The word "negotiation" often carries the associations of "winning and losing." But what happens daily between the reviewer and the requester or originating client is not contest but agreement-building. And the confidence in agreement-building functions not as the force that makes the other submit but as the force that sustains parity of dialogue across the difference of position. This volume reconstructs this "confidence as negotiating advantage" from both contemporary negotiation research and the classical art of war. The principled negotiation and BATNA of the Harvard Negotiation Project (Fisher & Ury 1981), Voss's (2016) tactical school, Galinsky et al.'s research on perspective-taking (2008), Tversky & Kahneman's (1981) anchoring and framing, and Sun Tzu's wisdom of "not fighting" — five traditions have pointed, in different words, to the same place: "advantage is born not from force but from parity." In the context of regulatory review, to this is added an ethic specific to the regulated industry.

01The Relation of Confidence and Negotiation — Not Force but Parity

The role of confidence in negotiation theory is often misunderstood. "The confident person wins"; "the bold close the deal" — popular rhetoric speaks this way, but half a century of empirical research does not support it. True negotiating advantage is born not from the strength that overwhelms the other but from the steadiness that sustains parity of dialogue across the difference of position.

In the reviewer's field this is especially important. The reviewer holds, vis-à-vis the requester, the formal authority of judging regulatory conformity; the requester holds commercial and time pressure. Position is not equal, but dialogue must be equal. Confidence is needed to sustain that tension. Not pressure that rides on authority, but the steadiness that sustains an equal dialogue — this is the confidence of this volume.

The five traditions of this volume can be organised as follows.

Tradition 1

Principled negotiation (Fisher & Ury)

Not the exchange of positions but the pursuit of interest. Make agreement by objective criteria.

Tradition 2

BATNA (Fisher & Ury)

Best Alternative To a Negotiated Agreement. This becomes the psychological foundation of negotiating power.

Tradition 3

The tactical school (Voss)

Loosen confrontation with empathy and tactical language. The technique that does not fear "No."

Tradition 4

Perspective Taking (Galinsky)

Empirical evidence that standing in the other's perspective works better in negotiation than empathy.

Tradition 5

Not fighting (Sun Tzu)

Reaching agreement without fighting is the highest negotiation. The pre-emptive wisdom of composing position and frame.

02The Harvard Negotiation Project — Principled Negotiation

The shape of contemporary negotiation theory was set by Roger Fisher (1922–2012) and William Ury's (1953–) Getting to Yes, published in 1981. It is the decisive postwar work of negotiation research, bringing together in one volume the accumulated work of the Harvard Negotiation Project of Harvard Law School.

"Negotiation in which one takes a position hardens the parties and damages the relationship. Instead, focus on the interest behind the position. When interests are shared, creative options that satisfy both come into view. (1) Separate the people from the problem. (2) Focus on interests, not positions. (3) Invent options for mutual gain. (4) Insist on using objective criteria — these are the four pillars of principled negotiation." — paraphrase of Fisher & Ury, Getting to Yes (1981)

The horizon Fisher & Ury opened is the turn of thought to inventing an agreement that satisfies both, rather than winning or losing. This carries directly into the regulatory-review context. The requester takes the position "I want this expression in"; if one replies in the opposed position, "It violates the regulation, remove it," the relationship erodes. What principled negotiation shows is pursuing the interest, "why does that expression need to be there?" — is it the clarification of the appeal point, differentiation from competitors, reach to a specific clinical population? When the interest is seen, alternative expressions that conform to the regulation can be invented.

03BATNA — The Psychological Foundation of Negotiating Power

Alongside principled negotiation, what Fisher & Ury popularised is the concept of BATNA (Best Alternative To a Negotiated Agreement). This refers to clearly possessing the option of "what will I do if this negotiation breaks down?"

"Negotiating power is born not from strength or volume of voice but from the quality of the BATNA. The one who holds the option that 'I am not in trouble even if this negotiation breaks down' need not accept an unfavourable agreement. So they can decline unreasonable demands. What BATNA gives the negotiator is psychological stability — that is, genuine confidence." — paraphrase of Fisher & Ury, Getting to Yes (1981)

BATNA psychologically shows the very structure of confidence. Genuine confidence is born from options that do not depend on the other. This resonates with Bandura's self-efficacy and Seligman's sense of control from Vol. 8. The reviewer's BATNA is, for example, the recognition: "if we cannot agree on this proposal, I have the options of escalating to a higher judgement, presenting an alternative expression on the basis of public materials, proposing postponement in light of regulatory revision trends." The one who has options is not forced into concession.

