Newsletter
The Ministry of Health and Welfare (MOHW) Announces Draft Amendments to the Pharmaceutical Affairs Act
To address the chaotic online sale of pharmaceuticals in the digital era, the MOHW has drafted amendments to partial articles of the Pharmaceutical Affairs Act. These updates aim to strengthen the management responsibilities and compliance obligations of internet service providers. The key points of the amendment and their corresponding articles are as follows:
1. Strengthening Management and Self-Regulation: Internet service providers are required to fulfill the duty of care of a prudent administrator (Amended Article 79-1).
Newly Added Article 79-1:
"Internet platform providers, internet application service providers, and internet content providers (hereinafter collectively referred to as 'internet service providers') shall exercise the duty of care of a prudent administrator regarding internet data that involves illegal circumstances as specified in Article 65, Article 68, Article 69, Article 82, or Article 83 (hereinafter referred to as 'illegal information'). Internet service providers shall establish a risk management and control mechanism for illegal information. Where an internet service provider restricts browsing or removes illegal information in order to implement the risk management and control mechanism mentioned in the preceding paragraph, and subsequently causes damage to a user or a third party, the provider shall be exempted from liability for damages. The criteria for determining the requirements, precautions, management measures, and other relevant matters regarding the duty of care of a prudent administrator for internet service providers in Paragraph 1 shall be prescribed by the central competent health authority."
2. Regulatory Inspection via Technology: Competent authorities are permitted to proactively conduct inspections using technology, and internet service providers shall not obstruct such actions (Amended Article 79-2).
Newly Added Article 79-2:
"The competent health authorities may utilize technological methods to proactively patrol the internet for illegal information, and the competent authority for digital development shall provide relevant technical assistance. Internet service providers shall not evade, obstruct, or refuse the inspections mentioned in the preceding paragraph."
3. Real-Time Take-Down and Retention: Access to illegal advertisements or counterfeit and prohibited drugs must be restricted immediately, and relevant data must be retained (Amended Article 79-3).
Newly Added Article 79-3:
"Where a competent health authority becomes aware of illegal information, it may order internet service providers to restrict browsing or remove webpage data related to such illegal information. Where an internet service provider becomes aware of illegal information through a competent health authority or other government agencies, the provider shall restrict browsing or remove webpage data related to the illegal information within twenty-four (24) hours of becoming aware. Internet service providers shall retain the webpage data specified in the preceding two paragraphs, along with the users' personal data and network usage log data, for at least one hundred and eighty (180) days from the date of restriction or removal."
4. Access Restriction Measures: For entities maliciously evading enforcement, internet access service providers may be ordered to restrict access to the illegal information (Amended Article 79-4).
Newly Added Article 79-4:
"Where the illegal information specified in Paragraph 1 of Article 79-1 involves any of the following circumstances, the competent health authority may order internet access service providers to complete the restriction of access to such illegal information within two (2) working days from the day following the date of notification:
(1) The contact information of the internet service provider is unknown, rendering service of process impossible.
(2) The nature of the violation involving the illegal information is severe, and immediate action is necessary to avert imminent danger or prevent the escalation of harm.
(3) After having its access restricted, the internet service provider evades enforcement by changing its domain name or through other methods, and illegal information reappears on the internet.
The competent authority for digital development, the competent authority for education, the competent authority for communications and propagation, and the competent authority for science and technology development shall assist in the execution of the access restrictions specified in the preceding paragraph."
5. Addition of Penalties: Failure to comply with these regulations will result in administrative fines (Amended Article 95-1).
Newly Added Article 95-1:
"Any entity that commits any of the following acts without justifiable grounds shall be fined not less than NT$200,000 and not more than NT$5,000,000 by the competent health authority, and shall be ordered to make corrections within a specified time limit; those who fail to make corrections by the deadline shall be penalized per violation:
(1) Evading, obstructing, or refusing in violation of Paragraph 2 of Article 79-2.
(2) Failing to restrict browsing or remove information in violation of Paragraph 2 of Article 79-3.
(3) Failing to retain data for one hundred and eighty (180) days in violation of Paragraph 3 of Article 79-3.
(4) Failing to restrict access to illegal information within the specified time limit in violation of Paragraph 1 of Article 79-4."
Please note that this advance notice of the draft amendments to the Pharmaceutical Affairs Act has not yet been finalized, and an effective date has not been determined. However, as this legislative change will significantly increase the obligations and liabilities of both internet service providers and internet access service providers, it is advisable to prepare and plan accordingly at an early stage. Our firm has a dedicated "Life Sciences & Healthcare Practice Group"; should you have any further questions regarding the aforementioned amendments and internal corporate compliance planning, you are welcome to contact our specialists at any time.