In September 2004, two separate incidents of counterfeits occurred within ten days of each other. Significant volumes of counterfeit Cialis, Eli Lilly's medicine for treating erectile dysfunction, were found after a patient complained about a crumbling tablet. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued an alert immediately. Only days later, the MHRA again had to issue a warning after counterfeit anti-obesity tablets, claiming to be Abbott's Reductil, were found in the legitimate supply chain.
The pharmaceutical industry is slowly facing up to this major patient safety issue. Pfizer is deeply concerned that counterfeiters are now targeting the legitimate supply chain, undermining its integrity and jeopardising patient safety. It is now vital that all stakeholders urgently address and respond to this growing phenomenon. In response to this, Pfizer is introducing new packaging solutions, such as tamper-evident packaging, to reassure patients and pharmacists of its medicines' integrity.
Patient safety and parallel trade
The legitimate movement of 140 million medicine packs through the porous borders of the EU is part of the grey market, otherwise known as parallel trade, significantly undermines the integrity of the European supply chain. Parallel trade is a legal practice in the EU, and all of these medicines are repackaged in compliance with EU regulation.
The Social Market Foundation, an independent think tank, warned of the probability of counterfeit medicines being introduced into the UK supply chain long before the Cialis and Reductil fakes were found. Its report, 'Parallel Trade in Medicines', highlighted concerns about purchasing medicines from parallel traders that source their medicines from across Europe, arguing that 'there are concerns that the practice of repackaging imported medicine has the potential to put patient safety at risk.'
The Social Market Foundation states that the repackaging and tampering of medicines undermines patient safety, by acting as a potential vehicle for counterfeits to enter the legitimate supply chain; through human error in the repackaging process; and by hindering batch recall.
The cross-border supply chain
The WHO estimates that 8-10 per cent of the global medicine supply chain is counterfeit, in some countries rising to 25 per cent. The largest counterfeit market with close proximity to the EU is Russia, where it is a generally accepted estimate that 12 per cent of medicines are counterfeit. The EU's border with Russia increased dramatically with the accession of the ten new member states, making it even more vulnerable to the global trade in counterfeit medicines. Dr Eshetu Wondemagegnehu, the WHO's expert on copied medicines, has said the risks are obvious.
Graham Satchwell, a former detective superintendent, has argued that through parallel trade counterfeiters have an easy route for selling fake and sub-standard products into the legitimate distribution chain. He warns that this high-volume and high-profit business activity, which poses a clear threat to patient safety, is not being sufficiently regulated and monitored.
The UK newspaper The Independent on Sunday reported that the website Paypill.com had been found to be selling counterfeit medicines for the second time. Paypill.com has stated, 'We purchase drugs directly from the same parallel imported sources as the NHS, so if we are selling fakes, then the NHS is selling/dispensing fakes too.'
Through the repackaging of medicines, any tamper-evident packaging is removed. The pharmacist and patient have no way of assessing whether their medicines are genuine. Instead, the medicines have either been repackaged in a new carton or the original carton has been over-stickered. The trader's ability to open a medicine pack and remove the original packaging undermines the ability of manufacturers to help protect their medicines against counterfeits for the benefit of patients through tamper-evident packaging and anti-counterfeiting devices.
Human error in the repackaging process
When a parallel trader opens a medicine pack, removes its contents and repackages it, the trader introduces the possibility of human error. Mistakes are inevitable. Pfizer has found numerous examples of human error with parallel imported medicines that could compromise patient safety, such as different doses of medicine inside the packs from those stated on the outside; the medicine pack containing capsules when the box clearly states tablets; the expiry dates and the batch numbers on the medicine boxes not matching those of the medicines inside; and patient information leaflets that are in the wrong language or out of date.
In an ongoing audit of parallel trade imports, Pfizer identified that over half of the medicines it saw had patient safety issues. Over a quarter of the samples were deemed serious enough to be referred to the regulator, the MHRA.
These incidents of human error may lead to patient confusion and compliance issues. Pfizer is not alone in raising concerns about the repackaging of medicines and its subsequent effect on patients' safety. In September 2004, a conference held by the UK patient advocacy group, the Patients Association, warned that repackaged medicines were putting patient safety in unnecessary risk. According to the patient group Depression Alliance, 'Parallel imported medicines are a major risk to patient safety.'
Parallel trade and batch recall
Medicines moving through the grey market can go through as many as 20-30 pairs of hands before finally reaching the patient. Inevitably, this greatly hinders the ability of regulators to recall medicines. If a batch of medicines sold in Spain is recalled, tracing where the entire batch may have been distributed is much more challenging when it encompasses the EU.
Yet there is no regulatory mechanism for recording the import and export of medicines across the EU. This means that the systematic track and trace of medicines across the EU supply chain is very difficult. This is exacerbated by the fact that commercial middlemen have repackaged the medicines, putting stickers over the original manufacturer's pack or repackaging them in a new box. Pfizer has a number of examples of medicines that have been repackaged where the expiry dates and the batch numbers of the medicine boxes do not match those on the medicines inside.
The threat of counterfeit medicines and the broader undermining of the integrity of the medicines supply chain is a growing risk. The integrity of Pfizer's medicines is paramount. When Pfizer finds incorrectly labelled parallel imported medicines (such as one dose marked as being another or capsules described as tablets) it takes appropriate action and involve the regulatory authorities to help protect patients' safety.
Pfizer will endeavour wherever possible to maintain the security of the supply chain and to ensure patient safety and the integrity of its medicines. It is pioneering changes in the packaging process to ensure that patients have confidence in the medicines that they take and are not placed at unnecessary risk. Recently, it has introduced tamper-evident packaging for certain medicines.
The new packaging will make any attempt to interfere with a medicine obvious before it reaches the patient. In 2005, Pfizer will introduce additional anti-counterfeit measures on its packaging in order to enhance patient safety.
The introduction of new packaging measures for Pfizer's medicines is only part of the process. The company believes that efforts to protect the integrity of medicines must include: new and enhanced regulations and oversight by regulatory authorities together with greater enforcement efforts; enhanced business practices by all participants in the medicines supply chain; and the consideration of new technologies to provide product authentication.
Pfizer trusts this can only be achieved through heightened diligence and increased accountability by all those involved in the medicines distribution channel, together with appropriate regulatory oversight.
The trader's ability to open medicine packs and remove original packaging undermines the ability of manufacturers to use anti-counterfeiting measures for the benefit of patients. Pfizer's view is that the process of repackaging tamper-proof medicines must cease. The underlying principle whereby tamper-evident medicines can be opened and repackaged within the grey market undermines the security of the medicines supply chain.
Regulatory authorities at EU and member state level must act to ensure the medicines supply chain is secure, and that patient safety is maintained. A solution must be found urgently that ensures patient safety and meets the needs of all stakeholders.