[Reporter’s View] Real reasons for disqualification?

A multinational pharmaceutical company Sanofi Korea has failed to qualify as a certified innovative pharmaceutical company.

 

Fairness aside, the transparency in the process seems questionable.

 

Since its first certification won in 2014, the company lost its certification status after six years.

 

Now, only three multinational companies—AstraZeneca, Janssen and Ostuka Pharmaceutical—are certified as innovative pharmaceutical companies in South Korea.

 

The certification is definitely not permanent; if a certified company is disqualified, then the company’s benefit should be taken away.

 

But the problem here is that there is no known reason behind the disqualification.

 

An innovative pharmaceutical company is evaluated based on investment performance, manufacturing facility status, R&D vision and strategy, collaboration and partnership with local and overseas university and research institute, licensing contract, business ethics and business transparency.

 

Reportedly, Sanofi has passed all the ‘quantitative criteria’ for the evaluation.

 

In other words, the reviewers saw disqualifying factor in ‘qualitative criteria.’ But the details have not been disclosed.

 

To Daily Pharm, the government official answered, “The innovative pharmaceutical company certification takes account of not only quantitative evaluation, but also quantitative evaluation.” However, Sanofi Korea has no clue on why they failed the qualification.

 

Their answer of ‘qualitative evaluation is also used’ is not a justifiable answer.

 

They need to state how the company’s qualitative factor scored lower than the passing score.

 

The rumor has it that ‘the health authority was offended by Sanofi terminating the licensing contract with Hanmi Pharmaceutical,’ or ‘the government is trying to reduce the ratio of certified multinational companies.’ But the government lacking transparency has no rights reprimand the rumors.

 

The innovative pharmaceutical company certification program allows the authority to officially certify and grant benefits to the qualifying companies.

 

Fairness and transparency is essential to the program.

 

At least the disqualified companies should have feedback to consider either prepare for the certification reapply or not.

 

The poor reputation of ‘offending the authority is a surefire disqualification’ cannot be good.

 

If such situation continues to happen, then Sanofi would not be alone in this.

 

The relationship between multinational pharmaceutical companies and South Korea should not be overlooked.

 

The country still does not have sovereignty over new drug.

 

Without a clear guideline on the government’s key program for those companies bringing new drugs, the country and the companies’ headquarters could spark a conflict.

 

Even private companies and universities are enforcing ‘blind interview’ to reinforce transparency in the application process.

 

A head coach keeping a silence to a player asking why they are benched should not complain for being replaced.