March 26, 2015 Industry news
The need of a pharma supply chain standardisation and compliance with local and Europe-wide regulatory systems will drive the most significant actions industry should take around product identification in the next three years.
- In the UK, the NHS eProcurement strategy mandates the use of GS1 standards and states that every supplier of every product and service into the NHS must comply with GS1 standards. It is a fact that in 2015 the UK healthcare system will move forward with a shared and consistent vision for product identification.
- In the EU, there is the Falsified Medicines Directive (FMD) for those supplying pharmaceuticals (API’s, finished product in all forms), which is planned to be published by December 2015. The directive introduces measures to prevent the entry of falsified medicines into the legal supply chain.
- In the US, the Food and Drug Administration (FDA) have introduced a phased programme to implement Unique Device Identification (UDI) regulations between September 2014 and September 2018.
Similar UDI regulations are likely to be issued in the EU in 2015 as part of a harmonised agreement with USA and other parts of the world.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) have a vision of GS1 standards being used on pharmaceutical products in Europe and beyond to enable the look up of product details, as well as any national numbers as required.
Some UK companies might only have to comply one or two of these new regulations, for others, they will need to comply with them all and – for those supplying to pharmaceutical products into the US there is an additional law with a 10 year roadmap for full implementation – the Drug Quality and Security Act (DQSA).
In the US, the eventual requirement is to provide a complete chain of custody record, or ‘pedigree’, for each and every product in the healthcare supply chain.
In Europe, we are currently adopting a point-of-entry/point-of-exit system which does not trace individual items through each stage of distribution through the supply chain – only at the point of packaging/production (entry) and the point of dispensing (exit). However, Europe is insisting that all the pieces are in place if it decides to move towards a US style Pedigree system at some point in the future.
Challenges and opportunities
A regulation like the FMD can only bring benefits to the industry – fake drugs could be costing the industry around £36.9bn a year, according to research by the World Health Organisation, as well as risking the lives of patients. Of course, challenges will come and that’s why industry needs to prepare and be ready.
The lack of time, knowledge and specialist skills can be the biggest barrier towards compliance. Many companies will face a very steep learning curve about the new regulations they will face and how they can become compliant to these new standards.
The biggest challenge is for CMOs and small manufacturers. Large multi-nationals are working on compliance to similar standards in other parts of the world, such as Turkey.
Some deadlines are very short:
- The FDA UDI regulations are already being implemented and the first deadlines have passed.
- The NHS eProcurement strategy is being put in place now and new supplier guidelines will be announced shortly for almost immediate implementation.
- FMD will become law by December 2015 and will have a three year implementation period in Europe.
Action is needed now. Industry needs to understand the changes, start making plans as soon as possible to meet deadlines, get GS1 standards in place and find the right people with experience and knowledge.
Companies must engage with the regulators and compliance bodies to understand what and how they need to comply through conferences, workshops, seminars and training.
At GS1 UK, we are ready to support industry with independent advice on adoption plans. This article was part of contribution first published on Manufacturing Chemist Pharma.
This article was part of contribution first published on Manufacturing Chemist Pharma.
Speak to our GS1 UK healthcare experts:
T 0207 092 3501 / 0808 178 8799
E healthcare@gs1uk.org
We also offer a range of free webinars and training courses.