Factors determining the post-patent entry of generic medicines in Malaysia: A survey of the Malaysian generic pharmaceutical industry

Abstract

Malaysia is reliant on the availability of generic medicines to contain the rising national pharmaceutical expenditure. This paper assesses the factors determining the market entry of a new generic medicine following patent expiration on the innovator product in Malaysia. Data were gathered by using mail survey approach. The prevalidated Likert-scale questionnaire was mailed to all licensed members of the Malaysian Organization of Pharmaceutical Industries. A usable response rate of 53.8% (14/26) was achieved following four successive mailings. The overall internal reliability coefficients for the 5-item entry decision variables scale and 11-item entry barrier variables scale were 0.62 and 0.82 respectively. The results revealed that the major factors driving decisions to develop and introduce a new generic medicine into the Malaysian pharmaceutical market are consistent with the business model of the generic pharmaceutical industry. The pre-patent expiration market value of the innovator product was found to be a significant factor influencing entry decisions for domestic market-oriented generic firms as compared with export-oriented firms (Z ¼ À2.36, p ¼ 0.01). Foremost among the barriers to new generic medicines development and market introduction in Malaysia were patent clustering by innovator firms and the earlier market entry of imported generic medicines. There is a need for strict adherence to the patentability criteria in the examination and grant of pharmaceutical patents in Malaysia, and coherence in policies related to local generic drug development and production is recommended in order to meet the policy objectives of drug affordability and containment of pharmaceutical cost.

Time to entry of generic medicines in Malaysia: implications for pharmaceutical cost containment

“…As reported for other countries, the findings of this present study thus suggest the existence of certain barriers to immediate entry of generic medicines following patent expiration in Malaysia. A recent study conducted in Malaysia showed that patenting strategies by innovators are the foremost entry‐barriers to generic medicines in Malaysia . Generic entry delays obviously have implications on pharmaceutical expenditures.…”

Malaysian generic pharmaceutical industries: perspective from healthcare stakeholders

“…[13,16,19,21,22] Five studies suffered from low response rates. [11][12][13]15,[17][18][19] Four studies used convenience sampling, [16,20,22] and two studies were of a small sample size, [14,16] which might have had an impact on generalization.…”

“…(2013) [11] National survey Mail survey 14 Generic manufacturers A small portion of the respondents indicated that the regulatory provision (i.e. Bolar provision) is either effective (21.4%) or highly effective (14.3%) in promoting early post-patent entry of generic medicines.…”

“…acquisition of multiple patents surrounding the basic patents of the drug products) and market competition from imported generics were the two of the main barriers to local production of generic medicines in Malaysia. [11] By identifying these barriers, the government can help to formulate strategies to facilitate the entry of generic medicines into Malaysia market. The Malaysia government's recent reluctance to agree with the TPPA was a good move to combat the patent extension by branded originator companies.…”

“…[10] Earlier entry of imported generic medicines into the Malaysia drug market was due to trade policy initiatives and the difficulty of local generic drug manufacturers in conducting bioequivalence (BE) studies. [11] Limited number of BE centres in Malaysia had cause difficulty for the local generic drug manufacturers to conduct BE studies, and the BE centres are mostly university based and non-profit orientated. [31] In fact, as of 10 December 2013, there are only five local centres that are listed in the National Pharmaceutical Control Bureau (NPCB), in the Ministry of Health Malaysia Compliance Program for Bioequivalence Centre.…”