Answers - Legal

Each year in the UK many thousands of workers are injured during the course of their duties. It is important that positive steps are taken by all injured parties to protect their legal rights should a compensation claim become necessary.

The latest figures released by the Health and Safety Comm

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

ission for 2004/2005 indicate that there were 150,559 non fatal injuries sustained by employees. This equates to 587 injuries per 100,000 employees. The number of actual compensation claims made for injury bears no resemblance to these statistics because most employees dare not or simply will no

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

Examples of combination products may in

claim against an employer.

Only 2 out of every f5 people will usually make a claim. The number of claimants runs into tens of thousands every year. Here are some basic points on health & safety at work and how an individual / employee should react to an injury sustained at work.

Wh

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

t should the employer do to ensure that accidents are reduced?

The general rule is that an employer must take “reasonable care” to ensure adequate health and safety measures are in place and that the risk of an injury being sustained by any worker is reduced as much as possible.

T

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

is is usually done by by providing a safe system of work where any potential risks are assessed and if possible reduced as much as is reasonably possible. This could be by something as simple as altering the layout of the premises or providing training and instruction on how best to carry out ta

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

Combination pro

ks in the safest manner.

Or by providing adequate plant, this may range from the provision of heavy machinery down to even the most basic of office equipment such as tables and chairs

Finally the employer must ensure that fellow employees are competent to reduce the risk of human error causing

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

accidents at work whether through ignorance, negligence or malice. So even if a fellow employee causes you to sustain an injury then as long as they are acting in the course of their work it is possible that your employer may be liable for their actions.

Employers Liability Insurance

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

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Once you are in a position to make an informed decision you may decide to make a claim against your employer. Any claims should be covered by the employers insurance.

Most employers are required by law to have Employers Liability Insurance, failure to have this can mean that sanct

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

ons are imposed against the employer. Taking such a policy out ensures that funds are available to meet the costs of compensation and legal fees where an employee is injured or becomes ill as a result of the fault of the employer. This also means that an employee can seek compensation even if th

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

t business goes into liquidation or receivership.

The claims themselves are dealt with via the employer’s insurance company and not the actual employer themselves. The employer only becomes involved in a claim where they have to provide details to the insurers when they are investigating the cl

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

im to prove where fault lies for the accident.

A copy of the Certificate of Insurance itself should be displayed where any employee could easily read it.

What should the employer do when an employee has an accident at work?

In any case regardless of the severity of the

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

Following aspects would a

injury caused to an employee a report of this should be made in the company accident book. The employer is obliged to keep an accident book on the premises. This should give details such as the accident circumstances, dates, identity of the injured party and details of what caused the accident i

dd to the challenges in developing combination products:

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

at all possible. It is very important that any accident is reported just in case the injury gets worse and this also serves as proof that the accident actually occurred in the manner described.

RIDDOR

Your employer has an obligation to comply with the Reporting of Inju

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

ies Diseases and Dangerous Occurrences Regulations 1995 otherwise known as RIDDOR. These require that any deaths, major injuries, injuries that result in an absence of more than three days, injuries to members of the public and dangerous occurrences or near misses be reported.

The Health & Safe

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

y Executive will usually intervene in a case referred to RIDDOR. More information on RIDDOR may be found on the HSE website.

What you should do if you have an accident at work

Most people tend to be in a state of shock when an accident occurs. Irrespective of whether th

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

s is through the pain caused, or just disbelief that the accident happened. Most people have the mentality that it will “Never happen to them”. Also as you reach adulthood people tend to think that only the young and elderly have accidents. Therefore, it is often it is a bigger shock to the syst

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

Professional from academic institutions, pharmaceutical industries, health care indust

m when an adult has an accident.

There are some very simple steps to follow which people often forget in the aftermath of an accident work, and so when they decide to make a claim they find it very difficult to prove that the accident occurred in the manner described.

· Report the acci

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

ent in the accident book as soon as possible;

· When the accident report is made ensure that it is factually correct before you sign it. Do not let the employer or senior management pressurise you into signing a document that is untrue;

· If there were any witnesses to the inci

.

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

ent then take their details. If there were no witnesses to the actual event it may be possible to get witnesses to system of work which may have caused the injury. This could also be of assistance to you should you wish to make a claim and the system of work employed was an unsafe one;

·

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

Companies that provide selfless information through particip

Go and see your own doctor or attend the hospital if the injury warrants it. This is so that there is a record in your medical history that you were injured and what the diagnosis was and whether you had to have treatment and medication;

· Get some legal advice from a reputable law fir

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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Answers - Personal Injury at Work - Protect Your Legal Rights

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