Main Subject - Business

Our style of negotiation will be influenced by the style of the other party. If both sides are ad

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

versarial; there will be little trust between the two parties, however, if one side decides to be

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

Examples of combination products may in

co-operative, there is a danger the other side will use this apparent sign of weakness to their

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

advantage.

Co-operative bargaining has the advantage of being a more efficient style of negotiat

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

on, however certain rules have to be followed by both parties for it to work. Let us look at the

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

Combination pro

two styles of bargaining and their features:

Features Of Adversarial Bargaining:

• Each si

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

de takes up a position and defends it.

• Opening bids are set at unrealistic levels; too high or t

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

o low, in order to give

room for manoeuvre.

• Movement is small or non-existent until later on in

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

the negotiation.

• Tactics are used to gain short term advantage.

• Too much emphasis is placed

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

on trust. .This really is my best price!

• Information is withheld, or misrepresented.

• The outc

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

me is often “win-lose”, or “lose-lose”.

• The more aggressive negotiator usually does best.

• Thi

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

Following aspects would a

s style does not encourage long term, mutually beneficial relationships.

• Neither side asks enoug

dd to the challenges in developing combination products:

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

h questions, or explores alternatives in sufficient depth.

Features Of Co-Operative Bargaining<

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

/b>:

• Each side recognizes that the other has needs and feelings and accepts implicit rules.

• O

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

jective measures are taken of what is fair and reasonable.

• Trust is not an issue as either side

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

is willing to share information.

• This style is friendly, but not soft. There is a willingness to

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

Professional from academic institutions, pharmaceutical industries, health care indust

trade concessions.

• There is a clear, communicable strategy.

• Bad behavior is punished.

• Thi

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

style involves creative problem solving.

• It encourages long term, mutually profitable relations

.

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

hips.

• Each side asks more questions and explores alternatives, rather than taking up fixed posi

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

Companies that provide selfless information through particip

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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Main Subject - Styles Of Negotiation

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