PNP Volume 2 Issue 1

>> Small-molecule API particles as small as 10 nm

>> Biological particles as small as 50 nm

>> High-potency API containment down to 30 ng/m3 OEL

Discover how our revolutionary nanoparticle technologies, coupled with our innovative formulation approaches and high-potency API handling capabilities, can address drug solubility issues and add value in novel small- and large-molecule drug delivery applications.

MANAGING DIRECTOR

Mark A. Barker

BUSINESS DEVELOPMENT

Anthony Stewart anthony@senglobalcoms.com

Mark A. Barker mark@senglobalcoms.com

EDITORIAL MANAGER

Beatriz Romao beatriz@senglobalcoms.com

DESIGNER

Jana Sukenikova www.fanahshapeless.com

RESEARCH & CIRCULATION MANAGER Virginia Toteva virginia@senglobalcoms.com

ADMINISTRATOR Barbara Lasco

FRONT COVER istockphoto

PUBLISHED BY Senglobal Ltd.

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Tel: +44 (0) 2045417569

Email: info@senglobalcoms.com www.pharmanaturepositive.com

4 FOREWORD GREEN VISION

6 Reduce, Redesign, Recover, Recycle

IPI speaks with Dr. Nazneen Rahman, CBE, Founder and CEO of YewMaker and Director of the Sustainable Medicines Partnership about why partnerships will be critical in the design, innovation, implementation, and execution of sustainable packaging solutions.

8 Catalyst for Sustainability within Pharma

CPHI Barcelona Aims to be a Catalyst for Sustainability within Pharma. Exhibitions, venues, and event organisers in the last few years have, rightly, become increasingly focussed on how we can still deliver worldclass services and events for our customers. Silvia Faroova Director Sustainability and Partnerships at Informa Markets discuss how we can reduce the impact we have on the places we visit and our overall environmental footprint.

10 Nemera: Committed to Sustainability

Nemera has established clear policies and ambitious roadmaps to engage all its stakeholders in the areas covered by its ESG strategy. In 2019, Nemera decided to take its climate commitments to the next level. We began by measuring the company's carbon footprint and carried out our first assessment using the Ecovadis methodology. Sebastian Perrier, Chief Operating Officer at Nemera discuss how they have by monitoring key performance indicators (KPIs) for the 4 strategic pillars of our ESG strategy, and the results achieved, we can assess the true performance of every ESG initiative, past, present, and future.

MITIGATION

16 Increasing Livestock Sustainability with Methane-mitigating Feed Additives

Political, Regulatory and Market Considerations

Demand for animal protein in developed countries is stable and increasing strongly in emerging countries. Reducing animal disease and optimising yield, through better genetics and preventative care means fewer animals are needed to meet global demand for protein. An emerging class of animal feed supplements that inhibit methane production in ruminants offers a promising new way to further reduce the climate footprint of livestock production. This article by Carel du Marchie Sarvaas, Executive Director at HealthforAnimals and Former Director for Agricultural Biotechnology at EuropaBio, analyses political, regulatory, practical and market considerations related to the introduction and use of methane-reducing feed additives, while offering recommendations to improve pathways to market.

20 Agroecology Science Farming System, and Social Movement

The opinions and views expressed by the authors in this journal are not necessarily those of the Editor or the Publisher. Please note that although care is taken in the preparation of this publication, the Editor and the Publisher are not responsible for opinions, views, and inaccuracies in the articles. Great care is taken concerning artwork supplied, but the Publisher cannot be held responsible for any loss or damage incurred. This publication is protected by copyright.

“Agroecology” is a merging of the word agriculture and ecology. The purpose is to reconnect agriculture with its biophysical, agronomic, economic, and philosophical roots in diverse natural ecosystems. Agroecology is frequently identified as farming systems that are rooted in the science of ecology or as the science of sustainable agriculture. Food Sovereignty is a global agricultural movement with member organizations in more than 80 countries. The movement defines food sovereignty as “the right of peoples to healthy and culturally appropriate food produced through ecologically sound and sustainable methods, and their right to define their own food and agriculture systems”. Dr. John Ikerd is Professor Emeritus of Agricultural Economics, University of Missouri-Columbia, USA,

CONTENTS

discuss what is at stake is not only the wellbeing of others of present and future generations but our own dignity and sense of self-worth.

ADAPTATION

26 The Consumer Driven Path to Circularity through Future Pharmaceutical Packaging

In an age where sustainability has taken centre stage on the global agenda, industries are reimagining the way they operate to align with sustainability principles and the application of increased circularity practices. Dr. Stefan Hellbardt, Vice-President Business Development and Scientific Affairs & Julien Storz Julien Storz, Director of Business Development within Aptar Pharma's Consumer Health Care (CHC) division, discuss the challenging tasks faced by drug delivery technology and pharmaceutical device manufacturers. Which is to find a way to achieve the intricate balancing act between manufacturing capabilities, the consumer drive for enhanced sustainability, and meeting the stringent regulatory requirements that govern the pharmaceutical industry.

32 Step-by-step Sustainability:

How

Nanoform is Shaping a Greener Future for Pharma

Pharmaceutical companies are working to drive more positive outcomes for patients, but to truly benefit patients and the world it is critical for the industry to examine and improve the environmental impact of their medicine’s value chain. When accelerating sustainability efforts across the pharmaceutical value chain, innovative technologies may hold the key to unlocking a greener future for the industry. Dr. Jamie Unwin, VP Strategic Insights at Nanoform explains how Nanoform’s suite of proprietary offerings can help businesses with this transition, making every step of the value chain more sustainable.

36 Owen Mumford: Supporting Pharma Partners to Reduce Scope 3 Emissions

Analyses of the pharmaceutical industry’s carbon footprint often cite the same study, which found that the sector’s emissions are 55 percent greater than the automotive sector. There is so much to consider when discussing sustainability in the pharmaceutical and medical device sectors that, without a collective effort and pooling of knowledge, achieving net zero goals will be much harder and slower. Michael Earl Michael Earl, Director of Pharmaceutical Services at Owen Mumford shows how they are making good progress with scope 1 (direct, in-house emissions) and scope 2 (emissions from purchased energy) emissions.

COLLABORATION

40 Driving Sustainability in Drug Discovery: A Community Approach

The pharma and biotech industry are growing. While this brings the promise of new therapeutics for currently untreatable diseases, the increasing environmental impact of the industry cannot be ignored. As a significant contributor to the global climate change crisis, biotech and pharma must also be part of the solution, if the net zero by 2050 Paris Agreement is to be realised. The impact of pharma and biotech on planet health can’t really be argued. Data shows the industry is a significant contributor of carbon and waste and uses incredible amounts of energy and water. European

Laboratory Research and Innovation Group (ELRIG), explain that sustainability can only be achieved if the drug discovery community works together.

