New Korean Law On Cutting-Edge Biologics Raise Hopes And Concerns
Executive Summary
A new South Korean law to support and manage the safety of cutting-edge regenerative medicines and biologics has been passed amid hopes these will become a national growth engine, although there are concerns that a further easing of rules could lead to another 'Invossa incident'.
The South Korean parliament has passed a new law to support and ensure the safety of novel regenerative medicines and biologics, giving a potential boost to cell, gene and other biologic therapies using the latest technologies.
The Cutting-Edge Regenerative Medicine and Biologics Support and Safety Act, which was finalized after repeated delays and modifications, was first proposed back in 2016 as regenerative medicine began to receive the spotlight as a future technology for treating rare and intractable diseases and others that are difficult to address through conventional methods.
The industry has welcomed the new law amid what they see as the need for customized policy, given that companies are jumping into the development of innovative biologics and as biotechnology is advancing rapidly worldwide. It also expects the legislation to help ease worries over the safety of biologics through tougher management of manufacturing and quality control.
Separate Law Needed
The pharma industry has been calling for a dedicated law because of the different considerations required for the approval and safety management of such products versus conventional synthetic drugs. South Korea’s current Medical Service Act and Pharmaceutical Affairs Act do not reflect these distinct characteristics.
Cutting-edge biologics for the scope of the new law refers to cell and gene therapies, tissue-engineered products and biotechnology-convergence products (excluding those whose main function is as a medical device) and other therapies that contain cell, tissue or gene components.
The new act, which will be formally implemented one year after passage, aims to more systematically manage biological drugs and support the development of innovative drugs for refractory diseases, and provide new treatment opportunities to patients with rare and intractable disease patients, the government said.
It will also enable the country to more systematically deal with new manufacturing and approval processes, reflecting the characteristics of novel products based on living cells, proteins and genes.
Invossa Incident Raises Worries
However, the new law comes amid public and political concerns raised in the wake of the cancellation earlier this year in South Korea of the approval of Invossa (TG-C), the world’s first allogeneic cell-mediated gene therapy for degenerative osteoarthritis of the knee, due to a discrepancy in its cell components. (Also see "Invossa Approval Revoked As Korea Confirms False Data Submission" - Pink Sheet, 28 May, 2019.)
The Ministry of Food and Drug Safety concluded Kolon Life Science Inc. submitted false data to support the approval of the pioneering product and asked prosecutors to press criminal charges against the company.
The incident led to calls for a suspension of any further easing of relevant regulations, which critics believed may have partly led to the Invossa woes. However, the drug ministry had urged the need for a separate cutting-edge biologics law to help step up the safety management of such therapies.
The new law is also in line with South Korea’s policy of nurturing the biotechnology sector as a major economic growth engine, and will help the country to become more harmonized with advanced markets such as the US, Europe and Japan, which have implemented separate laws to support the development of innovative biological drugs. (Also see "Korea Pledges Broad Innovation, Policy Support As It Eyes Global Stage" - Pink Sheet, 23 May, 2019.)
Regulatory Reforms To Help Access
The Ministry of Food and Drug Safety and the Ministry of Health and Welfare expect the new act to provide new treatment options to desperate patients with rare and intractable diseases, and to step up the general competitiveness of the country’s regenerative medicine technology.
The ministries intend to reorganize the drug approval and verification system, which has been operating with a focus on synthetic drugs, in ways suitable for the characteristics of cutting-edge biologics, and also beef up drug authorities’ approval and review capabilities. Safety management networks will be set up for all stages of product cycles from extraction of cells to final use.
The new law is set to accelerate approvals of novel biologics through fast-track reviews and a conditional approval system. Products will need to meet one of the following conditions to be eligible for accelerated reviews: have no alternative therapies; be for the treatment of serious diseases such as cancer; or be aimed at rare diseases or the prevention or treatment of infectious diseases caused by biological terror attacks or pandemics.
The government says it also plans to draw up a clinical research system like those in major countries to enable patients to receive regenerative therapies for life-threatening diseases. Clinical research will need to go through strict reviews by state committees on to determine urgency, safety and efficacy and gain consent from patients. Such treatments would only be administered at health ministry-designated medical institutions and the cost of the clinical research would be fully supported by the state.
The South Korean Centers for Disease Control And Prevention will be designated as the safety management institution to track adverse reactions, keep mandatory records of clinical research, and follow high-risk patients over the long term.