Friday, 5 June 2015

Predicting the impact of the Falsified Medicines Directive (FMD) - Part 2

A forum for expert views

In early 2015, the British Embassy in Switzerland and UK Trade & Investment organised a workshop in Berne, Switzerland to bring together expert stakeholders, medicines authentication experts and other leading professionals to provide a forum to communicate the impact of the EU Falsified Medicines Directive (FMD) (2011/62/EU), particularly with respect to Switzerland. 

The workshop was opened by Her Britannic Majesty’s Ambassador to Switzerland and Liechtenstein, Mr David Moran. He described how bilateral trade between the UK and Switzerland, worth over £27.4 billion a year, continues to prosper. He also highlighted the UK and Switzerland’s excellence in the life sciences sector. 

The first speaker, Dr. Heiner Sandmeier, Deputy Secretary General of Interpharma, cited the intact supply chain Switzerland and the absence of parallel trade as important reasons for the relatively low number of falsified medicines in Switzerland. Following an increase in the number of illegal imports for a number of years, the Swiss authorities had observed a drop of around 42% between 2010 and 2012. 

Dr. Sandmeier stated that the country is taking several efforts to fight falsified medicines and that the research based pharmaceutical industry is supporting the implementation of the FMD in Switzerland. The Swiss Anti-Counterfeiting and Piracy Platform is a non-profit association with 40 members from the public sector, private enterprises and consumer organisations. Its high profile “Stop Piracy” educational and awareness public campaigns emphasise the criminal background behind such falsification operations. In addition, the Revision of Swiss Medicines Law includes new measures relating to these issues (Art. 86/87). The imitation and falsification of medicines is clearly outlined as a criminal offence. In addition, Switzerland signed the Medicrime Convention on 23th October 2011, which is the Council of Europe convention on the counterfeiting of medical products and similar crimes involving threats to public health. Switzerland has considered ratification and a report by the Federal Office of Public Health (FOPH) on a Draft Implementation Act is expected during the second half of 2015.

Dr. Sandmeier went on to describe the European Stakeholder Model (ESM), a partnership of organisations involved in the pharmaceutical supply chain, and their work on a pan-European medicines verification system [1]. In Switzerland, a Working Group of the Refdata Foundation has started a consultation on a joint stakeholder-run verification system on the basis of the ESM. The Foundation membership includes the key stakeholders in the Swiss healthcare system. 

Real life experiences 

In the next presentation, Graham Smith, ‎Commercial Director at Aegate, provided further details on the Directive and its technical implications. Manufacturers will need to invest in order to meet new requirements. He estimated that 47% of the total cost of compliance to the FMD would relate to tamper evidence, 37% to serialisation and 16% to authentication costs [2]. However, there will be longterm benefits to be gained as this will also create a digitised network connecting manufacturers, wholesalers, pharmacy and patients. The FMD would effectively link 10 billion prescription medicine packs across Europe, 500 million people, 150,000 pharmacies and 4,000 manufacturers [2].

In a complementary presentation, David Brindley, from Oxford University discussed other opportunities that might arise as a result of the new end-to-end medicine verification system. In particular, he highlighted the potential benefits for improving patient adherence. Through better understanding of patient behaviour when taking their medicines coupled with harnessing appropriate elements of the system arising from the EU FMD it should be possible to make improvements. For example, the system could represent a vehicle for messaging to both patients and pharmacists. He described a UK pilot program that was being run in conjunction with Aegate based on their medicine verification and authentication system. The aims included an independent evaluation of and efficient integration of the company’s system into existing pharmacy software.

Graham Smith then provided an in-depth, practical look at Aegate’s End to End Service. He highlighted the wealth of experience that had been gained by the company across Europe and also in the US. To date, in Europe, the Aegate system has checked 3 billion medicine packs at 15,000 dispensing points, while maintaining a round trip response time to pharmacies of 250 milliseconds [2]. In order to develop an efficient system suitable for different national markets he stressed the importance of working closely with local stakeholders. This ranges from working with pharmacists to ensure integration with different software platforms to working with manufacturers to help them resolve serialisation data transfer issues.

As well as protecting patients from genuine dangers, he pointed out the need for any system to be able to rule out anomalous and false-positive results. He cited an incident in Belgium, where 79 packs with the same unique identifier had been found by the Aegate system [2]. An investigation quickly revealed that this was due to a manufacturer error and so Aegate were able to ensure pharmacists were reimbursed and the manufacturer avoided an expensive recall. 

Preparing for a new environment

Following the presentations, the attendees discussed their own experiences and expectations regarding medicine verification and authentication. One of the concerns was the delay by some stakeholders in preparing for the FMD. It was considered imperative for all parties to make the necessary investment in order to have appropriate measures in place as soon as possible. Other topics discussed centered on the developments in Switzerland regarding the FMD in relation to the bilateral agreements with the EU. Swiss experts at the meeting confirmed that the details of the FMD were being closely examined at an official level and details on Switzerland’s approach would be forthcoming.

In conclusion, the meeting organised by the British Embassy in Switzerland and  UK Trade & Investment highlighted the importance of a comprehensive strategy to deal with falsified medicines both at European and international level. The attendees were optimistic that ongoing dialogue between different healthcare stakeholders would help minimise this serious threat to public health. 


1. European Stakeholder Model (ESM)
2. Aegate.  

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