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Journal of Long-Term Effects of Medical Implants
Abstract of "Ethical Challenges with the Development of Biotechnology-Derived Allergy Therapeutics"
Dept. Bioéthique, Université de Montréal, Département de Bioéthique, C.P. 6128, succursale Centre-ville, Montréal (Québec) H3T 1J4 Canada
Biotechnology-derived pharmaceuticals are a new generation of therapeutics that hold promise of providing novel treatments for disease. Among emerging biotech drugs, recombinant versions of allergen vaccines may replace varieties of lower-quality vaccines derived from natural sources, providing benefit in the treatment of allergy. However, along with this benefit, this presentation demonstrates that potential ethical challenges are emerging as these biotech allergy therapeutics approach commercialization. Many of these challenges pertain to novel possibilities for pharmaceutical companies to gain influence over the regulation of these drugs and monopolize their production. Allergen vaccines are used in immunotherapy where current therapeutics derived from natural sources are of less-than-ideal quality, stemming from variations in their potency and composition between batches. Current biotechnology methods provide means to raise the quality of these therapeutics through the isolation of allergen genes, such that the corresponding allergen protein may be produced consistently and homogeneously. While beneficial in production-related issues, our research identifies potential problems with these emerging biotech drugs. For one, these drugs require the development of novel quality and efficacy assessment procedures. Our research identifies that in certain cases pharmaceutical companies are the developers of such assessment procedures. We demonstrate how this situation is ethically problematic in terms of conflict of interest, where a company, rather than government regulators, gains undue control over determining the quality, safety, and efficacy of pharmaceuticals. We further note how the development of these drugs, in conjunction with their assessment methods, provides new opportunities for companies to submit multiple patents on their products. Thus, the possibility to produce generic versions of emerging allergen vaccines may be inhibited, providing pharmaceutical companies with unwarranted and prolonged production monopolies. This in turn inflates the cost of pharmaceuticals, which can inhibit their broad application in clinical practice. Overall, this presentation aims to exemplify the need for ethical assessments in biotech-drug development and regulation.
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