EIPG webinar Archives - European Industrial Pharmacists Group (EIPG)

Draft ICH M13A guideline on bioequivalence open for consultation


By Giuliana Miglierini The draft ICH M13A harmonised guideline “Bioequivalence for immediate-release solid oral dosage forms” was endorsed by the International Council for Harmonisation on 20 December 2022 and is now open for consultation. Comments can be forwarded until 26 Read more

The Windsor Framework


On 27 February 2023, UK Prime Minister Rishi Sunak and the European Commission President Ursula von der Leyen announced that agreement had been reached on changes to the operation of the Protocol on Ireland/Northern Ireland. The Protocol has been in Read more

HERA reports on stockpiling of antimicrobials


By Giuliana Miglierini The European Health Emergency Preparedness and Response Authority (HERA) has published the two final reports, prepared by McKinsey Solutions for the European Commission, describing respectively the results obtained during the first and second phases of the antimicrobial Read more

Some perspectives on green pharmaceuticals

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by Giuliana Miglierini

The central role the green agenda plays within the EU Commission’s transformative policies impacts also on the development and availability of pharmaceutical products characterised by a improved sustainability. The concept of “Pharmaceuticals in the environment” (PiE) is entering the new legislative framework; the undergoing revision of the pharmaceutical legislation, for example, may include among other the request of environmental risk assessment and urban wastewater treatment. But also, the goal of a circular economy at net zero emission and the revision of the chemical legislation.

As explained by Dr Bengt Mattson, Policy Manager at the Swedish research-based pharmaceutical industry association Läkemedelsindustriföreningen (Lif) during a recent EIPG’s webinar, the EU Commission Action plan on environment for years 2021-2023 includes twenty legislative and non-legislative files impacting also the pharma sector.

The theme of the so-called “green pharmaceuticals” is also part of the broader approach to environmental sustainability of the chemical industry. The topic is not new, for example the EU and IMI-funded CHEM21 project in years 2012-2017 focused on the development of new manufacturing processes for the pharmaceutical industry to reduce the use of expensive and toxic materials. Another target of the project included the development of environmentally friendly methods useful to save time and costs, while reducing waste.

Activities focused on the antimicrobial drug flucytosine, with the final goal to use flow chemistry and biocatalyst techniques to make it more easily available also in lower income countries to treat a fungal form of meningitis in HIV/AIDS patients. The new, cleaner and safer method developed under the project allowed to reduce the need for expensive toxic chemicals and other raw materials, with a corresponding decrease both in costs and wastes. As a side activity, the CHEM21 project also explored more efficient screening methods to find new enzymes potentially useful as biocatalysts in industrial chemical reactions.

A Green-by-design future for pharmaceutical processes

At the EIPG’s webinar, Dr Mattson discussed from many different perspectives how R&D initiatives may influence green manufacturing. The attention moved from packaging and energy in the ’90-ies to APIs released in the environment at the beginning of the new millennium. The ’20-ies shows a greater attention to API-related emission and to aspects linked to the efficient use of resources and the resulting carbon footprint. From this point of view, it may result not easy to correctly estimate the expected environmental impact of a pharmaceutical product. Biological substances, for example, may be more easily biodegradable than synthetic small molecules, but they may also require more energy to ensure the correct storage conditions.

The development of green processes represents a great challenge for chemists and pharmacists working in the pharmaceutical industry. A possible approach to Green Drug Design has been explored, for example, by another IMI project, Premier. Results have been recently published in the Environmental Science & Technology Letters.

The “Greneer” approach includes among others, criteria aimed to achieve avoidance of non-target effects and of use of persistent, bioaccumulative, and toxic (PBT) substances, and exposure reduction. The final goal would be the development of “green-by-design” active pharmaceutical ingredients.

Green pharmaceutical processes should also prefer more eco-friendly, renewable raw materials, with a particular attention to the choice of solvents and reagents. Waste water treatment to eliminate residues of pharmaceuticals is a typical example of downstream measures put in place at the industrial level to reduce the environmental impact of manufacturing activities. As noted during the webinar, the main source of this type of pollutants remains excretion by patients, followed by inappropriate disposal.

The pharmaceutical supply chain, and in particular community pharmacists represented by PGEU, is also active to inform patients, develop national and regional collection schemes for expired and unused medicines, and to make available more sustainable packing materials and transports.

A call to action from the UK

In the UK, the request emerging from a report by the Office of Health Economics (OHE), commissioned by the Association of the British Pharmaceutical Industry (ABPI) is for the government and other stakeholders to take immediate action “to secure the era of green pharmaceuticals”.

The report highlights the challenges for the pharmaceutical industry in order to reach the ambitious target of net zero carbon. Among these is the difficulty to quickly change processes to increase sustainability while maintaining product safety, the need to collaborate at all levels along the complex global pharmaceutical supply chain, the high waste-to-product ratio on the supply side of the medicines market, the new environmental impact profile of innovative drug products compared to established small molecule technologies, and the lack of reward for sustainability.

The report also suggests high-priority activities, including investment in decarbonisation and a long-term energy strategy for transition away from fossil fuels. Common regulatory standards and environmental reporting standards should be agreed upon by regulators of different geographic areas, including the EU and US. Financial support for the adoption of greener technologies by both the industry and the NHS is also suggested. Improvements to the NHS’s supply chain may come by the Supplier Roadmap and more sustainable procurement processes and health technology assessment methods. Public-private partnerships may represent the tool to launch proof of concept pilots for sustainability schemes or co-invest on key infrastructure projects.

Standardised metrics to be used to publicly disclose emissions and progress against targets are suggested as a useful tool for the industry, together with the life cycle analysis (LCA) of products, and the development of innovative solutions for waste management and efficiency improvement.

Other insights on green pharmaceuticals

Many other things may be said on green pharmaceuticals, but we are running out of space. We then highlight some useful links readers may refer to deepen the topic.

An outcome of the CHEM21 project is represented by the CHEM21 online learning platform, managed by the ACS Green Chemistry Institute. The platform offers many free educational and training materials in the field of the sustainable synthesis of pharmaceuticals.

The Green Chemistry Working Group of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) has elaborated a Green Aspirational Level (GAL) metrics to assess the green efficiency for a given API’s manufacturing process, based on the complexity of its ideal synthesis route.

The industrial associations also committed to take action in the field of Environment, Health, Safety and Sustainability (EHS&S). The three main European groups representing, respectively, the research-based industry (EFPIA), the auto-cure (AESGP) and the generic and biosimilar sectors (Medicines for Europe) have developed the Eco-Pharmaco-Stewardship (EPS) framework. The initiative takes into consideration the entire life-cycle of a medicinal product, including roles and responsibilities of all parties involved.

The Medicine Maker’s editor Stephanie Sutton interviewed some industrial experts on different aspects of sustainability (here the link to the article). Some other comments from industrial representatives have been reported by Cynthia A. Challener in an article published on PharmTech.com