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Letters to the Editor
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Counterfeit medicines
An excuse to smear parallel trade, with no evidence
From Mr R. Freudenberg
As worrying as the two recent cases of counterfeits detected in the
UK are (PJ, 11 September, p335), the reaction to these events is also
of concern. The Patients’ Association “summit” to address
the issue — remarkably arranged and publicised in less than three
days after the Reductil recall was announced — seemed just an excuse
to smear parallel trade, without a shred of connecting evidence. In fact
there has never been a single confirmed case of a counterfeit medicine
reaching a patient as parallel trade, ever.
If Roger Odd knows of parallel trade being wrongly labelled or offered
when date expired, he should report these instances to the regulatory
authority and the traders concerned. As for patients being worried by
foreign language on the packs, this situation is mainly the consequence
of pharmaceutical companies using their trademark rights to block repackaging.
As for recalls, parallel traders can, and have, performed these just
as efficiently, promptly and comprehensively as any other pharmaceutical
distributor.
It is also disingenuous of Pfizer to claim that repackaging by parallel
traders is the “weakest point of the European supply chain”.
All overlabelling or repackaging plus insertion of an English language
version of the patient package insert, measures that are required by
law, are carried out by trained operators under strict GMP conditions
by parallel traders in possession of a manufacturer’s (assembly
only) licence. They employ an EU Qualified Person — invariably
a pharmacist with industry experience — and operate to standard
operating procedures agreed with the Medicines and Healthcare products
Regulatory Agency, which also performs regular inspections.
The tight, regulated European environment for parallel trade should not
be confused with the chaotic situation that prevails in the US. In the
absence of patient packs, multiple intermediaries (not just pharmacies)
repack from bulk there. Why does Pfizer not address this problem? Indeed,
its fears are ironic having just announced to UK wholesalers that it
will apply a rigid quota on supplies to them. Artificially restricting
stock in this way is known to create shortages — one of the factors
that attracts counterfeiters in the first place.
Counterfeit medicines in Europe remain remarkably rare. But if pharmacists
are worried about them they should specifically order parallel trade,
as these are the only products professionally examined as a matter of
routine after they leave the manufacturer.
Richard Freudenberg
Secretary-General
British Association of European Pharmaceutical Distributors
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Olivier Brandicourt, managing director, Pfizer Ltd, replies:
As Richard
Freudenberg points out, there have been two recent instances of counterfeit
medicines entering the legitimate UK supply chain. In August, the
Medicines and Healthcare products Regulatory Agency issued an alert
recalling
two batches of Lilly’s Cialis. In September, the MHRA issued a
second alert recalling a batch of Abbott’s Reductil.
Pfizer recently became aware of an internet pharmacy called Paypill
which supplied counterfeit Viagra to patients via the internet. Paypill
stated that it used
the same parallel traders for supply as the NHS.1 Pfizer is therefore deeply
concerned that the legitimate supply chain is at risk.
The World Health Organization estimates that 8–10 per cent of medicines
in the global supply chain are counterfeit.2 In Russia, for example, it is
estimated that 8–12 per cent of the medicines are counterfeit.3 Recent
expansion of the EU has brought it closer to Russia. Pfizer has found counterfeit
medicines across the globe and in every EU market. A WHO expert has stated
that risks of counterfeits entering the EU are “obvious”.4
A recent report by the Social Market Foundation stated that parallel trade “offers
a vehicle by which to introduce counterfeit products into the supply chain”.5
Each year, more than 140 million medicine packs are parallel traded in the
EU. A direct consequence of parallel trade is the repackaging of medicines.
Pfizer is concerned that repackaging provides an opportunity for counterfeit
medicines to enter the legitimate supply chain and jeopardise patient safety.
In 2003, the US Food and Drug Administration identified repackaging of medicines
as a weakness in the supply chain.
Last year, 18 million Lipitor tablets were recalled when counterfeit Lipitor
entered the US supply chain in Florida through third-party repackagers.6 The counterfeits were subsequently found in 15 states and suspected in six
others.
In June this year, the FDA announced that counterfeit Viagra had been sold
in two Californian pharmacies.7
Mr Freudenberg also refers to incorrectly labelled and out of date parallel
imports. In addition to the issue of counterfeits, the Social Market Foundation
report highlighted the possibility of human error during the repackaging
process.
In audits of sample parallel import Pfizer medicines destined for the UK,
Pfizer identified a number of regulatory compliance issues with the potential
to jeopardise
patient safety. Examples include:
· Different dosage strengths of medicines inside the pack to the strengths
stated on the outside
· A pack referring to tablets but containing capsules
· Discrepancies between the expiry date and batch number on the pack and the
expiry date and batch number on the medicines inside
The evidence described and Pfizer’s experience across the world
demonstrates that the integrity of the supply chain is at risk. Pfizer
is duty bound to highlight these concerns and the potential for them
to jeopardise patient safety.
Finally, Pfizer wishes to make the following comments in relation to the supply
policy identified in Mr Freudenberg’s letter. The policy, which operates
in many European markets, has been implemented in the UK in the context of
concerns about the security of an increasingly fragmented supply chain. The
primary objective of our supply policy, however, is to enable Pfizer to meet
its duty to ensure the continued supply of medicines to patients in the countries
in which it operates. By allocating quotas commensurate with UK national demand,
Pfizer is able to manage the supply of its medicines in the UK more efficiently
and reduce the risk of supply shortages that have become an increasing concern.
References
1. Independent on Sunday. 3 October 2004
2. World Health Organization. Substandard
and counterfeit medicines
3. Association of International Pharmaceutical Manufactures (AIPM) and the
Coalition for Intellectual Property Rights (ClPR), April 2002.
4. Dr Wondemagegnehu, quoted in the Independent on Sunday, 18 January 2004.
5. Maclean N. Parallel Trade in Medicines, Social Market Foundation, June 2004.
6. FDA News. FDA
initiates seizure of potentially dangerous drugs from repackager
7. FDA News. FDA
is alerting the public to counterfeit Viagra found in two california pharmacies |
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The
Pharmaceutical Journal