The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute
Issue link: https://lifescienceleadermag.epubxp.com/i/338402
INSIGHTS LIFESCIENCELEADER.COM JULY 2014 REGULATORY COMPLIANCE 36 THE PROBLEMS WITH FALSIFIED MEDICINES Falsified medicines are fakes that get into the supply chain, often via the Internet. These could be tablets or injectables that have the wrong amount of the right drug, with a dose that is too low or too high. They could include poor quality ingredients or completely different and potentially harmful active ingredients. Alternatively, they could be drugs that have been diverted from a legitimate source and repackaged, but not necessar- ily stored under the right conditions or with the right use-by date. The EU uses the term "falsified medicines" to differen- tiate these from counterfeits — copies of marketed drugs that do contain the right active ingredient but that infringe compa- nies' patents or trademarks. Falsified and counterfeit medicines make up around 1 percent of the volume of the global market, according to the EU, and up to 60 percent in West Africa, putting already vulnerable populations of patients at risk. The WHO believes that falsified medicines could be the reason behind around 100,000 deaths per year in Africa. The trade in falsified medicines is a highly lucrative one, as the drugs are generally high value, such as anticancer medica- tions, or in high demand, such as antivi- rals or drugs for malaria or tuberculosis. The WHO estimates the global market to be worth around $77 billion, having doubled in size between 2005 and 2010. According to Craig Stobie, global account manager, Domino Printing Sciences, speaking at the SMi Group's 8th annu- al conference on Parallel Trade in 2014, $1,000 investment in falsified medicines can lead to a return in $450,000, much more profitable for criminals than coun- terfeit currency, tobacco, and software combined. This money provides a source of income for organized groups that are hampering peaceful development, Andris Piebalgs, European Commissioner for Development, said in a statement. THE EU FALSIFIED MEDICINES DIRECTIVE Using legislation, countries around the world are working to combat the influx of falsified medicines into the supply chain. The approaches include track-and-trace and mass serialization, which use unique codes tied to central databases and allow genuine packs of drugs to be traced back to the license holders, manufacturers, and distributors. The addition of tamperproof technologies on the packs confirms that the product hasn't been repackaged or tampered with in any other way. In com- bination, these make sure that users (doc- tors, pharmacists, and patients) can verify the packs are authentic and contain the correct drug at the correct dose. There are rulings coming in or already in place worldwide to stop the trade in falsified medicines: EU – Falsified Medicines Directive United States – Drug Quality + Security Act (HR3204) Brazil – ANVISA (Agência Nacional de Vigilância Sanitária) Saudi Arabia – SDC (Saudi Drug Code) China – CFDA (China Food and Drug Administration; previously SFDA) India – DGFT (Directorate General of Foreign Trade) Around 80 percent of the requirements are common globally and tend to focus on item-level serialization and aggregation as measures for securing the pharmaceutical supply chain. The EU Falsified Medicines Directive, adopted in July 2011 and put into place from January 2013, is the core of the EU's legal framework for the licensing, THE FALSIFIED MEDICINES DIRECTIVE – WHAT DOES IT REALLY MEAN? By S. Elvidge The trade in falsified medicines — medicines that look real but really aren't what they seem — is a huge and growing one, and it is putting patients' health and even their lives at risk. Along with regulatory authorities around the world, the European Union is putting directives into place that could begin to slow this deadly trade. S U Z A N N E E L V I D G E Contributing Editor The Falsified Medicines Directive – What Does It Really Mean? @suzannewriter 0 7 1 4 _ R e g u l a t o r y - 1 . i n d d 1 0714_Regulatory-1.indd 1 6 / 2 0 / 2 0 1 4 1 2 : 2 9 : 0 2 P M 6/20/2014 12:29:02 PM