Fight the Fakes Alliance delivered a statement during the 78th World Health Assembly, on Monday, 26 May 2025, agenda item 13.5, echoing the points previously raised at World Health Organization Executive Board meeting.
In response to the WHO’s report evaluating the Member State Mechanism on Substandard and Falsified Medical Products—and its recommendation to enhance collaboration with non-State actors—FtFA reaffirms its commitment to working alongside Member States, WHO, civil society, regulatory authorities, law enforcement, customs officials, manufacturers, distributors, healthcare professionals, and all relevant stakeholders.
This statement was delivered by the World Heart Federation on behalf of Fight the Fakes Alliance at the 156th session of the WHO Executive Board:
Honourable Chair,
Distinguished Delegates,
The World Heart Federation, supported by the Fight the Fakes Alliance, welcomes the independent evaluation of the Member State Mechanism on Substandard and Falsified Medical Products.
The World Health Organization estimates that one in ten medicines in low- and middle-income countries are substandard or falsified, threatening lives and eroding trust in health systems. Globally, countries waste an estimated US 30.5 billion annually on such products.
We strongly support the recommendations to strengthen engagement with non-State actors and explore mechanisms to improve Member State participation as well as sustainable financing.
Our alliance stands ready to collaborate with Member States, WHO, civil society, regulatory agencies, custom officers, manufacturers, distributors, healthcare workers, and all relevant stakeholders to ensure universal access to safe, effective, and quality-assured medical products.
Thank you.
Video: Yunshu Wang, World Heart Federation, supported by the Fight the Fakes Alliance.
We are also pleased to note that falsified and substandard medical products (SFs) are referenced in the Pandemic Treaty: “The Parties shall, as appropriate, monitor and strengthen rapid alert systems and take regulatory measures to respond to substandard and falsified pandemic-related health product.”
Ensuring access to quality and safe medical products is essential for patient safety and the long-term sustainability of healthcare systems. Each year, an estimated $30.5 billion is lost due to SFs.
You can listen to the full statement below, delivered by our Chair’s organization World Heart Federation.
Statements by other non-state actors include:
International Alliance of Patients’ Organizations
The International Alliance of Patients’ Organizations, with support from the African Medicines Agency Treaty Alliance (AMATA), commends WHO and Member States for sustained attention to the public health threat posed by substandard and falsified medical products.
Regional regulatory systems have proven life-saving, offering protection, rapid response, and cross-border coordination.
Once operational, the African Medicines Agency will address Africa’s specific needs by harmonizing regulations, enhancing oversight across borders, and ensuring no country is left behind fighting substandard and falsified products.
Through our #AfricanMedsAgencyNOW campaign, AMATA urges all African Member States to urgently ratify the Agency Treaty, and calls global partners, including WHO, to support the implementation of the Agency as a strategic partner in this global effort, ensuring patient safety and patients’ timely access to effective and quality-assured medicines across Africa.
Thank you.
International Pharmaceutical Federation
Honourable Chair, Distinguished Delegates,
I speak on behalf of the International Pharmaceutical Federation (FIP), representing over four million pharmacists worldwide. Pharmacists are among the most trusted healthcare professionals, serving as medication experts for patients and communities. Through the FIP Development Goal on patient safety, FIP promotes safe pharmaceutical care and highlights the critical role of pharmacists in patient safety.
Pharmacists have the necessary knowledge and skills to use the appropriate medicines authentication system of medicines as well as educate patients on the availability of legal online channels when available. Due to the high safety risks of illegal online drug sellers and substandard and falsified (SF) medical products sold online, FIP has developed five new modules to be embedded into existing curricula. This resulting curricula is now strengthened to teach pharmacists on the broader issue of SF medical products globally.
Thank you.
International Pharmaceutical Students’ Federation
Honourable Chair, Distinguished delegates,
The International Pharmaceutical Students’ Federation (IPSF) represents over 500,000 pharmaceutical students and recent graduates in more than 100 countries.
Substandard and falsified medical products pose a direct threat to patient safety and healthcare integrity. As future pharmacists and healthcare professionals, IPSF acknowledges the responsibility we share in combating this issue. Our role extends beyond detection and prevention; we must also lead efforts to strengthen regulations and ensure quality control throughout the supply chain.
Therefore IPSF urges WHO, Member States and academic institutions to:
-Enhance pharmacy curricula to equip future pharmacists with the knowledge and skills needed to identify and combat substandard and falsified medical products.
-Strengthen regulatory frameworks by adopting low-cost, effective verification methods and mandatory inspections throughout the entire supply chain.
Thank you.
Medicus Mundi International – Network Health for All
We support option A of recommendation 1, which proposes to dissolve the MSM and establish a new format that would report to the DG. We believe that addressing substandard and falsified medical products need not and should not be through a standalone entity within the WHO, particularly in light of the current resource constraints highlighted in the report.
We emphasise that improving national-level regulatory capacity is key to combating substandard and falsified medical products. Neither the WHO nor the current MSM have the legal mandate to enforce penalties against suppliers of substandard and falsified medical products. Law enforcement falls under national jurisdictions; hence, we call on the WHO to support MS in developing regulatory capacity where substandard and falsified products circulate.
