The Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPMA) sharply criticized the government’s administrative notice to amend rules to give drug price benefits to “globally innovative medicines.” The pharma industry group said the planned policy would make local drugmakers become a scapegoat of the Free Trade Agreement between Korea and the U.S.
The Korean Research-based Pharma Industry Association (KRPIA), a group of multinational pharmaceuticals, also slammed the government’s new policy. The KRPIA said in spite of the government’s intention to treat local and global novel drugs equally, the new policy will be infeasible.
The Health Insurance Review & Assessment Service (HIRA) recently said it would put to notice an amendment of the rules on evaluation criteria and procedures for pharmaceutical reimbursements.
The revised rules require an innovative medicine to meet all the five following conditions: it should have a new mechanism or it should be a new substance; there should be no other alternative treatment, it should have clinically meaningful data such as extending survival time for a significant period, it should have the U.S. Food and Drug Administration’s designation of Breakthrough Drug (BTD) or the European Medicines Agency’s accelerated assessment of Priority Medicines (PRIME), and it should be an orphan drug or an anticancer treatment.
As for the requirements for innovative new medicines and drugmakers, the government deleted the requirements for innovative pharmaceutical companies and R&D investment. Instead, it newly inserted the provisions for “import or production of WHO (World Health Organization)’s essential medicines or essential national drugs.”
However, the KPMBA issued a statement on Friday saying, “The amendment released by the Ministry of Health and Welfare and the HIRA showed that the government, pressured by the U.S., has virtually given up on encouraging local pharmaceutical firms’ R&D, which is the ultimate goal of the new drug pricing system.”
The group went on to say that it was “deplorable to witness the government’s unreasonable measure which made the local pharmaceutical industry a scapegoat of the Korea-U.S. FTA.”
In particular, it is deplorable that the government has changed its policy stance to kill local drugmakers’ R&D commitment, it added.
The group also criticized that the government made a big mistake, making approval from the U.S. FDA or the EMA a precondition for new drug pricing benefits.
However, KRPIA, the group of foreign pharmaceutical firms, also expressed concerns over the amendment of the policy to give drug pricing benefits to innovative medicines.
In particular, it was unreasonable to require an innovative medicine to be only an orphan drug or an anticancer therapy, and without an alternative treatment, at the same time, the KRPIA said.
The group said there would be almost no drug that meets all the requirements, calling the new policy unrealistic.
“The requirements run counter to the government’s goal of making Korea the world’s seventh pharmaceutical power. We hope that the government could come up with realistic conditions through collections of industry opinions and additional discussions with the pharmaceutical industry,” the KRPIA said.
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