[Reporter's View] Double standard against natural medicines

The government announced the '4th New Natural Product Drug Development Promotion Plan' in May 2024.

 

The plan outlines a joint effort by seven ministries, including the Ministry of Health and Welfare, the Ministry of Science and ICT, Ministry of Trade, Industry and Energy, Ministry of Environment, Ministry of Oceans and Fisheries, Rural Development Administration, and Korea Forest Service, to build a foundation for natural new drug R&D and promote its industrialization.

 

To achieve this, the plan selected three strategies and six key tasks, and pledged support for customized consulting to enhance clinical success rates, as well as assistance for global expansion.

 

The budget allocated for this was KRW 153 billion, a 2.7% increase from the previous year.

 

However, in the reimbursement sector, the exact opposite policy is underway.

 

A prime example is the ongoing discussion to delist the mugwort extract treatment for gastritis from reimbursement coverage.

 

The government selected the mugwort extract as a target for the 2025 drug reimbursement appropriateness re-evaluation last year.

 

In discussions held this year, the conclusion was that it 'lacks appropriateness for reimbursement.' While an objection procedure remains, the prevailing view, considering past precedents, is that a dramatic reversal of this decision is unlikely.

 

On the one hand, the government is expanding the budget to industrially promote natural medicines, while on the other, it is reducing patient access due to a lack of clinical utility.

 

This contradiction of simultaneously fostering industrial growth and removing a flagship product is seen as a decision that weakens the government's policy consistency.

 

The problem of inconsistent policy is also evident in the differing results from two re-evaluations.

 

The mugwort extract had already been recognized for its usefulness in a reimbursement re-evaluation conducted by health authorities 14 years ago.

 

The Ministry of Health and Welfare reviewed the cost-effectiveness of five therapeutic categories, including cardiovascular and digestive ulcer drugs, as part of the 'Reorganization of the Listed Drugs List' in 2011.

 

At that time, the usefulness of Stiren's 'gastritis treatment' indication was recognized.

 

Conversely, its 'gastritis prevention' indication was questioned, and after a legal dispute over a delay in submitting clinical data, the conclusion was its removal from reimbursement.

 

No issues were raised at the time regarding the usefulness of its gastritis treatment.

 

This amounts to an opposite judgment being made on the same drug.

 

This leaves questions about the consistency of policy not only in clinical settings but also from the perspective of pharmaceutical and biotech companies.

 

A bigger problem is that this double standard has increased overall industry uncertainty and stifled research momentum.

 

In the mid-2000s, major pharmaceutical and biotech companies maintained one or two natural medicine development pipelines; however, this is no longer happening.

 

After Yungjin Pharmaceutical received approval for its atopic dermatitis treatment 'Yutoma' in 2012, no new natural medicines were produced in Korea for 13 years.

 

Yutoma was never even launched due to cost issues, and its approval was canceled in 2022 for failing to submit re-evaluation data.

 

In the same year, Chong Kun Dang received approval for its natural medicine 'G-Tec,' but it has not been launched due to delays in reimbursement listing.

 

A field that was once highlighted as a national strategic project has been halted due to institutional contradictions.

 

The controversy surrounding the mugwort extract extends beyond the survival of a few products and is directly linked to the trajectory of the Korean pharmaceutical and biotechnology industries.

 

While past achievements cannot be uncritically praised, it would be a loss to dismiss the experience and assets accumulated in that process as an anachronistic product.

 

Strengthening regulations to align with global standards is inevitable, but what is needed now is to correct this double standard.

 

The contradiction of simultaneously promoting industrial growth and discussing delisting must be resolved.

 

A balanced policy design that encompasses support for clinical research and commercialization, as well as quality standardization, should follow.

 

Only then can natural medicines re-establish themselves as a competitive asset for the Korean pharmaceutical and bio-industry.