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14:30 Welcome
Elisabetta Gardini, Member of the European Parliament (EPP, Italy)

14:40 Setting the scene: Health Technology Assessment
Cristian-Silviu Buşoi, Member of the European Parliament (EPP, Romania)

14:50 ECPC achievements in HTA advocacy
Francesco De Lorenzo, President of the European Cancer Patient Coalition

15:00 Patient involvement in HTA in Member States
Martin Danner, Representative of Patient Organisations, Federal Joint Committee (G-BA), Germany

15:10 Perspectives from the Member States

Germany: Ortwin Schulte, Head of Unit “Health Policy”, Permanent Representation of Germany to the EU

15:20 Panel on Access to Innovation

Academic Perspective
Heinz Zwierzina, President, Cancer Drug Development Forum

Medical Oncologist Perspective
Paolo G. Casali, EU Policy Committee Chair, European Society for Medical Oncology

Industry Perspective
Ivana Cattaneo, Vice-Chair of the Oncology Platform, EFPIA

European Regulatory Perspective
Markus Paulmichl, Pharmacogenomics Working Party Vice-Chair, European Medicines Agency

15:50 – 16:15 Panel debate and Q&A with the audience

16:15 Closing remarks
Lieve Wierinck, Member of the European Parliament (ALDE, Belgium)



In light of the European Commission’s legislative proposal for future EU cooperation on Health Technology Assessment (HTA), the European Cancer Patient Coalition (ECPC) together with Elisabetta Gardini MEP (EPP, Italy) will host a discussion organised in partnership with the Cancer Drug Development Forum. The meeting will provide an opportunity to highlight the impact of EU HTA regulation on the lives of people with cancer. MEPs will exchange views patients, researchers, oncologists, industry and other stakeholders to ensure that the current mandatory cooperation proposal translates into a tangible patient-centred legal framework.

Innovative diagnostics, drugs and therapies offer the potential to improve the lives of millions of people living with cancer, yet significant differences in time-to-access across the EU remain. While HTA is increasingly being performed by Member States, the variety of methodologies results in differences in how data and evidence are assessed. The European Cancer Patient Coalition has been working with Elisabetta Gardini MEP since 2014 for a more harmonised EU approach to HTA.

The proposed EU regulation presents an opportunity to address the fragmentation of HTA systems, as well as reducing disparities in access to innovative treatments and diagnostics. For example, biomarker and molecular testing hold potential to define a personalised cancer treatment strategy. Mandatory cooperation and uptake of Joint Clinical Assessment (JCA) reports is the best approach for successful cooperation in this field, in order to provide equal and timely access to valuable cancer therapies. The suggestion of some Member States to complement the clinical evidence used in JCAs as part of national appraisal processes should be considered, in order to ensure that JCAs become a reality in the EU.

The European Commission’s Report of the Expert Panel on Innovative Payment Models for High-Cost Innovative Medicines confirms that HTA has become a widely accepted methodology to identify and assess the value of new medicines. HTA is an important tool to support healthcare payers’ decision-making, clarifying when benefits from new products are significant, and when to exclude products with non-significant benefits. Improving HTA and strengthening cooperation across countries will also provide better estimates of the medical and social value of new products. The concept of value should go beyond clinical data, including patient-reported outcome measures, but also wider economic and societal impact medicines have and their contribution to the sustainability of national healthcare systems.

The European Commission’s proposal also seeks to dismantle barriers to involving patients in HTA, by establishing methods for providing patient evidence. However, more robust patient engagement schemes are needed at both the EU and Member State levels. Cancer patients are the ultimate beneficiaries of innovation in medical technologies. Their needs and preferences must be captured when assessing the value of new therapies.

The policy discussion is organised by ECPC and forms part of the two-day Multi-Stakeholder Workshop on “Biomarkers and Patients’ Access to Personalised Oncology Drugs in Europe” organised by the Cancer Drug Development Forum in collaboration with ECPC. ECPC works for a Europe of equality, where all Europeans with cancer have timely and affordable access to the best treatment and care available. Representing over 400 patient organisations, ECPC advocates for patients to be acknowledged as co-creators of their own health and as equal partners in healthcare, research and policy-making.



This session is part of a 2-day Multi-Stakeholder Workshop on Biomarkers and Patients’ Access to Personalized Oncology Drugs in Europe organised by the Cancer Drug Development Forum in collaboration with ECPC. The workshop will take place at the Thon Hotel EU in Rue de la Loi 75, Brussels and will host experts coming from academia, industry, and patients representative.

Click here to find out more about the Workshop