As stated in the 7th right of the European Charter of Patients’ Rights, each individual has the right to receive necessary treatment within a swift and predetermined period of time and this right applies at each phase of the treatment.
At this time the process for Marketing Authorization (MA) consists of a set of steps and procedures to ensure the drug safety and the safeguard of citizens' health. The current rules tend to seek a balance between the protection of health and the need to give quick answers to patients who often are in urgent need to treat severe conditions. Unfortunately, this collides with approval and reimbursement times that sometimes are very, if not even too, long.
Almost all the innovative and important drugs follow the centralized procedure to obtain marketing authorization (necessary time: about one year). After that starts the price-setting procedure for reimbursement, which can last more than an additional year. Thus, depending on the institutional framework of each Member State, citizens can then rely on the actual availability of an authorized drug only after a reasonably long period.
In March 2014, the EMA has proposed a first solution to speed up patient access to new medicines, identifying the adaptive pathways. The approach, formerly known as "adaptive licensing", is a process which provides the early authorization of an innovative drug for a targeted subgroup of patients and its subsequent expansion depending on the evidence gathered. This approach speeds up access and strengthens the collaboration between all those involved in the life cycle of the drug, but at the same time, pushes patients to accept a higher level of uncertainty and risk.
Then, in March 2016, EMA has launched the "PRIME" program (PRIority MEdicines) which provides for the acceleration of the drugs regulatory path, supporting companies (including academic start-ups) and reducing evaluation times (50 days instead of 210). This new procedure will focus on the development of drugs considered priorities, which can offer great advantages over existing treatments or provide an opportunity to patients with no other treatment options.
However, this process relates to the centralized procedure for the marketing authorization by the European Commission but not the procedures for defining pricing and reimbursement, which depends on each Member State.
The meeting, hosted by MEP Brando Benifei (S&D Group), has been organized by Active Citizenship Network in partnership with SIAR, the Italian Society for Regulatory Activities and intended to be a first follow-up step of the last European Patients’ Rights Day.
It aimed to stimulate, through a high level debate, the European issue on access to medicines and sustainability of healthcare systems, promoting a reflection on all possible options to ensure a more rapid real access to innovative medicines and strengthening the specific knowledge on the topic within patient organizations, for a more effective advocacy towards national Regulators, Ministries of health, etc.
During the event, SIAR presented a proposal addressed to European Countries on timely access to therapies for severe diseases with unmet medical need. It is an open document to which is it possible to contribute, submitting suggestions and concrete actions, by writing to This email address is being protected from spambots. You need JavaScript enabled to view it. by September 15th, 2017.
Click here to download the full position paper and the related study made by SIAR
Find below the meeting programme and download the presentations:
HOW TO ENSURE TREATMENTS AND THE RESPECT OF PATIENTS’ TIME ACROSS EUROPE?
Focus on timely access to innovative medicines after the European Commission approval
28th June 2017
from 15:00 to 17:00 - room ASP 5G315
European Parliament, Brussels
Programme
Registration & Accreditation
Meeting point: ex info point (Place du Luxembourg)
Chair: Joseph Torrent Farnell – Clinical Head of Clinical Pharmacology at Hospital de la Santa Creu I Sant Pau;
EMA COMP member and past Chair, Spain
Welcome address and keynote presentation
- MEP Brando Benifei - S&D Group
- Mariano Votta - Director of Active Citizenship Network
Timely access to therapies for severe diseases with unmet medical need
- Enrico Bosone - President of Società Italiana Attività Regolatorie (SIAR)
- Olga Solomon - Head of Unit B5 ''Medicines: policy, authorisation and monitoring'' at DG SANTE
1st session - Citizens’ and patients’ perspective
- Simone Boselli - Public Affairs Director at EURORDIS
- Lucia Ruggieri - Researcher at Gianni Benzi Foundation, TEDDY Network scientific secretariat, Italy
2nd session - Payers’ and HTA bodies’ perspective
- Ri de Ridder - Director general of RIZIV/INAMI, Belgium
- Gabriella Almberg - Director of Government Affairs at the European Federation of Pharmaceutical Industries (EFPIA)
- Neil Bertelsen - Chair of the HTAi Interest Group for Patient and Citizen Involvement in HTA
Q&A and closing remarks
