FAKE DRUGS ON THE WEB
Stemming the proliferation of fake drugs on the web
Without the internet, would global traffic of fake drugs have known such an expansion over the past 10 years? Obviously not.
With the web, traffickers have found the opportunity to sell their forged goods on a large scale, directly to patients, circumventing all secure distribution channels. One of the main difficulties encountered in the fight against the distribution of counterfeit drugs through the Internet lies in the fact that some countries have already legalized trade in online drugs, sometimes including mandatory prescription drugs. At stake for the international community: reconcile the ease of access offered by the internet with the need to control the quality and the origin of medicines.
1 The current situation
Since the end of the 1990s, the democratization of access to the internet has boosted sales of goods by correspondence, particularly in developed countries.
Although it is highly regulated in most countries of the world, the marketing of medicines has not escaped this global phenomenon. Today, the web offers a particularly extensive choice of websites which distribute products from almost all families of medicines, and almost always illegally.
In fact, according to legal authorities, there are three types of online pharmacies:
1.Some countries allow online pharmacies to deliver medicines to patients after reception of an electronic prescription issued by a doctor.
2.Online pharmacies circumvent this law by employing doctors who prescribe medicines on the basis of the information provided by the patient through an online questionnaire. Once the medication is prescribed, it is then sent to patients.
3.The most illegal pharmacies deliver all kinds of drugs everywhere in the world, including those requiring a prescription, without undertaking any form of control, as long as the patient is able to pay.
A major risk
If the lack of control or of personalised medical and pharmaceutical advice can already be questioned in the case of the online sale of authentic medicines, the main risk facing the patient engaged in a purchase on the internet is to acquire and consume a counterfeit, diverted drug or one that has not been validated by an authorization to be put on the market.
It is now established that this risk is ubiquitous on the web since it is estimated that at least half of the drugs available on the internet are fake or non-compliant.
This risk is even greater today as populations of all countries, including the most developed, seem to underestimate the danger.
Everywhere, the development of the concept of self-medication encourages patients to regularly visit on-line sites for information on their health or to order medicines.
-Every day in Europe, more than 2 million patients consult a drug-selling web site for advice or to purchase. (European Association of Mail Service Pharmacies).
The motivations of the users.
The motivations of patients purchasing drugs on the internet are very diverse:
-The price may be lower than in pharmacies.
-Preservation of their anonymity when purchasing medicines treating affections that are difficult to accept or regarded as “shameful” (erectile dysfunction, depression…)
-The intention to abuse the intended use of a drug (doping, addiction…)
-The wish to bypass the obligation of medical prescription;
-The possibility of purchasing drugs that have not obtained the authorization to be put on the market (AMM) in their own countries;
-Avoidance of having to go to a pharmacy
-The development of a web “culture”
A traffic facilitated by the operating mode of the Internet.
For their part, traffickers have found in internet an ideal channel for their fake medicines:
-The web knows no borders and allows to quickly reach millions of potential customers.
-The investment required to create a professional quality website is relatively modest.
-There are many opportunities to deceive the consumer: easily-reproduced photographs of products, names and photographs of false pharmacists on the home page, wrong telephone numbers and ghost addresses, false testimonies of satisfied customers…
-The anonymity offered by some providers promotes the proliferation of illegal sites while tax havens allow for significant revenue laundering.
-The fragmentation of the mailings weaken the Customs authorities’ capacity to operate controls and seizures.
Marketing of fake drugs on the internet is often subject to sanctions because it contravenes various regulations dealing with:
-misleading information and advertising,
-the offence of deceit and falsification,
-the illegal practice of the profession of pharmacist,
-the import of products without authorization to be put on the market,
-the violation of pharmaceutical regulations relating to drug dispensing,
-counterfeiting of products protected by intellectual property rights
-endangering the lives of others or even, in the most serious cases, the crime of homicide.
Finally, it is important to distinguish between:
1.The qualified pharmacist, who is authorized to exercise and respectful of the law of his country. His intention is to benefit from the opportunity of the internet to extend the physical activity of his pharmacy, to offer more convenient access and an additional service to patients.
2.The trafficker who knows nothing about pharmacy, and sees the opening of the online drugs market purely as a means to earn lots of money at little risk. He takes advantage of the gullibility of the Internet users to sell fake drugs.
It is nonetheless difficult to ensure that the laws are applied, because the organization of these networks is often segmented at the global level: the sales offer may well be physically located on one State’s territory while the hoster or the website owner is located in another state.
2. The legislation.
In all countries, online drugs marketing is regulated (and sometimes simply prohibited).
Some countries in Europe, the United States, and Asia have already legalized the creation of cyber-pharmacies.
However, the legislative situations are very different from one country to another and are changing rapidly.
