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Marketing plans for medicinal products available on prescription only: the current situation
The
Hague, July 2001, second revised edition
Health Care Inspectorate
P.O. Box 16119
2500 BC The Hague
The Netherlands
Contents
3 The individual marketing activities
3.1 Phase IV study (study after the registration of a medicinal product)
3.2 Refresher courses / visiting congresses
3.4 Systems that influence prescriptions
3.5 Opinion leaders
3.6 Marketing budgets of / for medical representatives
3.7 Sponsoring / other expenditure
3.8 Direct mail, advertising, public relations (PR)
3.9 Public advertising (direct-to-consumer, DTC) of medicinal products available on prescription only
3.10 Government
3.12 Marketing activities not yet mentioned
Table 1: Overview of marketing activity percentages
Figure 1: Marketing activities
Annexe 1. Extracts from the Decree of 31 October 1994, Bulletin of Acts and Decrees 787, concerning rules for the advertising of medicinal products (Reclamebesluit Geneesmiddelen – Medicinal Products Advertising Decree)
The Health Care Inspectorate Advertising Monitoring Department came into
being on 1 April 1999. On the basis of a strategic plan, the first year was
spent creating awareness. Parties in the field had to be informed that they were
to be monitored by the Inspectorate. Work started on redressing situations which
were in conflict with the Medicinal Products Advertising Decree.
In the second year, work was done on legal aspects of the offering of
inducements and the (prohibited) public advertising of medicinal products
available on prescription only.
At the end of the second year the department initiated a thematic survey,
the report of which you now have before you.
This survey looked at what marketing activities are systematically
budgeted for and carried out by the pharmaceutical industry and how they relate
to the laws and regulations.
The results indicate that the government still needs to enforce the
legislation for the time being until such time as self-regulation brings about
the operational development of initiatives.
The Chief Inspector for Pharmacy and Medical Technology
J.M.M. Hansen, pharmacist
After the advertising of medicinal products in Europe was harmonised by
Council Directive 92/28/EEC in 1992, this Directive was implemented in the
Netherlands in the form of the Medicinal Products Advertising Decree in 1994. In
April 1999 the Health Care Inspectorate Advertising Monitoring Department was
set up with the following mission:
To promote the more rational use of medicinal products in the Netherlands
through effective, transparent enforcement (monitoring and investigation) of the
Medicinal Products Advertising Decree.
In order to obtain an overview of the pharmaceutical industry’s
marketing activities, a survey was initiated with the aim of:
Obtaining an insight into the
kinds of marketing activities and the associated expenditure by the
pharmaceutical industry for medicinal products available on prescription only.
Since September 1999, copies of 28 marketing plans from 10 different
companies have been obtained as part of enforcement activities during visits to
pharmaceutical companies. Only a small number of companies and one or more
marketing plans from each company were involved. We do not know how many
marketing plans for medicinal products exist. This report covers 28 different
medicinal products available on prescription only. Two-year marketing plans were
obtained for six of these medicinal products. The other plans are for one year.
Some plans cover more than one medicinal product. The marketing plans are
business secrets.
All the plans requested were included in the survey. The survey is of a
descriptive and qualitative nature. The marketing plans surveyed are virtually
identical in structure. Extrapolations to cover all marketing activities should
only be made with caution.
The budgets of 27 of the 28 individual plans were divided up by marketing activity. In view of the dynamic nature of the marketing plans, it is not always possible to correlate this with the total budget for a particular medicinal product with 100% accuracy from an accounting point of view.
If relevant, the actual repercussions of the survey data for a particular
marketing activity are preceded by a standard and followed by an observation.
In the observation the findings of the
plans are coupled with the experience of the inspectors in their day-to-day
enforcement activities.
The total budget of the 28 plans surveyed amounts to about NLG
156,000,000 (about US $ 62,000,000). The cost of medical representatives,
product managers, rents, car expenses etc. are not included in these plans.
