Post-Marketing Observational Studies: Bribery Through the Back Door?!
Laura Chrobok 14.08.2026
Pharmaceutical companies are not allowed simply to offer doctors money to prescribe a particular medicine more frequently. Nevertheless, there is a legally permitted model in which manufacturers pay treating doctors while they document the use of the very medicine from whose sale the company profits: the post-marketing observational study. Officially, such studies are intended to provide insights from everyday medical practice. Yet even the Drug Commission of the German Medical Association warns that such studies often conceal marketing measures with little scientific merit. It has even explicitly advised doctors against participating in them.
In today’s article, we explain how post-marketing observational studies work, why pharmaceutical companies pay prescribers to participate in them, and why they can be described as bribery through the back door. We also look at the laws with which the German state seeks to prevent improper influence — the situation in Germany is similar to that in other countries — and why these safeguards do not reliably rule out the subtle influence of paid post-marketing observational studies.
What Is a Post-Marketing Observational Study?
A post-marketing observational study is a non-interventional study/treatment involving a medicine that has already been authorised or registered.
Unlike in a clinical trial, treatment is not determined by a study protocol. Rather, doctors are expected to prescribe the medicine as part of their usual clinical practice. They then document certain information about its use.
The information recorded may include:
· the condition being treated
· dosage and duration of treatment
· concomitant diseases
· medicines taken at the same time
· observed effects and adverse effects
· reasons for discontinuing treatment
· the experiences of doctors and patients.
In a genuine post-marketing observational study, additional diagnostic or therapeutic measures that go beyond normal treatment must not be prescribed solely by the observational protocol. Otherwise, the study could constitute a clinical trial requiring authorisation (Schott et al., 2020; BfArM, n.d.).
In principle, data from everyday clinical practice can be valuable. Clinical trials run for only a limited period and often involve selected patient groups.
After a medicine has been placed on the market, questions may therefore remain unanswered:
· How is a medicine used in older people or patients with multiple conditions?
· What problems emerge during long-term use?
· Are necessary monitoring examinations actually carried out?
The problem arises when a study that sounds scientific primarily serves to familiarise doctors with particular medicines and provide financial incentives for their use.
Pharmaceutical Companies Pay Prescribing Doctors
In a post-marketing observational study, treating doctors receive remuneration for documenting information. Formally, they are not being paid for the prescription itself, but for recording and providing data.
Nevertheless, the fundamental conflict of interest remains: doctors decide what to prescribe — and the manufacturers of the prescribed medicines pay them for subsequently documenting their use.
Depending on the contract, remuneration may be based, among other things, on the actual amount of work involved or the number of treatment cases documented. Prescriptions by doctors and payments made to them are therefore not clearly separable from an economic perspective.
A manufacturer may not say:
“You will receive money if you prescribe our medicine more frequently.”
Under certain legal conditions, however, it may say:
“You will receive money if you document the use of our medicine.”
Legally, these are two different processes. In medical practice, however, they can be closely connected.
The Drug Commission Warns About Marketing
Criticism of post-marketing observational studies by no means comes only from fundamental opponents of the pharmaceutical industry.
In 2020, the Drug Commission of the German Medical Association (AkdÄ) — a scientific committee of the German Medical Association — published an unusually unequivocal assessment. The authors stated that studies had shown that post-marketing observational studies often conceal marketing measures with little scientific merit (Schott et al., 2020).
And the criticism went even further:
· the scientific quality of many post-marketing observational studies was poor
· some research questions could not be answered at all using their study design
· only a small number of results were published
· remuneration was in some cases inappropriately high or insufficiently justified
· results unfavourable to manufacturers could remain unpublished.
The authors concluded that the available evidence suggested that pharmaceutical companies frequently initiated post-marketing observational studies in order to increase sales of the medicine under investigation and to provide participating doctors with money. The AkdÄ therefore explicitly advised doctors not to participate in post-marketing observational studies (Schott et al., 2020).
This is remarkable. After all, this was not a demand made by an organisation fundamentally critical of the pharmaceutical industry.
How Post-Marketing Observational Studies Influence Prescribing
A study published in the journal PLOS Medicine in 2020 investigated precisely this question.
