Securikett Position Paper - Security Labels to Comply with Directive 2011/62/EU

Securikett Position Paper - Security Labels to Comply with Directive 2011/62/EU Dr. Marietta Ulrich-Horn, MBA Version 5, January 2012 Table of Contents Table of Contents... 1 Executive Summary... 2 1 The New Directive... 3 1.1 Article 54(o)... 4 1.2 Securikett s Assessment of the EU Directive... 4 2 Scope and Limits of this Position Paper... 5 3 Security Labels... 6 3.1 Tamper-Evidence... 6 3.1.1 Die-cuts... 6 3.1.2 Void Effects in the Adhesive Area... 7 3.1.3 Void Effects between Two Layers of Film... 8 3.1.4 Easy-To-Open Despite Being Tamper-Evident... 8 3.2 Authentication Features in Labels... 9 3.2.1 Overt Features... 9 3.2.2 Covert and Forensic Features... 10 3.3 Identification... 11 3.3.1 The Difference between Identification and Tracking... 12 3.3.2 Different Code Qualities... 13 3.3.3 Code Display Formats... 14 4 Cost Factors... 15 4.1 Tamper-Evidence... 15 4.2 Authentication Features... 15 4.3 Identification... 15 4.3.1 Pre-printed Code Labels vs. Direct Printing of Codes in the Pharmaceutical Packaging Line 16 4.3.2 Off-the-Shelf Versus Proprietary Systems... 17 Securikett - This document may only be passed on to third parties with permission 1

4.4 Additional Costs per Pack to Fulfil the EU Directive... 17 5 Compatibility and Interoperability of Counterfeit Protection Measures Within the Meaning of the Directive... 18 5.1 The Securikett Proposal: Certified Multi-Code Portals... 18 5.2 Codikett the Solution for Different National Jurisdictions... 20 6 Closing Remarks... 20 Literature... 20 Executive Summary The new EU Directive 2011/62/EU is intended to broaden and standardise the counterfeit protection of prescription medicines placed on the market of the European Union. It regulates the sale of medicinal products via the Internet, the control and documentation of wholesalers and the import of active substances into Europe. In particular, however, it will have significant impacts in the area of pharmaceutical packaging, which in future will be required to include obligatory safety features that make it possible to verify the origins of medicinal products Authenticity: Evidence of the authenticity of the product Identification: Coding of each individual package Tamper-evidence: Evidence that the packaging has not been opened and refilled The Directive does not therefore, as is so often erroneously assumed, refer solely to the coding of packaging with 2D codes. The Directive is to be incorporated into national law within the next two years. Securikett views the Directive positively. Securikett is a leading supplier of security labels and in recent years has developed and brought to market successful, counterfeit-proof packaging solutions in cooperation with leading pharmaceutical companies. Above all, the Directive is far-sighted as it combines the three important aspects of authenticity, identification and tamper-evidence. Tamper-evidence in particular is often neglected in the discussion, but is in fact extremely important. Otherwise an original pack could, for example, be refilled with falsified products. Functioning solutions are available on the market for all three points: Authenticity: o Overt safety features: e.g. holograms, special effect colours etc. o Covert safety features: Taggants; these are markers which can only be identified using special detectors Identification: o 2D codes can be applied either on the security label or directly during the packaging process. Securikett - This document may only be passed on to third parties with permission 2

