Preface
The right to health is one of the most fundamental rights of every human being, making the regulatory framework governing health rights—especially in the pharmaceutical sector—extremely important. The engagement of government officials and lawmakers in this area can significantly enhance public health. Their involvement allows for the development of effective strategies to protect individuals and society from potential harms associated with pharmaceuticals.
In the Iranian legal system, the right to health is recognized and addressed through principles outlined in the Constitution. Additionally, laws governing medical and pharmaceutical affairs, as well as regulations concerning the manufacture and import of drugs and the establishment and operation of pharmaceutical companies, provide a more detailed focus on drug and health rights. Karimi & Associates Law Firm, with a team of lawyers and experts specializing in drug rights, is available to offer services and advice.
Rules & Regulations
Constitution Law
According to Article 29 of the Constitution, social security, including insurance for retirement, unemployment, old age, disability, accidents, and the need for health services and medical care, is a universal right. The government is required to provide these services and financial support to every individual in the country using public revenues and contributions, in accordance with the law. Additionally, Articles 3, Paragraph 12, and 43, Paragraph 1, emphasize that all members of society should have the right to health.
While the Constitution indirectly acknowledges people’s right to health and medical services, it is crucial to recognize both its strengths and the existing weaknesses in the Iranian pharmaceutical law system.
Law on the regulation of medical and pharmaceutical affairs and food and beverages
As mentioned earlier, alongside regulations that indirectly pertain to pharmaceutical law, the law governing medical and pharmaceutical affairs, as well as food and beverages, directly addresses issues related to medical law, particularly those concerning pharmaceutical law.
This law, approved in 1955, comprises 25 articles. While the Ministry of Health and Treatment typically formulates pharmaceutical laws, the current legislation covers various topics, including regulations on establishing medical institutions, requirements for obtaining medical licenses, management of pharmacies, formation of legal commissions responsible for issuing licenses, and related matters.
In general, the preparation and approval of laws governing medical and pharmaceutical affairs should involve relevant stakeholders, including pharmacists, doctors, importers, manufacturers, and distributors. Additionally, these laws should specify the conditions necessary to achieve the desired quality. However, the existing legal framework governing pharmaceuticals is in disarray. Challenges such as drug smuggling, difficulties in importing essential medications, self-prescription by patients, and irrational drug prescriptions by doctors are among the pressing issues that need to be addressed.
One significant problem is drug smuggling. According to Note 6 of Article 3 of the aforementioned law, crimes related to these provisions fall under the jurisdiction of the Islamic Revolutionary Court. However, the actual impact of these laws in society often differs from their written text. The ongoing prevalence of drug smuggling serves as clear evidence that the reality within this sector diverges from the intended legal framework.
Regulation on the Manufacture and Import of Medicines
This regulation, approved in 1989, consists of 62 articles. One of its key strengths is that it clearly identifies the parties involved in the pharmaceutical industry, including manufacturers, importers, doctors, and pharmacists. Additionally, Articles 1 to 3 categorize medicines into three types: generic, proprietary, and herbal.
A generic medicine is defined as one that has a chemical or common (non-proprietary) name approved by the Ministry of Health, Treatment, and Medical Education.
A proprietary medicine is a product that can be obtained either as a simple formulation or by mixing or combining several medicines. It results from the invention of a specific individual or legal entity and must be registered with a fixed formula, name, and a distinct industrial mark, whether in Iran or abroad.
Herbal medicine refers to products that are prepared entirely or predominantly from herbal components or extracts. The Ministry of Health, Treatment, and Medical Education is responsible for identifying herbal medicines, confirming their therapeutic effects, and determining or approving their names.
Human Rights Documents
Several international documents aimed at protecting human rights have also implicitly addressed the rights to health and medicine. Notably, this includes Articles 55(b) of the United Nations Charter, 25 of the Universal Declaration of Human Rights, and 12 of the Covenant on Economic, Social, and Cultural Rights.
Article 55(b) of the United Nations Charter states that the organization, in addition to addressing economic and social issues, also encourages attention to public health matters.
