Advice You - Business

If you were thinking of offering your employees special rewards as incentives for having good attendance records, then you must

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

read on. In fact, employers that offer attendance bonuses may find themselves falling foul of the law.

The Royal Mail introduce

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

Examples of combination products may in

d a rewards scheme for staff that did not to take time off sick. Under the Royal Mail's scheme, workers with full attendance rec

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

ords were entered into a prize draw to win Ford Focus cars or holiday vouchers worth ?2,000. As a staff incentive, it seemed to

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

ork. The Royal Mail says its overall sickness absence levels fell during a nine-month period (between August and April) by 11%.

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

Combination pro

However, such schemes could have serious ramifications from a legal viewpoint, and leave employers vulnerable to a variety of l

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

egal claims.

Discrimination

Employees could bring discrimination claims on the grounds of disability or sex. The success of th

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

ese claims would depend on each employee's particular circumstances and needs, whether in relation to their family, religion or

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

ealth. Alternatively, qualifying employees could bring claims for being subjected to detriment treatment as a result of assert

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

ing their statutory rights, for example, for:-

Time off for dependants and antenatal care; Time off for study or training or

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

time off for jury service Maternity leave; Adoption leave; or Paternity or parental leave;

Disability discrimination may

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

Following aspects would a

occur if, for example, an employee had time off connected to a disability and this was not taken into account by the employer un

dd to the challenges in developing combination products:

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

er the reward scheme. The employee might claim that the failure of the employer to set aside his/her absence for disability rela

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

ted reasons amounted to less favourable treatment. How can employers protect themselves from such claims?

Employers can avoid

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

these pitfalls by including a list of exceptions in the reward scheme, for example, jury service or study leave, taking into ac

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

count any statutory rights to time off; or Pay bonuses to employees connected to performance in their job rather than implemen

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing an attendance reward. Employers should be wary of adopting an attendance bonus scheme without legal consultation.

If you

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

require further information contact us.

Email: enquiries@rtcoopers.com

© RT COOPERS, 2005. This Briefing Note does not provide

.

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

a comprehensive or complete statement of the law relating to the issues discussed nor does it constitute legal advice. It is in

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

Companies that provide selfless information through particip

tended 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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