Main Subject - Business

When you left home for work this morning, did you feel ready to face the day knowing that you were going to have a number of successful negotiations? Chances are, the word "negotiation" never entered your head. Perhaps it should have!

We often think of negotia

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

tion as a formal process conducted behind closed doors by high powered executives, politicians or world leaders. Yet everyday all of us negotiate. You may have to agree with colleagues on the content of a report or presentation; with a customer over a disputed i

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

Examples of combination products may in

nvoice; with a supplier on the terms for goods or services; or with your partner on what to have for dinner tonight! All of these things are negotiations.

Our problem is that we don't recognise them as negotiations, nor ourselves as negotiators. As a result, w

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

e enter these discussions less prepared than we could be. The result? Sometimes a less-than-successful outcome!

To help make all our daily negotiations more successful (for both you and the other party), you need to:

- State your case clearly and appropriatel

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

- Organise your facts

- Control the timing and pace of your discussion

- Properly assess both yours and the other parties needs

How do you carry out these four points successfully? First, you need an understanding of some of the key principles of successful

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

Combination pro

negotiation. Try this quiz to test your knowledge of negotiating by answering "True/False" to each question.

1. Should you ask for twice the amount you need?
2. Is your aim to prevent the other party from saying "No"
3. Will a small concession re

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

lieve the pressure?
4. A "Win/Win" result is always possible.
5. Is admitting to an error or omission a sign of weakness?

The following answers will provide some useful tips for your negotiating situations.

1. Should you ask for twice the amount

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

ou need? False. You will have to back down and will lose an important opportunity to influence the other party. Research clearly indicates that negotiators who make large concessions end up worse off. The secret of successful negotiating is to first identify

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

your needs, then work out a range of options that will satisfy those needs. Start the negotiation by asking for the options that best meet your needs.

2. Is your aim to prevent the other party from saying "No"? False. In fact getting a "No" from the other

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

party can be very useful because it gives you the opportunity to ask "Can you give me your reasons?". This leads to uncovering the other party's real needs and some options that will satisfy them ?V options which you can probably supply.

3. Will a small conces

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

ion relieve the pressure? False: If you make a small concession, chances are you are negotiating over options rather than needs. Additionally, the other party may think you are weakening and put more pressure on. Far better to state or restate your needs and

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

Following aspects would a

then explore as many options as possible to satisfy them. As part of this discussion, you may come back to the offer that was just rejected, or you may find some even better options. Either way you have gained a lot more information and not weakened your posit

dd to the challenges in developing combination products:

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

ion.

4. A "Win/Win" result is always possible. False: It's desirable, but not always possible. Sometimes, even the best of negotiators have to "agree to disagree". The way to improve your ratio of "Win/Wins" is to focus very clearly on your own real needs

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

(not positions) and the needs of the other party. Searching for many different options to satisfy both party's needs generates more "Win/Win" situations.

5. Is admitting to an error or omission a sign of weakness? False: Research shows that disclosing such

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

nformation demonstrates honesty. In psychological terms, it breeds what is called "reciprocity" - if you do something for me, then I'll do something for you. People are far more likely to be honest with you when you are honest with them. Pulling the wool over

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

someone's eyes may give you a short term result at the expense of a long term relationship.

Four tips to help you negotiate successfully

1. If you want a better deal, ask for one. You'll never know unless you ask! Remember, make sure it will satisfy your nee

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

Professional from academic institutions, pharmaceutical industries, health care indust

ds - do not get locked into bargaining over positions.

2. Argue to learn, not to win. To meet your own needs you need to learn as much as possible about the other party and their needs. The more you learn, the better chance you have of getting a good deal.

3.

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

ake proposals regularly during the negotiation - proposals move the negotiation forward. Use proposals such as "If you will provide . . . . then I might consider . . . ." The other party's response to these proposals will give you a lot of information to work w

.

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

ith.

4. Ask for, and give as much information as possible. For example, questions such as "Can you explain your reasons for . . . . ?', "What are your priorities? and "What else is there that you think I should know?" are excellent ways of gathering the informa

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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If only “they” had given it to me on time. I asked “them” and they did not reply. I sent an email to “them” but have not yet had a response. We don’t have the budget we need. We don’t have the resources we need. Our organisational structure does not allow us to perform they way we need to. Are you tired of this? Tired of the lame excuses for non performance, missing targets, missing deadlines?

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