FINANCE

42 Animal Feed and Pet Food

The

Cost of Safety, Innovation and Sustainability

In the mature market of animal feed and pet food manufacturing, safety and quality of products is viewed by consumers as an absolute and fundamental expectation. Going beyond that, claims of innovation and sustainability are key to differentiate products, to provide better positioning for meeting consumer demands and to generate product sales and market leadership. Elaine Vanier, Technical Manager, Nicole C.K. James is the Technical Scheme & Ryan Daly, Senior Marketing Manager for Sustainability Services at NSF International, provides key recommendations for feed ingredient suppliers and feed and pet food manufacturers who want to source their ingredients more responsibly and sustainably.

LOGISTICS & SUPPLY CHAIN

46 Net Zero Healthcare

Priorities for Decarbonising the Pharma Supply Chain

The climate and our health are inextricably linked. The effects of climate change on global health systems and outcomes are already clear, with WHO proclaiming it to be the biggest health threat facing humanity today. And it’s projected to get worse over time. Every year between 2030 and 2050, climate change is expected to cause an additional 250,000 deaths. Pharma, as one of the largest global industries, is both part of the problem and the solution for minimising the adverse effects. Steve Brownett-Gale, Marketing Lead at Origin discuss why the next generation of pharma needs to be digitally literate and open to continuous learning to maximise the opportunities these new technologies present pharma.

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FOREWORD

The societal and environmental challenges in front of us are existential. Addressing them calls for a collective effort from all parts of society, including business. Sustainability is no longer an option; it is a requirement for every organisation on the planet.  At the same time there are significant opportunities to develop businesses or propositions and improve the lives of customers, colleagues and across society.

Being sustainable in strategy, practice and impact requires going beyond compliance. It involves designing and implementing strategies that create positive and tangible impact and value for your entire ecosystem of stakeholders.

This calls for a holistic and integrated approach that drives value and sustained growth; growth that meets the needs of today as well as those of tomorrow.

To execute truly sustainable strategies, organisations may need new processes, a refined organisational purpose, structural changes, and the systemic controls to align and mobilise your team, function, and organisation to protect your sustainability action plan from the perils and pitfalls that lie ahead. Some challenges are common to all strategic initiatives – other deeply specific to implementing sustainability strategies.

The 5 pillars, also known as 5 Ps of sustainable development, encompass 5 overarching areas that each of the Sustainable Development Goals (SDG) address. These are of critical importance to act towards over the next decade. They are, People, Planet, Prosperity, Peace and Partnerships, sustainability sitting at the core of each. These pillars are there to inform decision making around interventions installed by the government that work towards the SDG’s. When a new policy is adopted, it must consider the consequences it will have upon any of the 5 Ps. Today, United Nations successfully continues to consider these pillars against each of their development goals. They offer a blueprint that many organisations can measure their own actions against.

Sustainability is at the heart of the pharmaceutical industry’s day-to-day operations, with many skilled individuals working in sustainability roles.  We are starting to see initiatives from companies across the world, from investment in renewables, to low-carbon inhalers, to net zero buildings.

Industrial digitalisation is here to stay, and it’s not too late to join in!

Many manufacturers are in the early stages of digital transformation, assessing ‘digital readiness’ i.e. the ability to embrace digital technologies to meet organisational, operational, social and financial objectives.  Many manufacturers have an ad hoc collection of automation

projects and need to work out the ‘next step’: how to take the company to the next level of Industrial IoT.

Manufacturers are increasingly focussed on sustainability objectives throughout the organisation, as these become ever more fundamental factors for any growth and global competitiveness strategy.  Reducing waste and embracing environmental initiatives cannot be ignored; companies engaged in sustainability programmes cover all sizes, ages and sectors. The benefits of sustainable manufacturing are, reducing costs and waste to improve operational efficiency, reach new markets/customers and gain competitive advantage, strengthen brand reputation, and gain public endorsement, enhance long-term business viability and growth and adhere to current and future regulatory legislation and opportunities.

Sustainability is no longer a ‘nice to have’ opportunity for feel-good PR and communications.  Manufacturers now depend on a savvy sustainability strategy and implementation as a strategic imperative, an integral part of industrial transformation and the basis for long-term, profitable growth. According to the Climate Change Committee1, the COP27 climate summit in November 2022 reaffirmed the global commitment to tackling climate change considering the current energy crisis. There should be an urgency for manufacturers to step up their game and make progress with their net zero targets. After all, it is estimated that manufacturing operations uses somewhere in the region of 17% of energy consumption. Despite uncertainty on the impact that climate change action could have on production, more manufacturers are now realising that they can achieve business goals without sacrificing the needs of the planet.

Yes, carbon reduction and net zero are part of the agenda, but there are many other considerations for manufacturers, including utilities consumption, reducing labour turnover, capital funding, supply chain disruption etc.  All these factors are part of ‘sustainable manufacturing’. Traditional continuous improvement initiatives typically prioritise labour efficiency and productivity improvements.  Shifting towards resourcing and productivity for sustainability needs additional sustainability goals and KPIs.  Embedding sustainability into operations is key.  Leading manufacturers integrate sustainability/ESG* into industrial transformation strategies for maximum ROI.

Sustainability needs to be part of the discussion for all operational objectives. Sustainability is a core transformation initiative and success will depend on how well it is integrated with the overall business growth strategy.

In this issue of PNP – Pharma Nature Positive, you will read of thoughts, vision and initiatives taken by organisations to help the pharma business to rise to the sustainability challenge.

I hope you enjoy this issue.

Mark A. Barker, Managing Director, Senglobal Ltd

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Reduce, Redesign, Recover, Recycle

What gap does the Sustainable Medicines Packaging Awards address, and why are these awards needed?

If you want to make medicines more sustainable you have to include packaging front and centre, because the packaging is integral to a medicine’s effectiveness. This is more evident with drug delivery devices like inhalers, where it's clear the package is part of the product, but it is relevant to all medicines.

But because it's so integral, pharmaceutical packaging is subject to tight regulations, which presents challenges and makes it tough to be sustainable or to do things differently. That's why we wanted to shine a light on the ingenuity and engineering required to make good pharmaceutical packaging more sustainable, without compromising function.

If you're in the packaging industry, you might think it would be easier to start your sustainability journey somewhere else. But we discovered so many interesting ideas and innovations already in practice. We wanted to showcase these efforts because we know it's taken real commitment at every level to take a pharmaceutical packaging product or process in a more sustainable direction.

We hope the awards serve as an inspiration to others who may believe sustainable innovations are for the future or prefer to wait and see what others have done. We hope the awards inspire people to think: ‘okay, maybe we could do that, because these others have done it.’

Did the first round of awards, which launched in 2022, achieve those goals?

