Main Subject - Business

Negotiating means bargaining, give-and-take - and striking a deal that leaves all parties to a transaction happy with the outcome!

Bargaining touches all as

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

pects of life, from the kids promising to be quiet during your television programme in exchange for an increase in pocket money, to the boss offering an extr

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

Examples of combination products may in

day off to any employee willing to take his place at a forthcoming seminar.

Negotiating is a two-way process between parties who bargain until a middle poi

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

nt - a compromise - is reached which leaves everyone happy. So what's involved?

Whoever you're bargaining with, there are ways to spin the odds in your fa

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

our; subtle techniques that can make all the difference between getting what you want and being dissatisfied with a deal. This is the lowdown...

BE PREPARE

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

Combination pro

D

Make sure you know exactly what you want to achieve before you enter negotiations. Work out how best to achieve it. This means knowing something about th

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

other party, what they want from negotiations and what they are likely to ask for. It also means deciding - in advance - what concessions you can afford to

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

make without thwarting your primary objectives.

AIM HIGH

Enter negotiations willing to accept a little and that is exactly what you will get. At best! Go

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

n asking for MORE than you want, trade the less desirable elements, and leave the room with exactly what you wanted in the first place.

RANK YOUR OBJECTIVES

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

These can be divided up into different categories. 'Musts'. These are what you really want from the deal. These will not be conceded. 'Ideals'. These are

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

ot quite as important as musts, but they are things you'd really like to achieve just the same. These might be conceded but only if the price is right. 'Los

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

Following aspects would a

Leaders'. These are things you are prepared to trade in exchange for things you really want from the negotiating table.

KNOW THE OTHER PARTY

Ideally, you

dd to the challenges in developing combination products:

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

should be able to identify what the other party wants - and then work out how they are likely to rank these wants as 'musts', 'ideals' and 'loss leaders'. Th

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

s puts you in a position to swop their loss leaders for your musts or ideals. Trading loss leaders is usually pointless, unless the other party thinks you a

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

re making a greater concession!

USE SILENCE TO DEVASTATING EFFECT

Most people hate silence, especially in the middle of negotiations. Used cleverly, silen

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

e can make the other party feel uncomfortable - even to the point where that person will concede something they don't really want to lose!

EVALUATE THE NEGO

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

Professional from academic institutions, pharmaceutical industries, health care indust

TIATIONS

If you summarise the essential points of negotiations so far - and do this out loud - it will help to clear things in your mind and ensure the othe

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

party understands your views.

MAKE NOTES

This helps you focus on your objectives and stops you being side-tracked. Notes can be invaluable, especially if

.

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

the other party tries to change course. You can say, "But earlier you said ...What has changed since then?" This approach throws less experienced opponents

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

Companies that provide selfless information through particip

ff balance, and puts the negotations in your favour.

BOLSTER THE OTHER PARTY'S EGO

Remember, successful negotiations leaves both parties walking away happy

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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