The counterfeit problem

The assembly of the World Health Organisation (WHO) later this month is expected to feature counterfeit medicines as one of its important discussion points, and there is some hope that the ministers will agree on measures that will strengthen anticounterfeiting legislation and enforcement worldwide.

Philip Payne

Few people in the pharmaceutical industry need convincing of the danger counterfeit medicines pose to public health and commercial profit. Sadly, the world's politicians seem somewhat oblivious to the arguments, and there are many countries where counterfeit medicines are openly marketed or where the production of counterfeit medicines is either treated as no crime at all or something worthy of only minor punishment.

The most recent meeting of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), which took place in Lisbon (Portugal) last December, endorsed a document of principles and elements that may prove to be the precursor for international cooperation in enacting national legislation against counterfeit medical products.

IMPACT's impact

IMPACT was created by WHO in 2006 from a global coalition of stakeholders, including industry, regulatory and law enforcement representatives. Its remit was to forge international collaboration in combating counterfeit medicinal products and to raise awareness of related issues. Five working groups were established to specifically examine the issues and potential approaches offered by legislation, regulatory implementation, enforcement, technology and communication.

According to IMPACT, its stakeholders have surveyed national and international legislative instruments and, while further study is necessary, a number of key issues have been identified as contributory factors in the increasing prevalence of counterfeit pharmaceuticals:

• The definition of counterfeit medical products is absent or inadequate.

• Counterfeiting medical products is not considered a serious crime or, in some cases, not even a crime.

• If counterfeiting medical products is considered a crime, sanctions are sometimes more lenient than those for counterfeiters of products that have no health implications (e.g., t-shirts).

• Sanctions are not applicable unless it is proven that counterfeits have resulted in injuries or death.

• The responsibilities of those involved in the distribution system are not clearly defined.

• There are no provisions for effective coordination and information exchange among various authorities and other stakeholders at national, regional and international levels.

• There are no provisions that allow authorities to share information nationally, regionally or internationally, or to use information obtained by others in legal proceedings.

• There are no provisions addressing the problem of trade in packaging and labelling materials without the obvious involvement of the companies whose name appears on these materials.

• There are insufficient legal provisions concerning the confiscation and use of assets, equipment and other materials used in conjunction with the manufacture, trade and transportation of counterfeit products.

Based on these considerations, IMPACT prepared and endorsed a document of principles and elements designed to assist member states in establishing, complementing or updating national and regional legislations regarding counterfeit pharmaceuticals. In doing so, IMPACT specifically excluded some commercial considerations, such as intellectual property, parallel importation and theft of counterfeit products, to restrict its focus primarily to public and personal health implications.

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Combined effort

While accepting that all stakeholders can help combat counterfeit pharmaceuticals, IMPACT claims that the primary role rests with governments, and has created an extensive list of measures that governments must address to protect public health. These include recommendations on drawing up legislation and defining activity that should be seen as illegal and, additionally, suggesting sanctions for those illegal acts. A key element of IMPACT's argument is that the manufacture of counterfeit medicinal products should be punished with equal severity whether the product has damaged anyone's health or not.

Alongside these recommendations to governments, IMPACT also outlines the key responsibilities for manufacturers and distributors — particularly in complying with existing laws, GMP and good distribution practice (GDP). Technological solutions to the problem often have a limited benefit as some jurisdictions have limited access to appropriate technology and, where it does exist, it is expected to result in increased prices. There is even an argument that technological solutions can raise more problems than they solve.

Good distribution practices

If the recent upsurge in participation in GDP training courses is any indication, it seems that pharmaceutical professionals are realizing the importance of GDP, and are seeing that it applies to the whole supply chain rather than to an external or separate distribution channel. Advocates of GDP argue that it is a minimum requirement in helping to stem the flow of counterfeit products into legitimate distribution channels. This is because the practice of parallel distribution, and the complex interfaces between manufacturers, distributors and repackagers — particularly relating to withdrawal of product and subsequent disposal or reprocessing — are all areas of potential weakness that counterfeiters are only too willing to exploit. "All stakeholders in the pharmaceutical industry need to work together to ensure supply chain integrity, and that only bona fide suppliers and customers are allowed to supply and sell," says Ciaran Brady, a GDP consultant and tutor for RSSL Pharma Training (UK)." GDP is a must to ensure patient safety and protect ourselves from the likelihood of having our products and packaging copied or misused."

Aside from the counterfeiting issue, there are many areas that the pharmaceutical sector often falls down in when it comes to GDP. Previously, the UK's Medicines and Healthcare Products Regulatory Agency has identified deficiencies such as:

• Problems with general storage and transportation.

• Documentation and procedural deficiencies, such as a lack of written or insufficient standard operating procedures.

• Inadequate systems for dealing with returns.

• Personnel issues concerning duties of key staff, including the responsible person.

There is no reason to suppose the incidents in this list are in any way restricted to the UK as they are just as likely to relate to the rest of the world in a similar fashion.¹ Worryingly, temperature control and monitoring is a recurring theme, and human error and mechanical error have both contributed to pharmaceuticals being stored and transported at inappropriate temperatures. In the context of global warming, the industry needs to address this issue.

Hoping for more

Returning to the forthcoming WHO assembly, Dr Amor Toumi of WHO's Medicines Regulatory Support Department of Technical Cooperation for Essential Drugs and Traditional Medicine is optimistic that the assembly will at least result in IMPACT's ideas on regulation and enforcement being adopted into national legislation.

"Counterfeiting medicines is widespread and has escalated to such an extent that effective coordination and cooperation at the international level are necessary for regional and national strategies to achieve the ultimate goal of protecting the health of the public. We hope there will be genuine progress made at the next assembly, and that health officials in the world underline that no-one's interests are being served by allowing counterfeiters to go unchallenged and unpunished."

Philip Payne is Business Development Manager at RSSL Pharma (UK) with global responsibilities.

Reference

1. J Taylor et al., Pharmaceut. J. 270(7233), 127–129 (2003).