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LEGAL ALLIANCE, founded in 1995, is today one of the leading Ukrainian law firms specializing in legal support to pharmaceutical companies doing business in Ukraine and CIS countries.

OUR CLIENTS represent the following industries: pharmaceuticals, medical devices, consumer goods, medicine, cosmetics, para-pharmaceuticals, chemistry, biotechnology, agriculture and food products.

LEADING ASSOCIATIONS — AIPM Ukraine, APRaD as well as the EBA Healthcare Committee have chosen Legal Alliance as their legal advisor.

E-commerce of Medicines

А, 25.01.2021

On September 17, 2020, the Verkhovna Rada of Ukraine took an important step towards the approximation of Ukrainian legislation to European standards - the Law No. 904-IX was adopted, which allows electronic retail trade in medicines.

Having established general regulatory provisions, the law envisages the development and adoption of a range of bylaws aimed at its implementation. In particular, it is necessary to introduce amendments to the License Terms for carrying out business activities of drug manufacturing, wholesale and retail trade in medicines, import of medicines. It is also necessary to approve by CMU decree a template formedicines supply agreement.

In our opinion, when developing bylaws, it is important to remember the vector of development of our legislation, taking into account the Association Agreement with the EU signed by Ukraine.It is also important to clearly define which innovations are enshrined in the Law and what is the most important - which restrictions are set. With that said, the restrictions include the prohibition of e-commerce in prescription drugs (except those available by e-prescriptions), medicines that require a license to trade in narcotic drugs, psychotropic substances and their precursors, as well as the sale of potent, radioactive, and immunobiologicals. A separate paragraph prohibits the establishment of a mandatory minimum number of medicines and the size of the minimum order for e-commerce in medicines.

A review of the Law allows us to conclude that there are no restrictions on narrowing the range of entities that can do e-commerce to those who have been operating for more than two years and have at least 10 pharmacies.

There is a number of issues that need to be discussed between the representatives of the pharmaceutical community, the State Service of Ukraine on Medicines and Drugs Control, and the MOH of Ukraine. There are several such issues:

1. In what way the recently opened entity with a license, received in the prescribed manner, is worse than others? Let's keep in mind, that at the issuance of a license, compliance of facilities and equipment, and other aspects of the license terms were checked?

2. Who can assert with the reasonable argument that such an entity is less ready for e-commerce than an entity that has been on the market for two years?

3. Why entities with 1, 2, or 3 pharmacies are disqualified to engage in e-commerce, and what is the point of restricting patients, they have been providing with medicines (especially in small communities), in their right to get medicines by courier delivery?

E-commerce operations of several entities from one site also require additional discussion. On the one hand, the concerns of the licensing authority regarding oversight of such activities are understandable. On the other hand, the experience of European countries shows that this practice is widely represented in Europe.

Thus, in our opinion, it is necessary to find balanced approaches to the wording of bylaws to implement Law 904-IX and take another step towards the European way of medicines regulation.

Dmytro Aleshko, Managing partner

Legal Alliance Law Firm


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