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Internet shopping is highly competitive and a key aspect to success is getting visitors. One way of doing that is by endorsements from consumer watchdogs. Today, I am looking at one su

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

ch watchdog called Safebuy and asking a simple question – who watches the watchdogs and are they just seeking profits?

Safebuy is a newcomer to the watchdog scene. The private company

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

Examples of combination products may in

Software Research Limited registered the name (safebuy.org.uk) on 22 January 2003.

Companies House shows Software Research Ltd had 54,000 GBP in gross profit for the year ending 2006

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

.

Safebuy is endorsed by some impressive names such as Carphone Warehouse, Institute of Directors, Which, TrustUK, and others. These endorsements appear to be the result of business d

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

ealing by some key people. Safebuy states it is endorsed by the OFT. The OFT had a press release about Safebuy in 2006 which states Safebuy had more than 1000 members and was growing a

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

Combination pro

t 40 members a month.

Wikipedia has no entry for Safebuy, which surprised me and made me wonder why the people’s encyclopedia had no entry for Safebuy when it is supported by such hig

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

h level names.

When I wrote to Safebuy in January this year asking for the private company to state how it is held accountable, I got no reply at all. This week I contacted my Southen

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

Trading Standards office and they said it appears the sites supported by Safebuy have unlawful Terms and Conditions. The principal trading standards officer, Ian Ralph, referred this

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

matter to the OFT.

The controversially is about refunds and returns. Refunds are difficult in online retail, as a refund would result in a heavy loss to the retailer. When profits are

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

small, as they are in retail, one return can wipe out profits from ten sales. So retailers try and make returns hard.

The Distance Selling Regulations control how goods are sold onli

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

ne. The OFT publishes guidelines for the DSR. The actual regulations are lengthy but available online.

Under the guidelines from the OFT, we see some strange rules, but none the less

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

Following aspects would a

they are rules enforceable by the OFT. Under 3.64, consumers have the right the cancel the contract without returning the goods. The contract has no legal basis when it states goods mu

dd to the challenges in developing combination products:

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

st be returned within a set period of time in order to obtain a refund. Under 3.46, the consumer has the right to a refund without returning the goods.

The guidelines under 3.47 even

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

state that a refund cannot be withheld even when the consumer fails to take statutory care of the goods. The regulations clearly are unsound, but they are still the law. We have to liv

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

by the law, or descend into chaos.

If I look at many websites supported by Safebuy, I can see that the Terms and Conditions require a return of goods for a refund. Though that accord

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

s with common sense, and also established practice in online retail, it is not legal.

I pulled up one website from the Safebuy site at random, and after looking at a few, it was clear

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

Professional from academic institutions, pharmaceutical industries, health care indust

that there was a general breach of law. The one I looked at first was HomeandGardenGifts, which is endorsed by TrustUK, Safebuy and GA. Its Terms and Conditions state:

“Upon receipt

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

of the goods we will give you a full refund of the amount paid excluding P & P or an exchange or credit as required.”

Those terms breach the guidelines setup by the OFT and they appea

.

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

r to be illegal. They do appear to conform to commonsense, but they also appear to be illegal.

My experience is that when schemes are set up in the private sector to “protect consumer

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

Companies that provide selfless information through particip

s” they are usually just seeking profit.

The facts point to Safebuy supporting sites that have illegal trade terms, and by implication, Which, Carphone Warehouse have the same support

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.diggit.org.ua/article/47589/diggit-How-Safe-is-Safebuy.html">How Safe is Safebuy?</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/47589/diggit-How-Safe-is-Safebuy.html]How Safe is Safebuy?[/url]

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