Disclosure in Lithuania Now Also Covered by Law

In Lithuania, the Pharmacy Law was amended to add a disclosure obligation for marketing authorization holders (MAHs) regarding transfers of value (ToVs) to healthcare professionals (HCPs) or healthcare organizations (HCOs). The rules were approved by the Minister of Health on June 23, 2020.

Although many pharmaceutical companies were already reporting in line with the principles of the EFPIA Disclosure Code via their national associations IFPA and VGA, the new law now requires all Lithuanian MAHs and their representatives to disclose pursuant to the new law.

Reporting under the law is required for similar ToVs as under the code, including those related to events and consultancy. However, the law does not require reporting of research and development ToVs or support to patient organizations. Members of EFPIA, IFPA and VGA still need to report on these ToVs in line with the code of conduct.

Obligations in the new law include the submission of an annual report on ToVs made to HCPs or HCOs or a person representing their interests. The reports should be submitted annually before June 30th to the Lithuanian State Medicines Control Agency which will publish the data received for a period of two years and store the reports for three years.

When submitting for the first time, a MAH and/or its representative must submit the completed registration form as provided in Annex 3 of the rules. The rules also contain the report templates that need to be used in Annex 1 and 2.

The Department of Health hopes the new rules will provide a way for patients to select their doctors and other HCPs in a more informed way.

Our Legislative Watch page on Lithuania is already amended and provides a summary of all reporting obligations in Lithuania, including the link to the applicable law, rules and codes.

Frederique Reijntjes

Senior Legal Consultant, MediSpend

Posted on Jan 6, 2021 9:47:33 AM

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