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In the case of Atchoe v Camden Primary Care Trust [2006], the issue of unauthorised deduction of wages was heard before the Employment Tribunal. The employee worke

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

d in maintenance for the employer’s estates and facilities directorate. In addition, the employee was also occasionally employed out of hours when an emergency aro

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

Examples of combination products may in

se. This was an ‘on-call’ system and was organised on a rota basis. If an employee took part he or she would receive additional payments for being on-call. If an e

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

mployee was called out in an emergency he or she then received further payment for work carried out.

The employee’s contract stipulated a number of things:

* H

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 had to show evidence that he held the technical qualifications required to work in the position of maintenance worker

* He was expected to take part in the on

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

Combination pro

-call system; and

* The employer retained the right to vary the terms of his employment.

The employer asked the employee to show evidence of his qualifications

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

. It came into question whether the employee was able to provide this evidence. As a result of this, the employer removed the employee from the rota for the on-cal

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

l system on the grounds of safety. The employee therefore no longer received the extra payment for being on-call.

The employee relied on s13 of the Employment Rig

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

hts Act 1996 and claimed that the employer had unlawfully deducted from his pay.

The Employment Tribunal held that the employer had been entitled to remove the em

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

ployee from the rota on the grounds of safety. However, it was not entitled to deduct from his pay. The Tribunal had based its decision on three authorities upon w

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

hich the parties had not relied nor made submissions. The employer appealed to the Employment Appeals Tribunal (“EAT”).

The employer submitted that the Tribunal h

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

Following aspects would a

ad erred in its application of s13(3). Having found that the employer was entitled to remove the employee from the rota, the Tribunal should have found that the em

dd to the challenges in developing combination products:

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

ployer was entitled to deduct from the employee’s pay. As the employee was removed from the rota, he should not have continued to be paid. In addition, the employe

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

r argued that the Tribunal should not have relied on three authorities supporting its judgment upon which the parties had not had any opportunity to make submissio

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

ns.

The appeal was allowed for the following reasons:

* The Tribunal should not have relied on any authority which the parties did not have an opportunity to m

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

ake a submission. There had therefore been a material irregularity in the proceedings as neither the employer nor the employee had even mentioned the three authori

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

Professional from academic institutions, pharmaceutical industries, health care indust

ties.

* The Tribunal had erred in its application of s13(3).

* The Tribunal should have concluded that there had been no unauthorised deduction of pay by the

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

employer. If the employer was legally able to remove the employee from the rota, the employee was no longer entitled to the extra pay.

The decision would therefo

.

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

re reversed.

© RT COOPERS, 2006. This Briefing Note does not provide a comprehensive or complete statement of the law relating to the issues discussed nor does it

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

Companies that provide selfless information through particip

constitute legal advice. It is intended only to highlight general issues. Specialist legal advice should always be sought in relation to particular circumstances.

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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