EU Tense as CrunchTime for Counterfeits Approaches

Tensions are rising in Europe’s pharmaceutical sector as crunch-time approaches for the legislation to combat counterfeits. By this time next year, the European Commission is due to have decided on the mechanisms required to put into effect the European Union’s hugely complex new rules to keep falsified medicines out of the legal supply chain. The manufacturing industry will have to carry the cost of much of the chosen system – and there is wide disagreement about what sort of system should be introduced, and who should pay for it. First, the good news. The mould-breaking agreement on a possible system, forged more than a year ago between branded medicine manufacturers, wholesalers, pharmacists and – mirabile dictu – parallel traders, is still holding together. They are continuing to work in close coordination on what they call their European Stakeholder Model.  As Richard Bergström, director general of the European Federation of Pharmaceutical Industries and Associations, recently spelled out, this “shared stakeholders’ vision for a pan-EU product verification system” will ensure product and patient safety in a cost-effective way while providing interoperability between regional systems. The beauty of the system, he said, is that it can be accepted and supported by many different organisations, based on the same harmonised coding system and standardised work flows in different regions, but accommodating different needs (such as linking in to existing national systems) in different regions. And for EFPIA, an important element is that the system would be scalable, so that it to be extended over time to serve other purposes. Even before it is extended, the ESM will have to be able to meet the EU’s requirements for safety features that enable relevant persons to “verify…authenticity” and “identify individual packs”, and for evidence that a pack has not been tampered with. The Commission will decide in 2014 on the characteristics and technical specifications of the “unique identifier” for each pack, and the “extent and modalities of verification of the safety features” to “ensure the verification of authenticity of each dispensed pack”. It will also rule on the setting up of the data banks – “repositories”, in the legal jargon – against which packs can be verified. The coalition is lobbying hard to win support for its system – which will leave operations mainly in their own hands. But it hasn’t yet set the system up, and it is only now that the first trials of some elements of it are beginning. Meanwhile, the context is disturbed by both competition and dissension. Competition has arisen from other possible systems – and notably a concept advocated by the Council of Europe (this 47-member organisation is not, remember, the same thing as the 28-member European Union and its European Council!) called eTACT. The backers of eTACT include national health authorities, and one of their main arguments is that safety is too important to leave in the hands of ‘stakeholders’ – for which, read ‘industry’. The ESM coalition was initially dismissive of this alternative, but now takes it seriously enough to offer detailed criticisms of it – such as its relative lack of detailed knowhow of the medicines supply chain, and its almost total lack of support from ‘stakeholders’. But the contest is now fully underway as rival claimants aim to convince the European Commission that their approach should get official blessing. As if the competition for attention wasn’t bad news enough, the picture is further complicated by continuing dissension – this time within the manufacturing industry. The generic industry in Europe has refused to join the coalition of ‘stakeholders’ – citing, principally, cost. Generic products are high in volume, low in price, and as such offer thin margins – and therefore present little incentive for counterfeiting or falsification, argues the sector association, the EGA. Therefore generic products should be exempt from the obligation to carry the safety features that the new EU rules impose on prescription medicines. There is some provision for exemption in the new rules. In principle, all prescription products would be covered by the requirements, and non-prescription products would be excluded. But exceptions could be made, based on a risk assessment – so a ‘white list’ is envisaged of prescription products that, by their nature, are judged not susceptible to falsification, and which would be exempt. And a ‘black list’ of non-prescription products would bring under the scope of the new rules any medicines that were considered to be vulnerable to falsification. The precise criteria for this risk assessment, together with the processes for notification of products to be included or excluded, have yet to be decided. They too will emerge from the Commission’s detailed legislation next year. If generic medicines were to fall under the requirements, production lines would have to be modified, and software would have to be adjusted to apply the distinctive identifier on each pack, said Maarten van Baelen, medical affairs manager of the EGA. The proposed safety features could cost the average generic company €50 million, and the generic industry in Europe a total of €1 billion, he calculates. In addition there would be annual costs of €10 million per company – or €200 million across the sector. And all that expense would still not guarantee patient safety. The measure is simply not proportionate to the relatively low risk of counterfeits getting into the legal supply chain in Europe – and the still lower risk of them turning up as generics, he said. Paradoxically, the EU is taking no new measures to fight counterfeiting where it really occurs – in the illegal supply chain and on the internet, van Baelen continued.  And the EGA does not want to be part of the ESM, because it would then be expected to pay a big – and in its view disproportionate – share of the costs of a system created to protect against a risk that its members’ products do not present. This is the tangled background against which Commission officials are now trying to write the detailed rules – and prepare themselves for the decision they will have to make over which system to impose. And to make matters still more complicated, a new study from the consultancy KPMG has just urged caution on everyone, and suggested that the risks inherent in any such complex system are so great that it would be sensible to introduce it only bit by bit. That way, at least any errors or oversights can be remedied before full-blown – and highly expensive – roll-out of the complete system. “The Directive contains many uncertainties regarding the implementation, which could lead to budget overruns and time constraints if they are not properly addressed. Implementing the safety features initially on a smaller-scale would mean that the majority of these uncertainties could be dealt with; and the additional expenditure and reputational damage possibly arising from unexpected drawbacks will remain limited. Therefore, we advise carrying out a carefully-phased implementation”, says KPMG. The report lists a series of ambiguities and potential mishaps, whichever system is chosen, ranging from the diverse classification from one member state to another of what is prescription only and what is non-prescription, to the risk of “code harvesting”, under which a counterfeiter might easily acquire supposedly legitimate product identifiers in the event of glitch in the system, then use them to ensure acceptance of counterfeits. By no small coincidence, the KPMG report, which largely supports the EGA position, was commissioned by EGA. But to add to the confusion, EGA’s contention that generics are hardly ever counterfeited in Europe was dealt a heavy blow only weeks ago, when large stocks of counterfeit generic aspirin and omeprazole were discovered in Europe. Europe’s rich diversity is proving, yet again, to be something of a headache for legislators and for pharmaceutical executives. They should all make sure that the analgesic they reach for is not falsified. ENDS

