Patients and consumers across Europe will soon be able to directly report any adverse reactions to medicines, following approval by the European Parliament for it to be made a legal provision.
Aside from direct patient reporting of adverse events, other changes to EU legislation on pharmacovigilance included establishing public hearings to enable broader participation and input from stakeholders when reviewing the benefits and risks of medicines.
DPR is already in place in some European countries, but these new requirements pave the way for systems in all EU countries. “What we do not yet know is how direct patient reporting will be implemented. We have the legislation but now EU citizens need to be made aware the system exists and governments need to make sure the systems in place are friendly and accessible,” commented Health Action International Europe.
However, it adds, there was no commitment from the Parliament to public funding of pharmacovigilance systems, which would support impartiality. In addition, the HAI notes, the amendments also failed to address to issue of therapeutic advance, which would require new medicines to demonstrate their therapeutic advance relative to existing treatments in order to obtain marketing authorisation.