Regulatory Reform
TGS Baltic / Estonia
Key legal info on regulatory reforms in Estonia. Prepared in association with TGS Baltic, a leading law firm in Estonia, this is an extract from The Pharma Legal Handbook: Baltics, available to purchase here for USD 99.
1. Are there proposals for reform or significant change to the healthcare system?
According to the current plan and corresponding legislation, reform concerning owning pharmacies will be finalized in two years. The aim of the reform is to separate wholesale and retail sale of medicines and to establish a system where more than 50 per cent of the shares of the pharmacy and the dominant influence must belong to a pharmacist who works as the manager in at least one general pharmacy operating on the basis of an activity license issued to the pharmacy. This reform has caused much confusion and even court cases and it is not excluded that respective legislation will be changed.
Estonia is considering similar “no-fault system” mechanism for compensation of damages caused to patients in connection with healthcare services as is established in Finland and in some other countries. The aim of the “no-fault system” is to simplify compensation procedures (currently compensation can be claimed through courts) and to encourage physicians to collaborate with the system in detecting what caused the injuries. Compensation is based on proof of “causal” connection between treatment and injury and proof of negligence is not required.
2. When are they likely to come into force?
The reform concerning retail sale of medicines and owning pharmacies comes into force in 2020 if not changed before. Change of liability system of healthcare providers is not likely to come into force in the near future.