Tensions are rising in Europe’s pharmaceutical sector as crunch-time approaches for the legislation to combat counterfeits. By this time next year, the European Commission is due to have decided on the mechanisms required to put into effect the European Union’s hugely complex new rules to keep falsified medicines out of the legal supply chain. The manufacturing industry will have to carry the cost of much of the chosen system - and there is wide disagreement about what sort of system should be introduced, and who should pay for it.  

First, the good news. The mould-breaking agreement on a possible system, forged more than a year ago between branded medicine manufacturers, wholesalers, pharmacists and – mirabile dictu – parallel traders, is still holding together. They are continuing to work in close coordination on what they call their European Stakeholder Model.  As Richard Bergström, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), recently spelled out, this “shared stakeholders’ vision for a pan-EU product verification system” will ensure product and patient safety in a cost-effective way while providing interoperability between regional systems. The beauty of the system, he said, is that it can be accepted and supported by many different organisations, based on the same harmonised coding system and standardised work flows in different regions, but accommodating different needs (such as linking in to existing national systems) in different regions. And for EFPIA, an important element is that the system would be scalable, so that it to be extended over time to serve other purposes. 

Even before it is extended, the ESM will have to be able to meet the EU’s requirements for safety features that enable relevant persons to “verify…authenticity” and “identify individual packs”, and for evidence that a pack has not been tampered with. The Commission will decide in 2014 on the characteristics and technical specifications of the “unique identifier” for each pack, and the “extent and modalities of verification of the safety features” to “ensure the verification of authenticity of each dispensed pack”. It will also rule on the setting up of the data banks – “repositories”, in the legal jargon – against which packs can be verified. The coalition is lobbying hard to win support for its system - which will leave operations mainly in their own hands. But it hasn’t yet set the system up, and it is only now that the first trials of some elements of it are beginning.

