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What is an IVA? IVA stands for Individual Voluntary Agreement. It is a formal agreement with your creditors which

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

allows you to pay back just a percentage of your debt. With an IVA as much as 75% of your debt can be written off. IVA was introduc

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

Examples of combination products may in

d as a part of the Insolvency Act of 1986 and necessitates a debt of at least ?15,000 owed to three or more creditors. You only hav

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

to deal with one affordable monthly payment or in some cases a lump sum. Since an IVA is legally binding your creditors cannot cha

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

nge the IVA terms and conditions once they have agreed to it. Also they cannot threaten any legal action against you as long as you

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

Combination pro

maintain your monthly repayments. An Insolvency Practitioner helps to formulate your IVA.

The IVA Process:

•Your

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

appointed Insolvency Practitioner (IP) will prepare an IVA proposal

•IP will file an Interim Order in the Court to prevent any leg

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

al action against you

•Your creditors will meet to accept/reject the IVA proposal

•If 75% of the creditors vote in favor of the t

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

rms, then the IVA comes into being

Why should you choose an IVA over Bankruptcy?

•No negative publicity/stigma/r

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

strictions to deal with

•IVA does not affect your professional status

•You can operate a bank account (it should not have an over

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

raft facility)

•No fees or legal proceedings

•You don’t lose your home/property

The IVA Advantage:

•Up to 75%

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

Following aspects would a

of your debt is written off

•Overall debt is reduced

•Fixed/Legally binding agreement

•Deal with one affordable and easy to mana

dd to the challenges in developing combination products:

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

e monthly payment

•Interest on loans is frozen

•Get rid of creditor harassment

•Legal proceedings are stopped

•Repaired credit

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

ating

•Become debt free in 5 years or less

Does that mean that an IVA has no disadvantages? Not necessarily. An IVA might require

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

you to release some or all the equity that you have tied up in your property. Also you qualify for an IVA only if your total unsec

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

red debt is more than ?15,000 and if you can afford a monthly payment of ?200. When you have availed an IVA you will not be able to

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

Professional from academic institutions, pharmaceutical industries, health care indust

use any of your credit cards or store cards. You will not be allowed to borrow any more money until you have cleared your debt.

IV

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

A is becoming an increasingly popular option when compared to debt management program or bankruptcy. Various debt solutions might r

.

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

duce your repayments to a great extent but they leave you with a large part of your debt to pay back. These debt solutions are not

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

Companies that provide selfless information through particip

egally binding either. When compared to the various debt solutions an IVA is an ideal solution for both the debtor and the creditor

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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