BATNA has another implication. Estimating the other's BATNA. What is the requester's best alternative to this negotiation? Is the deadline truly fixed; are alternatives truly absent? If the other's BATNA is weak, one's position is strong. If the other's BATNA is strong, one must prepare to concede. This is not intimidation but the work of grasping reality.

04Voss's Tactical School — Tactical Empathy

Entering the twenty-first century, a powerful negotiation theory appeared from a lineage different from the Harvard school. Chris Voss (1957–), former FBI hostage negotiator, in Never Split the Difference (2016), drew from the field experience of hundreds of hostage negotiations a method emphasising tactics that diverges from Fisher & Ury.

"Do not deny the negotiation partner's emotion; label it — put it into words: 'It seems you are growing frustrated because the point of agreement is no longer visible.' This alone loosens the other's emotion. Tactical empathy is not affirming the other's emotion but accurately naming its existence and sharing the recognition." — paraphrase of Chris Voss, Never Split the Difference (2016)

Voss's method has stronger practical utility in scenes of confrontation than Fisher & Ury. The techniques he sets out are concrete — (1) mirroring (repeat the last three words of the other in interrogative form), (2) labelling (put the other's emotion into words), (3) calibrated questions (open questions using "how"), (4) drawing out the "No" (let the other safely refuse, deepening the relationship).

Voss and Fisher & Ury are not in opposition. Principled negotiation handles the strategy of "what to agree on"; Voss's tactical school handles the tactics of "how to converse" — two contributions at different levels. The ideal for the reviewer is to hold both. In a scene where the requester hardens position, Voss's tactical empathy loosens the impasse. Once principle is set, deliver it to Fisher & Ury's agreement-building.

05Perspective Taking — Galinsky's Research

In 2008, the Northwestern University professor Adam Galinsky (1969–) and colleagues published an important empirical paper in Psychological Science: "Why It Pays to Get Inside the Head of Your Opponent" — research comparing the effects of perspective taking and empathy in negotiation.

"In negotiation experiments, the group of subjects who tried to share the other's emotion (empathy condition) and the group who tried to understand the other's perspective and intention (perspective taking condition) were compared. The Perspective Taking group reached, more often, agreements that satisfied both. To see the world through the other's eyes works better in negotiation than to assimilate to the other's emotion." — paraphrase of Galinsky, Maddux, Gilin & White, Psychological Science (2008)

The implication of this discovery is deep. Empathy makes the warmth of interpersonal relations, but negotiating advantage is something else. The one who can coolly estimate the other's position, interest, constraints, and schedule is the one who can invent the agreement satisfying both. Galinsky's research can also be said to have given empirical backing to Fisher & Ury's principled negotiation.

The implication for the reviewer. One need not assimilate to the requester's emotion (assimilation in fact distorts judgement). But the work of coolly estimating the requester's perspective, intention, and constraints creates negotiating advantage. "Through whose eyes is this requester looking? What are they trying to achieve? Within what deadline? Facing what constraints?" — the questions of perspective taking change the quality of negotiation.

06Sun Tzu's "Not Fighting" — Winning Without Fighting

From the Eastern lineage, the most systematic classical philosophy of negotiation. The Chinese book of war from the Spring and Autumn / Warring States period, Sun Tzu (Sun Wu, c. 5th century BCE), is at the same time a book of negotiation and diplomacy. Its most famous proposition runs:

"Therefore, to win a hundred battles in a hundred encounters is not the best of the best; to subdue another's troops without fighting is the best of the best. Therefore, the highest warfare attacks the strategy; the next, attacks the alliances; the next, attacks the troops; the lowest, attacks the citadel." — Sun Tzu, The Art of War, "Plotting the Attack"

The core of Sun Tzu is the observation that reaching one's end without fighting is higher than winning by fighting. The best war reads the other's plan in advance and prevents fighting (attacks the strategy). Next, diplomacy breaks the other's alliances (attacks the alliances). Actual fighting (attacks the troops) is the middle means; siege (the most costly) is the lowest.

The implication reaches the reviewer's field. Before forcing agreement, re-arrange the structure of confrontation. In a scene where positions are opposed, do not immediately enter the back-and-forth; place perspective taking (Galinsky) and the pursuit of interest (Fisher & Ury) first. In many cases, opposition of positions arises from misunderstanding and lack of information. Merely by sharing information and organising interests, confrontation can disappear — this is the contemporary version of Sun Tzu's "attacking the strategy."

