Global alliance unites pharma pros to battle counterfeiting

Pharmaceutical counterfeiting is a widespread, pervasive problem that impacts not only pharma companies, but anyone who finds themselves in need of medicines. The minds behind Fight the Fakes launched the organization to bring together industry colleagues to work toward ways to thwart counterfeiters wherever they may strike.

Outsourcing-Pharma (OSP) recently spoke with Adam Aspinall (AA)—chair of the Fight the Fakes Alliance, as well as senior director of access and product management for the Medicines for Malaria Venture—about global counterfeiting, the group’s mission, accomplishments to date, and how individuals may join the organization in its work.

OSP: Counterfeiters are a sneaky but (unfortunately) smart bunch. Could you please share some of the ways in which they manage to pull off their fakery?​

AA: Counterfeiters have become increasingly sophisticated in the manufacture of falsified medicines and let’s remember the are engaging in criminal activity. Oftentimes the packaging as well as the product itself look extremely similar to the genuine product and it is very difficult to make out whether it’s a falsified or legitimate product.

Even anti-counterfeiting measures such as pack holograms or SMS verification panels have been counterfeited, so it’s essential to stay one step ahead through constant innovation. We have also heard anecdotes of genuine discarded medicine packaging being collected from hospital pharmacies in Africa to be re-used but with falsified medicines.

OSP: What are some of the challenges pharma companies, regulators and other stakeholders face in preventing and catching counterfeiters?​

AA: Weak regulatory systems, poor governance and corruption, porous borders, and the complexity of medical supply chains are all factors which are contributing to the difficulty of dismantling criminal networks manufacturing and trading falsified medical products. Wider availability of detection technology and stiffer sentencing measures to deter criminals are also crucial.

OSP: What kind of costs (financial and otherwise) do counterfeiters exact on companies, and on patients/consumers?​

AA: Falsified and substandard medicines have a considerable health as well as an economic/socio-economic impact – for individuals, healthcare systems as well as the industry. On an individual/ patient level, falsified medicines likely fail to treat the patient’s illness, and can lead to further disability or even death – the most expensive medicines, after all, are those that don’t work.

Additional – genuine - treatments will be needed and patients may require expensive hospitalisation at a cost to both themselves and healthcare systems.  In addition, it can increase mistrust in health care professionals and health care systems as well as fuel antimicrobial resistance. Financially, prolonged illness might lead to greater out-of-pocket expenses on healthcare and a loss of income/ productivity.

Falsified medicines also come with an increased burden for health care professionals, national medicine regulatory authorities, law enforcement and the criminal justice systems. They also inflict a considerable economic loss on health systems and manufacturers of quality medical products.

It is very difficult to quantify the extent of economic losses but the glimpse of data we have available highlights the extent of the issue: the London School of Hygiene and Tropical Medicine estimates that 116 000 additional deaths just from malaria could be caused every year by substandard and falsified antimalarials in sub-Saharan Africa alone, with a cost of about $38.5m USD to patients and health providers for prolonged care due to failure of treatment.

OSP: How does counterfeiting compare in developed areas like the US and EU, versus less-developed regions?​

AA: Substandard and falsified medicines are a global issue which COVID-19 has underlined. In the early stages of the pandemic, we have seen reports of falsified personal protective equipment (surgical gloves, hand sanitizers, face masks), fake diagnostic testing kits and rumors of cures coming in from all over the world. Last week, the first report of a COVID-19 fake vaccine being distributed has come from London.

However, while a global issue, the burden is generally greater across low- and middle-income countries (LMICs) as they are more likely to have weaker regulatory systems, more porous supply chains, more widespread corruption and lower access to detection technology. The WHO estimates that 1 in 10 medical products in LMICs are either substandard or falsified.

There are a few additional studies which highlight the worrisome extent of the burden of fake medicines. In a modeling study, the London School of Hygiene and Tropical Medicine estimates that 116 000 (64 000 – 158 000) additional deaths from malaria could be caused every year by substandard and falsified antimalarials in sub-Saharan Africa alone. Another analysis by the University of Edinburgh estimates that 72 000 to 169 000 children may be dying each year from pneumonia due to poor-quality and fake antibiotics.

The limited data available on this issue means the known figures almost certainly represent just a fraction of the true burden of falsified medicines around the globe.

OSP: How did Fight the Fakes get started?​

AA: Fight the Fakes was initiated in 2013 as an advocacy and awareness raising campaign by 10 founding members, including Medicines for Malaria Venture, the World Heart Federation, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), the International Council of Nurses (ICN), and US Pharmacopeia – all of these organizations are represented on the current executive board of the Fight the Fakes Alliance and are a driving force behind the work of the association.

