Report Synopsis

The adoption of genetically modified organisms and legal implications. A comparative analysis

Cecilia Fialho

The laws controlling the approval of genetically modified events in a particular country are very important, and must demonstrate their legitimacy while remaining safe for the use of animals, human beings and harmless to non-target plants. There are two major variables that determine the evolution of agricultural transgenes (and any other science) in a society: the scientific research and development, and legal support for it to act effectively. The present report explores the regulatory events of the approval of genetically modified materials in the countries of Brazil, China, the United States and the European Union.

Under a comparative method, the sequential steps are the update and validation of primary and secondary data and data processing, confronting the objects of study in consideration of four macro themes, which are: historical, institutional, regulatory and technical. The countries were then ranked, with Brazil’s legislation being the most sophisticated and functional, followed by the United States, China and the European Union.

Brazil, although not having originated the case law that regulates biotechnology, was the one that approved the largest number of events in the shortest time. The United States, despite the traditionalism in the adoption of biotechnology, now faces a period of clear need to have laws reviewed: these laws often seem unintelligible to both applicant companies and the population in general, and are costly and time-consuming to apply.

China is structurally well organized on the evaluation of genetically modified organisms (GMOs), but faces the challenge of educating its large population to their use, which is a challenging and complex task compared to other countries. In addition, the lack of national genetically modified products points to a reserved stance from the government in allowing trade access to foreign biotech companies. This conservative position may also reflect a desire to make Chinese technology more internationally competitive.

The European evaluation system is flawed, considering that every decision on the approval of genetically modified events in the European Union rests with the European Commission. Member States, in most cases, are not purely scientifically motivated, but give more weighting to political and ideological reasons when refuting the technology. Consequently, they are often unable to declare their reasons officially, thanks to a system that only legitimizes science as the only possible evaluation criteria.

Looking forward, it was concluded that Brazil is heading towards the improvement of genome editing techniques, and the progressive use of biotechnology in health.

The United States seek to simplify, within their biosecurity criteria, their regulatory framework, and to lead research in improving management techniques and use of scientific data in the field.

China aims to prepare and establish a new position in the global agribusiness trade, even to being considered as a potential exporting agent, and for increased agricultural competitiveness, by making use of biotechnology in the launch of national genetically modified products.

The European Union is going through a decision-making change in defining the role of the European Commission, currently and improperly responsible for the approval of transgenic events. If it is approved that Member States start to take full responsibility in biotechnology nature decisions, it could lead to a possible trade liberalization; the end of a single market would transform permanently the way the bloc interacts with international markets.

It is also expected that biotechnology will find more popular acceptance when it is applied to areas other than agriculture, which could ultimately promote the understanding of how the technology can be used in food production.

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