EBA initiated a multilateral discussion of the Draft Law on Medicines
On July 5, 2021, the EBA Health Care Committee held a round table discussion on draft Law №5547on Medicinal Products.
EBA became the first business community that brings together all stakeholders to demonstrate close attention to the implementation of EU pharmaceutical legislation and practices, improving access for Ukrainian patients to quality and modern medicines, and the functioning of regulatory procedures for the registration and sales of medicines, conducting clinical trials, licensing of wholesale and retail trade of drugs, including online.
The participants of the round table expressed their opinions on the issues and discussed the implementation of the relevant provisions in the Law, which was not always consistent with the interpretations of the current version of the provisions. Although all participants unequivocally emphasized the aspiration for unconditional support of the course towards harmonization with the EU legislation. Thus, the discussion was focused on the discrepancies of the published provisions of the draft law which do not ultimately contribute to Ukraine’s approximation to the EU.
Business associations represented by manufacturers, distributors, and pharmacies said that initiating changes for the implementation of fundamentally new regulation of the pharmaceutical sector, such as the new version of the Law “On Medicines”, should be based on the original State Strategy for Pharmaceutical Development. Such a Strategy should provide a comprehensive vision of the issues that currently need to be addressed and, obviously, cannot be fully resolved within a single draft law. First of all, such a Strategy should outline the state’s priorities in this area. For example, the priority of introducing innovative technologies in medicine, which in fact has already been supported by the state, and positively assessed by the professional community and reinvigorated by recent changes in legislation – the introduction of medical technology assessment (MTA), the adoption of a draft law on managed entry agreements in the first reading, gradual transition to a unified “positive list” of drugs that will be reimbursed in the future from the state budget for the benefit of patients.
Upon the consideration of the consolidated concept of the draft law, the participants of the round table expressed concern about the further development of clinical trials in Ukraine, access to innovative (original) medicines, further implementation of MTA, etc.
Discussions also continued on the application of simplified procedures for registration in Ukraine of those drugs registered in EU member states and countries with strict regulatory policies. One of the possible mechanisms for simplifying the procedure for such drugs, which are extremely needed by Ukrainian patients, maybe a separate registration of innovative, orphan drugs and advanced drugs registered by the European Medicines Agency (EMA) – a supranational association that provides the possibility of faster access to medicines for all 27 or part of the EU member states, depending on the EMA procedure used. Ukraine needs not lose the possibility for simplified access of innovations to the market, given that in the EU such possibility to accelerate the entry of drugs into the markets of EU member states exist thanks to the EMA.
Needless to say, transparency, non-corruption, and the sustainability of regulatory bodies are critical to any business. This is especially relevant to the providers of medicines to the population, including leading Ukrainian and international pharmaceutical companies who strictly adhere to codes of conduct and internal procedures s. Openness, well-organized processes, preservation of existing potential, and, as a result, the institutional development of public authorities lays the necessary conditions for investment development and promotes a “conscious commitment”, in particular, from global leading companies to stimulate their activities in a given country. In turn, this situation stimulates rapprochement between the countries concerned, the conclusion of bilateral mutually beneficial agreements, and the strengthening of cooperation. Instead, when confidence in the openness, sustainability, and consistency of the management in the pharmacy is lacking, potential opportunities for the industry are also hampered.
Given the provisions of the draft Law on a new single regulatory body for medicines, representatives of various professional associations emphasized the fundamental principles of its establishment. It is necessary to unambiguously maintain the approaches to “transparency” and “sustainable development”, namely: the creation of a single body “from scratch” with special status; clear competitive procedures for appointing the body’s management; direct identification of sources of funding and their assessment as “sufficient” for its independent operation; full digitalization of all services and processes (including the introduction of eCTD format); defining mechanisms of public control over the activities of the body (for example, through the formation of the Public Control Council) and avoiding conflicts of interest; consolidation of the procedure for administrative appeal of decisions of the new body.
This is how the newly created body is seen by the representatives of the professional pharmaceutical community and at the same time by the participants of the Extraordinary Coordinating Council of the relevant EBRD target project. EBA Health Care Committee representatives reiterated the need to preserve the professional and expert capacities of the body, a significant part of which relates to the field of drug registration and examination of clinical trial materials.
The participants also raised the issue of implementing a medicine verification system with 2D coding. Thus, the wording of the draft law raises concern as the European rules have not been taken into account yet. The expert community emphasizes that in the EU the system is created and supported by an association of NGOs and NPOs, the founders of which are drug manufacturers. This is not surprising because manufacturers are very interested in having authentic products and the absence of counterfeiting in circulation within the Ukrainian market. EU legislation clearly defines the sources of funding for the system, the requirements for its application and operation, an exhaustive list of grounds and conditions for public authorities to access the information stored in the system. Apart from the detection of counterfeit drugs in Ukraine, the adherence to European approaches will enable the rapid integration of Ukraine with the EU system, as well as simplification, first of all, of the export activities of domestic producers.
Representatives of the associations also stressed the need to maintain existing cooperation with EU state members and countries with strict regulatory policies and its expansion. The conclusion of the Agreement on Conformity Assessment and Acceptance of Industrial Goods (ACAA Agreement) with the EU is both a component of this process and its desired outcome. However, it is also necessary to continue to focus on maintaining the principles of cooperation, which were implemented in order to strengthen relations and gradually move closer to the EU – the procedure for recognizing GMP documents from such countries, enabling their residents to have authorized representatives of drug registration holders in Ukraine.
The issue of duplication of state quality control systems during the import of medicines and licensing of import activities was re-emphasized as it remains unresolved. Apart from the set of requirements for licensees and control over the fulfillment by licensees of their obligations to ensure proper handling, storage, and quality control, which is currently provided, import licensees also provide quality control of medicines by the state quality control body. That is, importers do not act as “managers” of their quality control activities. The existing requirements of the legislation depend on importers on the possibilities of state control in terms of time, finance, and technology (in particular, due to the lack of the necessary provision of laboratories for quality control of high-tech drugs, etc.). Such a system from time to time significantly prevents patients from quickly accessing drugs. According to business, the focus of government agencies, including the new single regulatory body, should be focused, in particular, on combating “gray” and “black” markets and ways of getting low-quality or counterfeit drugs into circulation, including on the Internet. This position was supported by all participants of the round table.
The European Business Association expresses its gratitude to the representatives of the Verkhovna Rada Committee on Nation Health, Medical Care and Health Insurance, the Ministry of Health, the State Medical Service, the State Expert Center of the MoH Ukraine, ACC, APRaD, AIPM, APAU and PharmUkraine for a professional and open roundtable discussion. We hope to continue a fruitful dialogue on the draft Law on Medicines and to take into account the proposals of the business community that will contribute to the development of the pharmaceutical industry.
At the invitation of the EBA Committee, the discussion was joined by key government officials in the field of medicines – representatives of state regulators of both legislative and executive branches, including Serhii Kuzminykh – Chairman of the Subcommittee on Pharmacy and Pharmaceutical Activity of the Verkhovna Rada Committee on National Health, Medical Care and Volodymyr Korolenko, Deputy Head of the State Service of Ukraine for Medicines and Drug Control, Yevheniya Tkachenko, Deputy Director of the State Expert Center of the Ministry of Health of Ukraine for Registration and Pharmacovigilance, Natalia Gutsal, State Expert of the Expert Group on Registration of Medicines and disinfectants of the Directorate of Pharmaceutical Supply of the Ministry of Health of Ukraine, as well as representatives of professional associations that operate at all stages of the circulation of medicines in Ukraine.