The UK’s National Institute for Health and Care Excellence (NICE) has clarified its guidelines on the process of appealing against its guidance for technology appraisals and highly specialised technologies, the decisions of which are crucial to the life sciences industry. Maria Isabel Manley and Victoria Kerr explain the changes.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-07.png606833Maria Isabel Manleyhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaria Isabel Manley2023-05-19 11:15:522023-08-15 11:34:36New Guidance on Appeals Against UK Health Tech Appraisals Applies From June
The European Parliament’s provisional agreement on the EU’s AI Act encompasses generative AI and imposes the requirements that are applicable to high-risk AI systems onto general purpose AI. As negotiations continue, Josefine Sommer, Eva von Mühlenen and Zina Chatzidimitriadou explain.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Josefine Sommerhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngJosefine Sommer2023-05-18 09:11:302023-05-18 09:11:30European Parliament’s Position on the AI Act Moots Significant Changes
The Review proposes to reduce IP rights across the board, with incentives to prolong them. Can any of these incentives work? Maarten Meulenbelt, Chris Boyle, and Zina Chatzidimitriadou discuss how the real-world effects of the Review have not been assessed, and where there is room for improvement in its critical provisions.
FDA details its view of the “limitations” of single-arm trials in oncology drug development and invites comment on its favored approach going forward. Becky Wood, Emily Marden, and Julea Lipiz explain.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Rebecca K. Woodhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngRebecca K. Wood2023-03-27 06:55:182024-11-15 15:36:57FDA Offers New Clinical Trial Guidance for Oncology Accelerated Approval
Pharma companies are currently assessing how the Pharma Review will affect their portfolios. Maarten Meulenbelt and Maria Koutsoupia discuss the need for analysis from the EU to support the Review’s claims, for example on the allegedly ‘invisible’ effect of losing €640 million in annual orphan drug revenues.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-05.png606833Maarten Meulenbelthttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaarten Meulenbelt2023-03-20 10:06:062024-11-15 15:36:24Missing Numbers: Seeking to Substantiate The Leaked EU Pharmaceutical Review
On March 16, 2023 the Court of Justice of the European Union (CJEU) rendered an important judgment[1] for the pharmaceutical industry as it brings some clarification on the test to assess if two products have the ‘same active substance’ and therefore belong to the same Global Marketing Authorisation (GMA). This is a crucial determination as products falling within the GMA of an existing product do not benefit from an independent period of regulatory data protection (RDP) and marketing protection.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Maria Isabel Manleyhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaria Isabel Manley2023-03-17 13:03:432023-03-17 13:03:43The CJEU Provides Further Clarity on the Application of the Global Marketing Authorisation Concept
The UK veterinary medicines industry needs to respond by March 31 to a consultation on proposed changes to the UK Veterinary Medicines Regulations which could boost data protection for regulatory submissions, incentivising innovation. However, companies need to be wary of potential increases in regulatory burden in other areas. Chris Boyle explains.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Dr. Chris Boylehttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngDr. Chris Boyle2023-03-17 06:00:142023-03-16 15:17:09Four Ways New Legal Proposals Could Boost the Animal Health Industry in Great Britain
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New Guidance on Appeals Against UK Health Tech Appraisals Applies From June
The UK’s National Institute for Health and Care Excellence (NICE) has clarified its guidelines on the process of appealing against its guidance for technology appraisals and highly specialised technologies, the decisions of which are crucial to the life sciences industry. Maria Isabel Manley and Victoria Kerr explain the changes.
Maria Isabel Manley
London
mmanley@sidley.com
Victoria Kerr
London
vkerr@sidley.com
European Parliament’s Position on the AI Act Moots Significant Changes
The European Parliament’s provisional agreement on the EU’s AI Act encompasses generative AI and imposes the requirements that are applicable to high-risk AI systems onto general purpose AI. As negotiations continue, Josefine Sommer, Eva von Mühlenen and Zina Chatzidimitriadou explain.
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Eva von Mühlenen
Geneva
evonmuehlenen@sidley.com
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
The EU’s Pharmaceutical Review Needs To Remain Grounded In Economic Reality
The Review proposes to reduce IP rights across the board, with incentives to prolong them. Can any of these incentives work? Maarten Meulenbelt, Chris Boyle, and Zina Chatzidimitriadou discuss how the real-world effects of the Review have not been assessed, and where there is room for improvement in its critical provisions.
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
FDA Offers New Clinical Trial Guidance for Oncology Accelerated Approval
FDA details its view of the “limitations” of single-arm trials in oncology drug development and invites comment on its favored approach going forward. Becky Wood, Emily Marden, and Julea Lipiz explain.
Rebecca K. Wood
Washington, D.C.
rwood@sidley.com
Emily Marden
San Francisco
emarden@sidley.com
Julea Lipiz
Washington, D.C.
jlipiz@sidley.com
Missing Numbers: Seeking to Substantiate The Leaked EU Pharmaceutical Review
Pharma companies are currently assessing how the Pharma Review will affect their portfolios. Maarten Meulenbelt and Maria Koutsoupia discuss the need for analysis from the EU to support the Review’s claims, for example on the allegedly ‘invisible’ effect of losing €640 million in annual orphan drug revenues.
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
Maria-Oraiozili Koutsoupia
The CJEU Provides Further Clarity on the Application of the Global Marketing Authorisation Concept
On March 16, 2023 the Court of Justice of the European Union (CJEU) rendered an important judgment[1] for the pharmaceutical industry as it brings some clarification on the test to assess if two products have the ‘same active substance’ and therefore belong to the same Global Marketing Authorisation (GMA). This is a crucial determination as products falling within the GMA of an existing product do not benefit from an independent period of regulatory data protection (RDP) and marketing protection.
(more…)
Maria Isabel Manley
London
mmanley@sidley.com
Victoria Kerr
London
vkerr@sidley.com
Four Ways New Legal Proposals Could Boost the Animal Health Industry in Great Britain
The UK veterinary medicines industry needs to respond by March 31 to a consultation on proposed changes to the UK Veterinary Medicines Regulations which could boost data protection for regulatory submissions, incentivising innovation. However, companies need to be wary of potential increases in regulatory burden in other areas. Chris Boyle explains.
(more…)
Dr. Chris Boyle
London
cboyle@sidley.com
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