Andréa D Bertoldi 1 ; Peter Stephens 2 ; Anita Wagner 3 ; Dennis Ross-Degnan 3

1. Evolution of the Generic Medicines Market in Brazil, 1998-2010: Antihypertensives, Antidiabetics, and Antibiotics Andréa D Bertoldi1; Peter Stephens2; Anita Wagner3; Dennis Ross-Degnan3 1Universidade Federal de Pelotas, Brazil; 2IMS Health. London, UK; 3Harvard Medical School and Harvard Pilgrim Health Care Institute. Boston, USA andreadamaso.epi@gmail.com

2. Problem Statement • Generic medicines were launched in Brazil in February 2000, after implementation of the Generic Medicines Policy in 1999 • Since then, three types of medicines have been available in the market • Original brands • Generics • All generic medicines must be commercialized unbranded • Only group of medicines which is considered interchangeable with the original brand • ‘Similares’ (non-original brands) • All the other brand medicines available on the market

3. Objectives • To describe changes in market share of selected original products, ‘similares’ and generics over time, following the 1999 Brazilian generics law Generics Original Brand ‘Similares’

4. Methods • Design:Time-series analysis • Setting: Longitudinal data on sales by wholesalers to retail pharmacies in Brazil collected by IMS Health (1998-2010) • Outcome Measures: Proportion, by original, ‘similares’, and generic products within three therapeutic classes of the total volume sold by quarter • Data analyses: • Proportions of the total volume sold by quarter • unit sales volume divided by the total volume of units sold in the market • Number of manufacturers of the products analyzed

5. Results • We analyzed 8,559 products marketed in Brazil between 1998 and 2010 • 448 medicines used in diabetes • 2,113 medicines used to treat hypertension • 2,825 systemic antibiotics

6. Antidiabetics • From period 1 onwards, there was a rapid rise in the number of manufacturers producing ‘similares’, but this was stabilized from period 30 onwards • From the introduction of generics in the market (period 14), there was a constant increase in the number of manufacturers producing them

7. Antidiabetics • The volume of sales in the whole period changed considerably • At the end of the period, generics corresponded to half of the sales, ‘similares’ to just over 30% and original brands to just below 20%

8. Antibiotics • At any point in time, there were more manufacturers producing ‘similares’ • The number of manufacturers producing generics has risen during the whole period under study

9. Antibiotics • The volume of sales changed very rapidly after the introduction of generics in the market • The market share of original brands tended to decline over time, and achieved less than 5% in the end of the period. Generics and ‘similares’ in period 48 were about 60% and 35%, respectively

10. Medicines used in hypertension • In period 9, the first generics were launched in the market • The number of manufacturers producing ‘similares’ was consistently higher than that of generics; however, from period 33 onwards, it was observed a decline in the number of manufacturers producing ‘similares’

11. Medicines used in hypertension • The volume of sales of both ‘similares’ and generics tended to increase until period 32. From that period onwards, volume of sales of generics continued to increase whereas that for ‘similares’ tended to stabilize

12. Conclusions • Sales of ‘similares’ and particularly original brands decreased substantially following the launch of generics in the Brazilian market • Using data from IMS Health, it is possible to evaluate the impact of the Generic Medicines policy in the Brazilian market share Funding Source IMS Health provided data in kind. Drs. Wagner and Ross-Degnan were supported by a grant from the WHO for the development of the ICIUM2011 scientific program