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[e-drug] IFPMA: Building a Consensus to Address the Health Threat Posed by Fake Medicines

  • From: "Guy Willis" <G.willis@ifpma.org>
  • Date: Mon, 28 Feb 2011 08:08:16 +0100

E-Drug: IFPMA: Building a Consensus to Address the Health Threat Posed by Fake Medicines

[This is a position statement and the justification by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) why IMPACT should continue. We encourage readers to comment on this position and share their opinions on why IMPACT should or should not continue or how WHO involvement should be different or how IMPACT should change, etc.. Warning - It is a long message. Moderator]

Dear All,

The following article has been posted on the "Inside View" column at
IP-Watch, at
s-the-health-threat-posed-by-fake-medicines/ .

Ahead of WHO Working Group of Member States on
Substandards/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical
Products, the research-based pharmaceutical industry body IFPMA sets out
some thoughts on building global consensus to address fake medicines. We
believe that this is highly topical, coming as it does just ahead of the
deliberations of the WHO Working Group of Member States on
Substandards/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical
Products. We hope that this article contributes to this discussion and
helps to move forward international efforts to address the specific
issue of fake medicines.

With kind regards

Guy Willis
Director of Communications
International Federation of Pharmaceutical Manufacturers & Associations

Chemin Louis-Dunant 15
P.O. Box 195
CH - 1211 Geneva 20
Tel: +41-22-338 32 24
Mob: +41-79-446 14 55
Fax: +41-22-338 32 99
www.ifpma.org <blocked::http://www.ifpma.org/>

Building a Consensus to Address the Health Threat Posed by Fake Medicines
Eduardo Pisani, Director General, IFPMA[1]

At the end of this month, the WHO Working Group of Member States on
Substandards/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical
Products will meet. The name indicates that terminology is an issue and
this article will advocate flexibility to resolve this. On the agenda is
the WHO's role in ensuring the availability of good-quality, safe,
efficacious and affordable medical products, including the prevention
and control of medical products of compromised quality, safety and
efficacy. More specifically, the working group will also review the
WHO's relationship with the International Medical Products
Anti-Counterfeiting Taskforce (IMPACT).

These are all important questions, affecting both global health and the
WHO's role in achieving it. For the IFPMA, the most important outcome of
this discussion must be that the WHO continues to play an active and
visible leadership role in helping to ensure that medicines everywhere
are of high quality, safe and efficacious, and that they are also what
they purport to be. Furthermore, the global effort to secure quality
medicines risks being undermined if Member States are unable to agree a
course of action which clearly signals that the production and
distribution of deliberately falsified medicines are an important threat
to patients' health and a serious crime.

Other quality issues, especially substandard medicines, may not be
criminal in nature, but they do present significant health challenges.
However, the need to address these does not diminish the imperative to
address "counterfeit" medicines, which pose a real and growing threat to
global health. In 2009, the Pharmaceutical Security Institute[2]
recorded 1,693 "counterfeit" medicine incidents, a 6.8% increase on the
previous year. Much bigger increases were reported for incidents
involving "counterfeit" medicines for serious medical conditions such as
central nervous system disorders and cardiovascular disease. The number
of countries reporting cases increased to 118, up from 100 in 2006,
indicating that the problem is not only growing, but also becoming more

If the Working Group's review should result in the WHO pulling back
significantly, either across the board or in a specific area of medicine
quality, it would have a doubly detrimental effect: it would dilute the
coordination of global efforts to address medicine quality issues; and,
perhaps more damagingly, signal a reduction in the importance of this
activity. Medicine quality is an issue that requires a broad effort,
across a very diverse range of stakeholders. This requires building
consensus around priorities and encouraging flexibility on the part of
key stakeholders, so the leadership function of the WHO is particularly

The WHO has prepared an overview of its work in the field of medicine
quality: WHO A/SSFFC/WG/2 Provisional Agenda Item 4[3]. This describes
an impressive and growing array of normative and technical support
activities - regarded by the IFPMA as very valuable - through which the
WHO provides global leadership in addressing a broad range of medicine
quality issues. It makes it clear that the WHO's work on "counterfeit"
medicines is a subset of its quality work, which is in turn a part of
its broader work on access, quality and rational use. The WHO has
confirmed its strong mandate from Member States to undertake activities
to address "counterfeit" medicines through various World Health Assembly
resolutions dating back to the 1980s and through recommendations by the
International Conference of Drug Regulatory Authorities. Nowhere in the
WHO Working Group papers is it suggested that WHO's work on
"counterfeit" medicines has been at the expense of its other
medicine-quality activities.

