by: Arturo Bustamante
As we have mentioned in previous installments of our blog, one of the objectives of this initiative is to keep you informed about the dangers that buying or consuming "pirate" products can bring you and help you find solutions in case you are affected by these products.
"Be careful what you buy" originates from a genuine concern about the phenomenon that is piracy which, unfortunately, is not completely regarded as the danger that it really is. Unfortunately, society in general tends to welcome “counterfeiting” and there are even "influencers" who take the trouble to explain why (see: "MrX and the pirates" in this blog).
But then, if society perceives piracy as something to be “welcomed”…. This initiative originates from whose concern? It comes from the concern of a group of people who found themselves in a place from which piracy no longer looks so attractive and who know, first-hand, the risks that it can bring.
"Pirate" products can kill the people who consume them; and this is no more evident than in the case of medicines.
To delve into the subject, this time we talked with four specialists in the field: Dr. Alejandro Luna, Parter at Olivares & Cía (Law Firm) and current President of the Mexican Association for the Protection of Intellectual Property (AMPPI); Mr. PJ Whyte, manager of investigations units at REACT, an international anti-piracy organization based in the Netherlands; Mto. Fernando Portugal, Director of Intellectual Property of the Mexican Association of Pharmaceutical Research Industries (AMIIF) and; Mto. Juan Carlos Macouzet, Legal Director of Astellas Farma México, a pharmaceutical laboratory.
We contacted them so that they could tell us, from their particular experience (in that place where piracy is no longer seen as attractive), about the dangers involved in "pirate" medicines, how they reach consumers, what it’s been done to combat them and what is the pharmaceutical industry's perspective on the phenomenon. They were kind enough to give us some comments that were linked to the experience of our Initiative and we now present to you.
Let’s start with a phrase that Mr. Fernando Portugal (from AMIFF) made when we talked to him about counterfeited medicines: “the lesser risk you take when consuming a pirated medicine is that they won't cure you” and let's think about it for a second… Medicines are products that we normally buy to treat an ailment or a disease hoping to be cured. If we understand that the “pirated” product is not what it is supposed to be but “something else”, then the first logical question would be… So what is it? And most importantly, how does it affect our health?
If the counterfeited medicament is really sugar or distilled water, for example, it will not cause us any harm, but it will not help to eliminate our illness. We will continue to be sick or with the ailment that the medication was supposed to alleviate. If the product is the substance that the doctor prescribed, but it is in a lower dose, our recovery will be slower or may not occur; If the product is the substance that the doctor prescribed, but in a higher dose or is "not so inocent", the risk of harming our health increases exponentially.
High concentrations of certain medicines can cause liver or kidney damage or various types of poisoning and if what is being delivered to us is a toxic compound instead of sugar or distilled water… We could be talking about attempted murder.
And how do bogus drugs get into the hands of consumers?
There are two sources of counterfeit medicines: imports from countries like India, Russia, China and Turkey (which is the gateway to Europe from Asia) or local manufacture in clandestine laboratories that can be found in small facilities everywhere.
Let's remember that counterfeit medicines can be literally "anything" and it really doesn't take much investment to make them: a tablet-making machine, a blister packing machine and the powder of choice (be it lime, salt, sugar, rat poison, fentanyl, etc)
Mr. PJ Whyte, from REACT, told us that in the movement of counterfeit medicines internationally, importers and distributors function as or are part of organized crime gangs dedicated to the trafficking of arms, drugs and other illicit merchandise that, unfortunately, also include people (as merchandise). Mr Whyte also told us that the market for pirated medicines is not uniform and varies from region to region. In countries where the use of electronic media is more widespread, the trade in counterfeit products takes place almost entirely online by using cryptocurrencies and complex payment systems, while in countries where there is not as much development technology, this trade occurs through vendors who operate clandestinely and make themselves known by word of mouth.
