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Fight the fakes

Safety features to combat falsified medicines in the legal supply chain must be simple, robust and cost-effective to work harmoniously across Europe

fencingThe emergence of falsified medicines in EU markets is of serious concern to the authorities and to the pharmaceutical industry. Last year, customs officials seized more than 11m illegal pills at EU borders. Counterfeits of medicines for treating cancer, cardiovascular conditions and schizophrenia, for example, have been detected, putting patients at risk.

While the prevalence of counterfeit medicines in the illegitimate supply chain, for the most part via illegal internet-based sales sites and fraudulent email-based advertising, is a severe problem, the vigilance of the industry and the support of public health authorities has reduced their presence in the legitimate supply chain.

The industry has introduced a number of measures to ensure that falsified medicines are kept at bay. The European Federation of Pharmaceutical Industries and Associations (EFPIA) has backed the European Commission's (EC) draft Directive, one part of the so-called 'pharmaceutical package' of measures, that is set to introduce harmonised, pan-European safety features to protect prescription medicines.

The pharmaceutical industry believes that the introduction of tamper-evident packaging, combined with a unique serial number, should be the standard of protection required by the Directive. With this serial number applied to packaging, a scan could reveal any duplication of data on packs, when checked against information in a central database. This would alert the dispensing pharmacist that a potentially falsified product had been detected which could then be removed from the system. Further, affixing a seal to packaging would highlight tampering when broken. This would be an essential complement to a product verification system.

Members of the European Parliament (MEPs) concur with the industry's call for the introduction of mandatory safety features, such as seals and serial numbers, for certain medicines. However, they add that while, in principle, these features would be required for prescription medicines, such an obligation could be waived, subject to an assessment by the EC, for certain drug types, like generics. MEPs also want the EC to assess, after four years, whether this requirement should be extended to non-prescription medicines.

It is of paramount importance that the integrity of a pack be guaranteed throughout the distribution chain. While the industry favours a total ban on repackaging in order to secure this, an alternative would be to place strict obligations on repackagers to replace mandatory safety features when repackaging products. The industry suggests that, where a product is repackaged, the original serial number should be replaced in the database with a new one by the repackager. The original and new numbers should be linked in the database in order to ensure that the product can be traced in the event of a safety issue arising or a possible recall.

The repackager should also be required to replace the original packaging with equally robust tamper-proof features. This would help maintain pack integrity. If any other specific protective features were included by the manufacturer, the repackager would need to replicate these to provide at least an equivalent level of protection.

In order for an effective and preventative system to work, all actors in the supply chain must be encouraged to play their part. This starts with manufacturers, but extends to repackagers and labellers, as well as pharmacists.

While manufacturers must build the features mentioned into the packaging, legal liability for errors should apply equally to them and to those who repackage or relabel products. This is particularly important where evidence arises that negligence has allowed a counterfeit product to enter the legal supply chain.

The identification and coding system will be the cornerstone of a future initiative, but it will not be fully effective unless the same system is adopted across Europe in a harmonised way. This means that Member States which currently operate their own, individual coding systems will have to make the transition to a single, effective system.

Continued fragmentation will limit the ability to verify a product's provenance to national product codes and create the problem of identifying counterfeit products that cross borders. As parallel trade accounts for some 10 per cent of all pharmaceutical sales in Europe, it is essential that products that have crossed borders are easily identified.

EFPIA favours a two-dimensional barcode which contains a unique serial number that may be checked against a central database that was successfully tested in a pilot project held in Sweden between September 2009 and January 2010.

The harmonisation concept must be maintained and carried forward to ensure that product verification database systems across the EU are capable of consistent co-operation. This would allow pharmacists in any Member State to check whether a pack has been dispensed before in Europe and alert the authorities if any duplication were detected.

It is the concept of verification from the point of manufacturing to the point of dispensation that is key to ensuring patients' safety. This means that each individual pack must be identified through a scan of the unique serial number and a cross-check with the central database. Once the medicine is in the hands of the patient, the database should record it as having been dispensed.

Simply by introducing mass serialisation, identification systems will become more popular and eventually essential tools. Currently, the EC proposals oblige Member States to embrace mass serialisation, but without setting timelines or guidelines on the appropriate technology. Only through standardisation and a requirement for interoperability will Member States avoid an increase in falsified medicines in the supply chain.

Mass serialisation could also help reduce reimbursement fraud, which results in significant revenue losses to national governments. In France, for example, reimbursement fraud costs the social security system €10-20m per annum.

