One Size FIts All
Among baggage reclaim carousels across the globe, passengers are reuniting themselves with exactly the same luggage in one country as they so trustingly parted from in another.
News in Brief
| Faking It |
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| Written by Laure James - Editor Pharmacy in Focus | |
| Monday, 16 February 2009 12:24 | |
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The public have remained largely protected from the issue and indeed associated safety risks of counterfeit medicines, with the majority of contraband batches withdrawn from sale promptly after they are identified. However, two major moves have hauled counterfeits – and possible supply chain flaws – under public scrutiny. Pfizer launched its ‘dead rat’ creative, a television commercial highlighting the dangers of illegal, fake medicines and a day later the Medicines and Healthcare Products Regulatory Agency (MHRA) published a consultation document on proposals to strengthen the UK supply chain.“Medicines counterfeiting is a growing threat worldwide,” a spokesperson for the regulator said. “Since 2004 the MHRA has investigated nine incidents in which batches of counterfeit medicines reached pharmacies and patients. In a further five cases counterfeit medicines were found at wholesale dealer level. In the light of these incidents we believe there is a strong case for strengthening the medicines supply chain to reduce the threat from counterfeit medicines and to protect public health.” Interestingly however, when the first direct to pharmacy models were announced and reducing the volume of counterfeit medicines was cited as the prime objective of such exclusive arrangements, many argued that counterfeit dealings were not enough of an issue to justify limiting the number of suppliers for a particular manufacturer or drug portfolio. So how would wholesalers now respond to the original suggestion that counterfeit problems were just a veil for commercial gain? Mark James, group managing director of AAH Pharmaceuticals who have a handful of DTP arrangements with various manufacturers, says that the relation between single chains and combating counterfeits is only one motive behind making such arrangements. “There are a whole host of reasons why some manufacturers have decided that DTP better meets their needs than traditional or reduced wholesale models,” he began. “Clearly they feel more confident dealing with a small number of agents - all of whom so far have been BAPW members - than a large number of wholesalers. Combating counterfeits is important to manufacturers - as it is to us - but I do not think counterfeits have driven decisions to move to DTP.” Mark also believes that the MHRA’s consultation represents a great opportunity to address some of the areas of concern which both AAH and other members of the British Association of Pharmaceutical Wholesalers (BAPW) have highlighted. “The paper talks about a ‘fit and proper person’ test for wholesale licence dealer applicants,” he said. “That seems to me to be a common sense measure. We would also support stronger specific criminal sanctions for medicine counterfeiters; fake medicines are a much more serious matter than counterfeit jeans.” Although counterfeits have traditionally been an industry-limited issue, the implications or indeed consequences of public engagement could be risky. Scaremongering has long been associated with the unscrupulous, piratical tabloid armoury and as Pfizer’s advertisement demonstrates, a hard-hitting tack can be adopted for maximum effect. Furthermore, many believe that public vigilance is crucial. “It is essential that the public understands there is next to no risk if they get their medicines through the legitimate supply chain, but a huge risk if they obtain medicines through unregulated sites on the internet,” Mark explained. “Informing the public in a fair and balanced way is essential. However, that implies a duty for all of those involved in the supply chain. For example, we have all read articles in which counterfeits and PIs have been placed in the same context. That kind of message risks confusing and alienating members of the public.” It would seem that the connections between fake, online pharmacies and high volumes of counterfeits infiltrating the supply mechanism are more common and easily drawn than we think. However, the consultation does not necessarily provide all the answers. “We have concerns about some aspects of the proposals which could lead to additional bureaucracy for compliant WLD holders without adding to the robustness of the legitimate supply chain,” Mark added. “It is also unclear if self distribution is included. It should be because the same high standards must apply whatever route a medicine takes to get from a manufacturer to a patient. “Through the unregulated sector, counterfeits are more of a problem now than ever before. These days, almost everyone has easy access to a computer and can contact internet sites anywhere in the world. In the legitimate supply chain the risk continues to be extremely low because we are vigilant and operate high standards.” The MHRA launches public consultations over a number of issues, although are seldom limited to the public and encourage engagement from all stakeholders. “We want responses from manufacturers, distributors, wholesalers and pharmacists, for a balanced overview,” a spokesperson said. “We do not tend to have an indication of the volume of patient responses we receive although it is generally relatively small. The MHRA will endorse any form of advertising or media campaigns that appropriately communicates a message warning patients about purchasing medicines online. “The public has a social responsibility and owe it to themselves to exercise vigilance and not to trust any site or outlet offering prescription medicines without approval from their GP or a prescribing healthcare practitioner. Similarly, if a patient who takes regular, perhaps daily medication and notices a difference in its appearance, texture, smell or taste or maybe unexpected changes in the packaging and they have acquired these through the legitimate supply chain, they need to report it to the MHRA. During 2008, we received no reported cases of counterfeits.” The MHRA will assess the responses to the consultation before putting forward concrete proposals for change. “We are committed to ensuring that any changes we introduce are proportionate to the risk that counterfeit medicines represent and that they are effective in protecting patients in the UK from harm.” Pfizer estimate that one in ten men in the UK have admitted to purchasing drugs from unlicensed and unregulated sources, which not only indicates that public health is at risk from patients making uniformed decisions but such activity will no doubt put a significant squeeze on manufacturing profit. Ultimately, it will be difficult for contractors to applaud any manufacturer who makes direct to pharmacy arrangements, even though the combat against counterfeits has been stepped up a gear. These are also the same contractors who are likely to have read articles in the consumer press which place counterfeits and parallel imports in the same context. Although actively opposing counterfeits is as important to manufacturers as it is to pharmacists, it may take more than a rodent corpse and a united front to convince practitioners of the benefits of DTP. |