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On March 28, 2006, the Board of IDA approved IDA’s participation in the Multilateral Debt Relief Initiative (

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

MDRI), requiring IDA to cancel all debt outstanding and disbursed owed by HIPCs to IDA as of end-2003 as soon

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

Examples of combination products may in

as these countries reached the HIPC completion point. The Bank began providing MDRI debt relief on July 1, 2

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

006.

The MDRI provides HIPCs that have reached the completion point irrevocable, up-front cancellation of de

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

t owed to IDA, the African Development Fund, and the IMF. Debt cancellation under the MDRI will be in additi

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

Combination pro

n to debt relief already committed under the HIPC Initiative. The full benefit of the MDRI from all three in

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

stitutions to the 21 countries that have so far reached completion point will be over US$18 billion (NPV) – a

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

out US$13 billion from IDA. The MDRI aims to provide additional resources to help countries reach the MDGs,

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

t the same time preserving the financing capacity of the International Financial Institutions. IDA donors th

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

erefore agreed to compensate IDA for all MDRI assistance provided. MDRI donor contributions to IDA are used

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

o benefit all IDA recipients: they are attributed to countries according to the performance-based allocation

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

Following aspects would a

echanism used by IDA. For newly qualifying completion-point HIPCs (Cameroon was the first in May 2006), qual

dd to the challenges in developing combination products:

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

ification for MDRI is automatic.

Avoiding the Need for another Debt Relief Initiative:

The Debt Sustainabil

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

ty Framework for Low-Income Countries

The debt sustainability framework is a forward-looking approach to gui

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

e borrowing and lending decisions to devote resources toward achieving the MDGs without creating the buildup

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

of unsustainable debt. By assessing each country’s circumstances, the framework balances the need for funds w

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

Professional from academic institutions, pharmaceutical industries, health care indust

th current and prospective ability to repay debt.

This approach puts responsibilities on both borrowers and

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

reditors. Low-income countries that seek new loans are responsible for strengthening policies and institutio

.

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

ns to enhance capacity to manage debt and reduce vulnerability to shocks. Creditors, for their part, review l

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

Companies that provide selfless information through particip

ng-term debt projections, which incorporate forward-looking economic analysis and account for possible shocks

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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This article differentiates between debt settlement and debt consolidation. There are many drawbacks to debt consolidation loans.

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A new digital audio player manufactured by Apple, which first became available during the Fall 2005, is known as the iPod Nano.

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