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Transparency in Lithuanian health care sector further strengthened

Pharmacy Law requires disclosure of any transfer of value to HCPs and HCOs from 1 January 2020.

An amendment to the Lithuanian Pharmacy Law introduces new disclosure obligations for transfers of value to Health Care Professionals (HCPs) or Health Care Organizations (HCOs) with the aim of further strengthening transparency in cooperation between pharmaceutical companies and HCPs or HCOs.

Although many pharma companies have for some years self-imposed an obligation to abide by a disclosure policy in line with the principles of the EFPIA Transparency Code via their national associations IFPA and VGA, from 1 January 2020 all Lithuanian Marketing Authorization Holders (MAHs) and their representatives are now affected by the new disclosure obligations established by law.

Pharma companies must comply with the following obligations:

  • Documentation of all direct or indirect transfers of value, whether in cash, in kind or otherwise to a HCP or a HCO or a person representing their interests by collecting the name, qualifications and identification number of the HCP or title of the HCO, as well as the concrete transfer of value
  • Submission of yearly reports on documented data to the Lithuanian State Medicines Control Agency according to the Order of the Lithuanian Minister of Health
  • Storage of collected data for three years from the day of first publication on the webpage of the State Medicines Control Agency
  • Permanent destruction of data after this period has elapsed.

The State Medicines Control Agency publishes data received once a year for a period of two years on its webpage.

In addition, the Lithuanian State Tax Inspectorate is obliged to pass on to the Medicines Control Service all information received under the Charity and Donations Act declaration. These are published in the same way on the same website.

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, at the same time more clearly informing patients by concentrating all information on one website for all pharmaceutical companies and all HCPs and HCOs.

The rules will also be an incentive for HCPs to prescribe medicinal products more objectively, thus avoiding unnecessary costs for patients due to more expensive medicinal products.

An earlier amendment to the Lithuanian Law on Pharmacy in 2018 already introduced a prohibition for representatives of pharma companies to personally meet or visit HCPs at HCOs with the aim of informing them about specific medicinal products. Informing HCPs of specific medicinal products has been allowed since 2018 only in the framework of special promotional events at HCOs. The organization of such events has to follow the rules of a special Order issued by the Lithuanian Minister of Health.

An Order of the Lithuanian Minister of Health establishing details of the procedure for disclosure and containing the forms to be used for disclosure is already in the pipeline. According to the draft Order reports on collected data must be forwarded to the State Medicines Control Agency no later than 30 June of the following year. The State Medicines Control Agency will publish the information received by 30 December of the following year on its webpage.