In Mexico we find an "intermediate" system in which sellers of "pirated" medicines advertise by electronic means and social networks seeking that the buyer contacts them to arrange the sale, the method of payment and the delivery of the products. It is also possible, fortunately to a lesser extent, to find apocryphal products in street and informal markets where most of the time they are sold as "stolen" or "discarded because of the expiration date" (but seldom counterfeits)… After all, as also Indicated by Mr. Portugal, "Would you really buy a medicine from the same person who sells you a pirated movie?"
The truth is that most of us don't, but to everyone's ruin, there are those who do, and the worst thing is that they don't buy these types of products for their personal use, but for re-sale, and that is how many apocryphal products end up in pharmacies and even in public health institutes.
Why?
Because it's a great business.
Dr. Luna, president of AMPPI, told us that since counterfeiting is not perceived as a high-impact crime, the authorities tend to pay more attention to other types of crimes, making it unlikely for those who sell counterfeit medicines to be punished; He also told us that the profits obtained from selling "pirate" medicines can be practically match those obtained from drug trafficking and the risk is much lower precisely because currently, neither the National Guard nor the army have the mission of catching sellers of counterfeit medicines.
Additionally, it is important to remember that we are usually not familiar with the drugs that we are prescribed until we purchase them, and thus, it is unlikely that we will be able to recognize whether the product we are buying is an original.
The plot thickens, because as Mtro Macouzet, from Astellas Farma México, told us, the pharmaceutical industry is a transnational business that makes manufacturers comply with different labeling requirements for each country and even for each market.
Suffice to remember that the medicines that we receive from public hospitals have different packaging than those we find in pharmacies.
Mtro Macouzet further explained that in most cases, there will be different packaging for the same medicine depending on the market and it is difficult to have a certain uniformity that would allow consumers to distinguish the original products.
But all is not lost. As Dr. Luna also told us, despite the fact that the Attorney General unfortunately has not sought a search warrant or carried out any operations to secure pirated products in the last three years and, despite the areas of opportunity that the Mexican Property Institute could have when fighting counterfeiting cases, the war against piracy is not entirely a bleak scenario and there are authorities that seek the protection of consumers regarding the threat posed by fake medicines.
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS), for example, has issued a manual that the AMIIF also makes available to the public on specific points that we must attend to to detect possible counterfeit medicines. The manual is not perfect (since it doesn’t take into account the variation in the packaging that Mr. Macouzet mentioned and starts from the premise that the original product is known/available), but it contains some indications that can help us to recognize an apocryphal product such as:
Non-existent, poor quality or overlapping labeling;
Deterioration, erasures or amendments in the packaging.
The data printed on the inside packaging of the medicine (blister, bottle, container) does not match the data printed on the box in which the product is sold.
The batch number, expiration date and sanitary registration MUST NOT BE ON SELF-ADHESIVE LABELS
Additionally, COFEPRIS receives reports on suspicious activities on the subject and publishes alerts about apocryphal drugs that are being found in the market and the customs authorities are attentive to stop shipments of this type of product.
We trust that the authorities empowered to intervene in the fight against this type of illicits will resume cooperation paths to withdraw them from the market.
We thank our interviewees for their time, their comments, the information they shared with us and that we now allow ourselves to share with you because we are all consumers and we must all take care of ourselves.
Please find a list with links to some materials used for making this article. Those responsible for this blog have no relationship or participation in the articles that appear in the links which are only presented as reference material.
Manual for the identification of counterfeit medicines by COFEPRIS
How easy is it to make a tablet?
How easy it is to pack a capsule or tablet in a blister pack?
Vice documentary on fake drugs for sale in Mexico.
https://www.youtube.com/watch?v=JsRBWSCvsI4&t=67s
Sanitary alerts issued by COFEPRIS (those with product names usually refer to counterfeit products found)
https://www.gob.mx/cofepris/documentos/alertas-sanitarias-de-medicamentos
Article on the lack of action of the FGR in matters of Piracy
https://www.reforma.com/omite-fgr-ir-contra-falsificacion-de-marcas-en-mexico/gr/ar2599438?md5=8f27d7e07831ef5ff96fe31016c68e8e&ta=0dfdbac11765226904c16cb9ad1b2efe&utm_source=whatsapp &utm_medium=social&utm_campaign=subscriber_promotion
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