07Anchoring and Framing — Tversky / Kahneman

The cognitive psychology of negotiation was deepened most by the Nobel-laureate economist Daniel Kahneman (1934–2024) and his collaborator Amos Tversky (1937–1996). The 1981 paper in Science, "The framing of decisions and the psychology of choice," is the starting point of contemporary behavioural economics.

"For the same option, depending on whether it is framed as gain or as loss, people's judgement changes dramatically. People feel loss more heavily than gain (loss aversion). Also, the figure presented first becomes the reference point of judgement (anchor) and distorts later judgement (anchoring effect). The rational economic person does not exist." — paraphrase of Tversky & Kahneman, Science (1981)

Anchoring in negotiation is a tactic widely deployed in contemporary theory. The figure, criterion, or deadline presented first binds the rest of the negotiation. This works in both directions for requester and reviewer. If the requester frames first, "we want this passed by Friday," that frame dominates the discussion. Conversely, if the reviewer calmly frames, "regulatory conformity is evaluated by the transparency of the judgement logic," the discussion converges around criteria and conformity.

The implication is clear. The framing of negotiation is set in the first utterance. This is at once a technique and a demand for ethics. Anchoring is powerful, and overused approaches the territory of manipulation. What is required of the reviewer is to frame with honest information and clear criteria. The proper use of anchoring is to place not distortion but the objective criterion (the fourth pillar of Fisher & Ury) first.

08The Ethics of Pharmaceutical Negotiation — Between Position and Parity

The "ethical" problem treated consistently through this series becomes most vivid in this volume. Between the reviewer and the requester are three asymmetries.

Asymmetry 1

Formal authority

Judgement of regulatory conformity is the reviewer's authority. This authority lies clearly on the reviewer's side.

Asymmetry 2

Commercial pressure

Commercial pressures such as deadlines, budgets, and sales targets weigh on the requester's side. The reviewer's judgement directly affects the requester's results.

Asymmetry 3

Specialised knowledge

For the interpretation of regulation and industry standards, the reviewer is the specialist. Clinical knowledge and disease-area expertise may be skewed to Medical or the requester side.

Within these asymmetries, so that negotiation does not fall into an exchange of force, a specific ethic is required of the reviewer. Avoid pressure behind authority. At the same time, do not yield to commercial pressure. Both are necessary. The former violates the requester's dignity; the latter violates the independence of regulatory work. Together as a pair they make the shape of the confident reviewer.

Four concrete ethical rules. (1) Keep the basis of judgement always transparent — speak by regulation and criterion, not by subjective preference (Fisher & Ury's objective criteria). (2) Do not bring emotional reaction into judgement — avoid being harsh with unpleasant requesters and lenient with pleasant ones. (3) Sustain an equal dialogue precisely because positions differ — do not translate the gap of authority into the inequality of dialogue. (4) Be clear about the BATNA — coolly grasp both what happens if you refuse and what happens if the requester refuses.

09In the Pharmaceutical Workplace — Scenes of the Reviewer's Negotiation

Let us bring the abstract down to the field. Concrete scenes in the reviewer's daily work in which the techniques of negotiation are tested.

Scene 1

"We want to keep this expression" strongly asserted (Voss-like labelling)

"It seems you feel that if this expression is deleted, the appeal point disappears" — label the other's emotion. This alone reduces the temperature of confrontation. Then pursue the interest (why is the appeal needed).

Scene 2

Pressure with deadline as shield (cool recognition of BATNA)

The pressure "we must pass it by Friday." Lay out coolly your BATNA (the regulatory judgement cannot be compromised) and the other's BATNA (refiling with an alternative expression, staged release). Do not let pressure become the ground for concession.

Scene 3

Framing at first presentation (anchoring)

When delivering a correction, make explicit first "the logic of regulatory conformity judgement." This becomes the anchor, and the discussion converges on the talk of criterion and conformity. Changing the frame later is hard.

Scene 4

With a hard-line requester (Sun Tzu's "not fighting")

Do not enter the head-on back-and-forth; coolly estimate the other's constraints and intent through perspective taking (Galinsky). If a common interest is found, the confrontation itself may disappear.

10Five Practices of Confidence in Negotiation

To bring the same place to which the five traditions pointed down into daily practice, five practices are set here.

