Falsified Medicines

 

Introduction

Falsified medicines are fake medicines that are presented as real, authorised medicines.

Falsified medicines may:

  • contain ingredients of low quality or in the wrong doses;
  • be deliberately and fraudulently mislabelled with respect to their identity or source;
  • have fake packaging, the wrong ingredients, or low levels of the active ingredients.

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.

Definition

The new legal definition of a falsified medicinal product is –

Any medicinal product with a false representation of: 

  1. its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients;
  2. its source, including its manufacture, its country of manufacturing, its country of origin or its marketing authorisation holder; or
  3. its history, including the records and documents relating to the distribution channels used

Falsified medicines are not the same as counterfeit medicines:

  • Falsified medicines are fake medicines that are designed to mimic real medicines;
  • Counterfeit medicines are medicines that do not comply with intellectual-property rights or that infringe trademark law.

 

Increase in falsified 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.

EU legislation on falsified medicines

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:

  • obligatory features on the outer packaging of medicines to demonstrate that they are authentic;
  • strengthened requirements for the inspection of the manufacturers of pharmaceutical ingredients;
  • the obligation for manufacturers and distributors to report any suspicion of falsified medicines;
  • an obligatory logo that must be placed on the websites of legally operating online pharmacies, with a link to official national registers.

 

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.

Role of the Medicines Authority

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.

Buying over the Internet!

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:

  • Whether the physical address is concealed. If it is, then probably that site is an illegal site with a high risk of it supplying falsified medicines;
  • Purchase only from countries which regulate internet pharmacies;
  • Check whether the name and website of its regulator is listed on the internet pharmacies’ webpage;
  • Look at the regulator’s website regulating the internet pharmacy to check whether that internet pharmacy is approved or not;
  • Ask whether it supplies Prescription Only Medicines without a prescription. If it does, then it is less trustworthy;
  • Beware of excessively cheap prices. Though most people go over the internet for cheaper prices, there is always a limit of how much cheaper you can buy genuine medicines;
  • And always, if in doubt do not take chances with your health.

 

Buying medicines over the internet presents a high risk and patients should be cautious about buying medicines over the internet.  

Further Information 

For more information speak to your general practitioner or pharmacist or visit www.info.medicinesauthority.gov.mt  

References  

1. WHO and IMPACT factsheet. Counterfeit drugs kill! From http://www.gphf.org/