Genetic Engineering - Essay Example

Problems in Getting a New Genetically Engineered Product into the Marketplace Genetic engineering is the process where genes from the same or different organisms are combined to form a transgenic organism, to produce new organisms with altered traits and with the capacity to produce novel or enhanced products. The transgenics present a whole range of possibilities, from treating and eradicating disease, to feeding the world’s burgeoning population. However, the commercialization of transgenic products has proven difficult; out of hundreds of products developed, only a few have been commercial successes. Following are the reasons why even some of the most promising technologies find it difficult to enter the commercial market (Rommens, 2010). 1. Ethical and moral issues hound the technology, and these issues are among the top reasons why new transgenic products are difficult to sell (MacDonald-Glenn, 2004). The ethical considerations are also entwined with other reasons for difficulty in market penetration. For example, is it ethical to give medicine produced by certain animals to specific segments of society who do not eat meat? Should people be informed that the medicines they are taking are products of genetic engineering? Perceived risks to the environment have been proposed, especially for growing transgenic crops. Moral factors are also important especially with respect to cloning of animals and animal chimeras for science and commerce. What are the dangers brought about by chimeric animals, especially if they escape into the environment? The fears of adverse health effects have resulted in tight biosafety testing and regulation for market entry of the products. These are costly, and increase the price of the products if and when they do enter the market. The high cost has resulted in unpopularity of some products, which lead to their withdrawal from the market. 2. The issues of intellectual property rights and the freedom-to-operate are entwined with moral, ethical and legal concerns that affect market entry of transgenics. Currently, there are patents on so many products and methodologies. These patent holders are the big companies (Dunwell, 2005) who will file cases against researchers once their efforts become commercially viable. Therefore, good products cannot be commercialized if some part of it was already patented by another entity. The question arises on the morality of patenting life processes, and life forms. 3. Most transgenic crops were developed for input traits, or those that have agronomically superior traits (e.g. herbicide tolerance, pest resistance). For every product that is commercially successful, there are many that have been tested. However, the transgenics perform similarly to the conventionally bred crops when grown under open fields (Rommens, 2010). Thus, they could not enter the commercialization phase. 4. Another reason why some transgenics are not marketable because their commercial viability is very low. The development of drugs using transgenic technology should be based on the importance and breadth of the disease problem. In agriculture, the development of transgenic crops should be worthwhile from a business sense. Developing transgenics for a narrow market is not worthwhile from the viewpoint of business. Good examples of commercially viable undertakings are disease eradication in important crops worldwide like banana, papaya and corn; and the improvement of the vitamin content of rice. For drug production, the disease should have a global impact, and the modifications introduced are not amenable to conventional approaches (for example, diabetes and insulin production). 5. Industry support for transgenic products is also important in the entry and acceptance of these products. This support concerns the effects of transgenic crops on international trade. In countries where there is no regulatory approval for transgenic products, products that contain transgenic contaminants could result in sending back the products to the country of origin, and subsequent banning of these products. Food retailers, and restaurant owners are also important influences in the market, and their declaration of non-acceptance of a transgenic food like fish could mean the end of the commercialization of such product. This influence has made the food retailers the main target of the efforts of non-governmental organizations who are against transgenic technology (Kalaitzandonakes & and Bijman, 2003). 6. Obtaining biosafety and regulatory approval is another hindrance to market entry of transgenic crops. Despite rigorous biosafety tests, concerns include the possibility of new toxins and pathogens, reduced nutritional values and unintended effects (allergens, transfer of antibiotic resistance, and effects on immune system). Regions like the European Union have difficult and complicated biosafety and regulatory requirements. The involvement of politicians in the regulatory process has inhibited researchers in EU from developing new transgenics, except in Spain which grows transgenic crops (Meldolesi, 2009). Compliance with biosafety and regulatory requirements is very costly; furthermore, the market restrictions are guided by these requirements. Regulatory criteria must be modified once a gene has been proven safe (Badford et al. 2005). 7. Retail and consumer acceptance is the most important factor that affects market entry. The lack of public support, in the European Union countries, was attributed to scientific illiteracy and the lack of consumer education. In addition, the depiction of transgenic foods as “Frankenfood” further strengthened the perception that transgenics are unsafe and harmful to people. Other marketing problems are due to dietary, religious and cultural practices aside from the ethical concerns discussed. References 1. Badford, K., Van Deynze, A., Gutterson, N., Parrott, W., & Strauss, S. (2005). Regulating transgenic crops sensibly: lessons from plant breeding, biotechnology and genomics. Nature Biotechnology, 23(4), pp. 439-444. 2. Dunwell, J. (2005). Review: intellectual property aspects of plant transformation. Plant Biotecnhology Journal, 3, pp.371-374. 3. Kalaitzandonakes, N., & and Bijman, J. (2003). Who is driving biotechnology acceptance? Nature Biotechnology, 21, pp. 366-369. 4. MacDonald-Glenn, L. (2004). Ethical issues in genetic engineering and transgenics. ActionBioscience.org . 5. Meldolesi, A. (2009). EU impasse over GM deepens. Nature Biotechnology, 27, p.304. 6. Onyango, B., & Nayga, R. (2004). consumer acceptance of nutritionally enhanced genetically modified food:relevance of gene transfer technology. Journal of Agricultural Research and Economics, 29, pp.567-583. 7. Rommens, C. (2010). Barriers and paths to market for genetically engineered crops. Plant Biotechnology Journal, 8, pp. 101-111. Read More