We are pleased to introduce an overview of the most recent legal developments relevant to the life sciences and healthcare sector in the Baltics and Belarus.
Lithuania: obligation to disclose links with healthcare professionals
The Lithuanian Cabinet of Ministers approved a proposal to introduce an obligation for manufacturers and distributors of registered medicines to publicly disclose information on their support for and cooperation with healthcare institutions, doctors and pharmaceutical professionals. The proposed amendments to the Law on Pharmacy are not yet in force and still have to be approved by the Lithuanian parliament.
Since last year, in-person advertising of medicinal products for healthcare professionals is not allowed in Lithuania. However, drug manufacturers and distributors find other ways to establish personal relationships with doctors and pharmacists. For example, they organise professional events or pay healthcare professionals for consultations and reports. So the proposed changes aim to further increase transparency in the healthcare sector.
The proposal is available here (in Lithuanian).
Latvia: new transparency requirements
As of 1 January 2019 amendments to the Regulations of the Cabinet of Ministers specify new transparency requirements with regard to promotional activities and financial support in respect of medicinal products. In particular, with these amendments the state broadens the scope of information that the manufacturer or distributor has to report annually to the Health Inspectorate. Most importantly these requirements include the obligation to indicate the name of healthcare professionals that are the end-recipient of financial support provided to a healthcare institution or professional organisation. In addition, manufacturers and distributors must report all events they organise or sponsor and must report all sums paid out to professional consultants and lecturers who have participated in these events.
Similar transparency requirements have been in place since 2015. However, as they were more vaguely formulated, reports received by the Health Inspectorate greatly varied in the level of detail that manufacturers or distributors chose to report. This meant it was neither possible to obtain comprehensive information about healthcare professionals who were major recipients of financial support, nor to obtain information about their biggest donors.
As the new reporting requirements are more detailed, the State ‒ in line with suggestions from stakeholders ‒ has set that these reports can be filed electronically by 30 June each year. The forms to be filled in are available on the webpage of the Health Inspectorate (in Latvian). These reports will later be published on the Health Inspectorate webpage.
Additionally, pharmaceutical sector tax topics were covered in the discussion organised by a Latvian business newspaper Dienas Bizness. Our tax partner Jānis Taukačs shared his insights on the key issues. You can watch the discussion here (in Latvian).
Estonia: Supreme Court ruling on premises used for provision of pharmacy services
On 19 December 2018 the Estonian Supreme Court ruled that provision of pharmacy services in the same commercial space as health and beauty stores is prohibited. A local pharmacy service provider had recently introduced a new concept where a pharmacy is located in the same commercial space as a health and beauty store with services provided under one trademark and employees wearing identical attire. Furthermore, consumers can only access the pharmacy through the health and beauty store.
The Supreme Court noted that the law does not explicitly regulate access to a pharmacy located in a shopping centre or prohibit use of the same trademark by a pharmacy and a neighbouring business. However, the clear aim of the law is to ensure safety and availability of pharmacy services and its distinctness from other services. The Supreme Court found that the premises used for provision of pharmacy services would not be clearly distinguishable from the premises of the beauty and health store. As a result, the availability and security of the pharmacy service would not be guaranteed. So the Estonian Agency of Medicines was correct to refuse to grant a pharmacy activity licence in this case.
The ruling is available here (in Estonian).
Belarus: new edict on public procurement of medical products
On 10 February 2019 the Edict “On Public Procurement of Medical Products, Pharmaceuticals and Therapeutic Nutrition” entered into force. The main novelty is that it allows public procurement organisers (the Belpharmatsiya public unitary enterprise and its local departments) and customers to conclude additional agreements to existing contracts with successful tenderers (pharmaceuticals and therapeutic nutrition suppliers), instead of executing a separate contract as a result of each procurement procedure. These measures are anticipated to attract foreign suppliers, cut the execution time for agreements and reduce the price of pharmaceuticals. Overall the new Edict largely retains the existing mechanism for public procurement of medical products which is aimed at centralising procurement.
The new Edict governs relationships arising after 1 January 2019. The full Edict is available here (in Russian).