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I read earlier this year that the Palestinian Prime Minister had received support from militants to give up their weapons in exchange for government jobs. On face value it struck me as a stark example of the difference between a person's interest and position. The

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

position of the "militants" is well publicised, their interests however, appear to be more personal. Job security providing an income to support their families is closer to their interest.

In negotiations, we often concentrate on positions rather than interests

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

nd we get a negotiation result which does not extract the greatest possible value out of the negotiation and may damage relationships.

In "Getting to Yes: Negotiating Agreement Without Giving In", a classic text about negotiating, Roger Fisher and William Ury, ex

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

lain: "Your position is something you have decided upon. Your interests are what caused you to so decide." In most negotiations, defining differences in terms of positions means that at least one party will "lose" the negotiation. When a difference is defined in t

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

erms of the parties' underlying interests it is often possible to find a solution which satisfies both parties' interests.

In a negotiation, the two parties usually have two concerns. One is about the substance of the negotiation and one is about the nature of th

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

relationship between the negotiating parties.

When a high degree of concern is expressed for the substance of the negotiation and a low degree of concern is expressed for the relationship of the parties, a "Defeat" behaviour pattern is produced. This pattern is

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

haracterised by win-lose competition, pressure, intimidation, adversarial relationships and the negotiator attempting to get as much as possible for him/her. Defeat the other party at any cost becomes the negotiator's goal

Interestingly, research shows that males

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

favour the "Defeat" approach more than females. A testosterone induced negotiating style perhaps?

When the focus is building a compatible relationship in the hope that the negotiation will be successful, an "Accommodate behaviour pattern is produced. This patter

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

is characterised by efforts to promote harmony, avoidance of substantive differences, yielding to pressure to preserve the relationship and placing interpersonal relationships above the fairness of the outcome.

When a low degree of concern for both the substance

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

of the negotiation and the relationship with the other parties is expressed, a "Withdraw" behaviour pattern is produced. This pattern is characterised by feelings of powerlessness, indifference to the outcome, resignation, surrender and taking whatever the other p

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

rty is willing to concede. Withdraw and remove oneself becomes the behaviour of the negotiator.

Withdraw is a negotiating style at times seen in negotiations between parents and teenage children flexing their wings of independence. The negotiation finishes abrupt

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ly with an "I don't care - do what you want" from either party when the realisation dawns that one party can't "win".

When a moderate degree of concern for both dimensions of negotiating behaviour is expressed, "Compromise" behaviour is produced. This pattern is

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

haracterised by compromise, meeting the other party's half-way, looking for trade-offs, splitting the difference, and other half-way measures. Conflict reduction is valued over synergistic problem solving. Find an acceptable agreement is the objective of this nego

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

iator's style.

Sometimes this style is mistakenly described as "win"-"win". From a purely personal point of view, in what I might label, "serious negotiations", accommodate is the least fulfilling negotiating style.

When a high degree of concern for both the sub

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

stance of the negotiation and the relationship with the other parties is expressed, a "Collaborative" behaviour pattern is produced. This pattern is characterised by searching for common interests with the other party, problem solving behaviour and recognizing tha

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

both parties must get their needs satisfied for the outcome to be entirely successful. Collaborative behaviour and synergistic solutions are the result. Working to build a win-win outcome is the main goal of the negotiator.

When negotiating parties concentrate o

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

interests, a collaborative style is a likely result. When negotiating parties concentrate on positions, it becomes almost impossible to have a collaborative style.

In the late eighties and early nineties, when procurement was becoming seen as an opportunity to r

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

educe costs in the automotive industry, the concentration was on positions. The auto manufacturers demanded a reduction in supplier costs of at least ten percent. Suppliers offered less and eventually an agreement was hammered out. The result was a reduction in co

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ts, but with variable quality and some suppliers not surviving.

In the late nineties, procurement tactics transformed to an understanding of interests. The common interests were in mutual viability. Favoured supplier status was bestowed on those suppliers willing

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

to work together to reduce costs of the entire supply chain from design to delivery. The result has been cheaper cars, more reliable quality and more viable manufacturers.

Negotiations need not be about win-lose or even win-win. They can be about just simply "WIN

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Today’s high-tech society is taking in and putting out more information than ever imaginable. Looking for an e-mail or searching for an electronic document is as big a challenge as finding our paper files, and, in spite of all the promises of the paperless office, statistics show that exactly the opposite is happening.

Many people say; It is All About Money when it comes to big corporations. Well yes, that is their job to make money and yet if you look around today you will might take a look and see that every thing you see everywhere you go was brought or built by a corporation. You cannot have it both ways. These people say that the corporations only care about shareholders equity and quarterly profits and cannot therefore focus on customer needs?

I love my dentist! When is the last time you could say that about yours? True, dentists do tend to get a bad rap (remember Steve Martin's sadistic character in the movie, Little Shop of Horrors?). But even real-life visits to the dentist aren't high on the list of relaxing things to do.

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