Transcript EMACOLEX Budapest 12 and 13 May 2011

EMACOLEX
Budapest 12 and 13 May 2011
Promotion of medicinal products
Icelandic Medicines Agency
Helga Thorisdottir
Applicable law
• Directive 2001/83 with amendments – Art.
88a – 100.
• Icelandic Medicinal Act No 93/1994
• Icelandic regulation on promotion of
medicinal products (soft law) No 325/1998
The Competent Authority with regard to
promotion of medicinal products in Iceland:
• According to Art. 3, para 8 of IS law 93/1994:
The role of the Icelandic Medicines Agency
(IMA) shall be:
To monitor advertising of medicinal products
and ensure that the promotion and
distribution of medicinal products complies
with current laws and regulations.
Is IS law/practice in line with EU law?
• When monitoring advertising of medicinal
products the most common phrase from
pharmaceutical companies is:
But this is allowed elsewhere in Europe!
• Is that the case?
Advertisements of medicinal products
on TV
• According to Directive 2001/83 and IS law it is
forbidden to advertise POM in television.
• According to IS law 93/1994 OTCs can also not be
advertised in television.
-the argument is that there is not enough time for viewers to realise that the
advertisement concerns a medicinal product
-the main aim of the pharmaceutical legislation being to protect consumers
• Is Iceland the only country in Europe banning
OTCs advertisements on televison?
Advertisements of Medicinal Products
in other media
• How about OTCs advertisements on the internet,
in the movies, on newspaper stands, flip posters,
in the radio – how is this regulated in Europe?
In Iceland we try to regulate this according to
common sense, i.e. the letters need to be big
enough to be read easily and to appear
sufficiently long enough for the reader to read
them or if that is the case - to hear them.
Is this IS approach in line with Europe?
IS experience of the most common cases:
• OTC medicinal products: Nicotinell / Nicorette
Also – advertisments on:
• Unbranded medicinal products
• Unlicenced medicinal product
Bold statements in OTCs advertisements:
•
Pharmaceutical companies advertise OTCs (Nicorette/Nicotinell)
and argue that it is:
-
the most popular medicinal product on the market
or
the best according to taste results:
This has been banned by IMA – since it´s not objective enough
according to Art. 3 of IS regulation No 328/1995. That kind of
advertisement of medicinal product can also encourage
unreasonable use of medicinal products wich is not in line with the
aim of the legislation in question.
Is this IS ban in line with the rest of Europe?
Advertisements of OTCs should be
according to the SmPC
-how much in accordance with the SmPC?
-how far can we reach in allowing different wording?
-how about wording that consists of additional
adjectives not found in the SmPC?
...Advertisements of OTCs should be
according to the SmPC
• Nicorette Fruitmint – A taste that surprises you
Your way, your decision, your Nicorette
• Nicorette Fruitmint – so good that men will disguise in order
to get it
• Nicorette Fruitmint is soft on the inside, has crunchy surface
and refreshing taste with delicous blend of fruit and mint. The
best way to quit. How far are you willing to go?
Is the IS ban of the above in line with Europe?
Words not in line with SmPC that IMA has banned:
• Nicorette/Nicotinell: Soft / fresh / sugarfree,
Argument: Information on medicinal products should be objective and not as
if discussing food.
• Nicorette/Nicotinell: Double the chances of quitting smoking! / The blue
packages will double the help / Double the gain
Argument: It is not allowed to guarantee results when using MP.
• Lamicil - Lets have beautiful toes this summer!
Argument: It is not allowed to guarantee results when using MP.
• How about: Actavis – Have a nice summer – Loritin
Would Europe allow this?
Unlicenced Medicinal Products
• Medicinal products which have marketing authorisations in Iceland
may be advertised and promoted in Icelandic according to IS law.
-How about discussions at European/International doctors’
conferences before a marketing authorisation has been issued?
-How about only informing a local group of doctors on OTCs/POM
some days prior to the marketing authorisation being issued?
IMA has demanded that no publicity on OTCs/POM takes place prior to
the issuing of a marketing authorisation.
Does Europe share our view here?
Unbranded Medicinal Products
•
The medicinal product Champix – POM
-Is it possible for the MA holder (or his agent) to advertise to the general public by
using a part of a logo/advertising material for Champix addressed to health care
professionals and argue that it´s unbranded advertisement?
-Also, is it possible to advertise the same MP to the general public with the above
mentioned logo/advertising material with the following words:
Search advise from your doctor concerning new methods to quit smoking
You are determined to quit – isn´t that so
Smokers that are determined to quit search advise from doctors
IMA´s view is that this is advertisement on POM since Pfizer is the company publishing the advertisement
wich has the marketing authorisation for Champix and advertising material for POM has been used for the
general public.
Does Europe share our view?
Thank you very much for your
attention!