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HOW TO OVERCOME THE OBSTACLES IN PATIENTS’ ACCESS

Track:
New and Known Substances - how to fit the rules to needs

Day & Time:
March 27, 2:00PM - 3:30PM (Central European Standard Time)

Session Number:
1507

Room Number:
5AB

Type:
Session

Title:
HOW TO OVERCOME THE OBSTACLES IN PATIENTS’ ACCESS

Chair(s):
Kristin Raudsepp, MD
Director General
State Agency of Medicines, Estonia

Description:
The session will look at the availability and accessibility of medicinal products. We try to find out if there is a favourable environment for all stakeholders, especially patients. The session will explore the possible hurdles for patients’ access to known active substances and look at the ongoing developments to accelerate the start of the marketing of generics in Europe, e.g., new transparency directive. Attention will be paid to the price pressure on generics. The experience will be given about the implications of the new directive on falsified medicines from the viewpoint of access to known active substances. We will discuss if the patent regulation and data exclusivity are fully in the interest of a patient and where is the best balance for new and known active substances. We will discuss the scientific development, including "repurposing" known products to more targeted populations with improving the safety profile or enhancing the efficacy. The session will explore the opinions of the industry, of the agency and of patients about the known active substances, including biosimilars and interchangeability.

Presentation(s) & Speaker(s):
Off-Patent Medicines - more valuable than ever
Richard Bergstroem, MS
Director-General
EFPIA, Belgium

Does the Current Regulatory Framework Constitute a Threat to a Long-Term Access to Generic Medicines?
Beata Stepniewska, MPharm
Deputy Director , Head of Regulatory Affairs
European Generics Medicines Association EGA, Belgium

Partners and Competitors in Ensuring Availability and Access
Kristin Raudsepp, MD
Director General
State Agency of Medicines, Estonia

Panel Discussion
Nicola Bedlington
Director
European Patients Forum, Belgium