Across 22 cases recorded from 2016 to 2024, promotional representatives consistently prioritized efficacy claims while omitting, minimizing, or actively obstructing the delivery of safety information. The pattern implicates PMD Act Article 68-2, which mandates proactive safety information provision, and the three affirmative duties under MSA Guidelines Principle (3). Recurring justifications — "the physician never asked," "the side effect is transient and minor," or "a confidentiality agreement is required" — reveal a structural assumption that safety data is a liability to manage rather than an obligation to fulfill.
Mio"Case 05-03 — the hypertension drug. The report says adverse events were already on record, yet the representative told the physician there were no safety concerns. Yui, what was the first thing that struck you?"
Yui"The representative had data showing adverse events existed, and still made a blanket denial. There was no basis for saying 'no problem.'"
Mio"Right. Now look at it from the representative's position — they wanted the physician to feel confident prescribing. The issue isn't the motivation. What is it?"
Yui"The claim has no evidence to support it. If adverse events exist, you cannot assert categorically that there are no concerns."
Mio"Precisely. Under PMD Act Article 68-2, the obligation to provide safety information is proactive — not reactive. Staying silent about known adverse events is itself a violation. Now look at 05-07: an oncology case where the representative required a confidentiality agreement before providing stability data. How do you read that?"
Yui"It looks like compliance on the surface — they offered to provide information — but they attached a condition that blocks access. That's obstructing the very obligation they're supposed to fulfill."
Mio"Reviewers who caught that were correct. MSA Guidelines Principle (3) requires affirmative provision. Erecting a contractual barrier negates any claim of proactive disclosure. — Case 05-11, the analgesic: side effects at high doses were described as 'transient.' What's the problem there?"
Yui"If the package insert says 'transient,' it might be defensible. But if the representative made that characterization without a documented basis, it's an unsupported minimization of risk."
Mio"The report flags exactly that — the evidentiary basis wasn't traceable in the materials. In document review, even a potentially correct statement requires a verifiable source. Our job is to ask: where is the basis? — One more: 05-19, the diabetes drug. A risk listed under 'important potential risks' in the RMP was reframed in efficacy terms when a physician asked about it. What does that look like in practice?"
Yui"The representative knew the RMP content, but when the question came up, redirected the answer toward efficacy rather than addressing the safety signal directly."
Mio"And that's the hardest pattern to catch — and the most serious. The representative had the knowledge. They chose how to use it. As reviewers, we're not asking whether the rep knew. We're asking what they did with what they knew."
22 real cases from the reports
05-01FY2016骨粗鬆症治療薬MR によるプレゼンテーション（口頭説明）
What happenedAn MR from Company M explained at a study session that serum calcium monitoring was not required, while at another institution a separate MR stated that absence of acute-phase adverse events meant no chronic-phase adverse effects would occur. Oral explanations inconsistent with the package insert's precautions were confirmed at multiple sites.
MHLW viewUnderstanding of adverse effects and safety was insufficient, and information provision on these matters was inadequate.
Competency lostKnowledge (accurate understanding of safety information), Communication (faithful conveyance of package insert precautions)
Next moveExplicitly include package insert precautions and RMP adverse event information in study session materials, and establish an in-hospital pathway for correcting MR misunderstandings via the drug information (DI) department.
05-02FY2016乾癬治療剤製品情報概要
What happenedDespite a contraindication in pregnant women due to embryo-fetal toxicity and an eight-item pre-dose checklist, Company N's product information summary stated that pre-dose screening and laboratory testing were not required, directly contradicting the established safety procedures.
MHLW viewPromotional activities were conducted that downplayed safety in a manner inconsistent with the contraindications and pre-administration screening requirements.
Competency lostRisk detection (verifying consistency between promotional materials and the package insert), Knowledge (understanding of contraindications and pre-dose requirements)
Next moveCross-check the safety statements in the product information summary against the package insert and appropriate use guide, identify contradictions, and request written correction from the manufacturer.
05-03FY2016高血圧治療薬MR による口頭説明
What happenedWhen promoting an unadopted antihypertensive, an MR from Company O stated that there were 'absolutely no safety concerns,' despite adverse events being clearly listed in the package insert and risk management plan (RMP). No safety information was provided.
