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Unfair dismissal
Dawn of the WorkChoices era

The effect of WorkChoices is t

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

hat it has brought about a return of the pre 1984 position in relation to unfair dism

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

Examples of combination products may in

ssal for those employees that are unable to jump through the following 3 hoops: (i) t

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

e 100 employee requirement, (ii) the sixmonth requirement, and (iii) The "genuine ope

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

ational reason" requirement.

A claim for unfair dismissal will now not be

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

Combination pro

ble to be made to the AIRC by an employee who works for an employer that employs 100

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

r fewer employees. This number is based on full-time, part-time and any casual employ

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

ees who have been employed by the employer on a regular and systematic basis for at l

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

ast 12 months. Some related companies of the employer’s company will be treated as on

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

entity. A claim for unfair dismissal against an employer who employs more than 100 e

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

ployees may only be made to the AIRC after the employee has worked for 6 months or mo

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

Following aspects would a

e with that employer.

Even if the employee is able to jump through these f

dd to the challenges in developing combination products:

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

rst two hoops, the employee’s claim may still be dismissed if the AIRC is satisfied t

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

at the employee’s employment was terminated for genuine operational reasons or for re

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

asons that included genuine operational reasons – i.e. reasons of an economic, techno

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

ogical, structural or similar nature relating to the employer’s business or part of t

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

Professional from academic institutions, pharmaceutical industries, health care indust

e business. This means that just to satisfy the threshold requirements for claiming u

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

fair dismissal, the employee (i) needs to have been employed by an employer with over

.

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

100 employees, (ii) needs to have worked for six months or more for that employer, an

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

Companies that provide selfless information through particip

(iii) must show that his/her termination did not include genuine operational reasons

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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