MOHW and MOJ oppose legislating mandatory INN prescribing

Government also cautious amid physician opposition... bill review remains a variable

Despite being President Lee Jae-myung's election pledge and national agenda, government ministries call for “careful review”

NA Welfare Committee to bring Rep Jong-tae Jang’s proposed revisions to the Medical Service Act and Pharmaceutical Affairs Act to the plenary session

The Ministry of Health and Welfare and the Ministry of Justice have expressed reluctance toward a bill that would only partially mandate and enforce physician international non-proprietary name (INN) prescribing for government-designated drugs with unstable supply.

 

Despite this being President Jae-Myung Lee’s presidential election pledge and national policy task to eliminate public inconvenience and confusion over recurring drug shortages, the Ministry of Health and Welfare and the Ministry of Justice have issued a ‘careful review’ opinion.

 

They cited the ongoing conflict between medical and pharmaceutical groups and emphasized the need to gather broader public consensus from patients (medical consumers) and society before moving forward.

 

The Ministry of Justice specifically expressed concern that mandating INN prescribing for drugs designated by the Ministry of Health and Welfare as having unstable supply, instead of brand names, could eliminate pharmacists' obligation to inform patients—unlike in cases of substitution dispensing—thereby restricting patients' right to know and potentially posing significant risks to public health.

 

It also added that the post-prescription accountability remains unclear.

 

This conclusion stems from reviewing the opinions submitted on the 11th by the Ministry of Health and Welfare and the Ministry of Justice regarding the bill mandating INN prescribing for drugs with unstable supply (partial amendments to the Medical Service Act and the Pharmaceutical Affairs Act), proposed by Representative Jong-tae Jang of the Democratic Party of Korea.

 

Rep.

 

Jang's bill mandates that when prescribing drugs designated as having unstable supply under the Pharmaceutical Affairs Act, the active ingredient name must be written instead of the brand name, as an exception to the current law requiring the brand name on prescriptions.

 

The bill also includes penalty provisions stipulating that violating the active ingredient name prescription requirement for supply-unstable drugs is punishable by up to one year of imprisonment or a KRW 10 million fine for noncompliance.

 

Ministry of Health and Welfare·Ministry of Justice “Careful Review” Both the Ministry of Health and Welfare and the Ministry of Justice, the main ministries responsible for the bill, submitted opinions calling for careful review.

 

Their view is that caution must be exercised in legislation, separate from the fact that it is a presidential election pledge and a national policy task of the Lee administration.

 

The Ministry of Health and Welfare expressed sympathy with the intent of introducing INN prescribing, which aims to ensure continuity of patient treatment during drug supply disruptions like shortages.

 

However, it stated that disagreements between doctors' and pharmacists' professional organizations regarding the safety and efficacy of INN prescribing must be taken into account.

 

This is the fundamental response the Ministry has repeatedly given in past statements regarding INN prescribing.

 

The Ministry further stated that criteria for defining drug supply instability, measures to ensure safety and efficacy of INN prescribing, and effective implementation methods for INN prescribing must first be reviewed.

 

The intent is to further discuss whether to introduce mandatory INN prescribing for physicians or adopt an indirect approach, such as providing incentives to prescribers who use INN prescribing.

 

The Ministry also raised concerns about the bill's penalty provisions.

 

It cautioned that criminalizing doctors by imposing criminal penalties for not following INN prescribing when prescribing drugs with unstable supply is an approach that requires careful consideration.

 

The Ministry of Justice provided more specific reasons for playing caution regarding the bill.

 

First, it stated that designating a drug as having an unstable supply would force doctors to prescribe by INN instead of brand name, which would have the effect of broadly permitting substitution dispensing regulated by the Pharmaceutical Affairs Act.

 

The current Pharmaceutical Affairs Act’s substitution dispensing provisions require informing the patient of the substitution and obtaining prior consent from the prescribing physician or providing post-notification within one day.

 

The Ministry of Justice opined that under Rep Jong-tae Jang’s bill, the obligation to inform patients would disappear for designated unstable-supply drugs, and the requirement to obtain prior physician consent or provide post-notification would also vanish, potentially creating problems.

 

The Ministry pointed out, “There would be no need to inform patients, and as notification or prior consent from physicians is not required, this may potentially be a significant risk to public health.

 

This restricts patients' right to know and also leaves unclear whether prescribers would bear responsibility after the fact.” KMA·KHA “Oppose”…KPA “Favor” The Korean Medical Association (KMA) and the Korean Hospital Association (KHA) voiced strong opposition.

 

The KMA argued that mandating INN prescriptions is excessive legislation, as it cannot be a fundamental solution to unstable drug supply issues, yet it stipulates penalties of up to 1 year in prison or fines of up to KRW 10 million for non-compliance.