MHLW viewPromotional activities were conducted that downplayed adverse effects and safety. [Re-cited case: the MR promoted the drug's position in treatment guidelines — a fact unrelated to therapeutic superiority — while providing no information whatsoever on safety.]
Competency lostKnowledge (understanding of adverse events documented in RMP and package insert), Communication (balanced provision of safety information)
Next moveObtain written documentation from the MR specifying the important identified and potential risks listed in the RMP, and verify consistency with the oral explanation provided.
05-04FY2017抗ウイルス薬MR によるプレゼンテーション（口頭説明）
What happenedAt a product presentation for an antiviral, an MR from Company X gave an explanation that could be interpreted as 'safe to use' regarding a functional impairment listed as an important potential risk in the RMP. When a healthcare professional raised concerns about combination therapy risks, the MR continued with safety-minimizing explanations, unaware of the RMP content.
MHLW viewUnderstanding of adverse effects and safety was insufficient, and information provision on these matters was inadequate.
Competency lostKnowledge (accurate understanding and application of RMP content), Risk detection (awareness of the obligation to communicate potential risks to clinical settings)
Next moveDocument RMP important potential risk items as mandatory topics for product presentations and request that the company report healthcare professionals' post-session concerns to internal safety departments.
05-05FY2017潰瘍性大腸炎治療薬MR によるプレゼンテーション（口頭説明・スライド・パンフレット）
What happenedAn MR from Company Y stated that adverse event rates were approximately 10% at a product session, while the package insert documented adverse events in approximately 55% of patients. Although a footnote in the brochure explained why a primary adverse event was excluded from the Phase III trial analysis, the MR did not proactively disclose this, nor did the MR address important potential risks listed in the RMP.
MHLW viewOnly information that underestimates the incidence of adverse effects was provided.
Competency lostKnowledge (accurate understanding of trial design limitations and package insert adverse event frequencies), Communication (proactive and balanced disclosure of adverse event information)
Next moveRequest written clarification from the MR on the discrepancy between package insert adverse event rates and those excluded from Phase III analysis, and review whether promotional materials adequately explain that difference.
05-06FY2017鎮痛剤MR による口頭説明
What happenedAn MR from Company Z described the analgesic as 'easy to use even in patients with reduced function,' while the package insert classified those patients as requiring caution and noted higher than normal blood concentrations. Without naming a comparator, the MR emphasized only ease of use, creating a misleading impression about safety.
MHLW viewThe safety profile for patients requiring special care was presented in an exaggerated manner.
Competency lostCommunication (avoiding misleading explanations that omit comparison context), Risk detection (ensuring safety information reaches healthcare professionals for patients requiring caution)
Next moveObtain written documentation from the MR covering the package insert's precautions and pharmacokinetic data for the patient population in question, and clarify the recommended monitoring protocol.
05-07FY2017抗がん剤MR による情報提供
What happenedBecause Company AA's anticancer agent contains no preservative, diluted solutions must be administered within 15 hours; however, the re-infusion protocol following infusion reactions makes exceeding that limit a realistic clinical scenario. When the institution requested stability data, the company responded that the data was confidential and could not be provided without a non-disclosure agreement, leaving clinically necessary information inaccessible.
MHLW viewClinically necessary information must be provided to healthcare professionals.
Competency lostCommunication (ensuring timely access to clinically necessary safety data), Relationship building (avoiding information access restrictions that undermine trust with healthcare institutions)
Next moveDocument clinical scenarios in which the 15-hour limit is difficult to observe, and formally request that Company AA improve its process for providing stability data, including simplification of any non-disclosure agreement requirements.
05-08FY2017C 型肝炎治療薬MR による情報提供
What happenedWhen a healthcare institution requested the appropriate use guide for a hepatitis C treatment, an MR from Company BB required submission of a consent form. Although the company's website referenced the guide, it was not available on the download page, effectively restricting healthcare professionals' access to it.