Absolutely. We were really impressed by the calibre of the applications, and with the engagement at the panel event at Connect in Pharma, in Geneva. There were so many people at the event, and there was such a good buzz surrounding it. The panelists were all award finalists and were so engaging and enthusiastic. The first awards and the launch event exceeded our hopes. We were delighted.

Is there anything you plan to do differently this year?

It's always tempting to fiddle with things, but it’s good to go through a period of solidification. So we haven't changed anything this year. It’s the same categories, and we’ve again made it very simple to enter. People liked that!

We had people say to us: ‘Oh, I didn't know something like that would qualify. We've got something that probably would be classed as more sustainable.’ We are keen to get people thinking broadly about how to define a sustainable innovation. It can be anything you want it to be, as long as it’s really reducing waste, or making things more efficient or making things more circular.

Is there anything in particular you're hoping to see this year? I do like it when people think out of the box a bit - that’s a bad pun – about what a sustainable advance might be. Often sustainability measures align with cost reduction measures. If you want to reduce costs, you'll often try to reduce materials, or to make things more efficient. It would be great if people can be open to thinking about what that definition of sustainable is and include measures that may also be more resourceeffective or more circular.

I think this is important because I would like the pharmaceutical industry to adopt an index of sustainability as a routine consideration in all packaging development. The more people think sustainability is part of their everyday goals and one of the routine things they measure, the sooner it will become standard. So, I'd really love for people to surprise us with how they've defined sustainability and sustainability innovation.

What are the most exciting or important advances emerging within the field of sustainable medicines?

The most important advance is the recognition that sustainability is an important multidimensional issue that must be addressed. This change is due to increasing awareness, demand, regulation and legislation, but mostly because people care. They want to know what packaging is made from, how it is disposed of and if it’s sustainable. They want transparency about a company’s ethos, targets and – above all – actions. This shift is driving momentum at a rapid pace, even since last year. I don't think there's anyone in pharmaceutical packaging who thinks the issues around sustainability are irrelevant. But I think there are plenty of people who are thinking, ‘I'm not sure what to do about it.’

The other cultural change we are seeing is people thinking that sustainable practices might be a commercial advantage. I think that's very exciting, because if we can show a sustainable-

IPI speaks with Dr. Nazneen Rahman, CBE, Founder and CEO of YewMaker and Director of the Sustainable Medicines Partnership about why partnerships will be critical in the design, innovation, implementation, and execution of sustainable packaging solutions.

focused business is just the best way to do business, we will see catalytic growth in sustainable packaging. And hopefully companies will start to think, ‘if we don’t build sustainable practices into our business, we might get left behind.’ These are important advances.

What about advances on the technological side?

There is exciting research and progress on new materials, and in circularity of materials. It's all very well making something recyclable, but we need to ask: is it actually going to get recycled? That is still complex and challenging, particularly for composite materials like blister packs.

We are seeing some progress on collecting and sorting, for example with invisible markers on packaging that sorting machines can read and separate, but both the technology and logistics of collection need to improve.

We are also seeing advances in recycling processes, particularly in advanced recyling – which is also known as chemical recycling. Advanced recycling involves breaking materials down to the molecular building blocks which are reused. In a fully circular system, the material is broken into constituent molecules that are reused to make the same material. This isn’t ready for the frontline, but there are examples, such as polystyrene being broken down to styrene, which are commercially in play, and I believe we will see more examples in the future. Of course, we will need the regulatory processes to certify and approve integration of recycled molecules in packaging to be developed, and this could benefit from more focus and momentum in pharma.

The area I hear less about is the first tenant of circularity –reduction. Manufacturers should optimise the size of their products and make sure that every part is there for a reason, every design choice is there for a reason and not just to make it look better on the shelves. I haven't seen as much of this as I would like to, but the use of computer modeling to design packaging that maximises the function, size, composition, cost, and sustainability of packaging is an exciting, burgeoning field. It has many parallels to the use of modeling to generate new medicines – the capabilities and thinking are already ripe for translation into packaging.

What priorities should the pharma industry have in their sights in the next five to 10 years in terms of sustainability?

A good place to start is with the four circular economy principles

GREEN VISION

(reduce, redesign, recover, recycle) and work through those priorities. The circular economy is much more than recycling. Rather, it’s an alternative framework that redefines the economy around principles of designing out waste and pollution, keeping products and materials in use, and regenerating natural systems.

The first thing to look at is reduction at every level: reduce the waste of medicines that are packaged but never used and reduce the size of the secondary or tertiary packaging. It's amazing how much impact the use of smaller boxes packed better could have. I don't think there is any manufacturer who couldn't have an impact in reduction if they chose to. There are plenty of low hanging fruits that could have a big impact in this area.

The second thing is to take a holistic approach. It’s not enough to make something recyclable, it also has to be recycled. Of course, you can't do it on your own. Typically, the people who make the packaging are not the people who are throwing away the packaging, or the people who are going to collect the packaging or do something with it.

Partnerships will be critical in the design, innovation, implementation, and execution of sustainable packaging solutions. It's not just about creating new materials or recycling options, but also about connecting all the different pieces to make a real impact. This requires a new way of working together that may be challenging, but it's essential for success. Probably the top priority is to get better data, across the whole supply chain. We need to know and understand how and where packaging is being used, wasted, disposed of. We currently have almost no data on this which makes it very difficult to plan, for example how many sorting and recycling plants are needed. Much of the data is already available – pharmaceutical packaging has barcodes, for example but it isn’t connected. I'm as certain as I can be that if we could see these data flows better, people would come up with solutions. It’s very hard to change what you can’t see.

Nazneen Rahmann

Dr. Nazneen Rahman, CBE, is a physician and scientist. She is the Founder and CEO of YewMaker and Director of the Sustainable Medicines Partnership – a not-for-profit, private-public, multi-stakeholder collaboration of 48 organisations. Rahman is also a Non-executive Director at AstraZeneca where she chairs the Science and Sustainability Committees. Before turning her focus to sustainability, Rahman was Professor of Human Genetics at the Institute of Cancer Research. Rahman and her team at YewMaker launched the Sustainable Medicines Packaging Awards in 2022 to recognise innovations in packaging that make medicines more sustainable and circular. In the run up to the award reception she is due to host at Connect in Pharma on 14 June 2023, Rahman spoke to Melissa Kerschen from Sciad Communications about the awards, the innovations she finds most promising, and the changes she would like to see within the next few years.

CPHI Barcelona Aims to be a Catalyst for Sustainability within Pharma

Exhibitions, venues, and event organisers in the last few years have, rightly, become increasingly focussed on how we can still deliver world-class services and events for our customers, but at the same time, reduce the impact we have on the places we visit and our overall environmental footprint. For a large-scale international event like CPHI Barcelona, this takes on even greater focus. Last year over half of our attendees travelled by air, so it becomes more important than ever to help them make every mile count productively. One of the best ways to ensure our events are having a positive carbon impact is, of course, to ensure they deliver value to the industries we serve, for example by reducing the number of meetings they may have to take throughout the year. So already, with such an international industry and supply chain as pharma, we are hopefully positively contributing as there is nowhere else in the world that so many contacts can meet simultaneously. In fact, over a third of attendees last year told us attending CPHI meant they took fewer flights throughout the year.

