AlpVision Launches Secured QR-Code to Combat Scams and Counterfeit Products

AlpVision is launching a new way to verify the authenticity of products: the secured QR-Code. The QR Code or Quick Response Code is a machine-readable, two-dimensional barcode containing information on the item to which it is attached. It was first designed for the automotive industry in Japan in the early 1990’sI, but is now used more widely, both in commercial and non-commercial settings. (more…)

Should Product Authentication Be at the Consumer’s Fingertips?

According to a recent white paper by Authentix, an authentication and information services company, brand owners should not delegate nor should they rely on consumers to authenticate products. Authentix first argues that consumers do not want to scan QR codes. The company draws on a 2016 case study conducted by Simpson Carpenter, a market research company, that found that “only 11% of consumers have used a QR code in the past.”I This first claim is based on the assumption that consumer authentication can only be accomplished through a barcode and excludes any other form of visible security feature, such as holograms, micro printing, or special inks. (more…)

Why Mass Serialization is Failing

According to the World Health Organization, over 920 Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products have so far been reported.I These products are manufactured in all regions of the world. In response, regulation in many different countries has led to the adoption of serialization as a means to track and trace pharmaceutical packaging through the supply chain from manufacturing to the point of dispense. The Falsified Medicines Directive (FMD) in Europe and Title II of the Drug Quality Security Act (DQSA), known as the Drug Supply Chain Security Act (DSCSA), are two examples of a required serialized program. Traditionally, serialization has been used to “…improve the accuracy and efficiency of internal and/or business to-business (B2B) transactions.”II This use was by no means intended to secure or help authenticate the products being bought or sold. However, because most large-scale pharmaceutical companies already used this tool to store and transfer product data, creating item-level identification or mass serialization was viewed as a solution to securing, then tracking those items through the supply chain. (more…)

Serialization vs. Aggregation: A DSCSA Progress Update

In April 2016, we reported on Title II of the Drug Quality and Security Act (DQSA), known as the Drug Supply Chain Security Act or DSCSA. Enacted in 2013 by the U.S. Food and Drug Administration, the DSCSA requires a unique federal traceability solution for prescription medicines across all 50 states at the product level. According to the FDA, the Act will enable better verification of the legitimacy of prescription drugs and swifter action when illegitimate ones are identified and need to be removed from the drug supply chain.I Manufacturers, repackagers and wholesale distributors have until November 27, 2017 to comply. Full interoperability is expected by 2023. (more…)

The Evolution of Authentication Technologies

At the beginning of the millennium, product authentication was mainly done with a special tool or with the naked eye. The former solution was reliable but cumbersome while the later became less and less useful as simple copies became very good.

Then, the smartphone appeared and triggered a totally new path for authentication: since everybody had one, it suddenly became possible to get the best of both worlds: easy to detect and secure. The basic idea is this: smartphone captures an image and provides a conclusion regarding product authenticity. (more…)

Cigarettes Top the List of Detained Articles in the EU in 2015

The European Commission recently published the 2015 Report on EU Customs Enforcement of Intellectual Property Rights.I While the number of cases (a ‘case’ refers to a detention that may contain one or more articles) dipped slightly in 2015 (95,194 in 2014 vs. 81,098 in 2015), the number of articles infringing an IPR continues to increase, with 43,7 million detained articles in 2015. That represents a 15 per cent increase on the number of items seized in 2014, a total value of over 640 million euros. (more…)

Counterfeit Medicines in Asia: Damage Suffered by Japanese Pharmaceutical Companies Abroad

Although counterfeit medicines affect every region of the world, many drug-counterfeiting rings originate in Southeast Asian countries, such as Cambodia, Thailand, Laos, Vietnam, and China.I Many factors tend to bolster this situation, including weak enforcement, lack of education and training, poverty, and little to no budget to enact regulations or conduct regular inspections.II In addition to counterfeit “lifestyle drugs,” infectious diseases affect these countries, favoring the production of counterfeit “life saving drugs”, such as anti-infectives.III As a result, not only do counterfeit drugs harm public health, some even causing the loss of life, they also damage businessesIV and nations.V (more…)

