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- Life Sciences Ireland welcomed the recent adoption by the EU of the Directive on Falsified Medicines

Falsified medicines pose a major threat to public health and safety. As the counterfeiters become more sophisticated in their methods the risk of falsified medicines entering the supply chain and reaching patients in the EU is increasing every year.

The severity of the problem was recognised when the International Medical Products Anti Counterfeiting Taskforce (IMPACT) was created by the World Health Organisation in 2006. The European Commission works together with the European Medicines Agency and the Council of Europe on specific questions related to falsified medicines.

You may ask “what is a falsified medicine?” As the term suggests they are fake medicines that pass themselves off as real medicines. Contrary to public perception counterfeit medicines are different. They refer to medicines that do not comply with EU law on intellectual and industrial property rights, such as registered trademarks or patent rights. The EU Directive, which will be discussed later, does not deal with counterfeit medicines. As falsified medicines have not been subjected to the standard evaluation of quality, safety and efficacy as required by the EU authorisation procedure they can be a major health threat. The problem is increasing at an exponential rate. According to EU Customs the number of medicines seized at the outer border of the EU has tripled between 2006 and 2009, reaching approximately 7.5 million items.

Given the complexity associated with getting EU wide legislation approved the obvious question that arises is where do things currently stand? In December 2008 the European Commission adopted a legislative proposal to amend Directive 2001/83/EC on the Community code relating to medicinal products for human use. The aim of this initiative is to address, in particular, the risk of falsified medicines entering the legal supply chain of medicines in the EU. Following a public consultation and impact assessment report the proposal was adopted by the European Parliament on February 16, 2011, and on May 27, 2011, the Council of the European Union formally adopted the Directive on Falsified Medicines. The Directive will have provisions including the addition of safety features for prescription medicines to allow verification of authenticity and identification down to the individual pack level, as well as tamper-evident seals. The Directive also tightens controls over the upstream supply chain, with registration requirements for importers, manufacturers and distributors of active pharmaceutical ingredients. The next step is for the legislation to be transposed by each Member State into the national law. This must be done within 18 months, after which the law will come in to effect.

Peter Finnegan, Life Sciences Ireland Manager, welcomes the amended Directive as it will ensure that the end user of the medicine, i.e. patient, will be safer as a result. And went on to say;

"The impact of legislation, whether already enacted or coming down the line, is no more keenly felt in industry than in the life sciences sector. It takes a plethora of people in a whole host of different organisations to examine its implications and to implement the changes are required within respective companies to ensure that they are in full compliance once the measures come in to force. This is where the IEA Life Sciences Ireland programme the ‘Security of supply and Patient Safety ‘ will be most valuable."

Life Sciences Ireland (LSI), a division of the Irish Exporters Association, is in the process developing a new supply chain initiative entitled ‘Security of Supply and Patient Safety’ for life science companies together with a Welsh partner organisation, supported under the Ireland Wales Programme 2007-2013 (INTERREG 4A).

LSI has already developed a Good Distribution Practice (GDP) Code of Practice and GDP Passport and has been to the forefront in delivering training in the area. Since 2008 over 600 people have participated in the various GDP courses offered by LSI.

According to Peter Finnegan the new initiative will target pharmaceutical and medical device company personnel who work in the supply chain area or who require an understanding of the important role that supply chain integrity plays in the aforementioned sectors. Mr Finnegan added that this exciting initiative will come on stream at just the right time, helping companies to ensure that they are aware of their obligations under the new legislation but also advising them on best practice in a range of areas identified by an industry-led Technical Cluster. The initiative will involve the development of a knowledge portal that will host a suite of tailor made training modules and will also act as an industry communication platform. The training modules will be delivered in a blended learning format, i.e. via online and classroom learning. The training will be accredited and will target different categories of employees. The knowledge portal and subject matter content will be developed over the next six months and will be ready to roll out to prospective users by year-end.

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