Patients will profit if Europe modernizes its coverage framework to replicate the distinct promise of cell and gene remedy, the Alliance for Regenerative Drugs will spotlight in 29 November EU Parliament occasion
Occasion will function first pediatric affected person to obtain a CAR-T remedy and concentrate on coverage suggestions to reverse Europe’s declining competitiveness
BRUSSELS – 24 November 2022
The European Union can reverse its declining competitiveness and guarantee affected person entry to transformative remedies if it modernizes its coverage and regulatory framework to replicate the distinct promise of cell and gene therapies as the way forward for drugs, the Alliance for Regenerative Drugs (ARM) will say throughout an occasion on the EU Parliament on 29 November.
ARM and Member of the European Parliament Dr. Stelios Kympouropoulos of the European Individuals’s Social gathering will spotlight regarding traits for superior remedy medicinal product (ATMP) builders, scientific trials, and funding within the EU.
“Cell and gene therapies signify large hope for sufferers with severe illnesses within the EU – but when we don’t act to make sure sufferers have entry, hope is all we may have,” stated MEP Kympouropoulos, who lives with spinal muscular atrophy, a uncommon genetic neuromuscular illness. MEP Kympouropoulos just lately signed a letter with 25 MEPs asking the European Fee to not undermine the European pharmaceutical and biotechnology sectors with its upcoming proposal to revise the EU prescription drugs laws.
The 29 November occasion – The Way forward for ATMPs in Europe — will concentrate on the first-in-a-generation revision of the EU prescription drugs laws, the long run implementation of the EU Regulation on Well being Expertise Evaluation, and different key coverage initiatives that may decide the position of cell and gene therapies in Europe’s healthcare panorama for years to come back.
“If Europe modernizes its coverage and regulatory framework to actually embrace ATMPs as the way forward for drugs, European sufferers dwelling with most cancers, uncommon illnesses, and different severe and infrequently life-threatening issues will profit tremendously,” stated Timothy D. Hunt, chief government officer of ARM. “The identical insurance policies and approaches that introduced us yesterday’s biomedical innovation merely won’t work for the cell and gene therapies of immediately and tomorrow. The EU has led earlier than — and might lead as soon as once more — however the time to behave is now.”
Seven of the 23 ATMPs which have been authorised within the EU have been withdrawn from the market. ARM’s information additional illustrates the sector’s struggles in Europe:
- As of the top of June 2022, the variety of ongoing business scientific trials in Europe elevated by simply 2% and the variety of builders headquartered in Europe declined by 2% in comparison with 5 years in the past, whereas the numbers in North America elevated by 41% and 42%, respectively, and the numbers in Asia-Pacific elevated by 74% and 271%, respectively.
- Europe accounted for simply 11% of latest trials beginning within the first half of 2022, with solely two section 1 trials.
Extra info could be present in ARM’s H1 2022 Sector Report, “Regenerative Drugs: The Pipeline Momentum Builds.”
Through the occasion, ARM will launch coverage suggestions that might modernize the EU’s regulatory and entry frameworks, and encourage cell and gene remedy firms to develop, check, and commercialize their therapies within the area.
Different audio system embrace Emily Whitehead, who was the primary pediatric affected person globally to obtain a CAR-T remedy, an engineered cell remedy that assaults most cancers cells. Ten years later, she is taken into account cured of leukemia.
“Attending to journey and advocate for this therapy in Europe is an honor,” stated Whitehead, now 17. “It’s my hope that each youngster on the earth can sometime have entry to those remedies and get again to their regular lives and be pleased and wholesome.”
Emily’s father, Tom Whitehead, president and co-founder of the Emily Whitehead Basis, may also communicate. “We have now heard from many households from Europe since Emily had her success with CAR-T cell remedy, and we’re honored to share our story to hopefully get extra entry to those new wonderful most cancers remedies so extra sufferers can’t solely survive their most cancers however thrive in life after.”
For extra info or for media requests and registration, please contact Stephen Majors, Senior Director of Public Affairs for ARM, at firstname.lastname@example.org.
Concerning the Alliance for Regenerative Drugs
The Alliance for Regenerative Drugs (ARM) is the main worldwide advocacy organisation devoted to realizing the promise of superior remedy medicinal merchandise (ATMPs). ARM promotes legislative, regulatory, reimbursement and manufacturing initiatives in Europe and internationally to advance this revolutionary and transformative sector, which incorporates cell therapies, gene therapies and tissue-engineered therapies. Early merchandise to market have demonstrated profound, sturdy and probably healing advantages which can be already serving to 1000’s of sufferers worldwide, a lot of whom haven’t any different viable therapy choices. Lots of of further product candidates contribute to a strong pipeline of probably life-changing ATMPs. In its 13-year historical past, ARM has grow to be the worldwide voice of the sector, representing the pursuits of 475+ members worldwide and 80+ members throughout 15 European international locations, together with small and enormous firms, educational analysis establishments, main medical centres and affected person teams. To be taught extra about ARM or to grow to be a member, go to http://www.alliancerm.org.