Counterfeit medicines are medicines which are deliberately and fraudulently mislabelled with respect to identity and/or source. (WHO)
The counterfeit medicines can be:
- drugs without active ingridients (eg. the “antibiotics” that are spread in the 3rd world countries)
- medicinal products that contain less active ingredients than it is indicated (again, it is common in those 3rd world countries where the counterfeiter presumes that at a possible verification procedure only the active ingredients is identified with the test-tube reaction, so the counterfeiter adds just a little amount into the medicine)
- medicinal products that contain other ingredients – either beside or as a replacement to the active ingredients (as an example, some years ago these have also appeared in our country administered by unwary biotherapists', these “herbal film tablets” that were supposed to be “natural extracted”, however it also contained synthetic steroids. In this case the counterfeiter presumes that the immediate and strong therapeutical effect will enthrall the patient therefore using the drug for an even longer period. The serious side-effects are only to come forward later);
- medicines with correct ingredients, but without authorisation, therefore cannot be spread through the legal channels (that was like the sexual drug copy from Thailand arrested by customs in Hungary as well.);
- medicines with correct ingredients, but the manufacturer (the marketing authorisation holder) is different from what is indicated on the package. (In this case the counterfeiter uses the reputation of the brand. Before we come to the conclusion that this is the least harmful from medical point of view, but take into account that the quality of the active ingredients is generally bad and the condition of manufacturing is not controlled!)
Hence, using counterfeit drugs is extremely dangerous, because neither their quality, nor their efficacy, nor the condition of the manufacturing are known and verified. Everyone risks his or her own health who obtains a medicine from an unidentified source, i.e. not authorized and not controlled place (e.g. from the market, from the internet).
Using adulterated medicine Could delay recovery or could be conletely ineffective. But there is also a chance that during the employment of fake antibiotics the adequate resistance will not evolve, thus other people's health is also at risk. In the most extreme case applying forged ‘medicine' can lead to death!
What does NIP do for protecting the patients?
The most effective and best known approach in fighting against counterfeit drugs is to ensure a closed circuit of distributional system. The quintessence of this is that every member of the distributiopnal system has to dispose of an administrative authorisation issued by medicinal supervisory authority of Hungary, also of all member states of the EU. This activity, validated by the administrative authorisation, is controlled continously by the authority.
It is significant to highlight that currently in Hungary we do not have information on any counterfeit drugs within this closed distributional chain. The domestic legal medicine-market is strictly controlled. The National Institute of Pharmacy controls the route of the medicine all the way till the pharmacy, meaning the quality of the drugs, their efficacy and safe usage, also the activity of the medicine wholesalers. The National Public Health and Medical Officer Service then checks on the retail-merchandising of the medicines (pharmacies, small retail shops with particular authorisations). Controlling this latter activity the NIP also participates in with validating the electronic informational systems that supports the drug retail outside the pharmacies.
In the event of purchasing or receiving a medicine at a provider withholding the referred authorisation the manufacturer, the wholesaler, the pharmacist and the practitioner undertakes financial, professional and moral responsibility, set by the legislative provisions. However, if the medicine is coming from an illegal source, the patient cannot count on legal redress, there is no chance for a complaint. In other words, when taking counterfeit drugs, the responsibility for product liability is absent – even in the case of possible inefficiency, side effects or damage of health.
The NIP inspects – regulated by legislative provisions – the (adaptable) responsibility of product liability among applicants soliciting manufacturer or wholesaler authorisation; since this pledge is not only for one-time legal redress, but often also for the protection of bigger groups of patients and/or populations. For instance, as a consequence of an unexpected side-effect or other long-term developing and human-health-risking problem, oft a new innovation is needed.
The tracking of the manufacturing of the ingredients has great importance among the wholesalers and/or manufacturers. Based on the Act of XCV. of 2005, § 20. “About human medicines and other modifications to regulatory acts of the medicinal market” the NIP is able to apply sanctions against improperly proceeding wholesalers. The ingredients with ambiguous origin can become components of counterfeit drugs.
The consequences defined in the act can be the following: to cease the non-legislative state, or prohibition of continuing this non-legislative state, such as product removal from the market, fine, release of verdict/decree about the suspension of pursuit, withdrawal of marketing authorisation. Namely the marketing authorisation is a continuously controlled procedure from our side (NIP), and the same applies to GDP, i.e. the controller of wholesaling.
While any pharmacy in Hungary can only obtain medicine or ingredients from an authorized wholesaler/retailer (executive distributor), then in abroad – because of the liberalization of medicinal retail – the problem of counterfeit drugs within the legal medicinal market has increased. To some extent the situation of internet-pharmacies is a little more favourable. These are never virtual in Hungary, unlike abroad. At us, only real providers can be deliverers, the ones possessing a proper marketing authorisation.
As NIP does not have a legal base for investigation the reconnaissance is in the competence of Hungarian Customs and Finance Guard (Police); they assist the authorities with identifications subsequent of retraced cases. In our laboratories we can not only make a distinction between medicines of proper and improper quality, but also we possess such modern technology for some high-fidelity instrumental analyses that can be “clinching”.
We recommend to the public that they should purchase their medicines in Hungary, from an authorized distributor , and if necessary, they should make their purchase at similar retailers in the states of the EU. Travelling outside EU passangers are recommended to buy their medicine before their journey and take them along.
In every case they should pay attention to the fact that all information regarding to the medicine should be from an authorized source, e.g. from a medical expert.
Never purchase any medicine through any distributional channels without authorisation, i.e. hawkers, street-markets, from the internet, via delivery.
From our website patients can continously be informed about the withdrawal of objectionable drugs such as the list of licensed manufacturers and wholesalers.
WHO has responded to the challenge by creating a global coalition of stakeholders called IMPACT (International Medical Products Anti-Counterfeiting Taskforce). The taskforce, created in 2006, has been active in forging international collaboration to seek global solutions to this global challenge and in raising awareness of the dangers of counterfeit medical products. (WHO/IMPACT)
The Heads of Medicines Agencies (HMA) has also established its own working group (Working Group of Enforcement Officers, WGEO, with a representative from each and every member state) aiming at co-coordinating the fight against the counterfeit of drugs. This working group has regular meetings and teleconferences. It examines the vulnerability of the European drug-supply system, and it determines the possibilities and priorities of cooperation. Employees of NIP take part in both groups.