Many of you may remember the Poly Implant Prothèse (PIP) silicone implant scandal in 2010 where the producer used potentially carcinogenic industrial quality silcone, rather than medical quality for implants and up to 500,000 women who had received PIP implants might have been affected. Interestingly, given our core distribution business, patients initiated legal action against PIP, TÜV Rheinland as well as the distributor who supplied the silicone! The PIP case is considered one of the largest ever legal claims in the healthcare sector and the political fall-out from it triggered a demand for the rapid (by standards of the EU!) revision of the EU Medical Device Directive (MDD). After much interaction between politicians of the EU member states, this has meant the existing Directive (or compliance guidelines for medical device production which are in addition to national guidelines) will be replaced in May 2020 by the Medical Device Regulation (MDR) which now contains cross-EU, minimum, legal & binding regulations. Simply put, we have moved from a situation where some countries had higher standards than others in Europe due to their higher national requirements, to one where everyone must do the same, regardless of EU location. All in all, this is good for patient safety (i.e. us) as it requires players in the Healthcare market to have more controls on their medical device materials of construction (MOC). What you may not be aware of is that ALBIS are having a direct influence on the implementation process of this updated regulation.
But how and why, I hear you ask, can ALBIS be involved in this process – surely it is something done by politicians, civil servants and bureaucrats who are located in Brussels or Strasburg? Well, whilst it is true that we at ALBIS nor any single company, can change an EU-wide political decision, what we can do is engage with HOW that political decision is implemented. Politicians have some good ideas – the important thing is to make sure that they are implemented in a good way for those involved (consider Brexit to be an extreme example of implementation). To this end, ALBIS joined MedPharm Plast Europe (MPPE) which is a sector group of the EuPC (European Plastic Converters). It was created in 2014 by and for companies involved across the complete value chain for plastic medical devices and pharmaceutical packaging in Europe. MPPE represents the interests of these different industry groups and as such, interact directly with the European Institutions such as the Parliament and Commission to support the delivery of final regulations (such as the MDR) in a way that mean they are workable for the industry, whilst not compromising patient safety. In 2017 ALBIS took over the Presidency of MPPE and also participates in their Regulatory Working Group Task Force. The group works through open, clear, two-way dialogue between the membership and authorities on regulatory changes as well as keeping the membership informed on their potential impact on the medical device and pharma packaging value chain. Increasingly, the group is being used by the authorities in order to get their ‘expert’ opinion on current issues; evidence that MPPE opinion valued.
The benefits of this level of industry engagement for ALBIS are immense; primarily, we have an early view and therefore the potential to influence regulations that can ultimately affect our own businesses such as the ALCOM® MED branded Healthcare compounds. Equally, this therefore allows ALBIS to be an ‘early adopter’ of upcoming requirements and hence meet customer needs before they even know they need them! Critically we are working directly, as equals, with our distribution partners such as Covestro, Eastman and INEOS Styrolution who are also members of MPPE, to present a plastics-industry view on the ‘hot topics’ for plastics in Healthcare. In terms of customer engagement, whilst being able to talk on behalf of and raise concerns of our direct-buying customers, ALBIS has also been instrumental through our long time relationships with their key plastic decision makers, in Sanofi the global Healthcare giant, joining MPPE this year. Finally, and perhaps most importantly, it raises the visibility of ALBIS within the whole Healthcare industry as a partner who is both aware of, and who is engaged with, the critical issues of the industry; creditability has only been increased through direct meetings with the United States Pharmacopeia and Federal Drug Administration representatives earlier this year.
Regulatory challenges will continue to increase across all businesses where plastics are used; in Healthcare, ALBIS is excellently placed to ensure any changes that do come, don’t, as they say in English, ‘throw the baby out with the bath water’!
If you want to know more, please contact any member of the Healthcare Team.
Dr. James Stern
Global Business Development Manager - Healthcare