The most contentious aspect of the WHO's activities in this area appears
to be its involvement in IMPACT; one NGO, Oxfam International, has even
called on the WHO to disband IMPACT. The WHO was one of seven global
intergovernmental organizations[4] which signed the 2006 Declaration of
Rome[5]. This set up IMPACT, to create awareness about this problem, to
promote inter-sectoral coordination, to develop technical competence, to
develop appropriate mechanisms for addressing the issue, to secure
political commitment, adequate legal frameworks and implementation, and
to provide tools for coordinated, effective law enforcement. The need
for coordination and leadership was underlined by the 160 bodies which
signed the Declaration of Rome, which included 57 national medicines
regulatory authorities and many NGOs. Since its creation, a wide range
of stakeholders have been invited to participate in IMPACT and many of
them have made important contributions to its work, including
enforcement and regulatory agencies from many WHO Member States,
representatives of patient groups, as well as the health-related
professions and industries. IMPACT's five subgroups have undertaken a
substantial range of useful practical work in the specific technical
fields of legislation and regulation, regulatory implementation,
enforcement, communication and technology[6]. A valuable aspect of
IMPACT's work is the provision of technical assistance to low income
countries, which are especially vulnerable to fake medicines.

Despite its many contributions and broad support, IMPACT has proved
contentious, because a small but vocal group of Member States and other
stakeholders have felt that its work endangered the supply of generic
medicines. The 19 shipments of generic medicines seized in 2008-09
during transit through the European Union to low and middle income
countries have often been cited in this context, but these accounts
never mention that all the shipments were subsequently released, that
the research-based pharmaceutical industry, through its European
association EFPIA, has clarified that it will not seek to use the
European Union's powers of customs detention to interfere with the
shipment of generic medicines[7], nor that the EU and India have reached
a political agreement to the same effect.

Major efforts have been made by many parties in the area of definitions,
to show that concerns about the use of the term "counterfeit" to
interfere with generics are misplaced. Manufacturers of legitimate
generic medicines have nothing to fear from efforts to address this
issue. Indeed, counterfeiters threaten the full spectrum of legitimate
medicines, including generics. Because counterfeiters do not
differentiate between originator and generic medicines, both R&D and
generic pharmaceutical manufacturers were actively involved in the third
General Meeting of IMPACT in Hammamet, Tunisia, in December 2008. There,
a very broad range of countries and stakeholders worked hard to agree a
definition which would set to rest such fears, including the
clarifications that: (i) "Violations or disputes concerning patents must
not be confused with counterfeiting of medical products" and (ii) that
medical products, generic or branded, that are not authorized for
marketing in a given country, but that are authorized elsewhere, are not
considered "counterfeit". However, the adoption of the Hammamet
definition was subsequently blocked by India at a meeting of the WHO
Executive Board.

The IFPMA then sought to make the research-based pharmaceutical
industry's views absolutely clear, via its "Ten Principles on
Counterfeit Medicines"[8]. These confirm our belief that "counterfeits"
are a crime against patients, which endangers global public health. Most
importantly, they spell out that "patents have nothing to do with
counterfeiting and counterfeiting has nothing to do with patents". They
also confirm that a medicine can be substandard without necessarily
being a "counterfeit". The Principles reaffirm that a medicine
authorized by one authority but not by another should not be regarded
per se as "counterfeit" in the latter's territory. In addition, the
Principles also underline our belief that global cooperation is needed
to address this international problem, with the full and active
involvement of all relevant stakeholders from around the World - WHO
leadership is crucial.

We have no agenda to interfere with the legitimate trade in generics.
Heightened efforts by high income country governments to fight fake
products of all kinds are not a pretext for imposing high IP standards
on others that may not be ready for them. When the UK Government called
for a further extension of the deadline for least-developed countries to
implement TRIPS[9], the IFPMA publicly supported its initiative[10],
recognising that many low income countries still lack the necessary
resources to implement the levels of IP protection required by TRIPS.

