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The employer / employee relations environment has been constantly evolving during the last 25 years. In Australia, as in many western nations, the balance between emp

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

loyers and employees has shifted back and forwards usually in response to supply and demand.

At times worker organisations, such as unions, have caused considerable

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

Examples of combination products may in

problems for employers while arguing that unionism protects workers pay and conditions.

While this has been true in some arenas it has also been true that this has c

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

ome at the expense of enterprise flexibility.

Small business today needs the flexibility to rapidly respond to technological and sociological change and the old awar

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

d system and its archaic inflexibility have to change.

In the late 80's and 90's there was a shift towards enterprise bargaining agreements and collective agreements

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

Combination pro

which gave an individual enterprise increasing workplace flexibility.

These agreements, at the enterprise level, where parties were normally unions on behalf of wor

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

kers and small business went some ways in achieving of flexibility but still retained some of the old thinking and inflexible practices. In essence the old award syst

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

em continued to be a reference point for minimum wages and entitlements for workers.

In 1996 the federal government introduced Australian Workplace Agreements (AWA)

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

which was specifically designed with individual business and worker in mind.

At its fundamental level an AWA is a formal written agreement between an employer and an

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

individual employee. A significant advantage to workers and business is that an AWA can be tailored to cover all particular requirements for your business.

AWAs hav

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

e a life of 3 years, however if they are carefully written can continue long after the 3 year expiry date.

By way of example you may own a farm where seasonal worker

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

Following aspects would a

s are required. Your AWA can be designed to reflect seasonal requirements that suite both worker and employer.

You employees may want a 4 day working week. Your AWA

dd to the challenges in developing combination products:

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

can tailor this requirement into the agreement and without payment of penalty rates for working in excess of 8 hours per day.

Take Australian Zoo owned by Steve and

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

Terri Irwin. Because of their unique requirements in caring for animals AWA’s have provided flexible working times. With a workforce of 450 people they have been abl

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

e to grow their business in the certainty of wages and conditions.

Other advantages of an AWA may be that an employee is able to cash out sick leave at the end of ev

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

ery year reducing the amount of sick leave taken and providing an added incentive for turning up for work each day. It all adds up to flexibility.

An AWA can overrid

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

Professional from academic institutions, pharmaceutical industries, health care indust

e state and federal award provisions, as long as the terms and conditions of the AWA overall do not disadvantage the employee when compared to the award. This gives t

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

he employer and employee certainty of conditions in the employment relationship. A business without a written formal agreement between worker and the employer is at

.

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

risk to claim before industrial tribunals and courts.

Certainly documenting and agreeing on individual workplace wages and conditions means certainty of cost and the

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

Companies that provide selfless information through particip

ability to be competitive.

Cash, Costs and People are the number one ticket item in many businesses today. For helpful information visit us 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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