Expenditure on combined scientific and marketing studies are sometimes included
under expenditure for research and development and clinical studies and not in
the marketing plans.
Standard
Please see annex 1 (prohibition on the public
advertising of medicinal products available on prescription only and articles
concerning the offering of inducements) for the articles in the Medicinal
Products Advertising Decree that are relevant to this report.
All studies (including Phase IV studies) must meet the criteria set out
in the Medical Research Involving Human Subject Act. These tests must be checked
by a medical ethics committee. Exposing people to non-scientific studies using
medicinal products is unethical.
Findings
In some cases the marketing plans refer to designations which fall under
the phase IV study, such as value-added projects, projects, post marketing
surveillance (PMS), seeding trials, phase IV study, clinical trial and study.
The
total budget for the phase IV study is approximately NLG 31,000,000 (about US $
12,000,000). This is about 20% of the total budget of the marketing plans. The
objectives of the phase IV studies described in the plans show that influencing
prescriptions for the product being promoted and building up relationships with
the doctor are mentioned in 48 of the 71 surveys (68%). There are no specific
study objectives in the remaining 23 surveys. In addition to money,
incentives in kind offered to doctors including sphygmomanometers, hand-held
computers etc. are mentioned.
Observation
The designations in the studies suggest that they could be described as
scientific studies. The fact that no specific study objectives were mentioned in
some of the studies leads us to assume that the execution of the study is not a
prime objective. The question is how the medical-ethics committees have
interpreted their tasks in these cases. This is all the more so in those cases
in which the marketing plans have explicitly mentioned influencing prescriptions
as an objective.
Presenting these forms of influencing as research can be seen as socially
unacceptable and unethical. It undermines the public’s trust in healthcare.
The articles in the Medicinal Products Advertising Decree are not legally geared
towards tackling this.
Standard
Please see annex 1 (article 14,
paragraph 2) for the articles in the Medicinal Products Advertising Decree
that are relevant to this report.
Hospitality at
scientific meetings is also understood to mean contributing to the expenses that
participants incur in participating in such meetings. These expenses include
travel and accommodation expenses and participation fees. Hospitality must
remain within reasonable limits and must be subordinate to the main objective of
the meeting. Refresher courses and congresses accredited by the professional
body must be independent and must be open to everyone in the target group
equally.
Findings
Approximately NLG 1,500,000 (about US $ 600,000), or about 1% of the
total marketing budget, is earmarked for refresher courses in the plans. A total
of NLG 28,000,000 (about US $ 11,000,000), or about 18% of the total marketing
budget, is earmarked for inviting such people as opinion leaders to congresses
and symposia. So a sum of NLG 10,000 (about US $ 4,000 ) per person per congress
is not exceptional.
Invitations to and selection for refresher courses and congresses are
generally arranged by medical representatives.
Observation
The
one-to-one relationship and the size of the sums for a select group of doctors
invited to congresses is regarded as the prohibited offering of inducements. The
criteria that hospitality must remain within reasonable limits and must be
subordinate to the main objective of the meeting are contravened.
Investigations
by the Inspectorate have revealed that about 50% of refresher courses for GPs
are sponsored and/or organised by the pharmaceutical industry. The
pharmaceutical industry often determines who is invited, thus creating
restricted access for the profession as a whole. Because the topics are
generally determined by the pharmaceutical industry, the course programmes are
more likely to be supply-oriented rather than demand-oriented. The question is
whether the needs of public health are served by this situation.
Standard
Please see annex 1 (article 15) for the
articles in the Medicinal Products Advertising Decree that are relevant to this
report.
Apart from the fact that hospitality at promotional meetings must remain
within reasonable limits, it must also not be extended to anyone other than
health professionals. In enforcement, a maximum of EUR 50 is taken as a
yardstick for “reasonable”.
In order to make a balanced
assessment of the information provided by the speaker or opinion leader, the
possible financial relationship between the opinion leader and the
pharmaceutical company must be transparent to the audience and/or health
professionals.
