Main Subject - Business

Many Westerners who come over to oriental societies have to immediate grapple with one reality - the strong culture and presence of gifts-giving and even bribery that takes place in our societies. It can range from the blatant (

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

Indonesia or Vietnam) to the indirect (China or Philippines) to the “legalised and regulated” (Singapore!).

I remembered my first encounter with gifts as a teacher - I got a very expensive book from a parent. It was very, very

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

Examples of combination products may in

difficult for me to return that gift without offending the parent so I approached my principal for advice. Public servants in Singapore (of whom teachers are a part of) have very strict instructions regarding gifts (declare valu

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

e, report to superiors, etc), to avoid any problems or even appearance of bribery. I decided to make that book publicly available to all my colleagues.

Over at the Shanghai Singapore International School, I encountered Korean p

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

arents - and I realised that Korean parents took their gift-giving very seriously. It’s something like a mark of respect or even “face” to them to present a gift of nominal value (chocolates, for example) to a teacher they respe

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

Combination pro

ct. But since I’m no longer a public servant, I could accept them without any problem.

There was one gift I had to return though, and that really destroyed my relationship with the parent (sigh). It was a very beautiful idol of

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

some Indonesian tribe or something, which we suspect to be a totem of some sort. I don’t think it’s very appropriate for a Christian family to have this in the house so I wrote a card explaining my position and returned the gif

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

t. That parent never spoke to me again.

I know that God has very serious instructions regarding bribery.

“And you shall take no bribe, for a bribe blinds the discerning and perverts the words of the righteous.” Exodus 23:8

“Y

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

ou shall not pervert justice; you shall not show partiality, nor take a bribe, for a bribe blinds the eyes of the wise and twists the words of the righteous.” Deuteronomy 16:19

“A wicked man accepts a bribe behind the back, To

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

pervert the ways of justice.” Proverbs 17:23

In other words, bribes are given to blind the eyes and to pervert justice. When money is given for the judge to award you his judgement, that’s a bribe. When money is given for a per

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

son to award you the contract, even if other parties obviously gives the better deal, that’s a bribe.

How about gifts? What does the Bible say about gifts (remember that the Hebrew society is an oriental one)?

“Many entreat th

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

Following aspects would a

e favor of the nobility, And every man is a friend to one who gives gifts.” Proverbs 19:6

“A man’s gift maketh room for him, and bringeth him before great men.” Proverbs 18:16

I think it is very clear here - a gift is an intro

dd to the challenges in developing combination products:

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

duction, a means to put ourselves in good standing before a person in an oriental society (I suspect it works in western societies as well!). Herein lies the great power of the oft-acclaimed Chinese guanxi 关Ŀ

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

95;, which literally means “connections” or “relations”. You can get guanxi by being a childhood friend or relative, or by being friends later in life (mostly through gifts - monetary, in kind or by being the leverage f

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

or your own personal guanxi elsewhere).

What gifts have I given so far that has given me some of this guanxi? I’ve a friend who has connections with government officials - she likes me, and I’ve been a great h

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

elp to her in establishing herself in Singapore. I’ve leveraged upon my network to create opportunities for the school to perform in public venues - both sides are happy in the process.

I learnt one thing though - that ultimate

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

Professional from academic institutions, pharmaceutical industries, health care indust

ly, we need to be discerning over what constitutes a bribe and what constitutes a gift (I suspect many of my definitions of “gifts” are considered bribes by most governments of today). I believe that as long as we are sure we ar

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

e not perverting justice or blinding the eyes of the decision-maker, any gifts we give to make room for us in high places would be regarded by God as wisdom. And what is the value God has placed upon wisdom?

My son, if you

.

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

receive my words, And treasure my commands within you, So that you incline your ear to wisdom, And apply your heart to understanding; Yes, if you cry out for discernment, And lift up your voice for understanding, If you seek her

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

Companies that provide selfless information through particip

as silver, And search for her as for hidden treasures; Then you will understand the fear of the LORD, And find the knowledge of God. For the LORD gives wisdom; From His mouth come knowledge and understanding; Proverbs 2:1-

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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