MHLW viewClinically necessary information must be provided to healthcare professionals. [(2) Examples of inappropriate promotional activities: Based on suspected-case reports obtained through this project and the FY2016 project, as well as outcomes of case review meetings, the following summarizes the main behaviors identified as inappropriate in pharmaceutical company promotional activities. (1) Oral explanations by MRs (Explanations implying unapproved indications or dosage regimens) — Introducing overseas indications: e.g., 'The indication in Japan is limited, but ** is approved as an indication overseas.' — Suggesting future expansion of indications: e.g., 'It is likely that ** will also be approved as an indication in Japan in the future.' — Presenting adverse effects as if they were indications: e.g., '(Regarding a drug whose adverse effect is an excess of component **) An increase in ** can be expected.' — Introducing dosage regimens unlikely to be rejected in medical fee claims review: e.g., 'Although off-label, if used in the manner of **, it will not be rejected in claims review.' (Explanations that exaggerate efficacy, safety, etc.) — Citing the reputation of other medical institutions or the views of the marketing authorization holder without scientific evidence, in a hearsay manner: e.g., 'The drug has a reputation at other hospitals for **,' 'It is said at the marketing authorization holder that **.' — Presenting characteristics of other drugs as characteristics of this drug: e.g., 'Our company manufactures drugs that are **, so this product is also **.' — Claiming superiority on the basis of facts unrelated to the product: e.g., 'The drug appears earlier in the guideline than comparators,' 'Differences in dissolution between authorized generics and generic drugs affect efficacy.' — Claiming superiority based on data or facts that do not correspond on a one-to-one basis with the comparator: e.g., '(Showing data from a comparator with the same active ingredient but different dosage form) There is superiority over a comparator with the same active ingredient and the same dosage form,' '(Regarding the fact that non-inferiority was demonstrated only against existing drug A in the active phase and only against existing drug B in the remission phase) Non-inferiority compared to existing drugs has been confirmed in both the active and remission phases.' — Failure to provide information on the content of the Risk Management Plan (RMP) and adverse effects. (2) Promotional materials (Materials using data of questionable reliability) — Introducing data other than data from regulatory approval submissions or peer-reviewed publications. — Claiming superiority based on data with a small number of cases: e.g., data from one medical institution that has adopted the drug, data with only 9 cases. — Introducing non-clinical data with no relevance to clinical data. — Introducing only clinical trial results that most prominently demonstrate superiority. — Failing to describe statistical methods or the results of statistical analyses. — Introducing data on unapproved dosage regimens or indications. (Materials using modified figures or tables from cited references) — Adjusting the maximum value of an axis or changing the scale of an axis to emphasize differences. — Adding supplementary lines, arrows, or coloring to emphasize differences. — Extracting only the favorable portion of figures or tables from cited references: e.g., extracting only the company's own product from a comparison between a comparator and the company's product; extracting only the single time point showing the greatest difference from a comparison at three time points; extracting only the data for the comparator that most clearly shows superiority or that fits the argument from a comparison with multiple comparators. — Adding data not present in the cited reference: e.g., the cited reference contained only data for the company's product group and the placebo group, but data on the between-group difference was newly added to emphasize the difference. — Changing the order in which data from cited references are presented: e.g., in a bar graph showing multiple data sets, repositioning data that makes the efficacy appear exaggerated or data showing secondary effects to a more prominent position. — Modifying data based on supplementary information in cited references: e.g., the cited reference presented data combining the blinded and open-label periods (with supplementary notes on the open-label period), but this was changed to data from the blinded period only, in a way that magnifies the difference. (Materials using compositions or expressions likely to cause factual misunderstanding) — Explaining content that differs from the stated purpose of a product presentation meeting: e.g., mixing in data on 'the conventional indication' at a meeting on an additional indication; recommending a drug that is not the subject of the product presentation meeting. — Failing to clearly distinguish information that should be clearly differentiated (data subject to regulatory approval review versus data not subject to review, primary endpoints versus secondary endpoints, reference information, etc.), or treating such information in parallel. — Using headings or titles that exaggerate data: e.g., using the heading 'shows a trend like **' for content that cannot be implied by the data. — Failing to disclose conflicts of interest.]
Competency lostCommunication (barrier-free provision of information necessary for appropriate use), Trust density (erosion of trust through unnecessary procedural requirements for information access)
Next moveFormally notify the company of the access barrier to the appropriate use guide and request in writing that the document be made available without a consent form, such as by direct posting on the company website.
05-09FY2018糖尿病治療薬医療関係者向け情報サイト上の座談会記事
What happenedA symposium article on a diabetes combination product, published on a healthcare professional information site, omitted the package insert's warnings on renal impairment and downplayed the important RMP risk of polyuria and pollakiuria by stating symptoms would resolve within one week of starting treatment.
