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The State Medical Service, in compliance with the Law of Ukraine dated 17.09.2020 No. 904-IX “On Amendments to Article 19 of the Law of Ukraine “On Medicinal Products” regarding electronic retail trade of medicinal products” (hereinafter referred to as the Law), developed and amended the Draft Cabinet Resolution of the Ministers of Ukraine “On Amendments to the Licensing Conditions for Conducting Business Activities for the Production of Medicinal Products, Wholesale and Retail Trade of Medicinal Products, Import of Medicinal Products (except for active pharmaceutical ingredients), and Approval of the Standard Form of the Agreement on Delivery of Medicinal Products to the End User” (hereinafter – Project) and put it up for public discussion.
According to the Association, some provisions of the Project set artificial restrictions for licensees and actually limit the possibility of new investments in the development of electronic retail trade of medicines, further development and transformation of the industry, and anti-competitively limit the number of participants only to entities that were on the market earlier.
When making changes to the first edition of the Project, most of the comments and suggestions were taken into account, but there are still several controversial provisions that require further changes.
Regarding item 184 2
Clause 184 2 states that “electronic retail trade of medicinal products is carried out by economic entities, provided that there is: an own website in the information and telecommunications network “Internet”, registered in the Ukrainian domain zone, the registrant of which is the State Accounting Service, and information about which is included in the List of business entities that have the right to carry out electronic retail trade of medicinal products .
According to the Law of Ukraine “On Protection of Rights to Marks for Goods and Services”, a domain name is a name used to address computers and resources on the Internet. Domain names in the .UA zone are granted only to owners of trademarks (marks for goods and services). The domain zone is specified during domain registration. When the URL of the future site is chosen, the domain zone is determined at the same time. Domain zones are divided into territorial (ua/ru/by), general (com/net/org) and domain zones of limited use (gov/edu/travel).
The registrar of domain names is an international non-profit organization created in the fall of 1998 with the participation of the US government called the Internet Corporation for Assigned Names and Numbers, or ICANN. ICANN offices are located in Los Angeles, Brussels and Washington. Therefore, the State Accounting Service is not and cannot be the registrar/”registrant” of either a domain name or an entire domain zone.
Moreover, according to the Regulations on the State Service of Ukraine for Medicinal Products and Drug Control, approved by Resolution No. 647 of the CMU dated August 12, 2015, the latter does not have the authority to register domain names on the Internet.
Therefore, the provision of the Project on the registration of the licensee’s website only in the Ukrainian domain zone, “the registrant of which is the State Medical Service”, does not correspond either to the current legislation or to the actual circumstances.
Regarding item 184 4
Clause 184 4 states that “the website of the licensee, which has the right to carry out electronic retail trade of medicinal products, cannot be used by another licensee for the organization of electronic retail trade of medicinal products. The use of other websites by the licensee is allowed solely for the purpose of posting up-to-date information on the availability and price of the medicinal product in a specific pharmacy, with a hyperlink directly to the website of the licensee, from which the electronic retail trade of medicinal products is carried out, and information about which is available in the List of sub “enterprises that have the right to carry out electronic retail trade of medicinal products”.
According to the Association, the provision should allow small e-retail pharmacies to post information and advertisements on other web resources, and to use the capabilities of aggregator sites or marketplaces to automatically collect applications and transfer them to e-commerce sites.
We propose to set out clause 184 4 in the following wording: The use of other websites by the licensee is allowed solely for the purpose of posting up-to-date information about the availability and price of the medicinal product in a specific pharmacy, assistance in placing orders on the websites of the licensees , with a hyperlink directly to the website the licensee from which the electronic retail trade of medicinal products is carried out, and the information about which is available in the List of economic entities entitled to carry out the electronic retail trade of medicinal products (the obligation regarding the hyperlink is mandatory only for pharmacy establishments that carry out electronic retail).
Regarding item 184 7
According to the Project, receiving and forming orders is carried out through the website of the licensee, which has the right to carry out electronic retail trade of medicinal products. In accordance with clause 184 4 , information provision of electronic retail trade of medicinal products, acceptance of orders for the sale of medicinal products remotely, can be carried out using the website of the licensee, information about which is available in the List of business entities entitled to carry out electronic retail trade drug trade, telephone, fax, e-mail.
Based on the content of this clause, the receipt and formation of orders can be carried out automatically with the help of electronic services of the website, at the same time, the intervention of a separately appointed person in the process of receiving and formation of orders is not foreseen. The operation of the website should only have the option of providing consultation (if needed and desired by the consumer) by a specialist of the licensee who meets the qualification requirements, when ordering a medicinal product through the website, indicating the phone number, e-mail address, the mode of providing such consultation.
We propose to set out clause 184 7 in the following wording: “For the organization of electronic retail trade of medicinal products, the licensee appoints at least one person who can provide advice when ordering a medicinal product through the website. The person(s) entrusted by the business entity with the duties of providing advice when ordering a medicinal product must be employed with the licensee…”.
Regarding item 184 15
“… It is not allowed to transport medicinal products to the end user by means of public transport used to transport passengers.”
We believe that the requirements for transport are inappropriate and restrict the conduct of business activities. This is due to the fact that in the modern world, a large number of deliveries can be made without the use of “transport” in the usual sense.
The project should regulate the issue of safe delivery of medicines to the end user, packaging and compliance with temperature conditions, not transport requirements. In this regard, we insist on the removal of conditions for transport from the Project, which should regulate only the conditions of packaging and compliance with the conditions specified by the manufacturer for the transportation of medicinal products.
We believe that it is necessary to additionally provide that the transportation can be carried out by any means of transport, subject to compliance with the packaging conditions provided for in this Project.
Taking into account all the above-mentioned comments, the Association proposes to make appropriate changes to the draft version of the Project.
We thank the Weekly “APTEKA” for placing the position.