This website uses cookies to ensure you the best experience and enhance site navigation.



Loading page ...

alternative text

The Ministry of Health and INFARMED - National Authority of Medicines and Health Products, I.P., in collaboration with the European Commission, will organise the 3As Conference to be held on the 29th-30th of April 2021, in Lisbon, via virtual form, under the Portuguese Presidency of the Council of the European Union.

One of the identified priorities by the Portuguese presidency is “Supporting Sustainable, Equitable and Universal Access to Medicines and Medical Devices”. This priority will be advanced by structuring discussions around 3 main pillars: Availability, Accessibility and Affordability. In this context, the conference aims to give a new and renewed momentum to the discussion on how to address these longstanding topics that have been on the agenda of those with the highest responsibilities in the European pharmaceutical policy. It is therefore necessary to continue this debate in the field of pharmaceutical policy at EU level, which addresses European and national developments and challenges in the various aspects of this subject in an integrated, ethical and sustainable manner.

Enhancing cooperation between EU countries is a key factor in the improvement of the accessibility, availability and affordability of medicines and medical devices. In this context, there shall also be a discussion on pricing and reimbursement policies, cost effectiveness of medicines, how public incentives are translated into the price of the product, regional collaborations, as well as the transparency throughout the value chain and the overall sustainability of health systems. It also looks for how ensuring access and accessibility when meeting needs and unmet needs and how to improve the market launch of centrally authorized products. In this sense, it would help improving accessibility, through a more equitable and adequate patient access to health technologies.

The 3As Conference aims to promote a multi-stakeholder debate on these specific issues pertaining to the identified topics that will inform collaborative approaches, define priorities and policy options to be translated into concrete action. It aims ultimately to contribute on promoting a European Health Union, through a larger and better cooperation between the different NCAs and stakeholders in the EU, namely, in the area of medicines and medical devices.

AGENDA

DAY 1: 29 APRIL | 08:30 - 16:50 WEST
WELCOME ADDRESS AND OPENING REMARKS
08:30
Marta Temido, Portuguese Minister of Health
HIGH LEVEL SPEAKERS
To be Confirmed
KEYNOTE SESSION
09:00 - 09:10
Portuguese Presidency priorities on access to medicines and medical devices
Marta Temido, Portuguese Minister of Health
09:10- 09:20
European Health Union and the Pharmaceutical Strategy for Europe
Stella Kyriakides, European Commissioner for Health and Food Safety
09:20 - 09:30
European Parliament perspective on access to medicines and medical devices
Pascal Canfin, ENVI Committee Chair (tbc)
09:30 - 09:40
Introduction to Conference
Rui Santos Ivo, President of Executive Board INFARMED, PT
PANEL I: AVAILABILITY OF MEDICINES AND MEDICAL DEVICES
Moderator: Christa Wirthumer-Hoche, AGES, AT
09:40 - 09:55
Addressing shortages: preliminary results from the Commission study
Andrzej Rys, European Commission
09:55 - 10:10
Availability of medicinal products
Nuno Simões, INFARMED, PT
10:10 - 10:25
A common understanding for a list of critical medicines and medical devices
Noël Wathion, EMA
10:25 - 10:50
Q&A
10:50 - 11:00
BREAK
PARALLEL BREAKOUT SESSIONS
11:00 - 11:50
Stakeholders solutions to medicines shortages
Moderator: Kristin Raudsepp, SAM, EE
SESSION 1: National experience on shortage’s management
Rapporteur: Xavier De Cuyper FAMHP, BE
SESSION 2: Shortages management plans to avoid availability problems
Rapporteur: Sinisa Tomic, HALMED, HR
SESSION 3: Hospital Pharmacists solutions for availability problems
Rapporteur: Aida Batista, EAHP
SESSION 4: Consumers and patients’ perspectives on medicines shortages, the case of small volumes and limited use medicines
Rapporteur: Monique Goyens, BEUC
11:50 - 12:10
Breakout sessions’ conclusions
12:10 - 12:35
Q&A
12:35 - 13:30
LUNCH
PANEL II: ACCESSIBILITY AND INNOVATION OF MEDICINES AND MEDICAL DEVICES TO PATIENTS
Moderator: Karl Broich, Bfarm, DE
13:30 - 14:00
HMA-EMA joint strategy 2025
Emer Cooke, EMA
PARALLEL BREAKOUT SESSIONS
14:00 - 14:50
SESSION 1: Access to medicines for special populations: Orphan and Paediatric Regulations & Revision of the system of incentives
Rapporteur: Helena Fonseca, PDCO and Violeta Stoyanova-Beninska, Chair COMP
SESSION 2: Unmet medical needs: medicines and medical devices research in view of patients and health systems needs
Rapporteur: Marco Greco, President, European Patients Forum (EPF)
SESSION 3: How the repurposing of old medicines may add new value on patients’ access to new therapies
Rapporteur: Cesar Hernandez, AEMPS, ES
SESSION 4: Generation of evidence for a better patient access & Health data space and big data: shared data for a better communication and coordination
Rapporteur: Xavier Kurz, EMA and Nikolai Brun, DKMA, DK
14:50 - 15:10
Breakout sessions’ conclusions
15:10 - 15:40
Q&A
15:40 - 15:50
BREAK
PANEL II (CONT): ACCESSIBILITY AND INNOVATION OF MEDICINES AND MEDICAL DEVICES TO PATIENTS
Moderator: Maria Lamas, AEMPS, ES
15:50 - 16:05
The new regulation of medical devices: State of play – Are we ready?
Anna-Eva Ampelas, European Commission
16:05 - 16:20
Will the new regulation promote accessibility of MD: Coordination, complexity and stringency vs. the need for regulatory exibility
Thomas Wejs Møller, Chair CAMD
16:20 - 16:35
The technological, scientic and regulatory convergence between medicines and medical devices (digital technologies, companion diagnostics, combination products)
Niall MacAleenan, HPRA, IE
16:35 - 16:50
Q&A
DAY 2: 30 APRIL | 09:00 - 12:45 WEST
PANEL III: AFFORDABILITY OF MEDICINES
Moderator: Rui Santos Ivo, INFARMED, PT
09:00 - 09:15
Developing an “affordability” agenda under the pharmaceutical strategy for Europe to keep the sustainability of Health Systems
Sylvain Giraud, European Commission
09:15 - 09:30
Effective ways of investing in health and patient access
Pedro Pita Barros, Nova SBE
09:30 - 09:45
Sustainability of healthcare systems: What costs? What value?
Francisco Ramos, ENSP
09:45 - 10:00
Q&A
10:00 - 10:10
BREAK
ROUNDTABLE
10:10 - 12:30
Collaboration and priorities for accessibility and affordability
Moderador: Marcel van Raaij, MoH, NL
The perspective of National Competent Authorities
Momir Radulovic, JAZMP, SI | Nicola Magrini, AIFA, IT
The perspective of the Industry
Nathalie Moll, Director General, EFPIA | Christoph Stoller, MfE | Serge Bernasconi, Medtech Europe | Monika Derecque-Pois, GIRP
The perspective of patients & health professionals
Yannis Natsis, EPHA | Annabel Seebohm, CPME | Ilaria Passarani, PGEU
CLOSING SESSION
12:30 - 12:45
Closing remarks
Diogo Serras Lopes, Portuguese Secretary of State for Health