Mapping Out the Tobacco Products Directive

Dated June 6, 2016, a “Roadmap” was published on June 9th on the EU Transparency Register covering implementing measures and delegated acts under Articles 15(11), 15(12) and 16(2) of the Tobacco Products Directive (TPD) 2014/40/EU.I

In E.U. terms, “roadmaps” are designed to describe a Commission initiative and the objectives to be achieved. They also show the different stages of the initiative and their impact on stakeholders. Finally, they help plan for and organize public consultation.II

Accordingly, the TPD Roadmap provides context for the initiative, describes the size of the problem (e.g. penetration of illicitly traded tobacco products estimated at 13%), reviews the safety requirements mandated in Articles 15 (tracking and tracing) and 16 (tamper proof security feature composed of visible and invisible elements), and their desired objectives (to reduce illicit trade and protect public health). (more…)

What Do Pharma Safety Regulations Look Like in the U.S.?

On February 9, 2016, the countdown to implementing the safety measures mandated by the Falsified Medicines Directive (FMD) Delegated Act started. This Act, which will come into force in early 2019, imposes item-level serialization and tamper evidence on pharmaceutical products in all European Union Member States.

Across the pond, the Drug Quality and Security Act (DQSA) was signed into law by President Barack Obama on November 27, 2013. Among other provisions, Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), requires that brand owners take steps to serialize their products at the item level. The end goal is for government officials and other stakeholders to be able to exchange “…transaction information, transaction history, and transaction statements”I in a secure, interoperable and electronic manner, about the location of a pharmaceutical product in the supply chain by 2023. (more…)

FMD Delegated Regulation (EU) 2016/161 Published

The publication of the Delegated Regulation (EU) 2016/161I supplementing the Falsified Medicines Directive (FMD) 2001/83/EC and its amendment 2011/62/EU was finally published in the Official Journal of the European Union on February 9, 2016. This date marks the three-year window in which manufacturers of pharmaceutical products in the European Union will need to comply with the requirements of the FMD, namely “…the placing of safety features consisting of a unique identifier and an anti-tampering device on the packaging […] for the purposes of allowing their identification and authentication.”II

The Regulation prescribes an “end-to-end”III verification system of medicine, from the point of manufacture through to its distribution to patients. The unique identifier takes the form of a two-dimensional barcode or matrix code that is machine-readable and consists of the product identity (name, dosage form, pack size and type, etc.), serial number, national reimbursement number, batch number, and expiry date.IV In addition, the Regulation mandates item-level serialization, meaning that the unique identifier “…should be unique to a given pack of medicinal product”.V The result is a randomly generated printed code that is less than 50 characters long and unique in the world. (more…)

A Deeper Look at the Financial Impact of the FMD Delegated Act

Our previous blog article (Cost-Benefit Analysis of a ‘European Hub’ for Medicine Authentication) analyzed the cost-benefit of creating a European hub – the European Medicines Verification Organization or EMVO – to link national verification systems throughout Europe and facilitate the creation of a central database to comply with the Falsified Medicines Directive (FMD) safety feature requirements.

We used FMD Project Manager Johan Verhaeghe’s presentation given at the Anti-Counterfeiting & Brand Safety World Summit London on October 1, 2015, to explore the strengths and weaknesses of this model. According to Verhaeghe, the combined cost to run the EU ‘hub’ (a shared cost), link the national verification system(s), and operate the data repository system would range between €5000 and €19000 per marketing authorization holder (MAH) – the company or other legal entity that has the authorization to market a medicine in one, several or all European Union Member States – per country per year. (more…)

Cost-Benefit Analysis of a ‘European Hub’ for Medicine Authentication

As described in our previous blog (New Developments in the Fight Against Falsified Medicines), the European Medicines Verification Organisation or EMVO was founded in February 2015 as a means to help EU Member States implement the requirements set out by the Falsified Medicines Directive (2011/62/EU).

