[Reporter’s View] Deadlines are set for a reason

Why no news is being heard of on the reimbursement of new drugs even after the end of the pricing negotiation deadline

The definition of ‘deadline’ is a time limit set in advance.

 

So what is the right thing to do if the deadline has ended without a conclusion being made?

 

Providing a justifiable explanation is very important in administrative affairs.

 

Explanations are necessary not only in the course of introducing or abolishing a system, but also when exceptions occur in the process of applying regulations.

 

However, no explanation has been given when the drug price negotiation term between the NHIS and pharmaceutical companies have been extended beyond the deadline.

 

The parties involved point to the ‘confidentiality clause’ as the reason for the lack of explanation.

 

They do not disclose whether the negotiations will be extended or terminated.

 

This is despite the fact that more and more drugs are entering into extended negotiations beyond the deadline.

 

In the era of the so-called “high-priced” drugs, so many good but high-priced drugs are being released, therefore, it may be difficult for the government and pharmaceutical companies to reach an agreement within the 60-day deadline.

 

But a deadline is a promise.

 

Moreover, the deadline was offered as a ‘benefit’ by the government, as it has announced a plan to shorten the review deadline for homegrown new drugs.

 

The reduced deadline was a device that limits the final negotiation period and speeds up the approval process while providing a sense of timing for the companies.

 

However, the responsibility lies with both sides.

 

At some point, the prolongation in negotiations becomes pervasive, and the sense that an expensive and difficult medicine can't be finished in a single term, as well as the lack of a mindset of delivering results on time, has been leading to the repetition of exceptional cases.

 

If discussions have become difficult, the conditions for initiating the negotiations should be strengthened.

 

The NHIS should receive strong pressure to discuss in advance the necessary documents for pharmaceutical companies to prepare at the Health Insurance Review & Assessment Service stage before the start of negotiations and to complete them within the deadline.

 

In the end, the patient is left to wait.

 

Patients who hear that drug price negotiations are left to just wait without promise.

 

After 3-4 months of await, no news is heard of the drug’s reimbursement.

 

Even when the patient calls the government and pharmaceutical companies, the only response he or she can get is that “They cannot comment on the matter.” It is understandable that the HIRA stage, which evaluates the adequacy of a drug’s reimbursement based on clinical efficacy and cost-effectiveness, and the drug price negotiation stage, which is directly related to the “financial condition” of the parties involved, can be more sensitive phases for governments and pharmaceutical companies.

 

But one has to wonder how long the ‘confidential’ clause can be seen as a just reason.

 

Times have changed.

 

Patients and their families will no longer stand on the sidelines.