Substandard, spurious, falsely labelled, falsified and
counterfeit medical products
Frequently Asked Questions
April 2014
How big is this problem?
SSFFC medical products are by their very nature difficult to detect. They are often designed
to appear identical to the genuine product and may not cause an obvious adverse reaction,
however they will fail to treat the disease or condition for which they were intended. There
are many estimates of the scope and scale of the market in SSFFC medical products but little
validated evidence to underpin those estimates. WHO have withdrawn all of their previous
estimations of the scale of the problem and in 2013 launched a global surveillance and
monitoring system to encourage Member States to report SSFFC incidents in a structured
and systematic format, to assist in arriving at a more accurate and validated assessment of
the scope, scale and harm caused by this issue.
Which medicines are most affected?
Reports received by WHO from Member States suggest that all therapeutic categories are
affected by SSFFC medical products. Anti-Infectives, Anti-Malarials and Genito urinary/Sex
Hormones are particularly badly affected. Expensive cardio vascular and oncology products
are targeted as well as low priced pain suppressants. Generic and Innovator medical
products are both vulnerable to falsification as are the most expensive to the cheapest
products. Those engaged in the manufacture, distribution and supply of medical products
have shown they respond quickly to demand, thoroughly understanding the market and are
fast to exploit opportunities.
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What is the harm caused?
Assessing the harm caused by SSFFC medical products is complex and difficult. Most cases
involve a medical product that fails to work properly, this can range from an anti- malarial to
an emergency contraceptive. Often the product will not cause a toxic reaction, but will fail
to work with potentially devastating consequences. A patient failing to respond to their antimalarial or who suffers an unwanted pregnancy will rarely consider the cause of the
problem to be their medicine. This needs particularly effective vigilance and awareness
amongst healthcare professionals, efficient reporting mechanisms for patients and strong
post market surveillance of medical products in circulation in order to quickly identify
problems.
Some SSFFC medical products do cause serious adverse reactions and sometimes fatalities.
When these incidents occur in a close geographic area over a short time period they are
more easily identified and reported.
Too often cases are reported to WHO arising from an unexpected and disproportionate rise
in mortality at a healthcare facility. The WHO Surveillance and Monitoring system and other
WHO vigilance systems are beginning to pick up this data.
How can I avoid SSFFC Medical Products?
The following steps will help minimise the risk from SSFFC medical products
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Source from trusted and licensed outlets
Examine the packaging for spelling mistakes or grammatical errors
Check the expiry dates
Ensure the medicine looks correct, is not discoloured, degraded or has an unusual
smell
If you suspect it is not working properly , discuss with your pharmacist or Doctor
What should I do if I think I have an SSFFC medical product?
You should discuss your suspicion with a pharmacist, Doctor or other healthcare
professional. You should also report your suspicion to the National Medicines Regulatory
Authority.
In cases where you have suffered an adverse reaction to the medicine, including its failure
to work properly, you should report this to a healthcare professional immediately.
Which countries are affected the most?
No countries remain untouched by this issue from North America and Europe through to
Sub Saharan Africa and South East Asia. What was once considered a problem suffered by
developing and low income countries has now become an issue for all. With the exponential
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increase in internet connectivity those engaged in the manufacture, distribution and supply
of SSFFC medical products have gained access to a global market place. This extends both to
consumers and business to business forums. A culture of self-diagnosis and self-prescribing
has led to the emergence of thousands of unregulated websites providing unsupervised
access to SSFFC medical products. However it is low and middle income countries and those
in areas of conflict, or civil unrest, with very weak or non-existent health systems that bear
the greatest burden of SSFFC medical products.
Why are some Countries more vulnerable?
Countries which have poor regulatory oversight, a lack of legislation, inefficient Criminal
Justice System, porous borders, high levels of corruption, lack of political will and limited
access to affordable medicines are particularly vulnerable.
Where do the SSFFC products come from?
SSFFC medical products are manufactured in many different countries and in all WHO
regions. Member States and the media frequently report successful operations against
manufacturers of SSFFC medical products. Some reports refer to large scale manufacturing
and others to small back street operations. With the availability of tableting machines,
ovens, and packaging materials clandestine manufacturing facilities are quick and easy to
assemble.
Where are SSFFC products discovered?
SSFFC medical products are frequently found in unlicensed and illegal outlets, this includes
street markets, hawkers and illegal internet pharmacies. However, they are also reported
from legal and regulated venues such as hospitals, clinics, pharmacies and drug stores in all
regions. These are precisely the locations where patients should have the highest degree of
confidence that the medical products they receive are safe, good quality and effective.
Who reports finding SSFFC products?
