Welcome!

News Feed Item

The Alliance for Regenerative Medicine Publishes Position on Hospital Exemption of Advanced Therapy Medicinal Products in Europe

BRUSSELS, BELGIUM and WASHINGTON, DC -- (Marketwired) -- 02/16/17 -- The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the cell and gene therapy and broader regenerative medicine and advanced therapies sector, today announced it has published its position on Hospital Exemption (HE) in response to vastly different interpretations and implementations across the European Union of Article 3(7) of Directive 2001/83/EC within article 28 (2) of the Advanced Therapy Medicinal Products (ATMP) Regulation.

ARM believes that HE is a useful pathway to enable patients to receive an ATMP under controlled conditions in cases where no authorised medicinal product is available for an indication with a high unmet medical need. However, varying interpretations and implementations of HE among European Member States may lead to the supply of a medicine under HE when there is an existing licensed alternative that has undergone rigorous quality testing and demonstrated proven safety and efficacy. This undermines the case for investment in the licensing of ATMP, and as such, may act as a deterrent to developers and could ultimately limit the supply of products for European patients.

"Throughout our efforts to advocate for the consistent interpretation and implementation of HE across the EU -- a topic that has been widely debated for several years -- we have been focused on understanding and defining an approach that will generate optimal outcomes for patients," said Jacqueline Barry, Chief Clinical Officer at Cell & Gene Therapy Catapult and chair of ARM EU Regulatory Committee. "This includes fostering a regulatory pathway for the development and widespread availability of innovative, disruptive medicines across the European community."

In its position paper, ARM has outlined a series of proposals aimed at creating consistent implementation of HE across European Member States, including:

  • Issue guidelines to more specifically define the scope of HE to situations of high unmet medical need and no treatment alternatives. Such guidelines should state clearly that when patients have access to an ATMP with a Marketing Authorization, Member States should not authorize HE for the same medical indication. The guidelines should also address the possible interference of HE with recruitment of patients in clinical trials for the same indication.

  • Create a publicly available registry of all sites using ATMP under HE and their therapeutic indications in all Member States.

  • Encourage Member States to make HE subject to the approval of an ethical committee review on a case-by-case basis.

  • Develop tutorials to educate the medical community and research institutions on requirements for ATMPs, clinical studies and marketing authorization.

  • Offer incentives at the EU and/or Member States level to stimulate academic/industry collaborations.

"ARM has taken an important leadership role in advocating for a consistent interpretation and implementation of HE among European Union Member States," said Eduardo Bravo, Managing Director and CEO of TiGenix, member of the ARM Executive Committee. "We believe that ARM's initiative for greater clarity on HE addresses the hurdle to patients' access to effective treatments that the current divergent implementation of HE across the EU poses. Important for companies in our sector, clearly, is market access, and the position proposes a way forward to ensure HE is not misused to circumvent the applicable legal instruments for the authorisation of safe and effective medicinal products in Europe."

ARM's official position on HE is available here.

"We are very pleased that a series of planned activities, published by the EMA on 2nd February 2017 to foster ATMP development and enable expanded patient access in the EU, includes support of more transparency in HE, as proposed in our position paper. We encourage the stakeholders involved in the elaboration of the EU plan seeking to optimize the current regulatory framework to consider the other recommendations proposed in ARM's position on HE," concludes Annie Hubert, ARM's director of European public policy.

About The Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine and advanced therapies worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Today, ARM has more than 250 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visit http://www.alliancerm.org.

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
Regardless of what business you’re in, it’s increasingly a software-driven business. Consumers’ rising expectations for connected digital and physical experiences are driving what some are calling the "Customer Experience Challenge.” In his session at @DevOpsSummit at 20th Cloud Expo, Marco Morales, Director of Global Solutions at CollabNet, will discuss how organizations are increasingly adopting a discipline of Value Stream Mapping to ensure that the software they are producing is poised to ...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In his Day 3 Keynote at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore t...
When NSA's digital armory was leaked, it was only a matter of time before the code was morphed into a ransom seeking worm. This talk, designed for C-level attendees, demonstrates a Live Hack of a virtual environment to show the ease in which any average user can leverage these tools and infiltrate their network environment. This session will include an overview of the Shadbrokers NSA leak situation.
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @ThingsExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.
Interested in leveling up on your Cloud Foundry skills? Join IBM for Cloud Foundry Days on June 7 at Cloud Expo New York at the Javits Center in New York City. Cloud Foundry Days is a free half day educational conference and networking event. Come find out why Cloud Foundry is the industry's fastest-growing and most adopted cloud application platform.
In his opening keynote at 20th Cloud Expo, Michael Maximilien, Research Scientist, Architect, and Engineer at IBM, will motivate why realizing the full potential of the cloud and social data requires artificial intelligence. By mixing Cloud Foundry and the rich set of Watson services, IBM's Bluemix is the best cloud operating system for enterprises today, providing rapid development and deployment of applications that can take advantage of the rich catalog of Watson services to help drive insigh...
Automation is enabling enterprises to design, deploy, and manage more complex, hybrid cloud environments. Yet the people who manage these environments must be trained in and understanding these environments better than ever before. A new era of analytics and cognitive computing is adding intelligence, but also more complexity, to these cloud environments. How smart is your cloud? How smart should it be? In this power panel at 20th Cloud Expo, moderated by Conference Chair Roger Strukhoff, pane...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
As enterprise cloud becomes the norm, businesses and government programs must address compounded regulatory compliance related to data privacy and information protection. The most recent, Controlled Unclassified Information and the EU’s GDPR have board level implications and companies still struggle with demonstrating due diligence. Developers and DevOps leaders, as part of the pre-planning process and the associated supply chain, could benefit from updating their code libraries and design by in...
The 21st International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Machine Learning and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding busin...
Existing Big Data solutions are mainly focused on the discovery and analysis of data. The solutions are scalable and highly available but tedious when swapping in and swapping out occurs in disarray and thrashing takes place. The resolution for thrashing through machine learning algorithms and support nomenclature is through simple techniques. Organizations that have been collecting large customer data are increasingly seeing the need to use the data for swapping in and out and thrashing occurs ...
SYS-CON Events announced today that DivvyCloud will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. DivvyCloud software enables organizations to achieve their cloud computing goals by simplifying and automating security, compliance and cost optimization of public and private cloud infrastructure. Using DivvyCloud, customers can leverage programmatic Bots to identify and remediate common cloud problems in rea...
Most DevOps journeys involve several phases of maturity. Research shows that the inflection point where organizations begin to see maximum value is when they implement tight integration deploying their code to their infrastructure. Success at this level is the last barrier to at-will deployment. Storage, for instance, is more capable than where we read and write data. In his session at @DevOpsSummit at 20th Cloud Expo, Josh Atwell, a Developer Advocate for NetApp, will discuss the role and value...
SYS-CON Events announced today that Tintri, Inc, a leading provider of enterprise cloud infrastructure, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Tintri offers an enterprise cloud platform built with public cloud-like web services and RESTful APIs. Organizations use Tintri all-flash storage with scale-out and automation as a foundation for their own clouds – to build agile development environments...
Cloud promises the agility required by today’s digital businesses. As organizations adopt cloud based infrastructures and services, their IT resources become increasingly dynamic and hybrid in nature. Managing these require modern IT operations and tools. In his session at 20th Cloud Expo, Raj Sundaram, Senior Principal Product Manager at CA Technologies, will discuss how to modernize your IT operations in order to proactively manage your hybrid cloud and IT environments. He will be sharing bes...