Delivered by Laetitia Bigger, Director, Vaccines Policy
IFPMA welcomes WHO’s efforts in developing a framework to avert shortages. While supply is one factor, shortages are influenced by a range of issues, such as unpredictable country demand, complex regulatory requirements, and lack of timely communication as referenced in paper A70/20. We call for the timely dialogue between manufacturers and public health authorities to address challenges to prevent shortages, anticipate the evolution of national health programs, ensure more accurate demand forecasting, and reduce and harmonize regulatory approval times for post-approval changes and in-country testing for lot release.
We regret that much of this important discussion has focused on the UN High Level Panel on Access to Medicines. Improving access to medicines across the world is one of the greatest challenges of our time, yet, as referenced by a number of Member States, the Panel’s mandate was too narrow and based on a false premise. The report has failed to address the genuine barriers to access that are critical to meet the targets of the UN’s Sustainable Development Goals (SDGs). This was a missed opportunity.
Consequently, the report’s recommendations are based on assertion rather than evidence. They fail to recognize the complexities around pharmaceutical R&D and the importance of strong IP to the development and diffusion of medicines to patients. Panelists themselves expressed strong divergence in their commentaries, and the UN Secretary General did not endorse the report.
The biopharmaceutical industry considers that neither this report nor its recommendations can be a sound basis for further consideration or action by the UN system. IFPMA and its members are committed to working with national governments to address the systemic causes of shortages and multiple barriers to access to medicines.