E-DRUG: Laws regulating drug promotion (3)

E-DRUG: Laws regulating drug promotion (3)
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I fully agree with Joel Lexchin's comments and may confirm that the
situation in Scandinavia resembles the Canadian one.
                                                                         
However, in Norway we do have regulations concerning drug advertising;
unfortunately we pay little attention to the need for an English version!
I will now give my own, quick translation. First, I would point out that
one thing is having regulations, another is enforcing them. See also my
comments at the end. What is in brackets are my own comments/explanations.

First Gerrit, I hope they may be of some value, please let me know if you
would like further explanations.

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I General

With advertising is to understand any form of written or oral mentioning,
picture and distirbution of free samples of drugs for humans and animals and
herbal drugs, which has been formulated in order to promote sale or use.

The regulations will a.o. apply to all forms of promotional activites
between producer/supplier and health personnel or the public, including
conferences, meetings and other sales promotional activites and support to
production of printed material, films or other material.

The regulations do not comprise namely label, package insert or the data
sheet. Further, it does not comprise a manufacturer's mentioning of health
related issues or disease as long as it is not directly or indirectly
linked to the mentioning of one or more drugs (see my comment later).

Advertising for drugs should be factual and sober and should promote
rational use in accordance with prevailing prescribing regulation. Must not
give a misleading or exaggerated picture of a drug's properties and medical
value. Advertising must not cause a use which is not medically well-founded.
Only permitted for approved drugs after they have been given market
authorisation.

Advertising for drugs on TV not permitted.

II Promotional activities towards the public

Advertising to the public only permitted for non-prescription drugs or
prescription drugs which in some package sizes are exempt, and only when
these solely are recommended for diseases or - symptoms which usually will
not need examination by doctor, dentist or vet. Such advertising must not
contain recommendations from doctor, dentist, vet. or others who because of
their position may encourage use of drugs. Illustrations must only pass on
information about the drugs properties and use in an objective manner
without exaggerating its effect. Illustrations must not appear misleading or
play on strong effects, e.g. a body changed by illness or trauma. It is not
permitted to mention seriuos illnesses such as TB, STDs, cancer or similar,
chronic insomnia, diabetes or endocrinological diseases.

It is not permitted to put advertisements, excl. approved package inserts,
in the packages. It is not permitted to link advertising to gifts, prizes or
any other form of reward. Free samples may not be given to the public.

The advertisements should always be designed in such a way that it is
obvious to the reader that it is a drug.

The following information should always be included:
- name, generic name (if single drug preparation)
- information which is necessary to ensure correct use, incl. uses and
important cautions/warnings. For veterinary drugs, type of animal must be
stated.
- a request to the user to read carefully the label and the package insert.

Advertising to the public must not:
- give the impression that it is not necessary to see a doctor
- recommend or indicate how the patient himself may make the diagnosis
- suggest that the drug will guarantee cure or that it is without side
effects
- claim that the drug is equivalent to or better than another treatment or
another drug
- claim that not taking the drug will cause deteriorated health
- be directed solely or mainly towards children
- refer to advice from health personnel or scientists as support for the
use of the drug
- indicate that the drug is a nutritional product, cosmetic or other
common commodity
- indicate that the drug's safety or effect is caused by the fact it is a
product of nature
- describe patient histories which may cause uncertain or wrong diagnosis
- refer to claims about cure in an improper and misleading way

III Advertising to health personnel

May only be directed towards doctors, dentists, veterinarians, registered
nurses and pharmacists, incl. students in these disciplines. Other
professions only after Ministry approval. Advertising should be
comprehensive and be in accordance with the approved data sheet.

Promotional material should contain the following information:
- name, dosage form, strength
- name for all active ingredients printed in clear letters and given a
prominent place
- name of licence holder and manufacturer, if relevant
- approved indications
- contraindications
- adverse effects, cautions, interactions
- dosage shcedule
- package size(s)
- prescribing regulations
- approved sales price per given date and reimbursement regulations, if any

Further, documentation of properties and effects must have reference to
scientific articles which are available to the recipient, e.g. professional
journals, reference books and published conference abstracts. Journals
without referee are not acceptable, nor company-internal research papers.
The information from scientific journals should be quoted accurate and
conclusions not exaggerated. For any documentation used in commercial
activites, the date of production or last revision should be given.

Promotional material may alternatively be sent as reminders and should then
contain only name, generic name and name of licence holder.

Advertising to health personnel must not be linked to gifts, prizes,
services or any other contribution of economic value. Health personnel must
not ask for or accept such contributions. This ban does not prevent
distribution of gifts of minor value which has connection to the discharge
of respective health worker's activity. (this would imply pens, note pads
etc). Entertainment as part of sales promotional activites should always be
kept on a reasonable level and be subordinate to the main purpose of the
meeting. It must not comprise other persons than health personnel. (i.e. no
wives, husbands)

IV Distribution of free samples

For distribution/delivery of free samples the following rules apply:
                                                                         
Samples must only be distributed to doctors, dentists and veterinarians.
For prescription drugs, limited to drugs which the recipient is allowed to
prescribe. Delivery must only take place as per written and signed
requisition from doctor, dentist or vet.
                                                                          
Only one sample per drug per year may be distributed. If the drug appears
in different dosage forms or strengths, one pack of each may be
distributed. The sample shall be of the smallest package size available.
(in Norway we have many different package sizes for each drug as we do no
dispensing in the pharmacy)

Each sample should be labelled "free sample - not for sale". Natural
products (herbal remedies) should be labelled "herbal drug".

