Retųjų vaistų prieinamumo problema įgyvendinant teisę į sveikatos priežiūrą

LTTeisės nuostatos, kuriomis remiantis grindžiamas retomis ligomis sergančių pacientų aprūpinimas retaisiais vaistais Lietuvoje, yra inspiruotos Europos Sąjungos (ES) teisėkūros. Nors teisinių iniciatyvų sprendžiant retų ligų gydymo problemą mūsų šalyje yra imtasi, tačiau kyla klausimas, ar jos yra pakankamos, ar nėra taip, jog nepagrįstai ribojamas vaistų, skirtų retoms ligoms gydyti, prieinamumas ir kartu retomis ligomis sergančių pacientų teisė į kokybišką sveikatos priežiūrą? Atsakymo į šį klausimą paieška pirmiausia reikalauja teorinio pagrindimo. Todėl pirmoji šio straipsnio dalis skirta istorinėms retųjų vaistų reglamentavimo ES sąlygoms, antroji -- retųjų vaistų prieinamumo ir teisės į sveikatos priežiūrą užtikrinimo sąsajų analizei. Registruotų ir neregistruotų vaistų retoms ligoms gydyti prieinamumo materialinės teisinės garantijos Lietuvoje, kaip praktinis šio klausimo aspektas, nagrinėjamos trečiojoje straipsnio dalyje. [Iš leidinio]Reikšminiai žodžiai: Retųjų vaistų reglamentavimas; Teisė į sveikatos priežiūrą; Orphan drugs legislation; Right to health care.

ENCurrently in the European Union (EU) approximately 30 million people suffer from rare diseases. A European policy on rare disorders was put into action with the Regulation (EC) 141/2000 adopted on December 16, 1999, setting out a Community procedure for the designation of medicinal products and providing incentives for research, development and marketing of orphan medicinal products in the EU. The legislation on orphan medicinal products is a part of a broader Community policy to identify rare diseases as a priority area for action in the field of public health, which constitutes the area of common competence of EU and Member States. The paper deals with the problem of accessibility of orphan medicinal products in the light of the right to health care. The aim of this article is to analyse historical, theoretical and practical aspects of this problem. There are no studies or researches done in this field in Lithuania so far. In order to achieve the aim of this article the following tasks are set: to single out the most important stages of the development of a policy on orphan medicinal products in the EU; to clarify the link between the concept of access to orphan drugs and the right to health care, to review the legal framework of access to approved and not approved therapies for rare diseases in Lithuania, and to discuss some legislation gaps. The problem of orphan drugs accessibility correlates with the patient's right to health care. Two main factors outline this link: extent of national constitutional obligations in the sphere of health care and limits of national health insurance budget to reimburse very expensive therapies.The incentives provided at the Community level stimulate the development of orphan medicinal products, in order to facilitate the accessibility of such products on the market. Consequently, the objective of the Regulation (EC) No 141/2000 can be qualified as a contribution to the attainment of an effective protection of the right to health care in the EU countries. By the same token it could be refered to the Article 5 of the Directive No 2001/83/EC and Article 83 of Regulation (EC) No 726/2004, which lay down the possibility of using an unauthorised medicinal product for compassionate use on a named patient basis and to cohorts of patients respectively. National legal framework and administrative procedures can provide us with useful indications on the accessibility of orphan drugs in the country. In Lithuania, the administrative provisions concerning the reimbursement of approved therapies in some cases can be treated as inappropriately restrictive, since the decision-making powers of the special commission at the State Patients' Fund lack clear and transparent procedures. At the same time it should be noted that not all legal possibilities of access to orphan medicinal products are implemented, eg. compassionate use programs. Therefore the situation of orphan patients in terms of protection of patient right to access to quality health care can be assessed as insufficient. [From the publication]