E-DRUG: A new report on drug and vaccine safety in global health
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Dear friends and colleagues,
It is our great pleasure to share with you a new report on drug and vaccine
safety in global health
<https://docs.gatesfoundation.org/documents/SSWG%20Final%20Report%2011%2019%2013_designed.pdf>,
sponsored by the Bill and Melinda Gates Foundation. The report was released
today with an endorsement by Trevor Munde
<http://www.impatientoptimists.org/Posts/2014/02/Want-better-medicines-Demand-better-safety-surveillance>l,
President for Global Health, on the Foundation's *Impatient Optimist* blog.
This report is the product of the Safety Surveillance Working Group, a
year-long initiative to develop a practical, scalable strategy for
improving drug and vaccine safety in low- and middle-income countries.
More than forty senior representatives of national regulatory agencies,
donor institutions, industry, global health initiatives, and international
technical agencies participated. TThe report is co-authored by Tom and Andy
Stergachis, Director of the Global Medicines
Program<http://globalmedicines.org/>at the University of Washington,
but represents the time and ideas of the
many who generously participated.
This report breaks new ground in two ways. First, the report conducts, as
far as we know, the first risk-based, data driven assessment of global
health product pipeline and its demands on the regulatory systems in low-
and middle-income countries. One of the heat maps in the report based on
that analysis is included below. It shows that multiple new drug and
vaccine launches will occur in the same countries over a relatively short
period of time and that many of those countries are clustered together
regionally.
Second, the report, based on that data analysis, outlines an innovative
strategy and implementation plan for strengthening post-market safety
surveillance in low- and middle-income countries. Given the expanding
access to treatment and immunization but limited resources in many of these
countries, we must prioritize our capacity building efforts. Investments
made in support of new vaccine and drug introduction should be done in a
manner that builds functioning safety surveillance systems and leaves
something behind to support future product introductions. Promoting
cooperative approaches and leveraging existing infrastructure would improve
the sustainability of those systems and spread their benefits to other
countries in the region.
The coming decade will be vital for improving drug and vaccine safety
surveillance. The only way we can make progress is through a coordinated
international effort of policymakers, regulators, industry, and health
professionals. We hope this report helps provide a way forward. In the
coming months, we will be looking to engage many of you on the next steps
following this report. In the interim, we would welcome your thoughts if
you have the chance to read the report.
Vincent Ahonkhai and Tom Bollyky
Thomas J. Bollyky
Senior Fellow for Global Health, Economics, and Development
Council on Foreign Relations
1777 F Street, NW
Washington, DC 20006
tel. 202.509.8517 <#> <#> fax. 202.509.8498 <#> <#>
tbollyky@cfr.org www.cfr.org
Samia Saad*
Senior Program Officer, Global Health Research & Development Advocacy
Global Policy & Advocacy
samia.saad@gatesfoundation.org
Bill & Melinda Gates Foundation
samia saad <samiasaad@gmail.com>