Findings
About NLG 18,000,000 (about US $ 7,000,000), or about 11% of the
total budget, is spent on promotional meetings which are often not accredited.
These meetings are made attractive to the target group by linking them to
attractive locations and/or events. The objectives mentioned in the plans
include persuading doctors that the medicinal product in question is the best,
increasing the number of patients treated, and encouraging or influencing
doctors to participate in phase IV studies.
Observation
The size of the sum coupled with the events or locations leads us to
suspect that the standard for the offering of inducements is being infringed.
The infringement of the standard is supported by the reports and experience from
the enforcement activities of the Health Care Inspectorate.
The
question is whether the described objectives of the promotional meetings are
sufficiently transparent for health professionals to be able to assess the
correct professional value of the information provided. Investigations have
revealed that the links between speakers and pharmaceutical companies are not
always transparent.
Standard
The government encourages professional harmony amongst health
professionals in the FT(T)O (Farmaco
Therapeutisch (Transmuraal) Overleg – Pharmaco-Therapeutic (Transmural)
Committee). The forming of opinions on a particular medicinal product must not
be influenced by financial inducements.
Findings
About NLG 800,000 (about US $ 320,000), or about 0.5% of the total
budget, is spent directly on the FT(T)O, EVS (Electronisch
Voorschrijf Systeem – Electronic Prescription System) and formulary
committees.
Observation
We
do not know any specific sums per health professional which can be checked
against the standard for the offering of inducements.
The
sum spent directly on the FT(T)O is small. Apart from direct financing, the
FT(T)O can also be influenced by means of payments to specialists and through
phase IV studies intended to promote the prescribing of a particular medicinal
product. Influence over, by and through opinion leaders, payments to specialists
for prescriptions and phase IV studies makes it difficult to implement
arrangements in the context of the F(T)TO[1]
properly.
Standard
Please see annex 1 (article 14
paragraph 1 and article 14 paragraph 2)
for the articles in the Medicinal Products Advertising Decree that are relevant
to this report.
The test relating to the offering of inducements will also be applied in
the case of a business relationship between an opinion leader and a
pharmaceutical company. In order to make a balanced assessment of the
information provided by an opinion leader, any relationship between the opinion
leader and the pharmaceutical company must be transparent to the audience and/or
health professionals.
Findings
In the marketing plans, about NLG 4,500,000 (about US $ 1,800,000) of
directly earmarked money was spent on this target group, the opinion leaders,
i.e. about 3% of the total budget. Opinion leaders are divided into various
subcategories, i.e. international, national, regional and local opinion leaders.
Separate programmes are developed for each subcategory.
Observation
The sum spent on opinion leaders is small compared with the total.
However it could be a substantial amount for each health professional because
the target group is relatively small, and the invitations to congresses etc. are
concentrated on them. This will therefore tend to overstep the mark when it
comes to the offering of inducements. Both the offerer and the person accepting
the offer are thus guilty of infringement.
Opinion leaders are by definition those who pass on their vision to their
colleagues. Investigations have revealed that the links between opinion leaders
and the pharmaceutical industry are not always transparent.
When they carry out a phase IV study they have to practise scientific
integrity. In view of the objectives on this point formulated in the marketing
plans, there could be a question mark over whether this is in fact done. As
stated earlier, performing non-scientific studies on human subjects is
unethical.
Standard
Article 13 of the Advertising Decree states that medical representatives
must be properly trained and have to provide a summary of the medicinal
product’s properties approved by the Medicines Evaluation Board. The
side-effects reported to the medical representative must also be passed on the
scientific service of the company concerned.
Findings
In the plans analysed, a total sum of about NLG 18,000,000 (about US $
7,200,000) was set aside for gimmicks, stands, detail aids, gifts, reprints and
literature services. This is about 12% of the total budget.
