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Whether Home Information Packs (HIPs) will or won't take effect is a theme that has been debated endlessly over the past few weeks and months. Leaves you thinking that everything that can

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

be said has already been said? Yet there as many different splinter discussions as there are minutes in the day, there appear to be four main areas currently under debate:

Whet

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

Examples of combination products may in

her HIPs will actually be implemented on 1 June;

If they do go ahead, whether they will be in the format currently agreed by the government;

The effect they will have on

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

the housing market, and;

What effect they will have on the Mortgage and Estate Agent industries.

After two years of preparation, some strong discussions, and a couple

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

of u-turns, Home Information Packs (HIPs) are set to go live on 1 June this year. Originally intended as a substantial modification that would revolutionise the manner in which propertie

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

Combination pro

are purchased and sold, HIPs were intended to make house sales quicker and cheaper, by including a basic survey - the Home Condition Report (HCR) - and search details in the information

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

provided by the seller. Two years on, the scheme has been comparatively watered down.

Last Summer research among over 1,000 mortgage brokers showed some strong concerns about the cont

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

ent and timing of the HIPs launch. Not long after the research was conducted, the government conceded that putting a HCR in the Home Information Pack was possibly not the best of ideas, ma

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

inly because it was becoming increasingly unlikely that the necessary 7,000 home inspectors would be recruited and trained in time for the launch.

Take a look at the government website o

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

n Home Information Packs and you will see that what was originally planned as an advancement to the system of house purchase has nearly turned into a green initiative on energy saving - not

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

a bad thing, but not quite what was intended when the scheme was devised. So, as the proposition now stands, the first document in the HIP will not be a report on the condition of the pr

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

Following aspects would a

operty. Instead, it will be an Energy Performance Certificate (EPC). The EPC is intended to be an energy rating for homes, giving consumers information about the energy efficiency of the

dd to the challenges in developing combination products:

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

property they purpose to purchase. This may be a great idea in itself, but it is not exactly something that will speed up the transaction process.

The revised HIP rules are now as follo

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

ws. From 1 June, sellers will be able to market their home as soon as the EPC and key legal documents are provided. A HCR can be included if the seller wishes to instruct one, but it is n

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

o longer obligatory - which to all intents and purposes means that most people won't trouble themselves. Similarly, searches will not need to be included in the packs, even though the

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

e too were originally supposed to be an comprehensive ingredient of the packs. They purely need to have been 'commissioned'. Properties that go on the market prior to the 1 June implement

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

Professional from academic institutions, pharmaceutical industries, health care indust

ation date will now be allowed to stay HIP-free until March 2008, rather than the original October 2007 deadline. This has led to conjecture that more properties may be put onto the market

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

in the first half of the year, with a consequent fall off in the latter half.

In the long term, HIPs probably will not about the revolution that the original proposal promised. Similarl

.

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

y, ideas which focus attention on green initiatives and energy saving have to be applauded. There are many other developments happening in the market which will work to make the process

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

Companies that provide selfless information through particip

quicker and more efficient. The great strides made to speed up the mortgage process have made a huge difference and if e-conveyancing fulfils its potential, it will have a dramatic effect

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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