10,000 pros & cons for generic substitution

Pharmacists expressed their opinions on two amendments to the Pharmaceutical Affairs Act initiated by Rep. Young-Seok Seo

Controversy between medical and pharmacist functions spread as pros and cons

There are a lot of unusual comments in the National Assembly legislation, where not even a single comment is usually posted.

 

These are the 'Simplification Act for Generic Substitution Post Notification' and 'The Act on Restriction of 1+3 Joint Biological Equivalence'.

 

All of them are laws related to the issue of generc prescription.

 

Among the 304 bills posted on the National Assembly Legislative Advancement System on the 9th, a total of 13,000 comments were posted on two partial amendments to the Pharmaceutical Affairs Act, initiated by Seo Young-seok (Bucheon), Rep.

 

of Democratic Party of Korea.

 

List of legislative notices posted on the National Assembly Legislative Notice System on the 8th

By around 11:30 a.m.

 

on that day, 7681 comments were posted on the legislative notice of the Simplification Act for Generic Substitution Post Notification bill, and the number of views exceeded 69,934.

 

Likewise, 5857 comments were posted on the legislative proposal for the The Act on Restriction of 1+3 Joint Biological Equivalence proposed by Seo, and the number of views was 48,395.

 

This is three to four times more than the Wildlife Protection Act (2,454 comments) with the most opinions among the comments posted on 302 other legislative proposals.

 

In particular, except for the top five legislative notices, most bills do not have less than 100 comments.

 

There are only hundreds of views.

 

As the two bills passing generic prescription spread to confrontation between doctors and pharmacists, it can be assumed that a systematic commenting campaign is underway.

 

Lee * Eun, who appears to be a doctor, objected to the bill when he claimed that "even if the ingredient is the same and passed the bioequivalence test, the effects and side effects of the drug are not the same." Hwang * Deok also pointed out, "It is not the same drug because the ingredients are the same.

 

The drugs used for each patient are different, which is contrary to the current trend of advocating precision medicine." However, Chansung, who appears to be a pharmacist, also confronted this.

 

Kim *Ah argued, "We need to change the perception of the same ingredient preparation.

 

Even now, it is awkward to say that doctors who prescribe the same drug to another drug company every few months to designate a company according to the patient." Mr.

 

Kim *Han also said, "I agree with the legislation that changes the name of the generic substitution with the same ingredient name to reduce public confusion.

 

It is very ridiculous for doctors to prescribe a company's medicine that is not clear to the manufacturer and rather changing it to an original.

 

In many cases, not a single comment is posted on the legislative proposal of the National Assembly Legislative System

The same comment was also occupied by the MFDS’ proposed The Act on Restriction of 1+3 Joint Biological Equivalence, which were unsuccessful contrary to the Regulatory Reform Committee.

 

The main idea of this bill is to limit the number of generics per original drug to three.

 

Rep.

 

Seo cited the reason, "The outbreak of consignment generics due to unlimited sharing of biometric data weakens illegal distribution such as rebates and R&D of pharmaceutical companies." There is a reason for the pros and cons of the legislation to limit the number of generics produced by bioequivalence testing.

 

This is because it also contains the content that 'because the type, content, and route of administration of the active ingredients are the same as for new drugs, bioequivalence test data must be submitted for drugs that are requested based on safety and efficacy data such as new drugs.' Oh *-hyun, who argued against this, commented, "It is said that it is the same, but if you take medicine, will you take the original, or will you take flour medicine from a third-rated pharmaceutical company that you have never heard of?" Regardless of the bill, Kim *young wrote, "If the pharmacy changes to a different drug with the same ingredient, patients can not take the medicine which doctor prescribe under specific manufacturer" He wrote a comment on a similar bill that would run on the bill.

 

Mr.

 

Kwon *-jin, who agreed to the bill, refuted, "People who disagree haven't read the text properly.

 

The prescription for the brand name in force now leads to rebates between doctors and pharmaceutical companies, causing reckless competition for generic drugs." Kwon said, "The prescription of ingredient names will limit the number of generics.

 

The case of using expensive original drugs without taking into account the patient's economic situation through rebates will disappear." He argued, "It can prevent the reckless competition for mass production of generics by pharmaceutical companies."