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3rd February 2022



Access Programs – What’s in a name

One of the most confusing areas of Access Programs is the terminology that is used. It seems like everyone has their own differing names for the same programs, however technically the differing names have different meanings depending on the Regulatory jurisdiction and the relevant Competent Authority and the jurisdiction the program is taking place in… 


Access Programs – What’s in a name - SmartNote

This note examines the major types of program, the difference between the types and provides some generally accepted definitions for the products.

Types of programs

In general, there are two differing types of programs:

1. Individual or Named Patient Programs 

2. Group or Cohort Programs

There are of course significant differences from one regulatory authority to another and care needs to be taken not to directly translate names across regulatory jurisdictions… 

Robert Donnell

EVP - Medicines Access

A Health Economist by training he has 25 years’ experience in the Pharmaceutical Industry first with P&G and then AZ across Sales and Marketing and Supply Chain. In the last 15 years he has specialized in the design and initiation of Expanded Access Programs working across all therapy areas including Oncology, Rare and Gene Therapies.

Nicole Lyons

Head of Regulatory Affairs

Post studies in Pharmaceutical Sciences she joined a UK distributor in the Regulatory Function rising quickly to become the Responsible Person (UK MHRA role who is responsible for all areas of GDP) She currently leads the Regulatory function across all of Smatway’s European sites and consults widely on international supply chain and GxP issues.

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