[Reporter’s View]Year of regulations, principle vs practice

In celebration of the TIger's Year, the industry should look back on its principles and practice to right the wrong

As in every other year, regulations imposed on the pharmaceutical and biopharmaceutical industry are again expected to be further reinforced this year.

 

In particular, GMP-related regulations will be strengthened even further.

 

Starting this month, the government may impose punitive fines on the arbitrary manufacture of pharmaceuticals by companies.

 

In addition, the government and the National Assembly are pushing to amend the law so that an assigned GMP investigator could conduct on-site investigations on drug manufacturing plants.

 

Also, a bill to revise the law to allow business suspension dispositions up to one year and license revocations in case of GMP violations is pending at the National Assembly.

 

Some may complain that such excessive regulations hinder the development of the pharmaceutical and biopharmaceutical industry.

 

However, the regulations did not appear out of nowhere.

 

There were always events that triggered the tightening of regulations.

 

The GMP regulations were reinforced due to the series of arbitrary manufacturing events that occurred last year.

 

The arbitrary manufacturing of pharmaceuticals that were once considered rare incidents conducted by one or two companies was identified in several companies last year.

 

The industry thus lost the public’s trust.

 

In depth, the ruling may indeed have felt unfair for some pharmaceutical companies.

 

However, their protests failed to gain public sympathy as their argument, in essence, is an excuse that they did not follow the 'principle' in the name of customs and practice.

 

And this is not an issue that just arose last year.

 

The license of Kolon’s ‘Invossa’ was canceled in 2018, Medytox’s botulinum toxin in 2019 because they were found to have manufactured their product differently from their approved specifications.

 

This would not have happened if the companies stuck to the basic principles.

 

This new year, the industry should look back on itself.

 

Companies should look back and examine whether they have chosen practice rather than principle in other areas of their business as well.

 

If so, they must remedy their ways immediately as these small incidents are what intensify to become serious issues.

 

The MFDS should also review its ways to become an institution that is faithful to principles.

 

This does not mean that the ministry should adhere to principles on every issue that arises.

 

Punishing pharmaceutical companies based on pure principle is not a fundamental solution.

 

If deviations of front-line pharmaceutical companies have become a practice, the ministry should more deeply look into the background on why it became so.

 

As the regulatory authority, the MFDS’s role is to establish principles in the direction that can protect the public’s health and further develop the industry.

 

In other words, if the regulations are causing the issue, it is the MFDS’ role to establish “new principles.”