Monday, November 16, 2015

Patent: The First Line of Defense in Counterfeiting

Drug counterfeiting is one of the biggest issues encompassing a global scale. From local governments to private pharmaceutical giants to various international non-profit organizations, anti-counterfeiting campaigns have been founded. The internet has been penetrated so has been the local market units from legitimate pharmacies to gray markets to black ones. Large authorities such as Food and Drug Administration (FDA), United Nations (UN) and World Health Organization (WHO) have already been involved, creating their own awareness programs and raid operations. Billions of dollar-worth of medicines was already confiscated from various physical manufacturers and online pharmacies. This goes to show that everybody is now taking this crucial issue more seriously.

Despite the best efforts, a lot of critics continue to question the late response of authorities to issues of counterfeiting. This, they say, has already been too late as thousands of people have already lost their lives from taking mislabeled, fraud, substandard, scammed and counterfeit medicines which contain little or no active ingredient at all but instead has hazardous substances such as chalk, paint or detergent.

“The persistence of this issue shouldn’t have been here if they have gotten security in the first place”, says Nicole Parker, head pharmacist and member of The Peterson Group, a non-profit organization campaigning against the proliferation of counterfeit medicine.

Big companies claim their security is legit, yet, their brands are the most likely to be counterfeited. For example, hundreds of counterfeit Tamiflu manufactured by Roche, one of the world’s largest and most trusted producers of medicines, have been seized in one of the legitimate pharmacies in Jakarta, Indonesia. When and how was the medicines distributed in one of the most anti-counterfeiting countries in the world, everybody is still trying to find out.

While the operations are still underway, the new medicines are being processed patents, the process which should have been implemented as the first step in countering production of fraud meds.

A patent allows the patentee to exclude third parties from making, using, importing, selling, or offering for sale patented products or methods of manufacture or use for a finite period of time, typically no more than 20 years from the date of initial patent filing. Patent protection must be obtained on a country-by-country basis. It is used to prevent others, for that geographical area and without the consent of the patent holder, from manufacturing and/or selling exact and close copies of the patented technology.

Thursday, November 12, 2015

Role of Generic Medicines on the Proliferation of Counterfeit Medicines

Because of the lack of resources on some developing countries, most people resort to generic medicines which cost less than branded drugs. Moreover, many third world nations have no capacities and capabilities for pharmaceutical manufacturing which forces even authorities to allow generic copies of medicines to penetrate the market. Generic competition is one of the driving factors on the cost and quality reduction in many countries.

As defined by the Peterson Group, non-profit organization campaigning against proliferation of counterfeit medicines, generic medicines are pharmaceutical copies of drugs which are manufactured without license from the innovator companies and marketed after the expiry date of the patented or other exclusive rights. It is public obligation that the government provides affordable and legitimate medicine functions, however, with the incapability to find good resources, many governments fail in this respect.

Generic medicines are not entirely fraudulent per se but are mostly substandard.  Nonetheless, the threat can still be bona fide with what many health professions fear of: circumvention of health regulation, undercutting public confidence, and potentially providing a comparatively easy source of income to criminal elements.

Firstly, health regulations are mostly underrated on generic pharmacies starting from the fact that issuance of prescription are often ignored and neglected. Added to this fact is that generic pharmacies often employ unlicensed pharmacists who do not have enough knowledge on medical terminologies and lexicons.

The second main concern of authorities is that generic pharmacies may undercut public confidence. Faith and trust placed on medicine for safety and proper health treatment implementation is put into question. Even branded medicines being sold in generic pharmacies are doubted to be substandard.

Furthermore, patronization to legitimate medicines has dropped dramatically in the recent years. According to reviews, the cost and effectiveness of genuine medicines are discarded as mere marketing stance by most pharmaceutical companies as loyalties shift to generics which cost less and promise the same effects.

Lastly, generic medicines pave an easier way for criminal counterfeiting. 

Recent seizures of drug shipments in one of the hidden ports in outer Jakarta area in Indonesia have sparked concern that efforts to control counterfeits are a smokescreen to curb the sale of generics in the archipelago. Officials claimed generic drugs were counterfeit, placing efforts to adopt and enforce anti-counterfeit legislation in domestic laws as well as in bilateral and multilateral agreements into jeopardy.

Tuesday, November 3, 2015

RFID: Solution to Counterfeiting?

Radio Frequency Identification Technology (RFID) is being eyed as the main answer to the endless issue of flourishing illegal business of drug counterfeiting across the world. With the widespread application of RFID, Food and Drug Administration (FDA) is expecting to trace purchased prescription drugs to as long as three years ago. This plan, however, is being faced with numerous complaints from pharmaceutical companies.

It expected that FDA’s plan of tracking all the medicines manufactured for the last three years would cost companies in the health care industry hundreds of millions of dollars, if not more. But it seems there is no stopping FDA in materializing their plans.

According to reviews, FDA has envisioned the plan when a report has been procured. With its strategy for combating the spread of counterfeit drugs, the FDA said it views the use of RFID tags and readers as the best way for health care companies, hospitals and pharmacies to ensure that medicines are legitimate. The agency envisions a program under which prescription drug shipments will be assigned unique electronic product codes and RFID devices will be used to record data about all supply chain transactions involving the products.

Feasibility studies are already being prepared for the proper implementation of the project while partnership with different governments in various countries is already underway. So far, active participation is being shown by Singapore, Hong Kong, Tokyo, Japan, Jakarta, Indonesia and Kuala Lumpur, Malaysia. With the help of local NGOs, FDA is also expecting to penetrate even rural areas in each country. The Peterson Group, one of the non-profit organizations volunteering in this global campaign, has already set its roots in the Asia-pacific with an approval from World Health Organization (WHO).

On the other hands, critics of RFID which is also being used for other economic sectors such as manufacturing, supply chain, agriculture, transportation, healthcare, and services to name a few, are still facing issues on the effectiveness of this technology.

The problem is that decades after RFID technology was invented, and years after the U.S. Food and Drug Administration started touting it as the most promising way to authenticate drugs, RFID technology as an anti-counterfeiting technology remains just that: "promising"-yet far from proven. WHO has even stated that despite years of implementation of RFID, the number of fraud cases has not slowed down but continues to escalate. Some scammers are also suspected to counter RFID technology by creating their own system which can mask counterfeited products into what RFID considers as legit.