Advice Pool - Health and Fitness

Bank-supported projects started in August 2004, when the Board of Directors approved a US$5 million emergency credit to

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

support Vietnam's National Action Plan for control of an avian influenza epidemic. In January 2006, the Board approved

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

Examples of combination products may in

the Global Program for Avian Influenza Control and Human Pandemic Preparedness and Response (GPAI). This new funding pr

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

ogram of up to US$500 million allows countries to rapidly access funding to strengthen veterinarian and health services

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

to address outbreaks in animals, minimize the threat posed to people, and prepare for, and respond to potential human fl

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

Combination pro

u pandemic. The Kyrgyz Republic was the first to obtain US$4 million under the new financing framework. In March, the

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

Bank approved US$5.1 million for Azerbaijan as well as a US$50 million IDA credit for Nigeria to prepare for and respond

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

to avian influenza outbreaks. There are additional proposed avian influenza control projects for Turkey, Moldova, Georg

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

ia, Nepal, Armenia, Albania, Bosnia-Herzegovina, Cambodia, Lao PDR, and Indonesia.

Tuberculosis

Tuberculosis is respon

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

sible for over 2 million deaths a year. It is a top cause of death among people who are HIV-positive, and is becoming m

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

ore dangerous with the spread of drug-resistant strains. Bank staff contributed to the new Global Plan to Stop TB for 20

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

Following aspects would a

06-2015 that was launched at the 2006 World Economic Forum in Davos.

We have financed TB control in over 30 countries,

dd to the challenges in developing combination products:

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

mainly through the cost-effective Directly Observed Treatment, Short-Course (DOTS) Strategy which focuses on identifying

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

and curing infectious patients. Total investments reach now more than US$560 million and include ongoing large projects

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

in India and China – together home to over 40% of the world’s TB patients. Other Bank-supported operations include a US$

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

150 million loan to the Russian Federation for TB and AIDS control and a similar loan for US$60 million to Ukraine. (The

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

Professional from academic institutions, pharmaceutical industries, health care indust

Ukraine operation was suspended as of August 22, 2006, pending agreed actions to restructure the operation).

We are am

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

ong the leaders in the Stop TB Partnership which now involves over 200 governments and organizations. In addition to dir

.

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

ect support for TB control, the Bank is providing cross-cutting work on service delivery to improve the systems for cont

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

Companies that provide selfless information through particip

rolling TB and most Multi Country AIDS Program (MAP) operations (as in Eritrea, Kenya and Uganda) include a TB component

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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