European Ministers of Health also adopted conclusions on innovation for the benefit of patients at a Council meeting on 1 December 2014. Ministers are calling on national governments and the European Commission to cooperate more closely on the 'life cycle approach' for new innovative medicines and move ahead with the implementation of health technology assessment.
The Council conclusions highlight the importance of early dialogue between technology developers, regulatory, health technology assessment (HTA) and pricing bodies that may promote innovation and quicker access to medicines at affordable prices and for the benefit of patients. It also referred to the Council conclusions on the reflection process on modern, responsive and sustainable health systems of 10 December 2013, as well as those on the economic crisis and healthcare of 20 June 2014, advocating for cooperation between the Commission and national governments, for strategies to manage spending on pharmaceuticals and medical devices, ensuring equitable access to effective medicines within sustainable national healthcare systems.
HTA can be defined as a systematic, broad-ranging evaluation of using technologies within a particular health system. The term ‘technology' encompasses almost every aspect of the healthcare system, including drugs, devices and medical and surgical procedures, as well as the organisational and supportive systems within which such care is provided.
The objectives of the HTA Network are defined as aiming to support national governments in providing transparent, comparable and transferable information on the relative efficacy as well as on the effectiveness of health technologies and to enable an effective exchange of this information.
National governments are asked to explore new opportunities for cooperation between competent bodies on exchanges of information pertaining to the 'life cycle approach' for innovative medicinal products including (a) early dialogue and scientific advice; (b) pricing and reimbursement models; (c) registries for monitoring the effectiveness of therapies and technologies; (d) appropriate re-assessments; and (e) post-authorisation studies. Governments and the Commission should enhance joint work on HTA; while the Commission should support governments' cooperation on implementing the HTA strategy and propose measures to ensure the long-term sustainability of HTA work.
The Council also invited the Commission to consider making changes to the 2007 Regulation on advanced therapy medicinal products and amending Directive 2001/83/EC, as well as the 2004 Regulation on analysing and reducing regulatory burdens to increase incentives for SMEs and academia - while maintaining the marketing authorisation principle. It also supports cooperation between the Commission and the MS to implement the HTA strategy through a Joint Action under the third Health Programme (2014-2020), in addition to exploring options for continued and sustainable financing.
Innovation and research to improve patient safety, treatment options and quality of care are of major importance to public health. HTA is likely to play an increasingly important role in the financing and organisation of healthcare systems in the future. The promotion of a more objective, reliable and transparent system, where the European Commission and governments can work together in promoting a more efficient and cost-effective environment for innovation, is also laudable.
Conclusions on innovation for the benefit of patients.
The Council referred to the 2004 Regulation laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (EMA) on one side, and Directive 2001/83/EC on the Community code relating to medicinal products for human use.