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Top Articles - Data Protection - Government Intends to Impose Tougher Penalties for Misuse of Personal Data
The Department for Constitutional Affairs (National) issued a press release on 7 F
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
ebruary 2007, stating that the courts will now be able to imprison anyone who trad
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
es in or deliberately mis-uses individual’s personal data.
This decision follows
This decision follows
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
a public consultation which looked at whether or not the existing penalties for de
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
liberately and willfully mis-using personal data were suitable.
As a result of a
As a result of a
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
consultation, the Government’s new stance is that current penalties (a fine) under
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
section 55 (4-8) of the Data Protection Act 1998 (“the DPA”), are not acting as a
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
strong enough deterrent.
Under section 55, it is an offence to sell (or offer to
Under section 55, it is an offence to sell (or offer to
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
sell) personal data which has been (or is subsequently) obtained/procured knowing
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
ly or recklessly without the consent of the data controller. The data controller h
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
s overall responsibility for an individual’s data.
Section 60 of the DPA states t
Section 60 of the DPA states t
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
hat:
On summary conviction, a fine not exceeding the statutory maximum; and
On c
On summary conviction, a fine not exceeding the statutory maximum; and
On c
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
onviction on indictment, a fine (unlimited).
The plan is to amend section 60 of t
The plan is to amend section 60 of t
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
he DPA to give the courts the authority to impose higher fines and even imprisonme
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
nt in certain cases. This shift in severity is hoped to further deter trade in per
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
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
sonal data.
The proposed amendment for Section 60 of the DPA is as follows:
- On
The proposed amendment for Section 60 of the DPA is as follows:
- On
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
summary conviction, up to six months imprisonment (increased to twelve months imp
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
risonment in England and Wales when s154 of the Criminal Justice Act 2003 comes in
.
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
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
to force); and
- On conviction on indictment, up to two years imprisonment.
For
- On conviction on indictment, up to two years imprisonment.
For
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
more information visit http://www.dca.gov.uk or Information Commissioner’s Office
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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