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Until midnight of Saturday 30th October 2004 the regulation of mortgage sales was done so on a voluntary basis which was overseen by the Mortgage Code Compliance Board (MCCB) - Lenders and brokers alik

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

e had pledged to adhere to this code which has now closed down. This changed on the 31st October 2004 when a large section of the mortgage market came under statutory regulation. At this time, control

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

Examples of combination products may in

f regulation was passed on to the Financial Services Authority (FSA).

The role of the FSA is to oversee the regulation of the financial services industry in the UK. The FSA is not a government departm

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

ent but is in fact a limited company - It has statutory powers, given to it under the Banking Act 1987. The FSAs board which makes its policy decisions is appointed by the treasury.

All mortgage brok

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

rs must be authorised by the FSA, either directly or through an authorised network/packager. You can check whether a firm is authorised via the register on fsa.gov.uk

What Are The Main Statutory Objec

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

Combination pro

ives Of The Financial Services Authority In Relation To Mortgages?

The FSA has been given a number of statutory objectives including:
# Maintaining confidence in the UK mortgage system.
# Pr

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

omoting public understanding of the mortgage system.
# Securing an appropriate level of protection for consumers.
# Reducing the scope for financial crime.

What Are The Main Features Of Mort

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

age Regulation Under The Financial Services Authority?

Regulation as laid down by the FSA is statutory and any person or any organisation found breaking the rules could be subject to discipline - fine

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

, bans and ultimately, jail time.

# The rules cover mortgage advice and sales, advertising and promotions.
# All mortgage advisors, whether you are a broker or a lender, must be authorised and re

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

gulated by the FSA.
# Any mortgage advisors must be suitably trained and professionally qualified.

In respect to mortgage sales and promotions, the FSA is very keen to bring about clarity to the

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

mortgage market - in order that borrowers can effectively shop around and make informed decisions. Any mortgage advice, whether this is provided by a lender or a mortgage broker, must be accompanied wi

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

Following aspects would a

h an Initial Disclosure document (IDD), and a Key Facts Illustration (KFI) before the borrower actually applies for the mortgage. These two documents have been standardised across the board in order to

dd to the challenges in developing combination products:

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

compare between different mortgage products.

What Is An IDD?

The initial disclosure document (IDD) must be provided to the borrower at the initial meeting, or if contact is via telephone, the key po

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

nts must be summarised and explained with written documentation provided in writing within five working days. The IDD must cover the following points:

# Whether advice is offered or simply product inf

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

rmation only.
# Whether the lender or broker has access to the whole of the mortgage market, or a limited panel - or even just one.
# Details of fees to be charged.
# Details of the comp

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

laints procedure - including a postal address for which to send in writing.

What Is A KFI?

A mortgage lender or broker must supply an accurate Key Facts illustration before a mortgage application is

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

Professional from academic institutions, pharmaceutical industries, health care indust

ade. The KFI is a standardised document and must contain the following points:

# The total cost of the loan to be repaid.
# Any associated fees including the amount of commission that the broker

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

arns subject to mortgage completion.
# The full details of the mortgage product including the interest rate, monthly payments and all fees.
# The risk of rate changes and the impact of paymen

.

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

ts.

DoesThe FSA Regulate All Types Of Mortgage Contract?

Buy-to-Let and commercial mortgages are not currently regulated by the FSA under the new regime.

What You Should Do In The Event Of A complai

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

Companies that provide selfless information through particip

t?

Firstly you must try and iron out the complaint with the mortgage broker or lender. If a satisfactory response is not made then the complaint may be taken further to the Financial Ombudsman Service

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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