[Reporter’s View] More legislation needed for CSO reporting

We need to amend the Medical Service Act in addition to the Pharmaceutical Affairs Act to ensure transparency in the CSO reporting system

The enforcement of the Pharmaceutical Affairs Act, which requires Contract Sales Organizations (CSOs) to report to local governments and educate their employees on the prohibition of rebates, is now 2 months away.

 

The pharmaceutical and CSO industries are hoping the implementation of the reporting system will serve as a milestone to increase the transparency of illegal drug rebate practices and put behind their past where CSOs were used as black money payment channels to promote the physicians’ prescription of certain drugs.

 

In law with the law's implementation, the Ministry of Health and Welfare (MOHW) announced the proposed amendments to the Enforcement Rules of the Pharmaceutical Affairs Act on March 18 and began collecting industry opinions.

 

Once the reporting system is implemented, CSOs are expected to ensure justice in sales practices within the pharmaceutical and biotechnology industry and be incorporated into the system, thus being manageable by the government.

 

Of course, the Ministry of Health and Welfare, the pharmaceutical industry, and the CSO industry will need to work together to improve the problems or shortcomings that may arise upon the implementation of the system, but the CSOs, whose existence has been virtually unrecognized until now, will be able to take shape and advance the pharmaceutical industry’s sales practices.

 

However, there is still legislation that needs to be enacted in line with the CSO reporting system -the Medical Service Act.

 

The act needs to prohibit doctors from accepting rebates, including financial kickbacks and entertainment provided by CSOs.

 

Such amendment to the Medical Service Act passed the Health and Welfare Committee review and was pending at the Legislation and Judiciary Committee’s 2nd Bill Review Subcommittee stage at the 21st National Assembly, but was eventually abandoned due to the closure of the 21st NA.

 

The CSO reporting system and training obligations will strengthen the government and local governments' control over CSOs' illegal rebate practices, but there are concerns that its effect may be halved unless it is followed by an amendment to the Medical Service Act, which will prohibit doctors from accepting rebates.

 

Article 23(5) of the Medical Service Act, which prohibits doctors from gaining improper financial benefits, needs to be amended.

 

The "drug suppliers" need to be changed to "drug suppliers and contract sales organizations (CSOs)" to provide a clear legal basis to punish doctors for accepting rebates from CSOs.

 

Some have even suggested that amending the Medical Service Act would be more effective in eradicating rebates than the CSO reporting system.

 

Therefore, the Ministry of Health and Welfare and the 22nd National Assembly should work together to promptly amend the Medical Service Act.

 

The authorities need to minimize the period of the CSO reporting system being operated as a half-baked system because the legal basis for prohibiting doctors from receiving rebates for CSO payments has not been established.

 

The MOHW should reiterate the need to quickly introduce, examine, and pass the proposed amendments to the Medical Service Act, and the ruling and opposition parties in the Health and Welfare Committee should also join forces to expedite the passage of such legislation to achieve the goal of eliminating rebates.

 

With the CSO reporting system set to go into effect on October 19th, the National Assembly needs to seriously consider passing amendments to the Medical Service Act to enhance the effectiveness of the system and fill in the gaps in the legislation in time.