o Traceability/authentication can be carried out by the consumer or a wholesaler by entering data over an Internet platform. In terms of practical design, this is no trivial matter. This type of solution is already available, e.g. Codikett, the web-based system from Securikett that can be used at any time without any further preparation. Tamper-Evidence: o There are a variety of void solutions and die-cuts that can be used for this purpose and when selecting them care must be taken that the packaging can be opened and that any text remains legible. All 3 security features can be integrated into a multi-functional security label, whereby the costs for large volumes are highly degressive. It is therefore advisable to use standardised solutions for several groups of medicines wherever possible. While the costs for bulk quantities of suitable security labels from Securikett amount to less than 0.01 euro per package for example, the costs of coding vary considerably. They depend, among other things, upon whether manufacturers have to develop their own systems to manage and print data, including hardware and peripheral devices, or whether they work with ready-made multi-functional seals that already include the code. It is important to note that extremely high security standards apply to the production and transport of counterfeit-proof packaging to prevent the packaging from falling into the hands of forgers. The converters must therefore adhere to stringent security measures, as must the manufacturers of the medicines during the packaging process. 1 The New Directive The first EU directive to standardise and regulate the pharmaceutical supply chain in Europe more strictly was issued in 2001. This Directive 2001/83/EU, which subjected manufacturers, wholesalers, pharmacists and drugstores to new rules, proved too weak to ensure the safety of European patients. Europe was not immune to the increasing global problems of counterfeit, ineffective, illegally sold and out-of-date medicines. This is the background to the new EU directive against falsified medicines. Directive 2011/62/EU issued on 8 June 2011 was a measure that was welcomed by many pharmaceutical companies and patient advocate groups alike. The Directive expands the regulations issued in 2001. It is expected that it will be transposed into the national laws of the EU Member States within the next two years and will then come into force in these national laws and interpretations. Wholesalers will be subject to stricter controls and will be required to keep more detailed records of the products sold than in the past. In formal terms, they will be subject to the same requirements as drug manufacturers. The import of active substances into Europe will be regulated more strictly, although some critics have expressed doubts about whether the measures will suffice. The repackaging of medicines, which is forbidden in most countries around the world, will, however, remain legal in Europe, although the regulations will be stricter and there are a number of issues which still have not been completely clarified. Securikett - This document may only be passed on to third parties with permission 3

The sale of medicinal products via the Internet will be regulated as far as the arm of the legislator can reach. Determined efforts will also be made to warn the public of the risk of counterfeits in the Internet. 1.1 Article 54(o) The implementation of Article 54(o) is expected to bring about significant changes for manufacturers, packers and in fact all members of the supply chain. This Article requires the mandatory integration of safety features in packaging which allow wholesale distributors and persons who are authorised or entitled to supply medicinal products to the public to, - verify the authenticity of the medicinal product, and - identify individual packs, as well as a device allowing verification of whether the outer packaging has been tampered with. 1 This paragraph also stipulates that packaging must have authentication features affixed, that individual codes must make it possible to identify individual packs, and that packs must be protected from tampering in a way that makes it impossible to open them and replace the contents undetected. This rule applies to all medicinal products in the EU that are subject to prescription, with a number of special exceptions. At the national level, Member States may, for example, extend the scope of the Directive to modernise labelling or reimbursement from health insurance funds. 1.2 Securikett s Assessment of the EU Directive As the name implies, Securikett has chosen to focus its production and research activities on security labels. In contrast to state-owned security printing companies which specialise in passports or ID documents for example, Securikett is one of a small number of suppliers which for 8 years has mainly supplied the commercial sector. In cooperation with Securikett a host of renowned pharmaceutical companies have developed solutions for counterfeit protection and introduced them worldwide. Securikett considers the three requirements contained in Article 54(o) to be both comprehensive and far-sighted: Proof of authenticity Identification of each pack, enabling traceability to the product's origin Tamper-evident packaging to prevent packaging from being filled with a falsified product. The Article leaves latitude in terms of the implementation of the Directive and does not give preference to any particular form of counterfeit protection. By not limiting itself to specific technologies, it ensures competition among suppliers and the further development of the 1 Source: Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicisee http://eurlex.europa.eu/lexuriserv/lexuriserv.do?uri=oj:l:2011:174:0074:01:de:html, accessed on 23.10.2011. Securikett - This document may only be passed on to third parties with permission 4

technologies. This in turn is an important factor in counterfeit protection given that the goal is always to be one step ahead of the counterfeiters at the best possible price. It is also prudent, because measures only make sense in combination with tamper-evidence. Otherwise falsified products could be put in used original packages etc. We also believe it is useful to combine authenticity features with identity codes. Although a good code system can to a large extent guarantee authenticity, we must always be aware of the threat posed by reprinted genuine codes, data theft and hackers. Given the range of applications they cannot be verified by the European Commission or national lawmakers. One might regard the requirement for identification and proof of authenticity as two complementary features. If the coding system is highly effective it can be combined with less sophisticated authentication features. If on the other hand, several extremely safe, overt and covert security features are in use, a simple group of consecutive numbers could also in theory protect identity. All in combination with tamper-evidence, of course. 2 Scope and Limits of this Position Paper The state-of-the-art technical possibilities for achieving tamper-evidence, verifiable authenticity and identification are set out below, with special consideration being given to the possibilities for using security labels and coding systems. In view of the fierce debates surrounding the identification of individual packs, the possibility of using pre-printed codes on labels is compared to the direct printing of codes at pharmaceutical packaging plants. An estimate is provided of the relative cost difference of different forms of coding. Last but not least, we will briefly examine the compatibility of different security concepts and coding systems as required by the EU Directive in relation to the requirements of pharmacies and other healthcare professionals who are supposed to work with them. How can interoperability be ensured? We will not for the time being deal with the legal repackaging of medicinal products within the EU. There are two important questions that have to be answered. By their very nature, covert and forensic features are not public knowledge how therefore should the re-packager know that they are present and be able to replace them by equivalent safety features. And secondly: What will the re-packager do with the codes which enable individual packs to be traced? Will he replace them by others and link the code system on the packaging with the new codes he has printed himself? Or will he reprint the existing codes? These issues require discussions which go beyond the scope of the current paper. Securikett - This document may only be passed on to third parties with permission 5

