Challenges of Global Technology Assessment in Biotechnology—Bringing Clarity and Better Understanding in Fragmented Global Governance

Abstract

Biotechnology involves the use and manipulation of living organisms such as plants, animals, humans, and biological systems, or parts of this, to modify their characteristics in order to create desired organisms or products. Biotechnology as a field touches on many aspects that are central to technology assessment (TA), and have been the focus of TA activities since the 1980s. By presenting three key topics in biotechnology—genetically modified food and crops, synthetic biology, and human genome germline editing—we show that a central feature of biotechnology is that the science is evolving globally and the products that it brings forth are traded across the globe. Yet, there are major differences in the regulation and governance of the academic and industrial sectors between countries. These stem from different needs and interests per country, as well as differences in traditions, cultural differences and public perceptions. As global governance is fragmented, with little scope for harmonization, global TA of biotechnology can bring clarity and better understanding, and enable better governance. In order to do so, an integrated global TA framework should consider international trade and differences in risk assessment; cultural variation and different value-systems between countries; and differences in countries’ capacities in R&D and coordination of public engagement efforts.

Marketability level of potato in Armenia: potato functional properties

“…In addition, the use of pesticides is a concern from the point of view of food safety [34][35][36][37][38][39][40][41][42][43][44], too. The demand for solutions to above-mentioned problems causes the rapid development of biotechnologies [45][46][47][48][49][50][51][52][53]. These refer both to the development of various "genetic" biotechnologies aimed at increasing the resistance of organisms [54], and to the "indirect" increase of resistance of organisms based on, for example, the use of pre- [55] and probiotic therapies [56][57][58][59][60][61].…”

Processes for regulating genetically modified and gene edited plants

“…In the 1980s and 1990s, governance of biotechnology through international consensus, coordination, and agreements was attempted by Organization for Economic Co-operation and Development (OECD), the Food and Agricultural Organization of the United Nations (FAO), the World Health Organization (WHO), and the World Trade Organization (WTO). 142 In 1990, a report on the safety of food produced by biotechnology was viewed as a move toward international consensus on how to assess the safety of foods obtained using biotechnologies. 143…”

“…In 1994, the WTO attempted to provide some common global standards for managing intellectual property rights through novelty, inventiveness, and industrial utility, and these were also to apply to biotechnology inventions 142 but giving the right of member countries excluding them in order to maintain public order and morality. 164 This became known as the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).…”