Answers - Legal

A bid by Sir Elton John to prevent the Daily Mail publishing a photograph of him walking with his driver from his car to his London home was rejected by the High Court. If Sir Elton had

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

been successful in obtaining this injunction, it would have completely revolutionised British newspaper and magazine practice.

Sir Elton had his picture taken by a freelance photographe

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

Examples of combination products may in

r whilst walking from his Rolls Royce to the front gate of his West London home. He then heard that the Daily Mail was planning to publish the picture, and he applied for an injunction t

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 prevent publication on the ground that it was an unwarranted infringement of his privacy. The picture merely showed him casually dressed, but he complained that it showed his baldness

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

was returning.

In his application, Sir Elton argued that the photo in question, which was surreptitiously acquired, was taken without consent, made no contribution to any matter of publ

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

Combination pro

ic interest, and its publication would be a breach of the Press Complaints Commission code. He supported his bid with the decision in the European Court of Human Rights case of Von Hanno

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

ver v Germany [2004] ECHR, which involved Princess Caroline of Monaco. It was held in this case that her right to a private family life had been violated by sustained paparazzi photograp

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

hy of her and her children.

Another case which sheds light on this situation is Campbell v MGN, which involved the supermodel Naomi Campbell. The House of Lords awarded her damages and

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

compensation against the Mirror for breach of confidence in relation to the publication of photographs of her outside a Narcotics Anonymous meeting. It was stressed, however, that the ac

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

tivity photographed must be private. With reference to Naomi Campbell, Lady Hale said:

“Readers will obviously be interested to see how she looks if and when she pops out to the shops f

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

r a bottle of milk. There is nothing essentially private about that information nor can it be expected to damage her private life. It may not be a high order of freedom of speech but the

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

Following aspects would a

re is nothing to justify interfering with it."

Sir Elton’s case is the first case where the inconsistency between Von Hannover v Germany and Campbell v MGN has been highlighted before t

dd to the challenges in developing combination products:

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

he court. The question in this case was:

Did Sir Elton have a reasonable expectation of privacy in respect of the information in the photographs and, if he did, did his right to ‘respec

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

t for his privacy’ outweigh the ‘right to freedom of expression’?

Sir Elton’s application for an injunction was rejected by the High Court on the grounds that the photograph, which the

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

Daily Mail subsequently published, did not convey any private information which could, for instance, call into question Sir Elton's health or his sexual relationships.

Comment: The cour

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

t also highlighted the fact that the Princess Caroline case involved an element of harassment from the photographers which caused suffering as she went about her daily business. This fac

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

Professional from academic institutions, pharmaceutical industries, health care indust

tor was lacking in Sir Elton’s application. This decision for Sir Elton means that where a celebrity’s photograph is taken in a public place, his/her lack of consent cannot prevent its p

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

ublication. There would have to be a special element to make the court consider the issue of privacy.

Please contact us for more information on media law at enquiries@rtcoopers.com

Vis

.

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

it http://www.rtcoopers.com/practice_mediaentertainment.php

© RT COOPERS, 2006. This Briefing Note does not provide a comprehensive or complete statement of the law relating to the issu

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

Companies that provide selfless information through particip

es discussed nor does it constitute legal advice. It is intended only to highlight general issues. Specialist legal advice should always be sought in relation to particular circumstances

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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