3 Security Labels On the basis of the EU Directive and other circumstances - of a mostly practical nature - we believe that for the purposes of the Regulation security labels must satisfy the following general requirements. Tamper-evidence, above all in relation to the sealing of folding boxes or with the over-sealing of liquid containers such as bottles or ampullae Easy to open by the patient or nursing staff Verifiable authenticity Full or partial transparency so that important information on the packaging is not concealed The label must be suitable for the particular coding method used, depending on whether a code is to be printed on the label or directly onto the packaging Appealing look which either enhances the appearance of the packaging or is at least not irritating, it should convey safety to the user Easy to process during pharmaceutical production Value for money at affordable prices 3.1 Tamper-Evidence There are various types of labels which change irreversibly or self-destruct if an attempt is made to tamper with them. They ensure that original packages cannot be refilled with falsified products. There are a number of materials which cannot be used for this purpose, although they are perfectly suitable for use in other applications: namely types of paper or opaque, foam or other white films, which due to their opacity cannot be stuck over other information without impairing the legibility of information. The text on packs that have once been registered should remain legible. We will therefore examine transparent and semi-transparent labels made of synthetic materials, which for ecological reasons should be based on polyolefin (i.e. PE, PP or PET) or plant based (WSA). As shown below, we distinguish between three types of tamper-evident protection, namely Die-cuts Void effects in the adhesive area Void effects between two layers of film 3.1.1 Die-cuts If a self-adhesive film has sufficient adhesive strength, die-cuts in the label suffice to prevent it from being removed and stuck back on again unnoticed. The key factor is the adhesive strength of the film in relation to the surface tension of the folding box and to the arrangement of the cuts. Securikett - This document may only be passed on to third parties with permission 6

3.1.2 Void Effects in the Adhesive Area Low-opacity ink is applied between the film of the label and adhesive to produce a separation effect if the label is removed, e.g. lettering that was previously invisible appears. The word open gradually displaces the word void. Securikett - This document may only be passed on to third parties with permission 7

3.1.3 Void Effects between Two Layers of Film The effect is similar to the one described above but takes place between two transparent layers of material. One of the advantages of this technology is that a tamper-evident code can be concealed at the same time. The compound may be fragile for reliable tamper evidence, yet easy to open for the user. 3.1.4 Easy-To-Open Despite Being Tamper-Evident In the interests of patient compliance, adequate care and attention must be given to ensuring that drug packaging can be easily opened by patients. Generally speaking, soft perforations along the edge of the box are easy to open. They should also open if the flap has been pressed in, as contrary to what one might assume, many users are unable to use a finger nail let alone scissors or knives. Void labels can also feature opening flaps, with which the label can be lifted. This has the advantage that the effect always has to be made visible, which is considered to be an additional security feature. In practice, the design of the tabs has to be tested in detail as many of them are problematical. Short finger nails, big hands, hands that are worn by work or weakened by illness or old age all have to be taken into account. Securikett - This document may only be passed on to third parties with permission 8

