Lietuvos sveikatos politikos retų ligų srityje kryptys: dabartinė teisinė padėtis ir problemos ; Lithuanian health policy in the field of rare diseases: existing legal situation and problems
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.