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EFPIA response to the press release following the informal Meeting of Health of Ministers on 10 and 11 September 2018 under the Austrian Presidency of the EU

EFPIA notes the press release from the Austrian Presidency of the EU following the informal Meeting of Health Ministers on 10 and 11 September 2018.
 
EFPIA shares a common goal with all partners in healthcare: to ensure that patients across Europe get rapid access to the latest, most effective and lifesaving medicines. With over 7000 treatments in development, the exciting new wave of medical innovation will play a key role in addressing the challenges faced by patients and healthcare systems in Europe.
 
Commenting on the statement, Nathalie Moll, Director General at EFPIA, said. “We welcome the focus on the supply of medicines and are keen to work with governments, healthcare systems and all healthcare partners including patients to find solutions to make medicines accessible and healthcare more sustainable, whilst securing future medical innovation that patients need.” 
 
EFPIA welcomes the intent to “establish mechanisms that enable payers to adapt as early as possible to the development of new product groups and products and to plan appropriately.” Any horizon-scanning system should enable countries to map potentially important innovative medicines before they reach the market and develop their systems to timely assess which health technologies will be coming and how to manage their introduction. Horizon scanning can help focus on the crucial interaction between industry and healthcare systems to facilitate the uptake of possibly disruptive innovations in healthcare systems in a sustainable way. Well-run horizon-scanning offer the opportunity to improve access of patients to new treatments and should encourage the adoption of the most efficient healthcare interventions by viewing drug budgets in the context of healthcare overall.
 
In the release, the Federal Minister highlighted the importance of assessment to ensure that medicines “provide patient benefit that meets our expectations”. EFPIA supports the Commission Proposal for an HTA Regulation where all centrally authorised medicinal products would undergo joint clinical assessments, i.e. a compilation and evaluation of the available scientific evidence on a health technology in comparison with one or more other health technologies. Many countries already do this today and the Commission Proposal would ensure that all countries have access to this evidence in the future. EFPIA calls on Ministers to ensure the proposed Regulation can deliver its promise by ensuring that joint clinical assessments are used and not duplicated at national level.
 
The statement also referenced delays in access to medicines in different countries across the EU. Barriers to access in any member state are often complex and multi-faceted and do not lend themselves to a single pan-European solution.  Where there is an access problem, this is typically resolved by working together to ensure that conditions and procedures for access to the national level are addressed. Proposals to change the status quo to require marketing in all Member States would run counter to the very principle of the centralised marketing authorisation and to the internal market principle of free movement and trade, as well as going against member states’ competences on pricing and reimbursement issues. 

We welcome the Ministers’ focus on digital health. EFPIA is an active partner in a number of projects designed to realise the potential of healthcare data to shape the future of research and advance patient care, such as Big Data for Better Outcomes and the European Health Data and Evidence Network through the Innovative Medicines Initiative and a new strategic alliance with the International Consortium for Health Outcomes Measurement (ICHOM) to catalyze the measurement of standardized health outcomes as a step towards improving patient care through more sustainable, outcomes-based health systems.