CHINA Trends and Developments Contributed by: Min Zhu, Ya-ling Gon, Yang Gu, Chai Lu, Ying Li and Shiye Yuan, Han Kun Law Offices
(For Trial) (Draft for Comment) and the Key Points and Determination Principles for the Supervi- sion and Inspection of Medical Device Clinical Trial Institutions (Draft for Comment). The two drafts provide comprehensive guidance on the stringent inspection criteria and procedures for clinical trial institutions. Once finalised, they are expected to significantly strengthen regulatory oversight and improve the integrity of medical device clinical trials. Compliance Practices Following the stringent anti-corruption measures in 2023, rectification actions in the pharmaceuti- cal industry continued to intensify in 2024. From legislation to enforcement, these efforts under- score China’s determination to combat corrup- tion in the life sciences and healthcare industries. Commercial bribery in life sciences and healthcare In 2024, Chinese regulators remained keenly focused on anti-bribery and anti-corruption, publishing a number of documents to maintain strong oversight of commercial bribery in the life sciences and healthcare sectors and to provide further compliance guidelines. Effective 1 March 2024, the Amendment (XII) to the Criminal Law of the People’s Republic of Chi- na adopted a more severe stance toward brib- ery in the healthcare sector. It explicitly outlined standards for “aggravated penalties” under vari - ous circumstances, with the maximum penalty against the offenders being life imprisonment. On 11 October 2024, the SAMR issued the Guid- ance on Preventing Commercial Bribery Risks for Pharmaceutical Enterprises (Draft for Comment). On 10 January 2025, the Guidance on Prevent- ing Commercial Bribery Risks for Pharmaceu- tical Enterprises (the “Guidance” ) was officially
released by the SAMR and took effect immedi- ately. The Guidance aims to assist pharmaceuti- cal and medical device enterprises in effectively preventing and addressing commercial bribery risks during their daily operations, ensuring com- pliance with relevant laws and regulations. On 25 December 2024, the Standing Committee of the National People’s Congress released the draft Anti-Unfair Competition Law of the PRC (the “2024 Draft” ) for public comment. The 2024 Draft would make significant revisions regard- ing commercial bribery, emphasising prohibi- tions against accepting bribes. Additionally, it would increase the maximum fine for commer- cial bribery from RMB3 million to RMB5 million and introduce personal penalties for legal rep- resentatives, primary executives and directly responsible personnel of entities engaging in commercial bribery. The 2024 Draft would also add provisions for administrative penalties for those who offer bribes. Meanwhile, anti-corruption enforcement and judicial actions in the pharmaceutical industry were strengthened nationwide in 2024. This again emphasises that both recipients and offer- ors of the bribe may be subject to punishment. On 27 May 2024, the NHC, the SAMR, the Min- istry of Public Security, the National Audit Office and ten other departments jointly issued the Key Work Points for Rectifying Malpractices in the Procurement and Sales of Pharmaceuticals and Medical Services in 2024. This document spe- cifically targets illegal activities such as bundled sales and “kickback sales” disguised as confer- ences, donations, research collaborations and trial promotions.
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