3.2 Authentication Features in Labels In general what is true of other security printed products, such as bank notes and passports, is true of safety labels: The greater the number of security features that are combined, the safer the label, as this raises the bar for forgers seeking to copy it. As Directive 2011/62/EU requires three features, namely tamper-evidence, authentication and identification, it is state-of-the-art and lays down a meaningful minimum requirement. However, it is perhaps wise to use more than one authentication feature. The soon to be published standard ISO 12931 Performance criteria for authentication solutions for anti-counterfeiting in the field of material goods, explains what is understood by authentication features. 2 Authentication features also frequently serve as copy protection for the security label. Depending on whether features are covert or overt, a non-specialist can also recognise whether they have an unauthorised copy in their hands. The following description of overt and covert features does not claim to be exhaustive and includes simplifications. 3.2.1 Overt Features In the case of overt features we think of generating holograms, which can also be produced in transparent versions. In specialist circles these are known as OVDs and the spectrum ranges from less secure, lower resolution digital images to structures produced by means of electron-beam lithography. The copy protection depends to a large extent on the accessibility of the technology as well as upon the know-how involved in the structures themselves. Within the meaning of the Directive, OVDs will either be small enough to prevent them from covering any texts, or transparent, which will make them suitable for universal use. Overt features also include changing colours of the kind seen on bank notes. Depending on the angle from which they are viewed a colour appears as purple or green for example. In many cases, this effect is only possible because of a dark substrate. Void effects are easily and overtly recognisable features. Customised to meet a client s specific needs they can be considered as practical medium-level security features, which only become apparent once a pack has been opened. They are not suitable for visual inspections along the supply chain. Micro-texts and modified matrix dots are also overt security features, however, in the light of modern reproduction technologies the copy protection they afford is often questionable and depends on details such as the colour of the printing ink or the reprographic technique. 2 The text was submitted for approval as a Working Draft by ISO PC 246 and then finalised. Securikett - This document may only be passed on to third parties with permission 9

3.2.2 Covert and Forensic Features Covert features can be identified with aids such as filters or testing instruments. In many cases OVDs contain such covert features in addition to the overt features. Authentication features which can only be identified using special authentication devices that are not publicly accessible, are often referred to in specialist circles as forensic. This is because they can Securikett - This document may only be passed on to third parties with permission 10

stand up in court as evidence, a demand which other forms of authentication, such as security holograms, also fulfil. The advantage of these completely hidden features is that they give counterfeiters absolutely no indication that there is anything there or what they should even imitate. This gives rise to the claim that they are the safest features. It is essential that stringent safety management procedures are adhered to when these features are indented or applied in some cases directly into the actual active substances or medicines. The disadvantage of forensic features is that they cannot be recognised by normal participants in the supply chain, in particular medical personnel or patients. It is therefore advisable to use an additional covert feature. 3.3 Identification The third pillar of Directive 2011/62/EU in relation to counterfeit-proof pharmaceutical packaging is the identification of each individual pack. Identification can usually be achieved by assigning a unique, non-repeatable number to a pack, provided the number and the provenance of the pack are linked in a database. Example: By entering the number ABC4711 in an enquiry portal, one would learn when and by which manufacturer the packet of XY medicine had been produced. Additional information could also be linked, such as the expiry date, instructions for use or explanations regarding other authentication features on the pack. The patient information leaflet can be read out as voice information etc. In this case, the code acts as the relay to information that is updated daily in the Internet. This also makes it possible to organise a recall at any time. Securikett - This document may only be passed on to third parties with permission 11

A few years ago experts were convinced that in future such unique codes would be applied to packaging by RFID (Radio Frequency Identification Device), namely the unique number that is anyway present in the chip. For technical reasons, but in particular for reasons of cost, the preferred solution nowadays is to print the code, primarily in the form of a 2D code. A number of data formats are available for 2D codes and what they all have in common is that they can store larger volumes of data than comparatively one-dimensional bar codes. 3.3.1 The Difference between Identification and Tracking The earlier example with the code ABC4711 shows that a system of identity codes clearly proves the provenance of a pack, significantly enhancing the safety of the patient as intended by Directive 2011/62/EU. In the battle against counterfeiting many manufacturers today want more, they want to identify the miscreants who bring dangerous, falsified drugs into the legal supply chain. This would be possible with a system in which products are tracked as they move along the supply chain by means of mandatory scanning of the code or the code of the repackaging material (hierarchy building) at each station from the manufacturer to the wholesaler, to the various distributors to the hospital or pharmacy. Entering the number ABC4711 in an enquiry portal would now not only show the identity of the manufacturer but also that of all distributors along the supply chain who had recorded the code and identified themselves as verifiers. One could also, it is believed, indirectly, establish which of the actors had channelled illegal products into the supply chain 3. Full track & trace systems like those used by courier services such as UPS or DHL, however, generate a host of practical and legal problems in relation to Ownership of and access to sensitive data of all participants in the supply chain, especially the data of competitors Limited possibility to oblige retailers to make the effort and disclose their sensitive data Additional costs and the question as to who should bear them The enormous volume of data generated by packs of medicines that are brought into circulation everyday across the world. Although a full track and trace system along the supply chain would appear useful for the purposes of localising counterfeiters, the expense and effort this would entail, as well as the legal feasibility of 3 This is not completely logical because only genuine codes would of course be covered, while illegal products could continue to circulate freely. Securikett - This document may only be passed on to third parties with permission 12