MHLW viewImportant precautions described in the package insert and RMP were disregarded, and appropriate information provision was neglected.
Competency lostRisk detection (verifying online materials against RMP and package insert), Knowledge (understanding of safety risks related to each component of the combination product)
Next moveCompare the symposium article against the RMP and package insert, then formally notify the company in writing that the renal impairment warning and polyuria/pollakiuria risk information are missing and request correction.
05-10FY2018慢性便秘症治療薬企業担当者による口頭説明
What happenedAt a study session for a newly approved chronic constipation treatment, a company representative suggested that long-term use was possible with dose adjustment, contravening prescription day restrictions, and encouraged recommending the drug for pediatric use. No explanation was given regarding the usage restriction requiring prior treatment failure before prescribing this agent.
MHLW viewA method of use contrary to the prescription-day restrictions for a new drug was promoted, and a biased explanation regarding safety was provided.
Competency lostKnowledge (accurate understanding of new drug prescription day limits and usage conditions), Communication (balanced information provision inclusive of usage restrictions)
Next moveConfirm the prescription day limit and the 'only after insufficient response to other treatments' condition with the drug information department, document the company representative's statements, and advise the prescribing physician on the correct usage requirements.
05-11FY2018鎮痛薬医療関係者向け情報サイト上の製品紹介動画
What happenedA product introduction video on a healthcare professional site described ALT elevations associated with high-dose analgesic use as 'transient and tolerance-inducing.' The original research paper documented marked ALT elevations with multiple treatment discontinuations, and the package insert carried a warning for high-dose use; the authority concluded that the video minimized a safety concern.
MHLW viewAn adverse effect requiring sufficient caution was described as 'transient,' thereby downplaying safety.
Competency lostRisk detection (verifying video content against source literature and package insert), Knowledge (understanding limitations of biomarker interpretation and accuracy of high-dose warnings)
Next moveObtain the source paper cited in the video, verify the details of discontinuation cases, and formally notify the company in writing of the discrepancy between the package insert's high-dose warning and the video's description, requesting correction.
05-12FY2018抗がん剤企業担当者による口頭説明
What happenedFor an anticancer drug subject to an optimal use promotion guideline, a company representative provided efficacy information only on two separate occasions without providing any safety information.
MHLW viewInformation on safety was neglected on two separate occasions.
Competency lostCommunication (balanced provision of both efficacy and safety information), Behavioral influence (thorough information provision that supports compliance with optimal use guidelines)
Next moveDocument the absence of safety information after the second presentation, specify the safety requirements of the optimal use promotion guideline, and formally request in writing that the company correct its information provision.
05-13FY2018緑内障・高眼圧症治療薬企業担当者による口頭説明
What happenedDuring a new drug hearing, a company representative told healthcare professionals that one dispensed bottle would last one month, effectively advising a usage pattern that circumvents the 14-day prescription limit applicable to new drugs.
MHLW viewThe company representative promoted a method of use that contravenes the 14-day prescription restriction applicable to new drugs.
Competency lostKnowledge (accurate understanding of approval conditions and prescription day limits), Risk detection (sensitivity to patient safety risks arising from advising non-compliant usage)
Next moveDocument the statement and promptly escalate to the pharmacovigilance/compliance team as a case of recommending usage that violates the prescription day limit for new drugs.
05-14FY2022糖尿病治療薬企業担当者による説明（オンライン）
What happenedAt an online briefing on a diabetes drug, a company representative showed a graph of the company's product only while verbally implying a favorable comparison with other agents, and emphasized low lactic acidosis risk despite the drug's RMP listing lactic acidosis as an important potential risk, without providing corresponding safety information.
MHLW viewDespite lactic acidosis being listed as an important potential risk in the Risk Management Plan (RMP), the information provided emphasized only the low risk without also providing safety-related information. Note that presenting animal study results in itself is not problematic.
Competency lostKnowledge (understanding of RMP-designated important potential risks and the obligation to provide safety information), Risk detection (sensitivity to the risk of misleading healthcare professionals through one-sided efficacy emphasis)
Next moveReview the briefing record and slides used, document that safety information corresponding to the RMP-designated important potential risk was not provided, and request the company to deliver appropriate corrective information.
