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This explains what an Individual Voluntary Arrangement (IVA) actually is and how it works.

What is an INDIVIDUAL VOLUNTARY ARRANGEMENT (IVA)?

An IVA is a formal agreement between you and your creditors where you will co

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

me to an arrangement with people you owe money to, to make reduced payments towards the total amount of your debt in order to pay off a percentage of what you owe then generally after 5 years your debt is classed as settl

; 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.

Due to its formal nature, an IVA has to be set up by a licensed professional

How does it work?

Once a decision has been made that an IVA is right for you, you will be asked questions regarding your current financial

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

situation. Based on the information you have given, a repayment amount will be agreed with you. Once proposals have been drawn up you will need to check and sign these and return them to your IP.

An application may then

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

be made to the court for an Interim Order. Once this is in place, no creditors will be able to take legal action against you. A creditor meeting will be arranged to which you should attend.

For an IVA to be approved, cre

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

Combination pro

ditors will be called upon to vote either for or against the arrangement. If only one creditor votes "for" the IVA, it will be approved. However, if only one creditor votes against it and they represent less than 25% of y

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

ur total debt, the meeting will be suspended for a later date and other creditors who did not vote will be called upon for their vote.

If the creditor who voted against the IVA represents more than 25% of the total debt

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

you owe it will fail. This is because an IVA will only ever be approved if 75% in monetary value is voted for. If any of the creditors don't vote, it is assumed that they will vote FOR the IVA.

The IVA will be legally bi

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

ding. As long as you keep up the repayments, when the term of your agreement is finished, you will be free from these debts regardless of how much has been paid off.

During the period of your arrangement your financial s

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

ituation will be reviewed regularly to see if there has been any change in your circumstances.

It is very important that consumers do not confuse an IVA with a Debt Management Plan, which is not legally binding.

Most IV

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

cases are based around one, affordable, monthly, payment, over a period of 60 months.

An IVA proposal has to be prepared by a licensed Insolvency Practitioner (IP) who then presents it to creditors at a creditors meetin

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

Following aspects would a

.

In the case of a consumer IVA it is unusual for any creditors or their representatives to attend the creditors meeting as most prefer to vote by fax or by post.

The rules of an IVA state that providing 75% (in value t

dd to the challenges in developing combination products:

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

erms) of those that have voted, vote to accept the proposals (with or without modifications) then the IVA is agreed and becomes legally binding on all other parties whether they voted or not.

When an IVA is accepted the

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

P's role becomes that of supervisor, monitoring the IVA's progress and ensuring that the terms and conditions that were agreed to at the creditors meeting are properly adhered to.

It is the debtor's responsibility to pay

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

the agreed payments to the IP who will then ensure that these payments are distributed to all creditors on a pro-rata basis in accordance with terms and until the successful completion of the IVA. It is in the debtors ow

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

interest to maintain their payments as failure to pay will almost certainly result in the failure of the IVA.

Upon the successful completion of the IVA the debtor will be considered debt free even though they may not ha

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

Professional from academic institutions, pharmaceutical industries, health care indust

ve actually paid off all of their debts in full. Any outstanding balances are written off (known as a composition of debts) and the debtor is then free to make a fresh financial start.

It is worth noting that if you do e

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

ter into an IVA with your creditors and you have an endowment policy linked to your mortgage then you may be expected to cash it in and pay the proceeds into the arrangement.

Likewise, if your property has a reasonable a

.

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

mount of equity then it is likely that a some of it will have to be released at sometime during the arrangement (usually the end), so it can be paid to creditors.

Drastic as this may sound it can be a deciding factor in

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

Companies that provide selfless information through particip

hether an IVA is approved by creditors and a realistic way in which a debtor can retain their property.

The IVA is an extremely powerful tool enabling you to clear your debt and return to a clean financial bill of health

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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