Answers - Legal

On 1 October 2006 the Regulatory Reform Fire Safety Order 2005 (RRO) came into force and, in doing so, replaced the previous fire safety legislation. From the end of October 2005, fire certificates were abolished and ceased to h

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

ave legal status.

According to the Government, the purpose of the RRO is to make the law easier to understand and comply with and, in doing so, reduce incidents of death, injury and damage caused by fire.

The most recently pub

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

Examples of combination products may in

lished statistics reveal that there were over 40,000 fires in non domestic buildings in the UK last year, and that there were 20 fire deaths in non domestic premises in the year to June 2005.

Who needs to comply?

The RR

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

O applies to virtually all premises and covers nearly every type of building, structure and open space. By way of example, it will apply to:

offices and shops
factories and warehouses
care homes and hospital

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

community premises and places of worship

communal parts of shared properties

pubs, clubs and restaurants

hotels and hostels

The RRO will not, however, apply to people’s private homes, including indi

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

Combination pro

vidual flats in a block or house.

Who is responsible for complying with the RRO?

The responsibility for complying with the RRO lies with the “responsible person”, who can be anyone who has a degree of control over certa

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

in areas or systems. In the workplace, this will be the employer and any other person who may have control of any part of the premises, for example the owner or occupier. In all other premises the person or people in control of

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

he premises will be responsible.

Although in many instances the identity of the responsible person will be clear, there will be other occasions when there will be two or more people who have some responsibility and will therefo

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

re be jointly responsible. In this case they will need to work together to ensure compliance.

What is required under the RRO?

Under Regulation 8, the responsible person must take such general fire precautions as is reas

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

onably practicable to ensure both the safety of employees and others. In order to identify what steps to take the responsible person is required under Regulation 9 to make a “suitable and sufficient” risk assessment. Most employ

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

ers and landlords will already be familiar with the concept of fire risk assessments as a result of their current obligations under the Fire Precautions (Workplace) Amendment Regulations 1999. These risk assessments will need to

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

Following aspects would a

be reviewed in light of the RRO, which requires various matters to be given special consideration. These include:

The size of the business and the nature of its activities
The existence of any dangerous substanc

dd to the challenges in developing combination products:

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

Whether people aged under 18 are or will be employed

That the premises is equipped with appropriate fire-fighting equipment, fire detectors and alarms

That routes to emergency exits are clearly marked and not o

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

bstructed

Information must be provided to employees, including details of the risks identified by the risk assessment and the preventative and protective measures put in place

That employees be provided with adequate s

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

fety training, for example in the use of fire equipment and how to respond in the event of a fire. Whilst the responsible person may delegate the task of preparing the risk assessment to some other competent person, they

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

will still be responsible in law for complying with the RRO.

Importantly, the risk assessment should be regularly reviewed to ensure that it is up to date. The responsible person will have to re examine the risk assessment if,

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

Professional from academic institutions, pharmaceutical industries, health care indust

for any reason, it is suspected to be no longer valid. This would normally include, by way of example, when there has been an accident or a ‘near miss’.

What happens if you fail to comply?

Enforcing authorities (princi

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

pally the Fire Authority but also, in certain circumstances, the Heath and Safety Executive) have the power to issue an Enforcement Notice requiring steps to be taken to remedy the failure or, if there is a serious risk of injur

.

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

y, a Prohibition Notice restricting or preventing the use of the premises until specified steps have been taken.

It is also an offence punishable by way of a (potentially unlimited) fine or to imprisonment for a period of up to

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

Companies that provide selfless information through particip

2 years or both if one fails to comply with the requirements of the RRO.

Further information and guidance on the RRO can be obtained from www.communities.gov.uk.

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 - Regulatory Reform Fire Safety Order 2005

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