Article 25(a) of the Universal Declaration of Human Rights asserts that everyone has the right to a standard of living adequate for their health and well-being, which includes access to food, clothing, housing, and medical care. In comparing these two articles, it becomes evident that the United Nations Charter regards merely raising awareness of health issues as sufficient. In contrast, the Universal Declaration of Human Rights considers access to health and medical care an inalienable right for all individuals.
Furthermore, Article 12 of the Covenant on Economic, Social, and Cultural Rights emphasizes the significance of health for the general public and offers specific recommendations. These recommendations include improving environmental and industrial hygiene, as well as establishing appropriate conditions for providing medical facilities and medical assistance to the public during times of illness.
Establishing and Operating a Pharmaceutical Company
To address this issue, one must refer to the regulations governing the establishment and operation of pharmaceutical companies. The related concerns are outlined below.
Definition of Pharmaceutical Company
Pharmaceutical companies are defined as those involved in the manufacturing, importing, and urgent importation of pharmaceuticals. These companies must have their qualifications approved in accordance with the law and hold the necessary activity licenses. Karimi & Associates Law Firm has a professional, specialized team ready to provide services across all matters related to pharmaceutical law.
Types of Companies
1- National Distribution Company: This is a legally registered company whose articles of association specify that its primary activity is the distribution of medicines. By obtaining the necessary licenses, the company is authorized to distribute a range of products nationwide, including medicines, powdered milk, dietary supplements, infant foods, medical consumables, cosmetic products, medical equipment, and other authorized pharmaceutical supplies. It acts as an intermediary between licensed pharmaceutical institutions and pharmacies.
2- Provincial Distribution Company: This is a legally registered company with articles of association that state its primary activity is the distribution of medicines. It has obtained the necessary licenses to distribute a range of products, including medicines, powdered milk, dietary supplements, infant food, medical consumables, cosmetic products, medical equipment, and authorized pharmaceutical supplies. The company operates at the provincial level, where the request is made, and has acquired the required activity license prior to the notification of this regulation.
Establishment conditions
According to Article 6 of the regulations mentioned above, any legal entity whose articles of association permit drug distribution may apply to establish either a national distribution company or a provincial distribution company, provided it meets the specified criteria.
According to Article 10, all members of the board of directors and the CEO must adhere to the following requirements:
1- Iranian Citizenship
2- Belonging to one of the official religions recognized in the constitution.
3- Certificate of completion of public service, or exemption from service, or certificate of employment of armed forces personnel.
4- Good service record, activity, and necessary capabilities in medicine, approved by the Legal Commission.
5- Providing a certificate confirming that there is no criminal record and no history of addiction.
Drug Pricing
According to Part Four of the Drug Manufacturing and Import Regulations, drug pricing will be based on the recommendations of the Pricing Commission, as outlined in Note 3, Article 11 of the Law on Amending Certain Articles of the Law on Medical Affairs, Pharmaceutical Affairs, and Food and Beverages, under the General Administration of Drug Supervision.
The Commission is required to consider all factors affecting drug quantity when determining pricing. After gathering the necessary information, it will announce the drug’s selling price to distributors, pharmacies, consumers, and government entities.
Drug manufacturers or importers must submit the requested documents to the Commission, including a detailed breakdown of drug costs for which pricing is being requested, along with their proposed price presented in a clear, itemized format. It is important to note that providing false information may hold the manufacturer or importer liable.
Furthermore, the price of a drug may be revised in response to increases or decreases in costs or purchase prices, upon request from the manufacturer, importer, or the Ministry of Health, Treatment, and Medical Education, provided there is sufficient justification. In such cases, the Commission will determine the new price after reviewing the relevant information and documents.
Overall, the legal framework governing drugs and the right to health is a critical issue that requires proper attention in every society. While existing principles and laws indicate initial efforts by the legislator, a more comprehensive review and amendment of regulations are necessary to enhance the effectiveness of the drug legal system. Continuous monitoring is also essential to ensure its proper functioning.