[FOCUS] Uncomfortable co-development regulation of medicines

There is a growing possibility that a bill will be implemented to regulate joint drug development by pharmaceutical companies.

 

Recently, the National Assembly's Health and Welfare Committee held a bill subcommittee to pass a partial revision to the pharmaceutical practices law that limits the number of drugs that can be licensed through a single clinical trial.

 

It allows up to four drugs that can be licensed with one biological equivalence test or clinical trial data.

 

It does not apply to biopharmaceuticals or generic drugs.

 

Biological equivalence testing is a kind of clinical trial for generic development, which effectively limits drug co-development by pharmaceutical companies.

 

In fact, regulating the number of pharmaceutical companies participating in joint drug development by law is hard to find even in foreign countries.

 

Sharing strategies for drug development through cooperation among pharmaceutical companies is an area of free business activities.

 

The government does not directly intervene by law.

 

If regulations on biological equivalence testing are applied, additional social costs may arise because the same drugs produced in the same manufacturer must be tested separately.

 

This is why the Regulatory Reform Committee has opposed it.

 

At a meeting of the Regulatory Reform Committee in October 2010, the restriction of biological equivalence tests was called a strange system, saying that "unscientific and logical regulations should be abolished." As the government pushed for the regulation again, the Regulatory Reform Committee opposed last year, saying, "Restricting pharmaceutical companies to enter the market also has low direct improvement in drug quality and safety and minimal R&D promotion." IMD's joint development regulations are also seen as the government's involvement in pharmaceutical companies' R&D strategies.

 

There have been many ways to jointly develop new improved drugs while sharing clinical costs with small and medium-sized pharmaceutical companies that do not have enough funds.

 

If development costs are divided and paid, this is to reduce risks caused by failure of development or sluggish sales after commercialization.

 

In other words, the government restricts voluntary R&D cooperation of pharmaceutical companies.

 

The MFDS, which is in charge of the project, is also burdened with regulations on joint development.

 

According to the minutes of the bill subcommittee, Kim Jin-seok, deputy director of the MFDS, said, "I think mentioning the same part as joint R&D in pharmaceutical law exceeds the legal scope." Like Rx drugs, OTC can be cloned indefinitely through consignment, but it is hard to understand that only specialized drugs are subject to regulation.

 

The KPBMA, one of the leading interest groups in the pharmaceutical industry, is welcoming the bill immediately after it is passed by the subcommittee.

 

It is somewhat unusual for the industry to express its support for tightening regulations.

 

It is undeniable that the "limit on the number of joint drug developers" is a strange system in science or common sense.

 

What is even more uncomfortable, however, is the deformed environment of the domestic pharmaceutical industry, which led to the introduction of a strange system.

 

More than 100 pharmaceutical companies are entering the large generic market and are excessively competing.

 

As of December last year, according to the HIRA.

 

A total of 139 pharmaceutical companies released Atorvastatin products.

 

It increased by 40 from 99 in 2015.

 

It has increased from 118 in 2018 to 133 in 2019 and 139 companies in recent years.

 

In 2015, there were 91 domestic pharmaceutical companies that released Clipidogrel, but five years later, it increased to 133 companies, increasing to 42 companies.

 

There were 112 pharmaceutical companies that released Atorvastatin in 2018, and 21 more joined in two years.

 

The number of companies that released Donepezil reached 134 in two years from 89 in 2018.

 

The value of generic is also gradually decreasing.

 

In foreign countries, when the patent of the original drug expires, cheap generic dominates the market.

 

The situation in IMD is similar.

 

The joint development of IMD is seen as trying to curb generics' entry into the market.

 

The new generic drug price system, which took effect in July last year, includes a stair-type drug price system in which the upper limit is lowered as the benefit is registered late.

 

If more than 20 generic items are listed in the specific ingredient market, the upper limit for newly registered items will be up to 85% of the existing lowest price.

 

If a certain pharmaceutical company develops IMD through clinical trials and recruits more than 20 delegated generics, the generic price will drop significantly.

 

Doubts have been raised that many pharmaceutical companies may be trying to reduce the motivation for entering generics through sharing IMD clinical data.

 

As a result, it led to the introduction of a strange system that also limits IMD clinical data sharing companies.

 

With the reorganization of the drug price system, IMD infinite cloning of delegated generics has emerged to preempt high drug prices, and side effects of "intentionally registering drugs at low prices to induce competitors to receive lower prices." It is hard for anyone to understand the recent unprecedented phenomenon of drug production.

 

Whenever regulations are made to solve urgent problems such as the general crisis, it is likely to backfire in the market.

 

Overseas, inexpensive generic drugs are encouraged, and at some point, generic drugs have been ignored in Korea.

 

It is time to reflect on where it went wrong and what responsibilities the government and pharmaceutical companies have and gather wisdom.