A qualitative study among potential manufacturers on the development of ‘Made in Malaysia’ biological products: Challenges and proposed solutions
DOI:
https://doi.org/10.5912/jcb814Keywords:
Malaysia, biopharmaceutical, development, challenges, solutionsAbstract
Aim: To examine the challenges in development of biological products among Malaysian pharmaceutical manufacturers.
Methods: We conducted in-depth interviews (IDIs) with senior management of five local pharmaceutical product manufacturers from December 2015 to September 2016. We performed a purposive sampling focusing on local pharmaceutical manufacturers with existing sterile manufacturing facility and known intentions to develop biological products. Audio recordings were transcribed verbatim and coded, with common themes identified and analysed. Information provided by participants was verified with a policy maker.
Results: Participants were generally apprehensive in viewing the sustainability of a local bio manufacturing industry, despite the availability of various government incentives. Our research uncovered some common themes on challenges in developing ‘Made in Malaysia’ biological products. These include: lack of technical capacity (know-how) in bio manufacturing, lack of understanding on regulatory requirements, susceptibility to litigation by originator biological product manufacturers, limited commercial viability of Malaysian biological products, and a fragmented government support system. Through our discussion with participants, some solutions to encourage a thriving bio-based industry in Malaysia through public and private contributions, are proposed.
Conclusions: There are genuine challenges to be addressed by local pharmaceutical manufacturers and policy makers in working together to develop a biopharmaceutical industry in Malaysia. From product research and development to commercialisation stage, public and private partnership towards commercial sustenance of ‘Made in Malaysia’ biological products is key to our country’s vision of a successful bio manufacturing industry.
References
Abas A and Khoo YSK. Regulation of biologicals in Malaysia. GaBI Journal 2014; 3(4): 193-8.
Abuduxike G and Aljunid SM. Development of health biotechnology in developing countries: Can private-sector players be the prime movers? Biotechnology Advances 2012; 30: 1589-1601.
Adner R. Match your innovation strategy to your innovation ecosystem. Harvard Business Review 2006: 1-11.
Albrecht K and Ettling S. Focus: Bioeconomy strategies across the globe. Rural 21 – The International Journal for Rural Development 2014; 3: 10-3.
Arantes-Oliveira N. A case study on obstacles to the growth of biotechnology. Technological Forecasting & Social Change 2006; 74: 61–74.
Ariff M. New Perspectives on Industry Clusters in Malaysia, in Ariff, M. (ed.), Analyses of Industrial Agglomeration, Production Networks and FDI Promotion, ERIA Research Project Report 2007-3, Chiba: IDE-JETRO; 2008, p.368-397.
Azmi IM. The gap between the legal and regulatory framework of health and medical biotech research and development in Malaysia and the needs of the R & D institutes in Malaysia. JIBL 2009; 6: 109-121.
Bioeconomy Corporation. Bioeconomy Transformation Programme (BTP), http://www.bioeconomycorporation.my/bioeconomy-malaysia/bioeconomy-transformation-project/; 2015 [Accessed 1st November 2016].
EDB Singapore. Pharmaceuticals & Biotechnology, https://www.edb.gov.sg/content/edb/en/industries/industries/pharma-biotech.html9/9 ;2016 [Accessed 11th November 2016].
Frew SE, Rezaie R, Sammut SM, Ray M, Daar AS and Singer PA. India’s health biotech sector at a crossroads. Nature Biotechnology 2007; 25: 403-17.
Kamal N and Che Dir Z. Accelerating the growth of bioeconomy in Malaysia. Journal of Commercial Biotechnology 2015; 21(2), 43–56.
Li JF and Garnsey E. Policy-driven ecosystems for new vaccine development. Technovation 2014; 34: 762-772.
Malaysian Government. Bab 6: Menjana Kekayaan Melalui Bioteknologi. In Rancangan Malaysia Ke-9, http://www.epu.gov.my/epu-theme/rm9/bahasa/Bab6.pdf; 2015 [Accessed on 25th May 2015].
Malaysian Science and Technology Information Centre (MASTIC). Biotechnology in Malaysia – Chapter 9. In Malaysian Science & Technology Indicators Report 2008, http://www.mastic.gov.my/documents/10156/ee78806e-5a85-4dcb-96d8-754c9094996a; 2015 [Accessed 22nd July 2015].
Malhotra H. Biosimilars and non-innovator biotherapeutics in India: An overview of the current situation. Biologicals 2011; 39: 321-4.
MTDC. Advisory & Value Added Services, AVAS Beyond Commercialisation, https://www.mtdc.com.my/index.php/introduction-avas/; 2017 [Accessed 10th February 2017].
NST Online. Going global: RM100 million fund for biotech companies, http://www.nst.com.my/news/2017/01/204315/going-global-rm100-million-fund-biotech-companies;15th January 2017 [Accessed 16th January 2017].
PEMANDU. ETP Annual Report 2014: Healthcare, Available at http://etp.pemandu.gov.my/annualreport2014/National_Key_Economic_Areas_(NKEAs)-@-Healthcare.aspx ; 2015 [Accessed 10th February 2017].
Pharmaceutical Executive. Country Report: Malaysia. Issue 1, 1st January 2015 by Pharmaceutical Executive Editors, http://www.pharmexec.com/country-report-malaysia; 2015 [Accessed 10th February 2017].
Philp J. Smart agriculture in the 21st century: Global perspectives on the global economy, https://www.usda.gov/oce/forum/2015_Speeches/JPhilp.pdf; 2017 [Accessed 10th February 2017].
PIC/S. Guide to good manufacturing practice for medicinal products Annexes. PE-009-13 (Annexes), http://academy.gmp-compliance.org/guidemgr/files/PE_009_13_GMP_GUIDE_XANNEXES.PDF; 1st January 2017 [Accessed 10th February 2017].
Pope C, Ziebland S and Mays N. Qualitative research in health care - Analysing qualitative data. BMJ 2000; 320: 114–6.
Standards Department Malaysia. MS 2424:2012 – Halal pharmaceuticals – General guidelines, http://www.jsm.gov.my/ms-2424-2012-halal-pharmaceuticals-general-guidelines#.WPb-ztR97lY; 2014 [Accessed on 19th April 2017].
