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EARLY ACCESS TO UNAUTHORISED MEDICINES

Track:
The Role of Transparency and Ethics: Legal aspects

Day & Time:
March 26, 2:00PM - 3:30PM (Central European Standard Time)

Session Number:
1303

Room Number:
F2

Type:
Session

Title:
EARLY ACCESS TO UNAUTHORISED MEDICINES

Chair(s):
Koosje Van Lessen Kloeke, LLM
Life Sciences Lawyer - Partner
Leijnse Artz, Netherlands

Description:
Recent examples from daily practice, media coverage and case-law give rise to interesting ethical and legal questions related to access to medicinal products that are not (yet) authorized or undergoing clinical trials. As a general rule, a medicinal product may be placed on the market only when it has been authorized after an evaluation of its safety and efficacy. However, EU law provides for certain derogations from that rule, for example for investigational medicinal products, named patient and compassionate use. This gives rise to diverging national practices as Member States set different requirements. This session will discuss the situation before and after marketing authorisation, and the situation between marketing authorisation and launch from different perspectives. Speakers will address the national practices in the EU regarding (post-study) access to investigational products, named patient supply, compassionate use and off-label use. Questions to be addressed are e.g. How to balance the interests of the parties involved (individual vs. group of patients, doctors, competent authorities, industry)? What about funding and reimbursement? Can doctors and/or pharmaceutical companies be (legally) obliged to supply unauthorised products for free? Should a reimbursement authority or healthcare insurer be allowed to promote the use of an unauthorised (indication of a) product over the use of the authorised product? What are the rules and limitations with regard to communication about early access and off-label use?

Presentation(s) & Speaker(s):
Setting the Scene: The basic EU law principles, the recently revised post-trial provisions in the Declaration of Helsinki, and practical examples of issues
Koosje Van Lessen Kloeke, LLM
Life Sciences Lawyer - Partner
Leijnse Artz, Netherlands

Making the Patchwork More Transparent: A comparison between national practices regarding (post-study) access to investigational products, named patient supply and compassionate use
Cristiana Spontoni
Squire Sanders, Belgium

Making the Patchwork More Transparent: A comparison between national practices regarding off-label use
Eveline Van Keymeulen, LLM
Senior Associate
Allen & Overy LLP, Belgium