Practice 1

Always clear about BATNA (Fisher & Ury)

Organise "what will I do if this negotiation breaks down?" before entering. Grasp coolly your BATNA and the other's. This is the psychological foundation of genuine confidence.

Practice 2

Pursue interest, not position (Fisher & Ury)

When the requester asserts a position, ask "why is that needed?" When interests are seen, an alternative option satisfying both can be invented. Avoid the exchange of positions.

Practice 3

Label the other's emotion (Voss)

Do not deny the other's emotion; put it into words and share recognition. The one line "it seems you feel ..." lowers the temperature of confrontation. Not empathy, but the sharing of recognition.

Practice 4

Take the perspective — not the emotion (Galinsky)

Do not assimilate to the other's emotion; coolly estimate the other's perspective, interest, and constraints. This makes negotiating advantage. Perspective taking over empathy.

Practice 5

Frame by objective criteria (Tversky / Kahneman, Fisher & Ury)

Frame the discussion not by subjective preference but by regulation, criterion, and transparent logic. Use anchoring honestly. The first utterance decides the whole discussion.

In Closing

Confidence as negotiating advantage is born not from force but from parity — five traditions have pointed, in different words, to the same place. Fisher & Ury's principled negotiation and BATNA, Voss's tactical empathy, Galinsky's perspective taking, Tversky/Kahneman's anchoring and framing, Sun Tzu's wisdom of not fighting. Each position differs subtly, but at the root is the same proposition: "Negotiating advantage is born not from the strength that subdues the other but from the steadiness that sustains parity of dialogue across the difference of position."

In the reviewer's context, an industry-specific ethic is added. Avoid pressure behind authority; do not yield to commercial pressure — both restraints support genuine confidence. The final volume of this series (Vol. 10) integrates everything treated so far and discusses the practice of cultivating confidence not as a one-off but as something lasting.

Key Points — Three to Take Away
  1. True negotiating power is born not from the volume of voice but from the quality of the BATNA (Best Alternative To a Negotiated Agreement) — the core of Fisher & Ury. To grasp coolly your own and the other's BATNA is the psychological foundation of confidence that cannot be forced into concession.
  2. Galinsky's finding — perspective taking works better in negotiation than empathy. Not assimilating to the other's emotion, but coolly estimating the other's interest, constraints, and intent, invents the agreement satisfying both.
  3. The ethic of regulatory review demands a paired restraint — avoid pressure behind authority and do not yield to commercial pressure. Both must be in place for the shape of the confident reviewer to stand.
References
  1. Fisher, Roger & Ury, William L. Getting to Yes: Negotiating Agreement Without Giving In. Boston: Houghton Mifflin, 1981 (2nd ed. with Bruce Patton, 1991).
  2. Ury, William. Getting Past No: Negotiating in Difficult Situations. New York: Bantam, 1991.
  3. Voss, Chris & Raz, Tahl. Never Split the Difference: Negotiating As If Your Life Depended On It. New York: HarperBusiness, 2016.
  4. Galinsky, Adam D., Maddux, William W., Gilin, Debra & White, Judith B. "Why It Pays to Get Inside the Head of Your Opponent: The Differential Effects of Perspective Taking and Empathy in Negotiations." Psychological Science 19 (4), 2008, pp. 378–384.
  5. Tversky, Amos & Kahneman, Daniel. "The framing of decisions and the psychology of choice." Science 211 (4481), 1981, pp. 453–458.
  6. Kahneman, Daniel. Thinking, Fast and Slow. New York: Farrar, Straus and Giroux, 2011.
  7. Raiffa, Howard. The Art and Science of Negotiation. Cambridge, MA: Harvard University Press, 1982. (the classical systematic work on negotiation)
  8. Lax, David A. & Sebenius, James K. 3-D Negotiation: Powerful Tools to Change the Game in Your Most Important Deals. Boston: Harvard Business School Press, 2006.
  9. Mnookin, Robert H. Bargaining with the Devil: When to Negotiate, When to Fight. New York: Simon & Schuster, 2010. (a classic discussing the boundary of negotiation and ethics)
  10. Thompson, Leigh. The Mind and Heart of the Negotiator. Boston: Pearson, 7th ed., 2020. (a representative textbook of negotiation psychology)
  11. Sun Wu, Sun Tzu (The Art of War) (China, c. 5th century BCE). "Plotting the Attack" ("a hundred battles, a hundred victories, is not the best of the best").