical and legal points of view. In this field, a suitable law, in addition to being based on the logic and needs of the people of the society, should be formulated in accordance with the values, beliefs and cultural, social and religious criteria of the people, because without considering these principles, comprehensive laws can never be hindered and Effectively achieved. Of course, through education and information, culture should be created in such a way that the interests of society are also provided in this regard.

Abstract Background and Objective: This study builds on the benefits of national and international experiences and their evolution as a new academic discipline. The right to health is one of the aspects of human rights, the realization of which is essential for the realization of other human rights and is inextricably linked to the right to life. Given the complexity and development of the relationship between health and rights at the national and international levels, it is necessary to have an overview of this old branch of law, which is today a new academic discipline. Health rights can be examined from different perspectives: bioethics, public health rights, and health care rights. The first is related to ethics, and the second and third are legal approaches to the subject. The right of individuals to determine their own destiny and the right to health are the main issues in these legal approaches.
Findings: This study was prepared by reviewing books, collections of articles, laws and regulations related to the legal system of policy-making, management, and supervision in the health system, Right to Health, Public Health Law, Healthcare Law, and Bioethics.
Conclusion: The ultimate goal of health rights is to ensure access to all elements of the right to health, including the rights of individuals and populations, especially vulnerable populations. Their legal responsibility is generally at the center of attention in health rights. According to national and international laws, government institutions have a legal responsibility to provide health care, protect health and promote it. These matters include issues related to health care rights, including privacy and confidentiality, legal liability of health care professionals, fraud and financial abuse, as well as food and drug rights, environmental rights, mental health rights and the health rights of vulnerable populations.

Abstract Background and Objective: According to the principles of the right to health, easy and timely access to quality medicines is one of the fundamental and essential rights of all human beings. Therefore, these medicines should be made available to people in need at the right time and in sufficient quantities.
Methods: This article was prepared using the documents and criteria available in the Food and Drug Organization of Iran and the World Health Organization (WHO), and it was expressed analytically by comparing and contrasting them.
Findings: From the perspective of the World Health Organization, access to essential medicines as a minimum right is considered one of the core indicators of the right to health. This issue has been considered by some countries, especially poor and less developed countries, based on its affordability. Due to the vital importance of these medicines, the World Health Organization publishes a list of essential medicines every year, taking into account the minimum needs, on a biennial basis.
Conclusion: Although the Islamic Republic of Iran has taken substantial measures to meet the pharmaceutical needs of its citizens through legal supervision of drug prices and markets, especially drug imports, and the implementation of the generic plan, no serious work has been done to prepare a list of essential medicines. However, given the progress in this field and the country's relative self-sufficiency, it does not seem necessary to prepare a domestic list in line with the World Health Organization's list of essential medicines. Each country compiles its own independent list of essential medicines based on its production capacity and needs. Accordingly, governments should prepare and supply (produce or import) the list of essential medicines based on the World Health Organization list, climatic conditions, production capacity, and domestic to ensure equitable access to essential drugs is provided to all segments of society.

Abstract Background and Objective: Euthanasia is one of the most controversial issues in bioethics and an important topic in health law, which can be studied from its various ethical, legal, and jurisprudential dimensions. Since the teachings and sources of Islamic jurisprudence form the foundation of the legal structure our country, strengthening the jurisprudential aspect can greatly help strengthen the legal and regulatory aspects of this issue. 
Methods: In this article, the views of some prominent Shiite jurists are expressed, and the interpretation and analysis of euthanasia rulings and laws are examined by reviewing verses, narrations, and international laws.
Findings: In Iran, the legal vacuum regarding euthanasia is quite noticeable, and since Shiite jurisprudence forms the foundation of our country's legal structure, it is essential for respected jurists, lawyers, and legislators to engage in further discussion and exchange of views on this issue to pave the way for eliminating this legal vacuum and achieving explicit laws in this regard.
Conclusion: The study of euthanasia from the perspective of its mandatory ruling (permissibility or non-permissibility) and its conditional ruling (right of retribution and blood money) is among the topics addressed in this article, which is accompanied by jurisprudential and philosophical justification and interpretation. In addition, the ruling of Article 206 of the Islamic Penal Code has also been carefully examined in this regard. Finally, while presenting the views of Shiite scholars on various aspects of euthanasia, a general conclusion is presented, which is hoped to be a step towards clarifying the issue and explaining jurisprudential rulings and laws, considering current conditions. Euthanasia should be further examined from legal, ethical, and jurisprudential perspectives, and attention should be paid to the human aspect, pain caused by the disease, the costs of patient care, and the right to human freedom, and decisions should be made based on these.

Abstract Background and Objective: Today, with the extensive progress of information technology, its role in the health sector has become more important than ever before. However, these applications create new challenges for privacy. As a result, governments are trying to take various measures, including passing criminal legislation, to address these challenges.
Methods: In this article, by comparing the criminal requirements of electronic health files in leading countries and Iran, by presenting a strategic model in this regard, suggestions have been made to improve the security and confidentiality of electronic health files.
Results: This comparative article examines electronic health records with a particular focuse on confidentiality in Europe, America and Iran from a criminal law perspective. Due a absence of comprehensive law specifically addressing "electronic health" and judicial procedures in Iran, related legislation such as the Islamic Penal Code, the Electronic Commerce Law, the Computer Crimes Law and the laws supporting the comprehensive health information system are addressed.
Conclusion: Different countries adopt various approaches to the protection of personal health data. European Union countries on individual rights and freedoms. In contrast, the United States is seeking to implement tougher penalties to is looking for the approval of tougher punishments to deal with such crimes. Iran is working to establish legal protection for privacy and personal information through a ten-year program, utilizing legislative model from leading conteies with comidering Islamic Jurisprudence and cultural contexts. Considering the extensive and rapid growth of the field of electronic health, it is necessary to adopt a specialized legislative approach for this area.

