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    Ignore at your peril

    Many British businesses have been slow to appreciate the full extent of changes that have occurred over the years to Employment Law and continue to adopt out of date disciplinary and redundancy procedures. Luc
    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
    ky for them then that the only people who seem less aware of the changes are the employees themselves; few employees would believe the extent that they are now protected, but that is not likely to last.

    With the maximum compensatory award in un
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    fair dismissal cases now over ?50,000 and with tribunals willing to make awards without any regard to a company's financial position, small to medium sized businesses are most at risk.

    Part-time and agency workers now have comparable rights as
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    those enjoyed by full time employees and discrimination now carries a much wider definition, with even more to come.

    With the introduction of "no win, no fee" legal representation an employee now has little to loose and much to gain by bringing
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    a claim against a former employer. Tribunals do not operate in the same way as a court of law, the company is not 'not guilty' until proven 'guilty' but rather considered guilty until they can prove otherwise. In the absence of real evidence a t
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ribunal will take anecdotal evidence and decide subjectively for themselves as to who, on balance, they believe.

    Redundancy guidelines

    The redundancy guidelines published by governing bodies and often the advice that is received
    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
    from employment law specialists is not always as helpful as some businesses might like. Take for example where redundancy guidelines talk of a 'consultation' process, what constitutes consultation is often open to interpretation and what an orga
    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
    isation might itself regard as 'consultation' a tribunal might take as 'a premeditated foregone conclusion'.

    This article views the redundancy process from an organisations point of view where senior managers are likely to be under considerable
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    pressure, frustrated and keen to act.

    Where fools rush in

    Few people, if any, relish the need for redundancies but often there is a desire from management to get a difficult task over with as quickly as possible so that the orga
    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
    nisation can move on. Managers need to be educated in the fact that although following the proper guidelines will take longer than just handing out redundancy notices letters the process can bring benefits to the employer if done properly.

    In a
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    redundancy situation companies are able to act with complete autonomy, there is no legislative body looking over their shoulders, monitoring the methods used and in the absence of a trade union, employees are unlikely to be au fait with details
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    of employment law. However, if claims of unfair dismissal are subsequently received the procedures and methods a company adopted will be laid bare and heavily scrutinized and the consequences of inadequate procedures penalised.

    A tribunal is no
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    t a pleasant place for any company official, with the benefit of hindsight a tribunal will asks difficult questions; what was a real crisis six months earlier may be difficult to convey to people who have no knowledge of the business or in some
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    cases the industry.

    Being seen to be fair

    Being a good employer who operates in good faith and with genuine intentions is not enough, such employers are more and more finding themselves having to pay substantial compensation to f
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    rmer employees, some of whom may be undeserving but nevertheless know how to play the system.

    UK companies are no longer seen as merely providing employment but as being socially responsible and when a company takes on new employees they are as
    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
    suming more responsibility for that person than many realise.

    Today companies have to be very aware of what their responsibilities are and how they must act. For small companies where the owners may be more entrepreneurial, the business more ha
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    nd to mouth, there is no provision to allow them to operate in any other way than that expected of larger and more established organisations.

    Some managers can often make the mistake of thinking that redundancy procedures do not apply to junior
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    staff and will still issue redundancies on the fly, such action will only expose them to a possible claim for unfair dismissal that they will have every chance of loosing.

    A step-by-step guide

    To support senior managers a questio
    .

    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
    nnaire has been devised that will guide senior management through the steps required when making redundancies.

    By completing the questionnaire a manager will obtain a redundancy procedure checklist and if each step is completed a company can be
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    confident that they will be able to vigorously defend any future unfair redundancy claims they receive.

    A Manager's Guide to Managing Redundancy in the UK


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