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The EU Parliament voted its position on the Unitary SPC


by Giuliana Miglierini The intersecting pathways of revision of the pharmaceutical and intellectual property legislations recently marked the adoption of the EU Parliament’s position on the new unitary Supplementary Protection Certificate (SPC) system, parallel to the recast of the current Read more

Reform of pharma legislation: the debate on regulatory data protection


by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision of the pharmaceutical legislation is approaching, many voices commented the possible impact the new scheme for regulatory data protection (RDP) may have Read more

Environmental sustainability: the EIPG perspective


Piero Iamartino Although the impact of medicines on the environment has been highlighted since the 70s of the last century with the emergence of the first reports of pollution in surface waters, it is only since the beginning of the Read more

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Some perspectives on green pharmaceuticals

January 20, 2023 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

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


The Made in Europe partnership for manufacturing

March 18, 2022 , , , , , , , , , , , , , , , , , , , , , , , , ,

by Giuliana Miglierini

The availability of a robust framework to support a sustainable European manufacturing system is undoubtedly a priority in the challenging times we are experiencing. In the pharmaceutical sector, the reshoring of productions of both active ingredients and finished medicinal products is already a key point of the new EU Pharmaceutical Strategy and of the consequent ongoing revision of the legislation governing the sector.

A broader action addressed to the entire European industrial system was launched in 2019 within the framework programme Horizon Europe (HE) 2021-2027: the Made in Europe manufacturing partnership aims to become the main driver for sustainable manufacturing in Europe. The partnership was modelled with the contribution of the European Commission, member states and the European Factories of the Future Research Association (EFFRA); the latter is also the leading entity in charge of coordinating the initiative, which include all actors taking part to the manufacturing ecosystem (i.e. academia, industry, non-governmental organisations and the public sector).

The main goals of the Made in Europe partnership

The two themes of ecological and digital transitions central to the policies of the von der Leyen Commission are the main source of inspiration for the Made in Europe partnership. The availability of a European manufacturing environment able to compete on global scenarios thanks to its technological leadership is the main objective of the initiative. Many challenges need to be faced to reach it, especially in the field of the integration of technologies based on artificial intelligence to fully exploit the potential of industrial data, the reshaping of a circular economy and a high flexibility in response to emerging trends and issues.

The Made in Europe partnership represents a common platform for national and regional manufacturing technology initiatives, including the required disciplines and technologies. The principles governing its actions are described in a guidance document available at the EFFRA website; a Strategic Research and Innovation Agenda (SRIA) is also available.

According to the guidance document, manufactured goods represented in 2018 83% of EU exports, and accounted for a annual trade surplus of 286 billion euro. Despite this very high surplus, the document warns it may be not sufficient to cover deficits arising from the purchase of non-manufactured goods and services. Also considering these factors, the balance moved from a surplus of € 22 billion in 2017 to a deficit of € 25 billion in 2018. This situation may now dramatically evolve further, due to the high increase of costs of energy and raw materials experienced in the last month, as a consequence of the war occurring at the Eastern boundaries of the EU. A situation that might make harder for the EU to also face the competition of Asiatic economies.

The guidance document identifies twelve challenges to be faced by the European manufacturing industry, starting from the need to strongly reduce to the minimal level its environmental impact. To this instance, optimisation of resource efficiency and the carbon intensity of the entire supply chains are among the main factors to be addressed, leading to the opportunity for European-made environmental-friendly but high-priced products. This switch also supports the development of circular models for the economy, and the use of next-generation sustainable materials and products, requiring to manage profound changes if the manufacturing systems and related supply chains. Recycling and re-manufacturing may play in the future an important role in redefining products’ life cycle. The resilience and agility of the European manufacturing industry shall be also tackled, in order to limit the impact of sudden crisis, as occurred with the Covid-19 pandemic or now with the Ukraine war. This goal calls for the availability of flexible and reconfigurable production lines within a country or region, suggests the document. The pharmaceutical sector already experienced criticalities during the Covid-19 arising from the dependence from extra-EU supplies; the same applies to all European industrial sectors, and according to the Made in Europe partnership it should be faced through achieving manufacturing sovereignty and technological leadership in key areas and critical value chains. A very challenging objective, that requires a coordinated European effort on manufacturing.

As for competition from other economies, the document warns that big public-private manufacturing partnerships are being launched also in Asia and America (i.e. Made in China). Environmental and social aspects should be jointly considered in the location/relocation of manufacturing companies, to account for the environmental sustainability of the businesses coupled to the requirements arising from a EU’s population mainly living in urban areas.

The challenges of digitalisation

Many of the above-mentioned targets identified by the Made in Europe partnership may benefit from the potential offered by the implementation of digital technologies to accelerate innovation and industrial transformation, thus leading to the improvement of the overall efficiency of manufacturing. Data are becoming a central driver for the creation of value, but companies are called to better understand the data economy also from a non-technological point of view. Cybersecurity should be also carefully addressed, as digitalisation is reflected by a higher vulnerability to cyber attacks.

Digitalisation also impacts on the availability of new business models, such as “manufacturing-as-a-service” and “collaborative product-service engineering”. Automated systems governed by artificial intelligence are now widely available in many industrial plants, and attention should be paid to modes of interactions between collaborative robots and human operators. Nevertheless, the availability of trained and skilled human staff is considered as a major barrier and threat by the Made in Europe partnership, particularly for SMEs.

The planned actions

Six different calls for actions in the field of green and digital transitions were launched by the Made in Europe manufacturing partnership within the Horizon Europe work programme 2021-2022. The total available budget is around € 1 billion. Topics of interest included AI enhanced robotic systems for smart manufacturing, zero-defect manufacturing towards zero-waste, laser-based technologies for green manufacturing, manufacturing technologies for bio-based materials, advanced digital technologies for manufacturing, and data-driven distributed industrial environments.

The Made in Europe partnership was also involved in calls about reconfigurable production process chains, products with complex functional surfaces, excellence in distributed control and modular manufacturing, intelligent work piece handling in a full production line, ICT Innovation for manufacturing sustainability in SMEs, and digital tools to support the engineering of a circular economy.

A consultation on possible topics to be included in the HE work programme 2023-2024 is still open to comments and can be accessed by the dedicated webpage at the EFFRA website. A summary document is also available presenting potential recommendations and discussion topics received up to now. New possible lines of actions may address the availability of “excellent, responsive and smart factories & supply chains” , how to achieve a circular products and climate- neutral manufacturing, new use models referred to new integrated business, product-service and production approaches, and models for a human-centered and human-driven manufacturing innovation.