With the imminent arrival of oncology biosimilars in the therapeutic paradigm, stakeholders including a clinician, specialist nurse, patient advocate, regulator and economist provide their perspective on optimising the uptake of these new agents in the treatment of cancer. A number of key messages emerge, based on the discussion that took place during a session of the European Society for Medical Oncology’s Annual Congress, ESMO Madrid 2017. First, for successful integration of biosimilars into the global healthcare paradigm, informing and educating the full scope of stakeholders, including clinicians, nurses, pharmacists and patients, is primordial. Success is dependent on providing solid evidence and ensuring all voices are heard. Second, for oncology medicines, much can be learnt from the growing experience of approved biosimilars in other disease indications, with success stories for patients, their healthcare providers and healthcare budgets alike. Finally, effective sustainability of the impact on healthcare budgets and the redirection of these savings require education and transparency.
The European Medicines Agency (EMA) started operating under its new
legal mandate on 1 April 2022. The mandate brings new responsibilities
to the Agency in three different areas: • Reinforcement of the role and
activities of the EMA pandemic Task Force(which is now known as the
Emergency Task Force (ETF)). • A stronger role of EMA in the monitoring
of shortages of critical medicines, medical devices and in-vitro
diagnostics, both in anticipation of and during a crisis. • A more
coordinated mechanism of European Union (EU) experts advice on medical
devices classified as high-risk (class IIa and III or class D (1)) and
in-vitro diagnostic medical devices. Here we consider the impact of the
COVID-19 pandemic on the operations of EMA and the European medicines
regulatory network, and how EMA’s new mandate will strengthen the
Agency’s and the Network’s ability to face crises. EMA’s extended
mandate brings clear benefits in terms of response to public health
emergencies at EU level, which ranges from improvements in crisis
management to avoiding medicine shortages and improving access to
diagnostics and medical devices that are safe and conform to their
expected function.
In an era of information overload and digital communication, patients increasingly welcome clear and unbiased information on the benefits and risks of medicines to participate in treatment decisions. Providing accurate information on benefit-risk evaluations (e.g. approval of a medicine or restrictions in its use), is key to EMA's role of promoting and protecting public health. From EMA's perspective as medicines regulator, challenges to overcome include: difficulty of summarising complex information while conveying a complete and balanced picture, addressing varying health literacy levels and measuring how useful the information is. EMA faces these challenges as it works to improve the information on the benefits and risks of medicines for the public, with the aim of ensuring that patients and healthcare professionals can access highquality information on medicines assessed by EMA.
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