Chapter 3 of the Guidelines on Sales Information Provision Activities for Ethical Drugs (hereafter "the GL") follows Chapter 2, which addresses corporate and management-level responsibilities, and turns its focus to the individual field representatives—MRs (Medical Representatives), MSLs (Medical Science Liaisons), and equivalent roles—defining their personal obligations across four provisions.
01The role of Chapter 3 — direct accountability for field representatives
The GL draws a clear line between corporate responsibilities (Chapter 2) and individual responsibilities (Chapter 3). Chapter 2 requires top management to put in place a supervisory department and a material review process. Chapter 3 takes that infrastructure as given and then sets out the conduct standards that must be met by the people who actually visit healthcare facilities and deliver information.
The four pillars are: (1) compliance with the GL; (2) points to observe during sales information activities (use of reviewed materials, prohibition of misleading expression, etc.); (3) commitment to continuing professional development; and (4) prohibition of unapproved materials.
So what: Representatives are not merely conduits for company-produced materials. Each one carries personal accountability for GL compliance in every interaction with a healthcare professional.
So why: Even a well-designed review process can be bypassed by a single representative who shares unapproved data or adds misleading oral commentary. Without direct obligations on individuals, the Chapter 2 corporate framework risks becoming a paper exercise.
02The four provisions at a glance
Section 3-1 (GL compliance) requires representatives to comply with the GL as a whole and, in particular, to refrain from any activity that violates Section 1-3 (the foundational principles). Section 1-3 establishes the bedrock standards—accuracy grounded in scientific and objective evidence, and consideration for conflicts of interest at healthcare institutions—and these standards bind every representative directly.
Section 3-2 (points to observe during activities) specifies concrete prohibitions for real-world interactions: activities must follow materials that have passed the supervisory-department review; any expression liable to mislead—intentionally or otherwise—is forbidden; and particular care is required to avoid presenting exceptional data as if it were a general finding, or using imagery that undermines professional dignity.
Section 3-3 (self-development) calls on representatives to recognise the social responsibility inherent in their role and to make continuous efforts to acquire the necessary scientific knowledge and to cultivate their professional ethics. Deficiencies in either area are a direct pathway to inappropriate information provision.
Section 3-4 (prohibition of unapproved materials) states explicitly that only materials confirmed as appropriate through the Section 2-3 review may be used. Independently prepared slides, photocopied journal articles that have not passed the review, or any other unapproved item are prohibited.
So what: The four provisions share a single underlying purpose: preventing representatives from expanding—on their own initiative—the scope or content of the information they provide. The mandate is to operate within the reviewed framework, accurately and honestly.
So why: Physicians, pharmacists, and other healthcare professionals use information from representatives in clinical decision-making. Because individual discretion can directly affect the quality of that information, personal accountability is the final safeguard for patient safety. Organisational controls and individual self-regulation together are what make the GL effective in practice.