- Tous > Medicine Information and Evidence for Policy > Medicines Policy
- Tous > Quality and Safety: Medicines > Regulatory Support
- Mots-clés > Essential Medicines List (EML)
- Mots-clés > Good Manufacturing Practices (GMP)
- Mots-clés > medicines regulatory authority (MRA)
- Mots-clés > National drug programme
- Mots-clés > national drug regulation
- Mots-clés > national medicines policy (NMP)
- Mots-clés > National Medicines Regulatory Authority (NMRA)
- Mots-clés > pharmaceutical reform
- Mots-clés > rational use of medicines (RUM) / rational medicine use (RMU)
- Mots-clés > registration of medicinal products
- Mots-clés > enregistrement des médicaments
(1994; 1 page)
In this article, Dr. Lembit Rägo reports on recent efforts in Estonia to establish a drug regulatory authority and privatize the pharmaceutical sector after the country gained independence in 1991. The State Agency of Medicines (SAM) is the regulatory body for drugs within the Ministry of Health. One department within the Agency handles registration of pharmaceuticals and information, and a second deals with quality control and inspection. A third department to monitor the operation of pharmacies is currently being established. Estonia’s essential drug list and regulations on pharmaceutical advertising are helping the country promote the rational use of drugs. Immediately after gaining independence, Estonia experienced a shortage of drugs because all pharmaceutical activities were state monopolies. This shortage prompted the opening of the market to privately owned wholesalers and pharmacies, and today 90% of Estonia’s retail pharmacies have been privatised. Additionally, since 1992 there have been three new factories established with the help of Nordic states that all meet good manufacturing practice (GMP) standards. The Estonian government has tried to control the cost of drugs with a few different regulations, such as limiting the profit margins for wholesalers and retailers, exempting drugs from sales tax, and creating a drug reimbursement system for people over 70 and under three. Despite these efforts, a lack of money at the individual and state level remains as one of the largest problems.
Abstract written by M. Tobin, 2013.