LEGAL DEFINITION OF THE TERM «INNOVATIVE DRUG»
Abstract
Problem setting. In the up-to-date legal and pharmaceutical framework absence of the single common definition for “innovative drug” / “brand-name drug” prevents the appropriate information exchange between various world countries aiming for the purpose of provision of protection of healthcare intellectual property rights. It also prevents creation of the single regulatory database, which will provide harmonization of the drug marketing authorization procedure efficient interaction of the authorized authorities in protection from expansion of the falsified drugs, and consequently it will promote to the public pharmaceutical care improvement.
The article defines suggestions for improvement of the legislation in-force.
Analysis of recent researches and publications. The studied issue was developed both by representatives of the juridical science and economics and healthcare professionals.
The present definition of “innovative drug” term and criteria for classification of the innovative drugs are reviewed in theses of economics researchers – Z. M. Mnushko, N. S. Klunko; pharmacy researchers – Y. O. Voloska, T. Y. Delvig-Kamenska, N. B. Driomova, Y. O. Korzhavykh, L. V. Moshkova, O. O. Umnova; legal researchers – O. Y. Kashyntseva, I. A. Kirychenko, V. M. Pashkova, and other Ukrainian and foreign researchers.
Purposes of research. The purpose of the research is to study the present in national and foreign legislation definitions of “innovative drug”, and, taking into account the study findings, to define the term, which is adapted to the national legislation. To achieve the objective it is required to solve the following: 1) to ground the necessity to legislate the term “innovative drug” / “brand-name drug”; 2) to analyze the essential features of this term in the legal (compared to the chemical and pharmaceutical) context; 3) to study the present legal framework and the degree of regulating of this issue in the national legislation; 4) to define the “innovative drug” term , taking into account the peculiarities of the national legal system.
It is important to note, that analysis of the legal protection forms of intellectual property subjects in pharmaceutical sphere is not the subject to review in this thesis.
Paper objective. The “innovation” term for the purposes of pharmaceutical healthcare sphere may be defined using these three approaches:
1) Commercial concept: innovation – any newly marketed goods of me-too category (me-too products), new substances, new indications for use, new formulations of drug and new treatment methods.
2) Technological concept: innovation means use of biotechnologies in manufacture of drugs and implementation of the new drug substance delivery system (patch, spray) to production, or selection of isomer or metabolite for the manufacturing process.
3) Concept of “therapeutic achievements”: innovation means advantages of the new treatment method compared to the current methods.
Conclusions and prospects for the development.For the purpose of improvement of the current legislation, the author suggests the following:
- After the received findings have been systematized, the author concluded that it is appropriate and timely to add the current Act of Ukraine “About drugs” with the “brand-name (innovative) drug” term in order to supplement the nomenclature of the Act.
- Compared to chemical, pharmaceutical and medical classifications, the legal classification of innovative drugs has its own peculiarities, and it is induced by the necessity to adjust the special professional terms with the present national legal framework and to harmonize it with the EU legislation.
- The brand-name (innovative) drug – is the drug, which was registered for the first time ever in the world, on the ground of the complete registration dossier (complete set of documents related to its efficacy, safety and quality) and has the patents protection for the active components for the definite period.
