Pharmaceutical Regulatory Affairs: Open Access

Regulatory Framework of Orphan Medicines in Albania

Abstract

Ilda Mallkuçi

There are no legal basis for the orphan medicines mentioned in Law No. 105/2014, 31.07.2014 “On drugs and pharmaceutical service”, amended. They are regulated by this low as the other medicines authorized in Albania according to the centralized procedure. This procedure is applied for the medicines authorized from EMA and FDA. The main document for this procedure is the Certificate of the Pharmaceutical Product from EMA or FDA. Specific requirements for the centralized procedure are detailed in Decision of the Council of Ministers No. 299, 08.04.2015. Actually in Albania are authorized for marketing 14 orphan medicines; they are designed for the treatment of rare diseases as mucopolysaccharidosis II and VI, Fabry disease, Cystic Fibrosis, Acromegaly Pituitary ACTH Hypersecretion, Idiopathic Pulmonary Fibrosis, Multiple myeloma etc. These medicines are authorized in Albania since 2008 until 2017 (although the lack of specified legal basis), most of them several months to 4 years from the first authorization by EMA. To qualify for orphan designation, a medicine must meet these criteria: it must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating; the prevalence of the condition in the EU must not be more than 5 in 10,000; no satisfactory method of diagnosis, prevention or treatment of the condition concerned can be authorized, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition. 60% of designated orphan medicines are intended for paediatric use. Because rare diseases are a global issue, the Agencies work closely with its international partners on the designation and assessment of orphan medicines. Recommendations: Approaching the Albanian legislation with EU legislation regarding orphan medicines and creating a data base on the extension of use of Orphan medicines in Albania.