Abstract Background and Objective: Cosmetovigilance is a recent concept. The term itself has just been indexed. It is a form of health public surveillance with a public health objective; it therefore differs from the surveillance carried out by industrialists, who aim at the safety of the product for commercial purposes, and differs from peer surveillance whose purpose is medical. Cosmetovigilance concerns cosmetic products. The 2006 European resolution has laid the ground work for a cosmetovigillance system based on case notifications. As of 2013, the new European regulation requires that serious undesirable effects reported to the competent authority should be transmitted to the competent authorities of the other Member States and to the person responsible for the cosmetic product. Two problems are yet to be solved: causality assessment and reporting categories. 
Methods: This applied research, conducted with an analytical-comparative approach, examines and compares the cosmetovigilance systems in Iran and the European Union from legal and executive perspectives. Data were collected through library and documentary studies and then extracted and compared using qualitative content analysis of key indicators. The temporal scope of the research extends from the implementation of European Regulation 1223/2009 to 2025, and the geographical scope includes Iran and the member states of the European Union.
Conlusion: Cosmetovigilance systems are genuine means of obtaining information on the safety of cosmetic products and their ingredients. They can be used by Europe to check that new directives ensure a high level of safety. Cosmetovigilance makes it possible to rule out or control potentially hazardous ingredients and can thus set our minds at ease about the products placed on the market.  Until now, there is no act to design and establish local cosmetovigillance system from the side of official authority in IRAN.

Abstract Background and Objective: The advancement of science and technology in the field of electronic communications has led to significant changes in scientific, practical, and applied fields, including educational and medical services. Smart medical universities and smart hospitals are considered to be one of these important advancements. Each of these new ideas has its own advantages and disadvantages.
Methods: First, the literature of the article was reviewed using books, printed and online articles, then qualitative data was analyzed through content analysis and an applied theory entitled “digital-human integration in the health system” was presented.
Findings: Reduced educational costs, elimination of the need for physical training location, the possibility of using multimedia tools, flexibility in time and method of education, facilitated storage of materials, reducing travel time and costs, and accelerating interactive processes are among the benefits of virtual education. Improved access to services, better selection of centers and doctors, ease of hospitalization and services utilization, remote monitoring of patient status, and better support and assistance for service users are also considered benefits of virtual hospitals.
Conclusion: Due to the complexity and sensitivity of some concepts and the hands-on nature of some medical science courses, it is not possible to provide education in this field only through virtual means. Therefore, blended learning, consisting of in-person and virtual classes, is recommended. In the field of medical sciences, which is a human-centered discipline with an emphasis on the interaction between doctors and paramedics and patients, it is better not to be limited to a virtual relationship that reinforces a sense of isolation.

Abstract Background and Objective: Since the beginning of the 1990s, economic sanctions have been increasingly used by major powers in the western block in order to achieve international political goals. Over the years, economic sanctions have caused violations of the right to health in the targeted countries.
Methods: In this article, the impact of sanctions on Iran and other countries is compared and solutions are suggested to reduce the negative effects of sanctions on Iran's economy and health. Also, the best model for dealing with sanctions for Iran's health system was presented.
Results: The imposed sanctions are purely economic and based on putting pressure on the governments, but what happened in reality is the violation of the principles of human rights in the countries under sanctions. The severity of these anti-human rights effects is closely related, especially with the duration of sanctions, as well as with the economic foundation of the target country.
Conclusion: Iran is not the first country to be sanctioned; Therefore, the adverse effects of sanctions on the people of this country were predictable by the Security Council and the countries that imposed the sanctions. In the future, before applying any economic sanctions, the international community must take effective measures to protect the human rights of the people of the target country. Also, use any political and legal means to prevent the violation of the rights of these people by other countries or international organizations.

Abstract Background and Objective: Industrial living conditions, the increase in the elderly population, and the occurrence of chronic and incurable diseases have led patients to use complementary and alternative medicine drugs and methods, including biofield-based or aura-based methods. These methods do not have the risks and side effects of chemical drugs and the high cost of common modern medical treatments. In order to be used optimally, this ancient medicine requires legal control and supervision to prevent financial exploitation and fraud, as well as negligence of therapists.
Methods: Regulatory methods and laws for complementary and alternative medicine in the world were reviewed, and the best regulatory methods and laws for complementary medicine in Iran were presented. 
Findings: The sanctions imposed are purely economic and based on putting pressure on governments, but what has actually happened is the violation of human rights principles in the countries under sanctions. The severity of these anti-human rights effects is closely related, especially to the continuation of the sanctions, as well as to the economic strength of the target country.
Conclusion: Iran is not the first country to be sanctioned; therefore, the adverse consequences of sanctions on the people of this country were foreseeable by the Security Council and the countries that imposed the sanctions. In the future, before imposing any economic sanctions, the international community should take effective measures to protect the human rights of the people of the target country and use every political and legal means to prevent violations of these rights by other countries or international organizations. What is certain is that sanctions are implemented to prevent countries from violating laws. Of course, some sanctions are implemented under false pretenses and to create dependence and submission of governments. But certainly, every sanction requires laws so that human rights, and especially the health of the society under sanctions, are not violated. Therefore, international organizations in this field must act independently in this regard, and government institutions must take appropriate measures to implement laws protecting human rights and remove sanctions from this issue.