Bayer speaks out on brand protection strategy

Bayer's new version of its erectile dysfunction therapy Levitra was launched in the UK last month and, anticipating interest from counterfeiters, the product has been protected with a level of anti-counterfeiting protection reminiscent of that used for banknotes.

Levitra 10mg Orodispersible (ODT) comes in a melt-in-the-mouth formulation designed to be simple and convenient, dissolving on the tongue within seconds, and has discreet packaging to match. Bayer notes that 120 anti-counterfeiting features are included in the product presentation.

"It is hoped that ultimately, the advantages of the new product and its discreet packaging … will reduce the growing numbers of patients purchasing counterfeit pills online and lead to improved patient satisfaction and treatment outcomes in ED overall," commented Marc van Unen, Business Unit Head General Medicine at Bayer.

For obvious reasons Bayer is not prepared to delve into the minutiae of the anti-counterfeiting technology used on the new product, but a spokesman spoke to SecuringPharma.com in more general terms about the company's brand protection strategy.

"Statistically speaking, Bayer HealthCare is only minimally affected by counterfeit drugs, but it wants to protect its patients against misuse and counterfeit drug products, and prevent its good reputation and that of its products from being harmed by unscrupulous criminals," said the spokesman.

As a preventative measure, all new products are subject to an assessment of their risk of being a target for counterfeiters, and this assessment is performed by a team representing all relevant functions within the company. The list of criteria used for this include patients' health risks, a products' properties, supply chain considerations and economic drivers, all considered in front of a potential counterfeiting scenario.

"Corresponding to the evaluated risk level appropriate anti-counterfeiting security features are applied," said the spokesman.  This examination is made at the point in time when product details are decided in preparation of the launch e.g. layout and design of the product application and its package. 

"As a specific anti-counterfeiting security measure, we have, for example, decided to apply visible distinctive features on certain drug products," he said.

Levitra is one of Bayer's at-risk brands for counterfeiting, in common with all erectile dysfunction drugs on the market, so has been given overt security features to help consumers distinguish between fakes and the genuine article.

Bayer has also taken the decision to add layered security features to other products, including some life-saving medicines which have not been targeted by counterfeiters to date.

The company's Kogenate (octocog alfa) product for haemophilia A, for example, has not been counterfeited to date but is such a critical medicine that Bayer has decided to take special measures to protect the brand.

"The packaging has seven security features that, taken in their entirety, represent almost complete protection against counterfeiting," said the spokesman.  Most of these features can be seen with the naked eye, according to Bayer, although for some features ultraviolet light and decoder templates are required.

Among other products singled out for overt anti-counterfeiting measures are Nexavar (sorafenib), Bayer's recently-launched treatment for renal cell carcinoma, and anticoagulant Xarelto (rivaroxaban).

In particularly high-risk regions, some products have other overt security features, said the spokesman.

"It is important to understand that anti-counterfeiting technology is not only about application of anti-counterfeiting security features," he added, pointing to Bayer's ongoing commitment to the serialisation and traceability efforts ongoing at the European level by the European Federation of Pharmaceutical Industries & Associations (EFPIA), which is pushing for the rollout of an 'end-to-end' verification system for medicines based on serial numbers in the EU and elsewhere in the world.

In addition, "anti-counterfeiting also encompasses analytics in the sense of physical, chemical and packaging material related efforts and thereof derived intelligence on how the criminals are trying to imitate and reproduce our genuine products."

While the addition of overt and covert anti-counterfeiting technologies is a key defence against counterfeits, Bayer points out that use of these is of little benefit unless the person who uses them to authenticate a product - be they consumer, enforcement authorities, customs etc - "knows how the feature looks and what is to be checked."

For this purpose Bayer has constructed a dedicated webpage - entitled Beware of Counterfeit - which is continuously being updated and which makes this specific information available for several of its products.

"Combating counterfeits is in the best interests of patients as well as the company itself, and the health of patients is the top priority," said the spokesman. "Preventing drug counterfeits is both an ethical and an economical imperative."