JPMA Code of Practice — A Voluntary Industry Norm Above the Law— not stopping at "legal," but asking oneself "is this worthy of trust?"

01Where this volume sits — a voluntary norm "above" the law

The Pharmaceutical Affairs Law, the Standards for Fair Advertising, and the Guidelines for Sales Information Provision we have seen are all public regulations set by the state — the "floor," whose breach is unlawful or subject to administrative guidance.

The JPMA Code of Practice taken up here is different in character. It is not law but a voluntary norm the industry association imposes on itself — a promise that goes above the legal floor: "even where the law would not punish us, we will go this far to protect trust." Why does an industry bind itself on top of the law? This volume reads through what that means.

02JPMA and the Code of Practice

The JPMA (Japan Pharmaceutical Manufacturers Association) is the industry body to which Japan's major research-based pharmaceutical companies belong. The code of conduct the JPMA asks of its member companies is the Code of Practice.

Once, a "Promotion Code" covering promotional activity was central; in 2013 this was developed into a comprehensive norm covering not only promotion but interactions with healthcare professionals, patient organizations, and researchers as a whole. Behind this lies alignment with the code of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Pharma is an industry that crosses borders, and Japan's voluntary norm needed to keep step with the international level.

03Public regulation and voluntary norm — two layers

The rules around advertising and information provision can be organized in two layers: public regulation and voluntary norm.

What matters is that "being legal" and "fitting the Code" are different. Conduct that does not touch the law but could damage the industry's trust — excessive entertainment, or relationships that leave conflicts of interest blurred — is covered by the voluntary norm. The industry disciplines, ahead of time, the territory the law has not caught up to.

04What it disciplines — attention to interactions as a whole

The Code of Practice covers not only the wording of materials but the various points of contact through which a pharmaceutical company engages with medicine.

• Promotional materials and information provision — accurate, non-exaggerated information consistent with the Fair Advertising Standards and the Sales-Info Guidelines
• Interactions with healthcare professionals — moderation in entertainment, gifts, and speaker fees, so that a benefit is not seen as consideration for prescribing
• Research and trials — prohibition of promotion disguised as research (sham research)
• Relations with patient organizations — transparency of support and regard for independence
• Transparency — disclosure of funds provided to healthcare professionals and institutions (the Transparency Guideline)

The common aim is the prevention and visualization of conflicts of interest. The relationship between a pharma company and a clinician is always shadowed by the suspicion that "a benefit may be distorting judgment." The Code asks for moderation so the suspicion does not arise, and for transparency that does not hide a relationship once it exists.

05Why a "voluntary" regulation?

With law in place, why does the industry go out of its way to bind itself? Because this industry's trust cannot be protected by compliance with the legal floor alone.

Medicine is a good the patient cannot verify for themselves (Compliance Vol. 2). So the stance "as long as the law is obeyed" quickly erodes trust. Raising the bar across the whole industry with a voluntary norm has another benefit: within a structure where one company's deviation injures the whole industry's trust, a shared rule prevents "unfair competition by cutting corners" and creates an environment in which companies that play straight are not penalized.

06Connection to the field — seeing in layers

For the person who reviews materials or provides information, the JPMA Code is "one more measuring stick." Judgment on the ground needs to be seen in these layers.

• Pharmaceutical Affairs Law (statutory prohibition) → Fair Advertising Standards (operating rule) → Sales-Info Guidelines (the boundary of information provision) → JPMA Code (the industry's voluntary add-on) → each company's own code / SOP (the implementation)

Rather than stopping at "it does not touch the law," one descends to "how does it look against the Code?" and "does it fit our own philosophy?" Corporate philosophy, through policy and SOP, finally bears on the approve/reject decision for a single material — and within that chain the JPMA Code sits.

07Connections to other chapters

The JPMA Code of Practice connects to other chapters of this site as follows.

• Advertising Regulation Vol. 4 (Sales-Info Guidelines) — the boundary between public guideline and voluntary norm, and how the two complement each other
• Compliance Vol. 3 (Corporate Philosophy) — whether a voluntary norm can truly be kept depends on whether the philosophy is real
• Ethics Vol. 5 (Corporate Ethics) — conflicts of interest and transparency, the central themes of the voluntary norm
• Drug Disasters 10 (Opioid Crisis) — the industry side's response to the reality that law alone could not stop runaway promotion