27.04.2018 | Brussels Background The Falsified Medicines Directive – a bridging gap between public health and the industry?

Falsified Medicines constitute a risk for Public Health and for the legal supply chain of businesses. The origin of falsifications are often hard to discover and trace due to the increasingly complicated supply chain of pharmaceutical companies and healthcare delivery. The European Parliament and the Council passed the Falsified Medicines Directive in 2011 in order to tackle these problems and to ensure safe access to medicines in the European Union (EU).

A medicine is falsified if it is labelled authentic but contains wrong or non-active ingredients or if it contains the right ingredients but in a wrong dosage. These products lack quality standards and do not conform to the required standards of medicinal products. Nevertheless they find their way into the legal supply chain and thus into the countries of the European Union. It is difficult to get clear statistics on the amount of falsified medicines within the EU. However, the Commission has identified severe increases of falsified pharmaceutical products over the past years. The European Union Intellectual Property Office published in their report from 2016 that sales are negatively affected by falsified medicines by 4.4% which account for 10.2 billion Euros annually. This amount is directly linked to an overall job loss of 37,700 jobs across the EU with further negative impact on other economies. Prominent falsification cases in the EU that were reported in recent years were amongst others falsifications of Avastin – one of the best selling drugs in 2017 -  in 2012, Aspirin in 2013, or Herceptin in 2014.

This potential harm for Public Health and the negative impact on the European economy cried for action against this form of organised crime. And in fact, the European Union took action. In June 2011 the European Parliament and the Council of the EU adopted Directive 2011/62/EU, the so called Falsified Medicines Directive, which needs to be enforced by the Member States until 9th February 2019. The goals of the Directive are increased security of access to save medicines for patients and better security of the legal supply chain. The Directive contains the introduction of a new end-to-end verification process for prescribed medicinal products along the supply chain. –Basically, a monitoring tool that checks a medicinal product from the production site to the patient by scanning a unique code for every charge of pharmaceutical products. The Delegated Regulation 2016/161 lays out the technical details for these ideas. But until today, there are still a lot of open questions for the stakeholders involved, forcing the European Commission to frequently publish Q&A documents, of which nine already exist.

Most of the EU Member States have a contract with one of two possible technical operators. Besides Germany, there is no country connected to the EU-Hub yet, which is the EU database connecting all the national systems and allowing data exchange between the Member States. But some other countries might follow soon, as e.g. Ireland, Bulgaria, France, or Sweden. But even if some countries are quite behind the schedule, it is expected that 75% of the EU Member States will be ready and connected on time. Countries where the on-boarding process has until recently not started are mostly Eastern European countries, such as Poland, Hungary, Croatia, and many more.

In Germany, the concerned stakeholders formed the initiative securPharm and by now Germany is the only country where a system is already in place and where the stakeholders involved can already familiarise themselves with the use of the software and tools. Even though Germany is doing a good job, errors are still being reported as i.e. through non-uploading of codes, double-scanning, or an invalid activation process to the EU-Hub. The familiarization process is essential as these complex processes require appropriate training in order to minimize possible errors until things get serious in February 2019.

But there are still open questions, some also concerning the further procedure of the UK. Do they have to implement the Directive on the exact date of 9th February 2019 and do they have to step out and disconnect from all databases as soon as they leave the EU? And who is the owner of the data which is created during the application of the software and tools, and what will happen with it?

For the pharmaceutical industry the implementation of the Directive has until today been related to high investments and high degrees of effort. But one may also wonder, whether it is the right approach by Germany to leave the implementation of the Directive solely to the industry, without any governmental involvement. Of course, one may argue that since the implementation is going on so well, there is no need for intervention and it appears that the industry is able to take care of the legal supply chain themselves. But is it enough to only focus on the legal supply chain? And is it sufficient to introduce an EU- wide logo for online pharmacies? As it is still the case that about 50% of falsified medicines are accessed via the internet this would be important to clarify. Hypothesis exists, that also online logos may be falsified and that it is hard for patients and consumers to distinguish between legal and illegal websites.  These are all measures trying to increase safety of the legal supply chain, but what about the illegal one and all the widespread areas of the internet and the dark web?