Informacijos apie vaistinius preparatus sklaida pacientams : teisinių apibrėžimų turinys, ribojimų teisėtumas ir atsakomybės už pažeidimus klausimas

LTStraipsnyje, pasitelkiant sisteminės analizės metodą, nagrinėjami informacijos apie vaistinius preparatus sklaidos pacientams teisinio reguliavimo nacionalinėje teisėje ypatumai. Pirmoji straipsnio dalis skirta pacientų informavimo apie vaistus būdų (farmacinės informacijos ir vaistinių preparatų reklamos) teisinių apibrėžimų turinio analizei. Išryškinami jų ypatumai, panašumai ir skirtumai. Antrojoje dalyje, remiantis Lietuvos Respublikos Konstitucinio Teismo jurisprudencija, atskleidžiami informacijos apie vaistus sklaidos pacientams ribojimų teisinio pagrįstumo kriterijai. Trečiojoje – nagrinėjamas teisinės atsakomybės už pacientų informavimo apie vaistus pažeidimus klausimas. Atkreiptinas dėmesys, kad tyrime apsiribojama būtent pacientų arba, kitaip tariant, gyventojų grupės informavimo apie vaistinius preparatus probleminiais aspektais, nesigilinant į informacijos apie vaistus sklaidos kitiems tiksliniams subjektams, t. y. sveikatos priežiūros ir farmacijos specialistams, teisines ypatybes. [Iš leidinio]Reikšminiai žodžiai: Farmacijos teisė; Farmacinė informacija; Informacijos apie vaistus sklaida pacientams; Pacientų teisė į informaciją; Pacientų teisės; Sveikatos teisė; Vaistinių preparatų reklama; Advertising of medical products; Advertising of medicinal products; Health care law; Patients' right to information; Patients' rights; Pharmaceutical information; Pharmaceutical law; Provision of information on medicinal products to patients.

ENAuthor employs the method of systemic analysis to analyze the features of national legal regulation on provision of information on medicinal products. The paper is limited to the problem aspects of providing information on medicinal products to patients, i.e. a population group, and does not analyze the legal features of providing information on medicinal products to other target subjects, i.e. health care and pharmacy specialists. The first part of the paper focuses on the analysis of the content of legal terms of patient information methods (pharmaceutical information and advertisement of medicinal products), as well as research of similarities and differences of these methods. The author discovers that the main difference from the point of view of patients is the purpose of the methods: pharmaceutical information does not aim to promote consumption (buying) of medicinal products, while advertisement of medicinal products always has this purpose. The second part of the paper aims to establish the legal reasonability criteria of the restrictions on provision of information to patients, in accordance with the jurisprudence of the Constitutional Court of the Republic of Lithuania. The author establishes that the main condition of lawfulness of the restrictions of information about medicinal products is threat to human health as the protected personal and public value.This in particular applies to the advertisement of medicinal products. Other (not less important) criteria are: the social need (necessity), statutory regulation of restrictions of information provision, and their proportionality. Only objective is the non-misleading advertisement of registered, obtainable without prescription medicinal products, allowed through media that is accessible to patients in Lithuania. The issue of legal responsibility for patient information on medicinal products is analysed in the third part of the paper. The conclusions state that legal responsibility may arise as a result of advertisement of medicinal products and other products that are presented as such to patients that is not objective, is misleading, hidden, and infringes or fails to comply with statutory requirements. It may also arise in case of non-quality provision of pharmaceutical service, or non-ethical activities of health care and pharmacy specialists. Legal analysis of legislation revealed that the regulatory basis of provision of information on medicinal products in Lithuania has been created. However, there are still many gaps in this field, e.g., insufficiently defined advertisement of medicinal products, advertisement of food supplements, and mandatory civil liability of pharmacies is not established. There are also control deficiencies, e.g. hidden advertisement of medicinal products, and quality of pharmacy services. [From the publication]