Advice You - Finance

Overview

The World Bank’s assistance to improving governance and combating corruption is aimed at helping countries d

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

eliver basic services better to the poor and create growth and employment opportunities by encouraging private investm

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

Examples of combination products may in

ent—both means of lifting people out of poverty. The Bank also has a fiduciary responsibility to its stakeholders to e

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

nsure that development funds are used for the purpose intended, rather than jeopardized by corruption.

The Bank is sc

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

aling up its already substantial focus on governance assistance. On March 20, 2007, the Board of Directors unanimously

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

Combination pro

endorsed the sector paper entitled “Strengthening World Bank Group Engagement on Governance and Anticorruption.” 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

paper was revised and improved following its presentation during the Annual Meetings in Singapore and incorporates fee

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

dback from consultations (November 2006 to January 2007) with governments, civil society, private sector, and multilat

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

eral and bilateral development partners, in 35 developing countries and 12 donor countries, four global events and thr

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

ough online web feedback—reaching a total of more than 3,200 stakeholders worldwide.

Key messages of the strategy inc

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

luded:

A call tostay engaged, even in poorly governed settings;
Engage not just with governments, but with a ran

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

Following aspects would a

ge of stakeholders, including non-executive institutions such as parliaments and the judiciary, the private sector, ci

dd to the challenges in developing combination products:

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

vil society, and media;
Strengthen country systems to fight corruption;
Increase emphasis on disclosure, par

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

ticipation, and third party monitoring in Bank operations;
Complement aggregate indicators with country monitorin

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

g and evaluation and disaggregated governance monitoring; and
Harmonize actions with donors and other actors.

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

Incorporating feedback from the consultations, the new strategy has three key pillars:

Building capable, transparen

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

Professional from academic institutions, pharmaceutical industries, health care indust

t, and accountable institutions and country systems, through assistance to countries. Minimizing corruption in Bank-f

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

unded projects by assessing corruption risk in projects upstream, actively investigating allegations of fraud and corr

.

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

uption, and strengthening project oversight and supervision. Expanding partnerships with multilateral and bilateral d

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

Companies that provide selfless information through particip

evelopment institutions, civil society, the private sector, and other actors in joint initiatives to address corruptio

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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Advice You - Governance and Anti-Corruption part 2

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