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There's been widespread speculation about the new legislation being introduced under the DDA (Disability Discrimination Act), which will ensure that websites are accessible to blind and disabled users. Try to find specif

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

ic information about it on the Internet and chances are you'll come up empty handed.

The RNIB (Royal National Institute for the Blind) and the DRC (Disability Rights Commission), two of the most renowned advocates for t

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

Examples of combination products may in

he DDA (Disability Discrimination Act) and accessible websites, have no specific information about the laws and what websites specifically need to do in order to meet the legal requirements.

So, what does the law state?

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

Part III of the Disability Discrimination Act refers to the provision of goods, facilities and services. The Code of Practice, which specifically mentions websites, can be downloaded in its entirety from the DRC websit

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

(http://www.drc-gb.org/open4all/law/Code%20of%20Practice.pdf 676kb).

The relevant quotes from this 175-page document are:

2.2 (p7): "The Act makes it unlawful for a service provider to discriminate against a disabled

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

Combination pro

person by refusing to provide any service which it provides to members of the public."

4.7 (p39): "From 1st October 1999 a service provider has to take reasonable steps to change a practice which makes it unreasonably d

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

ifficult for disabled people to make use of its services."

2.13 – 2.17 (p11-13): "What services are affected by the Act? An airline company provides a flight reservation and booking service to the public on its website.

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

This is a provision of a service and is subject to the act."

5.23 (p71): "For people with visual impairments, the range of auxiliary aids or services which it might be reasonable to provide to ensure that services are

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

ccessible might include ... accessible websites."

5.26 (p68): "For people with hearing disabilities, the range of auxiliary aids or services which it might be reasonable to provide to ensure that services are accessible

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

might include ... accessible websites. " When does the law come into force?

It's widely believed that the new laws will be implemented in October of this year, when the final part of the DDA comes into force. This fi

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

nal piece of legislation actually refers to service providers having to consider making permanent physical adjustments to their premises and is not related to the Internet in any way.

The law about accessible websites c

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

Following aspects would a

ame into force on 1st October 1999 (http://www.drc-gb.org/open4all/law/code.asp) and the Code of Practice for this section of the Act was published on 27th May 2002 (http://www.hmso.gov.uk/si/si2002/20020720.htm). This m

dd to the challenges in developing combination products:

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

ans that the majority of websites are already in breach of the law.

Can you be sued?

Well, probably. The RNIB claim that they've considered taking up a number of legal cases against organisations with regard to their w

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

ebsites. When they raised the accessibility issues of the website under the DDA, companies have typically made the necessary changes, rather than facing the prospect of legal action.

The DRC has now published their find

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

ings from their formal investigation into 1000 websites. (http://www.drc-gb.org/publicationsandreports/2.pdf). If your website was included then you will have to start thinking about making it accessible to all web users

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

in the very near future.

What do you need to do to comply?

It's widely believed that if, or perhaps more appropriately when, a case makes it to court that the W3C accessibility guidelines will be used to assess a webs

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

Professional from academic institutions, pharmaceutical industries, health care indust

te's accessibility and ultimately decide the outcome of the case. The W3C is the Internet governing body and its web accessibility guidelines can be found at http://www.w3.org/TR/WAI-WEBCONTENT/full-checklist.html.

To f

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

urther complicate matters, the W3C offers three different levels of compliance. Priority 1 guidelines, (which must be satisfied according to the W3C) will almost certainly have to be adhered to. Priority 2 guidelines (wh

.

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

ich should be satisfied and are the EU recommended level of compliance (http://www.disabilityworld.org/09-10_02/access/internetaccess.shtml), or some part of, will probably also need to be adhered to too.

The courts wil

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

Companies that provide selfless information through particip

l also no doubt take guidance from the outcome of an Australian case in 2000, when a blind man successfully sued the Sydney Olympics organising committee over their inaccessible website (http://www.contenu.nu/socog.html)

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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From the biggest boardrooms and the smallest business offices, executives gather around tables asking the same question, “Where's the data to prove it works?” Gauging return-on-investment, or ROI, for marketing dollars spent is one of the most-confounding parts of any marketing campaign. It's more than understandable for investors, managers and owners to want hard feedback on their investments. And in my experience, it doesn't matter whether the budget is $25 a month, the make-or-break investment for some small start-ups, or $25,000 a year, the significant budget of many medium to large corporations. All of them want to see success through numbers.

This article explains what is iGanit and how service providing businesses can take advantage of the internet based world's first services market place using video technology.

If you can design crafts, you sure can develop your own site to sell them. Making beautiful things is the easy part, getting potential customers to your products is a whole different story!

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