The Legal Deputy of the Presidency has once again emphasized the legality of pharmaceutical distribution platform activities and rejected claims of their illegality by the Food and Drug Deputy.
According to IDEA, the Legal Deputy of the Presidency, in a letter to the President of the Business Environment Improvement Center, reiterated their stance on the legality of pharmaceutical distribution platform activities. The Scientific, Technological, and Knowledge-Based Economy Deputy and the Food and Drug Organization had separately requested clarification and resolution of ambiguities in the decisions related to the activities of pharmaceutical distribution platforms. However, the Legal Deputy now emphasizes that there are no impediments according to the existing decisions regarding the activities of pharmaceutical distribution platforms.
Following the issuance of a decision by the Regulatory Clearance Council affirming the legality of pharmaceutical distribution platform activities, the Food and Drug Organization objected to this decision and claimed that the First Deputy of the Presidency had annulled it, although in another interview, the First Deputy of the Presidency made no mention of the annulment of this decision and emphasized the activities of online platforms.
In its letter to the Legal Deputy of the Presidency, the Food and Drug Organization had stated that the term “distribution of drugs” in the decisions only pertains to the supply of drugs from suppliers to pharmacies. However, the Legal Deputy stated: “Although the term ‘distribution’ has been used in various meanings in laws and regulations, considering the use of the term ‘distribution,’ the absence of a specific definition to limit its scope in the decision, the government’s policy on the use of smart mechanisms, and the functioning of internet platforms, which primarily facilitate the distribution or offering of goods rather than directly engaging in these activities, it is clear that the interpretation of the Regulatory Clearance Council regarding the term ‘distribution’ referring to the distribution of drugs by licensed pharmacies through platforms to end consumers (B2C) is confirmed.”
In Article 8 of the Regulations for Supporting Knowledge-Based Production and Employment, which was announced in December 2021, the Ministry of Health, in cooperation with the Ministry of Communications, was required to approve a plan for the smartization of the health-oriented services and products supply chain within two months, focusing on the regulatory-operator elements.
Additionally, the guideline requested the Ministry of Health to ensure the operationalization of drug distribution through platforms or online businesses while adhering to the principles of competition and preventing operational monopolies. After the non-implementation of this provision for two years, the Legal Deputy of the Presidency once again emphasized the activities of health platforms in July last year, leading the Electronic Commerce Development Center to establish the necessary identity verification infrastructure for the operation of health platforms.
However, all of these actions prompted the Food and Drug Organization to reiterate and announce its previous positions that the term ‘distribution’ refers to the distribution of drugs from the manufacturer to the pharmacy. Now, as the interpreting and reconciling body of the government’s decisions, the Legal Deputy has emphasized that the term ‘distribution of drugs’ in the government’s decisions is used in a general sense.
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