The digital economy working group objected to the draft regulation of the activities of electronic health operators due to the combination of three instructions in it
The Ministry of Health was obliged to completely separate the instructions for the distribution of medicine through the platforms from the executive regulations of the rules and principles governing smart operators in the field of electronic health and present it in the form of a separate instruction to the digital economy working group.
According to the Iran digital economy annotation, the draft of “executive regulations, rules and principles governing smart operators in the field of e-health” which was compiled by the Ministry of Health in the last days of November and submitted to the Steering Committee of the Digital Economy Special Working Group, with the objections raised by the member institutions from The meeting agenda of this commission was taken out and sent to the sub-committee to fix the deficiencies.
Combining the three tasks assigned to the Ministry of Health by the Board of Ministers in one regulation was one of the legal objections to this draft, based on which the Digital Economy Steering Committee required the Ministry of Health to remove the “instructions for distributing medicine through platforms” from the regulation. provided separately and set separately.
For this reason, the Ministry of Health was obliged to formulate the “Instructions for the distribution of drugs through platforms” subject of Note 2 of Article 8 of the regulation “Supporting the production of knowledge-based and productive employment in the field of health” separately.
After almost 15 months of the deadline set for the Ministry of Health, Treatment and Medical Education, this ministry submitted a draft entitled “Executive regulations, rules and principles governing smart operators in the field of e-health” to the Digital Economy Working Group for the task that the Council of Ministers of Tir In the month of 1401, he was entrusted with this ministry.
Last year, the Board of Ministers, by approving the regulation “Supporting knowledge-based and job-creating production in the field of health” and in Article 8 of this regulation, obliged the Ministry of Health, Treatment and Medical Education to cooperate with the Ministries of Communication and Information Technology within two months from the date of notification.
That is, in September 2022, the “regulations of the program of smartening the supply chain of health-oriented services and products” should be compiled and approved by the digital economy working group.
However, it took more than a year for the Ministry of Health, in line with its task, to present a draft to this working group, in which the operation of operators or vendors providing smart chain services for the distribution of drugs and other health-oriented products, predicts and rules for the sale of drugs. be specified to the end user through platforms.
Although the presentation of this draft by the Ministry of Health was an important step in the regulation of digital health platforms in Iran, it faced many criticisms and legal objections in the steering committee of the digital economy, and it was removed from the agenda of the steering committee of this working group and sent to a sub-committee for further review. became.
According to the regulation “Supporting the production of knowledge-based and job-creating in the field of health”, three tasks have been assigned to the Ministry of Health. In Article 8 of this regulation, this ministry is obliged to formulate a plan for smartening the supply chain of health-oriented services and products and approve it in the digital economy working group, and in Note 2 of the same article, it is obliged to formulate and notify guidelines for drug distribution through platforms, Provide platform activity.
In Article 22 of this regulation, the Ministry of Health is responsible for drafting the regulations for the operation of digital health businesses in cooperation with the ministries of communications and economy and finance, and to approve it in the digital economy working group.
However, while combining these three tasks, the Ministry of Health has compiled a draft of the “executive charter, rules and principles governing smart operators in the field of electronic health”, and each of the assigned tasks is different from each other in terms of the subject and the approving body. Each of them pursues a specific title and purpose. Therefore, legally, it is not possible to combine these three tasks in one regulation.
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