According to the European Commission 5% of all hospital admissions are due to serious side effects from medicines and many more cases may be unreported. Adverse drug reaction (ADR) is the fifth most common cause of death, accounting for around 200,000 deaths a year, at a cost to society of almost Euros 80 billion.

What are the changes?

The aim of the new Directive and Regulation is to update existing EU rules to improve data collection, treatment and dissemination and better inform the public and doctors. They propose a number of changes that will strengthen the way the safety of medicines for human use is monitored in the EU:

• All new or updated medicines are to be intensely monitored for five years. Doctors and patients are to be informed and encouraged to report all problems.
• A new EU ‘Pharmacovigilance Risk Assessment Advisory Committee’ is to be created within the EMA.
• There will be stricter, but simpler, rules on monitoring and reporting by drug companies.
• A European network of national reporting websites and an EU database, Eudravigilance, will be created containing relevant information and guidelines.
• There will be greater transparency through public hearings for ADR-related medicines.
• There will be greater coordination in case of emergency and better Patient Information Leaflets.

Both the EMA and the European Generic Medicines Association have welcomed the adoption of the new legislation, which is expected to come into force, after adoption by the Council of the EU, in mid-2012.

References

European Parliament. EP vote. Results of votes on Wednesday 22 September 2010.

European Parliament. Newsletter, 20–23 September 2010, Strasbourg plenary session. Better monitoring of medicines to ensure greater safety.

European Parliament. Newsletter, 20–23 September 2010, Strasbourg Plenary Session. New rules for safer medicines.

European Medicines Agency. News. European Medicines Agency welcomes adoption of new pharmacovigilance legislation by European Parliament. 22 September 2010.

European Generic Medicines Association. Press Statement. Adoption of the pharmacovigilance legislation by the European Parliament today in Strasbourg – 22 September 2010.