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Domino serialisation survey highlights debate over key aspects of European Falsified Medicines Directive

30th October 2013: Domino Printing Sciences has announced the results of its recent serialisation survey, initiated to gauge opinions of pharmaceutical manufacturers, industry bodies and thought leaders on the challenges of meeting the requirements of the EU Falsified Medicines Directive (FMD).

The survey highlighted a broad range of opinion around subjects spanning data repository funding, impact on Overall Equipment Effectiveness (OEE), implementation and aggregation.

  • 80% of respondents think counterfeiting is as much of a problem for generics as it is for branded pharmaceuticals
  • Opinion is sharply divided on where responsibility for data repository costs should lie
  • The majority of respondents think that serialisation will adversely impact OEE

When asked about the extent of the problem of counterfeit medicines, 80% of respondents answered that counterfeiting is as much of a problem for generic pharmaceuticals as it is for branded pharmaceuticals. While cases of generics counterfeiting may not be as high profile, survey respondents were in no doubt that it is a problem that affects the whole industry.

Opinion was more divided on the question of who should bear responsibility for funding the data repositories associated with FMD compliance: 50% of respondents believe responsibility should lie with the Manufacturing Authorisation Holder, 30% argued the Marketing Authorisation Holder while the remainder suggested variously that regulators, local supervising authorities and manufacturers, packagers and other ‘e-pedigree’ stakeholders should contribute.

The survey highlighted the concern among manufacturers about how the implementation of serialisation will impact productivity, with over half believing that OEE will be reduced – in some cases by as much as 20%. Of the remainder, a quarter forecast no change, while on a more positive note, 20% predicted a positive impact on OEE of up to 10% associated with the implementation of serialisation.

The survey also touched on implementation of serialisation schemes in the operations of mid-sized producers, a classification which includes many generics and contract packaging operations. When asked if the suggested time period of four to five years was correct, half of respondents agreed, 40% suggested this was more than adequate, while only 10% thought this was not enough time to implement a scheme.

The subject of aggregation – establishing traceability through subsequent packaging phases such as bundle, case and pallet –provoked significant comment, with nearly 70% of respondents believing that schemes to prevent falsification can work without aggregation. ‘If scanning only takes place at point of dispensing then aggregation is not needed,’ one respondent commented. Others felt that capturing data at points through the supply chain, including wholesalers and distributors, would both strengthen schemes and make them more efficient and transparent. One respondent went so far as to argue that aggregation is necessary, not only for medicines but for medical devices too.

Implementation and integration were highlighted as the foremost challenges posed by the Directive: as noted by one participant, ‘Implementing serialisation affects a large number of organisational units in a company. From that perspective, the serialisation project is as complex as any ERP or MES deployment and should be approached with the same degree of care.’ This view was shared by others, one noting that implementation of hardware on the line and getting electronic batch records and MES aligned with the serialisation software would pose a significant hurdle. Implementing data capture and uploading the required serialisation data to the central repository, were two key areas of concern for respondents.

Internally, securing funding and buy-in from senior stakeholders was expected by some to be the greatest hurdle, while for others, communicating the urgency and scale of the challenge at an organisational level was most significant. In both cases, the availability of internal expertise and resources were highlighted as a potential challenge. ‘The impact on the pharmaceutical sector is still underestimated; there is a huge lack of experience’, commented one respondent.  

“The survey highlights just how far the industry still has to go in agreeing the best way to address the challenge posed by compliance with the Falsified Medicines Directive,” says Craig Stobie, global life sciences sector manager at Domino. “Manufacturers are facing a tight deadline, yet there is still a significant degree of uncertainty surrounding the overall cost, particularly regarding funding arrangements for the European repository.

“There is also considerable concern about the impact of serialisation on OEE, with most manufacturers believing they are facing a challenging time both operationally and financially, with the total impact on their bottom line significant but as yet unquantifiable,” continues Stobie.

“That said, there’s no doubt that manufacturers recognise that serialisation is the best means at their disposal in the battle against falsified medicines and most are doing their utmost to meet the deadline, using all available expertise, including their equipment suppliers.”

 

Posted on Monday 18th November 2013