Submission of comments on The European Medicines Agency Road Map to 2015: The Agency’s Contribution to Science, Medicines, Health

11.06.2010

Submission of comments on the European Medicines Agency Road Map to 2015: The Agency’s Contribution to Science, Medicines, Health 

 

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.  

We would like to thank the Agency for the open and  constructive discussions at the April workshop with European Industry Associations. We believe that this is a useful mechanism to communicate and develop  a consensus amongst stakeholders on the best way forward.  This is particularly important in the case of the EMA which operates in a European network, with  key partnerships with the Heads of Medicines Agencies and  the European Commission, as well as with many other important stakeholders. 

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. 

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