Observation
The traditional role of the medical representative is to inform doctors
about a medicinal product. There were no details of compliance with statutory
obligations in the marketing plans. As a result of the relationship that medical
representatives have with doctors these days, they are increasingly involved
with other marketing tools such as refresher courses, promotional meetings,
congresses, developing phase IV studies etc. The pharmaceutical industry does
not include the manpower costs of medical representatives in the marketing
plans.
Standard
Please see annex 1 (article 14
paragraph 1 and article 15) for the articles in
the Medicinal Products Advertising Decree that are relevant to this report. Any
one-to-one relationship between a health professional and a pharmaceutical
company should not overstep the mark when it comes to the offering of
inducements.
Findings
About NLG 8,500,000 (about US $ 3,400,000), or about 5% of the total
budget, is spent on this ‘unclassifiable item’ in the plans. It is not
possible to obtain a breakdown of this amount from the plans.
Observation
The offering of inducements is not only a question of giving but also one
of taking. When visiting pharmaceutical companies, it was mentioned occasionally
that some health professionals are greedy when it comes to accepting
inducements. In this case both the offerer and the person accepting the offer
are guilty of infringement.
Because
there is no breakdown for sponsoring in the marketing plans, it is not possible
to establish the extent of any infringements of the standard on the offering of
inducements.
Standard
It is forbidden to promote the sale of medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, to persons qualified to prescribe or supply medicinal products except when their intrinsic value is minimal and they are important for the practice of medicine or pharmacy (see annex 1, article 14 paragraph 1).
Findings
About NLG 30,000,000 (about US $ 1,200,000), or approximately 20% of the
total budget, is spent on direct mail, advertising and public relations.
Observation
Reports to the Inspectorate have revealed that direct mail is frequently
used as ‘response mail’. An appointment with the medical representative is
requested in return for a gift. The extent to which the Advertising Decree is
being infringed in respect of the offering of inducements is not clear from the
marketing plans.
Standard
Please see annex 1 (section 2)
for the articles in the Medicinal Products Advertising Decree that are relevant
to this report.
Advertising medicinal products available on prescription only to the
general public is prohibited. So-called symptom advertising for medicinal
products available on prescription only is also prohibited.
Findings
A sum of about NLG 5,000,000 (about US $ 2,000,000) is earmarked for the
advertising of medicinal products available on prescription only in the plans.
This is about 3.5% of the total budget.
The marketing plans reveal that companies selling lifestyle medicinal
products run direct-to-consumer campaigns for this type of medicinal product.
Advertorials (advertising that looks like editorial copy, sometimes written by
doctors) are also used.
Observation
Two judgements by the courts have broadly clarified the parameters for
public advertising. Activities aimed at the general public are mainly carried
out for certain categories of medicinal products. The limits are always being
reviewed. Reports to the Inspectorate have revealed that pharmaceutical
companies collect patients’ names and addresses. No further investigation has
yet taken place in this regard.
Findings
In
the marketing budgets, money is set aside to influence the GVS (Medications
Reimbursement System). Pharmaceutical companies set up special programmes for
key opinion leaders. Key opinion leaders are encouraged to support a medicinal
product in order to ensure that its cost is reimbursed in full. How this happens
is not explicitly stated in the marketing plans.
Observation
Because hospital dispensaries have to get by with
lump-sum financing, very big discounts are often given by the pharmaceutical
industry, with a spin-off in the form of follow-up prescriptions in primary
healthcare. These discounts are not mentioned in the marketing plans because
they are covered by other budgets (e.g. sales plans).
About 6% of the budget, around NLG 10,000,000 (about US $ 4,000,000),
relates to activities on the Internet, presentations, market research, samples
and phase 3 (and lower) studies.
|
Marketing
activities |
Percentage |
|
Phase
IV studies |
20% |
|
Refresher
courses/congresses |
19% |
|
Promotional
meetings |
11% |
|
Systems
influencing prescriptions |
0.5% |
|
Opinion
leaders |
3% |
|
Medical
representatives budget |
12% |
|
Sponsoring/other
expenses |
5% |
|
Direct
mail, advertising, public relations |
20% |
|
Direct-to-consumer
advertising |
3.5% |
|
Other
activities |
6% |
|
Total
|
100% |
Figure 1 shows the relationship between the various marketing tools. Only
the most important tools (grey shaded circles/ovals) are discussed in this
report.