 

It further argued that forcing doctors to INN prescribe drugs with unstable supply without considering patient conditions disregards public health rights.

 

The KMA also contended that mandating INN prescribing undermines patient safety and treatment continuity, completely infringes on physicians' prescribing rights, and violates the fundamental principle of separating medical and pharmaceutical practices.

 

The KMA stated, “A physician's diagnosis and prescription constitute a professional medical act that comprehensively considers individual patient characteristics, including disease status, underlying conditions, presence of drug allergies, past drug reactions, and ease of administration.

 

When prescribing drugs, physicians select specific products—including the most suitable dosage form, strength, excipients, and coating technology—based on the specific disease and patient characteristics.

 

Forcing INN prescribing hinders patient treatment, infringes on physicians' prescribing rights, and undermines the principle of separation of medical and pharmaceutical services." The KHA also opposed the measure, stating that instability in drug supply arises from multiple causes, such as raw material shortages, production plant issues, distribution problems, pricing, and increased demand due to specific disease outbreaks.

 

KHA argued that legally mandating INN prescribing would be insufficient to resolve the problem and could potentially infringe on physicians' prescribing rights.

 

The KHA emphasized that establishing comprehensive national policies would be necessary to create an environment enabling a stable drug supply.

 

It further pointed out that penalizing non-compliance with INN prescribing, even when physicians may unknowingly prescribe by brand name due to difficulties in quickly and accurately assessing drug supply situations, violates the principle of proportionality.

 

The KHA stated, “Long-term, fundamental measures must be established, such as creating a management system to prevent supply instability in advance.

 

The penalties are excessive sanctions compared to other violations subject to the same penalties under current law, relative to the risk and illegality of the act.” The Korean Pharmaceutical Association (KPA) countered that INN prescribing is the most effective solution to respond swiftly to drug supply instability issues.

 

The association's rationale for supporting the bill is that this legislation will reduce the social and economic waste caused by drug shortages and enable timely dispensing and medication services for patients.

 

Specifically, the association argued that it is irrational for pharmacies to wait solely for a specific brand (product) to arrive when equivalent generic alternatives are available.

 

It also expects the bill to alleviate the burden on pharmacies, which must stock medications from multiple pharmaceutical companies to accommodate individual prescriptions from different medical institutions, even for the same active ingredient.

 

The KPA stated that Representative Jang’s bill does not contradict the existing legal framework, as the Medical Service Act and its enforcement regulations already permit INN prescribing.

 

It also argued that distrusting or claiming differing efficacy for generics approved and registered by the Ministry of Food and Drug Safety (MFDS) is unscientific.

 

The KPA emphasized, “When an INN prescription is issued, even if the supply of a specific pharmaceutical company's drug is unstable, the same active ingredient medication needed by the patient can be dispensed on time, preventing treatment gaps.

 

This allows patients to obtain their prescribed medication anywhere, strengthening public access to medicines and their right of choice.” Welfare Committee expert committee presents divergent views on generic efficacy equivalence The National Assembly Health and Welfare Committee’s expert committee acknowledged that legislation has a valid aspect, as mandatory INN prescribing could help stabilize drug supply.

 

However, it also presented points to consider during legislation.

 

Unlike substitution dispensing, INN prescribing eliminates the need for prior physician consent or post-dispensing notification by pharmacists.

 

In this sense, the expert committee noted that the differing opinions surrounding the therapeutic equivalence of identical-ingredient drugs (generics) must be examined.

 

The expert committee stated, “Those affirming the therapeutic equivalence of identical-ingredient drugs maintain that generics undergo the Ministry of Food and Drug Safety's strict approval and review system, thereby ensuring recognized bioequivalence.

 

“Conversely, those who deny equivalence argue that even with the same active ingredient, differences exist between products in formulation, dosage, excipients, coating technology, etc.

 

They contend that when patients take a different product than before, it increases the potential for drug side effects and may lead to uncertainty in treatment efficacy.” The expert committee also pointed out that the Ministry of Health and Welfare recently clarified the requirement for post-substitution notification.

 

It noted that the revised Pharmaceutical Affairs Act, which aims to enhance information sharing between doctors and pharmacists, passed the National Assembly, was submitted to the government, and was promulgated.

 

Finally, it stated that the penalty clause, which imposes imprisonment for up to one year or a fine of up to KRW 10 million for violations, should also be examined for potential excessiveness.

 

The expert committee stated, “Recently, concerns have been raised that imposing excessive penalties for administrative violations burdens criminal justice agencies and creates a large number of citizens with criminal records.

 

Consequently, legislative reforms are underway to convert fines for minor administrative law violations into administrative penalties.

 

In the exceptional situation where INN prescribing is mandated for unstable supply drugs, it is necessary to examine whether imposing criminal penalties for prescribing by brand name due to lack of awareness constitutes excessive punishment for violating administrative order.”