The researchers analysed the prescribing behaviour of doctors who had participated in non-interventional post-marketing studies of medicines. This was compared with the prescribing behaviour of a control group.
Participation was associated with a higher proportion of prescriptions for the medicine under investigation. The association was evident not only during the observational period, but also in the following year (Koch et al., 2020).
The study does not prove that every additional prescription was caused solely by the remuneration. It is possible, for example, that pharmaceutical companies preferentially selected doctors who had already prescribed the medicine in question more frequently beforehand.
But even then, the finding remains concerning.
An ostensibly neutral observational study takes place among doctors who are of interest to the manufacturer as prescribers. Over an extended period, these doctors engage intensively with a particular medicine, use it in several patients, document their experiences, and receive remuneration for doing so. The medicine thereby becomes part of their treatment routine. A paid documentation project ties doctors to a particular product for weeks or months.
Why Pharmaceutical Representatives Like Post-Marketing Observational Studies
For pharmaceutical manufacturers, such cooperation can be valuable even if the data collected ultimately have little scientific significance. The medicine enters clinical practice, is used in patients, and receives the attention of a professional group that is crucial to its sales.
The AkdÄ also pointed out that post-marketing observational studies were frequently conducted on expensive medicines, including cancer medicines and immunomodulatory drugs. In some cases, the medicines being studied had already been on the market for years (Schott et al., 2020).
The longer a medicine has already been in use, the more pressing the question becomes as to what new scientific knowledge another manufacturer-funded observational study is actually intended to provide.
Laws Are Intended to Prevent Bribery in the Healthcare Sector
The state has introduced several measures intended to prevent improper influence on medical decisions, some of which are particularly relevant to today’s topic.
Reporting Requirements for Post-Marketing Observational Studies
In Germany, studies intended to collect information on the use of authorised or registered medicines must be reported to several bodies.
These are:
o the competent higher federal authority
o the National Association of Statutory Health Insurance Physicians (KBV)
o the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband)
o the Association of Private Health Insurance.
The information to be submitted includes:
o the place, time and objective of the post-marketing observational study
o the observational plan
o the doctors involved
o contracts with participating statutory health insurance physicians
o the type and amount of remuneration paid
o the amount of work on which the remuneration is based
o justification for the appropriateness of the remuneration.
The law expressly stipulates that remuneration must be set at a level that does not create an incentive for the preferential prescription or recommendation of particular medicines (Section 67(6) AMG).
Within one year after completion of data collection, a final report must also be submitted to the competent higher federal authority. Notifications and final reports are made publicly accessible via an online portal.
The KBV also publishes overviews of completed post-marketing observational studies. These include information on the number of doctors and patients involved as well as the amount of remuneration reported. However, the KBV points out that this information is based on reports submitted by pharmaceutical companies or research organisations and that it does not guarantee its accuracy.
On paper, these regulations appear strict. Post-marketing observational studies must be reported, remuneration must be justified, and final reports must be published. However, notification does not constitute an independent scientific review.
The German Federal Institute for Drugs and Medical Devices (BfArM) expressly states that post-marketing observational studies — unlike clinical trials — do not require authorisation by the higher federal authority. They are merely subject to a reporting requirement. In this procedure, the BfArM has no influence on the subject matter or methodology of the submitted post-marketing observational study (BfArM, n.d.).
The authority can publish the fact that the study is taking place. However, this does not constitute confirmation that the post-marketing observational study is scientifically meaningful. Nor does disclosure of remuneration solve the problem. Transparency makes a conflict of interest visible. It does not eliminate it.
Something Should Change
Post-marketing observational studies can provide medically relevant data. Nor is appropriate remuneration for work actually performed fundamentally unlawful.
However, structural contradictions become apparent:
· Direct payment for preferentially prescribing a medicine is prohibited.
· Payment for documenting the use of the same medicine may be permitted.
· The manufacturer benefits financially from the prescription.
· The doctor receives remuneration after using the medicine.
The process is given a scientific name, involves a contract and is officially reported. Nevertheless, the money comes from the company that profits from the sale of the medicine.
Transparent Information
For patients, it is difficult to determine whether the medicine in question would have been chosen for them even without the paid observational study.
