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Baltic Statistics on Medicines 2010–2012 2 | Sales Statistics 2010–2012 Sales Statistics 2010–2012 |

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Baltic Statistics on Medicines 2010–2012 2 | Sales Statistics 2010–2012 Sales Statistics 2010–2012 | Sales statistics 2010–2012 | Baltic Statistics on Medicines 2010–2012 2 | Sales statistics 2010–2012 Sales statistics 2010–2012 | Baltic Statistics on Medicines 2010–2012 Tartu 2013 2 | Sales statistics 2010–2012 Edited by: Estonian State Agency of Medicines Ly Rootslane, Ott Laius, Janne Sepp, Katrin Kurvits Latvian State Agency of Medicines Andis Seilis, Elma Gailīte, Dace Ķikute Lithuanian State Medicines Control Agency Dr Jolanta Gulbinovič, Renata Tomaševič, Vaida Stasevičiūtė Published by: Estonian State Agency of Medicines 1 Nooruse Street 50411 Tartu Estonia [email protected] www.ravimiamet.ee When using or quoting the data included in this issue, please indicate the source. ISBN 978–9949–33–396–7 (print) ISBN 978–9949–33–397–4 (pdf) Printed by environmentally friendly printinghouse Ecoprint Sales statistics 2010–2012 | Contents 1. Preface ................................................................................................... 3 2. Facts about the Baltic countries ............................................................ 3 3. Medicinal products regulation and pharmaceutical services .............. 8 in the Baltic countries 3.1. Procedures of marketing authorisation of medicinal ................... 8 products in the Baltic states 3.2. Marketing authorization licences ................................................. 9 3.3. Non-authorised medicinal products ............................................ 9 3.4. Medicinal products mark-up ...................................................... 10 3.5. Generics market ......................................................................... 13 3.6. Retail and hospital pharmacies and wholesalers ....................... 14 4. Drug reimbursement systems in the Baltic countries .........................17 4.1. Description of the reimbursement systems ................................17 4.2. Changes in the reimbursement systems .................................... 20 (during the period of 2010–2012) 4.3. Reference price systems..............................................................22 5. Materials and methods used in the Baltic Statistics on Medicines ... 24 5.1. Data collection in the Baltic states ............................................. 24 5.2. ATC/DDD methodology and interpretation of drug ................... 25 sales statistics 5.3. Factors affecting the interpretation of drug utilization data...... 26 6. Cost of drugs as a share of total health care expenditure ................. 27 in the Baltic countries 6.1. The medicinal products market ..................................................27 6.2. Sale of drugs according to the ATC main groups ........................ 28 (DDD/1000 inhabitants/day) 6.3. Sale of drugs according to the ATC main groups (turnover)....... 30 7. Sales statistics 2010–2012 ................................................................... 33 8. TOP 15 of prescription only medicines ............................................. 156 9. TOP 15 of ATC 3rd groups ...................................................................157 10. TOP 15 of over-the-counter medicines ............................................. 158 11. Contacts ............................................................................................. 159 12. References ......................................................................................... 160 4 | Sales statistics 2010–2012 Preface | 5 1. Preface Kristin Raudsepp Inguna Adoviča Gintautas Barcys Director General Director Director State Agency State Agency State Medicines of Medicines of Medicines Control Agency Estonia Latvia Lithuania This book is a statistical summary of the medicines consumption data of the Baltic countries (Estonia, Latvia and Lithuania) in 2010–2012. The national consumption statistics are published annually in all the Baltic countries; this is the first joint publication which provides comparative data illustrating the trends of interest and the national differences. Medicines are classified according to the Anatomical Therapeutic Chemical (ATC) classification and the Defined Daily Dose (DDD) is used as a measurement – both of these are proposed by the World Health Organization (WHO) for the medicines consumption studies. These systems are coordinated by the WHO Collaborating Centre for Drug Statistics Methodology in Oslo. The history of the Baltic countries has been quite similar during last 70 years. At the beginning of the 1940’s all Baltic countries were occupied by the Soviet Union – during the Soviet period all the medicinal products were supplied centrally and the selection and availability of the products was similarly