Lietuvos sveikatos politikos retų ligų srityje kryptys : dabartinė teisinė padėtis ir problemos
Relying on the systematic, logical and analytical methods, national legislation, as well as on the research conducted by the Lithuanian and foreign scientists, this article deals with the ethical and legal peculiarities of Lithuanian health policy in the field of rare diseases and reveals related problems. Lithuanian health policy in the field of rare diseases is developed in two main directions: application of measures to prevent rare diseases and organization and systematic healthcare assistance to the affected persons. The author in the article states that legal regulation of universal screening of newborns in Lithuania is effective, although, in comparison with other EU countries, newborns are screened for a small number of rare diseases (only two diseases: congenital hypothyroidism and phenylketonuria). After the evaluation of legal regulation of genetic consulting, the following weaknesses were envisaged: legally not-regulated pre-implantation method; there is no national legislation defining the legal status of unborn child; there is no legal definition of “abortion”; termination of human’s life at prenatal stage is consolidated by the order of the Minister having the rank of secondary legislation. The following ethical objections were observed, as well: application of abortions to foetus that can be born with a disability; diagnosed incurable disease of unborn child as a way to offer abortion automatically calls into question the value of his life. These weaknesses are proposed to be corrected via adoption of Law on Protection of Human Life in the Prenatal Phase; the doctors are recommended to strictly follow the principles of genetic consulting ethics. The second health policy direction in the field of rare diseases is implemented using three measures: through the organization of personal healthcare service system; through the accessibility of healthcare services abroad and accessibility of medicines for patients suffering from rare diseases. It was concluded that personal healthcare service system for patients with rare diseases in Lithuania still does not work harmoniously. In order to improve the situation, it is proposed to revise the payment system currently functioning for the provision of personal healthcare services for the patients with rare diseases, as well to start the monitoring of rare diseases at the national scale. It has been determined that the legal regulations of the EU on cross-border provision of healthcare services to patients are implemented to the national law properly, however, the procedure related to the issue of permits for the patients to receive such services provides no specific exceptions for the patients with rare diseases. The analysis of legal regulation on the current accessibility to the medicine necessary to cure rare diseases states that Lithuania has conditions to supply orphan medicinal products to the Lithuanian market established. Essential weakness is that the so-called “compassionate use of medicinal products” has not been validated yet. The ethical problems are caused by the lack of reimbursement for orphan medicinal products, repeated procedures related to the evaluation of efficiency and therapeutic value of the orphan medicines at the national competent institutions.
- Straipsniai / Articles