After IFPMA, GSCF, and IGBA submitted a joint opening statement at the fifth session of the Intergovernmental Negotiating Committee (INC-5) for an international instrument to end plastics pollution, European Pharmaceutical Manufacturer spoke to Melchior Kuo, manager, Innovation and Vaccine Policy, IFPMA to find out more.
Golden Shrimp Shutterstock
How does plastic packaging ensure the safety and efficacy of pharmaceutical products?
Plastic materials and components are indispensable in every stage of the pharmaceutical lifecycle, and are crucial for medicine production, quality, and safety. This is because plastics have unique properties such as versatility, durability, transparency – as well as having the ability to be sterilised. Whether in the form of vials for vaccines, blister packs for pills, or infusion bags, plastics offer versatility and reliability that is not easily replicable with other materials.
Are there any ongoing efforts to redesign pharmaceutical packaging to minimise plastic use while maintaining regulatory compliance?
Many companies are committed to and are already working to reduce or eliminate the amount of plastic waste as well as supporting more sustainable alternatives. Examples include:
- AstraZeneca's shift from single use boxes to reusable thermal packaging for products used for clinical trials achieving 98% return rate and reduced packaging waste equivalent to the weight of a 747 jumbo jet
- Sanofi's plastic-free cardboard packaging for one of its vaccines halves the size of the box, which optimises its storage and reduces its environmental footprint
- Boehringer Ingelheim's reusable inhaler is expected to prevent 776 tons of plastic waste and 14,300 tons of CO2 emissions.
What specific challenges make testing and validation of new materials so time-intensive for pharmaceutical applications?
Any modification of the composition of our products and packaging requires a revision of the registration file used for regulatory approval of the product. This must also be accompanied by additional studies – including things like toxicological analyses and guarantee of sterilisation conditions – to prove that the new elements do not interfere with the integrity/quality of the health product. For packaging, this process could last between approximately 5 years for secondary packaging to 10 years for primary packaging.
How do international regulatory frameworks impact the ability to innovate in packaging materials?
The packaging for medical products is rightly subject to stringent legal and regulatory requirements. This means that there are strict criteria for design, safety, quality, and performance that must be met. It is important that regulatory frameworks remain stringent in this regard, while allowing for companies to look for alternative packaging approaches. When considering that different countries have different regulatory frameworks, this can be complex.
How would harmonised extended compliance periods support pharmaceutical companies in transitioning to sustainable alternatives?
Extended compliance periods provide the necessary flexibility for companies to ensure continuation of production and availability of high quality and safe medical and medicinal products for patients worldwide, while collaboratively exploring safe alternative solutions and navigating the regulatory landscape.
Are there any promising bio-based or recyclable materials being tested for pharmaceutical applications?
Currently, there are limited feasible options for using mechanically recycled content for any pharmaceutical primary packaging, contact sensitive packaging, or contact sensitive parts of devices. IFPMA members are exploring any potential bio-based or recyclable materials but are limited by technology and market development due to high health and safety requirements for the pharmaceutical sector.
Are there any industry-wide commitments or benchmarks for reducing plastics in pharmaceuticals?
Several collaborative initiatives exist:
- The Circularity in Primary Pharmaceutical Packaging Accelerator (CiPPPA) focuses recycling primary pharmaceutical packaging like blister packs and inhalers
- RETURPEN is a collaboration between Novo Nordisk, Lilly, Sanofi, and Merck for recycling injection pens
- The Innovative Health Initiative’s Safe & Sustainable by Design project promotes eco-friendly healthcare products.