Advice You - Business

Many times, business organizations encounter the dilemma of ethical decision making. “If a CIO says ‘I've never faced an ethical issue’, they're not living in the real world," says Larry Ponemon, chairman and founder of the Ponemon Institute, a security and privacy research think ta

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

nk based in Arizona.

Though business relationships are more economic in nature, their moral and ethical dimensions have an equal impact on profitability. When it comes to the ethics of outsourcing, matters become more complicated, as parities involved are continents away. A judicio

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

Examples of combination products may in

s choice between the right and the wrong person to do business with will determine the future of your outsourcing venture. Why is it important to do business with organizations that are ethical?

Ethical compliance presents a strong public image and upholds the integrity and charac

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

er of an organization. Whether personal or professional, not many of us will want to associate with unethical individuals. It makes a lot more sense to do business with ethical organizations as it has a direct influence on the overall functioning of a business.

When things go wrong

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

This is the acid test. The way your outsourcing partner reacts during a crisis is the best indicator of whether it is ethical or unethical. When there is mutual trust and responsibility towards each other, a crisis management mechanism will automatically evolve. Ethics creates a s

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

Combination pro

ace for itself and in ensuring the smooth running of businesses.

Legal aspects

Legal perceptions may differ from one nation to the other and ambiguity could arise when a dispute occurs, leaving both parties in a fix. The association becomes easier when the parties have a legal, mo

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

al and ethical obligation to comply with the agreement, with due respect to international law.

Information Security

The core concern of outsourcing ethics is confidential information security. Privacy and security fall under the ‘no compromise zone’. Sujoy Chohan, a consultant at

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

IT research specialists, Gartner Company, says, “If there is any industry which is investing in security tremendously, it is the offshore industry, whether it is India or elsewhere”.

Chief Privacy Officers are highly concerned about proper information security practices. If your ou

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

sourcing partner does not have adequate information security measures, it might be wise to stay clear of them.

How does an outsourcer identify organizations which are doing ethical business?

Everyone claims to be ethical. Though a clear definition of the parameters for identifying

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

organizations with ethical conscience will be a difficulty, some factors are vivid.

Vendor reliability

It is nothing but trust that makes someone want to outsource. Weigh the dependability and reliability of the organizations to which you want to outsource.

A clear definition and

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

practice of the ethical rules and privacy policies of the organization like non-disclosure of trade secrets, secrecy and non-disclosure contracts with staff, third party service providers and visitors is a prerequisite. This will reassure the outsourcer that it is safe to do busines

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

Following aspects would a

with a partner who is miles away. Employee Credibility

Information security will largely depend on the people who handle the information. Organizations that implement tough employee credibility measures have a direct implication on its outsourcing ethics.

Communication

Clear a

dd to the challenges in developing combination products:

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

d open communication channels are another sign of an ethical company. When a project does not go the right way, an ethical partner will always keep you informed of the problem and possible solutions and time needed.

Inquiry

A thorough enquiry should be made about the organization

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

nd their nature of work management. Talking to the employees and references will give a clear idea about the professional approach of an organization. Check if the following requirements are met by your outsourcing partner:

•Proper information security systems

•Appropriate quality

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

certifications such as ISO 9000 or SEI CMM

•Appropriate programs to protect the trade secrets of its clients, partners and their customers

•Infrastructure

•Training and upgrading the security skills and awareness of employees.

•Safety of electronic data storage

•Presence of a

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

histleblower

•Proper arrangement with third party service providers

How does being ethical help in reducing the risks of offshore outsourcing?

You can always find companies that offer services at very low costs. An ethical concern might seem to be a costlier choice. However, the

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

Professional from academic institutions, pharmaceutical industries, health care indust

rice difference could be deceptive as the variation will only be in the initial cost. In the long run, the overall cost will prove to be much lower when you are working with an ethical partner.

Ethical vs. Unethical partnership

Unethical partnership:

•The cost of maintaining the

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

roject and the relationship will be high

•Lack of trust

•Strained relationship

•Non disclosure of facts

•Lack of transparency

Ethical Partnership:

•Reduced costs

•Reduced risk

•Common focus

•Relationship equilibrium

•Knowing the risks and managing them together

•Proper ma

.

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

agement systems

Client responsibilities

Before making an outsourcing decision, the outsourcer should also be clear about the responsibilities that he should share. This will help in building a healthy relationship base.

•willingness to discuss

•manage expectations

•last agreed

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

Companies that provide selfless information through particip

ocument should be the basis

•build flexibility to contracts

•openness to intermediate scope and price review

Make sure that all the loop holes which can disrupt the outsourcing process are dealt with. The benefits of outsourcing are sure to show up with safe outsourcing practices

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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