[Desk’s View] New principles rouse moral responsibility

in the drug reevaluation process

The government’s reevaluation of approved and listed drugs is in full swing.

 

The stated purpose is to filter out ineffective drugs and provide coverage to better ones.

 

As this is very necessary for the public, it is the government's responsibility to fulfill this task.

 

The reevaluation is being conducted omnidirectionally by the Ministry of Food and Drug Safety (MFDS), which conducts the approval review, and the Health Insurance Review and Assessment Service (HIRA), which conducts the reimbursement evaluations.

 

MFDS is in charge of conducting the bioequivalence reevaluations for generic drugs and clinical reevaluations for drugs with little evidence literature.

 

HIRA is conducting a reevaluation of the reimbursement adequacy of drugs that lack clinical utility.

 

Last year, it also conducted a reevaluation of the insurance ceiling price, lowering the ceiling price of generic drugs that did not conduct direct bioequivalence tests.

 

Once the authorities create the standards, the evaluation itself progresses at lightning speed.

 

The problem is that the evaluation standards that are being applied after approval and listing this time are different from what had been applied before.

 

For example, in the case of generic versions of natural product-derived drugs, the MFDS requires a comparative disintegration test (a test that compares the disintegration rate under the same conditions for two solid dosage forms with the same active ingredient and route of administration before approval but requires more than a just a bioequivalence test during the post-marketing reevaluations.

 

Similarly, in the price ceiling reevaluations, companies were required to submit direct bioequivalence test results regardless of the criteria that had been applied before.

 

As a result, most generic versions of natural product-derived drugs such as Stillen and Layla were unable to pass reevaluations.

 

One company is said to be preparing a lawsuit against the unilateral price ceiling reevaluation standards that were applied, as it does not reflect the characteristics of each drug.

 

The MFDS is also expected to set ‘comparative clinical trials’ as the standard for natural product-derived drugs.

 

Since bioequivalence tests cannot be applied to natural product-derived drugs, the government is considering applying a higher standard of comparative trials.

 

Comparative clinical trials are more expensive and time-consuming than comparative disintegration tests or bioequivalence tests, and it is not easy to demonstrate equivalence through such trials, therefore, there is analysis that many companies will fail to pass reevaluation if the MFDS applies the comparative clinical trial card.

 

It is rumored that HIRA’s reimbursement adequacy reevaluations in 2025 will also include natural product-derived drugs such as Stillen and Joins.

 

In the case of Stillen, it is questionable whether it will be subject to reevaluations as it was judged to be clinically useful in the 2006 drug list reorganization project.

 

No one can object to the idea of conducting post-evaluation to weed out ineffective drugs.

 

However, if the criteria for pre- and post-evaluation are different, it would be unfair to those who already received the evaluations.

 

In that case, the government owes it to the company to at least explain why the standards have changed and why it was right then but wrong now.

 

Also, when a drug passed pre-evaluations and was taken with confidence by patients, but the post-evaluations showed opposite results, the government should at least express regrets, if not an apology, to the patients who may be unable to use the drug in the future.

 

Various reasons may lead to the same results, such as a lack of scientific evaluation methods at the time, or the fact that clinical utility can only be determined after their release, but this does not eliminate the moral responsibility of the state that is responsible for verifying the safety of the drugs for the public.

 

Therefore, the government should at least express their regrets at the least.

 

This is not something that can be passed over.