NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Flipper44,

Thank you for sharing the video!

POSTnotes

The Parliamentary Office of Science and Technology produces independent, balanced and accessible briefings on public policy issues related to science and technology.

Regulating Advanced Therapies
Published Friday, November 17, 2017

https://researchbriefings.parliament.uk/ResearchBriefing/Summary/POST-PN-0567#fullreport

"As complex therapies, ATMPs present a number of challenges to developers, regulators, and healthcare providers. They require a high level of expertise to develop and produce, which makes them expensive to market. Regulators have found it difficult to integrate their biological variability into pre-existing guidelines. Healthcare providers also face issues based on their complexity and expense. However, some national healthcare agencies have found creative solutions in funding them."

Full report:

Overview

? ATMPs are mainly regulated by EU law in which the UK’s regulatory bodies currently have a strong voice.
? The UK has a strong ATMP sector, concentrated primarily in academia and small biotechnology firms.
? ATMPs are expensive to develop and administer but several countries use flexible reimbursement mechanisms to fund their use in patients.
? ATMPs offer potential cures for diseases that currently lack them or are expensive to treat long-term.
? Retaining harmonised ATMP regulation with the EU after Brexit is seen as key for patient access, clinical research, and for the UK to retain its lead in the field.

http://researchbriefings.files.parliament.uk/documents/POST-PN-0567/POST-PN-0567.pdf