Five years on from the adoption of the EU falsified medicines directive (2011/62/EU) and the challenge continues. Here Vincenzo Salvatore, Healthcare and Life Sciences Focus Team, BonelliErede (Milan), looks at the reasoning behind the directive and what the next steps are to achieve the ultimate goal of protecting public health.
Long way to go
The illegal marketing of falsified medicines is constantly increasing and is a serious threat to patients’ health. Falsified medicines should be distinguished from other illegal medicinal products and from products that infringe IP rights: A falsified medicine is commonly defined as a fake medicine that passes itself off as a real, authorised medicine.
Over the last few years, national governments and international organisations have implemented several initiatives to address this phenomenon and mitigate the risk of exposing patients to falsified medicines, i.e., to medicinal products that (according to the definition approved by the World Health Assembly of the World Health Organisation, WHO) deliberately/fraudulently misrepresent their identity, composition or source. Falsified products usually contain sub-standard, falsified ingredients, no ingredients, or ingredients (including active substances) in the wrong dosage. A few years ago, the WHO also set up the International Medical Products Anti-counterfeiting Taskforce (IMPACT), which is tasked with developing principles to serve as a model for national legislation to combat falsified medicinal products.
The fight against falsified medicines is particularly challenging, as experience shows that they can reach patients through both illegal routes and the legal supply chain. This latter circumstance requires that national and international legislative measures be adopted to monitor not only the manufacturing process and identify the various means of product tampering but also to reinforce the obligations on all economic operators (manufacturers, wholesalers, distributors, etc.) in the supply chain. An obligation imposing them to cooperate in detecting and reporting all possible infringements to the competent national authority is essential to reach the goal. For legislative measures to be effective, they need to be accompanied, as is the case in Europe, by strong deterrents. These include significant financial penalties on stakeholders that fail to fulfil their legal obligations and greater cooperation from customs officers to check imported medicinal products.
The EU falsified medicines directive (Directive 2011/62/EU, adopted on 8 June 2011) is one of the most important tools adopted at European level: It sets out the rules to tackle the alarming increase in falsified medicinal products in the EU. The directive was recently implemented at EU level through the adoption of Delegated Regulation (EU) 2016/61, which will apply in less than a year: on 9 February 2019. The recently adopted delegated Regulation sets out what safety information must be included on the packaging of prescription only medicinal products.
Establishing and strengthening a robust regulatory framework at national and, to the best possible extent, international level is the most effective way to ensure a safe market. There is still a long way to go — especially if you consider that only 20% of WHO member states have effective, well-developed regulatory systems, compared to the approximately 30% that have no or very limited regulation. Implementing effective technologies, raising awareness and a good enforcement system all have to be identified as essential elements — to be used in combination — to achieve the goal (i.e., to better protect public health).