Meeting Highlights from DIA Europe 2022

Magda Chlebus
EFPIA

Sharon Gorman
Pfizer

Álmath Spooner
AbbVie

nvolving patients in drug development and decision making drives efficiency and ensures that new therapies address the real needs of patients. Industry, regulators, research foundations, and patients are actively working to improve the use of meaningful patient experience data in this process, but more action is needed. An interactive session at DIA Europe 2022, co-hosted by the European Federation of Pharmaceutical Industries and Associations and the European Patients’ Forum, explored how the system can be optimized by placing the patient and patient experience data at its center.

African Medicines Agency (AMA)

ince the minimum number of 15 ratifications by African Union (AU) countries was reached to establish the AMA in November 2021, the AU has stepped up efforts, through the African Union Commission and the African Union Development Agency, to prepare for the opening of the AMA Secretariat. They have developed a joint workplan, with elements including a continued push for further ratification by additional countries, developing an AMA roadmap for the first year and subsequent years, setting up AMA’s core activities and detailed procedures, and developing AMA business processes (including enterprise resource planning).

n February 15, 2022, the European Union (EU) announced that Team Europe—the European Commission, the European Medicines Agency (EMA), and EU Member States Belgium, France, and Germany—and the Bill & Melinda Gates Foundation will mobilize more than €100 million over the next five years to support the recently established African Medicines Agency (AMA) and other African medicines regulatory initiatives at regional and national levels.

group of industry partners have formed the APAC Digital Health and Data Consortium (ADDC) to serve as a platform for collaboration between industry and other organizations such as policy think tanks and regulators to shape digital health data frameworks in the APAC (Asia-Pacific) region.

n March 2022, the Australian Government announced the Clinical Trials Activity initiative. This initiative will support national and international clinical trials of new treatments, initially focused on rare cancers and diseases as well as unmet medical needs, and aims to attract investigator-led, international clinical trials in any disease facing unmet need. It has been funded through the Medical Research Future Fund (MRFF), a $20 billion (AUD) long-term investment supporting Australian health and medical research that has transformed health and medical research in Australia since its inception in 2015.

n April 2018, the India Ministry of Health and Family Welfare launched the National Patient Safety Implementation Framework 2018-2025 (NPSIF), a comprehensive guideline and roadmap toward strengthening the safety of patients in India that also aligns with India’s goal of universal health coverage by 2030.

ecision making in healthcare is a complex process that takes place along a continuum that moves from evidence generation to evidence review and deliberation, to decision making, and to communication of decisions made. In many low- and middle-income countries (LMICs), this process is often not systematic, deliberative, or transparent. This article highlights the links between Health Technology Assessment (HTA) and regulatory practices, including harmonization and collaborative efforts, in Latin America.

The Dilemma

New Fellows of DIA