Focus on advertising and promotion

November Issue 2005 7
Focus on Advertising and Promotion continued…
Worldwide survey on national controls of
pharmaceutical advertising and promotion
Robert Lynch, Baxter Healthcare, and Raun Kupiec, Genzyme Europe
Focus on advertising and promotion
www.topra.org
Introduction
Current legislative controls for pharmaceutical advertising have
achieved a degree of harmonisation in approach towards promotional
activities. This is especially true within the European Union, where
Directive 92/28/EEC originally established a set of minimum standards
for advertising of medicinal products within each Member State more
than ten years ago. (This Directive has since been incorporated into
2001/83/EC and now exists as Title VIII, Articles 86 – 100 of the
consolidated Directive.) As the EU has expanded, this harmonisation
of approach has been applied to the new members, and is now
applicable for a market that covers 457 million people and represents
roughly 30% of global pharmaceutical sales.
Apart from legal controls, self regulation by industry also plays a
major role in controlling the commercial activities of pharmaceutical
companies. There are numerous national industry association codes
of practice. In Europe, many national codes are roughly based on
the EFPIA European Code of Practice for the Promotion of Medicines.1
In the US, PhRMA has established a Code on Interactions with
Healthcare Professionals and a separate set of Guiding Principles on
Direct to Consumer Advertisements about Prescription Medicines.2
The Japanese Pharmaceutical Manufacturer’s Association (JPMA)
Code dates to 1993.3 However, self-regulation and harmonisation
extend beyond the US, Japan and Europe, and have a longer history.
The International Federation of Pharmaceutical Manufacturers and
Associations (IFPMA) originally established its Code of Pharmaceutical
Marketing Practices in 1981. 4 The EFPIA, PhRMA, JPMA, IFPMA and
other national industry association codes constitute internationally
accepted voluntary practices for companies, providing guidance on
allowable and prohibited activities.
The present survey arose from curiosity on the extent to which
national differences existed in the way that advertising was controlled.
One aspect of this, which we wanted to explore, was the balance
between legislative control (for example pre-approval of advertising
by regulatory authorities) and self-regulation. Against the background
of closer scrutiny of pharmaceutical industry by governments and
the public, it was also of interest to determine whether there was
any evidence for increasing strictness in the control of advertising,
such as whether there is a trend towards direct legislative control or
regulatory agency review.
Survey questions
Our Regulatory Rapporteur correspondents from
around the word were asked the following
questions about their national situation.
1. Does your Regulatory Authority require preapproval
of advertising for medicinal products?
If “yes” under what circumstances?
2. Is advertising actively monitored by the
Regulatory Authority?
3. Is advertising regulated by the Regulatory
Authority or through self-regulation?
4. Are advertisements challenged by competitors
by appealing to the Regulatory Authority, to an
industry association review board, or directly
by appeal to the court system?
5. Is there a national code of practice published
by your trade association?
6. Is there a web link to the code of practice?
Is the code of practice available in English or
French for the international community?
7. Any significant changes recently in your country
regarding control of advertising?
1 The 1993 and 2004 EFPIA Guidelines are available at http://www.efpia.
org/6_publ/default.htm.
2 These are both available on the web at http://www.phrma.org/publications/.
3 The current 2004 version is available in English at http://www.jpma.or.jp/
english/isuues/pdf/2004code.pdf.
4 The IFPMA Marketing Code, which underwent a major rewrite in 1994, may
be found in English, French and Spanish at http://www.ifpma.org/News/news_
market.aspx.
8
Regulatory
Rapporteur
T O P R A – T H E O R G A N I S A T I O N F O R P R O F E S S I O N A L S I N R E G U L A T O R Y A F F A I R S
Country Pre-approval
mandatory
by HA?
Active
monitoring
by Health
Authority?
Control by
HA/ Self -
regulation?
Complaints
handled by:
National
code of
practice?
Website for
of Code
Recent
changes
Australia No No Self-regulation Industry
Association-
Medicines
Australia
Yes
(English)
www.medicines
australia.com.au
Changes expected
with proposed
trans-Tasman agency
Canada Legally no / In
practice yes
No HA Non-profit
Orgs. ASC and
PAAB
Yes
(English and
French)
www.hc-sc.gc.ca/dhpmps/
advert-publicit/
index_e.html
None
Finland No Yes Both Industry
association
board
Yes www.pf.fi Code only came in
place 1.1.05
Germany No No8 Both, There
are several
self-regulatory
organisations
Directly
to Court
system, or by
notification
of one of the
“self-regulatory”
organisations
No Most recent changes
for OTC
Greece No1 Yes HA Industry
association/
HA/ or courts
Yes1a
(English)
http://www.sfee.gr/article/
english/252/65/index.