As substandard and falsified medicines have been an under-addressed global health issue for years, the 10 founding members of Fight the Fakes saw the urgent need for a dedicated campaign with the vision is to significantly reduce the harm from fake medicines to patients and all people worldwide. The move to a more formalized alliance will give us a louder voice, greater influence, the ability to implement programs at country level and ultimately, we hope, a seat at the World Health Assembly through a formal relationship with the WHO.

OSP: Who are your current members, and what kinds of members would you like to bring on as you grow?​

AA: The Fight the Fakes Alliance currently has 16 members organizations representing health care professionals, manufacturers, wholesalers, researchers, and patients:

• Association for Accessible Medicines
• European Medicines Verification Organisation
• GS1
• The Global Pharma Health Fund
• International Alliance of Patients’ Organizations
• International Council of Nurses
• International Federation of Pharmaceutical Manufacturers & Associations
• International Federation of Pharmaceutical Wholesalers
• International Pharmaceutical Students’ Federation
• King’s College London
• Medicines for Malaria Venture
• Medical University of Warsaw
• National Association of Boards of Pharmacy
• University College London
• US Pharmacopeia
• World Heart Federation

More information about all our members can be found on our website (FightTheFakes.org). The strength of the Alliance lies in the variety of its members. In the next years, we would really like to engage more regional organizations which have a presence on the ground where the burden of falsified medicines is the greatest, e.g. organizations in Africa and South/South-East Asia.

We are also aiming of expanding our network of academic members as the engagement of students and young people has been a tremendous resource of the campaign as they are particularly engaged on social media.

OSP: What are the benefits of bringing together companies and organizations from across the industry spectrum?​

AA: Substandard and falsified medicines are a multisectoral issue which require action from all stakeholders along the medical supply chain. Regulatory agencies, law enforcement, patient organizations, health care professionals (doctors, nurses, pharmacists), manufacturers, wholesalers and research all have an important role to play if we want to holistically tackle the manufacture and trade in falsified medical products.

With its diverse members, the Alliance is uniquely positioned to scale up action, build capacity and enhance education across the different stakeholders.

OSP: Could you please tell us about your work in the years since you launched?​

AA: Since its foundation in 2013, Fight the Fakes has become a well-known among global health stakeholders. Over the years, Fight the Fakes has established a far-reaching presence on social media platforms, and has been featured in international media outlets, such as the Guardian, Devex, Health Policy Watch, The Lancet, and others.

Beyond its very successful awareness raising on social media and media, Fight the Fakes has hosted three successful events at the World Health Assembly, most recently in 2019. Since 2018, Fight the Fakes has also hosted the annual Fight the Fakes Week in early December where all members and interested organisations and individuals are coming together to speak up against falsified medicines – both online as well as during on the ground events.

OSP: One of the action items on your FTF Week page is sharing stories—do you have any anecdotes or instances of counterfeiting that you would be willing to share?​

AA: Stories from the ground are a very valuable communication tool as they make the issue of falsified medicines more “real” emphasizing that this is really an issue that affects people around the world.

I think one of the most memorable stories is the one from Adebayo Alonge. As a teenager he spent 3 weeks in a coma after unknowingly consuming falsified asthma medication. After his recovery, he made it his mission to raise awareness about the issue and ultimately founded his own start-up which develops and distributes AI-based nano-scanners which can identify and verify medicines’ quality and authenticity.

OSP: How will the FTF Alliance alter/amplify your mission?​

AA: Our goal for the next few years ahead is to have a bigger impact in-country. We are planning to conduct education and capacity building workshops on the ground in countries with a great burden of falsified medicines (e.g. countries in Sub-Saharan Africa).

In addition, our advocacy and awareness raising efforts need to actually reach those people who are at greatest risk of unknowingly purchasing and consuming falsified medicines. Expanding our collaboration with academic institutions and youth groups will therefore be another focus.

OSP: If someone is inspired by your mission and work, how can they get involved?​

AA: If an organization is interested in getting to know more about Fight the Fakes’ work and potentially would like to become an official member, they can always reach out to us via our website. An individual can unfortunately not become an official member of the Fight the Fakes Alliance but anyone sharing our interests and values can of course use our various resources, engage with the Alliance on social media, and take part in our annual Fight the Fakes Week.

Ultimately, we would like to build a movement of allies in the fight against falsified medicines. And in this movement every person counts.