Therefore, we propose here to draw up a panorama of the situation in those countries where e-commerce in general is the most developed.
The online sale of medicines is permitted, but strongly regulated.
However, each State is susceptible to establish its own laws in this matter.
For this reason, the NABP (National Association of Boards of Pharmacy) offers a fee-paying online service (“NBPALaw”) allowing to verify the laws in force in each of the States of the country. This database is updated each year.
The association has also implemented a certification label, “VIPPS”, providing a strong indication of the extent to which the cyber pharmacy complies with the regulations in force.
To date the NABP has reviewed more than 8000 sites and only 4% of them appear to be in compliance with the legislation and the good practices governing the online sale of prescription drugs.
A number of pharmacies in Canada have legitimate Web sites that offer a limited range of products and services, particularly information to consumers.
Pharmaceutical practice in Canada is regulated by the provinces, and any authorized pharmacy that offers services on the Internet must comply with the standards of practice in its province. (Source: Federal Ministry of Health, Canada). In parallel to these legitimate sites, it should be noted that there are a large number of illegal pharmacies flying the Canadian flag.
The sale of drugs on the Internet in Switzerland is a special case of selling by correspondence. Although mail order drugs sales are in principle prohibited in Switzerland, the cantonal authorities may issue derogations to certain suppliers under certain conditions (legal basis: art. 27 of the Federal Act on medical drugs and devices (LPTh;RS 812.21)). So, to be delivered, any mail order of a drug must be justified by a medical prescription. A principle which also applies to drugs which are not normally subject to prescription.
The legislation gives the possibility to legally buy drugs abroad (legal basis: art. 20 al. 2 let. a of the law on therapeutic products (LPTh;RS 812.21) and art. 36 al. 1 of the order on the authorizations in the field of drugs (OAMed; RS 812.212.1)). An individual may thus import, for his own use – and not for third parties – drugs corresponding to one month’s treatment. As far as medicines containing narcotic drugs are concerned such as sleeping pills, tranquilizers or powerful painkillers, these orders must be accompanied by a prescription delivered by a Swiss physician.
(Source: Swissmedic guide 2008) www.pharmasuisse.org/data/Oeffentlich/fr/Medienservice/081015_MM_StopPiracy_Leitfaden_f.pdf
2011/62/EC “Fake drugs” and the internet
It was partly to remedy this situation of fragility that the European Council adopted a new directive (in Amendment of directive 2001/83/EC). (See Government actions section)
The directive poses a number of minimum conditions which online pharmacies must abide to in order to obtain the authorization to sell online:
– authorization or prior certification,
– provision of detailed information on the website and its operators,
– compliance with the national legislation of the country of destination.
Furthermore, the legal websites commercialising prescription drugs online must all display a common logo and a link that will redirect the user to the website of the competent authority in each Member State, the latter also being obliged to display a list of persons authorized to sell drugs on the Internet.
3. The risks inherent to the commercialization of drugs online.
The marketing of drugs online exposes the patient to various risks.
-The risks of “fraud”, including infringement,
-The risks associated with the lack of traceability.
-Risks related to the circumvention of public health policies.
-Risks related to a defect in the packaging of the drug and its conditions of carriage
-The potential lack of privacy and usurpation of identity,
-The inability to check interactions between medicines,
4 Ways to combat the trade of fake drugs online.
Internet and online marketing practices are very recent and therefore their legal and regulatory frameworks are still relatively weak.
Specialists have identified some avenues to be explored to combat the online trade of fake drugs.
The main axes are as follows:
1.The education of the general public.
Significant potential for improvement lies in increasing the Internet users’ awareness of the risks associated with the purchase of drugs on the internet in general and the risks of buying false medicines in particular.
Indeed, as the patient is the first concerned by the risk inherent to the consumption of fake medicines, he is the most likely to exercise the necessary vigilance.
Thus, the wide dissemination of good practice guides informing users about seeking health related information on the internet and advice on the online purchase of drugs (even in countries where this type of marketing is not allowed) should be encouraged.
•Several campaigns have been led, notably by the French Agency for the Sanitary Security of Health products (“Agence Française de Sécurité Sanitaire des produits de santé” –(Afssaps)), the “Bundesinstitut für Arzneimittel und Medizinprodukte” (BfArM) in Germany, Swissmedic in Switzerland, the MHRA in the United Kingdom and even the European Commission, to increase public awareness of the risks associated with the purchase of fake drugs on the internet. Even in countries where online pharmacies are permitted, as is the case for Canada and the United States, warnings are published by the drug control agencies.
2.The multiplication of targeted and coordinated repressive actions.
Among the large international police operations, PANGEA particularly targets networks engaged in the online sale of fake medicines. Federating more and more actors over time and ever better coordinated, these operations draw from past experiences and are gaining in efficiency. The last operation, Pangea IV, mobilized 81 countries. By participating in these operations, each national law enforcement body also increases its own expertise, progressively becoming better armed to respond to the challenge launched by pharmaceutical cybercrime.
