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One way to avoid bankruptcy in Canada is to file what they call a Consumer Proposal. A Consumer Proposal is a deal that is worked out

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

between the debtor and the creditors. A standard proposal would have a debtor possibly making monthly payments for a maximum of 5 year

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

Examples of combination products may in

. In America, Chapter 13 has the reorganization plan that also allows a repayment of 5 years but the difference is that in the United

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

tates you have to file bankruptcy to be the same result. In Canada there is no claim of bankruptcy and your credit report stays clean.

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

In most of the proposals the payments are a bit lower than what is the true debt is. Creditors more often than not accept the deals b

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

Combination pro

cause to them they are receiving some type of payment rather than have zero payments. It is logical and it turns out not to be a wash

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

he debtor is responsible for their debt and the creditor gets something.

Once a debtor offers this proposal then the creditors have 4

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

5 days to accept or reject it, if the proposal is accepted then the debtor will begin making payments to the Proposal Administrator ev

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

ry month and in turn the creditors are not allowed to call, write or harass the debtor in any way. But in the rare cases of a rejectio

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

then the debtor may have no other choice than to declare bankruptcy. A Consumer Proposal can only be made by a debtor whose debt is

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

more than $ 5000 and a maximum of $ 75,000, it the debt happens to be more than $ 75,000 then the proposal must be filed under the Div

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

Following aspects would a

sion I of Part III of the Bankruptcy and Insolvency Act.

In any case you will need the help of a Proposal Administrator is required.

dd to the challenges in developing combination products:

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

Proposal Administrator is a licensed trustee in bankruptcy but other people may be assigned to serve as administrators. The main poin

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

to filing a Consumer Proposal is that it avoids the black mark of bankruptcy on your credit report. You really want to avoid bankrupt

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

cy to save your credit if nothing else. Laws have changed in many countries making it harder to not be responsible in one way or anoth

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

r.

By filing a Consumer Proposal it allows both sides to benefit from a repayment plan. The creditor is likely not to get the entire

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

Professional from academic institutions, pharmaceutical industries, health care indust

ebt but it is better than getting nothing or taking their chances in bankruptcy, which can result in getting less money they would in

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

Consumer Proposal. The debtor does not get away scot free from their debt either. So in the interest of both parties a Consumer Prop

.

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

sal will serve a double purpose.

It does benefit the debtor more because they get a reduced debt, they have 5 years to pay it off and

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

Companies that provide selfless information through particip

they will not be harassed by collection agencies anymore. If you have more than one creditor it is possible to strike a deal with each

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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