Enactment of preferential pricing sublaws slow

establishment of subordinate statutes for Korean Innovative Pharmaceutical Companies progressing at a ‘snail’s pace’

KHIDI is making supplements to the research report for 4 months since its receipt

“Measure to avoid international trade conflict may not have been prepared yet”

The enactment of subordinate statutes for the so-called ‘preferential drug pricing for Korean Innovative Pharmaceutical Companies’ clause of the ‘Special Act On Fostering and Support of Pharmaceutical Industry’ is hardly picking up speed.

 

Although the research service ordered by the Ministry of Health and Welfare and the Korea Health Industry Development Institute and conducted by Professor Mi-Hye Park’s research team at the School of Pharmacy at Sungkyunkwan University, has been completed, the authorities are known to be having difficulty in preparing the specific provisions for the statute.

 

On the 5th, the MOHW responded that it is “supplementing the final result reports, including survey results, etc” to the separately written inquiry submitted by the NA Health and Welfare Committee regarding the results of the research service on the preparation of subordinate statutes for preferential pricing of drugs developed by Korean Innovative Pharmaceutical Companies.

 

The study had been conducted after specific subordinate statutes under the ‘Special Act On Fostering and Support of Pharmaceutical Industry (hereinafter “Special Act for the Pharma Industry”) for preferential pricing of drugs developed by Korean Innovative Pharmaceutical Companies had not been established for several years.

 

The MOHW had previously pointed to how preparing subordinate statutes for the preferential treatment of Innovative Pharmaceutical Companies could trigger international trade conflict due to the violation of WTO and FTA agreements.

 

However, the MOHW had initiated related studies through KHIDI after receiving much criticism at the NA audit from members of NA’s Health and Welfare Committee, including In-Soon Nam and Byung-Won Kang of the Democratic Party of Korea, and Byung-Won Kang of the People Power Party.

 

국내 제약사들은 혁신형 제약기업이 만든 의약품의 보험가격을 우대하는 제약산업특별법 제17조의2 조항이 위임한 하위법령이 수 년째 공백상태인 현실을 개선해 약가를 지원해야 한다는 입장이다.

The study was completed earlier this year and the result report was submitted to KHIDI in May, but the results have not been disclosed to the public yet.

 

With the research results undisclosed for nearly 4 months, some have been speculating that the government may not have been able to come up with a clear policy to provide drug pricing support for Korean Innovative Pharmaceutical Companies that do not cause trade conflict.

 

In fact, the MOHW had agreed on the need for a drug pricing support policy for Korean Innovative Pharmaceutical Companies in line with the international trade order to reinforce technology innovation and financial competitiveness of Korean companies to foster them to become global leading companies and lay the mid-to-long term foundation for the development of innovative new drugs but was unable to present the research results.

 

The research was conducted to survey the current status of drug pricing policy in Korea and abroad, collect opinions on drug price support for Korean Innovative Pharmaceutical Companies, review the need to provide pricing support for Korean Innovative Pharmaceutical Companies, prepare a pricing support policy measure for Korean Innovative Pharmaceutical Companies that align with the international trade order, and analyze data requested by organizations involved in establishing pricing support policiies for Korean Innovative Pharmaceutical Companies.

 

However, on its key results, the MOHW is only repeating the explanation that it is supplementing the final result report, including the industry survey results, etc.

 

An official from a domestic pharmaceutical company said, “It will be hard to come up with a clear plan to support drug pricing for drugs developed by Korean Innovative Pharmaceutical Companies without sparking trade conflict.

 

The research team is known to be specifically contemplating measures to provide preferential treatment to Korean Innovative Pharmaceutical Companies with the industry survey results.” The official added, “Whether the policy research results will be publicly disclosed and lead to the enactment of subordinate statutes of the Special Act for the Pharma Industry will depend on what measures the research team, MOHW, and KHIDI will come up with.

 

It will be significant if this leads to essential drug pricing support for products produced by Korean Innovative Pharmaceutical Companies, even if at a relatively narrow range."