Abstract
BackgroundTen years have passed since Latvia became a Member State of the EU in 2004. As a result European regulations, including those related to rare diseases and orphan drugs, have been applied to Latvian legislative system. Orphan diseases have been recognized as a priority area for action in the public health system, though there are significant differences in the national healthcare services for rare diseases among the EU States. This study aims to determine situation in the field of rare diseases in Latvia and compare it with other European countries.MethodsWe used the national plan for rare diseases, EUCERD reports, Orphanet data, Latvian and European regulations, publicly available data from the state agencies, and directly contacted drug manufacturers and wholesalers.ResultsNational plan for rare diseases was developed and approved in 2013. Although there are no official designated centers of expertise as well as no specific register for rare diseases. Newborns are screened for only two disorders: phenylketonuria and congenital hypothyroidism. Currently 34 orphan drugs are available on Latvian market. Three medicines (8.8%) are included in the reimbursement drug list, all indicated for Ph + CML. 15 drugs (44.1%) were reimbursed within the framework of individual reimbursement system, and five drugs (14.7%) were provided within the program of medicinal treatment of rare diseases in children.ConclusionsMajority of orphan drugs authorized in the EU are not available in Latvia, moreover those drugs that are available are often not accessible because they are insufficiently reimbursed. Besides, approval of the national plan might be an important step towards improving situation in the field of rare diseases.
Highlights
Ten years have passed since Latvia became a Member State of the European Union (EU) in 2004
Aim of the study This study aims to determine situation in the field of rare diseases in Latvia and compare it with other European countries
National plan for rare diseases Latvian national plan for rare diseases was written by the working group, which included health care professionals, representatives from the Ministry of Health (MoH) and patient organizations
Summary
Ten years have passed since Latvia became a Member State of the EU in 2004. As a result European regulations, including those related to rare diseases and orphan drugs, have been applied to Latvian legislative system. Ten years have passed since Latvia became a member of the European Union (EU) in 2004. Since the EU laws and regulations, including those related to rare diseases, have been applied to Latvian legislative system. According to the EU regulations disease is considered as rare if it affects not more than five in ten thousand people [1]. It is estimated that between five and eight thousand different rare conditions exist, affecting 6-8% of the population, concluding that about 30 million people are suffering from rare disorders in the EU.
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