Meanwhile, the context is disturbed by both competition and dissension. Competition has arisen from other possible systems - and notably a concept advocated by the Council of Europe (this 47-member organization is not, remember, the same thing as the 28-member European Union and its European Council!) called eTACT. The backers of eTACT include national health authorities, and one of their main arguments is that safety is too important to leave in the hands of ‘stakeholders’ - for which, read ‘industry’. The ESM coalition was initially dismissive of this alternative, but now takes it seriously enough to offer detailed criticisms of it - such as its relative lack of detailed knowhow of the medicines supply chain, and its almost total lack of support from ‘stakeholders’. But the contest is now fully underway as rival claimants aim to convince the European Commission that their approach should get official blessing.

As if the competition for attention wasn’t bad news enough, the picture is further complicated by continuing dissension – this time within the manufacturing industry. The generic industry in Europe has refused to join the coalition of ‘stakeholders’ - citing, principally, cost. Generic products are high in volume, low in price, and as such offer thin margins - and therefore present little incentive for counterfeiting or falsification, argues the sector association, the EGA. Therefore generic products should be exempt from the obligation to carry the safety features that the new EU rules impose on prescription medicines.

There is some provision for exemption in the new rules. In principle, all prescription products would be covered by the requirements, and non-prescription products would be excluded. But exceptions could be made, based on a risk assessment – so a ‘white list’ is envisaged of prescription products that, by their nature, are judged not susceptible to falsification, and which would be exempt. And a ‘black list’ of non-prescription products would bring under the scope of the new rules any medicines that were considered to be vulnerable to falsification. The precise criteria for this risk assessment, together with the processes for notification of products to be included or excluded, have yet to be decided. They too will emerge from the Commission’s detailed legislation next year.

If generic medicines were to fall under the requirements, production lines would have to be modified, and software would have to be adjusted to apply the distinctive identifier on each pack, said Maarten van Baelen, medical affairs manager of the EGA. The proposed safety features could cost the average generic company €50 million, and the generic industry in Europe a total of €1 billion, he calculates. In addition there would be annual costs of €10 million per company - or €200 million across the sector. And all that expense would still not guarantee patient safety. The measure is simply not proportionate to the relatively low risk of counterfeits getting into the legal supply chain in Europe - and the still lower risk of them turning up as generics, he said. Paradoxically, the EU is taking no new measures to fight counterfeiting where it really occurs - in the illegal supply chain and on the internet, van Baelen continued.  And the EGA does not want to be part of the ESM, because it would then be expected to pay a big - and in its view disproportionate - share of the costs of a system created to protect against a risk that its members’ products do not present.

This is the tangled background against which Commission officials are now trying to write the detailed rules – and prepare themselves for the decision they will have to make over which system to impose. And to make matters still more complicated, a new study from the consultancy KPMG has just urged caution on everyone, and suggested that the risks inherent in any such complex system are so great that it would be sensible to introduce it only bit by bit. That way, at least any errors or oversights can be remedied before full-blown - and highly expensive - roll-out of the complete system. “The Directive contains many uncertainties regarding the implementation, which could lead to budget overruns and time constraints if they are not properly addressed. Implementing the safety features initially on a smaller-scale would mean that the majority of these uncertainties could be dealt with; and the additional expenditure and reputational damage possibly arising from unexpected drawbacks will remain limited. Therefore, we advise carrying out a carefully-phased implementation”, says KPMG.

The report lists a series of ambiguities and potential mishaps, whichever system is chosen, ranging from the diverse classification from one member state to another of what is prescription only and what is non-prescription, to the risk of “code harvesting”, under which a counterfeiter might easily acquire supposedly legitimate product identifiers in the event of glitch in the system, then use them to ensure acceptance of counterfeits.

By no small coincidence, the KPMG report, which largely supports the EGA position, was commissioned by EGA. But to add to the confusion, EGA’s contention that generics are hardly ever counterfeited in Europe was dealt a heavy blow only weeks ago, when large stocks of counterfeit generic aspirin and omeprazole were discovered in Europe.

Europe’s rich diversity is proving, yet again, to be something of a headache for legislators and for pharmaceutical executives. They should all make sure that the analgesic they reach for is not falsified