[Reporter's view] A plan to expand the reference country

The government's explanation is insufficient

The pharmaceutical industry is strongly opposed to the government's plan to expand drug price reference countries.

 

Although the Ministry of Health and Welfare says it has gone through a sufficient discussion process, the industry is strongly criticizing it as a one-sided push.

 

The revision of the HIRA's administrative notice on the 21st of last month calls for expanding the comparative reference countries of PE drugs to two countries.

 

It is to add Canada and Australia to the current reference countries such as the United States, Japan, the United Kingdom, Germany, France, Italy, and Switzerland.

 

On the 5th, the KRPIA clarified its opposition that the amendment seriously undermines access to new drugs for patients with severe and rare diseases, as well as hinders the development of the domestic pharmaceutical industry.

 

The KRPIA said, "There are cases where benefits are delayed or abandoned due to too low prices and difficulties in insurance registration in Korea, but this amendment will delay the introduction of new anticancer drugs and severe and rare diseases, seriously affecting patients' access to new drugs." Multinational pharmaceutical companies with many new drugs are expressing concerns that the expansion of reference countries could lower the price of related drugs.

 

The domestic pharmaceutical industry, which focuses on generic business rather than new drugs, is also strongly opposed to the revision.

 

This is due to concerns that the revision of the expansion of reference countries could be used to re-evaluate registered drugs in the future.

 

Moreover, Australia argues that the price of generic drugs in Korea will inevitably be lowered further if the re-evaluation is carried out due to the low price of generic drugs.

 

Based on the results of policy research conducted in 2019, the government claims that the revision has been sufficiently collected as it has been discussing the revision by forming a working-level association with the pharmaceutical industry for four months since May this year.

 

However, as expected from the announcement of the implementation of the revision bill in January next year, which is opposed by the pharmaceutical industry as a whole, it cannot be said that the opinions of both sides have been well collected.

 

The Korea RPIA also expressed regret that the government unilaterally pushed ahead with the announcement of policy results focused only on reducing drug costs without drawing a reasonable agreement with the industry.

 

In order to push for a proposal that the parties are opposed to, there must be a good reason, but it is difficult to understand even if you look at the reasons for the Far from persuading the parties, it is questionable why this amendment is necessary to anyone who is a third party.

 

The HIRA announced in advance that it has prepared the revision to enhance transparency and clarity and supplement validity due to the long and insufficient formula for calculating adjusted prices that convert drug prices from seven overseas countries.

 

However, there is a lack of explanation as to why the existing calculation formula lacks evidence and whether additional inclusion of Australia and Canada complements transparency, clarity, and validity.

 

The revision is known to be based on the "Measures to Improve Reference Standards for Foreign Pharmacists" conducted by Gachon University's Industry-Academic Cooperation Group in 2019.

 

In this study, Taiwan as well as Canada and Australia were added to the existing seven countries.

 

The reason for the addition is that Canada and Australia have similar economic levels as Korea, and HTA (medical technology evaluation) plays an important role in the process of determining drug benefits.

 

In the case of Taiwan, it was added because the economic level and health insurance system were similar and geographically close.

 

However, it is reported that Taiwan was excluded because it was conscious of China.

 

However, this explanation seems to be insufficient as a justification for Canada and Australia to be added to the reference countries among many countries.

 

In addition, it is not known why it is a problem to charge drug prices with the existing seven countries as reference countries.

 

Although pharmaceutical companies strongly oppose the revision during the period of submitting their opinions on the revision, it is under the impression that the government is not properly explaining the legitimacy of the revision.

 

In this way, even if the amendment is implemented, it is difficult to avoid criticism that it is a hasty push.