Farmak advocates harmonization of legislation and regulatory requirements of Ukraine and the EU in order to improve the effectiveness, safety and quality of medicinal products for Ukrainian patients.
Farmak and other pharmaceutical companies appealed to Prime Minister of Ukraine D.А. Shmyhal and Chairman of the Verkhovna Rada Committee on Public Health, Medical Assistance and Medical Insurance M.B. Radutskyi stating the unreadiness and inopportuneness to introduce 2D coding of medicinal products in Ukraine.
The initiative was joined by more than 10 companies that manufacture a significant portion of pharmaceutical products for the Ukrainian market: Halychpharm, Kyivmedpreparat, Farmak, KUSUM PHARM, Pharmaceutical company Darnitsa, Kyiv Vitamin Plant, Pharmaceutical company “Zdorovye Narodu”, GNCLS Experimental Plant, Pharmex Group, Borshchahivskiy CPP.
The companies express their support for the processes of harmonization of the Ukrainian legislation and regulatory requirements with the EU legislation and requirements, but consider it appropriate to substantially revise the “Concept of implementing the state policy to prevent falsification of medicinal products and approval of action plan for its implementation” taking into account the EU experience and to postpone its implementation at least until the consequences of the COVID-19 pandemic are overcome.
Full text of the letter
To Prime Minister of Ukraine
Copy: Chairman of the Verkhovna Rada Committee
on Public Health, Medical Assistance
and Medical Insurance
Regarding unreadiness and inopportuneness
to introduce 2D coding of medicinal products
Dear Denys Anatoliiovych,
the Ukrainian pharmaceutical companies support the processes of harmonization of legislation and regulatory requirements of Ukraine with those applicable in the EU in order to improve the effectiveness, safety and quality of medicinal products for Ukrainian patients.
In 2016, the EU published the Guide with the requirements for safety features on the packaging materials of certain medicinal products (Regulation (EU) 2016/161). They became mandatory in all EU member states, except for Italy and Greece (it is planned to implement them in these countries in 2025) from February 9, 2019.
Thus, in 2019, the EU launched a system of serialization and control of the first packaging opening, i.e. the application of security features on the packaging of medicinal products as additional (to the existing strict regulatory system in the EU) means to combat falsification of medicinal products. This Guide sets out clear requirements for the unique identification numbers of medicinal products to be applied to packaging materials, the requirements for the application and printing quality of 2D codes and the system for verifying the safety features of medicinal products.
The EU has also set up the European Medicines Verification Organisation (EMVO) which is responsible for collecting and storing information on products and safety features, and provides platforms to verify the authenticity of medicinal products by end and intermediate supply chain operators (hospitals, pharmacies, distributors, etc.). The EMVO is a non-governmental non-profit organization founded by the European professional associations of pharmacies, hospitals, distributors and manufacturers of medicinal products. It is funded by membership fees of the system participants; the role of the EU member states and neighbouring regulators is to supervise the work of the EMVO and to approve the relevant regulatory documents.
Taking into account the European experience, the Cabinet of Ministers of Ukraine adopted Order No. 301-r of 03.04.2019, which approved the “Concept of implementing the state policy to prevent falsification of medicinal products and approval of action plan for its implementation”. The document is solely aimed at creating the system of labelling packaging with 2D codes, without mentioning of any other mechanisms to combat falsification of medicinal products. Moreover, since serialization has been implemented in the EU as late as in 2019, there is currently no evidence base for the effectiveness of the current system to which the Ukrainian Government refers.
Following more careful analyses of the European approaches, the national Concept and the provisions of the relevant pilot project, we consider it appropriate to revise the Concept in terms of measures, responsible persons, technical requirements for the system, list of drugs subject to serialization, etc., and to postpone the planned deadlines for the implementation of measures for the following reasons:
In particular, the section “Problem to be solved” states: “According to the WHO research, almost 10.5 per cent of all medicines used in low- and middle-income countries are falsified.” As these data are presented by the authors of the Concept in this section, it is obvious that they assess the level of falsified medicines in Ukraine as well.
In fact, this figure in the WHO publication “A study on the public health and socioeconomic impact of substandard and falsified medical products” (2017) https://www.who.int/medicines/regulation/ssffc/publications/SE-Study_EN_web.pdf?ua=1 (p.7, last paragraph), where the above-mentioned information was taken from, characterizes not the number of falsified medicines, but the sum of substandard and falsified products taken together. In addition, the WHO does not estimate in this publication the number of medicines used by patients, but those found among the tested samples: “*The aggregate observed failure rate of tested samples of substandard and falsified medicines in low and middle income countries is approximately 10.5%.”
