MOHW proposes an alternative to law on generic substitution

shifts stance to granting “conditional approval”

Possibility of revision to the Pharmaceutical Affairs Act increases, but HIRA remains cautious

A revision to the Pharmaceutical Affairs Act that would allow pharmacies to report generic substitution to the Health Insurance Review and Assessment Service (HIRA) through its work portal is likely to pass the National Assembly.

 

The background to the sudden increase in the likelihood of legislation is that the Ministry of Health and Welfare submitted its own alternative proposal to the National Assembly regarding the bill to simplify generic substitution by pharmacies and changed its position to conditional approval (acceptance) on the premise that its alternative proposal would be adopted.

 

If the National Assembly accepts the alternative proposal submitted by the MOHW, the simplification of post-notification of generic substitution will be legislated in the Pharmaceutical Affairs Act, a law, rather than as an Enforcement Rule, a subordinate law.

 

The alternative submitted by the MOHW stipulates that the Minister of Health and Welfare shall be able to support related administrative tasks, such as post-notification of generic substitution, and that such support tasks may be entrusted to the Health Insurance Review and Assessment Service.

 

Rather than specifying the method of post-notification of generic substitution in the law, the proposal broadly stipulates that the MOHW shall provide support and legalize the framework for entrusting the MOHW's duties to HIRA.

 

On the other hand, HIRA maintained its cautious stance, citing concerns for patient safety in the event of an accident involving a medication misadventure and the lack of legal grounds for entrusting the task to HIRA.

 

This follows the Ministry of Health and Welfare’s submission, on the 18th, of its opinion on the amendment to the Pharmaceutical Affairs Act (aimed at simplifying generic substitution) to the National Assembly Health and Welfare Committee’s First Legislative Subcommittee.

 

The law to simplify generic substitution was proposed by Representative Young-seok Seo of the Democratic Party of Korea and Representatives Sujin Lee and Byung-deok Min of the same party.

 

The Health and Welfare Committee plans to hold the 1st Subcommittee meeting on the 19th to review the bill.

 

The main contents are a provision to change the term “substitute dispensing” to “generic name substitutions” and a provision to expand the scope of post-notification of substitute prescriptions to HIRA.

 

The change in terminology provision has been strongly opposed by the medical community, including the MOHW, and it is unlikely to pass the National Assembly.

 

The provision to simplify generic substitution by expanding the scope of post-notification was once rejected by the subcommittee after the MOHW expressed its need for cautious review.

 

However, the MOHW submitted a legal alternative it had drafted itself to the subcommittee and changed its position to support the legislation on the condition that it be passed by the National Assembly as is.

 

The simplification of post-notification of generic substitution is expected to take effect on February 2 next year, as MOHW has already confirmed the revision of the Enforcement Rules of the Pharmaceutical Affairs Act, and the possibility of the National Assembly revising the Pharmaceutical Affairs Act has also increased.

 

The MOHW has once again expressed its cautious stance on legislation that would require HIRA to notify prescribing doctors of the results of post-notification of generic substitution by pharmacies.

 

The MOHW argued that this is not in line with the purpose and scope of HIRA's establishment and that the increase in the notification period could raise concerns about the safety of drug use.

 

The MOHW also pointed out that the amendment to the Enforcement Rules of the Pharmaceutical Affairs Act allows post-notification via HIRA's information system in addition to telephone and fax.

 

However, in consideration of the need to clarify the legal basis for the HIRA information system currently being developed by the MOHW and the necessity of substitute dispensing in response to drug supply uncertainties, the MOHW stated that an alternative plan would be necessary to establish a basis for HIRA's policy support.

 

So the alternative submitted by the MOHW to the National Assembly stipulates the establishment of “support for generic substitution under Article 27-2 of the Pharmaceutical Affairs Act” and, in Paragraph 1, stipulates that the Minister of Health and Welfare may provide support for matters specified by MOHW ordinances, such as support for post-notification of generic substitutions.

 

Paragraph 2 allows the Minister of Health and Welfare to entrust HIRA with the task of providing support for post-notification of generic substitution, and paragraph 3 stipulates that the details and methods of support and other necessary matters shall be determined by MOHW ordinances..

 

However, HIRA maintained its cautious stance on the bill.

 

The logic behind its need for cautious review is that if post-notification generic substitution is carried out through HIRA, the notification period will increase, and if an accident occurs due to a lack of awareness on the part of doctors, this will raise concerns about patient safety.

 

In addition, HIRA argued that it can only perform tasks entrusted to it by other laws and regulations in accordance with Article 63 of the National Health Insurance Act, and therefore, a separate basis for entrusting tasks related to generic substitution notifications is necessary.

 

Furthermore, it also argued that unique identification numbers in accordance with the Personal Information Protection Act, regulations on the handling of sensitive information, and provisions exempting HIRA from liability for medication misadventure are necessary.

 

d The Korean Pharmaceutical Association in favor, Korean Medical Association and Korean Hospital Association oppose The Korean Pharmaceutical Association supported the bill.

 

On the other hand, the Korean Medical Association and the Korean Hospital Association maintained their opposition.

 

The Korean Pharmaceutical Association predicted that allowing HIRA to notify doctors and dentists electronically would eliminate administrative inconveniences and streamline procedures, thereby promoting generic dispensing, considering the difficulty of notifying doctors and dentists when pharmacists substitute drugs due to factors such as failure to include fax numbers or failed phone connections.

 

The Korean Medical Association argued that pharmacists could arbitrarily change medications without the consent of doctors, which could undermine the right of doctors to prescribe medications, make it difficult to respond quickly to adverse drug reactions, and raise questions about the accountability of the dispensed generic substitutions and their side effects.

 

The Korean Hospital Association also opposed the bill, arguing that notifying just the HIRA of generic substitutions would make it difficult for doctors and pharmacists to share information about generic substitutions, which could delay the necessary treatment for patients in cases of inappropriate generic substitutions.