Evaluating the Impact of the Falsified Medicines Directive in Switzerland

The European Union Falsified Medicines Directive (FMD) (2011/62/EU) (1) was introduced in July 2011 to prevent falsified medicines from entering the legal supply chain and reaching patients. In early 2015, the British Embassy in Switzerland and United Kingdom Trade & Investment organized 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 FMD in Switzerland.

Switzerland is not a member of the EU and is not likely to join in the foreseeable future; however, it has a unique position in Europe, with strong business links to the UK (2, 3). In Switzerland, economic and trade relations are governed by approximately 100 bilateral agreements (4). The EU and Switzerland closely monitor each other’s legislative developments to maintain harmonious relations. At present, the EU is Switzerland’s main trading partner, and likewise, Switzerland is one of the most important EU trading partners (4).

Bilateral trade between the UK and Switzerland is worth more than £27.4 billion a year (2), and it continues to prosper, remarked Mr. David Moran, Her Britannic Majesty’s Ambassador to Switzerland and Liechtenstein, as he opened the workshop. Mr. Moran also highlighted the UK and Switzerland’s excellence in the life-sciences sector. The UK and Switzerland share a reputation as leaders in scientific innovation, and their vibrant pharmaceutical and biotech sectors have outperformed many other industrial sectors (3). Of the European pharmaceutical industry’s total €29 billion annual R&D investment, the UK accounts for 19% while Switzerland accounts for 17% (5).

A major threat to public health and safety
Falsified medicines are counterfeit medicines that are passed off as real, authorized medicines (1). They may contain ingredients of low quality or in the wrong doses, be deliberately and fraudulently mislabelled with respect to their identity or source, have false packaging, or contain low levels of the active ingredients, or the wrong ingredients altogether (6). In recent years, falsifications have become increasingly more sophisticated, as criminals attempt to enter them into the legal supply chain. In 2011, 30 million counterfeit medicines were seized at EU borders (6).

The serious health threat posed by falsified medicines led to the implementation of the FMD (see Table I),
which came into force on 1 Jan. 2013. In parallel, the Commission started work on a Delegated Act to ensure uniformity and standardization of key safety features required by the legislation (7). The adoption and subsequent publication of this Delegated Act sets off a three-year timeline for implementation at the EU member state level (7, 8). By 2018, the full requirements are envisaged to be implemented across the region. The FMD represents a major development for pharmaceutical manufacturers, wholesalers, and pharmacists across Europe. It will, however, also have an impact on national healthcare providers and regulators.

According to Heiner Sandmeier, deputy secretary general of Interpharma, the intact supply chain in Switzerland and the absence of parallel trade were important reasons for the relatively low number of falsified medicines in the country. 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 organizations. Its high profile “Stop Piracy” educational and awareness public campaigns emphasize 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 23 Oct. 2011, which is the Council of Europe convention on the counterfeiting of medical products and similar crimes involving threats to public health (9). 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.

Sandmeier went on to describe the European Stakeholder Model (ESM), a partnership of organizations involved in the pharmaceutical supply chain, and their work on a pan-European medicines verification system (10). 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.

Practical experiences of medicine verification and authentication
Graham Smith, commercial director at Aegate, provided further details on the directive and its technical implications. Manufacturers will need to invest to meet new requirements. Smith estimated that 47% of the total cost of compliance to the FMD would relate to tamper-evidence measures, 37% to the implementation of serialization, and 16% to authentication costs (7). However, there will be long-term benefits for the industry, as these efforts to comply with the FMD will also create a digitized network connecting manufacturers, wholesalers, pharmacies, and patients. The FMD would effectively link 10 billion prescription medicine packs across Europe, 500 million people, 150,000 pharmacies, and 4,000 manufacturers (7).

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, Brindley 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 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 programme that was being run in conjunction with Aegate, based on their medicine verification and authentication system. The aim of the programme included an independent evaluation of and efficient integration of the company’s system into existing pharmacy software.

Smith then provided an in-depth, practical look at Aegate’s end-to-end service, highlighting the wealth of experience that had been gained by the company across Europe and also in the United States. 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 (7). To develop an efficient system suitable for different national markets, Smith stressed the importance of working closely with local stakeholders, which range from working with pharmacists to ensure integration with different software platforms to working with manufacturers to help them resolve serialization data-transfer issues. He pointed out the need for any system to be able to rule out anomalous and false-positive results, as well as protecting patients from genuine dangers. He cited an incident in Belgium, where 79 packs with the same unique identifier had been found by the Aegate system (7). An investigation quickly revealed that the issue was due to a manufacturer error, and Aegate was 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 so that appropriate measures can be put in place as soon as possible. Other topics discussed centred 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.

The meeting highlighted the importance of a comprehensive strategy to deal with falsified medicines both at the European and international level. There was a sense of optimism that ongoing dialogue between different healthcare stakeholders would help minimize this serious threat to public health.

References

• European Commission, Falsified Medicines, accessed 16 Mar. 2015.

• UK Trade & Investment, Doing business in Switzerland: Switzerland trade and export guide, accessed 16 Mar. 2015.

• British-Swiss Chamber of Commerce, 95 Years: Where tradition inspires change, accessed 16 Mar. 2015.

• European Commission, Swtizerland Trade Picture, accessed 16 Mar. 2015.

• EFPIA, The Pharmaceutical Industry in Figures, accessed 16 Mar. 2015.

• EFPIA, Stamping out Falsified Medicines, accessed 16 Mar. 2015.

• Graham Smith, “Falsified Medicines Directive,” presentation at the Falsified Medicines Directive workshop, (Residence of Her Britannic Majesty’s Ambassador to Switzerland and Liechtenstein, 3006 Berne; 29 Jan. 2015).

• The Pharmaceutical Journal, The Falsified Medicines Directive: time to get it right, accessed 16 Mar. 2015.

• International Law Office, Changes expected to legislation on falsified medicines, accessed 16 Mar. 2015.

• European Stakeholder Model, accessed 16 Mar. 2015.

• EMA, Falsified Medicines, accessed 16 Mar. 2015.

About the Author
Faiz Kermani, Basel Committee Member, British Swiss Chamber of Commerce.

Article DetailsPharmaceutical TechnologyEurope
Vol. 27, No. 4
Pages: 8-10
Citation: When referring to this article, please cite it as F. Kermani, “Evaluating the Impact of the Falsified Medicines Directive in Switzerland,” Pharmaceutical TechnologyEurope27 (4) 2015.