The AkdÄ also referred to recommendations by the BfArM and the Paul-Ehrlich-Institut (PEI), according to which patients should be informed about participation in a post-marketing observational study. Participation should be voluntary and take place only with their consent (BfArM & PEI, 2022).
People
should also be informed:
· which company is funding the post-marketing observational study
· whether the doctors are being paid for it
· who is analysing the data
· whether and where the results will be published.
This would enable patients to draw their own conclusions about the extent to which they believe a conflict of interest exists ...
Post-Marketing Observational Studies: Research on Paper, Pharmaceutical Marketing in Practice
Post-marketing observational studies have the appearance of serious scientific research. And indeed, in individual cases they can provide important insights into the use of a medicine.
But why are manufacturers allowed to pay precisely those people to observe their product who also decide whether to prescribe it?
In principle, legislators seek to limit conflicts of interest. Outright bribery is a criminal offence, remuneration must be reported and must not create an incentive for preferential prescribing. Nevertheless, post-marketing observational studies are possible without their scientific quality having been confirmed.
By and large, the system of post-marketing observational studies can be justified scientifically, but it can also be ideally suited to pharmaceutical industry marketing. One possible reason why extensive marketing may be necessary: pressure from Chinese manufacturers.
FAQ — Frequently Asked Questions About Post-Marketing Observational Studies
1. Can I find out whether my doctors participate in post-marketing observational studies?
Post-marketing observational studies must be reported, and certain information is made publicly available. However, it is not necessarily easy to determine directly from this information whether your own doctor is participating in a particular study. If in doubt, you can ask directly whether your treatment is part of a post-marketing observational study.
2. Can I refuse to participate in a post-marketing observational study?
Yes, participation must not take place against a patient’s wishes. If health data are processed or shared for the study, providing information and obtaining consent are particularly important. Refusal must not affect regular medical treatment.
3. What happens if previously unobserved adverse effects are identified during a post-marketing observational study?
Suspected adverse effects must be recorded and reported in accordance with the applicable pharmacovigilance rules, irrespective of the post-marketing observational study. This is precisely where such studies can provide a meaningful benefit: rare problems, or problems that only become apparent in everyday clinical practice, can be identified. However, this requires the data to be systematically analysed and communicated.
4. Where can I find out which post-marketing observational studies have been conducted on a medicine?
Reported post-marketing observational studies and final reports can be searched via the competent authorities or their registers. The National Association of Statutory Health Insurance Physicians also publishes overviews of reported post-marketing observational studies. For interested patients, it can also be worthwhile consulting product information, study registries and publications relating to the medicine in question.
Further information — also on many other topics — can be found on our blog. You can also find our “Medizinskandale” book series and the “Codex Humanus”, whose fifth volume was recently published, in our online shop. We look forward to your visit.
Sources:
· Schott, G. et al. (2020): “Anwendungsbeobachtungen: Erkenntnisgewinn ist gering,” Deutsches Ärzteblatt.
· Bundesinstitut für Arzneimittel und Medizinprodukte (o. J.): “Nichtinterventionelle Studien.”
· Koch, C. et al. (2020): “Impact of Physicians’ Participation in Non-interventional Post-marketing Studies on Their Prescription Habits: A Retrospective 2-Armed Cohort Study in Germany,” PLOS Medicine.
· Arzneimittelgesetz (AMG): “§ 67 Allgemeine Anzeigepflicht,” Bundesministerium der Justiz.
· Kassenärztliche Bundesvereinigung (o. J.): “Anwendungsbeobachtungen – Melden einer AWB oder nichtinterventionellen Unbedenklichkeitsprüfung.”
· Bundesinstitut für Arzneimittel und Medizinprodukte; Paul-Ehrlich-Institut (2022): “Gemeinsame Empfehlungen des Bundesinstituts für Arzneimittel und Medizinprodukte und des Paul-Ehrlich-Instituts zu Anwendungsbeobachtungen nach § 67 Absatz 6 Arzneimittelgesetz und zur Anzeige von nichtinterventionellen Unbedenklichkeitsprüfungen nach § 63f Arzneimittelgesetz.”
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