Saving lives and accelerating innovation?

Antecedents and implications of the Expanded Access Programme in the pharmaceutical industry

Providing ‘investigational’ drugs to treat life-threatening conditions and severe diseases in developing countries through Expanded Access Programme (EAPs) could help save millions of lives – but raises obvious ethical and financial issues. This investigation examines the barriers that pharmaceutical firms face in releasing products through an EAP to better understand the challenges and identify ways for business to embrace innovation and corporate social responsibility. In doing so, it could help solve one of the most urgent global health challenges of our time.

WORLDWIDE

The challenge

The lack of access to drugs that treat deadly diseases is a massive global health challenge, especially in developing countries. In 2016, of nearly 37 million people living with HIV, one million died due to a lack of effective drugs and therapies. This study examines the relatively understudied strategy of ‘early access’ in the pharmaceutical industry context, where firms pursue two distinctly different goals: saving lives and making money, with the result that the industry does not focus solely on saving lives.

The intervention

An Expanded Access Programme (EAP), in which a pharmaceutical company provides ‘investigational’ drugs to patients with a life-threatening condition or severe disease, is a pathway to solving such problems. However, providing such a drug has ethical and financial concerns; hence adopting an EAP is complex for pharmaceutical companies and currently only a fraction have done so. This research examines the concerns and barriers pharmaceutical firms face in releasing products through an EAP to better understand the associated social and economic challenges.

The impact

An EAP is a philanthropic undertaking. By providing insights into how pharmaceutical companies allocate resources in making investigational drugs available to the patient segment that needs them the most, this research will identify ways for business to embrace innovation and corporate social responsibility. In doing so, it will help solve one of the most urgent and socially and economically debilitating global health challenges of our time.