Potential changes in the pharmaceutical regulation

Disclosure of the information regarding the support provided

28 May 2019 the Parliament of the Republic of Lithuania has agreed to the proposal of the Ministry of Health of the Republic of Lithuania regarding the amendment and supplement of the Law on Pharmaceutics of the Republic of Lithuania (hereinafter – Law on Pharmaceutics). The alterations offered would oblige the drug manufacturers and their agents (i.e. distributors) to publicly present information about the direct or indirect support they provide to healthcare facilities and professionals and to pharmaceutical professionals public.

The current version of the Law on Pharmaceutics prohibits a drug distributor's visit to a healthcare facility for a personal meeting with a health care professional, who is qualified to prescribe medications. However, the personal meetings are restricted in the healthcare facilities only. Meanwhile, the Law on Charity and Assistance of the Republic of Lithuania establishes that legal persons (and thus health care institutions) may be supported by in the transfer of any property, including manufactured goods (i.e. the drugs including). Provisions of this Law enable manufacturers of medicinal products and their representatives to establish contact with healthcare and pharmaceutical professionals by passing medicinal products manufactured to them and providing all relevant information accordingly at certain events.

If the President of the Republic of Lithuania approves the proposed amendments of the Law on Pharmaceutics, from 1 January 2020 all the information regarding the cooperation in any form between the pharmaceutical manufacturers and their representatives with healthcare facilities, professionals, and the pharmaceutical professionals (including cooperation at the aforementioned events) will be made publicly available. These legislative changes are intended to ensure transparency in healthcare facilities and to eliminate any mistrust possibly arising.

State-run pharmacies - the near future?

Another proposed amendment to the Law on Pharmaceutics, which is broadly supported by the Government of the Republic of Lithuania, is the extension of the hospital pharmacy business. According to the current regulation, a hospital pharmacy is defined as a division of a healthcare institution that supplies medicinal products and/or pharmacy goods to that institution.

If the Parliament of the Republic of Lithuania will approve the proposed changes, the commercial activities of hospital pharmacies would no longer be limited to the sale of medicinal products only to healthcare facilities such as the parent hospital pharmacy companies, but such pharmacies would also be able sell drugs or pharmacy goods to all other customers, including individuals (natural persons).

Possible amendments to the Law on Pharmaceuticals are not only a source of dissatisfaction in the private sector, but also the competent persons of the Lithuanian Competition Authority have raised concerns about potential breaches of competition rules. There is a potential conflict of interest between commercial and public administration activities of the healthcare institutions, as well as issues of transparency, efficiency and risk of corruption.

It shall be noted that the amendments that would extend the scope of the activities of the hospital pharmacies are not yet approved by the Parliament of the Republic of Lithuania and the President of the Republic of Lithuania has not expressed his will accordingly.

Please be informed that Leinonen legal team is able provide comprehensive and exhaustive legal advice not only in the context of the Law on Pharmaceutics, but also on any other legal issues that your business may be concerned about.

Information above was prepared by Leinonen Lithuania Legal Team.