The European Medicines Agency (EMA) has unveiled PRIME (PRIority MEdicines), a groundbreaking initiative aimed at accelerating patient access to innovative medicines across Europe. Launched on Monday, the program represents a strategic response to close the growing approval timeline gap between European and US markets.
Bridging the Transatlantic Approval Gap
Recent examples highlight the significant delays European patients face in accessing breakthrough treatments. Merck's Keytruda, approved through the FDA's breakthrough route in September 2014, took an additional 10 months to reach European patients. Similarly, Bristol-Myers Squibb's Opdivo, despite utilizing existing accelerated assessment pathways, experienced substantial delays in European authorization.
The FDA's Breakthrough Therapy Designation has demonstrated notable success, with average approval times decreasing from 14 months in 2013 to 11.5 months in 2014. The program has granted over 110 breakthrough designations in four years, leading to 30 drug approvals.
Enhanced Support and Scientific Dialogue
"We want to ensure that breakthroughs in medicines reach patients quicker," states Dr. Tomas Salmonson, Chair of the Committee for Medicinal Products for Human Use (CHMP). The initiative promises "early, proactive and enhanced support" to medicine developers, focusing on both accelerating regulatory processes and providing ongoing scientific guidance.
Companies seeking PRIME status must demonstrate a compelling scientific concept backed by robust non-clinical studies and preliminary safety data. Professor Guido Rasi, EMA's Executive Director, emphasizes that the program aims to "foster better planning of medicine development" to generate high-quality data necessary for comprehensive assessment.
Integration with European Healthcare Systems
PRIME will operate alongside ADAPT SMART (Accelerated Development of Appropriate Patient Therapies), creating a comprehensive approach to expedited drug development and approval. A key distinction from the US model is the early inclusion of health technology assessment bodies and reimbursement agencies in the dialogue.
Sue Forda, Vice President of International Regulatory Affairs at Eli Lilly, notes that PRIME could help address both development and access challenges: "The sooner we bring key healthcare decision makers to the table, the better our chances of getting much-needed new treatments to patients sooner."
Priority Areas and Impact
EU Commissioner Vytenis Andriukaitis highlights PRIME's potential impact on areas of significant unmet need, including rare cancers and dementia. The initiative also aims to accelerate the development of new antibiotics to combat antimicrobial resistance.
While the European pharmaceutical industry organization EFPIA has welcomed the initiative, they acknowledge that implementation will be a learning process. The program maintains strict criteria for acceptance, similar to the FDA's approach, where 181 breakthrough requests have been denied to date.
Market Access Considerations
Despite PRIME's promising framework, challenges remain in harmonizing pricing and reimbursement decisions across European markets. While the initiative addresses regulatory bottlenecks, national governments retain control over reimbursement decisions, making a unified European approach to market access unlikely in the near term.
