E-Articles - Health and Fitness

At the global level, the World Bank will continue to follow up with donors to monitor delivery of pledged assistance, to help make sure that countries with robust programs have access to adequate grant resou

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

rces (which can help reduce their dependence on borrowing for avian flu control, including from IBRD and IDA). The World Bank reported on progress to an international meeting organized by the European Commis

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

Examples of combination products may in

sion and the US and Austrian governments in Vienna in June 2006. The progress report showed that out of the $1.9 billion pledged in Beijing, $1.2 billion was already committed to specific programs, indicatin

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

g a rapid initial response compared to other emergencies such as major natural disasters.

This momentum now needs to be sustained. Moreover, new approaches and additional financing are likely to be required

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 Africa, where governments and communities have particularly weak capacities and are unlikely to be able to take on the avian flu challenge without special assistance. More effective measures are urgently

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

Combination pro

needed in Indonesia, where the animal disease continues to spread unabated. Compensation to farmers when poultry need to be culled is key to controlling the disease, but difficult to implement effectively i

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

n most developing countries. These issues are likely to dominate the agenda of the next high-level international meeting, convened by the African Union in Bamako, Mali, in December 2006.

Applying the Lesson

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

s of the Past

The lessons from SARS and other outbreaks are very much on the minds of many people. One lesson is the importance of bringing the different players together and getting them to work together a

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

t an early stage. For instance, in 2004, we brought together Vietnam health officials with doctors and researchers in Australia using the Global Learning Development Network's (GDLN) videoconferencing capabi

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

lities. GDLN is also a platform for a series of inter-country exchanges on avian and human influenza policy issues, which was launched in July 2006, by linking animal and human health policy makers in Nigeri

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

a, Thailand, Turkey, and Vietnam to discuss integrated country programs. The second session is planned in close collaboration with the US Centers for Disease Control and will address risk communications; goo

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

Following aspects would a

d communication is necessary for reducing the costs of avian flu and will be key to mitigating negative impacts of a human pandemic. SARS and the Bank's experience in assisting countries affected by HIV/AIDS

dd to the challenges in developing combination products:

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

also reiterated the importance of responding quickly and in a coordinated manner. We need to make certain governments are taking the lead, and then we can help facilitate access to expert technical partners

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

and other donors.

Another important lesson from past global experience is that it is preferable to respond as quickly as possible on the core animal health issue. If we fail to aggressively assert control

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

over outbreaks of the disease in animals, it's a foregone conclusion the spread to humans will be even more dramatic. No one likes to see on the news the large-scale culling of animals, however it is a neces

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

sary part of the long-term strategy so countries can limit the impacts on human health. It is important, especially at this early stage of the emergency, to keep the animal health issues front and center. Ul

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

Professional from academic institutions, pharmaceutical industries, health care indust

timately, however, the majority of funding will go to the human health responses.

Yet another key lesson from past outbreaks has been that our responses need to be forward looking and must be designed to co

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

ntrol the spread of infectious disease in a holistic way. Our work to address outbreaks needs to help countries be prepared to respond to avian flu, SARS, or similar diseases in a long-lasting manner, which

.

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

helps build their capacity. Regional approaches can be useful and cost-effective if they complement country-level actions. We want our assistance to countries to be relevant for other risks and other situati

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

Companies that provide selfless information through particip

ons so crucial resources are not wasted.

Preventative measures, early international coordination, and collaborative response efforts will continue to be important priorities for the Bank in the months ahead

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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