Counterfeit Drugs 7: WHO, InterPol and IFPMA on SFFC

The spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines or simply counterfeit medicines is a big public health problem. Patients who take such fake and/or substandard drugs will not experience improvement from their illness unless their immune system is strong enough. At worse, their condition might even worsen as the disease can mutate and evolve into something more complicated, and can even result to death.

While the more commonly faked medicines are those patented or newly-introduced ones and hence, are priced high, even cheaper but popular generic drugs are also counterfeited. The Department of Health (DOH) and the Food and Drug Administration (FDA) are also raising public awareness of this problem, like this DOH poster.

At the World Health Organization (WHO) website, this basic information is posted.

http://www.who.int/mediacentre/factsheets/fs275/en/

Medicines: spurious/falsely-labelled/ falsified/counterfeit (SFFC) medicines

Fact sheet N°275
May 2012

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Key facts

• Spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines are medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source.
• Use of SFFC medicines can result in treatment failure or even death.
• Public confidence in health systems may be eroded following use and/or detection of SFFC medicines.
• Both branded and generic products are subject to counterfeiting.
• All kinds of medicines have been counterfeited, from medicines for the treatment of life-threatening conditions to inexpensive generic versions of painkillers and antihistamines.
• SFFC medicines may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient or too much active ingredient, or with fake packaging.

Recently, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), based in Geneva like the WHO, produced a short video clip about the danger of SFFC medicines, Watch Out for False Friends.

Some of the points mentioned by the WHO above were reiterated there. It also highlighted that some 124 countries are impacted/affected by these fakes, and 532 products have been counterfeited. The longer, 3:30 minutes version, is found here.

These fakes that are dangerous to public health are being exposed by certain civil society organizations including the federation or association of pharma companies themselves, both innovator and generic. And there is a big role for the government here, when civil society effort are not enough and a bigger, wider network of government agencies, local and national, armed (the police) and non-armed, are needed. After all, the main function of government is to promulgate the rule of law, including the law against stealing the intellectual property of certain companies like trademark, patent and copyright.

The former Executive Director of PHAP, Reiner Gloor, wrote a paper about this subject a few months ago. He discussed the role of the Interpol, in coordination with country governments, drug manufacturers and civil society organizations, in battling this global crime. For instance,

In 2012, an Interpol-supported initiative spanning 100 countries aimed at disrupting the organized crime networks behind the illicit online sale of medicines, resulted in some 80 arrests and the seizure of 3.75 million units of counterfeit medicines worth $10.5 million.

Below is the article.
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http://www.bworldonline.com/content.php?section=Weekender&title=Interpol-in-fight-vs-fake-medicines&id=67608

Interpol in fight vs fake medicines

Medicine Cabinet -- Reiner W. Gloor

Posted on March 21, 2013 07:22:41 PM

FAKE MEDICINES are found everywhere in the world. Emerging economies like the Philippines, as well as highly developed countries with strong regulatory systems, have fallen victims to pharmaceutical counterfeiting.

In the Philippines, close coordination between the government and the pharmaceutical industry has resulted in the monitoring and seizure of counterfeit medicines in Metro Manila and some provinces. A multi-stakeholders alliance advocating patient safety called the Safe Medicines Network has also been established to help the government in the campaign against fake medicines.

EMHN 8: Brand Protection and Safe Medicines

Our international health network has produced another good paper, Fake medicines in Asia The importance of brands to medicine quality. Authored by a good friend Philip Stevens, this six pages long paper is able to argue that corporate brand protection and brand competition coupled with rule of law, are the best way to protect the public from counterfeit and/or substandard medicines.

Fake or substandard drugs are dangerous and can be fatal. Either the patient does not get well, allowing the disease inside the body to mutate and become more serious, or the drug causes several adverse reactions and trigger more diseases and complications. 

As the "cheaper medicines" mantra is all over the country and the planet, somehow it gives an opening to dirty businessmen to offer really cheap but fake or substandard medicines. They do this by introducing unknown or lesser known brands to non-suspecting patients and drugstores. Or they simply copy the logo, brand and trademark of some known drug manufacturers, innovator or generic, and sell cheap.

