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Pharmaceutical Manufacturing and Packing Sourcer

Medicine for Pharma

The pipeline of new active ingredients is close to empty and legislation is making it even more difficult to bring new pharmaceuticals to the market.The reimbursement of registered medicines is also under pressure and generic manufacturers are entering the market with medicines for which the original patents have expired at far lower prices. As a result, ΦΠΙ (pronounced as phi-piiota) has several issues to address.

A unique European multi-company project, ΦΠΙ is characterised by accessible packaging design and therapy-compliance, integrating packages with information technologies, and learning from packaging innovators in other, non-medical areas.Within the ΦΠΙ project, three elements have been combined: the world’s changing demography; a concern for the rights of people with disabilities worldwide; and the concept of ‘point-of-use’ as a starting point for the supply chain of packaged products such as pharmaceuticals and medical devices.

Inspiration for the ΦΠΙ Project

The world is experiencing tremendous population growth and two major Medicine for Pharma The pharmaceutical industry may be experiencing a pipeline crisis, but a remedy is at hand in the form of the ΦΠΙ project for pharmaceutical packaging innovation, which is bringing new perspectives to the industry effects can be discerned within the latest figures. Firstly, as people are living longer, many countries will need to adjust to life with an ageing population.




Topping the list is Japan; in 2009 nearly 30 per cent of the Japanese population were more than 60 years old.The next 25 countries on the list are all in Europe.The US (number 42) and China (number 46) show figures of around 18 per cent in this age group and the figure for India (number 105) is about seven per cent. In a recent study by the Global Forum for Longevity, healthcare and pharmaceuticals were identified as key industries likely to benefit from the longevity trend.

Secondly, people want to keep on living independently when they grow older or if they develop disabilities.This trend has been reflected in the United Nations Convention on the Rights of Persons with Disabilities, which entered into force on 3 May 2008.The Convention marks a paradigm shift in approach to people with disabilities. It takes to a new height the shift from viewing persons with disabilities as victims needing protection, towards a position that views people with disabilities as subjects with rights, who are capable of claiming those rights and making decisions based on their free and informed consent.The Convention adopts a broad categorisation of persons with disabilities, and reaffirms that all persons with all types of disabilities must have access to human rights and fundamental freedoms.

When applying these insights to the packaging of pharmaceuticals and medical devices, it is important that packaging is temporarily integrating an external function and a product to enable the use of that product. Basically, this means that packaging must make the product accessible to the consumer – in this case the patient. This is not easy however, as the requirements placed on the package change during the journey from the factory to the patient’s bedside. Firstly, the medicine must be protected; only at the point-of-consumption (POC) should the patient be able to take it. POC is used for consumables and point-of-use (POU) for nonconsumable products like medical devices. The same holds time for the information that is supplied with the product. Some parts are needed for the transport and others for the legislator, and only part of the information is addressing the patient. All data must be accessible and understandable to the user. The user can be involved professionally (in the manufacturing, logistics or medical field) or as the user-patient. Innovation is needed to think ‘outside of the box’ and solve difficult problems.

Applying the UN Convention when designing any individual packaging means that certain steps need to be taken.The same goes for the application of the POC concept. However, bridging this gap can create a wealth of opportunities for both the patients and the industry that is involved in the distribution, manufacturing and supply of packages and accessories of pharmaceutical products and medical devices.This is what the ΦΠΙ project is aiming to do. Worldwide standards are in development and NVC Netherlands Packaging Centre is actively participating in this field, along with The Japan Packaging Institute (JPI) led by Ken Sagawa and Nahoko Ishisaki (the Chairman and Secretary of the ISO working group that develops the standards respectively).The first milestone was met early on with the publication of the international ISO-standard packaging – Accessible Design General Requirements. Although the requirements started by focusing on disabled persons in a physical way, ‘intercultural’ disabilities were also addressed. In particular, this relates to the use of texts and images for branding and in user manuals or patient information leaflets.

The POC concept has also been addressed. Careful analysis of hundreds of packaging innovations in the Netherlands over the past 50 years clearly shows the shift in emphasis from manufacturing and product protection (1960 to 1980), through distribution and logistics (1980 to 2000) towards user-applicability (2000 onwards).Of course, new functionality must come in addition to, and not to the detriment of, the previous measurement. So, logistics and product protection remain as important as they were, but now user-focused measures must also be taken into account.The POC is the place and/or moment at which the consumer actually takes the pill or uses the medical device. A package may contain more individual tablets, for example in a blister.The POC not only refers to the first tablet, but also to the last one – which may be taken many weeks later.






Conclusion

Every second, the world packages – and unpackages – about 100,000 products. A single company like Coca-Cola already sells 1.6 billion drinks each day. Pharma packaging may only constitute around three per cent of the total volume of packaged products worldwide, but it is increasingly subject to the same trends which affect other areas, like the importance of controlled logistics, the purchasing power of retail chains, the advent of private labels and generic brands, and, especially, the shift towards customer-orientation in combination with manufacturing efficiency. ‘Horizontal learning’ from the other 97 per cent using packaging is not only a clever thing to do, it is actually a necessity to ensure the survival of the pharma industry as margins erode and competition stiffens. An NVC study conducted in 2003 showed that €1 spent on packaging equates to around €15 of gross margin on the average pharmaceutical product. For standard bodycare products, this ratio is seven times lower. By joining forces in a precompetitive way and sharing best practices with other sectors, innovations can be created for a multitude of pharmaceutical and medical device products.The only realistic way for the pharmaceutical and medical devices supply chain to survive is to take what the doctor ordered and adapt to these new realities.

Acknowledgements

The support of the participants in the NVC ΦΠΙ project mirror group is gratefully acknowledged. Additional insights were obtained from the Pharma Packaging & Labelling Compliance Conference that took place in Barcelona on 23 to 25 March 2011.


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Michael Nieuwesteeg is Managing Director of NVC Netherlands Packaging Centre. NVC was founded in 1953 and is a unique association from the Netherlands, addressing all aspects of the supply chain of packaged products. With more than 550 member companies (including recycling, retail and packaged goods manufacturing such as pharmaceuticals) the NVC focuses on information, education and serving the interests of its members in packaging. Michael Nieuwesteeg graduated with degrees in Chemistry (Utrecht University, with honours) and Chemical Engineering (Twente University). Before NVC, he held positions in publishing, electronics and the medical device industry. Email: m.nieuwesteeg@nvc.nl
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Michael Nieuwesteeg
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