In this way, making your events deliver value is a crucial aspect as we begin to look at sustainability, and too often overlooked. But we are of course also looking to the direct reductions onsite we can make, and this is where our recent journey really begins.

The first step was to get a feel for exactly where are right now, identifying ‘low hanging fruit’ that would be easier to address and what we might need to work towards for our longer-term objectives, as part of our strategic roadmap for the portfolio. We looked at other events we admired and tried to take on the learnings from their best practices – sustainability is a major focus across Informa Markets, so there are plenty of lessons to take from our peers and beyond. And finally, we spoke with our exhibitors and attendees to see what is important to them and how we can help them reduce their impact. For context, CPHI Barcelona is the world’s largest pharma event, and our exhibitors are the supply chain partners making the ingredients, the finished drugs, the packaging, and machinery of many of the medicines saving lives globally – not least of which include the Covid-19 vaccines. So, while pharma is inherently a socially responsible industry thanks to the lives it saves.

What is often not well understood outside the sector, is that unfortunately the manufacturing and development of these much-needed drugs does often come at some environmental cost – chiefly because of the way drugs are approved [as quickly as is possible meaning production methods are not always optimised]. In fact, pharma is one of the most polluting industries globally and has a larger carbon footprint than even the automotive industry. A complex supply chain and strict regulations have historically meant a significant environmental

footprint, however, in the last decade the industry has embarked on a massive global drive to try and improve this environmental impact.

Much great work has been done and in areas like pharma packaging we already see tremendous improvements –particularly in Europe, where we have been pleased to see our event, Pharmapack is widely acknowledged to have been instrumental in accelerating this change.

Which brings me full circle back to CPHI Barcelona and how we can piece together this complex web and make the biggest positive contribution we can. We have been taking great strides to make the event as sustainable and carbon neutral as possible, but we are not content to pause here. For our team sustainability is very much a continual improvement philosophy and we are following the examples of Pharmapack and help be a key facilitator of global change within the pharma industry itself.

This means we have split our focus. Many of our sustainability efforts are centred around activities to improve the solutions we provide when we host out events, but beyond this – and perhaps ultimately the bigger impact – we are exploring how we can be the catalyst of change for attendees, our exhibitors, and wider pharma industry.

What we are striving for is to be the central point of debate on these key issues, from sharing learnings and case studies at our events and online to introducing prospective working groups on essential areas. With upwards of 40,000 executives expected

at Barcelona, alongside our global network of 470,000+ pharma professionals, we understood that we really can have a central role to play in shift towards greener technologies. These are obviously ambitious goals, and we don’t take them lightly – as we see this as 3-year+ transformation within our business – but our goal is to be one of those case study exhibitions that others then look to in how we can make a much wider impact.

More immediately, we have been looking to other event organisers and speaking with venues, seeing what learnings they have, and what has worked before for other regional shows. For example, I would like to complement Fira Barcelona here as they are already incredibly active and when we approached them asking ‘what more we can do’ they really bought into this. So a lot what we achieved I would say can be done by other organisers by getting out there and just asking questions. Partnering with your local networks, with your venues and exhibitors.

For CPHI Barcelona, we have been taking ambitious steps that build towards a big picture. We have looked at easier fixes with full recyclable carpets, and making sure we have sustainable stand builders, buying carbon offset credits for the event and considering the amount and types of energy used on site. Going further we are looking to partner with the local tourism body and are introducing a list of sustainable restaurants and even eco taxis – we do however promote public transport first.

The other aspect we are particularly pleased with is our efforts to work with local food suppliers. It’s a simple thing, and it not only lowers the carbon impact, but also contributes to the local

economies we visit. Similarly, and perhaps now bridging our work into pharma, we have also looked at what benefits we can give to the local industries within our host cities – so for example we have introduced a new Start-Up Market for early-stage local companies to access the global industries we serve, with support from local government organisations. That enabling of the local industry within a global event is a model I would encourage others to follow.

This is where in the longer term, we really want to make that transformation impact by giving global pharma as many resources as we can, to bring together the industry and create spaces for these conversations, and already we are looking at widening our agendas. We are also thinking about ‘closed working groups and case studies, remaining conscious of industry sensitives and how we can share knowledge in an environment that safeguards IP. Similarly, as a global event we have also brought about learnings and challenges from different regions to explore how the industry can improve at a global level – for example, we will bring in learnings from Europe and the US if these are relevant to accelerate change in India or China. Our great strength is the ability to bring all these global actors together and by hosting a large sustainability programme, theatre, or track at our events we are providing a tremendous resource in accelerating adoption. Not least because there are already groups out there driving change – sometimes struggling for reach – and we give them the platform to talk direct to the manufacturers and supply partners so that they can educate on the tools needed to change.

The final aspect is that once you begin, you quickly find allies. We have introduced specialist sponsorship packages for key sustainability exhibitor partners to fund carbon offsetting at the event and we of course are more than happy to exchange our marketing power as a thank you.

My main advice to any event organiser is therefore to see this as a continual journey and a continual process – it’s not a discrete activity but something you work toward each year. So, at CPHI we are also looking to bring our exhibitors along on the journey with improvements each year, setting them gradually bigger and bolder challenges – the chief of which of course is for sustainable stands as per our agreed frameworks.

What I am enthused by is the response we have had and the demand – our role is now to bring all these greater partners together and to collectively bring about changes. What has struck me the most is that, yes, we are not in the day to day of these industries, but for something global like sustainability in a complex industry like pharma, with different regulators… event organisers are incredibly well placed to be catalysts of change. I think that’s the big take away: we have only just started scratching the surface here, and my prediction is we won’t be alone in driving sustainable change in industry through events.

Silvia Faroova

Director Sustainability and Partnerships at Informa Markets.

Nemera: Committed to Sustainability

We put patients first. The added value of our patient-centric devices is recognized worldwide. Our products make a difference to the lives of people with chronic, acute, serious or benign diseases or conditions. We are keenly aware of our central role in the healthcare system, along with our impact on society and environment. And it`s by walking the talk that we strive to be the ideal partner for the pharmaceutical, biotech and generic companies.

Setting an Example

At Nemera, we’re committed to acting in an ethical and socially responsible way. Whether it's a customer or supplier, or any other stakeholder, we believe in setting an example through our behaviour. We believe in working with integrity, empathy and accountability because the products we make improve the lives of thousands of patients. Our Code of conduct and business policies provide each and every employee at Nemera a framework that gives them the freedom to act responsibly.

