DOI: https://doi.org/10.25040/medicallaw2016.02.055

Med. pravo., 2016; 2(18): 55-62

UDС: 346.7

PASHKOV VITALIY MYKHAYLOVYCH

doctor of Law, associate professor, head of the Department of civil, economic and environmental law, Poltava Law Institute, National University “Yaroslav the Wise Law Academy of Ukraine"

Legal Framework for Implementation of the EU Legislation on Medical Drugs Circulation

One of the roles of government in drug policy is to provide the funding and framework that ensures the appropriate level of quality of health care services. Although the drug policy is primarily determined at the national level, there is nevertheless a considerable amount of relevant international and regional norms and standards, including the EU legislation on medical drugs circulation.

This article explores the legal means to ensure the implementation of the EU legislation on medical drugs distribution in the Ukrainian legal system. It also highlights some legal means of regulating the influence of the state on the conduct of pharmaceutical activities. The concrete ways of implementing the EU legislation in the Ukrainian legal system are proposed, and the risks of suppression of the EU legislation implementation are assessed. In addition, the author pays particular attention to bringing information about medicines to stakeholders and advertising them.

The author states that an indicator of the effectiveness of state policy in the sphere of drugs circulation should be the rapid market goal, namely meeting the demand for medicines of high quality to the consumer, along with the profitability of entrepreneurial enterprises working in this sphere.

In this context, the author notes that national implementation of the European standards for medical drugs circulation actually sets new legal means of regulating the influence of the state on the conduct of pharmaceutical activities, although they meet certain similar means in the Ukrainian legislation, but have a wider meaning.

Based on the fact that currently Ukraine is not an EU member state, the author notes the EU regulations do not apply automatically in Ukraine. To resolve this issue, national legislation should be brought into line with the EU law and policies in accordance with the Association Agreement between the European Union and its Member States, of the one part, and Ukraine, of the other part, and subsequent amendments to it.

Another problem on author’s opinion is that decisions, such as approval of medicines for their manufacturing, their admission to the market, prevention of patient-centered health and public health risks, licensing, inspection, are taken in different legislative and policy environments through a variety of legislative procedures. The competent authority in Ukraine cannot participate in the decentralized procedure or mutual recognition procedure on medicines manufactured in the EU. These medicinal products require a separate national marketing authorization (registration certificate). For the same reason medicines approved by the competent authority of Ukraine on the basis of EU law, cannot be exported to the EU member states without marketing approval in the European Union. That is why the procedure and criteria for marketing authorization for the medicinal products in Ukraine have to comply with EU legislation while government secures health policy objectives, such as protecting public health, guaranteeing patient access to safe, effective and of high-quality medicines by maintaining necessary licensing procedures.

The primary goal of bringing the legislation of Ukraine into line with the EU law on drug circulation is effective legal regulation of activities in the sphere of medicines circulation related to manufacturing of medicines, issuing trade licenses, import, wholesale and distance sales, control of medicines quality, determining rights and obligations the entities may exercise and powers of public authorities in this area.

Thus, bringing the legislation of Ukraine into line with the EU law on drug circulation can be an important step towards improving the national health care system through the formation of effective and efficient mechanisms regulating the circulation of drugs. In addition, the author notes that among other things it will: improve the protection of health rights and interests of patients; protect patients from dangerous, falsified and substandard drugs; improve the system of control of medicines quality according to the requirements of the EU legislation; minimize the negative effects of unwarranted state interference in the manufacturing and circulation of drugs; regulate clearly the relationship between the executive, the pharmaceutical market operators and the consumers of medicines; determine the procedure for ensuring the quality of drugs produced, imported and being in circulation; reduce corruption in the sphere of manufacturing and circulation of medicines; increase the availability of safe, effective and of high quality medicines; minimise the cost of medicines, etc.

The author states that bringing national rules on medical drugs circulation into line with the EU law, among other things, is a prerequisite for the fulfillment of Ukrainian international obligations and declared in the Concept of the development of the pharmaceutical industry of the healthcare system of Ukraine for 2011-2020. The above implies the adoption of the new codified act, which is due to review the principles of legal regulation in the sphere of medical drugs circulation, shifted emphasis towards proper ensuring patients’ rights in this area, improvement of the quality, effectiveness, and safety of medicines and their availability.

One of the features of this code should be the establishment of a single legal regime for a variety of entities of pharmaceutical activities on medical drugs circulation, including economic entities, both residents, and non-residents. The author notes that particular attention needs to be paid to resolving the issue of distance selling of medicines, including distance selling pharmacy websites, as online pharmacies should be licensed and operated under the same regulatory system as traditional pharmacies in order to prevent illegal trade of medicines.

The author states there are many different approaches to regulating pharmaceuticals in Europe and Ukraine that affect policy and legislation on medical drugs circulation while improving efficiency, quality of health care and equity. At the same time, the author notes such comparison may contribute to a better understanding of how different measures and policies are implemented. However, such factors as the social, economic, medical, health care and political environment, as well as institutional and legal frameworks, play a major role in how the EU legislation on medical drugs distribution is implemented in Ukrainian legal system in practice.

Key words: medicines, implementation of the EU legislation, economic and legal regulation of the market of medicines.

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