New pharmaceutical data protection system begins

Strengthening IMDs’ monopoly rights

Integrated operation of post-marketing safety management and risk management system

Representative Jeon Hye-sook's representative motion, "Improvement of pharmaceutical industry research and development capabilities"

Legislation is being promoted to abolish the drug reexamination system, establish a separate legal basis for the drug data protection system, encourage research and development in the pharmaceutical industry, and strengthen the monopoly on the IMDs market.

 

It also includes provisions to reduce the burden on pharmaceutical companies due to the reexamination system and overlapping operations by integrating the drug post-marketing safety management system into the risk management system.

 

On the 3rd, Jeon Hye-sook, a member of the Democratic Party of Korea, announced that she had proposed a partial amendment to the Pharmaceutical Affairs Act to this effect.

 

The Ministry of Food and Drug Safety has been insisting on the necessity of this legislation since 2020, and it is expected to be passed in the 21st National Assembly.

 

The key to Representative Jeon Hye-sook's bill is to abolish the drug reexamination system and establish a separate legal basis for the drug data protection system.

 

We encouraged domestic pharmaceutical companies to actively conduct clinical trials by expanding the scope of application of the law so that drugs approved by submitting new clinical trial data in addition to drugs under the existing reexamination system can also be subject to the data protection system.

 

Looking at the data protection system contained in Representative Jeon Hye-sook's bill, 'orphan drugs' are 10 years from the date of product approval, 'new drugs' are 6 years, and 'the type of active ingredient is changed to improve the safety, efficacy, and usability of drugs that have already received product approval.' The protection period for clinical trial data was set at 6 years for 'medicines that require submission of new clinical trial data, such as 'for drugs that require submission of new clinical trial data to obtain product approval', and up to 4 years for 'other drugs that require submission of new clinical trial data to obtain product approval.' This is expected to lead to the effect of granting a 4-year data protection period to pharmaceutical companies that developed a new phase 3 clinical trial, allowing them to have market exclusivity for a certain period of time.

 

This means that the current re-examination system has improved the irrationality of failing to grant a re-examination period to some IMDs.

 

Rep.

 

Jeon Hye-sook explained, “The drug re-examination system is intended to ensure post-marketing safety, and it has been pointed out that it does not fit the purpose of the data protection system.” She explained, "We will improve the pharmaceutical industry's research and development capabilities by submitting new clinical trial data in addition to drugs under the existing reexamination system so that approved drugs can also be subject to data protection."