Korea Seeks Fast Tracks For Innovative And Public Health Crisis Drugs
Executive Summary
Korean pharma industry welcomes a bill that aims to establish fast-track review and approval system for innovative drugs and medicines used in public health crises.
South Korean lawmakers have submitted a bill to support the development of innovative drugs and also medicines used in public health crisis situations, including establishing a fast-track review and approval system for such products, in a bid to lead the growth of innovation in the domestic pharma industry as well as to preemptively deal with public health emergencies and ease related supply disruptions.
Social demand has been rising in the country to develop treatments and establish a supply system to preemptively and effectively deal with public health crisis situations, which could include a biochemical weapons attack, radiation leakage accidents, and the pandemic outbreak of various infectious diseases.
However, new rules are required as South Korea isn't completely equipped to support accelerated approval of drugs under the regulatory framework of the existing Pharmaceutical Affairs Act. The country was seen as needing to introduce a new pathway that can promptly support new drug development and deal in a timely way with the rapidly changing environment surrounding the pharma industry.
Basic Framework
According to the basic outline of the planned system, the special rules will be applied to designated new drugs developed by innovative pharma firms that are determined to have social and ethical responsibilities, and which invest a certain amount of capital in new drug R&D. South Korea already grants various incentives to designated innovative pharma companies, and the new rules will also apply to medicines required for use in public health emergency situations.
Under the proposed bill, South Korea will come up with a system to designate novel drugs and public health crisis medicines that will be eligible for priority reviews and administrative support, such as simplified data requirements for document submission.
A safety management committee will also be established under the Ministry of Food and Drug Safety (MFDS) to review and advise on safety management systems and rules, the designation of drugs and support for development, and product approvals or cancellations.
Once drugs are approved using the priority review system, their comprehensive therapeutic value - including safety and efficacy - will be posted online following evaluation.
It is not clear at this stage when the parliament will discuss or may pass the new bill.
It has also been put forward as the cutting edge biologics act bill, which was proposed last year, is still pending in the parliament. As part of the MFDS’s plans for 2018, the ministry said in January that it aims to introduce fast-track review and approval systems for cutting edge biologics and medical devices in late 2018. (Also see "Korea To Introduce Fast-Track Review For Cutting-Edge Biologics, Devices" - Pink Sheet, 25 Jan, 2018.)
KPBMA Welcomes Move
The Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) has welcomed the bill's submission, saying it is set to beef up access to drugs for which it may be difficult to proceed with clinical trials, and would strengthen the competitiveness of the domestic pharma industry.
The bill is seen as aiming to promptly review and approve new drugs being developed by innovative companies and encourage new product development, and also to create jobs, along with speeding up development of medicines needed for public health crises.
The shorter time frames are seen as particularly valuable. “In modern times, new drug development is a fight against time. The key is to become a first mover and lead the market. As a result, the importance of speed is growing as the commercial success of new drugs depends on how much time from clinical trials to the launch period can be reduced,” the KPBMA said.
In addition, there have been frequent global outbreaks of infectious diseases such as Middle East Respiratory Syndrome (MERS), influenza and the Zika virus, so it is crucial to develop treatments and preventive vaccines.
No Decisions Yet On Global Innovative Drug Pricing System
Meanwhile, South Korea's government still hasn't decided how to modify the global innovative drug pricing system as agreed in the revised Free Trade Agreement with the US. (Also see "US, Korea FTA Talks To Improve Pro-Innovation Pricing System" - Pink Sheet, 2 Apr, 2018.)
Under the system, introduced in 2016, prices of designated "global innovative novel drugs" will be set 10% higher than the current ceiling reimbursement price of alternative drugs, or existing drugs or treatments used for the same indications.
The industry is closely eyeing if prices for global pharma firms' new products will rise due to the revision of the system, or if the government will opt to reduce the relative pricing benefits given to domestic pharmas as part of the system.
Under the revised FTA, South Korea has to come up with a draft of the revisions to the global innovative drug pricing system by the end of October.
From the editors of PharmAsia News.