• Establish an ATMP coordination body at EU/EEA level
• Ensure authorities in regions of treatment are compensated for costs of treating patients from other regions
• Encourage greater alignment within Europe on product value assessment activities

The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the cell and gene therapy and broader advanced therapies sector, today published a positioning paper outlining recommendations for the timely and effective access to cross-border healthcare for patients.

Today’s new position paper focuses, and further elaborates, on the recommendations of ARM’s July 2019 report on ensuring timely access to ATMPs in Europe (see the report here). It represents the views of the ARM members and aims to stimulate debate and reach consensus among key stakeholders, including marketing authorisation holders, payers and treatment centres, on solutions to ensure all European patients can secure access to ATMPs, irrespective of their country or region of origin.

Challenges to expanded ATMP access in Europe

• Not all approved ATMPs are expected to be made available to all countries in Europe or to all regions of a given country.
• The legal frameworks that grant the right to cross-border healthcare for patients in Europe are not optimal for ATMP treatments.
• The lack of Health Technology Assessment (HTA)/pricing assessment in the patient’s country of origin and regional budgets or multiple payers/insurers in some countries can constitute barriers to cross-border or cross-region treatment with ATMPs.

            
ARM’s key recommendations

In order to ensure that patients across Europe can access ATMPs, ARM recommends the following:

• Establish a ‘one-stop shop’ ATMP coordination body at EU/EEA level to act as a broker between the different stakeholders and facilitate cross-border patient treatment and funding.
• Create ‘one-stop shop’ ATMP coordination bodies in countries with regional funding or with multiple payers/insurers to ensure authorities in the regions of treatment are compensated for the costs of treating patients from other regions.
• Encourage more effective coordination of HTA activities to ensure greater alignment within Europe on product value assessment measures.

Additional recommended measures to facilitate industry engagement in existing initiatives could include: improved opportunities for cross-country collaboration, removing duplicative processes at national level, and adopting policy principles to enhance cross-country collaboration.

Janet Lambert, CEO of ARM, commented: “Europe has always been a leader in ATMP innovation, both in R&D and getting products to market, however, to ensure that patients have access to these transformative treatments, there are several challenges that need to be overcome at EU, national and regional levels. This paper builds on the EU Market Access Report published in 2019 and the subsequent European stakeholder meeting in Brussels, and outlines the challenges and the recommendations that we, alongside our members, believe will most effectively get these therapies to patients in a sustainable manner.”

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 worldwide. Founded in 2009, ARM 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 350+ member organizations worldwide. ARM represents the interests of therapeutic developers, academic research institutions, major medical centers, investors, and patient groups that comprise the broader regenerative medicine community and is the prominent international advocacy organization in this field.

ARM has 70+ members across 15 countries in Europe. ARM aims to work closely with European stakeholders, leveraging its membership to create a supportive commercial and regulatory environment to create better conditions for the development and commercialization of ATMPs in Europe; develop strong stakeholder support around proposed solutions to improve patient access to ATMPs; promote clear, predictable and efficient regulatory framework across Europe; and promote international convergence of key regulations and guidance. For more information, visit alliancerm.org.