•“Thanks to the success of the operation Pangea IV, Interpol’s member countries and partners have proved that the Internet is not a place that safely guarantees anonymity for the traffickers of illicit drugs”. Ronald K. Noble, Secretary General of Interpol.
•“We will use all the national legislative arsenals; we will prosecute for fraud, infringement, endangering the life of others, and deceitful advertising. But this is not enough. We need more targeted repressive legislation”. Aline Plançon, head of the Interpol’s “counterfeit medical products department” after the Pangea IV operation.
3.The standardization of e-pharmacies.
The constraints governing the creation of online pharmacies are currently much less restrictive than those regulating the opening of a physical pharmacy. It is for this reason that the International Pharmaceutical Federation (FIP) requests that the standards applied to online pharmacies be identical to those required for all pharmacies: registration and inspection by a competent national authority; use of quality labels; source of supply of drugs….
4.The responsible implication of the web providers.
An important action still remains to be lead in order to engage the responsibility of Internet professionals – the providers responsible for registering the names of domains, the hosters, the search engines and advertisers – in the fight against counterfeit drugs.
Refusal of the anonymous registration of domain names: Technical providers should be obliged to require the licensee to provide official proofs of identity before registering a domain name.
Provision of access to reliable information about the Web sites through hosters: In the same way as for other professional databases (eg. the registry of commerce) the bodies that host internet sites could be forced to keep a register of their clients and allow universal and transparent access.
The involvement of search engines has led to closer collaboration with enforcement bodies during the last major dismantling operations of illegal sites engaged in the sale of fake medicines (Pangea IV).
Involvement of financial intermediaries (bank cards providers and money transfer operators)
5.The establishment of a list of legal sites.
In countries where cyber drug marketing is authorized, a solution would be for example to host the list of the secure, legal sites on the website of the country’s health departments.
As an example, such a measure was taken by the Food and Drug Administration in the United States.
A complementary security dispositive would be to oblige online pharmacies to display a link redirecting to the webpage hosting this list.
6.The creation of labels for securing online pharmacies.
The new European directive on falsified medicines recommends the creation of common labels for the benefit of Internet pharmacies. This recommendation is inspired by certain labels that have emerged, particularly in the United States, of which the most famous is the VIPPS ® standing for “verified internet pharmacy practices sites” delivered by the National Association of Boards of Pharmacy (NABP).
Unfortunately, these labels could themselves be forged by the illegal sites.
Therefore, in order to stem this counterproductive consequence, the directive provides that these labels must incorporate broader security strategies.
7.The improvement of the legal online offer of drugs.
Despite the risks involved, the online trade in drugs appears to satisfy an important and inevitable consumer/patient expectation. Some players even believe that the deficit of legal offers on the internet (less than 5% of e-pharmacies) leaves the field open to traffickers and promotes the proliferation of fake drugs on the web. It therefore seems that a measure to consider would be to encourage licensed pharmacists to invest in e-commerce by creating pharmacies on the Web that would be made accessible to the public through a national Web portal. Such is the opinion of the European Council, for example, who in 2007 adopted the resolution on: “good practices for the distribution of medicines sold by correspondence to protect the security of patients and the quality of the medicines issued.”
Its text stated: “the criticism concerning the sale of drugs by mail mainly relates to the dangers arising from the illegal sale on the internet of drugs that may be counterfeit, but the legal sale of drugs by mail is often forgotten”.
And recognising that the consumer demand was unavoidable, the resolution considered that “the only way to protect the public against illegal offers is to help it to make the distinction between these offers and the properly identifiable legal offers and to ensure that the web sites of pharmacies give comprehensible, reliable and precise information”.
•Between 1999 and 2008, the number of infringing articles (of all kinds) seized at the borders of the European Union was multiplied by 7: 25 million in 1999 / 178 million in 2008. In Europe, seizures of drugs more than doubled between 2007 and 2008 to reach 9 million items. (UNIFAB)
•In France, the purchase of drugs on the Internet and their delivery by mail or express freight are subject to very strict regulation. In all cases the drugs must be reported to customs. Moreover a private individual can only import drugs if they are for his personal use. In addition, the Internet buyer must present to the customs service the authorisation obtained from the French Agency of Sanitary Safety of Health Products (AFSSAPS).
•According to a study by the OECD, “Pharmaceutical Pricing Policies in a Global Market: policies and issues”, “France and Spain paid below OECD-average retail prices in 2005, while the U.S., Canada and Germany paid 30 % more than the OECD average. The highest retail pharmaceutical prices were found in Iceland and Switzerland, exceeding the OECD average by more than 50%”