limited in all countries. When countries regained their independence in the early 1990’s the national health care systems and marketing authorization procedures were developed with some differences between the countries. Since May 1st, 2004 all the three countries are Member States of the EU and their frame for regulating the pharmaceutical market is based on the same basic directives and regulations. Still, national differences 6 | Preface may be met in some areas. Over the 20 years of development the drug regulatory agencies have become stable organisations with all the possibilities to meet the developments in science, pharmaceutical industry and legislation. Current publication gives the reader an overview of how the differences and similarities of our countries have influenced the drug use. You will find the description of the reimbursement systems, an overview of the medicinal products market and other related subjects followed by the data on the consumption of the main groups of medicines. The specialists of the State Agencies of all three countries were involved in compiling this publication and we hope that it is the beginning of a new tradition. Facts about the Baltic countries | 7 2. Facts about the Baltic countries Estonia Latvia Lithuania Population (01.01.2013) 1 286 540 2 023 825 2 979 310 Total health expenditure (2011, 921 mln 1 242 mln 2 121 mln euro) Total health expenditure per capita 687.4 634 614.5 (2011, euro) GDP per capita (2011, euro) 11 904 9 873 10181 Total health expenditure as a % of 5.8% 6.2% 6.6% GDP (2011) Medicinal products turnover (2012, 222 mln 260 mln 404 mln wholesale, VAT excluded, euro) Number of general pharmacies per 37 43 47 100 000 inhabitants (01.01.2013) Number of physicians per 100 000 468 343 420 inhabitants (01.01.2013) Total number of reimbursed 7.6 mln 5.7 mln 12 mln prescriptions (2012) Currency (01.01.2013) euro Latvian lat Lithuanian 1 euro is litas equal to 1 euro is 0.7028 lats equal to 3.4528 litas 8 | Medicinal products regulation and pharmaceutical services in the Baltic countries 3. Medicinal products regulation and pharmaceutical services in the Baltic countries 3.1. Procedures of marketing authorisation of medicinal products in Baltic States The procedure of the marketing authorisation of the medicinal products in the Baltic States is following the European Union (EU) law as well as the EU and international guidelines. The procedures are similar in all EU member states. An application for a marketing authorisation for a medicinal product may be filed under the mutual recognition, decentralised, centralised or national procedure. The National Procedure may be used when an application for the marketing authorisation of a product is filed for the first time in the EU. This procedure may also be applied to the ’extensions of marketing authorisations’, wherein an application is filed, for example, for a new strength or pharmaceutical form of a product already approved nationally. After the evaluation of the application the product may be granted a marketing authorisation nationally. The Mutual Recognition Procedure (MRP) makes use of a marketing authorisation already granted for the medicinal product by an EU Member State (or by Norway or Iceland). The Member State whose evaluation statement is used as grounds for recognising the marketing authorisation is known as the Reference Member State (RMS), while the member state recognising the authorisation is known as the Concerned Member State (CMS). The Decentralised Procedure (DCP) may be applied for products that do not have a marketing authorisation in any Member State. This procedure will allow concomitant application for authorisations in both the RMS and the CMS. The process is conducted by the RMS while the CMSs participate in the evaluation of the application prior to the granting of the marketing authorisation in any of the Member States taking part in the process. In the event that a marketing authorisation is recognised, the product will be granted a national marketing authorisation as soon as the national translations of its summary of product characteristics (SPC), package information leaflet (PIL) and labelling confirming to the SPC mutually agreed in the Mutual Recognition or Decentralised Procedure are ready and approved. The Centralised Procedure is used when a marketing authorisation is applied within the entire EU area for the new biotechnological and other innovative medicinal products. Such marketing authorisation applications are filed with the European Medicines Agency (EMA). Applications for the marketing authorisation concerning the medicinal products for human use are evaluated by the Committee for Medicinal Products for Human Use (CHMP) and those for veterinary use by the Committee for Medicinal products regulation and pharmaceutical services in the Baltic countries | 9 Medicinal Products for Veterinary
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