SSFFC medical products are discovered and reported by many different organizations, these
include;
National
Medicines Regulatory Authorities,
Laboratories,
Customs,
Police,
Pharmacovigilance Networks, Non-Governmental Organizations, Procurement Agencies, UN
Agencies, Healthcare practitioners including Doctors and Pharmacists, Supply chain
professionals and the public.
How do SSFFC products enter the supply chain?
Most commonly SSFFC medical products enter the legal supply chain at distribution level
through hospitals. clinics, pharmacies and wholesalers sourcing medical products from
unknown sources and intermediaries without checking their credentials or conducting any
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due diligence. Supply chains can be long and complex. The more extended the supply chain
the more vulnerable they are to weak links and the insertion of SSFFC medical products.
When do the WHO issue Medical Product Alerts?
The principal objective of a WHO medical product alert is to ensure a timely, proportionate,
and consistent response to health events arising from SSFFC medical products which
represent a significant threat to International public health.
The Surveillance and Monitoring unit within the Safety and Vigilance Team of the Essential
Medicines and Health Products Department will take the following criteria into account
before issuing a Medical Product Alert:
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Has the report been validated
Does a genuine and significant risk to public health exist
Does the risk extend beyond the Country where the product was discovered
Have any warnings or alerts concerning the product subject of this incident already
been issued, and if so where
Have adequate steps already been taken to remove the product from the supply
chain
Is the report recent or is it likely the product remains in circulation
What is the root cause of the problem?
Consistent access to affordable and quality medicines is a key determinant, but many
reports have been received of very low priced medicines remaining vulnerable if that low
price can be undercut even further.
Those engaged in the production, distribution and supply of SSFFC medical products have so
far been motivated by the profit that can be achieved balanced against the minimal risk of
prosecution and low criminal sanctions compared to other illegal activities.
Are deterrents strong enough?
Many countries have started to strengthen their legislation in respect of SSFFC medical
products and specifically intentionally falsified medical products. Traditionally sanctions
have been weak and remain so in many Countries. Strong legislation alone is not enough,
Criminal Justice Systems need to be willing to handle these types of cases in an effective and
efficient manner. Many investigations concerning SSFFC medical products are International
in nature. This makes gathering evidence more complex. Countries need to have in place
Mutual legal Assistance treaties to permit gathering of evidence from other jurisdictions to
support prosecutions. Member States with legal powers to restrain and confiscate assets
and recover the proceeds of criminal activity have met with some success. Especially if laws
allow for a proportion of the seized assets to be reinvested in purchasing detection devices
and laboratory equipment or awareness campaigns and training events.
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What is WHO doing to tackle this problem?
WHO provides the secretariat to the Member State Mechanism to address SSFFC medical
products. This is a Member State forum who have agreed an 8 point work plan to increase
co-operation, collaboration and co-ordination, increase capacity and awareness and
encourage surveillance and information sharing to fight SSFFC medical products.
WHO has launched a Global Surveillance and monitoring system to encourage Countries to
systematically report incidents involving SSFFC medical products. The objective is to provide
immediate technical support and coordination in emergencies, but also to establish a
validated body of evidence of incidents to identify vulnerabilities and make policy
recommendations. WHO have conducted 4 workshops training over 130 regulatory,
pharmacovigilance and laboratory specialists from 57 Member States in the use of the
system and building capacity in the prevention, detection and response to SSFFC Medical
Products.
This system has already led to the provision of technical support to Member States, access
to Laboratory testing facilities and issue of International medical product alerts. The system
will be rolled out to more Member States in 2014 through 4 planned workshops.
Additionally a consultation and workshop with large International procurers is scheduled in
early 2014 to encourage reporting from their organizations.
What happened to IMPACT?
The International Medical Products Anti-Counterfeiting Taskforce was a multi stakeholder
initiative launched in 2006 with the secretariat provided by WHO. A wide range of public
and private sector organizations gathered to tackle the growing issue of counterfeit
medicines. Whilst the taskforce was developing practical guidance and carrying out
operations, some Member States perceived that the focus was leaning towards the
protection of Intellectual Property Rights which was detracting from the core issue of
protecting public health. Questions were raised concerning the mandate for this activity and
eventually in 2010 WHO engagement was suspended and the secretariat was temporarily
adopted by the Italian Medicines Regulatory Agency AIFA.
Negotiations commenced amongst Member States which resulted in World Health
Assembly Resolution 65.19 being adopted and establishing the New Member State
Mechanism on SSFFC medical products. The new mechanism held its first meeting in 2012 in
Argentina and second meeting in 2013 in Geneva.
What is the objective and role of the Member State Mechanism on SSFFC?
The Member State Mechanism is the global forum at which Member States can convene,
coordinate decide and organise activities to address SSFFC medical products.
Copy General Goal and Objectives here
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The Chair of the mechanism alternates between WHO regions and is supported by a
Steering committee comprising of 2 vice chairs from each of the 6 WHO regions. The
Mechanism reports through the Executive Board to the World Health Assembly.
