To introduce a phase 3 clinical drug preferential policy

Pharmaceutical Pricing and Reimbursement Policies

There is an opinion to introduce an incentive system

It can be introduced only by revising the drug adjustment standards

Attention is focusing on whether the industry, the National Assembly, and the MOHW will be able to derive a reasonable and efficient institutional direction in relation to the "policy for preferential treatment of new drugs in phase 3 clinical trials for Koreans." According to related industries on the 23rd, after the drug preferential regulations for innovative pharmaceutical companies were deleted during the 2018 Korea-US FTA negotiations, Article 17-2 of the Pharmaceutical Industry Promotion Act was introduced, but the legislation process seems urgent.

 

Generic, which is released by innovative pharmaceutical companies, can get additional drug prices if it meets certain items of drug decision and adjustment standards, while there is no incentive for new drugs developed by all domestic and foreign pharmaceutical companies, that is, new drugs that have conducted clinical trials in Korea.

 

As the global innovative drug preferential system was virtually stranded due to trade friction such as WTO and FTA three years ago, drug preferences such as 10% of the highest price of alternative drugs to encourage innovative pharmaceutical companies to develop new drugs and application of similar drugs (adjusted lowest price) in A7 countries have disappeared.

 

With the outbreak of the COVID-19 Pandemic, public opinion on the formation of public opinion on the independence of vaccines and treatments and the government's justification for establishing pharmaceutical sovereignty is also gaining momentum.

 

As Big Pharma such as Pfizer, Moderna, AstraZeneca, and MSD exclusively develop vaccines and treatments, other countries may suffer supply and demand difficulties at any time, as well as the fact that they are not the main clinical subjects.

 

The "Phase 3 Clinical New Drug Treatment for Koreans" is a system that benefits 5-10% of alternative drugs when domestic and foreign pharmaceutical companies conduct clinical trials (300-1000 people) or higher in Korea when developing innovative drugs.

 

In order to prevent international trade problems such as negotiations on the revision of the Korea-US FTA in 2018, there is an international obligation to introduce a drug price system within the scope of compliance with the agreement.

 

The regulations in question in the FTA agreement at the time allow drug and medical device registration or procedures, rules, standards, and guidelines applied to establishing benefits for medicines and medical devices to apply for benefit based on evidence of safety.

 

The phase 3 clinical drug preferential treatment for Koreans is a system that provides common benefits not only to domestic companies but also to foreign companies, so there is no concern about trade friction.

 

In the case of new drugs that have proven that there is no difference in safety and effectiveness of drugs due to ethnic factors, they have the advantage of creating customized drug therapy, providing appropriate treatment, and securing clinical data while maintaining the maximum drug effect.

 

The revision of the HIRA's drug adjustment standards can achieve the desired results, preventing waste of time and unnecessary costs due to the preparation of new bills such as legislation of the National Assembly and government.

 

According to Article 7 (7) of the Drug Adjustment Standard, the cost of medical care benefits for drugs that omit drug price negotiations is 90% of the weighted average price of alternative drugs, but exceptionally 100% for new drugs, biopharmaceuticals, and rare diseases.

 

An industry official said, "As a result of reviewing 122 drugs registered over the past six years, 4·13 domestic and foreign drugs will be applied to the preferential treatment of phase 3 clinical drugs in Korea." This can benefit in common from domestic and foreign pharmaceutical companies through various legal review, so there is no concern about trade friction due to the application of special cases, he said.

 

In addition, he predicted, "Multinational pharmaceutical companies' drugs are unlikely to be subject to the revision as they are exempted from submitting Bridge study data due to anticancer drugs and rare drugs, and biological drugs will need to be given 100% of the average drug price."