Pharmacovigilance produces near-constant scrutiny of medicines on the EU market. Yet in the years since the EU gave itself the power to fine companies for pharmacovigilance failures, that power has been formally triggered once, and no fine has followed.<\/pre>\n\n\n\nThe EU monitors the safety of authorised medicines continuously. Companies must track and report adverse events, national authorities inspect their systems, and the European Medicines Agency (EMA)<\/a> assesses the safety of centrally authorised products on an ongoing basis. Set against that volume of routine oversight, one figure stands out: since Regulation (EC) No 658\/2007<\/a>, the Penalties Regulation, empowered the EU to impose financial penalties for such failures, it has produced a single infringement procedure, and that procedure closed without a fine.<\/p>\n
Why so much monitoring but so little penalising? Part of the answer is that enforcement power is divided. A national authority may detect a problem, the EMA investigates it, but the decision on penalties is taken elsewhere, by the European Commission. When responsibility for an outcome is split this way, it can become unclear who is answerable for the result.<\/p>\n
This post uses two distinct ideas to explain that. The first is responsibility<\/strong> in Dennis Thompson’s sense: ownership of an outcome, that is, whose conduct produced it. The second is accountability<\/strong> in Mark Bovens’s sense: the obligation of an actor to explain and justify its conduct to a forum that can question it and pass judgement. The argument is that when many hands produce an enforcement outcome, responsibility for the overall result becomes diffuse, and no forum is positioned to hold that overall result to account.<\/p>\n
The framework itself is extensive. Directive 2001\/83\/EC<\/a> sets out the general rules for medicinal products. For authorised medicines distributed within the EU, Regulation (EC) No 726\/2004<\/a> establishes the EMA’s role and powers. The Clinical Trials Regulation<\/a> and the EU’s pharmacovigilance rules<\/a> add further safety and monitoring obligations. What determines whether these rules matter in practice is how they are applied.<\/p>\n
Pharmacovigilance rules\u00a0 \u2013 <\/strong>\u00a0the legal requirements and guidelines ensuring that medicines are monitored for safety, so that their benefits continue to outweigh their risks.<\/pre>\n\u00a0<\/p>\n\n\n\n
In practice, enforcement is divided between actors, each with a defined role:<\/p>\n
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- National authorities detect problems at Member State level<\/a><\/li>\n
- The EMA investigates and assesses possible infringements<\/a><\/li>\n
- The European Commission decides whether to impose penalties<\/a><\/li>\n<\/ul>\n
The EMA is central to supervision and investigation, but it cannot impose fines. Although penalties can reach 5% of a company’s EU turnover for certain infringements<\/a>, the power to impose them rests with the Commission. This leaves a gap between investigating a breach and deciding what follows from it. When enforcement is shared<\/a> across institutions, establishing accountability becomes harder.<\/p>\n
Comparative perspective<\/strong><\/p>\n
Other EU agencies are built differently. The European Securities and Markets Authority (ESMA)<\/a> and the European Central Bank (ECB)<\/a> can investigate breaches and impose penalties directly. ESMA can supervise specific market actors and adopt binding decisions, including financial penalties<\/a>, without depending on another institution; the ECB supervises banks and sanctions breaches of EU banking rules. In those models, the body that builds the case also owns the outcome. The EMA model separates the two.<\/p>\n
How Enforcement Works in Practice<\/strong><\/p>\n
One procedure, nineteen medicines, no fine<\/strong><\/p>\n
The first and, to date, the only infringement procedure opened under the Penalties Regulation tells us less about wrongdoing than about how the system divides authority.<\/pre>\n\u00a0<\/p>\n\n\n\n
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