dailypharmkorea

Opinion
[Reporter’s View] Now is the time for drug reclassification
by Lee, Tak-Sun May 06, 2022 05:46am
10 years have already passed since the heated discussion arose on the drug reclassification and sale of over-the-counter drugs in non-pharmacy venues. As the Korean saying goes, even nature can change in one decade. In that not-so-long but also an epoch of a period in terms of change, many drugs have established safety profiles and await better patient access. In other words, the time has now come for discussions on drug reclassifications, just as we have done in 2012 a decade ago. Above all, we need to make an opportunity to discuss reclassifications because no system that regularly reclassifies drugs exist in Korea. The Ministry of Food and Drug Safety announced that it would establish a regular system at the time of the reclassification in 2012, but the switchings based on overseas and safety data are not being performed smoothly. There are cases where the reclassification process itself is at a standstill despite rising social demand, such as in the case of the morning-after pill. This is mainly due to the absence of an applicant, but this doesn’t mean that the government should just let go of the matter. The government should actively come up with a plan and have applicants such as pharmaceutical companies, medical/pharmaceutical associations, and consumer groups fill out application forms. The environment and timing are also set for reclassifications, as 10 years have passed since the full reclassification and the people who led the reclassification at the time have returned with the administration change. Of course, opposition from medical and pharmaceutical groups such as the Korea Medical Association and the Korean Pharmaceutical Association is expected. KMA is opposed to the reclassification plan, and the KPA is also passive in reclassification to avoid increasing the number of over-the-counter drugs. Also, civic groups are much less interested in enabling reclassification than a decade ago. The pharmaceutical companies that rely on insurance prices are less likely to request reclassification on their part. However, it is negligence on the government's part to let go of the drug classification issue due to fear of conflict. The authorities must do what is needed despite the expected turmoil. Update the overseas cases and collect the new safety data to reform the outdated system. Just firmly withhold the set principles during the reform. Allow easier access for drugs with verified safety, if not, tighten access. Stop walking on eggshells in fear of the medical and pharmaceutical groups and gather the experts who are aware of the gravity of the situation and hear their opinions.