Clinigen backs white paper calling for recognition of early access schemes

UK-based Clinigen Group (AIM: CLIN) has published a new International Society for Pharmaceutical Engineering (ISPE) white paper covering regulatory-compliant mechanisms that enable access to medicines for patients who have exhausted all other treatment options.

Chaired by Mark Corbett, senior vice president of Clinigen Global Access Programs (Clinigen GAP), Improving Access for Patients with Unmet Medical Needs – Overview and Best Practices for Success, describes these programs which are known by various names around the world including expanded access, named patient programs and compassionate use, and offers best practices for implementation.

Mr Corbett said: “For many patients, access to new medicines through well-known and well-defined clinical trial processes or through traditional commercial channels is not an option. Access programs can provide a robust and ethical solution, both locally and globally, for relevant patients in need. Unfortunately, low awareness of these programs and confusion as to how and when they are best applied limit their use in the proper circumstances. We believe this white paper will help address these issues and demonstrate the value of these important programs.”