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The Regulation of Investigatory Powers Act 2000 requires public authorities to establish a system of prior authorisation before conducting surveillance. This article addresses the particular types of surveillance the local government councils are permitted to unde

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

rtake. For a Local Council the main areas that require RIPA authorisations are:

1) Directed Surveillance;

2) Covert Human Intelligence Sources (CHIS);

3) Requests for Communications Data.

RIPA does:

• require prior authorisation of directed surveillance.

• p

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

Examples of combination products may in

ohibit a local Council from carrying out intrusive surveillance.

• require authorisation of the conduct and use of a CHIS.

• require safeguards for the conduct and use of a CHIS.

RIPA does not:

• make unlawful conduct which is otherwise lawful.

• prejudice or

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

dis-apply any existing powers available to the Council to obtain information by any means not involving conduct that may be authorised under this Act. For example, it does not affect the County Council's current powers to obtain information via the DVLA or to get

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

nformation from the Land Registry as to the ownership of a property.

‘Surveillance' includes:

• monitoring, observing, listening to persons, watching or following their movements, listening to their conversations and other such activities or communications.

• r

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

Combination pro

cording anything mentioned above in the course of authorised surveillance.

• surveillance, by or with, the assistance of appropriate surveillance device(s).

Overt Surveillance

Most of the surveillance carried out by the Council will be done overtly. In many cas

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

s, Officers will be behaving in the same way as a normal member of the public (e.g. in the case of most test purchases), and/or will be going about Council business openly (e.g. a market inspector walking through markets). Similarly, surveillance will be overt if

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 subject has been told it will happen (e.g. where a noisemaker is warned (preferably in writing) that noise will be recorded if the noise continues, or where an entertainment licence is issued subject to conditions, and the licensee is told that officers may vis

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

t without notice or identifying themselves to the owner/proprietor to check that the conditions are being met. CCTV is usually overt because people know it is occurring and is not directed at a specific person over a prolonged period.

Covert Surveillance

Covert

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

urveillance is carried out in a manner calculated to ensure that the person subject to the surveillance is unaware of it taking place (Section 26(9) (a) of RIPA). RIPA regulates two types of covert surveillance, (Directed Surveillance and Intrusive Surveillance

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

and the use of Covert Human Intelligence Sources (CHIS).

Directed Surveillance

Directed Surveillance is surveillance which:-

• is covert; and

• is not intrusive surveillance;

• is not carried out in an immediate response to events which would otherwise make

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

Following aspects would a

seeking authorisation under the Act unreasonable, e.g. spotting something suspicious and continuing to observe it; and

• it is undertaken for the purpose of a specific investigation or operation in a manner likely to obtain private information about an individual

dd to the challenges in developing combination products:

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

(whether or not that person is specifically targeted for purposes of an investigation). (Section 26(10) of RIPA).

Private information in relation to a person includes any information relating to his private and family life, his home and his correspondence. The fa

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

t that covert surveillance occurs in a public place or on business premises does not mean that it cannot result in the obtaining of private information about a person. Prolonged surveillance targeted on a single person will undoubtedly result in the obtaining of p

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

ivate information about him/her and others that s/he comes into contact, or associates, with.

‘Directed Surveillance' must be authorised by an Authorising Officer who must follow the RIPA authorisation procedures.

Intrusive Surveillance

This form of surveillanc

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

can be carried out only by police and other law enforcement agencies. Council Officers must not carry out intrusive surveillance.

Intrusive Surveillance is when it:-

• is covert;

• relates to residential premises and private vehicles; and

• involves the prese

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

Professional from academic institutions, pharmaceutical industries, health care indust

ce of a person in the premises or in the vehicle or is carried out by a surveillance device in the premises/vehicle. Surveillance equipment mounted outside the premises will not be intrusive, unless the device consistently provides information of the same quality

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

nd detail as might be expected if they were in the premises/vehicle.

General observation forms part of the duties of many law enforcement officers and other public authorities and is not usually regulated by the 2000 Act. For example, police officers will be on p

.

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

trol to prevent and detect crime, maintain public safety and prevent disorder or trading standards or HM Customs and Excise officers might covertly observe and then visit a shop as part of their enforcement function to verify the supply or level of supply of goods

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

Companies that provide selfless information through particip

or services that may be liable to a restriction or tax. Such observation may involve the use of equipment to merely reinforce normal sensory perception, such as binoculars, or the use of cameras, where this does not involve systematic surveillance of an individual

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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