Subjects - Business

While I have nothing against Lawyers leading any negotiation and believe they have a major role to play in negotiating complex IT contracts. Leading t

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

he contract negotiation in the majority of cases however, should be left entirely to trained commercial negotiators.

Lawyers

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

Examples of combination products may in

should be important members of the negotiating team but not the lead. I also think that a great number of lawyers may also agree with me on what loo

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

s like a harsh statement to make. To clarify my statement let me say that IT contracts as a result of the negotiation approach taken can end up being

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

either legally or commercially oriented.

You may say, so what, we have a contract any way and all our

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

Combination pro

interests are protected; but are they?

To reply to this, I would say: There is no much difference in both types of contracts while things are going w

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

ell and the solution is delivered on time without any technical problem and on budget. In fact in this case you do not really need a contract at all.

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

Unfortunately, this is not the case in the majority of IT contracts whether they being, systems integration, outsourcing or buying hardware & Software

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

Paradoxically as it may seem, when it comes to dealing with breaches i.e. Acceptance, Delivery, and Fixing Bugs and so on, a legall

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

y minded contract becomes a hindrance to resolving such breaches and getting on with the development in a sensible commercial manner.

A legally minde

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

contract will rely heavily on the Law to resolve its breaches. We all know what it means to go to court to resolve contractual issues.

Basically the

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

Following aspects would a

users suffer if they were the complainants while the solution never gets delivered and the cost of going to court will be hard to bear. The contract

dd to the challenges in developing combination products:

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

therefore failed in delivering its objectives: protecting the delivery of the solution that the users desperately need for their business to succeed.

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

A commercially minded contract on the other hand has been drafted with full understanding of all the potential issues and breaches that may occur. Suc

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

h contract focuses “fanatically” on delivering the solution to the users and not merely getting the money back when things go wrong or involve the cou

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

t to resolve the breaches.

Put another way, a legally oriented contract relies on the Court for remedies at the first instance of breach, while a com

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

Professional from academic institutions, pharmaceutical industries, health care indust

mercially oriented contract relies on its own wits to remedy breaches and get on with the development. Such commercial contrac

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

t states all the possible remedies for most of the potential breaches before hands, thus removing the need to go to court at the first instance. Comme

.

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

cially oriented contracts are by their nature – their own court and judge. Of course both contracts have to be governed in th

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

Companies that provide selfless information through particip

e end by the laws of land and eventually if all goes wrong and all remedies failed, the Courts and Judges must decide.

Copyright 2007 – Osama El-Kad

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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