Answers - Legal

Planning Gain Supplement (PGS) is a proposal for a fixed levy on the enhanced land value after it receives pla

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

nning permission. It is the Government’s intention to move forward with this new land tax if, after further co

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

Examples of combination products may in

nsultation, it continues to be deemed workable and effective and PGS will then come into force in 2009. The pr

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

perty industry is firmly against the implementation of PGS and there was qualified support for an extended rol

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

e of S106 Agreements.

Calculating PGS

Below is how we expect PGS to be calculated with an e

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

Combination pro

ample to illustrate.

Current Use Value (CUV) Planning Value (PV)

PV – CUV = uplift

PGS liability = PGS rate

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

(20%) x uplift

An example, 5 acre greenfield site:

CUV = ?20,000 PV = ?4,020,000 Uplift = ?4m PGS = 20 % of

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

?4m = ?80,000

Main Feature of PGS

The main features of PGS are that it would apply to resid

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

ential and non-residential development, the S106 obligations would be scaled back and that the revenues would

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

e dedicated to local communities and the provision of infrastructure.

Problems with PGS

Man

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

y people have argued about the problems with introducing PGS, and these are summarised in the following points

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

Following aspects would a

:

• Transitional arrangements

• Make your planning application now

• Thresholds

• S106 to continue

• Will

dd to the challenges in developing combination products:

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

it affect supply of land

• Allocating PGS revenues

• Added bureaucracy

Benefits of PGS

Th

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

e Government are committed to PGS and say the it will improve efficiency and speed up process. It will assist

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

he property sector as it will provide certainty, and reduce the wide variations in S106 that currently occur.

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

Also, the revenue from PGS will help to fund infrastructure on a local and regional basis.

Conclusion

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

Professional from academic institutions, pharmaceutical industries, health care indust

/strong>

Richard

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

Hegarty concludes, "The PSG will have a major influence on the land supply available for development. I th

.

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

nk some landowners may decide to act very quickly before PSG comes into force to avoid paying, but many landow

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

Companies that provide selfless information through particip

ners who have thought about selling will simply keep their land and hope for a change in policy in the future.

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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Answers - UK Planning Gain Supplement Explained

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