Healthy Skepticism International News
March 2002
Marketing plans for medicinal products available on prescription only: current situation.
March/April 2002 Vol 20 No 3/4
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
Foreword.
1 Introduction
2 Structure of the survey
3 The individual marketing activities
3.1 Phase IV study (study after the registration of a medicinal product)
3.2 Refresher courses / visiting congresses
3.3 Promotional meetings
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
3.11 Hospital dispensaries
3.12 Marketing activities not yet mentioned
Table 1: Overview of marketing activity percentages
Figure 1: Marketing activities
4 Observations and conclusion
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)
Foreword
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
1 Introduction
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.
2 Structure of the survey
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.
3 The individual marketing 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.
3.1 Phase IV study (study after the registration of a medicinal product)
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.
3.2 Refresher courses / visiting congresses
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.
3.3 Promotional meetings
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.
3.4 Systems that influence prescriptions
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.
3.5 Opinion leaders
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.
3.6 Marketing budgets of / for medical representatives
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 Âservices. 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.
3.7 Sponsoring / other expenditure
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.
3.8 Direct mail, advertising, public relations (PR)
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.
3.9 Public advertising (direct-to-consumer, DTC) of medicinal products available on prescription only
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.
3.10 Government
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.
3.11 Hospital dispensaries
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).
3.12 Marketing activities not yet mentioned
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.
Table: Overview of marketing activity percentages
| 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: Marketing activities
Figure 1 shows the relationship between the various marketing tools. Only the most important tools (grey shaded circles/ovals) are discussed in this report.
4 Observations and conclusion
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.
Annex 1
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)
§ 2. Public advertising
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.
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