IMD-generic drug price differential regulation is revised

Simultaneously review the delayed implementation of IMD price regulation and premium pricing policy

Industry Recognized as “Pharmaceutical Development Effort”

Correction seems to go through administrative procedure again

Expectations are growing in the news that the Ministry of Health and Welfare is announcing the reform of the generic drug price regulation, which recognizes the value of IMD and maintains the premium pricing clause.

 

In particular, the revised plan will postpone the regulation of IMD next year instead of this year, and if there are not many new drugs of the same class released, it is likely to include a plan to maintain the current drug price.

 

There is an evaluation that the Ministry of Health and Welfare has signaled that it will implement a policy based on advanced IMD.

 

According to the industry on the 13th, the reform of the drug price regulation of the Ministry of Welfare will not stop at simply easing the price regulation of IMD.

 

Some experts believe that it can also be seen as a ‘game changer’ that will stop the current bitter generic competition and serve as a cash generator to lead the pharmaceutical industry ahead of new drug development.

 

The Ministry of Health and Welfare is expected to proceed with some revised administrative notices of the Amendment and Adjustment Criteria.

 

It contains the Ministry of Welfare's policy to adjust the price of IMD, unlike simple generics, to exempt regulations.

 

The Welfare Ministry will release it as early as this week.

 

In this case, the basic framework of some amendments announced by the government last year is likely to be implemented in July of this year, and the revised parts will be implemented afterwards through administrative procedures.

 

The industry's proposed amendment is to revise the revised synthetic and biopharmaceutical adder system to guarantee the addition maintenance period of IMD.

 

This means that they will be differentiated from generics in recognition of their efforts to develop IMD.

 

This is due to the consensus that the government, the pharmaceutical industry, and the National Assembly's Health and Welfare Committee created a consensus on maintaining IMD’s premium pricing policy.

 

There are two additional scenarios that the industry anticipates: delaying the implementation of IMD price regulations and premium pricing policy demonstrating progress.

 

As a kind of methodology, the postponement of implementation is intended to give a period of preparation for IMD development capabilities for generic pharmaceutical companies.

 

Demonstrating progression In the case of advanced IMD, if a number of IMD of the same type are not developed and released, there is a possibility that a policy will be prepared to maintain the current price advantage.

 

If a IMD can't be released by anyone, it is determined that it is a medicine that has proven to be somewhat progressive.

 

Source: Korea Pharmaceutical Bio Association

Specifically, experts in the pharmaceutical industry classify the criteria for the IMD into ▲the improvement of patient medication convenience through the change of administration route, ▲the improvement of patient medication compliance through the change of dosage forms such as sustained-release tablets, and ▲the improvement of dosage and usage through the change of salt.

 

For example, the famous antivirals, Tenofovir by Gillead Science replaces the existing TDF (Tenofovir disoproxyl fumarate, Viread) with TAF (Tenofovir alafenamide fumarate, Vemlidy).

 

This proved progressive.

 

TAF with altered TDF salt improves renal and bone cell side effects and is equally effective with a 10% dose of TDF.

 

It is estimated that 90% of the drug used to obtain the drug is reduced, and the size of the pill is smaller, improving patient safety and medication convenience.

 

The industry understands that the policy of the Ministry of Health and Welfare is to ease the drug price restrictions on the IMD.

 

The pharmaceutical industry is in full agreement with this view.

 

A pharmaceutical company official in Korea said, “IMD proves to be progressive will in some way inspire the development of pharmaceutical companies and encourage the advancement of the entire industry, in particular, the Ministry of Health and Welfare was convinced of the exception of the regulation on the price of IMD, and it seemed to signal the generic developer to turn to overseas market by turning to IMD”.

 

A official said, “But at present, no specific proposals are disclosed, so we cannot expect too much IMD price regulation positively, and The Ministry of Health and Welfare will need to be unveiled on which price exceptions will apply”.

 

Another B Pharmaceutical official said, “We believe that the Ministry of Health and Welfare has largely embraced the claims of the pharmaceutical industry.

 

Both probation and preferential treatment are more than expected, and we wonder how the IMD standards will be proven and many pharmaceuticals will go ahead and improve the constitution”.

 

The official said, “When the government's drug price regulation was first released, it was burdened with the licensing and restriction of the addition system, and the biggest meaning is that the Ministry of Health and Welfare agrees that the IMD is more valuable than generics”.