E-Articles - Health and Fitness

The World Bank's comparative advantage lies in its capacity to put avian flu and pandemic preparedness on the development agenda: raising awareness and mobilizing finances,

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

building capacity, sharing knowledge, and bringing together health officials, animal disease experts, and ministry officials from different countries.

Addressing avian fl

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

Examples of combination products may in

will require a long-term effort, a high degree of coordination, and a global strategy. Actions now to control HPAI infections at source and prepare for a pandemic can sign

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

ficantly reduce the projected catastrophic costs of a pandemic.

The Bank is playing a convening role and has worked closely with affected countries, the UN System Coordina

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

or David Nabarro, and the international technical agencies-the World Health Organization (WHO), the Food and Agriculture Organization (FAO) and the World Organization for A

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

Combination pro

nimal Health (OIE)-whose global strategies inform the international response. While the international technical agencies are positioned to help address scientific and techn

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

cal issues, the Bank has ongoing health and rural development programs in most developing countries, which can help bring together and coordinate national agencies and inte

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

national experts.

At a meeting in November 2005 in Geneva, partners in the international response have:

confirmed the centrality of an integrated approach—one that addres

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

es the existing threat of HPAI in animals while preparing for, and acting to limit the impact of, a pandemic, and that draws on protocols developed by the FAO, OIE, and WHO

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

;

characterized the cost and type of investments required at each phase of the disease;

provided the first rough estimates of the potential resources needed to address HP

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

I; and explored options for an international financing framework and coordination mechanisms to support a coherent response at the country, regional, and global levels.

S

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

Following aspects would a

bsequently, in January 2006, the Bank, the European Commission, and the Chinese Government cosponsored a pledging conference in Beijing, to elicit support for the priority

dd to the challenges in developing combination products:

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

ctivities identified at the meeting in Geneva, building on a flexible funding framework agreed by donors. Pledges amounted to almost $1.9 billion, including about $900 mill

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

ion in grants, over three years. The Bank's contribution comprises $500 million in IBRD and IDA financing, as well as financing channeled to developing countries through Ba

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

k-administered trust funds, including through a newly established $75 million multidonor Avian and Human Influenza Facility, to which the European Commission is the largest

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

donor.

To make sure that pledges are translated into results in developing countries that need help to effectively address the avian flu threat, the Bank is already workin

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

Professional from academic institutions, pharmaceutical industries, health care indust

in more than 30 countries, providing advice on preparation of projects for financing under its $500 million program. By the end of fiscal 2006, $147.4 million has been app

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

roved for fully-developed programs in eleven countries (Albania - $5m, Armenia - $6.3m, Azerbaijan - $5.1m, Georgia - $7m, Kyrgyz - $4m, Lao PDR - $4m, Moldova - $8m, Niger

.

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

a - $50m, Tajikistan - $5m, Turkey - $34.4m, Vietnam - $18.6m) and preparations of projects were underway in more than twenty other countries, which could result in World B

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

Companies that provide selfless information through particip

nk commitments reaching about $250 million by end-December 2006. The World Bank is acting under its policy framework for emergency operations, facilitating quick processing

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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