Terminology is currently an obstacle to international agreement. The
term "counterfeit" is widely used without misunderstanding in industry,
commerce, enforcement and justice. However, the advantages of its broad
recognition are negated if this term is unacceptable to some key
stakeholders - to fight this issue effectively on an international basis
requires consensus, including the "buy-in" of key global stakeholders.
We therefore need to agree on a term to identify, clearly and
unambiguously, in all jurisdictions, a medicinal product that is not
what it purports to be. If that term should be something other than
"counterfeit" - "falsified", perhaps - then surely the advantages of
switching to a new term would outweigh the burden of having to modify
national legislative and regulatory instruments and practices. This is,
of course, providing that the new term allows everyone to condemn this
criminal activity, characterized by the intent to deceive patients.
Introduction of a new term would certainly be worthwhile if it would
permit the building of a true global consensus to address the problem
under the continued leadership of the WHO.

The IFPMA encourages WHO Member States to undertake the following

1) Agree on a common term
Member States should unite around an agreed term that will permit the
building of a truly global shared commitment to address the fake
medicine issue effectively, as part of the broader effort to combat poor
quality medicines.

2) Build a long-term platform for international collaboration
Some WHO Member States were critical of the process which led to the
creation of IMPACT. Member States should therefore seize the current
opportunity, either to agree on a consensus-building process to refine
the existing IMPACT partnership, or to create a new one to fight fake
medicines. As the IFPMA advocates in its Ten Principles, there has to be
a global partnership - regardless of its name - and it has to embody a
multi-disciplinary approach, embracing all relevant stakeholders, to
address this problem as a threat to global public health and as a
serious crime. It is important that the WHO plays a strong leadership
role in such a partnership.

3) Ensure continuity
A long-term platform may take time to agree. In the meanwhile, Member
States should ensure that IMPACT can continue its work, with the
participation of the WHO.
To do anything less would be play into the hands of the criminals who
are profiting at the expense of patients' health.

Geneva, 25 February 2011

[1] The International Federation of Pharmaceutical Manufacturers &
Associations - www.ifpma.org
[2] An alliance of leading pharmaceutical manufacturers to combat
pharmaceutical crime - see www.psi-inc.org.
[3] http://apps.who.int/gb/SSFFC/pdf_files/A_SSFFC_WG2-en.pdf
[4] The other IGO signatories were Interpol, the Organisation for
Economic Co-operation and Development (OECD), the World Bank, the World
Intellectual Property Organization (WIPO), the World Trade Organization
(WTO) and the World Customs Organization (WTO).
[5] www.who.int/medicines/services/counterfeit/RomeDeclaration.pdf
[6] See Annex to "WHO's relationship with the International Medical
Products Anti-Counterfeiting Taskforce" at
[7] www.efpia.eu/content/default.asp?PageID=559&DocID=6574
-development/docs/t/11-717-trade-investment-for-growth.pdf> (see p.68,
3rd bullet point)
About the IFPMA:
The International Federation of Pharmaceutical Manufacturers &
Associations is the global non-profit NGO representing the
research-based pharmaceutical industry, including the biotech and
vaccine sectors. Its members comprise 26 leading international companies
and 46 national and regional industry associations covering low, middle
and high income countries. The industry's R&D pipeline contains hundreds
of new medicines and vaccines being developed to address global disease
threats, including cancer, heart disease, HIV/AIDS and malaria. The
IFPMA Clinical Trials Portal (www.ifpma.org/ClinicalTrials), the IFPMA's
Ethical Promotion online resource (www.ifpma.org/EthicalPromotion/) and
its Developing World Health Partnerships Directory
(www.ifpma.org/HealthPartnerships) help make the industry's activities
more transparent. The IFPMA supports a wide range of WHO technical
activities, notably those relating to medicine efficacy, quality and
safety, and coordinates industry participation in the WHO IMPACT
initiative to combat counterfeit medicines. It also provides the
secretariat for the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human Use
For further information, please contact:

Guy Willis
Director of Communications
E-mail: g.willis@ifpma.org
Tel: +41 22 338 32 00
Fax: +41 22 338 32 99
Web: www.ifpma.org
"Guy Willis" <G.willis@ifpma.org>