Team:Amazonas Brazil/HP/Silver
Have you seen my DNA?
Understanding how legislation impacts science
One of the most important milestones for an iGEM team is when the biological parts kit arrives. It is a long way from Boston for every team around the world to receive their packages. How much time did we lose waiting for ours to arrive instead of doing lab work?
Even then, why and how did this happen?
For the kits to finally get to our hands, they must go through scrutiny and analysis by the Brazilian Regulatory Importing Agency, and, only upon lengthy inspection, they are finally cleared to their final destinations. That, of course, considering everything goes well.
However, as the Second Law of Thermodynamics (scientist’s very own Murphy’s Law), things can derail quite quickly. As the kits may get entrenched in the entropy of trade legislation, the material may be returned to the sender, be lost midway or, most simply, be denied shipping fulfillment due to biosafety issues. Considering the kit survives this internal process, it can take a good few months of waiting time and unnecessary anxiety.
This long and inefficient process - unknown by many iGEMers – was addressed by our team. We longed to understand the importing and exporting policies for biological parts in Brazil, and worked alongside ANVISA (the Brazilian Agency responsible for regulating the traffic of these materials), to find ways to solve this problem.
How we did it
The National Agency For Sanitary Surveillance (ANVISA in Portuguese) is the federal entity that inspects and regulates Food, Drugs, and other products potentially harmful products (analogous to the FDA in the United States), being responsible for devising the policies and norms regarding biological material distribution throughout the country.
We studied the Brazilian legislation, focusing on the procedures regarding importing of nucleic acids and proteins. We collaborated with professor Carlos Gustavo and Matheus Costa, both having expertise in this area and clarified us about the legal aspect of it. We concluded that there is no specific policy concerning importing and exporting of biological parts in Brazil.
Aiming to map the obstacles, we developed a survey and sent it to many research groups and laboratories in Brazil, with questions regarding the waiting time, the accessibility of the legislation and beyond.
Finally, to draw a comparison between different international settings, we also sent the same forms to iGEMers abroad.
What we found
While studying the normative laws, we realized that there aren’t specific laws for biological parts – nucleic acids and proteins. Generally, in Brazil, the approval or confiscation of biological material is decided on the inspector’s interpretation of the case. Beyond this bibliographical research, the analysis of the forms and comparison of the responses from Brazilian and International perspectives revealed some alarming bureaucratic questions.
The lack of specific legislation governing biological parts would give the scientific community the security and legal support to import these materials, vastly reducing the amount of time necessary to access these components. We then met with the ANVISA representatives once more to discuss what could be done in the legislative sphere and presented suggestions for the importing process of biological materials.
Data analysis
Our sample consisted of 29 surveys from Brazil and 15 from iGEM teams worldwide. There were six questions in the study and, after comparing both groups, we observed exciting trends.
Next steps
As iGEMers, after verifying the disparity of answers, we decided to bring to ANVISA our necessity to make the entry and exit of biological material less bureaucratic and more efficient, allowing Brazilian scientists to have practicality and allow open discussion about how these problems negatively influence the national scientific development efforts. We reunited with regional representatives and established that current laws regarding the subject are limited to the human genetic material (body fluids, cells, tissues, blood, organs). Thus, alongside them, we demanded ANVISA what could be done to address this lack of specific policy for biological parts and urged for them to regulate it. Going further, we also developed a guideline to aid researchers to import and export biological material, validated by ANVISA as well.
Our Human Practices members Maria Cecília and Wlademir meeting regional representative of ANVISA (National Agency For Sanitary Surveillance) Marco Antonio Pinto to discuss the current legislation to import biological parts in Brazil.
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