The EuropaBio contribution to the EMA Roadmap to 2015 consultation

03.05.2011

The EuropaBio contribution to the EMA Roadmap to 2015 consultation

EuropaBio welcomes the opportunity to input into the consultation on the European Medicines Agency Road Map to 2015 and, overall, is supportive of the Agency’s future strategic vision as outlined in the consultation document.

At this time of new and emerging technologies, there is increasing pressure on ensuring that patients gain access to approved medicines whilst making certain that healthcare systems optimise the use of their healthcare budgets; and the European Medicines Agency no doubt has a key role to play in this. As the scientific evaluator of the risk-benefit profile of a medicinal product, the Agency is best placed to provide information on its scientific recommendations to external stakeholders, be they patients, Member States’ competent authorities, HTA agencies or payers.

Increasingly, more information about a product becomes available post-marketing authorisation, as the medicinal product finds its way into the general target patient population. Findings should be used to update the information available on a given authorised medicine. Additionally, technology convergence means that medicinal products are increasingly connected with other technologies, traditionally outside the scope of the Agency. EuropaBio believes that dialogue with stakeholders is vital to establish the most effective way to ensure that these new technologies are able to deliver benefits to patients.

EuropaBio is strongly supportive of the Agency’s effort to improve efficiency for a successful delivery of its core business. This will be vital in light of the increased complexity of the Agency’s tasks. We would also welcome the ongoing consideration of measures to reduce the administrative burden on stakeholders who interact with the Agency.