Assessment Of Policies, Determinants And Characteristics Of Generic Medicines Entry Into The Malaysian Pharmaceutical Market
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Date
2014-02
Authors
Oladuntoye, Fatokun Omotayo
Journal Title
Journal ISSN
Volume Title
Publisher
Universiti Sains Malaysia
Abstract
The Malaysia healthcare system relies on the availability of generic equivalents of
innovator medicines to curtail the rising pharmaceutical expenditure. This study
assesses the dimensions and dynamics of generic medicines entry following patent
expiration on the innovator drug products in Malaysia. This was a mixed-methods
study. The findings of this research revealed 14 categories of policies and regulatory
measures with varying effects on generic entry in Malaysia. The mail survey yielded a
usable response rate of 53.8% (14/26) following four successive mailings. Reliability
coefficients for the multi-item entry decisions and entry barriers variables were 0.62 and
0.82 respectively. The major factors driving generic development and entry decisions in
Malaysia were pre-patent expiration market value of innovator’s products (Meanrank=
3.75, M=4.14, SD=1.03), cost of generic development and approval (Mean-rank=
3.04, M=3.50, SD=1.40) and compatibility of the new generic medicine with firms’
existing products range (Mean-rank=2.79, M=3.64, SD=1.2). The innovator product’s
pre-patent expiration market value was a significant entry driver for domestic-market
oriented generic firms as compared with export-market oriented firms (U=0.00, Z=-
2.36, p=0.01). The Major barriers to generic medicines development and market entry
in Malaysia were patent clustering by innovator firms (Mean-rank=7.96, M=4.07,
SD=0.83) and earlier market entry of imported generics (Mean-rank=7.75, M=4.07,
SD=0.73).
Description
Keywords
Generic Medicines Entry , Malaysian Pharmaceutical Market