While safety features designed to block the emergence of falsified medicines in the legal supply chain are of paramount importance, they can only be introduced across the pharmaceutical sector if they are simple, robust and cost-effective. EFPIA's pilot project in Sweden tested a solution that clearly fits all these requirements.

Finding the appropriate technology is an important step, but pharmaceutical manufacturers' actions to go further in this direction should not be restricted by the EC legislation under discussion. The industry favours a clause that would allow manufacturers to retain the right to include additional, overt, visual safety features, as is currently permitted under European law. The deployment of such features is particularly important in the case of high-risk products, including cancer preparations and drugs used to treat circulatory diseases. In order to maintain a consistent level of safety, repackagers should also be obliged to retain these security features.
In essence, the entire purpose of the barcode, verification system and central database is for patient protection, which is the fundamental goal of the EU Directive on falsified medicines. More broadly, this means protecting not only patients' health, but also safeguarding the corresponding data.

The use of safety features to authenticate medicines generates data that may be personally sensitive. Information about personal medicine consumption must be subject to relevant data protection laws.

The legislative process in the EU is making headway, but it still has some way to go. When dealing with the Directive at first Committee stage in the Parliament, MEPs noted that it did not focus enough attention on the internet, where sales of counterfeit medicines via illegal websites are a major source of revenue for counterfeiters.

As this issue goes to print, the European institutions are in negotiation with a view to reaching an agreement on the falsified medicines directive soon. Reaching a quick agreement is critical to enable stronger protections to be put in place for patients fast.

The Author
Stuart Hurst
is senior director, European Government Affairs and Communications & Advocacy, ACE, Lilly

To comment on this article, email pme@pmlive.com


Current initiatives

Falsified Medicines Directive

The EU's legislative initiative is known as the 'Falsified Medicines Directive'. The EC employed the term 'falsified' in order to distinguish the issue from Intellectual Property (IP) violations, which it calls 'counterfeits'.

It contains a series of proposals designed to secure the pharmaceutical supply chain against falsified medicines. These include the introduction of safety features such as serial numbers and seals, which are already promoted by the industry, improved regulations on inspections, stronger requirements for imports of active pharmaceutical ingredients (APIs) and obligatory requirements for wholesalers. The draft Directive also increases patient data protection and proposes a new definition for excipients and APIs.

The legislation also envisages stronger monitoring of internet pharmacies in those Member States where they are permitted to operate. Should the legislation be passed in its present form, these pharmacies will be required to obtain a special authorisation and their internet presence will bear an EU logo, in order that public can be assured that they are linked to an authorised pharmacy. All authorised internet pharmacies will be linked to a central website at Member State level and listed in a European database.

The plenary vote on the Falsified Medicines Directive is imminent. If MEPs cannot agree on the text at this stage, it will go to a second reading. However, it is expected that the Directive will be passed in its current form.

IMPACT
In 2006, the World Health Organisation (WHO) created a global coalition of stakeholders, known as IMPACT (International Medical Products Anti-Counterfeiting Taskforce) to forge international collaborations to find global solutions to medicines counterfeiting and raise awareness of the dangers of these products. Under IMPACT, the WHO developed and published guidelines that provide advice on measures to combat counterfeiting. Governments and stakeholders are encouraged to adapt or adopt these guidelines.

A major feature of the IMPACT initiative is its focus on imparting the message to patients and consumers. It requires ministries of health, national medicines regulators, health professional associations, non-governmental organisations and other stakeholders to participate in campaign activities with a view to promoting awareness of the problem of counterfeit medicines.

ACTA
Also in 2006, the US and Japan began constructing a plurilateral agreement to establish international standards in enforcing IP rights. Known as the Anti-Counterfeiting Trade Agreement (ACTA), its aim is to establish a new international legal framework that countries join voluntarily. It has its own governing body, independent of the World Trade Organisation (WTO).

The apparently final version of the agreement was leaked on the internet in mid-November 2010. Developing countries, including China and India, have suggested that its content contradicts the WTO's IP rules. Those in favour of ACTA have said it is a necessary accord that will help combat the prevalence of counterfeit medicines globally, among other things.

Within the framework of ACTA, the US and EU are pursuing strenuous requirements for data exclusivity and patent linkage. This should offer better market protection to originator pharmaceutical manufacturers.

If ACTA's civil enforcement provisions cover patents when it is released officially, this will have implications for goods in transit. EFPIA has said that it recognises the right of Member States to stop suspect products from entering the supply chain. Such actions, supported in ACTA, may require the temporary detention of some products for verification and testing.

The Author
Box text supplied by James Leeming, an independent healthcare journalist and analyst who is not associated with Lilly

18th January 2011

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