What are the effects of policies that regulate how drugs can be marketed?

Key messages

Many countries have introduced policies to regulate how the pharmaceutical industry is allowed to market its products. However, we do not know what impact these policies have because there is a lack of well-conducted studies.

What are drug marketing policies?
It is very expensive to develop new drugs and bring them to the market. The pharmaceutical industry therefore uses a lot of resources to promote their drugs and increase their use. They often encourage patients and consumers to use these drugs, and they encourage health professionals to prescribe them. They also promote their drugs to health insurance organisations and governments. They do this, for example, through advertisements, visits from sales representatives, free drug samples, and education awareness programmes. 
These strategies can spread useful information about health conditions and the drugs that are available for them, but they can also cause harm. For instance, patients, doctors and organisations can be persuaded to use or prescribe drugs that are unnecessary, expensive and sometimes harmful.
Because of these problems, governments and non-governmental organisations often try to regulate how drugs are promoted. For example, in some countries, the pharmaceutical industry is not allowed to promote prescription drugs to patients and consumers. In other countries, they are only allowed to promote drugs to healthcare professionals in certain ways, such as through medical journals. In some countries, governments and organisations work
alone. In other countries they collaborate with the pharmaceutical industry.


What did we want to find out?
We wanted to assess the effect of drug marketing policies on people’s access to and use of drugs, their health and their use of healthcare services, and on costs.


What did we do?
We searched for studies that compared the effect of one drug marketing policy to another or to no policy.


What did we find?
We did not find any well-conducted studies that could answer this question.


How up to date is this review?

We searched for studies that had been published up to January 2023.

Authors' conclusions: 

We sought to assess the effects of policies that regulate drug promotion on drug use, coverage or access, use of health services, patient outcomes, adverse events, and costs, however we did not find studies that met the review's inclusion criteria. As pharmaceutical policies that regulate drug promotion have untested effects, their impact, as well as their positive and negative influences, is currently only a matter of opinion, debate, informal or descriptive reporting. There is an urgent need to assess the effects of pharmaceutical policies that regulate drug promotion using well-conducted studies with high methodological rigour.

Read the full abstract...
Background: 

The costs of developing new treatments and bringing them to the market are substantial. The pharmaceutical industry uses drug promotion to gain a competitive market share, and drive sale volumes and industry profitability. This involves disseminating information about new treatments to relevant targets. However, conflicts of interest can arise when profits are prioritised over patient care and its benefits. Drug promotion regulations are complex interventions that aim to prevent potential harm associated with these activities.

Objectives: 

To assess the effects of policies that regulate drug promotion on drug utilisation, coverage or access, healthcare utilisation, patient outcomes, adverse events and costs.

Search strategy: 

We searched Epistemonikos for related reviews and their included studies. To find primary studies we searched MEDLINE, CENTRAL, Embase, EconLit, Global Index Medicus, Virtual Health Library, INRUD Bibliography, two trial registries and two sources of grey literature. All databases and sources were searched in January 2023.

Selection criteria: 

We planned to include studies that assessed policies regulating drug promotion to consumers, healthcare professionals or regulators and third-party payers, or any combination of these groups.In this review we defined policies as laws, rules, guidelines, codes of practice, and financial or administrative orders made by governments, non-government organisations or private insurers. One of the following outcomes had to be reported: drug utilisation, coverage or access, healthcare utilisation, patient health outcomes, any adverse effects (unintended consequences), and costs. The study had to be a randomised or non-randomised trial, an interrupted time series analysis (ITS), a repeated measures (RM) study or a controlled before-after (CBA) study.

Data collection and analysis: 

At least two review authors independently assessed eligibility for inclusion of studies. When consensus was not reached, any disagreements were discussed with a third review author.  We planned to use the criteria suggested by Cochrane Effective Practice and Organisation of Care (EPOC) to assess the risk of bias of included studies. For randomised trials, non-randomised trials, and CBA studies, we planned to estimate relative effects, with 95% confidence intervals (CI). For dichotomous outcomes, we planned to report the risk ratio (RR) when possible and adjusted for baseline differences in the outcome measures. For ITS and RM, we planned to compute changes along two dimensions: change in level and change in slope. We planned to undertake a structured synthesis following EPOC guidance. 

Main results: 

The search yielded 4593 citations, and 13 studies were selected for full-text review. No study met the inclusion criteria.