Spotlight Series: Pharmaceuticals and Biologic Standards

PAHO/WHO Collaborating Centre Spotlight Series 

Reference Number: BRA-56

Official Title: PAHO/WHO CC for Pharmaceutical Policies
Institution: Nucleus for Pharmaceutical Policies, National School of Public Health, Fundação Oswaldo Cruz (FIOCRUZ)

Reference Number: CAN-82

Official Title: PAHO/WHO CC for Governance, Transparency and Accountability in the Pharmaceutical Sector
Institution: Leslie Dan Faculty of Pharmacy, University of Toronto

Reference Number: USA-304

Official Title: PAHO/WHO CC in Pharmaceutical Policy
Institution: Centre for Global Health and Development, Boston University School of Public Health

Reference Number: USA-289

Official Title: PAHO/WHO CC for Biological Standardization
Institution: Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA)

Health System

Category 4 (SP 14-19)

Outcome 8 (SP 20-25)

Dr. Porras

Dr. Analia Porras, Unit Chief, Medicines and Health Technologies, is the PAHO staff member who acts as the Region’s focal point and also has a supporting role to the WHO focal point to coordinate the collaboration between the institution and the Organization.

The main activities for these Centres include: (1) providing technical assistance and expertise; (2) producing publications and literature reviews related to access to medicines; (3) conducting consultations on pharmaceutical governance and regulations in the Caribbean; (4) developing International Reference Standards with WHO; and (5) supporting the implementation of institutional developments plans developed by regulatory authorities.

The Centre at FIOCRUZ created a training module on access to medicines, trade and international agreements on PAHO’s Virtual Campus (available in English and Spanish) and hosted by the Edmundo Granda Ugalde Leaders in International Health Program (LHIP-PAHO). The objective of the module is to strengthen the students’ advocacy and negotiation capacities in the pharmaceutical field, through the historic reconstruction of the access to medicines as a human right, as well as understand the characteristics of the global medicines trade and their health, economic, political and social implications. The Centre is also producing a paper on “access to medicines in the past 30 years of the Brazil National Health Service” (in process).

The Centre at the University of Toronto leads activities focused on pharmaceutical governance, transparency and accountability. For example, the Centre completed an evaluation of pharmaceutical governance in Trinidad and Tobago by conducting a desk review of publicly available information, based on a transparency tool that was developed by WHO. The results were then presented back to the government in Trinidad and Tobago. The staff at the Centre also led a review of existing legislation for potential establishment of a national regulatory authority in the Bahamas and identified gaps and recommendations for a draft legislation. Given these engagements, PAHO has been invited to present a paper on PAHO’s approach to regulatory systems strengthening in small states at the University of Toronto in 2020.

The Centre at Boston University supported the creation of indicators for country profiles to define pharmaceutical policies and regulations for medicines. The Centre also participated in discussions for a publication regarding transparency in pharmaceutical policies as a reference for WHO. The Centre has also conducted literature reviews related to the access of medicines in order to support PAHO with defining concepts.

The Centre at FDA is focused mainly on biological standardization and regulatory systems strengthening at the global level. The Centre remains a key partner for PAHO/WHO during global discussions at the World Health Assembly and the PAHO Directing Council Resolution on Regulatory System Strengthening. The Centre also supports PAHO/WHO to develop the International Reference Standards (IRS): (1) technical report series on WHO from the WHO committee of biological standardization and (2) measurement standards used internationally to evaluate quality of biological products, as part of registration activities and post marketing surveillance. Lastly, the Centre supports the implementation of institutional development plans prepared by regulatory authorities and provides expertise on regulation of blood products or blood derived medicines.

Webnotes such as these serve to inform how Collaborating Centres are contributing to the Organization’s priorities and mandates.