[Reporter’s View] Unresolved insulin cold chain issue

With no clear alternative found for insulin distribution in Korea, on how to set the regulations for cold chain transport of insulin remains unresolved and beleaguered.

 

Unlike other biological agents that are mainly prescribed in hospitals, insulin is often dispensed at outside pharmacies.

 

And the lives of patients with Type 1 diabetes, who cannot produce insulin in their own bodies, may be threatened if this insulin is not readily available.

 

However, on the pharmaceutical distribution companies’ part, insulin is a ‘white elephant.’ Although it is not a favored item on the companies' part due to its low distribution fee, it is an essential item when considering the companies' business relationship with patients and customers.

 

For this reason, distributors refer to insulin as "a drug that is being distributed as a service item with little or no distribution margin." In other words, although the companies are currently distributing insulin, there is no reason or benefit for the company to distribute it at a loss.

 

When the transport regulations for vaccines were revised earlier last year, and then extended application to all biological products, the government did not consider the difficulty and complexity the revised regulations would bring to insulin distribution.

 

The fact that insulin would be included as biologics may not have even crossed their minds during the revision process.

 

There Ministry of Food and Drug Safety had newly enacted guidelines thereafter to reflect the voices of the industry after receiving countless complaints from the distribution companies but to no avail.

 

Although the newly enacted guidelines showed some progress, such as allowing insulin to be contained in various transport containers and not taking issue with temperature fluctuations during delivery to pharmacies as long as the company can verify the validity of the cold chain process.

 

However, even these changes were not worth the excessively increased workload and cost required to maintain the thorough cold chain requested by the government.

 

In fact, as of July 17th, when the revised regulation was implemented, instability in insulin supply and demand arose at distribution sites.

 

Also, with orders piling up due to fears of stock shortages, this instability in supply and demand continued to deepen.

 

The reduced number of insulin deliveries and extended terms between deliveries to pharmacies further heightened the anxiety of the patients.

 

And due to railing opposition from diabetes patient groups, the MFDS granted an additional 6-month guidance period specifically for insulin distributions.

 

However, anxiety continues to sweep through the industry with the sentiment that this problem cannot be resolved without further consideration of the fundamentals of the revision itself.

 

Officials from distribution companies jointly voiced that “the guidance period is virtually meaningless.” With no distribution, an increased amount of insulin stock would be useless.

 

Also, with the government holding a close eye over the issue, insulin may be better distributed in the short term during the guidance period, but it is clear that the same problem would return as soon as the eye moves away.

 

In other words, there is no other viable option without the additional review of the revised regulations.

 

However, how the revisions should be re-revised remains a further issue, and concerns deepen due to lack of reasonable grounds required for additional revisions of regulations.

 

It is not easy to make further revisions because the regulations were not made after collecting sufficient data and identifying realistic situations in the first place.

 

The government is continuing discussions with the industry, patient organizations, and relevant organizations, and the proposal for holding a public hearing is only now being discussed.

 

It is odd that a public hearing, which should have been conducted before the revision was finalized, is only being discussed now, 8 months after the enforcement of the regulation.

 

It is understandable how frustrated the patients would feel about the unresolvable insulin distribution issue.