05-15FY2022先天性代謝異常症治療薬企業担当者による説明（直接対面）
What happenedWhen explaining a revision to the package insert of a drug for congenital metabolic disorders, a company representative stated that the upper limit for infusion rate had been removed, but omitted to mention that the revised prescribing information still requires the initial infusion rate to not exceed 0.25 mg/min due to the risk of infusion reactions.
MHLW viewProviding information without accompanying peripheral safety information risked causing misunderstanding and was therefore inappropriate.
Competency lostKnowledge (accurate grasp of the revised package insert in its entirety, including remaining precautions), Communication (awareness that selective information presentation can generate misunderstanding)
Next moveReview the full revised package insert and request the company representative to provide a supplementary explanation covering the remaining infusion rate precautions at the next visit.
05-16FY2022その他の循環器官用薬企業担当者による説明（オンライン）
What happenedDuring a hospital formulary committee hearing for a cardiovascular drug, the company representative did not voluntarily disclose the package insert statement that the effect of suppressing progression to renal failure may be weaker in Japanese patients, and only presented this information on a separate slide after a direct question from a healthcare professional.
MHLW viewAlthough the hospital had secured sufficient time for the explanation, this was a case in which it is suspected that the company representative deliberately withheld negative information. The MSA Guidelines (Promotional Activity Guidelines) require that information about failure to demonstrate superiority must also be properly communicated.
Competency lostRisk detection (sensitivity to the obligation to proactively disclose negative data), Behavior change facilitation (recognition that withholding unfavorable information erodes trust)
Next moveConfirm with the company representative the obligation under the promotional activity guidelines to proactively disclose Japanese subgroup data, and request that such information be presented from the outset at future hearings.
05-17FY2023糖尿病治療薬企業担当者による説明（直接対面）
What happenedDuring a hearing on a diabetes drug, a company representative used slides labeled 'reference information' to explain lipid-related effects as efficacy, whereas the review report classified lipid effects as safety information, making the explanation an out-of-approval claim.
MHLW viewInformation that should have been provided as safety information was instead explained from an efficacy standpoint, constituting information provision that disregarded safety. Furthermore, when the term 'efficacy evaluation endpoint' is used in promotional materials or product information summaries, it is advisable to include an explanation of what an 'efficacy evaluation endpoint' actually is, so as not to cause misunderstanding among healthcare professionals.
Competency lostKnowledge (accurate understanding of the efficacy/safety distinction in the review report and approved labeling), Risk detection (sensitivity to the risk of misleading healthcare professionals through out-of-approval claims)
Next moveCross-check the 'reference information' content on the slides against the package insert and review report to determine whether it constitutes an out-of-approval efficacy claim, and if so, request the company to discontinue use of the material and revise it.
05-18FY2023高カリウム血症改善剤企業担当者による説明（直接対面）
What happenedAn MR for a hyperkalemia treatment highlighted the drug's potassium-lowering effect to a physician by comparing it favorably with a competitor's product, but made no mention of the potassium monitoring required for safe use of this drug.
MHLW viewIt is necessary to provide not only information concerning efficacy but also information concerning safety.
Competency lostKnowledge (awareness of monitoring requirements essential for safe use), Risk detection (sensitivity to the patient safety risk arising from omitting monitoring instructions)
Next moveDocument that the MR omitted mandatory safety information on potassium monitoring, and request the company's medical information department to follow up with a complete safety briefing.
05-19FY2023糖尿病治療薬企業担当者による説明（直接対面）
What happenedDuring an explanation of a diabetes drug, in response to a question about the multiple dosage strengths available, a company representative mentioned that higher-dose formulations are used for obesity treatment abroad and voluntarily stated that an indication for obesity had been filed in Japan, where it remains unapproved.
MHLW viewThis product is one of those for which off-label use as an anti-obesity agent has become a concern; accordingly, explanations regarding indications and adverse reactions (weight loss) are required to be provided with particular care. 'Safety related to weight loss' has been designated as an important potential risk and should be communicated appropriately as safety information rather than as a benefit alongside the antihypertensive effect.
Competency lostKnowledge (understanding of restrictions on information about unapproved indications and the safety risks associated with weight loss), Risk detection (sensitivity to the risk that information implying off-label use can mislead healthcare professionals)
Next moveDocument that reference was made to an unapproved indication, and report to the company's compliance department that safety information on weight loss listed as an important potential risk in the RMP was also not properly communicated.
