The license that had been issued by the Regulatory Authority for online pharmaceutical sales platforms has been invalidated by the First Vice President. It is planned that obtaining this license will proceed through the legal framework. However, the annulment of the Regulatory Authority’s decision falls within the jurisdiction of the Administrative Court, not the First Vice President.
According to IDEA, last summer, it was announced that the operation of digital health platforms in the context of pharmaceutical sales is legal, and licenses for this type of activity were issued through the Regulatory Authority. These platforms could distribute pharmaceuticals from the source to the end consumer based on this license. However, it has been declared that this license has been revoked by the First Vice President.
At the time of issuing this license, the Legal Department of the Ministry of Health and other agencies had been requested to prepare the prerequisites for carrying out this process and expedite their work in this regard. It appeared that the regulator had recognized the necessity of using these platforms and considered it a positive step in the development of the country’s digital health, although this matter did not seem very favorable to the Food and Drug Organization.
The Food and Drug Organization was opposed to this license
Seyyed Heydar Mohammadi, the head of the Food and Drug Organization, who has been against the issuance of this license and online pharmaceutical sales from the beginning, considers the online sale of medication to be a mistake and believes that this distribution should take place through the defined channel.
But what does Mohammadi mean by the defined channel for medication distribution? Does speeding up the process of selling and delivering medication, even with a careful examination of prescriptions, conflict with the defined channel? When is this framework expected to be regulated and announced by the Ministry of Health?
The law regarding online pharmaceutical distribution, which has been in the works by the Ministry of Health for quite some time, continues to be delayed. After approximately a year, the activities of pharmaceutical sales platforms remain shrouded in ambiguity. Although the online pharmaceutical sales process is entirely transparent and prescriptions are thoroughly reviewed, this type of distribution will also assist the Ministry of Health in data collection.
However, the reason for the Ministry of Health and the Food and Drug Organization’s opposition to these activities is entirely unknown. If the ministry is pursuing transparency in medication distribution and statistical information, it should welcome the activities of these platforms. Failing to issue guidelines by the Ministry of Health constitutes a form of legal breach and should be pursued through legal channels.
Online medication sales increase public access to medicines and reduce stockpiling. Nevertheless, the absence of a clear law in this regard, which has always been a major challenge in the country’s digital health, hinders investment in this field.
Whose jurisdiction does the revocation of this license fall under?
According to some legal experts, the annulment of regulations by the General Assembly of the Administrative Court is enforceable, and not only the First Vice President but no other entity or individual has the authority to annul such regulations.
Both the Food and Drug Organization and the Ministry of Health have not performed satisfactorily in matters related to the digital economy and e-commerce in the context of health and hygiene. For example, Article 60 of the Electronic Commerce Law, which was approved in 2003, has not yet reached the implementation stage. Additionally, the Regulatory Authority, in an attempt to expedite the process and resolve issues in the short term, stepped in, but this development requires a fundamental decision by the Food and Drug Organization and the Ministry of Health.
The Market Regulation Headquarters has been established by the Council of Ministers, but this does not grant the authority to annul the regulations of the Regulatory Authority to any entity or individual.
As the head of the Market Regulation Authority is the First Vice President, it has been raised in the relevant working group, and this decision has been determined. From a legal perspective, it is evident that the decisions of the Regulatory Authority can only be annulled through the Administrative Court, and that too if the decision is in violation of the law.
According to Mohammad Hossein Amiri, the CEO of Vindad, the First Vice President does not have the authority to annul this decision. Amiri stated, “If it is intended for decisions made by the Regulatory Authority, which is composed of various individuals, including the Minister of Economy, to be nullified by a single individual, then what is the philosophy behind establishing such a body? Even if the head of the Food and Drug Organization, the First Vice President, or any other entity or individual decides to annul a decision, they must go through the legal processes via the Administrative Court to be able to revoke this decision.
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