such a system, make its implementation in the near future unlikely if the first objective is to protect patients from falsified medicines. Traceability systems which only enable the origin and authenticity of a product or its code to be verified are less problematic in legal terms, as the person submitting the enquiry is not required to disclose their identity. Distributor XY can therefore identify the provenance of his commercial products without having to hand over his own data to a third-party data storage system. Such systems to identify the manufacturer (traceability) are already available on the market. Codikett from Securikett is one such system. Although it does not require a complete track & trace system to be set up along all stations of the supply chain, it does make it possible, so that the intensity of the record-keeping can be gradually expanded according to need. Identity codes permit checks at all stations of the supply chain, but without a mandatory requirement to keep full records. The crucial factor in terms of patient safety is that identity can be verified at the point of sale. Full track & trace systems of the kind used by parcel services are not therefore necessary to comply with the Directive. Securikett shows how this option can nevertheless be kept open. 3.3.2 Different Code Qualities Sequential codes are those which use sequential numbers, such as A001, A002, A00X. A nonsequential code, such as 3a8z57, uz47yh, is impossible or hard to guess, which is why such nonsequential codes are to be preferred as proof of identity in connection with counterfeit protection. Otherwise counterfeiters could reprint large groups of numbers fairly easily even if they know only a single genuine number. The use of alphanumerical random codes is therefore standard practice for preventing or exposing counterfeits. They can be generated using a random distribution method, by using randomness based on natural random occurrences, for example, surface structures, or mathematic encryption of a series of numbers. Securikett - This document may only be passed on to third parties with permission 13

Can numbers be generated twice? Sound cryptology offers 100% safety here. Only the use of a mathematical method can exclude doubles, which is in turn crucial for proving identity. Sequentieller Code Zufallscode 1,020,001 AC235FH 1,020,002 BFG0987 1,020,003 DRA345C 1,020,004 OI9345T 1,020,005 P987KO0 1,020,006 ZU78969 1,020,007 678HJKL4 3.3.3 Code Display Formats Nowadays the most widespread method is the use of 2D codes supplemented by human readable characters. Widely used as the code for mobile telephones, the QR code is also recognised by many people. In the pharmaceutical industry, however, it is the GS1 data matrix code that everyone is talking about. This format is a standardised form of depicting content as a 2D code and also in optical characters. The content is mainly intended for the retail and logistics industries - the most widespread predecessor in the form of a barcode is commonly known as an EAN code. This system is typically used to depict article numbers, quantities, production batches or expiry dates. A predefined area of this GS1 data matrix format is intended for serialisation for the purposes of identifying each individual pack. In this area, a sequential number or an alphanumerical code can be printed, and thus also a Codikett code. GS1 data matrix codes are usually printed directly in the production lines, although in principle preprinting in the form of labels is also possible. Comparable solutions are also used in the car industry. As the code promises to solve a host of problems in the pharmaceutical supply chain it is favoured by most of the industry as the best possible overall solution for the aspect of identification, the most hotly discussed aspect of Directive 62. The question of whether the GS1 format can harness the full potential of code systems for the purposes of authentication will have to be settled by the ongoing discussion and future developments. The total system costs of the GS1 format will very probably be higher than those of pure ID codes. This will have to be set against the overall benefits arising from the additional logistical aspects. Securikett - This document may only be passed on to third parties with permission 14

