Enhancing safe and effective online drug retailing

In this article, our Managing Partner, Nguyen Van Phuc will analyze the regulations related to ensuring the management of online drug retailing through e-commerce platforms. This article was part of HM&P's series of articles about pharmaceutical, published in The Saigon Times No. 19-2024, dated on May 9, 2024.  Below is the English version:

The expansion of e-commerce in Vietnam has brought positive changes to Vietnam's economy, especially during the COVID-19 pandemic when consumers cannot go shopping by traditional means. At that time, a product that many consumers used to buy in person can now be bought online. The variety and convenience of this shopping method also benefits consumers, especially those who cannot go directly to the physical pharmacy. However, as a product that can significantly affect consumers' health and lives, the distribution of medicines should be strictly regulated. To meet this requirement, the question is how to manage online drug sales safely and effectively.

The revolution in drug retailing

(Source: The Saigon Times)

Nowadays, is easy for consumers to buy medicines at the click of a mouse. This is thanks to the development and expansion of e-commerce and social networking platforms in Vietnam. For example, major drug retail brands such as Long Chau and Pharmacity have introduced drug sales on their websites. Drug sales and purchases are also taking place on social media platforms, raising concerns about consumer safety, especially in the sale of prescription drugs.

Currently, online drug sales, whether in an e-commerce environment or on social media platforms, are not yet regulated by a specific legal framework. As a result, many legitimate businesses are unsure whether the sale of drugs on their websites or through e-commerce platforms is legal. Meanwhile, for those who profit from selling substandard drugs on social media platforms, the lack of legal regulation is an advantageous condition for them to operate freely.

In order to improve the management and control of drug e-commerce activities, the Draft Law on Amending and Supplementing Some Provisions of the Existing Pharmaceutical Law (the "Draft Law") has added some progressive and groundbreaking provisions. Accordingly, the Draft Law allows companies that have been granted the certificate of eligibility for pharmacy business to conduct business through e-commerce means, such as websites, e-commerce mobile apps; e-commerce platforms licensed by the Ministry of Industry and Trade (the sale of drugs through social media platforms and live streams is prohibited). In particular, pharmaceutical companies are allowed to sell drugs within the list of drugs eligible for online sale issued by the Ministry of Health and in accordance with the scope of business, as well as publish product information without obtaining approvals from state agencies for items that have been previously approved, such as commercial packaging of drugs, drug use instruction sheets following the contents of information on approved drug use instruction sheets and drug labels.

From the above provisions, except for social media platforms and live streams, the sale of drugs carried out on commercial websites, e-commerce mobile applications or e-commerce platforms is allowed. Thanks to the above, pharmaceutical companies will enjoy a proper legal basis for selling drugs through online means. However, the provisions prohibiting the sale of drugs on social media platforms and live streams, if carefully enacted with appropriate sanctions, may prevent the rampant sale of drugs on social media platforms. However, the growth of e-commerce and social media platforms (Tiktokshop) may require changes in the above prohibitions. Therefore, the author believes that the sale of drugs on social media platforms should be allowed in a controllable manner to resolve poor quality drugs and similar to the existing trend in e-commerce. Some solutions to be referred to are allowing pharmaceutical companies to sell drugs on social media platforms, on livestreams (through KOL) for non-prescription drugs, and issuing a list of drugs that are prohibited from being sold on social media. At the same time, the sale of medicines on social media must be limited. For example, it should not last more than 180 days per year, provided that the pharmaceutical company notifies the state agency of the information on the drugs sold, the price, and the selling time on social media before and after each selling session.

Online drug sales are a special business

Although the retail sale of drugs can be carried out online, such activities still have some unique characteristics, as they must follow special regulations.

According to the 2016 Pharmaceutical Law, two activities that drug retailers must be aware of are clinical pharmacology and pharmacovigilance. Accordingly, Clinical Pharmacology is the scientific research and consultation on drug use to ensure the safe use of drugs. In short, this activity is aimed at providing advice to purchasers when drugs are sold at the drug retailer, and drug retailers must ensure that they have the staff to carry out such activities. Meanwhile, pharmacovigilance is the detection, evaluation and prevention of adverse effects caused by drugs. This is also one of the obligations of drug retail establishments during operation. In fact, for traditional drug retail establishments, these two activities have been carried out by their responsible personnel. This is no exception in the case of online drug retail. The challenge for drug retailers now is how to fulfill these two obligations in the e-commerce environment.

(Source: Pharmacity)

According to the author's research, online drug sales are widely conducted on commercial websites or mobile apps of drug retailers. When accessing the websites of major drug retail establishments, buyers are required to be consulted by pharmacists before purchasing prescription drugs. This is one of the ways that retail drug stores could comply with clinical pharmacology regulations. However, for e-commerce platforms, drug retailing is limited due to the lack of a regulatory framework. In fact, many e-commerce platforms do not allow the sale of drugs. Soon, when drug retail activities are allowed on e-commerce platforms, preparation for clinical pharmacology and pharmacovigilance will become a greater challenge for drug retailers, as drugs will be more readily available to consumers. In order to ensure compliance with these two obligations, drug retail enterprises must prepare personnel (meeting prescribed standards), machinery and technology to ensure timely consultation for consumers before buying drugs and to receive user feedback during and after drug use, especially for enterprises that sell drugs in many different online forms.

In terms of state administration, the responsibility for ensuring that drug retail outlets comply with the law rests with relevant state agencies. In addition to managing traditional pharmacies, government agencies must now monitor the operations of drug retail outlets on their websites, mobile apps, or even e-commerce platforms where these outlets operate. However, administrative activities are necessary to balance free trade and consumer protection.

In conclusion, it is not an exaggeration to say that the bill will revolutionize e-commerce in drug retail and the pharmaceutical industry in general. There is no better way to promote e-commerce in drug retail than to allow drug retail outlets to sell drugs by this means. In this context, the responsibilities of drug retail outlets and the role of state authorities are more important than ever, because ultimately the pharmaceutical business is only effective if consumers are safe when using drugs.

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