Nemera's manufacturing facilities operate under environmental, health, and safety (EHS) conditions that comply with guidelines and rules set by the company's executive management and within the legislative framework of the countries we operate in. In our day-to-day activities, we pay close attention to recycling, waste management and water management. We choose reusable materials wherever possible and leverage other opportunities to use resources more wisely.

Our operations are designed to guarantee the maximum safety of our employees. We follow the lean manufacturing approach to foster a culture of continuous improvement. This facilitates production and helps reduce defective products or scrap. In addition, we are optimising our consumption of energy, raw materials, and transportation.

Making a Difference!

Nemera's drug delivery device solutions are designed with three things in mind: patient, ease of use and treatment efficacy. By focusing on solutions that make patients' lives easier and safer, we have built a strong portfolio of innovative products and technologies.

In addition, we have extended our offering as an integrated services partner. Nemera's integrated contract development, consulting and manufacturing services allow customers to achieve the outcome of a successful regulatory submission and the commercial launch of safe, effective and differentiated combination products.

Nemera is a single partner applying an agile process across the device and combination product value chain. This provides customers the benefit of patient centricity and engagement, innovation that is consistently sustained across the journey, as well as the reduction of risk and increased speed of market access for both customer organic development and utilisation of IP platforms.

Quality is not an obligation, but a duty to us. It is an integral part of every aspect of our work because we strongly believe that quality creates value.

As the world grapples with climate change, it's becoming increasingly critical for businesses to measure the impact they make on the environment. Research, studies, experts, and most importantly, the science, have made it clear that a lot needs to be done – and faster, to avoid the worst repercussions of climate change and secure a thriving, sustainable economy.

“A long-term ESG approach is a musthave for us. We are embedding sustainability criteria in our company processes, empowering our people to make a positive impact on the world around us and establishing a solid governance to deliver on our ESG commitments. We are reporting our performance via external third-party international standards to ensure transparency and full disclosure. Sustainability is not a destination, but a journey leading the way to a healthier future for all of us. We are in this together!”

Marc Hämel, CEO Nemera

Aligning with International Standards

Global warming and the consequences that follow are primarily caused by human beings. At Nemera, we understand the role we need to play as a company in preserving the environment and transitioning successfully to a low-carbon economy. To be

able to live up to this big challenge, the strategic decision to reduce the impact of our activities was made. The roadmap of our sustainability strategy is based on internationally recognised objectives and standards.

Delivering on our ESG Commitment

“Since 2020, we have stepped up our actions and investments as we seek to play our part in a low-carbon future, in line with the 2015 Paris Agreement and the United Nations Sustainable Development Goals (SDGs). This is why we created a Global EHS Department in January 2021. Within this department, my teams and I are moving forward step by step to implement our roadmap and to meet the objectives set for the short, medium and long term. The result is an ambitious collective movement reflected in the hands-on initiatives underway at our sites around the world. Success is built with people. This belief is shared by our management and employees alike. Due to the nature of our industrial activities, safety and the quality of working conditions have always been a top priority. Over time, however, as our environmental, health, and safety (EHC) processes have matured, Nemera has broadened its sphere of action to include more global issues, with the fight against climate change at de forefront.”

Sandrine Coutarel, Global EHS Director, Nemera

The Rise of ESG

In 2019, Nemera decided to take its climate commitments to the next level. We began by measuring the company's carbon footprint and carried out our first assessment using the Ecovadis methodology. Amid growing climate concerns all around the world, it goes without saying that this approach has proved to be highly appreciated by our customers.

When it came to studying the ESG ecosystem and its trends in our industry, the challenge presented for Nemera was that the industrial plastic injection activities are intertwined with those of the pharmaceutical and biotechnology sectors. An analysis of these two sectors ensued, enabling us to identify the different ESG action to be implemented and to choose EcoVadis and SBTi as the sustainability framework to monitor our progress.

Nemera's ESG objectives are based on environmental, social, and business aspects. Making ESG criteria an integral part of our internal and external processes represents a critical steppingstone.

Since the company was founded, in 2014, several milestones have been achieved: EHS teams present at each of the sites have developed policies and processes to keep our people safe; environmental projects with a focus on waste sorting and management of chemicals were rolled-out; and feedback from customers and suppliers is being taken into account to adapt our supply chain accordingly.

A 360 degree Strategy with Solid Governance

In January 2021, a central function was created to strengthen the governance and coordination of our ESG strategy. Depending on the ESG policies and actions involved – overall strategy, energy, EHS, diversity, etc. – , the central team works with the operations, HR, and EHS departments across our locations, along with Plant Directors in Europe and America.

Every year, Nemera's Board of Directors signs-off the ambitions, commitments, and resources for ESG. And all these are swiftly integrated into multi-year plans and budgets.

Leveraging Innovation

In August 2019, Nemera acquired Insight Product Development, a Chicago-based design and consulting firm. The idea was to strengthen capabilities in early-stage development and to reinforce client proximity in North America.

Insight Product Development' front-end innovation, design research, human factors and design engineering complemented nicely Nemera's strong late-stage development, as well as the clinical and commercial manufacturing capabilities.

The research carried out by our teams in Europe and North America focuses on designing for patients and ensures diverse populations are taken into account throughout our innovation

GREEN VISION

process. By working on projects that consume less plastic, we aim to create “eco-designed” products.

Long-term Strategic Commitments

Nemera has established clear policies and ambitious roadmaps to engage all its stakeholders in the areas covered by its ESG strategy. A major effort has been made to formalise our approach through a series of documents:

• Our Code of Conduct sets out the ethical and social responsibility rules for Nemera's employees as well as suppliers;

• Our Diversity and Inclusion Policy acts as a reminder to foster a work environment that values and celebrates difference, is fair and equitable, and is enriched by openness, curiosity and accountability;

• Our commitments to human rights and the United Nations Charter, along with the International Labour Organisation's core labour conventions, are clearly stated;

• Our obligations under all competition laws around the world are embedded in our relevant policies, and cover all Nemera entities, subsidiaries, affiliates, as well as officers, directors and employees.

Involving all our Partners in our ESG Strategy

To date, Nemera's ESG approach has been shared with over 3.500 customers, suppliers and other stakeholders. Informing the people we work with helps create new opportunities to collaborate on shared initiatives. Our stakeholders, themselves, have ESG objectives. We reach out to those who have less experience in ESG matters to bring them up to speed. But at the same time, we are open to feedback on our choices and policies.

Bringing together more than 200 experts in the US and France and managing more than 180 families, our Insight Innovation Centre works alongside customers and suppliers to develop technological solutions that reduce the environmental impact of our products, whilst optimising the benefits for patients.

Assessing the Risks

Astorg, a private equity company and joint owner, with Montagu, of Nemera, is supporting the company every step of the way in its transformation process.

