Actual - Legal

The case of McLean v Rainbow Homeloans Ltd [2006], involved an employee who was employed as a mortgage advisor. He had commenced employment on 14 April 2004, and had

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

had his employment terminated on 1 April 2005.

The employee asserted that during the period of his employment, he had regularly worked for between 55 and 60 hours

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

Examples of combination products may in

per week. He claimed that the employer had then asked him to work at the weekends, in addition to the hours that he had been working already. The employee refused th

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

at request, at which point on 23 March 2005, he received a letter from his employer which he interpreted as giving notice that his employment was to be terminated.

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

The employee brought proceedings before the employment tribunal. The tribunal held that it had no jurisdiction to hear the employee's claim. It cited the reason for

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

Combination pro

this decision being that the employee had not claimed that he had been dismissed for attempting to assert a statutory right under the Working Time Regulations 1998 S

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

I 1998/1833 (“the Regulations”). The tribunal said that in those circumstances, his claim for unfair dismissal could proceed no further on the basis that he had not

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

accrued the requisite qualifying period of service under s.108(1) of the Employment Rights Act 1996 (“the Act”).

The employee appealed to the Employment Appeals Tri

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

bunal (EAT). The employee submitted that the tribunal had erred in finding that it had no jurisdiction to hear his claim. He argued that:-

- It was

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

wrong to prevent his claim from continuing on the ground that he had not alleged that he had been dismissed for attempting to assert a statutory right.

-

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

the tribunal had failed to have regard to the provisions of s.101(A) and s.108(3)(dd) of the Act. Those provisions dis-applied the statutory continuous servic

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

Following aspects would a

e requirements in respect of an unfair dismissal claim where it had been alleged that an employee had been dismissed for refusing to adhere to an employer's requirem

dd to the challenges in developing combination products:

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

ent that would have contravened the Regulations.

- this applied to his case due to the fact that he had been asked to work many more hours than he

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

should have been.

The appeal was allowed. In this case, it was held that the tribunal had erred in law by directing itself that it had no jurisdiction to hear the c

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

laim on the ground that the employee had not alleged that his dismissal had been a consequence of his attempt to assert a statutory right. The EAT said that it was p

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

lain from the terms of the Act that the tribunal had jurisdiction to hear the employee's claim on the basis that he had alleged that his dismissal had been a consequ

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

Professional from academic institutions, pharmaceutical industries, health care indust

ence of him having refused to accept the employer's request to work hours in contravention of the Regulations.

It was decided that the employee's claim would be rem

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

itted to the tribunal for re-consideration.

If you require further information please contact us at enquiries@rtcoopers.com or Visit http://www.rtcoopers.com/practi

.

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

ce_employment.php

© RT COOPERS, 2007. This Briefing Note does not provide a comprehensive or complete statement of the law relating to the issues discussed nor does

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

Companies that provide selfless information through particip

it 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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