Republic of Armenia

In the Republic of Armenia, orphan (rare) diseases are those with a frequency of no more than 1 case per 10,000 people. According to the Law of the Republic of Armenia dated June 13, 2016 No. ЗР-86 "On Medicines", orphan drugs are defined as those intended for the treatment of such rare diseases.

The legislation of Armenia in the field of orphan diseases is regulated by the following acts:

• The Law of the Republic of Armenia "On Medicines" dated June 13, 2016 No. ЗР-86, which in Article 3, paragraph 31 defines the concept of orphan drugs and establishes the basis for their circulation. Expertise and registration of vital but rarely used, including orphan drugs, can be carried out at the expense of the state (Article 16, paragraph 11).
• 2. Programs of state guarantees for free provision of medical care, including provisions on the provision of medicines for the treatment of rare diseases.
  Provision of medicines to patients with orphan diseases in Armenia is carried out within the framework of state programs. However, the treatment of rare diseases in the country requires additional public funds to fully provide patients with the necessary drugs.
  The main challenges in the field of treatment of orphan diseases in Armenia are:
  - Insufficient funding: there are difficulties in providing patients with the necessary drugs due to a limited budget.
  - Limited access to modern drugs: not all necessary orphan drugs are registered and available in the country.
  - Need to improve the regulatory framework: it is necessary to develop and implement additional legislative acts aimed at supporting patients with rare diseases.
  To improve the situation, it is recommended:
  - Increase in public funding: allocate additional funds for the treatment of orphan diseases.
  - Ensuring the availability of modern drugs: accelerating the process of registration and import of necessary drugs.
  - Development of a national action plan: creating a comprehensive strategy for the diagnosis, treatment and support of patients with rare diseases.
  Thus, despite the existing legislative framework, the system of care for patients with orphan diseases in Armenia requires further development and support to ensure full treatment and improve the quality of life of patients.