NEW DRUGS IN BRAZIL IN THE GLOBALIZATION ERA:COMPARISON BETWEEN THE BRAZILIAN

MARKET WITH THE AMERICAN AND EUROPEANFROM 1998 TO 2002

Carlos CF Vidotti, MSc 1,3, Marcus Tolentino 1,2, Rogério Hoefler BSc 1,Emília V Silva, MSc 1, Ana Paula P Lima 1,2 and Lia LC Castro, PhD 4. 1Brazilian Drug Information Center (CEBRIM), Federal Council ofPharmacy (CFF), Brasília, DF, Brazil ; 2 School of Pharmacy, Centro deEnsino Superior Unificado de Brasília (CESUBRA), Brasília, DF, Brazil ;3 Pharmacoepidemiology Research Group of Brasília, Brasília, DF, Braziland 4 GRUPURAM, UFMS, Brazil .

Brazilian DrugInformation Center Federal Council of Pharmacy

www.cff.org.br/cebrim // cebrim@cff.org.br

Background

The multinational pharmaceutical industry has beenmarketing different drugs in different countries accordingto the strictness of their regulatory authorities. In theGlobalization Era, with so many changes in trade and withsome regulatory harmonization initiatives, what is thecurrent behavior of the pharmaceutical industry towardsdrug development and registration?

Objectives

The purpose of this study is:1- to describe new drugs marketed in Brazil and2- to compare their marketing status in the USA and Europe.

Identification of the new drugs marketed in Brazil approved byBrazilian Sanitary Surveillance Agency (Anvisa) from 1998 to2002, in each year and whole. In Brazil, new drugs approvedreceive the code 175. We used the software PRVS®(Optionline)¹ to select products identified by that code. Theproducts searched by that code labeled as diagnostic products,radiological contrasts, vaccines, haemodialysis products, drugcombinations, blood derivatives and immunoglobulins wereexcluded. For all proprietary names of drugs, we identified theactive substance and the first level of ATC classification.The Index Nominum® (Micromedex®)² database was used toidentify the market status in the USA and Europe; we also usedthe FDA´s website³ to check the USA market status.

Methods

In the period studied, we identified 437 new products from which weexcluded 182(41.6 %)[Figure 1].Out of the 255(100%) selected drugs, 113(44.3%) were registered in 1998,59(23.1%) in 1999, 40(15.7%) in 2000, 22(8.1%) in 2001 and 21(8.2%) in2002[Figure 2].These new drugs were classified by their therapeutic classes according thefirst level of the ATC classification system, the nervous system (N) and theantineoplasic and immunomodulating agents (L) are the biggest classeswich have 11,8% each one, alimentary tract and metabolism (A) with28(11%), general antiinfectives for systemic use (J) with 28(11%) andgenito urinary and sex hormones (G) with 25(9.8%).The other drugs classified under another therapeutic classes represent 45%,and inclued cardiovascular, muculo-eskeletal system, blood and bloodforming organs, sensory organs, dermatologicas and others grups as shownFigure 3.

Results 1

Regarding the international marketing status, 169(66.3%) weremarketed in the USA and Europe, 58(22.7%) were marketed inEurope but not in the USA, 18(7.1%) were marketed in theUSA but not in Europe, 9(3.5%) werent marketed neither inthe USA nor in Europe, and the market status was notidentified for 1(0.4%), This distribution is shown in Figure 4.Out of 255 new drugs, 4(1.6%) were withdrawn from market:alosetron, cerivastatin, ebastine and podofilox.

Results 2

Figure 1: New health products approved in Brazil from 1998 to 2002 (n=437)

n= 25558%

n= 18242%

Selected drugs

Diagnostic products, radiological contrastcs, vaccines, haemodialysisproducts, drug combinations, blood derivatives and immunoglobulins

113

59

40

22 21

0

20

40

60

80

100

120

1998 1999 2000 2001 2002

Figure 2: Number of new drugs approved* by Brazilian Sanitary Surveillance Agency (ANVISA)

Figure 3: Therapeutic classes (ATC) for Brazilian new drugs (n=255)

Alimentary tract and metabolism

11%

Genito urinary and sex hormones

9,8%

Nervous system11,8%

Antineoplasic and immunomodulating

agents11,8%

General antiinfectives for systemic use

11%

Sensory organs6%

Various3%

Others45% Antiparasitic products,

insecticides and repellents1%

Respiratory system4%

Musculo-skeletal system7%

Blood and blood forming organs

6%

Cardiovascular system9%

Dermatologicals6%

Systemic hormonal preparations, exclud. sex

hormones3%

EUROPE 58USA 18

Not identified = 1

n= 255Figure 4: Brazilian, American and European new drugs

Neither in the USA nor in Europe = 9

BRAZIL, USA and EUROPE

169

Conclusions 1

This study verify that 255 new drugs was regitered in Brazil inthe studied period and the number of registers decreased fivetimes from 1998 to 2002. This could be a result of theregulatory changes in Brazil during that period. These newdrugs belongs mainly to the following therapeutic classes(ATC): N, L, A, J and G.The biggest part (66.3%) of new drugs registered in Brazil weremarketed in the USA and Europe and only 3.5% were notmarketed neither in the USA nor Europe,On limitation of this study is the use of 175 code. This codewas attributed by the law, but the are evidences that new drugsis registered under another codes.

References

1- Produtos e Resoluções em Vigilância Sanitária – PRVS. Optionline Database & Training, versão1.4.3 – Módulo Gold,

2- Index Nominum: International Drug Directory, Edited by the Swiss Pharmaceutical Society ©2003. Medpharm Scientific Publishers, Stuttgart, Germany,

3- U. S. Food and Drug Administration website: http://www.fda.gov/

Conclusions 2

Because of several differences in the epidemiological profile ofthe populations of the countries considered, further studiesshould verify if new drugs introduced fit the social needs ofBrazilians prevalent and neglected diseases, such astuberculosis, malaria, Hansens disease and filariasis.