OBJECTIVES: Therapeutic monoclonal antibodies (mAbs) are capturing an increasingly larger proportion of the pharmaceutical market. Their specificity for biological targets allows them to effectively treat a variety of indications. Yet, despite their successes, the various stakeholders’ viewpoints in European Union (EU) countries are often at odds. We explore mAbs as a drug class, specifically, how they are approved for use by the European Medicines Agency (EMA) and other regulating bodies and how stakeholders’ opinions diverge from regulatory decisions METHODS: The following were summarized for mAbs approved for use in EU countries from 2000-2011: regulatory approval decisions; comparing and contrasting payer coverage decisions in selected EU countries; and position statements from patients, advocacy groups, and medical organizations. Discrepancies between initial or post-approval regulatory decisions and the statements of the other stakeholders were highlighted RESULTS: Nineteen mAbs have been approved by the EMA during the past 10 years. The summary data show how stakeholders use clinical data to reinforce their agenda. For instance, bevacizumab has been undergoing battles in both the US and the EU: regulators want to remove specific labeled indications based on safety and effectiveness data and NICE has advised against coverage for treating metastatic colorectal cancer, citing inadequate benefits for the costs, while patients fight for continued access to the therapy to extend their life at all costs CONCLUSIONS: After product approval, physicians have traditionally been the key treatment decision makers; however, the influence of other stakeholders are increasingly affecting the availability and use of drugs. The discordance between decisions made by regulators and payers has forced drug manufacturers to not only show that it is safe and efficacious to regulators, but to demonstrate a product’s value to patients and payers. Incorporating the viewpoints of payers as well as patients in the drug development process will narrow the gap between stakeholders