October 18, 2024 Source: drugdu 84
Another province issued compliance guidelines, 8 behaviors need to be closely watched. On October 14, the Jiangxi Provincial Market Supervision Administration issued the "Compliance Guidelines for Anti-Commercial Bribery in the Pharmaceutical Industry" (hereinafter referred to as the "Guidelines"), becoming another province to issue pharmaceutical compliance guidelines after Fujian and Chongqing.
The "Guidelines" are divided into four chapters and 15 articles. The so-called pharmaceutical companies refer to operating entities engaged in the production, research and development, sales and other related commodities and related businesses of medical products such as drugs and medical devices, including but not limited to drug/medical device marketing authorization holders (MAHs), drug/medical device contract research organizations (CROs), drug/medical device contract manufacturing organizations (including CMOs, CDMOs), drug/medical device contract sales organizations (CSOs), and drug/medical device commercial distribution companies. Among them, 8 behaviors that may be suspected of commercial bribery are specifically listed, and pharmaceutical companies and medical and health institutions are reminded to pay close attention to prevent the occurrence of bribery.
Specifically include:
(i) Reimbursement of related expenses in the name of sales expenses, promotion expenses, etc., and giving improper benefits to medical institutions or their internal departments and practitioners.
(ii) Giving improper benefits to medical institutions or their internal departments and practitioners in the name of paying commissions.
(iii) Giving improper benefits to medical institutions or their internal departments and practitioners in the name of conducting academic activities, scientific research collaboration, academic support, etc.
(iv) Giving improper benefits to medical institutions or their internal departments and practitioners by giving gifts, arranging travel, catering or entertainment activities.
(v) Giving improper benefits to medical institutions or their internal departments and practitioners through sponsorship or donations.
(vi) Linking the rental income with the diagnosis and treatment activities of medical and health institutions in the name of renting venues.
(vii) Pharmaceutical companies giving improper benefits to medical institutions or their internal departments and practitioners in order to obtain cooperation opportunities with medical and health institutions.
(VIII) Medical institutions or their internal departments and practitioners prescribing medicines in violation of regulations, receiving kickbacks or improper benefits from pharmaceutical companies. The Guidelines also propose that, in addition to the above-mentioned behaviors, we should also pay close attention to various activities carried out in the name of free clinics and consultations, and examine whether these activities are linked to the sales of drugs, medical devices and medical products, and whether there is the possibility of commercial bribery.
At this stage, the compliance guidelines for pharmaceutical companies to prevent commercial bribery risks have been significantly strengthened. The national and local levels guide pharmaceutical companies to truly assume their own principal responsibilities.
Just a few days ago, the State Administration for Market Regulation issued the "Compliance Guidelines for Pharmaceutical Companies to Prevent Commercial Bribery Risks (Draft for Comments)" and publicly solicited opinions on it, which clearly stated that "pharmaceutical companies are the first responsible persons for preventing their own commercial bribery risks, and should implement their principal responsibilities and strengthen internal control and compliance management to prevent commercial bribery risks." The document also specifically lists the commercial bribery risks in nine scenarios, including academic visits and exchanges, receptions, consulting services, outsourcing services, discounts, allowances and commissions, donations, sponsorships, funding, free delivery of medical equipment, clinical research, and retail terminal sales. In the draft of the national version of the compliance guidance document for comments, specific risk behaviors of different business activities are also sorted out. At the local level, in addition to Jiangxi, Fujian, Chongqing and other places have also previously issued compliance guidelines for anti-commercial bribery in the pharmaceutical field.
At present, the intensity of anti-corruption in the pharmaceutical industry is still significant. Since October, articles on the official website of the Central Commission for Discipline Inspection have disclosed details of anti-corruption in the pharmaceutical industry in Shaanxi, Sichuan, Guangxi and other places. Among them, Guangxi has launched a special action since April this year to solve the problems of inadequate implementation of procurement policies for drugs and medical consumables in public medical institutions and heavy burdens on people's medical treatment and medication, breaking the deadlock by investigating and handling typical cases, and promoting reform and governance through cases.
Focusing on violations of discipline and law such as poor supervision, abuse of power for personal gain, dereliction of duty, and interest transfer in the medical field, the autonomous region's discipline inspection and supervision organs have uncovered clues to problems in recent years, using information technology such as big data to collect clues, and laying a solid foundation for case investigation and handling.
The Discipline Inspection and Supervision Commission of Huangling County, Shaanxi Province has strengthened cooperation and coordination with auditing, inspection and other units, uniformly received and efficiently handled all kinds of transferred problem clues, and implemented various supervision coordination and joint punishment for complex, difficult and policy-related and professional problem clues.
In the process of anti-corruption, in addition to investigation and arrest, systematic and institutionalized comprehensive governance has been put on the agenda. For example, the Discipline Inspection and Supervision Commission of Guangxi Autonomous Region has deepened the use of linkage mechanisms, promoted the implementation of supervision and regulatory responsibilities, promoted the "expansion and quality improvement" of centralized volume procurement of drugs and consumables, standardized online procurement of drugs and consumables, and continuously eradicated the soil and conditions for corruption in the medical field.
In the official website article "Practice and Enlightenment丨Doing the "Second Half of the Article" of Investigating and Handling Cases" released by the Central Commission for Discipline Inspection in September, it was proposed that in the face of new types of corruption and hidden corruption, the focus of work should be placed on timely investigation and punishment, and more importantly, active actions should be taken to eradicate the soil and conditions for corruption.
It is expected that more provinces will issue compliance guidelines for anti-commercial bribery in medicines in the future. For pharmaceutical companies, internal compliance construction must also be further strengthened.
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