[Editor’s View] Why still linger on bioequivalence test?

The South Korean government seems to be still lingering on the notion of restricting the joint bioequivalence test the Regulatory Reform Committee has put a brake on.

 

At the recently convened National Assembly Annual Audit, Minister Lee Eui-kyung of Food and Drug Safety stated that she “fundamentally agrees with the restricting the ‘one-plus-three’ joint bioequivalence test.” The minister’s agreement was expressed on the regulatory bill introduced to the National Assembly to only approve of up to three generics using a single source of consigned bioequivalence tests.

 

With the lawmaker’s boost, the ministry is rekindling the effort to legislate the restriction on joint bioequivalence test that was halted by the Regulatory Reform Committee.

 

The restriction on joint bioequivalence test is viewed as a strict measure to prevent saturation of the generics market.

 

When the number of consigned bioequivalence test per original test can be limited, the number of generic launched in the market could also be contained.

 

Regardless of the Regulatory Reform Committee objecting to the restriction twice, the Ministry of Food and Drug Safety (MFDS) is relentlessly, and incomprehensibly, trying to reinforce the regulation without clear explanation as to why.

 

Regarding the bioequivalence test restriction, the Regulatory Reform Committee concluded, “It is difficult to see it as an effective measure to achieve the objective of the regulation.

 

And restricting pharmaceutical companies entering the market seems unlikely to directly improve the pharmaceutical quality and safety, or to promote R&D in the industry.” The committee also pointed out the restriction on joint bioequivalence test has been abolished by them in 2010, and no specific changes in the scene have been occurred to overturn their decision.

 

MFDS is maintaining its stance on the toughening the joint bioequivalence test regulation without a clear justification, although the committee has reviewed that the restriction is an unfair regulation.

 

The previous restriction on joint bioequivalence test was stipulated temporarily in distrust of Korean-made generics.

 

When a number of drugs have been uncovered to have manipulated the joint bioequivalence test in 2006, total 307 items were revoked of approval.

 

MFDS judged the heated competition in the generic market was also caused by the manipulated test results, and the ministry implemented the regulation on joint bioequivalence test from May 2007 to restrict the number of participating companies to two.

 

But only after five years, in November 2011, MFDS removed the restriction on the joint bioequivalence test as recommended by the Regulatory Reform Committee.

 

During the October Regulatory Reform Committee meeting in 2010, some criticized the unjustifiable restriction on joint bioequivalence test by claiming “Such non-scientific and irrational regulations should be abolished.” Also some argued, “Regulating the excessive competition is unreasonable, and besides the safety issue, the government intervening the market is a stretch.” And it is still a mystery if the restriction on bioequivalence test would hinder the generic market to get extremely saturated.

 

The new drug pricing system has already demotivated new generics to enter the market.

 

The newly revised drug pricing system effective from last July has put a lower cap on the generic pricing for those that did not individually conduct a bioequivalence test.

 

Since the valsartan contamination incident, the Ministry of Health and Welfare (MOHW) put down the limitation on the drug pricing to solve the excessive generic competition.

 

However, the unprecedentedly heated competition among the generic has already begun thanks to the South Korean government strengthening the regulation.

 

As the government disclosed its plan to toughen the regulation, over 5,000 generics have been released to the market since last year.

 

Some are even saying the government has instigated the excessive competition.

 

Nevertheless, the government is still pointing its finger at the joint bioequivalence test for the cause of the phenomenon.

 

About the regulation on joint bioequivalence test, a MFDS official at a Regulatory Reform Committee meeting stated, “Encouraging an individual bioequivalence test aims to raise the level of pharmaceutical quality and safety management.” Does it mean a generic that receives an approval based on results of consigned bioequivalence test has an issue?

 

Could it mean the government granted an approval regardless of the risk of quality and safety management?

 

For the government to set a policy, it needs its deserving justification.

 

Moreover, it needs to persuade the stakeholders.

 

And side effects of implementing a new policy should be checked beforehand.

 

The voices from the industry should be heard to set an intricate policy.

 

When it disregards the industry’s voice, the legitimacy of the policy is lost.