Regulatory reform in Lithuania – a comprehensive legal overview. Prepared in association with TGS Baltic, a leading law firm in Lithuania, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for GBP 99.
1. Are there proposals for reform or significant change to the healthcare system?
Yes, there are proposals for reforms in the healthcare system.
The following initiatives has been recently approved:
- Allowing the sale of prescription medicinal products (except for medicinal products containing narcotic-psychotropic substances included in particular lists approved by the Minister of Health). Even though the legal basis for online sale of prescription medicinal products is in place (except for medicinal products containing narcotic-psychotropic substances included in particular lists approved by the Minister of Health), relevant authorities have not been able to prepare online systems which will be invoked in performing such activities. Thus, in practice online sale of prescription medicinal products is currently not available;
- Allowing pharmacies to perform vaccination (i.e., with inactivaTed vaccines against seasonal influenza, tick-borne encephalitis and also COVID-19 vaccines) and to test population with COVID-19 rapid antigen tests. In order to be able to provide such services pharmacies shall have valid HCI licenses and pharmacists – healthcare professionals’ licenses;
- “First prescription” rule established in the Law on Pharmacy of the Republic of Lithuania. When the reimbursable medicinal product is prescribed to a patient with an electronic prescription marked “First prescription”, the patient in the pharmacy should be dispensed with a reimbursable medicinal product for which the lowest patient surcharge applies. However, if a patient refuses to purchase a reimbursable medicinal product with the lowest patient surcharge, another reimbursable medicinal product of the same generic name, strength and pharmaceutical form specified in the prescription may be sold given that the patient by reimbursing the patient for the base price of the chosen medicinal product. The following initiatives are being considered:
- To amend the requirements for sales promotion events of medicinal products in HCIs. Major suggested amendments are:
- regulating the ability to organise online promotional events of medicinal products;
- creating legal basis for an online database where all of the promotional events shall be registered.
- The Government also programmed to review and amend the framework for reimbursement of medicinal products and devices to facilitate use of the innovative products. However, specific initiatives or amendments (apart from derogation of “first prescription” rule) have not been made public, yet.
2. When are they likely to come into force?
The initiatives described in items (i) and (ii) above are now in the last stage of approval by the Parliament of the Republic of Lithuania. It is most likely that these initiatives will come into force in late 2018, or early 2019.
It is not yet clear whether the initiatives described in items (iii) and (iv) above would be approved by the Parliament of the Republic of Lithuania.