Among other measures, the FMD mandates that Member States place a ‘Unique Identifier’ (UI) on individual medicinal packs for authentication. According to the draft Delegated Act published in August 2015, describing the technical characteristics of the safety features, the UI takes the form of a 2D barcode or matrix code containing a unique serial number, a product code, an expiration date, a batch number, and a national health number (where necessary). In addition, this code must be verifiable at the point of dispensing to the patient. (more…)

New Developments in the Fight Against Falsified Medicines

In addition to the recent publication of a draft delegated act laying down the technical specifications of the safety features, two other major developments have taken place since the EU Falsified Medicines Directive (2011/62/EU) came into effect in January 2013.

The European Medicines Verification Organisation (EMVO)

According to a European Federation of Pharmaceutical Industries and Associations (EFPIA) press release I, the European Medicines Verification Organisation or EMVO was founded in February 2015 as a “hub” to link national verification systems throughout Europe. Established as a nonprofit organization and located in Luxemburg, the EMVO will play a key role in promoting the European Stakeholder Model (ESM) – “a point-of-dispensing verification system that allows pharmacists to check a unique identification code on each individual pack when it is dispensed to the patient.II(more…)

Draft EU Falsified Medicines Directive Delegated Act Published

The Falsified Medicines Directive (2011/62/EU) adopted in June 2011 and put into force in January 2013, calls on the European Commission to prepare and adopt delegated acts that will lay down the technical specifications of the safety featuresI, determine the methods for the verification of the security elementsII, and institute a repository system to store and manage themIII. A draft of the EU delegated act was recently published on August 12, 2015. Although the European Parliament and Council still need to review the document, the European Commission is set to publish it in Q4 2015IV. Once published, pharmaceutical companies will have exactly three years to comply with the EU-FMD, roughly by the end of Q4 2018. The text begins with the introduction of a 2D barcodeV containing data such as product, serial and batch numbers. Authentication is then described as an “end-to-end verification system”VI enabling the control of the authenticity of medicinal products at the point of dispense. Finally, the repository system should be established and managed by relevant stakeholdersVII, in other words manufacturers, distributors, and providers. As for tamper-evidence, “the choice […] is left to the manufacturerVIII.” (more…)

AlpVision Response to Feasibility Assessment of Covert Security Features in EU Tobacco Control

On May 7, 2015, the European Commission published an analysis and feasibility study on the existing traceability and authentication solutions applicable to the tobacco industry. The report was successful in parsing the “marketing fluff” from the “real stuff” and emphasizing the need for both track and trace and security features, meaning that “… authorities, supply chain actors, and consumers need, in addition to traceability provided by track and trace, a method to authenticate that the product and / or markings are genuine.”I

However, we believe the report was less successful in properly ranking the covert security features available on the market today. Here’s why.

The authors present their findings of the assessment of the covert security feature technologies on page 136. The different solutions are analyzed and rated against imitation, affordability, ease of training, prevalence of authentication device, and industry suitability. (more…)

Feasibility Report on EU’s Traceability and Authentication of Tobacco Products: A Look at Covert Security Features

In response to Articles 15 (Traceability) and 16 (Security feature) of the second Tobacco Products Directive 2014/40/EU, the European Commission published on May 7, 2015, an analysis and feasibility report defining the technical standards for traceability and authentication of tobacco products. 274 solution providers were identified and contacted. The organization representatives who provided “real” facts and who were successful in conducting and completing a survey were retained. Of the 44 organizations that completed the survey process, 32 were providers of a track and trace solution and 38 of a security feature suitable for the tobacco industry.

As with the Directive, the report reinforces the fact that tracking and tracing alone does not provide sufficient protection against attempts to counterfeit or manipulate tobacco products. Instead, “Combining authentication and traceability provides a robust mechanism to combat counterfeiting, detect smuggled goods not authorized for an internal market, and guard against goods movement frauds […] within and between EU Member States.” I (more…)