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European Parliament, Brussels

10. svibnja 2017.


10th May 2017, 10:00 – 14:00
European Economic and Social Committee – Room VMA1
rue Van Maerlant 2, 1040 Brussels

The European & national medicines regulatory systems:
the challenges for an equitable, timely and suitable access to innovation


Active Citizenship Network will celebrate the 11th European Patients’ Rights Day with a multi-stakeholder conference, to be held on 10 May 2017 in Brussels.

The aim of the convention is to discuss, inform and suggest new approaches to the existing European and national medicines regulatory systems, for better management of access to innovation. Indeed, the access to innovative therapies strongly contributes to define the quality of life of patients and the quality of healthcare services provided, respecting the fundamental values recognised by the European Charter of Patients’ Rights. The event will be an occasion to inform, discuss and take commitments to improve the respect of patients’ rights and their involvement in the policy-making and regulatory processes at national and European level.

The Council conclusions on Innovation for the benefit of patients during the European semester of the Italian Presidency (December 2014) recognised that “innovations in healthcare can contribute to health and well-being of citizens and patients through access to innovative products, services and treatments that have added value with regard to the existing ones and can also lead to more effective ways to organise, manage and monitor work within the health sector as well as to improve the working conditions for healthcare staff”.
Nevertheless, for example, in many European countries patients still have to wait a long period of time before the medicines – although already approved by the European Commission on the basis of the EMA/CHMP positive feedback – are available.

The European legislation has provided many tools to facilitate the early availability of therapies. However, in many cases long national procedures for reimbursement can delay this availability. Unacceptable disparities in patients’ access – due to different pricing models, authorisation times, information accessibility, channels and criteria of distribution, etc. – in particular to innovative medicines, persist, and they have been made even worse by the adoption of austerity measures and by the reduction of healthcare spending in many Member States since 2009.

European and national regulatory authorities and institutions, patient Organisations and companies should work together to overcome the increasing number of barriers and inequalities.
In this context, the first steps should concern a clear and shared definition of innovation, but also current procedures – and their transparency – for authorisation, pricing and reimbursement, and bridging the gap caused by the lack both of information and of patient involvement in these processes.
Indeed, despite their differences, each National Health System of the EU Member States should guarantee the same rights to patients and people in general.

  • Topics to be treated

The actual regulatory system model in Europe and the point of view of civic/patient associations
– how to assure an equitable, timely and suitable access to innovation?
– should the role of the European Medicines Agency (EMA) be enhanced?

 National experiences of management of innovation
– from Marketing Authorization to concrete access for patients: successes and failures of medicinal products in different EU countries (e.g. Hepatitis C) and other experiences (e.g. medical devices)

The involvement of patient organisations in the regulatory process
– sharing good examples of involvement of patient organizations in EMA and the different patients’ engagement modalities in the national medicines agencies processes.

  • Future challenges

The outcomes of the Conference will be implemented through several follow-up activities:

– Concrete policy suggestions will be made and then shared with the MEPs Interest Group “European Patients’ Rights & Cross-Border Healthcare”.

– Initiatives will be promoted in the different Member States, in partnership with local civic and patient associations, in order to sensitize the National Authorities about patient involvement in their internal processes.

– Training courses addressed to the leaders of European civic and patient associations on themes such as access to generic medicines; European and national Regulatory Systems; Health Technology Assessment; etc.., will be promoted in order to encourage the active sharing of reflections and experiences.


10. svibnja 2017.