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The popularity gained overtime and the ever-increasing crowd of investors in the Hedge Fund industry has augmented the need for higher degree of regulation in the hedge f

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

und market.

Hedge funds are very similar to mutual funds except that there are fewer regulations on hedge funds. As a result hedge funds require a much larger investment

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

Examples of combination products may in

. Hedge funds are very reticent, that is, they are private, between individuals, and do not have to be made known to the government or other companies. This allows hedge

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

funds to be free from the regulations that mutual funds have to adhere to. Because of this large companies move undisclosed amounts of money and gain significantly withou

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

t authorities noticing. This reticent nature of hedge funds makes them look suspicious and leads to many apprehensions in the minds of the investors, such as; these funds

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

Combination pro

are unethical, speculative and risky. Also their high price tag and the extravagant amount of money required for their initial purchase makes people think that the inves

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

tors are being hood winked into putting money into these funds. Only ensuring high levels of transparency in the working of the hedge fund industry so that an investor kn

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

ows exactly where his money is going can clear these apprehensions.

. Moreover, better regulation will produce more accountable hedge fund managers in future and the i

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

nvestors would be able to simply research the background of a hedge fund manager before entrusting their money into his hands.

Another negative aspect of the non-regulat

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

ion of hedge funds is that there are no official hedge fund statistics. Most hedge fund holders are large companies and hence, little is known about their financial movem

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

ents. Hedge funds are based in offshore jurisdictions, making them look even more suspicious. For instance, unlike mutual funds that have a base in large cities like New

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

Following aspects would a

York, hedge funds are based in places like Bermuda, Cayman Islands, and the Virgin Islands.

Hedge funds also have a higher failure rate than traditional funds. Many of t

dd to the challenges in developing combination products:

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

hem fail by the second or third year of operation. It has been estimated that about 5.7% of the existing 8500 hedge funds closed in 2005. This vulnerability to quick fall

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

s that can be detrimental and can lead to sudden losses can be brought down with the help of regulations.

In London, the techniques used for the hedge funds operating fr

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

om there, have bothered the Financial Services Authority. Hence, to check the functioning of this industry, the FSA has now decided to start regulating hedge funds and th

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

eir managers. Also, a special hedge fund unit has been set up to determine how the London hedge fund industry which has been estimated at ?500-billion, can be controlled

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

Professional from academic institutions, pharmaceutical industries, health care indust

better.

However, the Canadian Securities Administrators that is the umbrella organization for Canada’s provincial securities commissions has decided that the currently e

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

xisting rules for investment vehicles are sufficient to regulate the burgeoning Canadian hedge fund industry (a $30-billion industry). This implies that no additional rul

.

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

es and regulations would be laid down specifically for hedge funds in Canada.

Thus, with the proper regulations in place, the clouds of suspicion and uncertainty that ar

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

Companies that provide selfless information through particip

e hovering over the hedge fund industry will certainly clear up and would pave the way for a much safer hedge fund market that would attract a larger number of investors.

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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