The British Medical Journal recently published a report by Davis and colleagues titled “Availability of evidence on overall survival and quality of life benefits of cancer drugs approved by the European Medicines Agency: retrospective cohort study of drug approvals from 2009-2013”. In this report, the authors state that their “systematic evaluation of oncology approvals by the European Medicines Agency in 2009-13 shows that most drugs entered the market without evidence of benefit on survival or quality of life. When there were survival gains over existing treatment options or placebo, they were often marginal… When expensive drugs that lack clinically meaningful benefits are approved and paid for within publicly funded healthcare systems, individual patients can be harmed, important societal resources wasted, and the delivery of equitable and affordable care undermined.”

The European Medicines Agency has stated that the outlook for Europeans with cancer would not improve if they were to only approve medicines with indisputable evidence of improvement in overall survival or quality of life. The Agency’s evaluations are scientific in nature and do not consider economic factors, such as the costs of medicines. The Agency regularly consults patients to make sure that the measures used as a basis for approval are meaningful for the patients concerned.

The European Cancer Patient Coalition appreciates the work of the European Medicines Agency and the European Commission in ensuring a harmonised system of centralised marketing authorisation for cancer medicines. We value the interactions that the European Medicines Agency has with patient organisations throughout Europe, and we are an active member of the Patients’ and Consumers’ Working Party, providing recommendations to the European Medicines Agency and its committees.

The report by Davis and colleagues published in the British Medical Journal examined the efficacy of recently authorised cancer drugs, but did not take into account the safety or quality of these products.

The role of the European Medicines Agency and European Commission is to authorise cancer medicines that are high quality, safe, and efficacious. It is not the role of the European Medicines Agency to evaluate the relative effectiveness of cancer medicines. Even if a treatment has equivalent quality, safety, and efficacy compared to the existing standard of care, the treatment should still be authorised by the European Medicines Agency, as this can often result in decreased prices due to competition.

The European Union must work towards a harmonised and rapid assessment of relative effectiveness that is conducted at the European level, with institutionalised involvement of patient organisations. When it comes to pricing and reimbursement decisions, only cost-effective treatments must be approved, in order to ensure an equitable and sustainable healthcare system. It is essential to support the European Medicines Agency and strengthen co-operation on healthcare throughout the European Union.

Furthermore, the European Cancer Patient Coalition calls for quality of life and social benefit (such as reduced absenteeism and reduced medical costs) to be a secondary endpoint in all Phase 2 and Phase 3 trials of oncology drugs. These factors should be taken into account when determining the pricing and reimbursement of cancer treatments, though, unfortunately, this does not occur in most cases. Furthermore, the existing safeguards to revoke authorisation if the product is demonstrated to lack efficacy or safety should be strengthened, and these safeguards must be rigorously applied to ensure all Europeans with cancer are receiving the best possible healthcare.