Alternative Access Schemes as Hybrid Governance in European Pharmaceutical Regulation

2. Health technologies between global markets and local health systems Access to medicines in Europe is typically subject to regulation by Health Technology Assessment (HTA) – an evidenced-based review of the clinical, economic, social, ethical and other consequences of new medicines and other health technologies. HTA is usually carried out by specialized expert bodies that issue recommendations on whether a drug should be reimbursed from public funds. However, for expensive new drugs, patients can increasingly gain access through Alternative Access Schemes (AAS) that operate alongside formal HTA procedures. This paper uses data on 82 AAS across 21 European countries to examine how access is governed where global markets meet national health systems. We treat AAS as hybrid governance mechanisms. The analysis looks at who initiates access, who decides, and how regulatory, clinical, market, and legal authority are combined in practice. An inductive typology identifies five patterns: clinician-led discretionary access, centralized fund-based access, regulatory early access, judicialized access, and negotiated market-based access. The findings show that similar labels, such as early access or compassionate use, hide major differences in decision-making and accountability. Physicians often act as key intermediaries between patients, regulators, payers, and pharmaceutical companies. By showing how countries combine multiple AAS to handle uncertainty and exceptional cases, the paper contributes to debates on the governance of health technologies and the tensions of integrating global pharmaceutical innovation into country-specific health systems.