Falsified medicines are fake medicines that are presented as real, authorised medicines.
Falsified medicines may:
Falsified medicines do not pass through the usual evaluation of quality, safety and efficacy, which is required for the European Union (EU) authorisation procedures and because of this they can be a threat to health.
The new legal definition of a falsified medicinal product is –
Any medicinal product with a false representation of:
Falsified medicines are not the same as counterfeit medicines:
The phenomenon of falsified medicines is on the increase, with more and more medicines now being falsified. These include expensive and life saving medicines, such as anti-cancer medicines, and medicines in high demand, such as antivirals.
The EU has a strong legal framework for the licensing, manufacturing and distribution of medicines. Indeed, all the legal supply chain is regulated throughout, by means of EU and national legislation. In Malta, at the end of the distribution chain, only licensed pharmacies are allowed to offer medicines for sale. In some EU countries this would also include the legitimate sale via the licensed internet pharmacies.
In July 2011, the EU strengthened the protection of patients and consumers by adopting a new Directive (Directive 2011/62/EU) on falsified medicines for human use.
This Directive aims to prevent falsified medicines entering the legal supply chain and reaching patients. It introduces harmonised safety and strengthened control measures across the EU by applying new measures, including:
The Directive came into force on 21 July 2011. Member States will have to start applying these measures as from January 2013.
The European Commission has published a new draft guideline on Good Distribution Practice for medicines, which brings it into line with the recently-adopted Directive on Falsified Medicines. Whilst bringing in some new actors in the regulatory field of medicinal products’ supply chain such as brokers, the new draft, lays out comprehensive requirements for medicine wholesalers, focusing on: quality management; personnel; premises and equipment; documentation; operations; handling of complaints, returns, recalls and suspected counterfeits; contract operations; self-inspections; and transportation.
The Medicines Authority is working closely with the European Commission, European Medicines Agency (EMA) and the other Competent Authorities in other EU Member States to implement this Directive.
The protection of patients from the dangers of falsified and counterfeit medicines is a global effort. The Medicines Authority is also co-operating with international anti-counterfeiting trade agreements and other criminal-law instruments, such as the Council of Europe's Medicrime convention amongst others.
The majority of consumers are becoming far more trusting of buying goods over the internet than they were a few years ago. Through a survey conducted by the Medicines Authority amongst the Maltese population more than 1 in 7 (15%) of correspondents have admitted to purchasing medicines over the internet, sometimes even prescription only medicine without a prescription. It should be noted that over 50% of all medicines sold on websites which conceal their address are fake1.
Do you know what you are buying online? Always check for the following before purchasing your medicines online:
Buying medicines over the internet presents a high risk and patients should be cautious about buying medicines over the internet.
For more information speak to your general practitioner or pharmacist or visit www.info.medicinesauthority.gov.mt
1. WHO and IMPACT factsheet. Counterfeit drugs kill! From http://www.gphf.org/