Homeopatijos teisinis reguliavimas Europos Sąjungoje ir Lietuvoje

LTKylanti susidomėjimo sveiku gyvenimo būdu ir ekologija banga įtraukia į savo judėjimą ir homeopatiją. Nors homeopatinių vaistų veiksmingumo įrodymai iki šiol vertinami labai prieštaringai, tai praktiškai vienintelė tam tikrą teisinį pripažinimą įgijusi alternatyviosios medicinos forma. Šis straipsnis skirtas homeopatijos teisinio reguliavimo ypatumų Europos Sąjungos (ES) ir nacionalinėje teisėje tyrimui. Lietuvos teisės doktrinoje šis klausimas iki šiol nebuvo analizuotas. Straipsnyje išnagrinėtas sąvokos „homeopatinis vaistinis preparatas“ apibrėžimo turinys ir ES teisės normomis nustatyti reikalavimai derinant pramoniniu būdu pagamintų homeopatinių vaistų registravimo procedūras valstybėse narėse. Taip pat analizuojamas homeopatinių vaistų registravimo, ženklinimo ir reklamos teisinis reguliavimas Lietuvoje, gilinamasi į homeopato praktikos reglamentavimą nacionalinėje teisėje. Palyginti pateikiamas ir kitų valstybių ES narių įstatymų leidėjų požiūris į homeopatijos vietą sveikatinimo paslaugų sistemoje. [Iš leidinio]Reikšminiai žodžiai: Homeopatija; Homeopatijos teisinis reguliavimas; Homeopatinis vaistinis preparatas; Homeopathic medicinal product; Homeopathy; Legal regulation of homeopathy.

ENHomeopathy is a non-traditional medical treatment which came to Europe a few hundred years ago and is presently attributed to the complementary and alternative medicine. Although the assessment of evidence on effectiveness of homeopathic medicinal products has been very contradictory, homeopathy in practice is the only form of alternative medicine that has received certain legal recognition. The paper focuses on the study of the legal regulation of homeopathy in the European Union and in national law. The author analyses the contents of the concept of ‘homeopathic medicinal product’ and the EU legal norms on harmonisation of procedures for registry of homeopathic medicinal products in the Member States. It is concluded that the market of homeopathic medicinal products in the EU still lacks coherence and unity. Registry procedures under the EU law on this category of medicinal products do not apply to some of the homeopathic products, and the Member States are provided with discretion of adopting a special registry procedure, i.e. providing requirements on their discretion with regard to pre-clinical and clinical research on homeopathic medicinal products.The introduction of mandatory simplified registry procedure for homeopathic medicinal products in all EU Member States is a positive step. The author observes that the simplified procedure in principle ensures only the safety of homeopathic medicinal products on the market, because evidence of effectiveness are not required if homeopathic medicinal products are placed on the market without therapeutic indications. In the author’s opinion, the lack of credibility of the effectiveness criterion in theory allows questioning of the status of homeopathic preparations as ‘medicinal products‘. The article also aims at analysing the legal regulation of registration, labelling and advertising of homeopathic medicinal products in Lithuania. Apparently, homeopathic medicinal products are registered in Lithuania under three types of procedures: the simplified, special, and standard procedure. The special procedure for registering homeopathic medicinal products in Lithuania was established in 2010. It provides for a possibility to register homeopathic medicinal products with certain confirmed indications, without providing all the data that is usually required to claim the right to market a medicinal product. [...]. [From the publication]