The proliferation of falsified medicines and medical devices poses a direct threat to public safety, that extends well beyond mere intellectual property concerns. The phenomenon is driven by the high profitability of the pharmaceutical market and facilitated by regulatory weaknesses that are systematically exploited by transnational organised crime groups. Several legal frameworks – including the Italian one – are still too fragmented and marked by significant interpretative uncertainties that undermine effective enforcement and complicate international cooperation. This is why the Medicrime Convention seeks to address these challenges by harmonizing criminal law responses, strengthening judicial cooperation and combining repressive, preventive, and protective measures. Many considerable benefits may come from its ratification, but concerns remain regarding the risk of excessive penalisation: an overly repressive approach may generate protectionist or chilling effects, ultimately restricting access to medicines and harming patients.