Policy Review: Addressing the Complex Challenges of Regulating Biotherapeutics

  • FengYun Li University of Calgary
  • Shalpinder Dhothar University of Calgary
  • Elena Fekete University of Calgary
  • Nishi Patel University of Calgary
  • Tiffany Dang University of Calgary
  • Rachelle Varga University of Calgary
  • Syed Jafri University of Calgary
  • Neliza Mendoza University of Calgary
  • Siddhartha Goutam University of Calgary
  • Nilesh Sharma University of Calgary
  • Noshin Karim University of Calgary
  • Nicholas D'Aleo-Sotas University of Calgary
  • Christine Phan University of Calgary
  • James Johnston University of Calgary
  • David Nguyen University of Calgary
  • Nick Jette University of Calgary
  • Dan Ziemianowicz University of Calgary
  • Mayi Arcellana-Panlilio University of Calgary
Keywords: Biotherapeutics, cell-based therapeutics, regulations, Health Canada, Public Health

Abstract

The advancing industry of biotherapeutics is providing the public with new promising and innovative drugs which may pose risks if their production, distribution, and marketing are not directly governed by legislation. Apart from international agreements, such as the Cartagena Protocol, there are no specific and direct laws or regulations governing manipulated cell-based therapeutics in Canada. The introduction of these laws and regulations in Canada will allow for the safe research and use of biotherapeutics in a proactive manner.

Author Biographies

Shalpinder Dhothar, University of Calgary
Faculty of Science, Student
Elena Fekete, University of Calgary
Faculty of Science, Student
Nishi Patel, University of Calgary
Faculty of Science, Student
Tiffany Dang, University of Calgary
Faculty of Engineering, Student
Rachelle Varga, University of Calgary
Faculty of Science, Student
Syed Jafri, University of Calgary
Cumming School of Medicine, Student
Neliza Mendoza, University of Calgary
Faculty of Engineering, Student
Siddhartha Goutam, University of Calgary
Cumming School of Medicine, Student
Nilesh Sharma, University of Calgary
Faculty of Science, Student
Noshin Karim, University of Calgary
Faculty of Engineering, Student
Nicholas D'Aleo-Sotas, University of Calgary
Faculty of Science. Student
Christine Phan, University of Calgary
Faculty of Science, Student
James Johnston, University of Calgary
Cumming School of Medicine, Student
David Nguyen, University of Calgary
Faculty of Engineering, Student
Nick Jette, University of Calgary
Cumming School of Medicine, MD/PhD Candidate
Dan Ziemianowicz, University of Calgary
Cumming School of Medicine, Graduate Student
Mayi Arcellana-Panlilio, University of Calgary
Cumming School of Medicine, Professor

References

M. Fischbach, J. Bluestone, W. Lim. Cell-Based Therapeutics: The Next Pillar of Medicine.
Sci. Transl. Med. 5(179), 179-80. 2013.

Wilson Center. “U.S. Trends in Synthetic Biology Research Funding”. Synthetic Biology Project, Pennsylvania, WA, 2015. Retrieved August 27, 2016 from http://www.synbioproject.org/publications/u.s-trends-in-synthetic-biology-research-funding/

J. Curran. “IBIS World Industry Report NN001. Biotechnology in the US”. IBIS World, 2016. Retrieved August 24, 2016 from http://www.ibisworld.com/industry/default.aspx?indid=2001

Government of Canada. “Food and Drugs Act”. Minister of Justice, Ottawa, ON, 2016.

N. Yeates, D. Lee, M. Maher. Health Canada’s Progressive Licensing Framework. CMAJ. 176(13), 1845-47. 2007.

V. Nichols, I. Theriault-Dube, J. Touzin, J. Delisle, D. Lebel, et al. Risk Perception and Reasons for Noncompliance in Pharmacovigilance. Drug Safety. 32(7), 579-90. 2009.

“Biotechnology: Product Life Cycle”. Health Canada, Ottawa, ON, 2015. Retrieved August 12, 2016, from http://www.hc-sc.gc.ca/sr-sr/tech/biotech/health-prod-sante/prod_life-vie-eng.php

“Toxic Substance Control Act”. US Environmental Protection Agency, Washington, DC, 1976.

Secretariat of the Convention on Biological Diversity. “Cartagena Protocol on Biosafety to the Convention on Biological Diversity: text and annexes”. Cartagena )Protocol, Montreal, QC, 2000.

Health Products and Food Branch Inspectorate. “Good Pharmacovigilance Practices (GVP) Guidelines GUI-0102”. Health Canada, Ottawa, ON, 2013.

Health Products and Food Branch Inspectorate. “Inspection Strategies for Good Pharmacovigilance Practices (GVP) for Drugs POL-0041”. Health Canada, Ottawa, ON, 2013.

H. Meisel, T. Ganey, W. Hutton, J. Libera, Y. Minkus, O. Alasevic. Clinical experience in cell-based therapeutics: intervention and outcome. Eur. Spine J. 15, 397. 2006.

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. “Pharmacovigilance Planning E2E Step 4”. ICH Harmonized Tripartite Guideline, Geneva, Switzerland. 2004.
Published
2017-07-24
Section
Review Articles