Every year, millions of people experience an adverse drug reaction from the medicines they take. This can range from a mild side effect or cause disability and even death. In the European Union alone, adverse drug reactions substantially increase the financial burden of healthcare systems. They also kill an estimated 197,000 people annually.

To ensure medicines are sufficiently safe, governments must continuously monitor adverse drug reactions using dedicated surveillance systems (pharmacovigilance). Spontaneous reporting of drug reactions by patients and healthcare professionals is essential. And when safety concerns about a medicine arise, governments must take swift action to reassess its risks and benefits and inform healthcare professionals and patients about their concerns. If the drug is found to do more harm than good, it must be removed from the market to protect patients.

Health Action International advocates for improved and transparent pharmacovigilance programmes and transparent practices. We provide evidence and recommendations to national governments that help improve adverse drug reaction surveillance. We also urge them to raise awareness amongst patients and consumers and healthcare professionals about the crucial need to report adverse drug reactions.

Keys to Improving Access and Innovation of Needed Medicines in the European Union

Direct Patient Reporting in the EU: A Snapshot of Reporting Systems in Seven EU Member States