Substandard (low-quality) medicinal products are the products manufactured by legal manufacturers, but with deviations from regulatory requirements. Their number in countries that do not have strict regulatory requirements (GMP) may be substantially higher than the number of falsified medicinal products.
Another incorrect paragraph in the text of the Concept is the statement: “There are virtually no statistics on medicinal products falsification in Ukraine. The impossibility to determine their volumes is due to the lack of the unified system for monitoring the circulation of medicinal products.”
In fact, the State Service of Ukraine on Medicines and Drugs Control of the Ministry of Health has kept statistics on the detection of falsified and substandard medicinal products in Ukraine since 1999. In particular, the monograph by S.O. Lebed “Historical aspects and current state of medicinal products falsification in Ukraine and the world” (Rivne: Volynski oberehy, 2018. – 320 p.) presents the statistics of the State Inspectorate/State Service of Ukraine on Medicines and Drugs Control for 1999-2017 and conclusion that “the percentage of substandard and falsified medicines detected in Ukraine ranges from 0.03 to 0.34%.” Thus, there are official data on the number of detected falsified medicinal products in Ukraine. Although they may differ from the actual number of falsified products in the market, but they are at least 30 times less than those specified in the Concept approved by Order of the Cabinet of Ministers No. 301-r of 03.04.2019.
The thesis that the problems of medicines falsification in Ukraine may be completely solved by implementing the system of labelling and monitoring medicines circulation (serialization) is also doubtful. Since when implementing the European approach to labelling only prescription medicines with 2D codes (except for most infusion solutions, etc.) and one over-the-counter drug, and taking into account the shares of prescription and over-the-counter drugs in the Ukrainian market (about 40:60 in packs) only about a third of medicines in Ukraine will have mandatory labelling with 2D codes. Accordingly, this system will not cover two-thirds of packs in the market and will not be able to prevent falsification.
In our opinion, the adoption of the Decisions by the Cabinet of Ministers on mandatory labelling of medicinal products in Ukraine in 2021-2023 in the current meaning of the system will entail significant capital investment of domestic manufacturers in the design, implementation and commissioning of equipment for labelling medicines with 2D codes. And, most importantly, these investments will not be used due to the defects of the proposed system and the non-fulfilment of the obligations by other project participants (including public authorities).
Moreover, the technical differences between the serialization system proposed to implement in Ukraine and that in force in the EU will unlikely contribute to increasing the export of domestic medicines to the EU. The foreign companies have also repeatedly expressed concern that due to technical differences, especially in the nature of the labelling code and the information contained therein, they will not be able to meet the necessary conditions and become participants of the proposed system. In fact, there is a risk of creating two parallel 2D coding systems – Ukrainian and European.
In this regard, we propose to substantially revise the Concept, taking into account the EU experience in technical, organizational and procedural aspects, and postpone its implementation at least until the consequences of the COVID-19 pandemic are overcome.
We believe that in the next 2-3 years it is better for state organizations and all market participants to focus on solving more pressing problems of the pharmaceutical sector of Ukraine, such as development of reimbursement program (”Affordable Medicines”), improvement of public procurement of medicines, their rational use, restoration of the practice of dispensing prescription drugs from pharmacies, streamlining of e-commerce, harmonization of registration, licensing procedures, requirements for the manufacture of medicines with those applicable in the EU, etc.
of JSC Halychpharm Oleksandr Blonskyi
of JSC Kyivmedpreparat Oleksandr Yatsiuk
of JSC Farmak Volodymyr Kostiuk
of KUSUM PHARM LLC Rajeev Gupta
of PrJSC Pharmaceutical company Darnitsa Andrii Obrizan
of JSC “Kyiv Vitamin Plant” Volodymyr Teliavskyi
of Pharmaceutical company “Zdorovye”, LLC Andrii Velychko
of GNCLS Experimental Plant Ltd. Olena Shvinahir
Director of LLC KPE
“Zdorovye Narodu” Olha Lovashnichenko
of Pharmex Group LLC Serhii Parubochyi
of PJSC SIC “Borshchahivskiy CPP” Yuliia Zdarevska
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