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Business welcomes the legalization of online sale of medicines

28/ 09/ 2020

This year, on September 17, the Verkhovna Rada of Ukraine adopted draft law №3615-1 on the electronic retail trade of medicines in the second reading and as a whole. Such a decision ultimately introduces the widespread world practice of online sales and the delivery of medicines into the legal field of Ukraine.

According to the business community, the introduction of legal distance trade of medicines on a permanent basis will help to improve both the physical availability of medicines for patients, especially low-mobility groups, for whom it is difficult or impossible to go to pharmacies, or for people living in rural areas and financial affordability by increasing competition in the field of retail trade in medicines.

The draft law was developed by the relevant Verkhovna Rada Committee with the active involvement of the representatives of the business community. It introduces a number of much-needed requirements for online medicine trade. Thus, only licensed entities, namely pharmacies, will have the right to carry out these activities. Also, information about the official websites, engaged in the online sale of medicine, will be included in a separate List which allows every citizen of Ukraine to check whether it is legal, and hence safe for the purchase of drugs. For the convenience of users, each legal medicine selling website will have a special logo that confirms the legitimacy of such a site, as well as a hyperlink to the above-mentioned List.

Separately, the draft law №3615-1 regulates the issue of control over the delivery of medicines. In particular, it will be possible to carry out the control exclusively from pharmacies. Thus, the organizational and technical requirements must be defined for them to be complied with by the pharmacy delivery services or contract postal operators. The Cabinet of Ministers of Ukraine will introduce a standard form of agreement on the delivery of medicines to the final consumer, for which the draft law defines a number of essential conditions that are also designed to ensure the control and safety of such activities.

Moreover, the draft law №3615-1 is in line with the aspirations of Ukraine towards European integration, as it takes into account the practice of EU member countries, as well as the provisions of the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and Commission Implementing Regulation (EU) No 699/2014 of 24 June 2014 on the design of the common logo to identify persons offering medicinal products for sale at a distance to the public and the technical, electronic and cryptographic requirements for verification of its authenticity.

We hope that the adopted draft law will establish a balanced and clear “rules of the game” on e-commerce at the legislative level while ensuring reliable protection of consumers from dangerous and low-quality drugs.

At the same time, there is a need for further separate regulation and detailing of the provision on the possibility of using the websites of so-called electronic medical information systems when ordering medicines because, as a general rule, such activities should be carried out through the website of an entity, authorized to carry out electronic retail trade of medicines. In addition, at the secondary level, it is necessary to detail the provisions on the procedure for the State Service of Ukraine on Medicines and Drugs Control to exercise its supervisory powers over market participants at all stages of circulation of medicines, including the delivery, contractual relations of such entities (in particular, through the approval of the Cabinet of Ministers of Ukraine of the Standard Form of the contract on delivery of medicines to the final consumer). Such a set of legal regulations should, first of all, protect the interests of the final consumers because in this case there will be clear traceability of the entire route of medicines – from order to receipt by the consumer, and the consumer will be confident that the quality of drugs won’t be worse if purchased online because all methods of purchasing drugs (from pharmacies directly or through delivery) will be set the same strict requirements and rules.

At the same time, business representatives expect further active involvement of pharmaceutical specialists from the Government, the Ministry of Health, and the State Service of Ukraine on Medicines in order to develop bylaws to regulate the distance trade of medicines, which should contain clear details of the provisions of the adopted law, including the changes to the License Terms, the approval of the Standard Form of the contract on delivery, procedures for maintaining the register of online pharmacies and the use of the logo, etc.

 

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