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Such liberalisation comes the risk of these new entrants conducting less than ethical business practises that were impossible for a state controlled monopoly; and so with liberalisation comes a new wave of regulation.

A fact of the

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

telecom's industry is that all new entrants have had to resell all or part of the incumbent monopoly’s infrastructure. However, by using the Internet and the unbundled local broadband loop, VoIP is a technology that will allow a new

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

Examples of combination products may in

breed of telecom operator that has no recall to the incumbent monopoly other than to interconnect with it to pass traffic between each other.

VoIP, therefore has attracted the attention of regulators, and from a European-wide perspe

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

ctive, the issue is that this attention varies from country to country. Each National Regulatory Authority has a different view. According to a recent survey conducted by networking technology company Spirent Communications, the I

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

nternational Engineering Consortium and Total Telecom magazine, twenty per cent of European telecoms executives said that government regulation is the biggest threat to VoIP, meanwhile 84 per cent believe the technology is ready for

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

Combination pro

widespread deployment.

According to a Gartner report in January 2006, no common approach has so far been adopted among National Regulatory Authorities (NRAs) for the delivery of voice over Internet Protocol (VoIP) across Europe. In

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

some countries, the service is treated as being equivalent to a regular circuit-switched telephone connection, while in others, it is considered more as a data service. Until a common approach is implemented, VoIP service providers w

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

ill be unable to deliver common service platforms across multiple countries, removing one of the key opportunities enabled by the underlying technology — that of cross-national competition.

The survey found that NRAs have resisted d

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

eveloping specific policies or regulations concerning VoIP. While no one has an appetite to aggressively regulate this technology, changes will need to happen to accommodate the rapid move in consumer and business use patterns. Gartn

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

er believes that with VoIP and other IP-enabled or electronic communications service (ECS) maturing, end users are often unaware that protection and statutory rights are not the same with VoIP services as for switched voice.

Therefo

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

re, Gartner concludes, VoIP will force broad regulatory changes, because voice telephony is being redefined. IP not only affects the pricing of voice services, but also changes the way voice services and features are ordered, provisi

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

Following aspects would a

oned, delivered, marketed and regulated. As a result, the inevitable regulatory changes will add cost to the provisioning of IP-enabled services, thus closing the end-user price advantage currently enjoyed by VoIP services.

As rega

dd to the challenges in developing combination products:

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

rds the UK market specifically, under the Communications Act of 2003 Ofcom’s primary regulatory control on the VoIP market is to police a code of conduct for providers of a pubic telephony service – over whatever technology – to cons

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

umers and small business. (As for big business, caveat emptor.) This code of practise deals with the business process as opposed to the underlying technology and, as far as the consumer is concerned, is all that is required.

To q

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

uote from Clause 52 of The Act itself:

(2) Those matters are-
(a) the handling of complaints made to public communications providers by any of their domestic and small business customers;
(b) the resolution of dispute

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 between such providers and any of their domestic and small business customers;
(c) the provision of remedies and redress in respect of matters that form the subject-matter of such complaints or disputes;
(d) the informati

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

Professional from academic institutions, pharmaceutical industries, health care indust

on about service standards and about the rights of domestic and small business customers that is to be made available to those customers by public communications providers;
(e) any other matter appearing to OFCOM to be necessary

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

for securing effective protection for the domestic and small business customers of such providers.

VegaStream’s position regarding regulating the VoIP industry is similar to that of OfCom’s. The application is straightforward

.

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

– the ability to enable people to talk to each other over a telecommunications network. With VegaStream gateways this network can contain both IP and TDM elements and that fact is completely transparent to the end. Regulators shoul

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

Companies that provide selfless information through particip

d therefore continue to refine their ability to protect the consumer against bad business practise and ensure that the innovators within the VoIP industry can bring the full benefits of this technology to business and consumers alike

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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