05-20FY2023抗ウイルス剤電子メールによる DM
What happenedA mass email promoting an antiviral agent selectively cited a medical society guideline table to show competitor drug interactions while omitting most of the company's own product interactions, and described the drug as providing consistent cure across patients with various backgrounds without disclosing the contraindication for patients with eGFR below 30.
MHLW viewThe information provided gave an impression that the adverse reactions of the company's own product were fewer than those of competitor products, and the expression 'patients with diverse backgrounds' was used; overall, the information provision disregarded safety-related information, including contraindications.
Competency lostKnowledge (understanding of the obligation to disclose safety information including contraindications, and the requirement for fair citation of guidelines), Risk detection (sensitivity to the risk of misleading healthcare professionals through selective citation and omission of contraindications)
Next movePreserve the email as evidence, document the omission of the contraindication and the selective use of the interaction table as issues of misleading promotion and safety underrepresentation, request the company to halt distribution and issue corrective communication, and consider reporting to the regulatory authority as appropriate.
05-21FY2024代謝性医薬品企業担当者による説明（直接対面）
What happenedWhen informing healthcare professionals of a relaxed pediatric dosing limit for a metabolic drug, an MR communicated only that 30 mg could now be administered and provided no rationale or safety information for the dose increase. When asked for supporting data and safety details, the MR said an immediate answer was not possible, and two weeks later returned only to hand over an interview form with a sticky note marking the relevant section.
MHLW viewWhen communicating that dosing restrictions have been relaxed, it is required to provide safety information in conjunction with that disclosure.
Competency lostKnowledge (awareness of safety information and revised adverse reaction data accompanying the dosage change), Communication (ability to structure an explanation that pairs the dose increase rationale with corresponding safety information)
Next moveObtain in writing from the company's medical information department the data supporting the dosing limit relaxation and the revised adverse reaction information, and document that both were delivered to healthcare professionals together.
05-22FY2024循環器官用薬企業担当者による説明（直接対面）
What happenedAt a product briefing for a cardiovascular drug, an MR spent approximately 20 minutes presenting only the risk reduction results for cardiovascular and renal composite endpoints in the overall population of an international trial, with no mention of the critical safety caveat—reflected in the package insert and integral to the drug's approval history—that the hazard ratio for renal failure events in the Japanese subgroup exceeded 1.
MHLW viewIt is necessary to provide not only information concerning efficacy but also information concerning safety.
Competency lostKnowledge (awareness of Japanese subgroup data relevant to the approval history and the package insert warning), Risk detection (sensitivity to the risk of biased information provision when only positive data are presented)
Next moveMaintain a record of the briefing, confirm that the package insert warning regarding the Japanese subgroup was not communicated, and request the company to conduct a supplementary explanation covering that information.
The Anatomy of Failure ── All 8 categories
- 01. Promotion of Unapproved or Off-Label Indications and Dosage (33 cases)
- 02. Claims Lacking Evidence or Scientific Basis (69 cases)
- 03. Cherry-Picking, Data Manipulation, and Selective Presentation (33 cases)
- 04. Exaggerated and Misleading Expressions (28 cases)
- 05. Emphasizing Efficacy While Downplaying Safety (22 cases) (this category)
- 06. Disparagement and Defamation of Competitors' Products (28 cases)
- 07. Undisclosed Conflicts of Interest and Improper Conduct in Lectures and Prescribing Guidance (10 cases)
- 08. Cross-Category Violations Rooted in Process Failures (4 cases)
Key points
- Failure to provide safety information violates the proactive duty under PMD Act Article 68-2; 'the physician never asked' is not a valid defense.
- Imposing procedural barriers — confidentiality agreements or consent forms — to restrict access to safety materials constitutes a substantive obstruction of the information provision obligation.
- Reframing RMP- or package insert-listed safety signals in efficacy terms is treated as deliberate minimization: the representative demonstrably had the knowledge and chose not to convey it accurately.
Sources
- MHLW, "Monitoring Project on Promotional Information for Prescription Drugs — Annual Reports" (FY2016–2024).
- PMD Act, Article 68-2 (Obligation to provide information on pharmaceuticals, etc.)
- MSA Guidelines, Part 1-3, Principle (1): Four requirements including accuracy, fairness, and dignity
- MSA Guidelines, Part 1-3, Principle (3): Three affirmative duties, including proactive safety information disclosure