“We are seeing a lot of pressure from large pharma companies with extremely demanding sustainability requirements. Corporate stability is another key factor when selecting a healthcare provider. Among the various requirements, climate targets and carbon footprint assessments are considered extremely important.”

Viviana Occhionorelli, ESG Managing Director, Astorg

The demands made by Nemera's partners can vary according to their location. In the US, for example, customers are more focused on diversity than the environment. However, this is set to change soon due to the latest SEC regulations, which will require all publicly traded companies to disclose their carbon emissions as well as their approaches to managing climate risks.

Manufacturing medical devices made of resins involves risks in terms of production processes and the industrial facilities themselves. These risks are constantly under review, as they are closely connected to the quality of Nemera's products. The Board of Directors and the monitoring committee are particularly vigilant about potential issues at Nemera manufacturing facilities.

Every quarter, Astorg teams liaise with Nemera 's ESG teams about their assessment of the challenges and the monitoring of risks, particularly those involving climate issues. Astorg also uses Ecovadis monitoring tools to enhance the risk assessments for Nemera and its main partners, drawing on external data.

The Sustainable Development Goals (SGDs), an Essential Pathway

Adopted in 2015 by the United Nations, the 2030 Agenda for

Sustainable Development sets 17 goals. Although not legally binding, implementing SDGs is the responsibility of governments with significant contribution from businesses.

At Nemera, we deliver on three of the 17 SDG goals on a daily basis: the production of our drug delivery devices for the biotechnology, genetics, and pharmaceutical industries is fully aligned with the accomplishment of SDG 3 (Good Health and Well-Being); the contribution of sharing the benefits of economic growth and the work of our HR managers to provide training and diversity advocacy through career management are helping us to meet SDG 8 (Decent Work and Economic Growth); SDG 4 (Quality Education), a strong quality culture is part of Nemera's DNA.

As a user of energy and plastic components, Nemera has developed a strategic environmental plan to reduce its impact, and to achieve SDG 12 and 13 (Responsible Consumption and Production, and Climate Action) by 2030. To meet this target, our teams are committed on working hard to limit waste. We are also working on conducting product lifecycle analyses from 2023 onward. Similarly, by implementing sound governance and ethical practices, Nemera is also helping to create a more open and sustainable society, which is precisely the goal of SDG 16 (Peace, Justice, and Strong Institutions).

What are Scopes 1, 2 and 3?

A company carbon emissions footprint is measured and analysed using different parameters.

Direct emissions: Scopes 1 & 2

Scopes 1 & 2 cover the greenhouse gases emitted to produce the energy – electricity, gas, fuel -, needed for all Nemera activities, which include the fuel/electricity/gas for company cars and the impact of refrigerant gas leakage.

Indirect Emissions: Scope 3

Scope 3 covers all other emissions created throughout the life cycle of our products. It includes various stages, such as the supply of raw materials, the inbound and outbound transportation, the machines and equipment we buy, the waste and all travel, business and commuting.

Nemera SBTi Commitment on Scopes 1 & 2

90% reduction by 2030 vs 2019 baseline in absolute emissions (tons of CO2)

Initiative, and ISO 26000, the International Standards Organisation's benchmark for ESG.

EcoVadis covers 21 ESG criteria around environment, labour and human rights, ethics and sustainable procurement, with the indicators divided into three categories: policies, actions and results.

Nemera has been working with EcoVadis since 2019. Its highly structured framework enabled us to quickly launch the first assessment of our ESG strategy. Thanks to a clearer overall vision of our strengths and weaknesses, we have been able to develop policies for greater efficiency and improved performance within our supply chain.

Going Beyond Mere Compliance

Today, the support of EcoVadis provides the recognition of the work we're constantly doing. Our aim is to inspire our main suppliers to adopt the same approach, to increase the sustainability of global supply chains and to prompt all our partners to go beyond mere compliance.

We need to go beyond mandatory reporting on our climate commitments if we want to make a real difference. Nemera has committed to disclose its environmental impact by submitting the climate change questionnaire through the Carbon Disclosure project (CDP) platform, ensuring full transparency of its actions. The CDP is an international not-for-profit organisation that enables companies and communities to measure, manage and share their environmental information. Stakeholders can then use this information to keep track of their partners commitments and identify the opportunities created by a responsible and sustainable approach. Thanks to this initiative, Nemera has been able to craft detailed indicators complementary to EcoVadis and SBTi.

Ensuring Quality and Compliance with Standards

Nemera's environmental management process it's subject to a continuous assesment and improvement. For example, the production units at Le Verpilliere, Le Treport and Neuenburg operate an effective management system certified to the ISO 14001 standard. A range of reliable indicators enable any corrective actions to be carried out if necessary.

Nemera SBTi Commitment on Scope 3

55% reduction by 2030 vs 2019 baseline in carbon intensity (tons of CO2/added value)

EcoVadis –

Providing a Framework for Nemera's Global ESG Strategy

Ecovadis is a sustainability and ESG rating organisation that assesses more than 90.000 companies worldwide. Its methodology is based on recognised standards, such as those of the United nations Global Compact, the Global Reporting

“Our ESG strategy is part of who we are, and we bring it to life in two main ways. Firstly, by ensuring that ESG aspects act as a strategic growth driver; a mission spearheaded by our leadership team, and aiming at leading the way towards sustainable drug delivery devices. Secondly, by having a solid connection with our ecosystem and this means engaging all our employees, suppliers, customers and when possible, our patients, in this fundamental transformation. Our approach is currently based on the four pillars of sustainable development:

environment, social and human rights, ethics and responsible purchasing. To deliver on this strategy, we are obviously not starting from scratch. We are building on everything that has already been achieved over many years across all our locations, including energy-saving initiatives, waste reduction recycling programs or reusable devices.”

Sebastian Perrier, Chief Operating Officer, Nemera

Action Plan to Reduce Energy Consumption

Our action plan starts by measuring our consumption and improve the granularity of energy metering. According to our strategy, we work towards installing new meters on machines that consume the most electricity at all sites, to better monitor their consumption and detect any room for improvement. A practical example is the replacement of chilling equipment with new, more energy efficient systems at several production sites.

The next step in our plan is to implement the ISO 50001 standard, a certification that fosters continuous improvement. Our sites at Le Treport in France and Neueburg in Germany were certified in 2021 and we started the process at Le Verpilliere in 2021, with the objective to achieve certification in 2023. We plan to get the remaining plants certified by 2030.

Energy Sourcing: From Grey to Green

Plastic injection moulding and work in clean rooms consume a lot of energy. As energy consumption is Nemera's primary environmental impact, since 2019, the company has implemented a plan to gradually transform its use of electricity, by adapting its technical installations and switching consumption to carbon-free or renewable sources. Where renewable energy is not available, as in United States, our teams have taken steps to use carbonfree energy.

