EU’s Double Standard in Medical and Agricultural Biotechnology Directives

No epidemic in the world has been as impactful in health, economic and social terms as Corona-19. Following the emergence of the virus, its isolation and gene mapping were achieved within a few weeks, thanks to genetic engineering and new molecular biological techniques. Developed with these unimaginable advances in science, the PCR test method has enabled Covid patients to be identified quickly. The need to develop a vaccine against the rapidly spreading disease has put great pressure on the society. Again, new molecular biological techniques stood out as the most promising method in this regard. But there was a timing problem here. Environmental impact assessments, which were part of this type of research would have taken a long time, posing a major problem. To address this problem, EU officials decided to remove environmental impact assessment tests as a requirement for drug development in July 2020 and to continue research by decommissioning environmental impact assessment tests.
As a result, four Covid 19 vaccines were developed with genetic modification towards the end of 2020 and put to worldwide application . In fact, in the last 20 years, 297 new drugs were registered with gene engineering method in Germany . Since its first registration in 1998 with the genetically modification, 22 insulin drugs have been registered. Due to the low cost of the system, the pharmaceutical industry has started to develop medicine for a variety of diseases from leukemia to meningitis, hepatitis B to ebola in addition to vitamins B2, B12, C with this method. In fact, the genetic modification was applied to animals to obtain some drugs, and their products were used as medicinal drugs: (1) the active ingredient of the thrombosis drug, the transgenic (genetically modified goat) to obtain “arthrin” and (2) the transgenic rabbit for the rare hereditary angioedema disease. Food preservatives and colorants such as ascorbic acid and riboflavin obtained from genetically modified microorganisms in many other categories have also been put on the market.
Gene transfer can be carried out not only in microorganisms but also in plants and animals. In 2003, the United Nations put into effect the Convention on Biological Diversity and Cartagena Biosafety Protocol to solve the problems caused by these new GMO products and transgenic animals in terms of human, animal and environmental health.
The implementation of this protocol differs by country. A number of countries are growing transgenic crops like corn, cotton, soybean and rapeseed etc. the production area of which reached 190 million hectares in 2019 which makes up 13% of the world’s cultivated area. On the other hand, EU and countries with strong trade relationships, such as Turkey, prohibit transgenic crops production. It is notable that the EU imports close to US$40 billion of corn and soybean a year from GMO-growing countries. Turkey’s soybean import is around US $ 4 billion annually. It is also very interesting that corn farmers of the two EU countries, Spain and Portugal, can benefit from the blessings of transgenics.
Growing transgenic varieties has agro-economic gains of approximately 30%. But developing new transgenic varieties costs hundreds of millions of US$. Therefore, such varieties are only developed and marketed by giant international seed companies. Most of the said amount is comprised of the cost of tests to assess health and environmental risks.
In recent years, a revolutionary biotechnological system has been developed that earned its inventors the Nobel Prize in chemistry. Gene editing made with the revolutionary CRISPR / Cas9 method can increase and decrease the effect of the gene by adjusting the bases in the gene with enzymes, and even silence the gene. This is actually a manmade micro mutation. It is critical to reduce the classical breeding period of 10-15 years required for the breeding of new plant variety to 4-5 years. The significance of shortening the production cycle for new varieties that are resistant to diseases-pests, climatic conditions and high performance cannot be overstated for the agricultural world.
Interestingly, many varieties have been developed outside the EU in a short time by gene editing, especially by small and medium-sized seed companies. And in this process, the registration procedures were carried out according to standard plant breeding principles, not transgenic legislation. However, the EU requires that gene regulations should be evaluated according to GMO product legislation involving health and environmental risk tests. This practice that seed companies oppose due to increased cost, would lead to EU farmers not being able to maintain their competitive advantage because they would not be able to benefit from the mentioned advantages of biotechnology.
Our hope is that the changes made in the biotechnology legislation used in the rapid development of the Covid vaccine would be applied to EU seed cultivation, which would in turn maximize our agriculture and food production potential.
Nazimi Acikgöz
Note: A summary of this article has been published under the title “Biotechnology and Covid Vaccine” at http://blog.milliyet.com.tr/biyoteknoloji-ve-kovid-asisi/Blog/?BlogNo=630411.