4 Cost Factors It is always difficult to estimate costs without erring in the one or other direction. Apart from the high degree of quantity-dependent price degression in this market, the requirements of the individual organisation must also be taken into account. Below an attempt. 4.1 Tamper-Evidence Transparent films with die-cuts are generally cheaper than void constructions, be it adhesive void or dry-peel void. However, void constructions have a higher reminder and recognition value. If they are produced customized and in alignment with the label format they also act as authentication features. At this point, it should also be mentioned that sleeves and cap-sleeves provide tamper-evident seals for liquid containers if combined with integrated authentication features. 4.2 Authentication Features Holograms (OVDs) generally have the additional benefit that customers perceive them to be a form of high-quality protection, which makes it possible to argue the costs in terms of marketing. In the case of medicines, preference should be given to transparent holograms. Colours that change depending on the angle they are viewed from are available in a wide range of price categories. Frequently, additional pigments are incorporated into these colours which become visible under infra-red or ultra-violet light. While this makes them more expensive, it also makes them safer. Materials that can only be read back using reading devices are also available in a variety of price categories and security levels. It should be assumed that these are for expert use, as the distribution of reading devices might prove difficult, especially if they are expensive. Conversely, they provide a high degree of proof of authenticity, as it is almost impossible for counterfeiters to even know what they should forge in the first place. The most cost-effective solutions are probably UV and IR pigments with the caveat that they are relatively accessible to counterfeiters. Combinations of several features are often advisable. The decision as to which features and costs make sense can only be established in an analysis carried out together with the pharmaceutical company. The probability and intensity of potential attacks must always be evaluated within the framework of a risk analysis. They might be so great that the measures envisaged in the EU Directive do not suffice, especially if a medicinal product is subject to global attacks. 4.3 Identification This is the most difficult part of a cost estimate. Factors to consider include: a) Pre-printing of codes on the label vs. the direct printing of codes in the pharmaceutical packaging lines b) Use of ready-made identity code systems including their infrastructure vs. developing proprietary systems. Securikett - This document may only be passed on to third parties with permission 15

4.3.1 Pre-printed Code Labels vs. Direct Printing of Codes in the Pharmaceutical Packaging Line A single industrial coding system, for example a DOD Inkjet printer with smudge-resistant UV-cured ink and a camera system for controlling the quality of the codes, can produce enormous quantities of coded labels, let s say 500 million labels per year or more. In contrast, codes that are printed decentrally in the packaging lines of the pharmaceutical manufacturers are more expensive, as incomparably more printers have to be installed, serviced and operated. However, if (high-quality) printing systems for the printing of 2D codes are anyway available in the packaging lines or are required for other reasons, this cost factor is neutralised and identity codes can be printed relatively easily here. Nor should one underestimate the logistical and administrative work and expense involved with providing the code, managing the code securely and eliminating the possibility of double numbers. Doing this successfully in several packaging plants across the world or throughout Europe is a challenge. These factors support the centralised assigning of codes during the production of precoded labels. Uploading the correct code series to the various packaging lines represents another cost factor. If ready-made Codikett codes are used for example, only the beginning and end of the Codikett series has to be assigned to the pharmaceutical production batch. The possibility that codes can be used twice must also be completely ruled out. Again, in the case of ready-made code labels this is done once by the label manufacturer using appropriate test processes. Put somewhat simply, the decentralised printing of identity codes in the packaging plants of the pharmaceutical manufacturers is only cheaper than ready-made code-labels if the printing and computer infrastructure are also required for other reasons or are anyway available. The demands in terms of process security, e.g. to prevent series being printed twice, must not be underestimated. Codes are used to be printed on the cartons in the pharmaceutical packaging line. It is possible to cover the codes tamper-proof code to prevent unauthorized reprint. Securikett - This document may only be passed on to third parties with permission 16

Preprinted codes on labels are an alternative. 4.3.2 Off-the-Shelf Versus Proprietary Systems Anyone who supposes that codes can be easily produced using a random generator, put in a database and then checked at the point of sale is mistaken. The reality is more complicated and the number of packs thrown onto the market every hour and minute of the day too great. In contrast, a system like Codikett guarantees that codes are never repeated, recognises if and how often a code has already been checked, and can be accessed around the clock with extremely fast access times. It has user hierarchies for both manufacturers and those wishing to retrieve information and is thus largely immune to hacking within the production process. And it also offers a host of benefits that express a commitment to healthcare professionals and patients. The organisation of recalls is an essential aspect of this. Pharmaceutical companies can save themselves the expense of a system like Codikett and other independent systems by developing systems of their own. However, it is questionable whether this really does save costs. The ready-made system is developed only once for a large number of users and is therefore cheaper, it is also exposed to competition on the market. A pharmaceutical company can employ several different systems complete with service, and compare their performance. It does not have to commit itself to a single system and can select the best one for its particular requirements. In summary, it can be concluded that ready-made systems are cheaper than in-house systems in the medium term. 4.4 Additional Costs per Pack to Fulfil the EU Directive As the price of security labels and coding systems is highly degressive, we assume that pharmaceutical companies will group together several of their products with a view to using a single solution for all of them. We estimate that the costs for suitable security labels for large quantities of a product amount to less than 0.01 euro per pack. Added to this are the costs for the coding. If ready-made code labels and a system like Codikett are used, this amount could roughly double. We are assuming an average lifecycle of 5 years, while the service for the active response and verification pages for each individual code shall be available worldwide. Securikett - This document may only be passed on to third parties with permission 17

