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October 2004 saw the introduction of the Employment Act 2002, which has brought a new approach to staff dispute resolution.

It has long been acknowledged that disputes in the workplace are dis

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

ruptive, stressful, and costly – both for employers and employees. Once time and legal expenses are taken into account, the average cost of an employment tribunal for a UK employer is ?2,

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

Examples of combination products may in

000. In addition, it is said that 50% of employees who take a case to a tribunal end up in lower paid or lower status jobs after the hearing, and almost a quarter find themselves unemployed.

I

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

a recent twelve month period, the UK employment tribunal service received over 94,000 claims. But research showed that in more than 33% of cases, the employee and his or her manager had not ha

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 any prior discussion about the problem.

The new legislation in the Employment Act aims to address these problems by:

encouraging both employers and employees to discuss disputes
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro
promoting alternative ways to resolve disputes
enabling the employment tribunal system to work more effectively.

Since October 2004, all employers and employees hav

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

e been required to follow a new three-step process when dealing with most dismissals, disciplinary actions or grievances. If they don’t, they could face a financial penalty should a dispu

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

te reach a tribunal.

The stages in this new three-step process are as follows:

Write a letter explaining the issue

If an employer is considering disciplinary action, he must

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

ut the reasons for this in writing to the employee. Similarly, if the employee has a grievance against his employer, he must put it in writing in a letter to his employer.

Have a m

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

eeting to discuss the issue

A face to face meeting must take place between the employer and the employee to discuss the issues raised in the letter. There must be a suitable amount of tim

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

prior to the meeting for the recipient of the letter to consider the other party’s complaint. Following the meeting, the employee must be informed of the employer’s decision and no

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

Following aspects would a

tified of their right to appeal.

Have an appeal meeting if required

This may happen after sanctions have already been imposed. The employer must inform the employee of the ou

dd to the challenges in developing combination products:

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

tcome of the appeal.

The above standards are intended to be a minimum which must be met by all UK employers. However, so long as these minimum standards are complied with, companie

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

are free to personalise the procedures to suit the needs of their own business.

Remember, if a dispute reaches tribunal and one of the parties has not followed the three-step process in full,

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

they will almost certainly face penalties.

If an employer fails to follow the new rules, then any award made to the employee by a tribunal will be increased by a minimum of 10% up to a maxim

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

m of 50%

If the employee fails to follow the procedure, any award they are adjudged to receive is reduced by a minimum of 10% up to a maximum of 50%.

In light of the new regulations, all busi

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

Professional from academic institutions, pharmaceutical industries, health care indust

nesses need to:

Understand the new laws
Review existing disciplinary and grievance procedures
Put in place new procedures where none exists
Inform employe

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

es of their new rights and where they can go to obtain more information

Update company documents such as the employee handbook to reflect the new legislation

Follow the new

.

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

hree-step process when dealing with any disciplinary matters of staff grievances.

------

Copyright 2004 David Miles. You are welcome to reproduce this article on your website, so lo

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

Companies that provide selfless information through particip

ng as it is published "as is" (unedited) and with the author's bio paragraph (resource box) and copyright information included. In addition, all links to external websites must be left in place

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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