It has become clear that understanding the environmental impact of human activity is of the utmost importance. The healthcare sector must also play its part. Both by realising its impact on the environment and by building upon opportunities to enhance longterm organisational resilience.
We are all familiar with the headlines regarding climate change, the environment and sustainability. It has become clear that understanding the environmental impact of human activity is of the utmost importance. The healthcare sector must also play its part. Both by realising its impact on the environment and by building upon opportunities to enhance long-term organisational resilience and by developing sustainable business practices. The healthcare sector is not immune from societal concerns about the environment and will have to go green over the next few years. In this issue of the Regulatory Rapporteur, the focus articles explore some of the many and varied issues that the healthcare sector is facing regarding sustainable operations.
Healthcare products have a high standard of quality and safety, which must not be affected by environmental initiatives. The concept of sustainability affects the entire life-cycle of a product, including manufacturing, packaging, distribution and waste. This month, we look at some of the current measures that tackle this complex area. Our first focus article looks at how electronic product information leaflets led to a reduction in packaging waste. The article ‘The paper patient leaflet replaced by its digital version for hospital-only medicines: a pioneer pilot in Belgium and Luxembourg’ explores the pilot and its advantages and limitations. The article looks at how this can be implemented and the role of healthcare practitioners and hospital pharmacies.
There are several European initiatives regarding the accumulation of plastic in the environment. The focus article ‘The EU restriction proposal for intentionally-added microplastics: A focus on solid dosage form medicinal products and food supplements’ considers the proposed measures and impact of the European Chemicals Agency (ECHA) microplastics proposal, on the restriction of intentionally-added microplastics. The article focuses on solid immediate-release oral dosage forms and food supplements, showing that the pharmaceutical industry has a responsibility to deal with matters of immediate concern to the environment.
This issue also covers sustainable medical device development. The industry is exploring how it can limit the environmental impact of medical devices by implementing sustainable regulations and standards. The article ‘Planning for the future: sustainable medical devices’ by Alastair Willoughby looks at how medical device developers can anticipate future sustainability regulations, by building sustainability into their products and business practices today. In the veterinary field, we have an intriguing focus article that explores environmental risk assessments.
The article ‘Terrestrial ecotoxicological studies for veterinary pharmaceuticals in livestock dung in the field‘ by Jörg Römbke looks at how the microbial composition of dung and decomposition can be used to design test methods, which interpret the potential impact of veterinary medicinal products on the environment. These articles explore a wide range of topics to illustrate how current initiatives take a broad approach to issues of sustainability. Future initiatives must also have a broad scope, by exploring and reducing the environmental impact of every part of the healthcare industry, from packaging to medical devices to the impact of waste on the environment.
The standalone articles include further discussion on the regulatory landscape since Brexit, including the changes that have occurred and what that may mean for the relationship between the UK, the EU and the rest of the world. This month we also have an interview with Dr Susan McCune from Thermo Fisher Scientific, on the challenges faced in the development of paediatric products, collaboration with regulatory agencies and thoughts on future trends. We also have a meeting report of the DIA’s accelerating CMC workshop. This issue shows the multitude of considerations involved in going green. The regulatory environment is as complex and diverse, as the natural environment and the healthcare sector has just as an important role to play in its protection, as any other industry. We hope you enjoy reading.