5 Compatibility and Interoperability of Counterfeit Protection Measures Within the Meaning of the Directive 5.1 The Securikett Proposal: Certified Multi-Code Portals How the different coding systems are supposed to coexist on the European market without a great deal of effort and expense is unclear, but the work of ISO TC247 WG3 provides some indications. 4. Securikett has put forward a proposal under which certified portals would be installed, then when any kind of identity code is scanned the portal would identify the system to which it belongs. This check should verify that the code originates from an accredited system and not from a counterfeiter. The code will then immediately be forwarded to the respective system for verification and for assignment to response pages. The check would also be easy for pharmacists to carry out. They would only have to work in the portal certified for pharmacists in EU member state X, for example, and this would then automatically access the actual code platforms. Even without such industrial portals, code systems nowadays work very easily for the user, as the code platform's Internet address is usually also stored in the form of a 2D code or QR code so that the link to verification is automatically opened upon scanning. The proposal to set up multi-code portals is primarily driven by a desire to prevent the occurrence of counterfeit response pages. This type of code system clearing house will further enhance the reliability of identity codes in the interests of patient safety. This will lead to a host of legitimate code systems which are completely open for the future and for all further technological developments in the field. Each pharmaceutical manufacturer will choose its own specific code system. The content that appears on a response page when the code is verified will also be left to the company's discretion. This will automatically lead to the development of a best practice of good response pages with a range of information and service aspects. It is also important that the concept of interoperable identity code systems outlined here does not prompt manufacturers to place their information and data in a higher level system, the discretion of which would be hard to guarantee in the long term. Manufacturers will merely use different webbased coding systems, which in turn are then addressed by neutral industry platforms for the purposes of verification. 4 The technical committee ISO TC 247 WG3 is carrying out work on the international level under the current working title Guidelines for interoperable object identification and related authentication systems to deter counterfeiting and illicit trade. Securikett - This document may only be passed on to third parties with permission 18

Era of Mass Serialisation - Several Billion Coded Products are in the Market Securikett - This document may only be passed on to third parties with permission 19

5.2 Codikett the Solution for Different National Jurisdictions It is already becoming apparent that pharmaceutical manufacturers will have to use different code systems in order to comply with national regulations in different markets. This is already the case outside Europe where governments have adopted national solutions. In this respect, Codikett enables a groundbreaking simplification in labelling with identity codes. Depending on which national portal is used to request a code, the data is returned in the appropriate format for the particular portal, for example as a GS1 code pursuant to EFPIA, as a code that complies with Turkish regulations or in Chinese characters in accordance with Chinese regulations. At the same time, the system notices if products move to sales markets for which they were not intended. Grey market trade, be it legal or illegal, is reported by automatic statistic functions. 6 Closing Remarks We hope that these comments have been able to provide an insight into the manifold technical possibilities that are in use not just in the EU but globally. There is great potential here, also in a positive sense, to become active in the interests of patients and their protection and to stand out on the market. While to many people Directive 2011/62/EU at first sight appears to do no more than require serialisation, in reality it goes much further and in terms of its approach is well thought out and far-sighted. As a specialist in this field and as a member of the relevant technical standardisation committees, Securikett is pleased to make its experience and knowledge available to facilitate the realisation of the Directive in the Member States. System openness and system compatibility are of the essence for enabling rapid, efficient and costeffective implementation in the interests of patient protection. Literature Directive 2001/83/EU of the European Parliament and of the Council of 6 November 2011 on the Community code relating to medicinal products for human use Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (Text with EEA Relevance) ISO 12931 Performance criteria for authentication solutions for anti-counterfeiting in the field of material goods ISO/WD 16678 Guidelines for interoperable object identification and related authentication systems to deter counterfeiting and illicit trade ISO PWI 16125 Security Management System - Fraud countermeasures and controls ISO CD 14298 Management of security printing processes Securikett - This document may only be passed on to third parties with permission 20