We strive to achieve greater energy efficiency. Our goal is to have 100% renewable energy at all sites by 2030.

As a world leader in the design, development and production of drug delivery devices, Nemera puts patients' expectations first.

Today, these expectations go beyond the healthcare sector. Taking action to help the environment throughout its value chain means taking action on the company`s performance, resources, and ability to deliver enhanced environmental and societal value to patients. Key in our environmental policies, this interdependence guides our efforts to improve our environmental performance. Transitioning our energy model, reducing our carbon intensity, and improving the management of our raw material and resource flows have all been a focus of our work in recent years.

Numbers say a lot when it comes to telling a story! We monitor the performance of our strategic 4 pillars via established indicators and KPIs. The tracking methodology, inspired by EcoVadis as well as SBTi, involves collecting, assessing and aggregating data. Every ESG initiative at Nemera has a clear objective and our people are passionate about contributing to our ESG journey.

By monitoring key performance indicators (KPIs) for the 4 strategic pillars of our ESG strategy, and the results achieved, we can assess the true performance of every ESG initiative, past, present and future.

NEMERA

As a world-leading partner for drug delivery device solutions & combination product services, our purpose of putting patients first enables us to design and manufacture devices that maximize treatment efficacy.We are a holistic partner and help our customers succeed in the sprint to market of their combination products. From early device strategy to state-of-the-art manufacturing, we’re committed to the highest quality standards. Agile and open-minded, we work with our customers as colleagues. Together, we go the extra mile to fulfill our mission.

To know more, visit: www.nemera.net

Increasing Livestock Sustainability with Methane-mitigating Feed Additives

Political, Regulatory and Market Considerations

Demand for animal protein in developed countries is stable and increasing strongly in emerging countries. The combination of their nutrient density, desire of people to improve their diets and a growing world population will continue to drive future growth. The United Nations Food and Agriculture Organisation (FAO) projects that global demand for milk and meat will rise by 58% and 74% between 2010 and 2050.

Demand at that scale cannot be met solely through expansion; livestock must also be raised more efficiently and sustainably, and animal health solutions offer a path to achieve this goal. Reducing animal disease and optimising yield, through better genetics and preventative care means fewer animals are needed to meet global demand for protein.

An emerging class of animal feed supplements that inhibit methane production in ruminants offers a promising new way to further reduce the climate footprint of livestock production. This article analyses political, regulatory, practical and market considerations related to the introduction and use of methane-reducing feed additives, while offering recommendations to improve pathways to market.

The Emissions Challenge

The main GHG emissions (carbon dioxide (CO2), methane (CH4) and nitrous oxide (N2O) are emitted from both natural and man-made sources (see Chart 1). Scientifically, the sources of emissions are irrelevant because the warming effect is the same, yet from a societal acceptance perspective there are differences. Society tends not to question naturally occurring biological processes created through millions of years of evolution – including for example ruminant enteric fermentation. But society does increasingly question the effect of many man-made activities, especially if they are wasteful and the emissions are significant.

To illustrate, unintentional methane leaks from energy production – often from poorly maintained pipelines – release about as much methane (3.11 billion tonnes CO2 equivalent annually) as all of agriculture (3.45 billion tonnes CO2 equivalent), and certainly more than ruminant enteric fermentation.

Methane is different than CO 2 – it is 28 times more potent than CO2, but unlike CO2, which has a life span of centuries, methane breaks down after 10 or so years. Cutting methane emissions therefore almost immediately reduces its concentrations in the atmosphere and slows warming. It is no surprise that over 150 countries support the Global Methane

40% of methane is emitted from natural biological sources like decomposition, ocean release, etc. and 60% is from man-made sources like landfills, oil and natural gas systems, mining, combustion, wastewater treatment, and industrial processes, according to the International Energy Agency. Beef and dairy cows eat plants which contain carbon, which their stomachs convert into methane, 90% of which is belched out and 10% of which is flatulence. Considering methane emissions from agriculture, enteric fermentation by ruminants represents about 31% as shown in Chart 2.

Animal Health and Animal Feed Solutions

The animal health sector can play a contributing role in both GHG mitigation and adaption strategies. Mitigation strategies are those that aim to reduce existing GHGs from the environment or reduce the rate of new GHG emissions. Feed additives are part of both the mitigation and adaptation stories. Adaptation strategies aim to reduce the effects of climate change. For the animal health sector, this can include helping animals manage heat stress, increase capacity to address emerging diseases, and responding to diseases in new geographies.

Further improving animal health is the most efficient way to ensure that as few as possible greenhouse gasses are emitted.

Pledge to lower methane overall emissions by 30% by 2030, and this target could be sharpened further.

Healthier animals are more productive, less prone to disease, weight loss or death, leading to more animal protein being produced using fewer resources. In addition, existing good feed practices and products that improve digestibility, reduce pathogens, or increase weight, also contribute significantly to lower emissions. The feed sector is constantly developing new fats, oils, carbohydrates, minerals, etc. with positive effects on digestion.

Various new natural and synthetic supplements specifically geared at reducing methane emissions are either on the market or in development. Most of them function by disrupting methane production, or by moving the composition of the microbial community away from methane-producing microbes. The most prevalent are considered here.

Red seaweed (Asparagopsis) fed to ruminants has shown encouraging results of 80% methane reduction. A large-scale trial in Australia concluding in 2023 showed methane reductions of around 28%. The active ingredient is bromoform which is categorized by the U.S. EPA as a probable human carcinogen with a potential human safety concern. Commercial developers state the product is safe given the very

low bromoform levels. In addition, some research has found residues in some animal proteins, and this, combined with a possible carcinogenic effect, raises challenges regarding acceptance in international trade of animal products fed the additive. Although a promising product, its likely more safety data will be needed before permits are granted in major markets.

3-Nitrooxypropanol or 3-NOP is a feed additive that reduces enteric methane emissions from dairy and reproductive cows. It is approved for commercial use in 45 markets including large ruminant markets like Brazil and the European Union, with approval expected in the U.S. in 2024. Application works by adding a small amount daily to feed, and this can reduce beef cattle emissions by about 45% and dairy cow emissions reductions by an average 30%. The product has no negative production quality effects and leads to an increase in milk fat.

There are a range of other products and approaches. For example, one commercially available product blends plant-based products including wild carrot and coriander seed oil and claims to reduce enteric emissions from dairy cattle by 11%, though these claims are questioned by several academics. Another blend brings together garlic and citrus extracts and claims a 38% reduction. Another company has an additive that stimulates a natural process in the rumen, creating ammonia from hydrogen, which would otherwise become methane, and states that it leads to a 10% methane reduction. There is a probiotic formula which claims to reduce methane emissions by 20%.

Research is ongoing in many public and private entities including into areas such as adding natural gas ozone into cattle drinking water (reduce emissions by 20%), and new vaccines that can reduce methane emissions.

