‘INN prescribing can hinder high-quality drug development’

“Drug shortages are caused by diverse factors: API shortages, quality issues, deteriorating profitability... the effect of INN prescribing on addressing the issue is questionable”

Director Choong-ki Kim, “Even bioequivalent drugs with the same active ingredient cannot be regarded as identical”

Rep. Jia Han (middle) hosted an NA forum on ingredient-name prescribing for drugs with unstable supply, together with the Seoul Medical Association.

Amid diverse causes of drug supply instability, such as API shortages, export restrictions at the national and global level, quality issues leading to GMP violation sanctions, and pharmaceutical companies exiting markets due to deteriorating profitability, the medical community has argued that the “limited international nonproprietary name (INN) prescribing” policy adopted as a national agenda by President Jae-myung Lee may be ineffective or even be counterproductive.

Critics further pointed out that because pharmacies cannot stock every medication, and as combination drugs for conditions such as hypertension and diabetes cannot be simply substituted, INN prescribing could lead to a “pharmacy hopping” situation in which patients must visit multiple pharmacies to find one stocking the specific drug listed on their prescription.

The medical community also reiterated that even drugs with proven bioequivalence are not identical medications.

Under INN prescribing, patients may receive generics from different manufacturers depending on which pharmacy they visit or on each pharmacy’s inventory situation, but equivalence among generics is not fully guaranteed.

These views were presented on the 29th at a National Assembly forum titled “INN Prescribing for Drugs with Unstable Supply,” hosted by Rep. Ji-ah Han of the People Power Party and organized by the Seoul Medical Association. The presentation was delivered by Chung-gi Kim, Policy Director of the Korean Medical Association.

Director Kim explained that drug supply instability arises from multiple causes.

He explained that supply disruption arises from a multifaceted combination of structural causes, such as reduced global supply, manufacturing/quality issues, or pharmaceutical companies voluntarily withdrawing product approvals due to drug price/market conflicts, as well as logistical causes stemming from regional/temporal imbalances in distribution.

Kim argued that attempting to resolve such multifactorial supply instability through INN prescribing is unreasonable.

He cited several limitations of INN prescribing, including the potential to trigger “pharmacy hopping,” the fact that even bioequivalent generics cannot be regarded as identical drugs, and the possibility of discouraging qualitative advancement and formulation innovation in pharmaceuticals.

Specifically, he diagnosed that INN prescribing is ineffective because it operates on the premise that a generic substitute exists when production or supply is restricted due to API shortages or quality issues like GMP violations.

In cases where pharmaceutical companies voluntarily exit the market due to the low profitability of low-priced essential medicines, INN prescribing could further intensify price competition and accelerate market withdrawal by manufacturers.

Even in situations of temporary supply instability caused by logistics imbalances, where certain pharmacies or time periods experience stockouts, INN prescribing offers little benefit, and issues could instead be addressed through direct supply management by medical institutions or adjustments in physicians’ prescribing practices.

Director Kim specifically pointed out that, on average, a single pharmacy stocks over 2,000 to 3,000 types of drugs, highlighting the physical limitations of resolving supply instability through INN prescribing.

Considering the inherent mismatch where pharmacies cannot stock every drug, and the fact that combination drugs for conditions like hypertension and diabetes, with their varied ingredients and dosages, cannot be simply substituted, INN prescribing risks creating a “pharmacy hopping” problem. This forces patients to search for a pharmacy that stocks all the drugs listed on their prescription.

Kim further argued that when INN prescribing leads to substitution of originator drugs with generics, or substitution among generics, the ‘trap of bioequivalence’ may place patients in a situation where they cannot take the exact medicine prescribed by their physician.

Furthermore, he argued that INN prescribing could act as a mechanism that discourages pharmaceutical companies from advancing the quality of drugs or pursuing formulation innovations.

If ingredient-name prescribing is implemented, manufacturers may be discouraged from investing in high-quality medicines, such as reducing tablet size for patients with dysphagia, improving moisture resistance and stability for better storage and efficacy, masking unpleasant tastes, or optimizing drug release profiles.

Kim stated, “Drug supply instability is a matter of national security. The current shortage is a structural phenomenon that has become chronic. This instability stems from dependence on global supply chains, low drug pricing and bidding structures, and weak quality and production incentives.”

He elaborated, “The structure that maintains unsustainable prices causes pharmaceutical companies to abandon manufacturing and exit the market, leading to repeated shortages and the collapse of treatment continuity. The solution lies in securing resilience through demand management, including predictive early warning systems, appropriate drug price compensation, supply-chain diversification, and the introduction of alternative treatments.”

Kim concluded, “We must shift the policy paradigm from individual drug-centered approaches to treatment-continuity-centered policies, and shift the focus from administrative convenience to clinical impact and patient safety. What is needed is not fragmented or temporary INN prescribing, but an integrated, cross-ministerial governance r framework.”