Résumés
Abstract
This case, based on personal experiences and on those found in the literature, highlights the delicate tension faced by drug development companies having to balance research integrity and their profitability.
Keywords:
- business ethics,
- clinical trials,
- corporate decision-making,
- drug development,
- profitability,
- research ethics,
- venture capital
Résumé
Ce cas, basé sur des expériences personnelles ainsi que sur celles trouvées dans la littérature, met en évidence la tension délicate à laquelle sont confrontées les entreprises vouées au développement des médicaments soit d’équilibrer l’intégrité de la recherche et leur rentabilité.
Mots-clés :
- capital de risque,
- développement des médicaments,
- éthique de la recherche,
- éthique des affaires,
- essais cliniques,
- prise de décision de l’entreprise,
- rentabilité
Parties annexes
Bibliography
- 1. MacDonald C. Business ethics 101 for the biotech industry. BioDrugs. 2004;18(2):71–7.
- 2. Fortin J-S, Bélisle Pipon J-C, Ganache I. Visées éthiques, développement et usage du médicament. In: Beaulieu P, Pichette V, Desroches J, du Souich P, editors. Précis de Pharmacologie. 2nd ed. Montréal, Québec: Presses de l’Université de Montréal; 2015. p. 1011–21.
- 3. Bélisle Pipon J-C, Williams-Jones B. Drug Familiarization and Therapeutic Misconception via Direct-To-Consumer Information. Journal of Bioethical Inquiry. 2015;12(2):259–67.
- 4. Bélisle Pipon J-C, Williams-Jones B. Regulating Direct-to-Consumer Drug Information: A Case Study of Eli Lilly’s Canadian 40over40 Erectile Dysfunction Campaign. Healthcare Policy Politiques de Santé. 2015;10(4):16–23.
- 5. Thakur P. Offshoring and outsourcing of core corporate activities: The global relocation of pharmaceutical industry clinical trials. [PhD]: Rutgers, The State University of New Jersey - Newark; 2010.
- 6. Bélisle Pipon J-C. De la binarité au modèle AI3R : la bioéthique écosystémique comme modèle d’analyse normative de l’industrie biopharmaceutique. [Masters]. Montréal, Québec: Université de Montréal; 2013.
- 7. Bailey R. Deciding about your health care: the ethicist as policy-maker. Health Care Analysis. 2001 Oct 1;9(3):265–81.
- 8. Lipworth W, Little M. Deriving and critiquing an empirically based framework for pharmaceutical ethics. AJOB Empirical Bioethics. 2014 Jan;5(1):23–32.
- 9. Lipworth W, Montgomery K, Little M. How pharmaceutical industry employees manage competing commitments in the face of public criticism. Journal of Bioethical Inquiry. 2013;10(3):355–67.
- 10. Klopfenstein M, Campen LEV, Garnett T. Expanded access programs: ethical and practical considerations for biopharmaceutical sponsors. Therapeutic Innovation and Regulatory Science. 2015;49(3):352–8.
- 11. Health Canada. Drug Licensing Process. 2007.
- 12. Patented Medicine Prices Review Board. Annual Report 2014. Ottawa: Government of Canada; 2015.
- 13. Schubert C. Pharmaceutical sector: Delicate transition. Nature. 2012;486(7402):281–3.
- 14. Nicholas J. Outsourcing Clinical Trials. Journal of the National Cancer Institute. 2012;104(14):1043–5.
- 15. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. 2014
- 16. Health Canada. Guidance for Industry: Good Clinical Practice: Consolidated Guideline - ICH Topic E6. Government of Canada; 1997.
- 17. Alex AA, Storer RI. Chapter 1: Drugs and their structural motifs. In: Metabolism, Pharmacokinetics and Toxicity of Functional Groups: Impact of Chemical Building Blocks on ADMET. 2010.