With this document, the Association expresses the vision of the member companies regarding the development of the draft of the new version of the Law of Ukraine “On Medicinal Products”, within the framework of the Working Group created in the Subcommittee on Legislative Support for the Development of Pharmacy, Implementation of Pharmaceutical Activities, Availability of Medicines, Production and Distribution of Medical Products, of the development of modern medical technologies of the Committee on Health Protection of the Verkhovna Rada of Ukraine.

It should be noted that the majority of the pharmaceutical community, whose work is based on the specified Law, including representatives of the Association, became aware of the development of the specified Project with mass media already after the start of such work and the holding of relevant meetings of the Working Group.

According to the results of the analysis of the above-mentioned Project by the experts of the Association, we believe that further work on the development and consideration of the Project is impractical and cannot lead to the receipt of a truly progressive, modern and effective Law of Ukraine “On Medicinal Products”, which would meet, first of all, the interests of citizens of Ukraine and patients.

Yes, the proposed Project contains a large number of risks and controversial provisions that may cause the termination of a stable supply of safe and effective medicines, which is the main goal of pharmaceutical companies. At the same time, the initiators of this Project demand its consideration as soon as possible, which is an obstacle to the possibility of its actual proper processing, during which it would be possible to take into account the comments and suggestions of experts.

In addition, in our opinion, it is not possible to develop the specified branch law without the participation of official representatives of specialized state authorities and expert institutions – the Ministry of Health, the State Expert Center, etc.

The project proposes significant changes to the main stages in the process of production, supply and circulation of drugs, which are either completely unacceptable or require a wide professional discussion. Also, the Project contains a number of provisions that conflict with the obligation of Ukraine to bring its legislation into line with the norms of the European Union, including within the framework of the Association Agreement between Ukraine and the EU.

We are also surprised by some of the proposed regulations that eliminate the recently introduced progressive provisions aimed at simplifying and speeding up the access of Ukrainian patients to innovative drugs, namely the actual cancellation of the simplified registration procedure for drugs registered by the EMA under the centralized procedure and in a number of other countries with strict regulatory system.

Also, the Project proposes to introduce changes in the procedure of import of medicinal products, which significantly change the requirements for the activity of importers of medicinal products. It should be noted that any changes in the regulation of the indicated process require a long-term transition period and, first of all, a complete early determination of the expected model of an effective system of quality control of medicinal products, the absence of which still raises questions among market participants and is not resolved in this Project , on the contrary, existing contradictions intensify.

Starting in 2020, it is proposed to introduce a system of special labeling of medicine packages with a unique code. It should be noted that the Association has repeatedly initiated the issue of the need to implement the specified individual marking in Ukraine, however, the need to develop a model of such a system in advance, to resolve issues related to the development of the necessary infrastructure in Ukraine, sources of its funding, etc., has always been separately emphasized. We pay special attention to the possibility of increasing the cost of the medicinal product for the end user due to the addition to the cost price of the costs of maintaining the corresponding additional equipment, which is a very significant circumstance considering the current socio-economic condition of the citizens of Ukraine. Prior to the introduction of the specified marking, it is necessary to harmonize the intended legal acts with EU legislation, including regarding the type of marking, methods of checking additional security measures, provisions on the creation, management and availability of databases where information on security measures should be placed. At the same time, the Project does not provide answers to any of these questions, but it is proposed to introduce such a system as soon as possible.

We note that, in our opinion, currently the system of regulating the production and circulation of medicinal products in Ukraine, defined by the Law of Ukraine “On Medicinal Products”, lacks such critical problems that require the adoption of its new edition as soon as possible, at the same time, representatives The associations confirm their readiness to participate in balanced and professional work on improving the specified law or developing its new version, which, unfortunately, does not take place within the framework of this Working Group. We suggest focusing attention on the more urgent problems of the pharmaceutical industry – further reforming the system of procurement of medicines, implementing a truly modern model of reimbursement of the cost of medicines and defining a model of an effective system of quality control of medicines.

Of particular concern is the fact that, in our opinion, the said Project, taking into account its provisions and efforts to develop and consider it as soon as possible, looks like lobbying for the interests of the local pharmaceutical industry. We emphasize that the unilateral implementation of the proposed regulation, which does not take into account the specifics of the activities of all other participants in the pharmaceutical market, will lead to a collapse in the process of providing citizens of Ukraine with high-quality, effective and safe medicines.

We emphasize that the development of the new version of the Law of Ukraine “On Medicinal Products”, like any other basic industry law, requires a preliminary definition of the general concept of the development of the industry, a comprehensive, professional, weighted and planned process of development and discussion.

On the basis of the above, we support the proposal voiced by the representatives of the pharmaceutical community of Ukraine and ask to withdraw the said Project from processing and consideration.