E-commerce of medicines – position of the Legal Alliance
Let us recall that the consideration of bill No. 3615-1 in the Verkhovna Rada of Ukraine Committee on Public Health, Medical Assistance and Medical Insurance was scheduled for September 16, 2020, with the subsequent submission to a vote in the session hall on September 17.
Principally, Legal Alliance supports this legislative initiative for several reasons. Firstly, the practice of distance selling is provided for by Directive 83/EU of the European Parliament and of the Council and is widely used in European countries. Secondly, with a formal ban on electronic commerce of medicines in Ukraine (before lockdown), everyone knows that it is possible to order medicines online and get them delivered by a courier. Taking into account the general trend of increasing digitalization in all spheres of life, sooner or later, Ukraine would come to the need to settle the issues of electronic commerce of medicines at the level of the relevant regulatory legal acts.
According to the company, there is no urgent need to bring such regulation to the level of the Law of Ukraine "On Medicines." In fact, it would be enough to amend the Licensing conditions in the section regulating the retail trade of medicines. The rest is politics.
The undoubted advantage of the project is that it introduces clear requirements for the website of a retailer that is engaged in electronic commerce of medicines, by analogy with European regulation, including the ability to check details about such a website on the web portal of the State Service of Ukraine on Medicines and Drug Control.
Given the general course of deregulation, there is no need to introduce a separate licensed type of activity related to the delivery of medicines. The Legal Alliance law firm believes that delivery itself has nothing exceptionally challenging or dangerous for the citizens' health, to make it into a separate licensed type of activity. After all, in most cases, now the patient purchases a pack of medicines at the pharmacy, puts it in his/her pocket, and delivers it to his/her home.
The initiative is risky to extend the right of distance selling to prescribed medicines dispensed by electronic prescriptions. This innovation must be in line with amendments in other regulatory legal acts aimed at increasing responsibility for the dispensing of prescribed medicines without prescriptions, as well as strengthening control in this matter.
Since the title of the bill implies that it only regulates retail electronic commerce, there is no need to raise the issue of prohibiting the wholesale electronic commerce of medicines, otherwise, in the wording proposed in the bill, this may lead to legal conflicts.