Pharma Industry Overview

Product and brand value protection beyond measures from regulation and compliance in the pharma industry is related to combined and orchestrated measures that limit the ability of counterfeiters to bring falsified or stolen medicine onto the market. It is not limited to a channel and covers online marketplaces as well as traditional pharmacies, hospitals and more. Of even greater importance is the protection of sensitive information by eliminating security gaps in the relevant processes.

In the pharmaceutical industry all product and brand protection measures can be assigned to one of three categories. These include legal measures, such as IP and brand registrations, prosecution and enforcement of rights, process-related measures beyond the regulatory and compliance requirements such as the integration and control of processes across internal and external stakeholders to prevent the leakage of sensitive information, and protective measures such as internet searches and the application of adequate protection on physical products. Measures of all categories are mutually reinforcing and equally important in your fight for protecting patients from counterfeit drugs. 

Through intelligent utilization of data, product protection and marketing become complementary elements and not opposing forces, thus leveraging the benefit of investments in brand protection in marketing. The product flow, from production all the way to the customer’s hand, give you insights into unique market data that allow you to develop marketing-relevant knowledge. Anti-counterfeit measures demand a well thought-out, strategic approach. Product protection can be implemented visibly or out of view. Depending on the strategy and technology such as augmented reality (AR), several interaction possibilities and possibilities can be used to engage with the patients, nurses and doctors and get medicine authenticated.

Most product protection solutions are based on a single feature. Whatever the feature is, it has a specific range of applicability which can be wider or more narrow. Therefore for the the pharmaceutical market and medicine protection, a portfolio of features is required to combine and leverage other specific efforts such falsified medicine directive (FMD), serialization, but with regard to  the way of supplying patients, protecting primary as well as secondary packaging might become a necessity. Further, solutions to fight falsified medicine may well differ in the level of protection they provide as well as in how invasive they are to your existing processes, their application and recognition. While most of the solutions are isolated, significant advantages can be achieved form integrated solutions.

Protection in the medicine market operates on a principle of securely confirming the existence of an authentic mark. A confusing variety of mechanisms exist. The mark applied to the product can be visible, or invisible, passive or active. Mechanisms may further differ in the way they can be verified: by consumers, experts or forensics, online or offline, digitally, visually by the customer or automatically and more. Especially in the highly regulated pharmaceutical market, there is a misunderstanding of implied security by serialization respectively, the security that goes along with the uniqueness of a serial number. While the serial number is very helpful to understand deep details of the product, its trace, it does not ensure that what you held on  your hand is a genuine product. Our expertise is there to help you choose a tailor-made protection solution to fight against falsified medicine, without having to evaluate individual features.

The majority of counterfeits can be rather easily distinguished from a genuine product when both are compared side by side and you know which one is the original. Unfortunately, this is pretty seldom the case. In the pharmaceutical market, where there are quite some different models from production to supplying medicine to patients,  product protection and brand value protection solutions may need to detect a variety of complementary and superposed product features with which genuineness of products can be authenticated.  If the product is not being authenticated it might well be a counterfeit.

In order to sustainably protect your brand, just a specific or all of its pharmaceutical product portfolio,  a bundle of coordinated measures is required. In addition to securing the underlying rights, the same steps are always used to build effective protection and enhance patient safety, independent of the marketplace: information on the situation, setting up of protective measures and to fight against misuse, enforcement of the law. These steps protect both online and physical marketplaces against counterfeiting, but just as important is the protection of relevant processes along the value chain.

Counterfeiters, producing and distributing fake medicine, undercutting supply chains to substitute substances with falsified ones or infiltrate health organizations supply chains to sell fake medicine, prove to  make quite much efforts and therefore do produce almost identical counterfeits. To substantially protect your product, you need two kinds of protection measures. Such  ones that actively protects all the processes respectively associated data of and in between everyone involved in the creation, registration, production, packaging, transportation, distribution of the products, and such ones that use a set of features that allows  distinguishing your product from counterfeit ones.

In the pharmaceutical market, missing securing of all necessary underlying rights to claim ownership of the brand name to be able to defended the rights in legal disputes, is much a issue. Also this is normally given, it does not prevent the brand value from being undermined, as this depends very much on the consumer's sense of trust. That's why you ultimately need to focus your brand protection strategy on patient safety. You accomplish this by making sure that actively all the processes respectively associated data of and in between everyone involved in the creation, registration, production, packaging, transportation, distribution of the products are protected and finally when supplying the patient, he can verify the genuineness of the product.

While the pharma industry is already highly regulated, the primary focus of the pharmaceutical or medicines regulations, are of technical, administrative or legal nature. Issued by different bodies such as governments, agencies, industry bodies etc. comprising all kinds of documents such as policies, recommendations, procedure, guidelines and more, they are aimed at ensuring best practices, compliance etc. ensuring the efficacy, quality and safety, accuracy of information of medicines.

After all of this, ensuring a medicine of up to date known quality, it can be assumed, that the the medicine behaves within the documented scenario. 

But there is still the risk, that the patient gets willfully or unwillingly fake medicine administered undermining the trust in the brand value. 

Also if the medicine industry is highly regulated, this final mile of protection is still insufficient. 

If anti-counterfeiting measures are strategically and systematically taken, the solution needs to be as minimal invasive as possible and it needs to leverage additional benefits from the investments. Depending on the cycle you are in, brand protection and product protection can start silently with the aim of gaining more information about the facts. Depending on the situation, market verification information can be obtained through different bodies, such as investigative or customs organizations. This information can well support further communications as well as anti counterfeiting measures. An alternative approach to bring patient safety closer to the individual would be the integration of medicine authentication to apps that maintain at the same time information on the patient's compliance. Further possibilities might be the integration in augmented reality (AR) medicine information apps, gaining authentication information and allowing bi-directional communication with patient, pharmacist or doctor.  Communication is always a sensitive matter. Factors that help to define target-oriented communication are, for example, user groups who are to carry out the verification, whether they are experts or consumers, as well as market features, customer awareness and brand loyalty.

The pharmaceutical industry in general is well aware that, as with other security and protection solutions, there is no single protection feature that is 100% reliable. The reliability of anti-counterfeit and product  solutions depends, among other things, on the mix of technologies used, the complexity and thus the impediments to imitation, the requirements for providing the protection, environmental influences and the handling by the verification users. Under these conditions, the aim is to find a balance with which the greatest possible effect can be achieved in the fight against counterfeits and to protect the value of the brand.  

Product protection and brand value protection solutions, to prevent fake medicine reaching the patients, do recognize specific product markings, partial information of the product and intelligently combine and match this information with different trusted sources to authenticate genuine products. Depending on the marking technology, a specialized device is required or a smartphone device with an app can be utilized. If the product can be authenticated, it indicates that product does meet one’s expectation of an origin product. Otherwise it might be an expired, stolen or counterfeit drug.