Legal differentiation in the case of domestic legislative default in the field of intellectual property for medicines
In this article, the author raises current issues regarding the formation of a national legal system in the field of intellectual pro -
perty for medicines, which caused a legislative default, which, in the author’s opinion, is determined by the lack of interaction of interconnected
laws, which, ideally, should be interchangeable. Negative tendencies of modern law – making, which are manifested in the
distinction of homogeneous in direction, single – sectoral laws with the introduction of formal changes that do not reflect the solution
of the problem in the regulations of special legislation in the field of intellectual property for medicines. The author proposes to include
in the list of normative legal acts a section of specialized legislation, in this study, – laws concerning medicines.
Also, analyzed on the example of the laws of special and specialized legislation, as an additional filter of the cumbersomeness of
the system of legal regulation of intellectual property in the pharmaceutical industry in terms of the studied aspects. It is proved that it is
appropriate to pay attention to the number of changes, the chronological indicator of their introduction, and the content of these changes,
which indicate unjustified staticity, which will lead to collapse in legislation, will block legal regulation in the pharmaceutical industry.
non-compliance of Ukrainian legislation with the EU legal system and will be the basis for legislative gaps that create opportunities for
such offenses as counterfeit pharmaceuticals, drug counterfeiting, patent trolling, corruption schemes in medical institutions, etc.
In addition, the author proposed the distribution of regulations with changes in types and kinds, which confirmed the author’s
unbiased assumption about the formalization of the legislative process, and the obvious spontaneity and spontaneity in the creation of
regulations on the content and objectives, in the form of laws with changes that have led to legislative accumulation, legal layering,
where the laws are organizational in nature, not coordination. It should also be emphasized that legal differentiation is considered necessary,
is the separation and specification of the regulatory framework, both for medicines, medical devices in the medical field, and intellectual
property in civilization, with the spread of legislative influence of legal system elements on intellectual property.
Thus, given that the law, being the most stable normative – legal act, regulates the most important, significant, basic public relations,
which are the competence of the country’s parliament, given the above problems, the depth of which can not be deliberately
ignored, it is believed that harmonization of national legislation with the legislation of the European Community – a process that affects
the legal ideology and legal practice, possible under conditions of complete reset of the domestic legal system.
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3 Law of Ukraine on Medicines № 123/96-VR (1996, April, 4). Vidomosti Verkhovnoyi Rady Ukrayiny, 22, 86. URL: https://zakon.rada.gov.ua/laws/show/123/96-вр [in Ukrainian].
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5 Law of Ukraine On Amendments to Certain Laws of Ukraine Aimed at Increasing the Availability of Medicines, Medical Devices and Auxiliaries Purchased by a Person Authorized for Procurement in the Field of Health Care of March 17, 2020 for № 531-IX / effective from 18.03.2020. / Vidomosti Verkhovnoyi Rady Ukrayiny (VRU), 2020, №16, p.101/URL: https://zakon.rada.gov.ua/laws/show/531-20#Text [in Ukrainian].
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8 Vishar Yu.Iu. (2020) Legal differentiation in the domestic legislative default in the field of intellectual property for medicines // Chasopys Kyyivs`koho universytetu prava, 2, 311-318. URL: http://kul.kiev.ua//images//A/Chasopis/CHAS20__2.pdf [in Ukrainian].
9 Directive 2011/62 / EC of the European Parliament and of the Council of 08 June 2011 amending Directive 2001/83 / EC on the Community code relating to medicinal products for human use, to prevent the supply of falsified medicinal product supply chains / Yevropeys`kyy Parlament i Rada YeS. OJ L 174, 1.7.2011, p. 74 / URL: http://farmpalata.com.ua/novyny/zvit-komisiyi-do-yevropejskogo-parlamentu-ta-rady-pro-perenesennya-derzhavamy-chlenamy-statti-118a-dyrektyvy-2001-83-yes/ [in Ukrainian].
10 DIRECTIVE 2001/83/EC. (2001, November 28). Community code relating to medicinal products for human use. Yevropeys`kyy Parlament i Rada YeS. OJ L 311, 67. URL:https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf [in English].
11 Law of Ukraine On Amendments to Certain Laws of Ukraine Aimed at Increasing the Availability of Medicines, Medical Devices and Auxiliary Products Purchased by a Person Authorized for Procurement in the Sphere of Health Care of March 17, 2020 for № 531-IX / effective from 18.03.2020 /Vidomosti Verkhovnoyi Rady Ukrayiny, (VRU), 2020, №16, Article 101/ URL: https://zakon.rada.gov.ua/laws/show/531-20#Text [in Ukrainian].
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14 Law of Ukraine On Amendments to Article 3211 of the Criminal Code of Ukraine on Strengthening Liability for Counterfeiting of Medicinal Products or Circulation of Counterfeit Medicinal Products of 12 November 2019 under № 284-IX (Vidomosti Verkhovnoyi Rady Ukrayiny, VRU, 202, №2, Art. 8) URL: https://zakon.rada.gov.ua/laws/show/284-20 [in Ukrainian].
15 Order of the Cabinet of Ministers of Ukraine On approval of the Concept of implementation of state policy to prevent counterfeiting of medicines and approval of the action plan for its implementation /03.04.2019 for № 301-2019-r./ URL: https://zakon.rada.gov.ua/laws/show/301-2019-р [in Ukrainian].
16 Androshchuk H.O. (2019) EU directive on falsified medicines has entered into force / Yurydychna Hazeta. 02/26/2019/ URL: https://yur-gazeta.com/publications/practice/medichne-pravo-farmacevtika/direktiva-es-pro-falsifikovani-liki-nabrala-chinnosti.html [in Ukrainian].
17 Law of Ukraine on Protection against Unfair Competition of 07.06.1996 under №236 / 96-ВР /current version 11.12.2019, basis 286-IX/. URL: https://zakon.rada.gov.ua/laws/show/236/96-вр [in Ukrainian].
18 Bayer begins to use blockchain to control drug supply / Zdrav. Expert. Medtekh – portal. 04.2020/ URL: http://zdrav.expert/index.php/ [in Ukrainian].