Studies have shown that some pharmaceutical companies based within the EU promote expensive brand-name pharmaceutical products under the guise of post-marketing observational studies, especially in low-income countries, since the medicine used becomes more prominent when observational studies are carried out.
In addition, participating doctors are often paid to convert a person onto a new regimen which includes the newly marketed agent. Once the study is over, most patients remain on the analogues rather than going through another change of regimen — which would be uncompensated for the physician. These studies often do not generate any published results, which suggests that they are of a marketing rather than a scientific nature.
As a comparison, companies based in the US do not have recourse to such practices, owing to the very strict guidelines for pharmaceutical manufacturers issued by the Office of Inspector‑General of the Department of Health and Human Services, which deal with kickbacks and other illegal forms of remuneration.
1. What action, if any, is the Commission taking to avoid kickbacks and prevent drug trials that could be considered as disguised marketing?
2. Would the Commission consider introducing tougher anti-kickback legislation along the lines of that applicable in the US?