Question

1. What would be the benefits or drawbacks of having one single regulatory agency versus the three separate existing agencies we currently have in place?
2. What is meant by the statement “delicate dance of regulation and innovation”?
3. How does the premarket phase in the regulatory process help companies, and how does it work to the benefit of the consumer?
4. The company 23andMe almost failed because of regulatory issues. What could product developers have done differently?
5. What are the potential benefits of “modernizing” the process of biotech regulation?

Answer 1

As per the given Question

1.

When there is a one single regulatory agency, instead of three, then there are some benefits. The first benefit is the one agency looking after different regulatory issues and it helps in synchronization and coordination among the departments to solve the issues that ate linked with each other. The second benefit is the creation of one database at one place that has the records of all the regulatory matters. Hence, resolution of the regulatory issues becomes easy. The third benefit is the operational efficiency of the agency. Resources can be better utilized when there is one agency looking up for the different regulations.

But, there are drawbacks as well. The first drawback is the slowed process of decision making and companies have to wait. The second drawback is the generalization of the work, but regulations are technical and one regulation in one industry, cannot work for any other industry. It is the reason that three agencies are set up at present. The third drawback is the scope of the prevalence of bureaucracy in the organization, delaying in resolution. Rather, agencies should be lean and technically expert in specific regulatory matters. So, there are some benefits as well as some drawbacks.

---------

2.

Statement means that there should be delicate balance between regulation and innovation. There should be regulations in place to promote the free market spirit, free and fair competition, but it should not be overburdening to suffocate the innovation in the industry. Hence, market should be regulated, but sufficient space should be created for innovation. It is the reason that innovation has been granted patent rights, licenses and other IP rights to promote the innovation even if regulation for the anti-competitive practices are in place.

thank you for the question...kindly rate....it helps me a lot