Health and Welfare Committee receives first policy briefing in 2H

Reimbursement for new drugs, expansion of convenience-store medicines and regulation of warehouse-style pharmacies also among key issues

MOHW and MFDS may face questions over the need to tighten the 1+3 limit on consigned bioequivalence studies

The National Assembly's Health and Welfare Committee is set to hold its first plenary meeting under the second half of the 22nd Assembly later this month, during which it will receive policy briefings from the Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS).

Lawmakers are expected to question government officials on a range of key issues, including follow-up measures to strengthen the pharmaceutical industry's competitiveness after the implementation of the generic drug pricing system reform, tighter regulation of CSO (Contract Sales Organization) rebates, and expanded National Health Insurance (NHI) reimbursement for innovative medicines.

Other major pharmacy-related agenda items are expected to include expanding the list of over-the-counter medicines available at convenience stores and tightening regulations on warehouse-style pharmacies.

On the 9th, the ruling and opposition party secretaries of the National Assembly Health and Welfare Committee were coordinating the schedule for a plenary committee meeting later this month.

With the ruling Democratic Party of Korea’s national convention set to conclude on the 17th, the ruling and opposition parties are reportedly discussing holding the plenary meeting sometime between the 18th and 21st.

The main agenda will include ministry policy briefings, formation of legislative subcommittees, and settlement of accounts. As this will be the first policy briefing since the committee was reorganized for the second half of the current Assembly, lawmakers from both parties are expected to raise a broad range of healthcare policy issues.

One of the committee's main areas of interest is follow-up administrative and legislative measures to improve the structure of Korea's pharmaceutical industry following the generic drug pricing reform.

Lawmakers are closely watching how the MOHW plans to reshape the country's multi-generic market and increase the likelihood of developing domestically produced innovative medicines, following the introduction this month of lower reimbursement prices for generics and preferential pricing for innovative drugs.

More specifically, the issues involve tightening the “1+3” restriction on consinged bioequivalence studies for generic drugs and strengthening regulations on contract sales organizations, or CSOs.

Lawmakers seeking policies to address an environment in which the proliferation of generics produced through consinged bioequivalence studies leads to CSO rebates, ultimately reducing opportunities to create competitive homegrown blockbuster drugs, are expected to question Health and Welfare Minister Eun-Kyeong Jeong and Ministry of Food and Drug Safety Commissioner Yu-kyoung Oh about relevant countermeasures.

Expanding National Health Insurance coverage for ultra-expensive new drugs is another major issue. The ministry has announced plans to launch a pilot program under which drugs are listed first and evaluated afterward, and has pledged to operate the insurance system in a way that accelerates coverage for new drugs proven to deliver therapeutic benefits to patients.

At the same time, the ministry said it will continue reviewing the need to provide insurance coverage for new injectable obesity treatments such as Wegovy and Mounjaro, as well as prescription hair-loss treatments.

Committee members from both parties are considering the need to question the government on how it will set priorities and ensure fairness in providing coverage for ultra-expensive new drugs and high-demand prescription medicines within the constraints of the National Health Insurance budget.

Among pharmacy-related agendas, deregulation of convenience store medicines is expected to receive significant attention, as Minister Jeong has identified expansion of the list of OTC medicines available at convenience stores and easing restrictions on retail outlets as key policy priorities for the second half of the term.

With the pharmacy community strongly opposing the ministry’s policy direction toward deregulating convenience-store medicines, pharmacists are expected to closely watch the line of questioning taken by lawmakers from both parties.

Lawmakers are also expected to scrutinize regulations on warehouse-style pharmacies. An amendment to the Pharmaceutical Affairs Act restricting the signs and advertising used by warehouse-style pharmacies has passed both the relevant standing committee and the Legislation and Judiciary Committee and is awaiting a vote at a plenary session.

Minister Jeong has announced plans for additional safeguards extending beyond sign and advertising regulations, including appropriate pharmacist staffing standards to reduce the risk that large pharmacies could encourage medication misuse or abuse.

As a bill aimed at screening and preventing the registration of warehouse-style pharmacies involving outside capital and pharmacies illegally operated under a pharmacist’s name has also been introduced (Rep. Jeon Jin-sook) and remains pending in the National Assembly, lawmakers may therefore raise questions about the need for this legislation.

A standing committee official said, “This policy briefing will be a watershed moment in determining the direction of the Lee Jae-myung administration’s healthcare and pharmaceutical and biotechnology policies during the latter half of its term. As the National Assembly begins full-scale legislative and administrative oversight activities with these agency briefings, discussions will accelerate on restructuring the generic drug industry, regulating pharmaceutical distribution, easing regulations on convenience-store medicines and regulating warehouse-style pharmacies.”