The marketing plans provide an insight into the budgets and the priorities which the pharmaceutical industry applies to its marketing.
If the marketing activities mentioned in this report are tested against the spirit of the Medicinal Products Advertising Decree (which is based on the provision in Council Directive 92/28/EEC that prescription practices may not be influenced by direct or indirect financial inducements), then it becomes apparent that the percentages of the marketing budgets taken up by the following activities are:
|
Phase IV study/seeding trials |
20% |
|
Direct payments for congresses |
18% |
|
Promotional meetings |
11% |
This is almost 50% of the amounts mentioned in the marketing plans.
On the basis of the marketing plans it can be concluded that the Medicinal Products Advertising Decree is being infringed in respect of the offering of inducements and public advertising.
In complying with the Medicinal Products Advertising Decree, the government is keen for self-regulation to play a role. The parties will therefore have the opportunity to put their own houses in order within the legal limits. The Inspectorate subscribes to this but observes that self-regulation has not yet resulted in widely-accepted codes of conduct that are actually being adhered to.
Adequate monitoring by the government is still needed.
Extracts
from the Decree of 31 October 1994, Bulletin of Acts and Decrees 787, concerning
rules
for the advertising of medicinal products (Medicinal Products Advertising
Decree)
Article 5 of the Medicinal
Products Advertising Decree:
It is forbidden to advertise the following to the general public:
a. medicinal products that are available on prescription only;
b. medicinal products prepared by pharmacists or dispensing
physicians or prepared under their supervision in their dispensaries
Article 6 of the
Medicinal Products Advertising Decree:
Advertising aimed at the general public must be of such a form and content that
it is clear that it is an advertisement, and that the product is clearly
identified as a medicinal product.
…………..
§ 5. The offering of inducements
Article
14, paragraph 1 of the Medicinal Products Advertising Decree:
It is forbidden to promote the sale of medicinal products by the gift, offer or
promise of any benefit or bonus, whether in money or in kind, to persons
qualified to prescribe or supply medicinal products except when their intrinsic
value is minimal and they are important for the practice of medicine or
pharmacy..
Article
14, paragraph 2 of the Medicinal Products Advertising Decree:
The first paragraph does not constitute an obstacle to
hospitality offered directly or indirectly in the context of events of an
exclusively professional or scientific nature to which one or more
pharmaceutical companies make a financial contribution. Hospitality must always
remain within reasonable limits and must be subordinate to the main objective of
the meeting, and it must not be extended to anyone other than health
professionals..
Article
15 of the Medicinal Products Advertising Decree
Hospitality at meetings that are entirely or partly paid for by one or more
pharmaceutical companies and that are convened with a view to promoting the sale
of medicinal products, must be kept within reasonable limits and must be
subordinate to the main objective of the meeting; it must not be extended to
anyone other than health professionals.
Article
16 of the Medicinal Products Advertising Decree:
The acceptance of or request for services or goods prohibited under Article 14
paragraph 1 or in contravention of Article 15 by persons qualified to
supply drugs is prohibited.
Annex 2
Authors
Mrs. J.S. van Egmond-Vettenburg, project team member, Health Care
Inspectorate, advertising monitoring department
Mr H. ter Steege, senior inspector, Health Care Inspectorate, advertising
monitoring department
[1] Metz, J.E. de, Eijk, M.E.C. van, Schuurmans, A., Vries, M.A.J. de, Woerkom, M.H.G.A. van, (2001) Handboek FTTO voor het realiseren van een regionale aanpak van de geneesmiddelenvoorziening [FTTO manual for the achievement of a regional approach to the supply of medicines]. Newsletter no. 4 De Proeftuin Pharmacie Groningen.