The Role of Named Patient Programme: Whitepaper Overview
Named Patient Programme is the mode of accessing or obtaining medicine before marketing authorization where a healthcare professional (doctors, nurses and caretakers) requests supply of an unauthorised medicine directly from the manufacturer/ supplier to treat serious or immediately life-threatening disease or condition of an individual patient under the direct supervision of doctors. Globally, each country has its own set of guidelines to regulate the use of such medicines in their territories.
This paper provides an overview of named patient programmes available worldwide, highlighting country-specific provision in certain countries across the globe, viz. the United States (US), European Union (EU), the United Kingdom (UK), Gulf or Middle East, ASEAN and Latin American Countries to help patients in dire need of treatment for a disease or ailment for which no another treatment is available in the country.
Difference Between Named Patient Programme, Expanded Access Programme and Compassionate Use: Highlights
Named Patient Programme enables individuals and healthcare professionals (doctors, nurses and caretakers) to access medications that have been approved in other countries but are not yet commercially available or authorised for marketing in their own country. These programmes are for those with serious or debilitating illness, for which there is no locally authorised medication or therapy available.
Compassionate Use (CU): This is a pathway to make a medicinal product available to a group of patients suffering from chronic, serious, debilitating or life-threatening diseases and who are deprived of an effective treatment option in their own country. This is applicable to medicinal products either undergoing a clinical trial or are eligible for authorisation application as per Regulation (EC) No 726/2004, Article 6.
Expanded Access: This is a pathway to access unapproved medicines if there are no authorised treatment options available and where patients cannot participate in clinical trials. Expanded access programmes provide critical treatment options for patients in dire need who cannot wait for formal drug approval.
Special Access: An exemption from the need for a marketing authorisation for a medicinal product is provided wherein the medicinal product is manufactured and assembled in accordance with the specification provided by a health care professional (doctor, dentist, nurse, etc.).
APCER’s Regulatory Affairs Capabilities & NPPs
APCER’s team of highly experienced Regulatory professionals have been helping our clients in identifying the correct and updated requisites for Named Patient Programmes available locally in different countries across the globe. Keeping a close eye on the updates pertaining to named patient programmes ensures timely availability of unapproved medicines and patient safety.