A complete data sheet must accompany the sample.

Samples of non-approved drugs must not be distributed.

Samples of drugs in group A (narcotics) or drugs which contain substances
classified according to international conventions on psychotropic or
narcotic substances must not be distributed.

The individual company should keep a record of all samples diatributed.
These records must be kept for two years and turned over to the regulatory
authority on request.

V Sales representatives

Sales reps should be given sufficient training by the company they
represent, in order to pass on scientific knowledge in an accurate and
complete way. At each visit, the rep. should carry the approved data sheet,
incl. info on price and reimbursement regulations. (this is not necessarily
the same info as in the annually revised book of drugs on the market,
produced by the industry association). The rep. should report back to the
company all relevant info, in particular concerning adverse effects he
receives at visits.

VI Control

The Norwegian Medicines Control Authority is surveilling the promotional
activites. When the regulations are violated, the NMCA may demand that the
advertisement is stopped or confiscated and impose the violator to send a
letter of correction to the recipient(s).

After continued violations, NMCA may prohibit all advertising for the
product in question for shorter or longer term, alt. permanently. NMCA
should state the reason for its decision and make it public.

The above mentioned regulations do not prevent the pharmaceutical
manufacturers from establishing their own control body. Violations may be
handled there.

The holder of the marketing authorization should establish an information
service with professional competence and assign a person as responsible for
the information given about the products being marketed.

The responsible person should:
- send a copy of all written promotional material to NMCA or to any
voluntary professional body which the NMCA decides may perform the funtion
of surveillance. Promotional material should be dated and a list of
recipient(s) be given.
- ensure that the company's promotional material complies with rules and
regulations
- test that the sales reps are given enough training and fullfil the duties
they are assigned
- pass on to NMCA or a voluntary professional body, if any, the information
which they need to exert their control and authority
- ensure that decisions and orders made by the Authority or the control body
are attended to immediately and completely
- ensure filing of promotional material for at least two years, both written
material and material saved in any other form.

VII Exemptions

NMCA may exempt from these regulations for protection of the public or out
of consideration for patients security and health. For those companies for
which surveillance is delegated to the voluntary professional body, this
body's view should be invited. (this body only represents the companies that
are members of the pharmaceutial association)

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Comments:
In Norway, until a few years ago, the Medicines Control Agency had to
approve beforehand any promotional material. However, it was of limited use
as any violation would not cause much of a punishment and because they could
more or less only control written material. Everything the rep. used in
meetings with doctors or in seminars etc. would go uncensored. So, it was
decided to use self-justice, i.e. the industry association set up its own
body. This again works like in Canada by handling complaints, usually from a
competing company. Complaints from health personnel are very few. The
medical and the pharmaceutical associations have up guidelines regulating
the relationship between the respective professions and the industry, but
again, violations are plenty and often go unnoticed (unless the industry
forget to delete from their lists of invitations doctors who might go to the
press; I'm quite sure they keep positive and negative lists).

However, it is not solely a pressure from one side. I know of many instances
where the company intended to offer a modest dinner at the end of a seminar,
but where the participants expected to be taken to nightclubs, have
champagne for ladies paid etc. Often the company did not "dare" to say no.

Medical students are a popular target. Two years ago I took a training
course for military medical officers. The doctors, just out of medical
school and enrolled in the course as introduction to their mandatory
military service, spent every evening at company dinners after one of them
had been assigned the duty of calling up companies and making arrangements
for dinners! It should be unnecessary to mention that they had trouble being
present at the morning parades! One of the pharmacists told me that at one
earlier event to which a company had invited both medical and pharmacy
students, the equivalent of USD 270 was placed by each dinner seat for no
obvious reason. These types of events are clear breaks of the agreed code
between the industry and the professions.

When it comes to promotional activities targetting other groups, the nursing
journal last year had a feature article about nurses being the new target
for the pharmaceutical industry. For consumers it is only allowed to
advertise for non-prescription drugs in journals, newspapers and on the
commercial radio stations. However, I think there is only a question of time
before we have to accept TV advertising as EU will probably force us. (some
of our commercial radio stations broadcast from abroad). The industry has of
course developed ways of advertising which circumvent the regulations such
as disease oriented information which are allowed, but where there is a
delicate balance between what is allowed and what not(Astra had one large
campaign earlier this year.

I am afraid EU is more relaxed than FDA towards promotional activities.
Recently, articles about choice of brand names (often chosen for their
"popularity potential") and risk of errors caused by similar names have said
that FDA is taking this seriously and a committee look at the problem before
the drug is approved, whilst the EU response was that they had no intention
of acting.

Then there is the sponsoring of patient organisations, even establishing
them (Glaxo and migraine sufferers) which in my country is not regulated and
where there is no duty/culture to disclose funding sources.

At least I know the regulations myself by heart after this exercise!!

Regards Kirsten
Ms Kirsten Myhr, MScPharm, MPH
Bygdoy Alle 58B
0265 Oslo
Norway
Tel: +47 22 56 05 85 (h)
Fax: +47 22 24 90 17 (w) Tel: +47 22 24 90 04 (w)
E-mail: myhr@online.no
or (w): kirsten.myhr@helsetilsynet.dep.telemax.no

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