Do WHO work with INTERPOL and World Customs Organization?
Both of these Law enforcement organizations carry out operational activity to tackle SSFFC
medical products. Whilst WHO does not participate in these Operations it is important to
understand precisely which medical products are being seized and clarify which are
unlicensed, substandard or falsified products. It is also necessary to ensure a focus on public
health and determining if an immediate and serious risk exists in relation to any seized
products. Some of these operations take place at Ports of Entry and some within the market
place. It is important to work with these organizations to validate the information gathered
and assessing more accurately the scope, scale and harm caused by SSFFC medical products,
informing post market surveillance in Countries and identifying the medical products most
at risk.
Do WHO work with the Pharmaceutical Industry?
When WHO are notified of an SSFFC medical product by a Member State we will always ask
if the genuine manufacturer is known and has been contacted. If requested WHO will
contact the manufacturer to establish the facts. Samples of the suspect medicine may be
sent to the genuine manufacturer for laboratory analysis. We will always contact the
manufacturer if the SSFFC product is imitating a WHO pre-qualified product. If WHO are
considering issuing an International Medical Products Alert we will contact the genuine
manufacturer if known , to discuss the content of the alert.
What can be done about SSFFC Medicines available on the Internet?
In many countries it is perfectly legal to obtain medical products via websites. Some
countries have verification systems to help consumers decide if the site is subject to some
sort of oversight. However tens of thousands of websites operate illegally supplying
unlicensed, substandard and falsified medicines. Risks to patients and consumers are
significantly increased when purchasing medicines from unregulated websites, particularly
those that conceal their physical address. National awareness campaigns aim to provide
consumers with sufficient information to make an informed choice and the risks involved.
Consumers have no guarantees of the product they will receive, how or where it was
manufactured, what it contains or how it was stored. Apart from the risks to public health
there is also the risk of credit card fraud, identity theft and computer security issues all of
which have been experienced during investigations in to illegal on line pharmacies.
No Country or Organization can tackle this international issue alone, collaboration and coordination of effort is critical to success. Police, Customs, National Medicines Regulatory
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Authorities, Payment Providers, Internet infrastructure organizations and other
stakeholders work together to carry out Worldwide Operations focusing on illegal Internet
Pharmacies. Operation Pangea, now in its 7th year and co-ordinated by INTERPOL has been
responsible for raising awareness, closing websites, making seizures and carrying out
prosecutions against tens of thousands of websites acting illegally.
Should there be a Universally Agreed definition of SSFFC Medical Products?
There is currently no universally agreed definition of what used to be widely known as
‘Counterfeit Medicine’. Pending negotiation amongst Member States, WHO will continue to
use the term Substandard, Spurious, Falsely labelled, Falsified and counterfeit (SSFFC)
Medical Products .
It is widely accepted that whilst spurious, falsely labelled, falsified or counterfeit medicines
are substandard, it is not necessarily the case that all substandard medicines are spurious,
falsely labelled, falsified or counterfeit. The latter may include accidental manufacturing
errors
Whilst a universally agreed definition would be useful, it is unlikely to alter Member States
positions, who have relied on their own domestic legislation, some of which is based on the
old WHO definition, to sanction offenders for many years. In terms of data collection and
analysis it is important to identify and examine the characteristics peculiar to each
suspected SSFFC medical product in order to determine the intentional or accidental aspects
of the incident. This approach does not necessarily require a universally agreed definition.
Is organised crime involved in SSFFC Medical Products
Some of those involved in the manufacture, distribution and supply of spurious, falsified and
counterfeit medical products have access to sophisticated networks of off shore companies
to facilitate the movement of the products, off shore bank accounts to launder the proceeds
and flexible freight networks to ship the products to their eventual destinations. They
operate a highly organised, professional, lucrative and criminal business. Others involved
are relatively disorganised with small illegal manufacturing site
Is there a need for an International Convention of SSFFC Medical Products?
The manufacture, distribution and supply of SSFFC medical products is a Global issue. With
the globalization of the pharmaceutical sector and wide access to internet and
communications technologies no single country or organization can hope to effectively
tackle the problem in isolation.
Some aspects of the issue require a regulatory response, others a criminal law response, but
most require International collaboration. Many countries rely on existing Mutual legal
assistance treaties, extradition treaties and co-operative arrangements, others do not have
those facilities available.
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The United Nations Office on Drugs and Crime (UNODC) are currently developing a
legislative framework in relation to this topic concentrating on fraudulent medicine. Link?
The Council of Europe have developed the Medicrime Convention which is a binding
international instrument in the criminal law field on counterfeiting of medical products and
similar crimes involving threats to public health. Link?
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