Dr L. Rägo, Estonia
The action plan for reform within Estonia was created in 1990, and implementation began in 1991. The basic philosophy behind the action plan is that the pharmaceutical sector is an integral part of the health care system.
In 1990, a Governmental decree gave power to regulate the drug sector to the Ministry of Health and in 1991, the Estonian Centre on Medicines (ECM) was created followed by the passage of the first detailed legislation concerning such issues as drug registration.
In 1993, progress was made through the establishment of a fully operational drug regulatory agency, the State Agency of Medicines (SAM), and a reimbursement system was set up. In 1996, the Medicinal Products Act, together with appropriate sub-laws and regulations, was implemented. As a result of rapid national and regional developments, priorities have changed over time and there has been a trend towards promoting awareness in safety and efficacy.
Increasing transparency is also essential. Drug registration decisions are based on a written assessment of the required documentation and laboratory analysis, if appropriate. Since its foundation, SAM activities have been reflected in international journals and other publications. The most effective method to increase transparency has been the creation of a Website. It is important to have this in both the national language and in English. The Estonian State Agency of Medicines has been present on the Internet since late 1996 at http://www.sam.ee.
In addition to being accountable to the Ministry of Health, transparency of the Agency’s operations to the general public is essential. Detailed annual reporting is carried out in addition to quarterly reporting of pharmaceutical sector activities in the areas of statistics, detected quality problems, violations of law, and actions taken. Audits by the State Audit Office and Ministry of Finance are carried out on a regular and ad hoc basis.
The State Agency of Medicines is constantly updating its internal standards of practice (SOP) and around 20 guidelines are presently in effect or drafted dealing with such topics as administration, complaints, importing unregistered drugs and the handling of registration applications and their assessment. Inspection and classification of manufacturing sites is also carried out.
Efficient administrative practices and timelines are essential for the proper functioning of all governmental processes. As a rule, any correspondence must receive an answer within thirty days. Marketing authorization timelines are established by law as follows:
• New applications are dealt with in a maximum of 270 days. The average time for registration (95% of applications) is 8.5 months
• Two months are allowed for registering products that have been cleared through the EU centralized procedure-with recognition of EU scientific expertise according to the CADREAC/EU unified procedure.
• Renewals take an average of 4 months
• If a deficiency letter is issued, no time limit is applied until an answer is received
The State Agency of Medicines is a disseminating point for the following information:
• Legal acts and guidelines applicable to foreign customers, and foreign acts and guidelines applicable to local customers.
• National financial drug statistics at the retail and hospital pharmacy level.
• National statistics according to the WHO ATC/DDD drug statistics methodology- published annually and used for comparisons in use of medicines and decision-making.
• The Drug Information Bulletin for medical doctors and pharmacists and other free of charge drug information which is independent of business.
• Informational seminars for business structures (manufacturers, wholesale dealers and pharmacies).
• Sharing of information with other national authorities and inspections upon request.