Answers - Legal

In the case of Vaseghi and another v. Brunel University and another [2006], the employees made separate complaints of race discrimination and claimed compensation against their employer. Settlement discu

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

ssions began before an initial set of tribunal hearings in 2004, however, no settlement was reached.

Following the initial hearings, the employer released a quarterly newsletter which outlined that it w

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

Examples of combination products may in

as spending a large amount of money on defending employment claims. It made particular reference to two tribunal hearings which had cost in excess of ?60,000. It also criticised employees and the trade u

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

nion for pursuing unfounded allegations and making unwarranted demands for money. The two employees lodged grievances in response to the newsletter. They claimed the following:

* The employer had

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

initiated the attempts at settlement;

* The employer had raised the prospect of financial settlement; and

* The newsletter had amounted to victimisation.

The grievance committee heard o

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

Combination pro

ral evidence on the discussions between the parties in their attempts to reach a settlement, however, it was decided that the grounds for the grievance had not been established. The employees then began

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

new tribunal proceedings.

At the new hearings the employer challenged the admissibility of the evidence relied upon before the grievance committee by the employees. The employer argued that the evidence

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

concerning the settlement discussions were protected by ‘without prejudice’ privilege. The tribunal concluded in favour of the employer, and held that the evidence should have been inadmissible. It shou

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

ld be noted however that the tribunal also held that the references to the discussions in the grievance committee’s report would be admissible. If they were not, the case for the employees would be preju

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

diced. The employer appealed and the employees cross appealed.

The employer submitted that the references to the discussions in the grievance committee’s report should have benefited from the ‘without p

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

rejudice’ privilege. They argued that the privilege was of more importance than the due administration of justice in relation to putting the case of the employees under severe prejudice.

The employees s

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

Following aspects would a

ubmitted that they should be allowed to use the references to the discussions in the grievance committee’s report, as that was the only evidence of what happened in the settlement discussions in support

dd to the challenges in developing combination products:

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

of their victimisation claims. They claimed that the allegations of unwarranted demands for money were not supported by what had occurred in the settlement discussions. Therefore, they argued that they s

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

hould have been able to rely on the settlement discussions, despite them technically being subject to the ‘without prejudice’ privilege, because there was an overriding public interest in eradicating the

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

evils of victimisation. If they could not rely on the evidence they would not be able to present their case for victimisation.

The employment appeal tribunal held that the employees claims would have b

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

een too severely hampered were they not permitted to rely on the settlement discussions as evidence against the allegations that they had not made unwarranted demands for money. The employer, through the

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

Professional from academic institutions, pharmaceutical industries, health care indust

publication of the newsletter had brought the matter into the public domain, and subsequently could not rely on the ‘without prejudice’ privilege. To prevent the employees from relying on the evidence i

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

n support of their victimisation claims would have been a clear abuse of a privileged occasion. The eradication of discrimination and victimisation was deemed more important than the protection of the ‘w

.

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

ithout prejudice’ privilege. Therefore the appeal was dismissed and the cross appeal allowed.

© RT COOPERS, 2006. This Briefing Note does not provide a comprehensive or complete statement of the law rel

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

Companies that provide selfless information through particip

ating to the issues discussed nor does 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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