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AT A GLANCE:

The international commitment to the Millennium Development Goals (MDGs) recognizes the need for scaling up the volume and quality of aid. 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

his commitment, stemming from a global consensus reached at the 2002 UN Conference on Financing for Development in Monterrey, also calls for all developm

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

Examples of combination products may in

nt partners to share the responsibility of making aid more effective —and it calls for action on both sides of the aid relationship.

Nationally, governm

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

nts are increasingly setting clear goals and targets linked to public actions, improving their budgeting and monitoring systems and embracing a more incl

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

sive discussion of national priorities and policies. Donors are working harder to align and harmonize assistance with countries’ priorities, and are tryi

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

Combination pro

g to fill country-specific analytical gaps. Yet connecting results with resources remains a major challenge. Aid allocation based on country performance

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

(in governance, policies and intermediate indicators of results) is on the rise.

The March 2005 Paris Declaration on Aid Effectiveness, agreed to by mor

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

than 90 countries, represents a shift from past aid practices and appears to be slowly having an impact. In 2006, indicators of donor harmonization and

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

lignment were collected and monitored for the first time.

But at the same time, the architecture of the global aid system is becoming more complex, with

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

the emergence of new donors and a multitude of earmarked funds. Scaling up aid to meet the MDGs requires a more coherent 'aid architecture', with better

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

onor coordination and less fragmentation and ‘ear-marking’ of aid.

The global community is also working on better practices to deliver aid to fragile st

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

Following aspects would a

ates, where poverty is increasingly concentrated.

Recognition is growing that governance is crucial to ensuring aid effectiveness—the 2006 Global Monito

dd to the challenges in developing combination products:

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

ing Report on the MDGs(GMR) proposed a framework to monitor governance, including actionable indicators. Since then, developing countries, donors and int

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

rnational financial institutions began adapting parts of the framework to improve practices and to get more out of their development dollars. For its par

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

, the World Bank is undertaking a new Governance and Anti-Corruption Strategy that places issues of institutional quality, accountability and better proc

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

rement and fiduciary rules at the center of the development agenda.

The 2007 GMR assesses recent trends in official development assistance (ODA) and exa

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

Professional from academic institutions, pharmaceutical industries, health care indust

mines the performance of international financial institutions (IFIs), since those entities aim to serve as standard-bearers for improved aid coordination

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

harmonization and effectiveness.

‘Confronting the Challenges of Gender Equality and Fragile States’ is the theme of the 2007 GMR. The report stresses t

.

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

at achieving gender equality and the empowerment of women (MDG3) is essential to advancing the other millennium goals of halving poverty, primary educati

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

Companies that provide selfless information through particip

n for all, and a lowering of the under-five mortality rate. And, improving prospects for the 485 million people living in fragile states is vital as well

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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