Advice You - Business

Introduction

The successful introduction and passing of the work choices legislation in Australia in December 2005 embarks Australia on the

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

most comprehensive shake up of industrial relations since federation.

While naturally the ‘devil is in the detail’ what we do know is the

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

Examples of combination products may in

industrial and employment environment has forever changed.

Changes include

• A unitary (single) system of industrial relations where previ

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

usly there had been a federal system and one for each state,

• An emphasis on the Australian economy away from wages and conditions,

• Cha

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

nges to Awards and Agreements including transitional arrangements,

• A reduction in the number of awards from an estimated 4,000 to 12,

•

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

Combination pro

The setting up of the Australian Fair Pay Commission to determine minimum wages and conditions,

• A reduction in the powers of the Australi

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

n Industrial Relations Commission,

• State Industrial Relation Commissions will become redundant,

• Flexible work practices and the abilit

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

y to cash out of some benefits (annual leave). These changes may lead to problems with workplace health and safety obligations,

• New Dismi

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

ssal Provisions that are not as straightforward as have been trumpeted,

• New transmission of business rules (buying and selling a business

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

and your people),

• Union restrictions,

• The scrapping of the ‘no disadvantage test’.

Will these changes affect my Business!

With these

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

changes to the industrial relations systems comes complexity. It will be a very lax business that enters this new era without some understa

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

Following aspects would a

nding of how these changes may affect their business.

Some examples include,

• Small business owners will need to understand the broader c

dd to the challenges in developing combination products:

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

ncepts of employer obligations applicable to their unique business situation.

• Your 'Accounting' software may need minor changes (in some

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

instances).

• You will be ill advised to terminate an employee before taking advice even if you have less than 100 employees. Employees ar

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

e already starting to make claims for unlawful dismissal i.e. discrimination.

• The cost of defending a discrimination claim is dramaticall

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

higher than unfair dismissal. In one case we were involved in recently for age discrimination the legal fees for defending the case were qu

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

Professional from academic institutions, pharmaceutical industries, health care indust

oted at $30,000 and this was before any settlement of the matter.

• The changing of awards and agreements will add a layer of complexity to

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

business until the transitional phase has passed (5 years).

• If you intend to purchase a business you would be advised to appraise yourse

.

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

f of the transmission of business changes.

In conclusion business owners will now need to grapple with a new layer of complexity.

Biz Mome

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

Companies that provide selfless information through particip

ntum are up to date with work choice changes and can assist your business.

You will find other helpful free articles at www.biz-momentum.co

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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