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The Age Discrimination Regulations came into force on 1 October 2006 and implement the age component of the European Framework Employment Directive. The DTI Regulatory Impact analysis predicts that 8,000 Age Discrimination claims will be brought in the Emp

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

loyment Tribunals per year. Employers need to familiarise themselves with their obligations under the new provisions to avoid costly litigation.

Scope

The Age Discrimination Regulations apply equally to employees of all sizes of companies. As is so often

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

Examples of combination products may in

the case, small firms will in some ways be expected to operate their policies as if they had the benefit of a human resources department of a large corporation at their disposal. There are no exclusions for part-time workers and unlike the position in the

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

USA, there are no exclusions for employees below a certain age.

They apply to employees and the self-employed ("workers"), contract workers (such as those provided by third party agencies), adults receiving training or education from employers; further an

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

higher education institutions and adult education programmes; those in work experience and members or an applicant for membership of a trade organisation, including a trade union. Unpaid volunteers are not protected.

Default Retirement Age

However, the

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

Combination pro

Age Discrimination Regulations are nothing to do with the debate on extending the retirement age. In fact, the Age Discrimination Regulations provides for a default retirement age of 65 and excludes employees from claiming age discrimination in respect of

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

forced retirement of those aged 65 and over. Interestingly, this particular limitation only applies only to "employees". Of course, one must remember that even for those employees over 65 a new retirement dismissal procedure must be followed for the dismis

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

sal to be fair. A mandatory retirement age for non-employees, even of the age of 65, will have to be "objectively justified".

What Is Unlawful Age Discrimination?

For the purpose of the Age Discrimination Regulations, there are two types of age discrimin

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

tion: (1) Direct age discrimination; and (2) Indirect age discrimination. A person (A) directly discriminates against another person (B) if on grounds of B's age, A treats B less favourably than he treats or would treat other persons. Indirect Age Discrimi

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

nation is where A applies to B a provision, criterion or practice which he applies or would apply equally to persons not of the same age group as B, but which puts or would put persons of the same age group as B at a particular disadvantage when compared w

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

th other persons, and which actually puts B at that disadvantage. There is also protection for those of a perceived age. If someone is discriminated against because they look too young, or too old, for a particular job, they will be able to complain succes

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

Following aspects would a

fully even if the discriminator is wrong about their actual age.

The distinctive feature of the Age Discrimination Regulations is that direct, as well as indirect, discrimination will be capable of being "objectively justified", and the same test will app

dd to the challenges in developing combination products:

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

ly to both forms of discrimination.

How Does One Objectively Justify Age Discrimination?

The Age Discrimination Regulations are new and there is not yet a body of UK case law, but it is highly unlikely that the high costs of employing older people, for e

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

ample, will be a justification for an employer that would allow him to discriminate on the basis of age. It is further highly unlikely that customer preference will be a legitimate aim allowing employers to discriminate on the grounds of age. In other word

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

s justification for age discrimination cannot be related to age discrimination itself. The DTI have given the following example: "A retailer of trendy fashion items wants to employ young shop assistants because it believes that this will contribute to its

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

im of targeting young buyers. Trying to attract a young target group will not be a legitimate aim, because this has an age-discriminatory aspect." There is also the need to be proportionate. This means that employers must use the least discriminatory meas

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

Professional from academic institutions, pharmaceutical industries, health care indust

ure possible even to achieve a legitimate aim. An employer may have to show why it was proportionate to use directly discriminatory age barriers rather than age neutral potentially indirectly discriminatory policies.

Age-based Harassment

A subjects anoth

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

r person (B) to harassment where, on grounds of age, A engages in unwanted conduct which has the purpose or effect of: (1) violating B's dignity; or (2) creating an intimidating, hostile, degrading, humiliating or offensive environment for B. Harassment wi

.

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

ll only be regarded as having had the effect of violating the B's dignity or of creating an offensive working environment if it "should reasonably be considered as having that effect". Ageist jokes and teasing may very well create such an environment. Cond

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

Companies that provide selfless information through particip

ct must be "unwanted" by the recipient.

Conclusion

We can see that there are many aspects of human resources and discrimination policy that will have to be fundamentally reviewed in light of the Age Discrimination Regulations.

Copyright (c) 2006 Ian Man

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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