Falsified medicines are a major threat to public health and safety and the number are, according to the European Commission, increasing each year.
Falsified ('fake') medicines and drugs are a major problem for patients, their families and health care providers. The main risk with falsified medicines is with medicines which are targeted at those who are seriously ill. Such medicine may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose.
The main source is from internet sales, marketed by illegitimate or unethical companies. The big problem is that - globally - legislation has been relatively weak.
Within Europe, a strategy to combat falsified medicines has recently been put together. The European Medicines Agency (EMA) has worked with the European Commission to put together a new directive published in the Official Journal of the European Union addressing the rise in falsified medicines in the European and global supply chain. The directive, which was supported by the European Parliament, is being implemented during 2012 and all member states must have applied the measures by the beginning of January 2013.
The Directive breaks some new ground. The ruling has a clear definition of "falsified medicinal products" which distinguishes those products from other types of illegal drugs or from those that infringe intellectual property rights. From this a falsified medicinal product is defined as any medicinal product with a false representation of:
• its history, including the records, and documents relating to the distribution channels used
• its source, including its manufacturer, its country of manufacturing, its country of origin, or its marketing authorization holder
• its identity, including its packaging and labelling, its name, or its composition as regards to any of the ingredients including excipients and the strength of those ingredients
The Directive also examines the way in which medicines are distributed. Here the legislation focuses on brokers, who are not considered wholesale distributors and so previously were unaccountable. To ensure transparency it is recommended that a database of wholesale distributors, which must have passed member state-inspection, is established at the European Union (EU) level.
Although the Directive is a step forward, there are aspects of the final document which leave the interpretation ambiguous and some elements open to debate. Over time, further refinement as to the scope of the legislation will be required. Certainly the Directive deals with prescription medicines only in the first instance.
Similar legislation is in place in the USA and regulated by the Food and Drug Adminstration (FDA).