Business looks forward to discussing pilot project on individual drug coding and future plans
Last week, the CMU approved a regulation on the introduction of a pilot project on control marking and monitoring of medicines, which is part of the Concept for the Implementation of the State Policy for Prevention of Medication Falsification. At the same time, the text of the document wasn’t discussed with the professional community.
“Business is waiting for a discussion that is about to take place. After all, it should be clear what is laid down in each stage of implementation of the system, what changes are required in the legislation, in what timeframe, what is expected from business today in connection with the pilot project. Speaking about the further implementation of the monitoring system, there should be a clear understanding of the “content” of coding in accordance with European rules. Also, the implementation of coding in any case will affect the planning of operational activities of pharmaceutical companies. That’s why, for a truly successful implementation, which would meet the intended purpose, we need mutual understanding of the rules and opportunities of both public authorities and business”, – explained Natalia Serhienko, Executive Director of the EBA Health Care Committee.
According to the information previously announced, from September 2019 a special marking, which can check “fake” drugs will start to appear on the packaging of some medicines, at the end of the year products can be checked through a mobile application.
However, manufacturers and other market participants currently have a lack of information on how the monitoring system and pilot project will be put into practice, whether the Ukrainian system will be integrated with the relevant system in the EU, and which information should be encoded. In addition, there is no information on further plans to provide infrastructure for drug coding monitoring at all stages. Business is also concerned that there may be confusion between the contents of the 2D code and the QR code.
The Association also stresses that it is advisable to provide a thorough analysis of the requirements for individual coding of medicinal products, which are defined by EU legislation and are implemented in EU Member States. Any “internal” peculiarities could lead to an undesirable significant rise in the price of medicines produced by EU Member States for the population of Ukraine, and create unexpected barriers to the export of Ukrainian products to EU member states in the future.
According to Ms Serhienko, now we can talk only about feelings of unrealistic timing of the pilot project as specifics are not yet available for consideration. Manufacturers need more information on all conditions and rules that will apply.
The EBA expects that these issues will be discussed in the near future and will jointly evaluate the approaches, availability of resources, concrete steps involved in the processes of government bodies and structures in the future. Without this, it is difficult to talk about the readiness of pharmaceutical manufacturers to implement a new system to prevent falsification of medicines on the pharmaceutical market. Business hopes that this discussion will take place in the near future.