None
Ireland No No Mainly selfregulation
IPHA Industry
association
Yes www.ipha.ie Irish code currently
being updated
Italy Yes
(prescription
drugs only)
No Self-regulation Depends: usual
practice is
Farmindustria,
but HA also
possible
Yes Yes, in Italian Legislation pending;
industry Code of
Practice has added
requirement for
Notified Body for
certificaion
Japan No Some Both ------- Yes http://www.jpma.
or.jp/english/isuues/pdf/
2004code.pdf
None
Jordan Yes No HA HA No No None
Malta No Yes Self-regulation HA No No No
Netherlands No No Self-regulation Special
commission
Medicines
Advertising
Yes3
(in Dutch)
www.cgr.nl None
Norway No No Self-regulation Norwegian
Association of
Pharmaceutical
Manufacturers
Yes
(English)
www.lmi.no None
Feedback
The level of feedback from colleagues was excellent, and the findings are summarised in the table below:
November Issue 2005 9
Focus on Advertising and Promotion continued…
www.topra.org
Country Pre-approval
mandatory
by HA?
Active
monitoring
by Health
Authority?
Control by
HA/ Self -
regulation?
Complaints
handled by:
National
code of
practice?
Website for
of Code
Recent
changes
Portugal Legally No Yes Oother Mainly Industry
Association
Yes ? Recently approved
code of practice
Russia No, but only
based on presubmitted
data
No HA HA Yes Continual changes
Spain No (Yes for
OTC, though)
Yes7 Controlled
by regional
autonomous
authorities
HA, but also an
Industry Board
Yes http://www.farmaindustria.
es/Index_secundaria_
ingles.htm
New version of
Code of Conduct
June 2005:
more restrictive
regarding hospitality,
inducements, etc.
Switzerland Yes4 No Both Health
Authority
and Industry
Association
Yes
(French and
English)
http://www.sgci.ch/plugin/
template/sgci/*/11927/-
--/Pharmakodex_2004_
A4_E.pdf
Law updated in
September 2004
UK No Limited Mainly selfregulation
PMCPA/
MHRA5
Yes www.abpi.org UK code of practice
currently be
updated
USA Yes6 Yes
(By DDMAC)
FDA Appeal to FDA
or court
Yes PhRMA
codes
www.phrma.org/
publications/policy
/2004-01-19.391.pdf
www.phrma.org/
publications/policy
/2005-08-02.1194.pdf
None
Feedback (Continued)
1. Advertising material must be submitted to competent authority
(The National Organisation of Medicines), including doctor’s specialities
and dates the materials are to be used.
1a The Greek industry Association is called the Hellenic Association of
Pharmaceutical Companies (SFEE).
2. Translations of relevant law are available at www.jsmi.jp/english/profile/04.
html
3. A separate, special commission reviews advertisements for OTC products
(www.koagkag.nl).
4. For advertisement on radio, TV, cinema and some specific drugs.
5. MHRA complaint findings published on website.
6. Pre-approval required for drugs and biologics which receive accelerated
approvals. Also, pre-approval sometimes required subsequent to past
infringements.
7. Each year a specific therapeutic areas is selected for examination.
8. Local authorities will occasionally take samples of advertising and
promotional pieces during periodic inspections.
Regulatory
10 Rapporteur
T O P R A – T H E O R G A N I S A T I O N F O R P R O F E S S I O N A L S I N R E G U L A T O R Y A F F A I R S
Commentary
Although there is legislation controlling advertisements in almost
all countries (and in all of our sample), the degree of intervention
and enforcement differs from country to country. The need for
pre-approval of advertising by the regulatory authorities is rare in
European countries. It is interesting to note that although public
advertising is allowed for prescription medicines in the US, this
liberalisation is balanced by the need to seek FDA approval for
particular categories of Drugs. In the case of Canada, the high level
of scrutiny of industry was revealed in the feedback that while preapproval
is not legally required, it is common practice to seek such
approval as future defence against legal issues arising from contested
claims.
The role of self-regulation seems to be significant in many counties,
with these industry associations playing a large part in setting
standards and investigating alleged breaches of advertising law. In
order for the current balance between self-regulation and direct
legislative control to continue, the voluntary codes of practice must
be demonstrably effective. In view of the increased scrutiny of the
commercial activities of the pharmaceutical industry by government,
health professionals and media, any deterioration in the effectiveness
of the industries’ procedures to effectively influence promotional
behaviour could result in the need for stricter controls in the form
of pre-approvals, and increased monitoring by competent authorities.
References
1. Directive 92/28/EEC
2. EFPIA Code of practice
Acknowledgement
Many thanks to the following colleagues who contributed to
the survey:
Paul Larocque, Feddo Hillen, Tom Vanthienen, Laila Buø,
Masami Tamura, Majeda Al-Sayeh, Lisbeth Forss, Ioanna Koukli,
Owen Farrugia, Rebecca Cramp, Jennifer Svec, Raun Kupiec,
Maria João Azevedo, Francisco de Val, Rainer Kautz, Katya
Travina, Marco Radice
EFPIA and PhRMA have responded to the changed environment with
the public updates of their codes of conduct and reaffirmations of
the intent of the industry to lead the way in establishing ethical and
transparent promotional practices.
Contact Steve Binysh, Chairman of the InTouch
sub-committee, with your news or ideas by e-mail at:
intouch@topra.org
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