Digital technology p has been adopted in almost every line of people’s lives. One of the impacts is changes in people’s behavior, such as the increase in online buying and selling transactions. This digital-based selling mode has eased the public to engage in daily commercial activities.
Although digital technology has had numerous positive impacts on society, negative impacts of using digital technology are unavoidable. For example, the widespread distribution of various types and classes of medicine freely on e-commerce platforms that have potentials to threat the health and lives of people.
So far, permission for the online distribution or sale of medicine have only been granted to parties who already have permits issued by the relevant agencies, such as Pharmacy Electronic System Operators (PSEF), pharmaceutical wholesalers, branches of pharmacy wholesalers or pharmacies that use Electronic Systems (PSE). ).
The use of medicine that are not appropriate and not in accordance to doctor’s recommendations will endanger lives and have the potential to cause abuse, especially if the medicine being sold does not have a distribution permit.
In essence, the distribution of medicine with certain types and groups cannot be done freely without a doctor’s prescription. This also applies to medicine sale through e-commerce.
To protect the public from the risks arising from the distribution of counterfeit medicine or illegal medicine, online pharmaceutical service providers are required to fulfill the stipulations in the Regulation of the Food and Drug Supervisory Agency (BPOM) No. 8 /2020 on Control of Medicine and Food Circulated Online by taking into account Law No. 36/2009 on Health, Law No. 35/2009 on Narcotics and Law No. 5/1997 on Psychotropics.
Provisions for online medicine distribution based on the Food and Drug Supervisory Agency Regulation No. 8 /2020, are as follows:
- Online distribution of medicine by the Pharmaceutical Industry, Pharmaceutical Wholesalers, Branch Pharmacy Wholesalers and Pharmacies must use an Electronic System.
- Distribution of medicine online is prohibited through social media, daily deals and classified ads.
- Medicine that are distributed must have a distribution permit and meet the requirements for a good way of making and distributing medicine as well as the requirements for safety, efficacy, and quality of medicine.
- Circulation of medicine online can only be carried out for medicine that are included in the class of over-the-counter drugs, limited over-the-counter drugs and hard drugs provided that hard drugs must be based on a doctor’s original prescription.
- Online medicine delivery by pharmacies can use the Pharmacy Electronic System or provided by licensed PSEF in accordance with the provisions.
- Delivery of medicine that are distributed online can be carried out directly to patients or sent to patients, where delivery can be carried out independently by pharmacies or in collaboration with third parties in the form of legal entities. In this delivery process, pharmacies must be responsible for the safety and quality of medicine, such us providing product information, labels containing information on medicine use, maintaining the confidentiality of the contents of the shipment, ensuring that medicine are sent to the right destination and documenting medicine delivery.
- Online medicine delivery by pharmacies to patients is carried out in accordance with the provisions for the delivery of goods and services in Electronic System trading.
- Pharmacies and/or PSEF are prohibited from distributing online drugs that include:
- Hard drugs, including specific types of drugs based on the existing regulations.
- Drugs containing pharmaceutical precursors
- Medicine to treat dysfunction.
- Injection preparations, other than insulin.
- Implant preparations.
- Drugs listed in the class of Narcotics and Psychotropics.
The government rules strict sanctions against business actors, PSE and PSEF violating the provisions of online drugs distribution as stipulated in Article 32 Paragraph (1) the Food and Drug Supervisory Agency Regulation No. 8 /2020. The sanctions range from warnings to closing or blocking the electronic sales system. Sanctions from revocation of licenses to withdrawal of drugs sold can be imposed on a number of parties, including pharmaceutical service facilities.
In addition to administrative sanctions, the practice of distributing illegal drugs, whether online or offline, can be subject to criminal sanctions with sanctions stipulated in the following articles;
Article 197 of Law no. 36 of 2009;
“Everyone who intentionally produces or distributes pharmaceutical preparations and/or medical devices that does not have a distribution permit as referred to in Article 106 paragraph (1) shall be subject to a maximum imprisonment of 15 (fifteen) years and a maximum fine of Rp. 1,500,000,000, – (one billion five hundred million rupiah)”.
Article 106 paragraph (1)
“(1) Pharmaceutical preparations and medical devices can only be distributed after obtaining a distribution permit.”
This action is one of the actual actions in dealing with the progress of the digital era in responding to the development of online drug buying and selling transactions.
For this reason, business actors who operate digital health platforms or e-commerce platforms providing online pharmaceutical services must be more careful in marketing drugs and ensure that licensing requirements are met in accordance with applicable regulations.
Author / Contributor:
|Asdel Fira, S.H., CHRP|
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