Lithuania – Update on ‘Sunset Clause’ Requirements for Medicinal Products

The State Medicines Control Agency on the ground of market monitoring data has compiled the list of medicinal products authorized in the Republic of Lithuania which more than for three years had not been supplied to the Lithuanian market.

Following Part 7 Article 14 of the Law on Pharmacy in the exceptional cases and for the interests of public health, the State Medicines Control Agency of Lithuania may not withdraw the validity of the marketing authorisation of the medicinal product which according to the Part 6 of this article has not been supplied to the market.

Marketing Authorisation Holder seeking that the validity of marketing authorisation would not be withdrawn according to Part 6 Article 14 of the Law on Pharmacy has to submit to the Agency a request with motivation on the basis of which the Agency could accept the decision not to revoke the validity of marketing authorisation of the medicinal product.

The State Medicines Control Agency after receipt of motivated request from Marketing Authorisation Holder or its representative by 30 March 2018 considers whether not to apply „sunset clause“ for specific medicinal product. After that date the validity of marketing authorisations of the medicinal products listed in the table is revoked.

To add the macro perspective, economic growth in Lithuania has been rapidly gaining momentum with the GDP growth in 2017 estimated at 3.8%. Lithuania’s productivity growth rebounded in 2017, alleviating pressure on competitiveness. While Lithuania’s business environment continues to improve, the investment rate remains low, below the EU average, despite a strong recovery in GDP growth. Investment would benefit from improved strategic planning and efficiency of public investments, increased transparency and competition in public procurement and stronger innovation environment.

As a share of GDP, total current health spending has increased from 5.6% in 2005 to 6.5% in 2015. Some 32% of health spending, mostly on pharmaceutical products, is paid out-of-pocket compared to the EU average of 15%.

Some measures have been taken to improve the performance of the health sector but raising the efficiency and quality of both primary and hospital care remains a challenge. Lithuania made limited progress with improving the public health policies and strengthening the accountability at the local level. The effectiveness of measures taken to reduce the high level of out-of-pocket payments and their substantial financial burden on low income population groups remains to be assessed.

For further information regarding regulatory submissions, MA approval and national authorisation procedures in Central and Eastern Europe, please contact Jane Smith at Grove Group Pharmaservices or visit our website