Subjects - Business

People who are successful negotiators, always have a well thought out strategy before entering into the negotiation, are well prepared, self confident and structure the nego

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

tiation, so that they remain in control of the negotiating process.

The recommended structure for negotiations is:

• Establish the issues being negotiated

• Gather inform

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

Examples of combination products may in

tion

• Build a solution

Stage 1. Establish The Issues

Begin by agreeing an agenda for the negotiation i.e.

• What needs to be discussed and agreed?

• Who will b

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 involved and what will be their role?

• What timescales are we working towards?

• What are the major issues that need to be agreed?

Many negotiators make the mistake of

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

negotiating too quickly whereas skilled negotiators spend 20% more of their time asking questions and looking for alternatives.

Do be aware that professional buyers will

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

Combination pro

ant to gain your commitment on issues, such as: price, early on in the negotiation but you should never commit yourself to anything until you have established everything tha

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

t is being negotiated.

Seasoned negotiators will often bring up an issue at the end of the negotiation, when you are vulnerable and likely to agree to a one sided (Lose-Win

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

concession, in order to conclude the deal. You can legislate for this ploy by asking the other side for their . “shopping list” before beginning the negotiation and refuse

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

to accept any last minute additions to the list.

Issues will include things like price, delivery schedule, payment terms, packaging, quality of product, length of contract

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

etc. At this stage issues are kept general and no concessions are made or agreements reached

Stage 2. Gather Information

This is a vital part of the negotiation and

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

you need to remember that there are four kinds of information

• Information you have that you are willing to give to the other side

• Information you have that you are unw

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

Following aspects would a

lling to give to the other side

• Information the other side has that they are willing to give you

• Information the other side has that they are unwilling to give you

Yo

dd to the challenges in developing combination products:

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

u need to decide, before the negotiation, how much you are willing to share information and what your own information requirements are. This will set the climate for the neg

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

tiation and will determine the amount of trust that exists between both parties. Skilled negotiators are able to ask a range of open, closed and follow up questions and are

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

ble to listen effectively. They also wait until they have all their information requirements, before making concessions

Stage 3. Build A Solution

Having gathered in

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

formation the next stage is to begin to put together a solution. Usually this will take the form of the selling side putting forward a proposal, or opening bid. The opening

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

Professional from academic institutions, pharmaceutical industries, health care indust

bid should be ambitious, but defensible. You should always challenge an opening bid and refuse to let an unacceptable bid stay on the table

Typically, there will then be a

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

rocess of bargaining, concessions will be traded and movement take place, until, hopefully, agreement is reached. Concessions should not be given away for free and you shoul

.

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

d be wary about conceding on issues for which you are not prepared.

A final tip: The very best negotiators always enter into negotiation with a “three position plan”

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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