Principiul consimțământului informat - principiu fundamental de drept farmaceutic
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ZNAGOVAN, Alexandru. Principiul consimțământului informat - principiu fundamental de drept farmaceutic. In: Congresul Național de Farmacie, 15-17 septembrie 2021, Oradea. Oradea-Chișinău : Editura Universităţii din Oradea, 2021, Ediția a XVIII-a, p. 128. ISBN 978-606-10-2144-4.
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Congresul Național de Farmacie
Ediția a XVIII-a, 2021
Congresul "Congresul național de Farmacie "
Oradea, Moldova, 15-17 septembrie 2021

Principiul consimțământului informat - principiu fundamental de drept farmaceutic

Principle of informed consent - fundamental principle of pharmaceutical law


Pag. 128-128

Znagovan Alexandru
 
Universitatea de Stat de Medicină şi Farmacie „Nicolae Testemiţanu“
 
 
Disponibil în IBN: 29 aprilie 2022


Rezumat

Obiectivul studiului. Studiul si argumentarea teoretica si practica a principiului consimtamantului informat al consumatorului de medicamente in legislatia Republicii Moldova ca principiu fundamental al dreptului farmaceutic. Material si metode. Legile farmaceutice ale Republicii Moldova prin prisma abordarii sistemice, sinteza, deductia logico-juridica, analiza de continut si comparativa. Rezultate. Lacunele reformarii asistentei farmaceutice in Republica Moldova, au generat formarea treptata, dar sistematica a reglementarilor juridice si al statutului de subiect principal al relatiilor sociale si de drept in domeniul ocrotirii sanatatii al persoanei-pacient, persoanei-consumator de medicamente. La fel, treptat, si reglementarile relatiilor traditional paternaliste din sistemul lucrator medic-farmacist-pacient sunt inlocuite cu altele, moderne, bazate pe recunoasterea principiilor deplinei autodeterminari si autonomii a persoanei-pacient, persoanei-consumator de medicamente, a participarii lor active la evaluarea si selectarea tratamentului. In aceste conditii, incet dar sigur, principiile determinante de drept si etice in reglementarea relatiilor in sistemul farmacist - pacient, consumator de medicamente devin veridicitatea, confidentialitatea si consimtamantul informat. Studiului au fost supuse 7 legi adoptate de Parlamentul Republicii Moldova, 12 hotarari adoptate de Guvernul Republicii Moldoiva si cca 50 de ordine ale Ministerului Sanatatii si Agentiei Medicamentului si Dispozitivelor Medicale. Concluzii. In Republica Moldova exista, in general, ‚Äûmatricea” reglementarii juridice a relatiilor din domeniul serviciilor farmaceutice. Insa nici una din componentele sale nu descrie principiul consimtamantului informat al consumatorului de medicamente. Concluzia referitor la importanta acestui principiu poate sta la baza recunoasterii independentei lui, elaborarii unor norme, reglementari juridic-specifice, imperios necesare apararii drepturilor consumatorilor de medicamente.

The objectives of the work. Study and theoretical and practical argumentation of the principle of informed consent of the consumer of medicines in the legislation of the Republic of Moldova as a fundamental principle of pharmaceutical law. Materials and methods. Pharmaceutical laws of the Republic of Moldova through prisme of systemic approach, synthesis, logical-legal deduction, content analysis and comparison. Results. The gaps in the reform of pharmaceutical care in the Republic of Moldova have generated the gradual but systematic formation of legal regulations and the status of the main subject of the person-patient, the person-consumer of medicines in social and legal relations in the field of health care. Likewise, gradually, the regulations of the traditional paternalistic relations in activ system doctor-pharmacist-patient are replaced with modern ones, based on the recognition of the principles of full self-determination and autonomy of the patient-person, the drug-user, of their active participation in the evaluation and treatment selection. Under these conditions, slowly but surely, in the regulation of relations in the pharmacist system - patient, drug user, determinant legal and ethical principles become veracity, confidentiality and informed consent. The study was subject to 7 laws adopted by the Parliament of the Republic of Moldova, 12 decisions adopted by the Government of the Republic of Moldova and about 50 orders of the Ministry of Health and the Agency for Medicines and Medical Devices. Conclusions. In the Republic of Moldova, in general, there is the “matrix” of the legal regulation of relations in the field of pharmaceutical services. However, none of its components describes the principle of informed consent of the consumer of medicines. The conclusion regarding the importance of this principle can be the basis for the recognition of its independence, the elaboration of some norms, specific regulations, imperativ necessary for the protection of the rights of drug users.