SPEAKER HIGHLIGHTS

Marta Temido

Portuguese Ministry of Health

Stella Kyriakides

European Commission

Rui Santos Ivo

INFARMED – National Authority of Medicines and Health Products, I.P

Christa Wirthumer-Hoche

AGES - Austrian Medicines and Medical Devices Agency

Nuno Simoes

INFARMED – National Authority of Medicines and Health Products, I.P (PT)

Noël Wathion

EMA - European Medicines Agency

Kristin Raudsepp

SAM - Estonian State Agency of Medicines

Sinisa Tomic

HALMED - Croatian Agency for Medicinal Products and Medical Devices (HR)

Aida Batista

EAHP - European Association of Hospital Pharmacists

Monique Goyens

BEUC - The European Consumer Organisation

Karl Broich

Bfarm - Federal Institute for Drugs and Medical Devices (DE)

Emer Cooke

EMA - European Medicines Agency

Helena Fonseca

PDCO

Violeta Stoyanova-Beninska

COMP - Committee for Orphan Medicinal Products

Marco Greco

EPF - European Patients Forum

Cesar Hernandez

AEMPS - Spanish Agency of Medicines and Medical Products (ES)

Xavier Kurz

EMA - European Medicines Agency

Nikolai Brun

DKMA - Danish Medicines Agency (DK)

Maria Lamas

AEMPS - Spanish Agency of Medicines and Medical Products (ES)

Anna Eva Ampelas

European Commission

Thomas Wejs Moller

CAMD - Competent Authorities for Medical Devices

Niall MacAleenan

HPRA - Health Products Regulatory Authority (IE)

Sylvain Giraud

European Commission

Pedro Pita Barros

Nova SBE - Nova School of Business and Economics (PT)

Francisco Ramos

ENSP - National School of Public Health (PT)

Marcel van Raaij

MoH - Ministry of Health (NL)

Momir Radulovic

JAZMP - Slovenian Medicines and Medical Devices Agency (SI)

Nicola Magrini

AIFA - Italian Medicines Agency (IT)

Christoph Stoller

MfE - Medicines for Europe

Monika Derecque-Pois

GIRP - European Healthcare Distribution Association

Yannis Natsis

EPHA - European Public Health Alliance

Annabel Seebohm

CPME - Committee of European Doctors

Ilaria Passarani

PGEU - Pharmaceutical Group of the European Union

ALL SPEAKERS

FOR FURTHER INFORMATION CONTACT US AT

PTPresidency2021@infarmed.pt