The chief government regulating agency is the Food and Drugs Administration (FDA, http://www.fda.gov.ph/ in the Philippines, http://www.fda.gov/ in the US, and so on). The big problem is that this small bureau is mandated to check on the quality of (a) drugs, medicines and vaccines for humans, (b) drugs, vaccines for animals and fishes, (c) food/drink supplements and vitamins, (d) food and juice ingredients, sauces, etc., (e) perfumes, shampoo, soap, detergents, body odor spray, etc., (f) poisonous substances like insecticides and pesticides, and many others.

I think these products constitute at least 10 percent of the total output of the economy. FDA therefore, should have pharmacists, doctors, dentists, chemists, physicists, biologists, engineers, on top of having lawyers and administrators. Is it possible to have such an agency with supposedly super-technical powers and capability to minimize or control mistakes in doing its functions? I really doubt it.

One way to minimize risks and threats to public health, is to devolve product quality to the manufacturers and traders themselves, via brand protection and competition. Like "Jollibbee or McDonalds burger yan", "Starbucks or UCC or Figaro coffee yan", "Pfizer or GSK or Unilab or Pharex medicines yan", "Mercury or Watsons or The Generics yan", and so on. Consumers hold on to the brand as generally safe and these companies do all they can to avoid not even a single, not one, case of food or drinks or drug poisoning. 

Thus, products of these brands will be given minimal regulations and approval process. The main regulator for these brands and companies is the fear of being blacklisted or boycotted or sued by consumers due to bad or unhealthy products. Since these are huge if not global brands, the thought of being put in a bad light scares them more than the peering eyes of a few inspectors from the regulatory agency. Then the latter can focus their energy and resources on new products and brands. Shrewd and opportunist businessmen can put up a company and sell bad products and services that can harm public health. When the company is blacklisted, they simply close down the company and put up a "new" one and create new schemes to fool the public.

The sub-topics discussed by the paper are:

* Limits of regulation
* Brand competition and drug quality
* Intellectual property and brand integrity
* Brands are not just for multinationals
* Rule of law in defending brands
* Technological solutions to fake medicines
* Malysia's meditag scheme
* 2D and QR barcodes
* Dangers of government-mandated technology

And the paper's brief conclusions are:

The most fundamental cause of the spread of fake drugs in Asia has been the inability of manufacturers to protect the identity of their products. This is largely down to a lack of functioning rule of law, which makes it very difficult for manufacturers to protect their trademarks and brands via the civil and criminal courts – thereby handing a free rein to counterfeiters. The extra regulation called for by many commentators may well entrench the corrupt relationship between criminals and certain drug regulators. 

Strengthening the rule of law is a vital but long-term process. In the meantime, the private sector should take advantage of its innovative capacity to experiment with different technological solutions to brand infringement. It is well placed to lead this process, as it has unparalleled access to the entire pharmaceutical supply chain, as well as the clear financial incentive to protect its revenue. Governments should encourage this process, but refrain from mandating specific technologies or systems.

This new paper is another good reference for both government administrators and healthcare advocates in the country or abroad. Markets work. And though there are indeed market failures, there are also market solutions to such failures. Government simply have to focus on only one thing: rule of law. Private players and enterprises should do what they say they are supposed to do, and not offer counterfeits or substandard if not entirely useless products and services. If they don't, existing  governmentregulations and the penalty system should be slapped on them. No exception and no one can grant an exception. The law applies equally to unequal people.
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See also:
On IPR Abolition 12: Patent, Mini-Monopolies and Trademark, September 20, 2011
EMHN 4: Free Trade, TPP and Public Health Protection, January 13, 2013
EMHN 5: Free Trade and Markets in Healthcare, January 17. 2013 
EMHN 6: Fake Medicines in Asia, February 15, 2013
EMHN 7: Free Trade Improves Public Health, February 26, 2013