Success Criteria for Products

These products are at different stages of development, acceptance, and commercialisation. Some have generated large amounts of scientific data and credibility, others have not. Looking ahead and in the hope that use of methane reducing additives will increase, it is important that products meet certain requirements, the most important of which are considered here.

1. Proven safety. An additive must be proven to be safe for consumption by animals, consumption by humans through animal protein, for handling by humans (on-farm and in production), and for the environment (excretion). The only acceptable way to guarantee these safety conditions is through an assessment by a government agency.

2. Effect on performance. An additive will not be used if it has a negative effect on an animal’s welfare or on output/ performance. This is not a trade-off farmers will accept.

3. Methane reduction efficacy. An additive must reduce sufficient qualities of methane, and the assessments showing such quantities must be based on independent and accessible scientific evidence. A life cycle analysis of a product needs to incorporate all the GHG's emitted including during its production.

Chart 1: Global greenhouse gas emissions by sector

Chart 2: Sources of methane emissions by agricultural sector

4. Usability. An additive must be easily usable by dairy and beef farmers. Globally, 37% of ruminant enteric methane emissions are generated by ruminants on free-ranging systems on rangelands and grasslands, 60% in mixed systems, and 2% from beef cattle in feedlots. How to get the right amounts to the cattle at the right times in different settings is an important consideration.

5. Production. An additive must be produced in the right quantities. This may present challenges for some technologies. For example, how to grow, harvest, process, and transport red seaweed in sufficient quantities? What is the full life GHG emissions from such processes?

6. Consumer acceptance. If an additive meets the first three conditions, it should not be challenging to gain consumer acceptance of a product which reduces methane emissions and contributes positively to reducing greenhouse gas emissions.

7. Value. Farmers will use additives if they can recoup the cost outlay. There are different ways costs can be recouped.

• Market incentives through enhanced feed efficiency. Up to 12% of ingested gross energy (feed) can be lost in the form of methane. Additives that enhance efficiency by helping the ruminant to conserve energy that would otherwise be lost as methane are an incentive to pay for methane reducing feed additives.

• Market prices. Charging higher (premium) prices for meat and milk from animals fed the additives. This is challenging as the evidence shows that few consumers are prepared to pay more for this type of societal benefit, and this means there will be a de facto niche market for animals that have being fed the additives. In addition, asking consumers in emerging markets to pay more does not work.

• Government intervention. For example, providing a subsidy for feeding additives that allow farmers to reduce their emissions. Some governments may go this way, some may not. Another government intervention is standards –requiring farmers to produce more sustainably – may work in some areas, though not in others.

• Methane tax. Such a tax could make it more attractive for farmers to use feed additives to reduce emissions. This could include a carbon credit/market approach. Taxes are politically undesirable and technically difficult to implement and would not work in emerging countries.

Market Perspectives

Many food processors, retailers, food and beverage companies and farm operations have a true interest in reducing their emissions, and many companies have taken significant action. Many corporations have climate pledges to lower their emissions and are increasingly being held accountable by shareholders regarding what actions they are taking. There is pressure to do better.

These new feed additive technologies offer these companies real and immediate possibilities to reduce emissions in their production chains. Adoption of these technologies should be encouraged. Groups such as the Global Dairy Platform – that brings together all major global dairy companies, have called for increased use of feed additives. Several meat companies have also actively called for adoption and application of these techniques. A major challenge for many of these companies are the costs related to the additives, as well as the credibility of the accounting systems of methane emissions avoided through use of the products.

Political and Regulatory Considerations

The United Nations Food and Agriculture Organisation (FAO) states most countries are not properly leveraging animal health as a pathway for emissions reductions. Only 14 of 148 countries who submitted national climate action plans in 2021 included improving animal health as a way to do so.

Some regions are moving. For example, the European Union specifically mentions, as part of its overall methane reduction strategy, the use of technologies such as feed to reduce emissions. It approved a 3-NOP product in 2022 stating “Cutting farmingrelated methane emissions is key in our fight against climate change and today’s approval is a very telling example of what we can achieve through new agricultural innovations.” In the U.S., there is a proposal to establish a new pathway for manufacturers to receive approval for feed additives that improve efficiency in meat and dairy production.

Whichever regulatory approach is taken, it requires some level of political drive from policy makers who would like to facilitate methane emission reduction strategies and tools.

Looking Ahead

Adoption of products that reduce methane emissions is desirable from an environmental point of view, and some additives will have secondary benefits attractive for farmers. For adoption to be accelerated, the following areas need to progress.

Governments should incorporate animal health tools into their National Climate Action Programs, including the use of methane reducing additives.

There needs to be consensus that assessment of products and their claims is needed. This is usually done by governments, and such assessment benefits farmers and society, reassuring that products are safe and have the claimed effect.

Stakeholders and governments need to work together to implement proactive political strategies to promote research and encourage uptake. Such strategies could include financing of research, encouraging uptake through financial benefits, regulatory fast lanes, farmer carbon credits, and consideration of public subsidies to achieve public good. Similar financing has happened in many other areas to promote uptake of carbon friendly technologies.

The wider food and agriculture chain and support industries have a responsibility to promote the uptake of technologies that reduce methane, including feed additives. This responsibility runs from farm to fork. Different models exist to work together.

Proactive communication about benefits and drawbacks needs to be part of this.

There needs to be clarity and standardisation regarding how to calculate methane reductions claims. A life cycle approach is best. Currently there are too many ways of calculating emissions from ruminants. To illustrate this point, is an example of a large convenience food company that had its beef farmers use a lemongrass-based additive. Claims were made that methane emissions were reduced by some 33%. Upon rigorous scientific review, 33% applied only to part of the emissions and the actual emissions saved was 3%. There was no suggested mal intention by the company, only unclear calculations.

Research into any approaches or mechanisms that inhibit methane emissions from cattle and other ruminants needs to continue and be supported. This includes ongoing existing partnerships, public and private research.

Carel du Marchie Sarvaas

Carel du Marchie Sarvaas is the Executive Director, HealthforAnimals and Former Director for Agricultural Biotechnology at EuropaBio. Mr. Carel Du Marchie Sarvaas, a Dutch national, has many years of experience as a senior public affairs and communications advisor in Brussels, The Hague, and Washington DC. He has broad knowledge of the key issues facing the industry with extensive experience of designing and implementing integrated public affairs and communication strategies.

MITIGATION

Agroecology

Science, Farming System, and Social Movement

“Agroecology” is a merging of the words agriculture and ecology. The purpose is to reconnect agriculture with its biophysical, agronomic, economic, and philosophical roots in diverse natural ecosystems. Agroecology is frequently identified as farming systems that are rooted in the science of ecology or as the science of sustainable agriculture. Ecology is sociocultural as well as biophysical. Food Sovereignty is a global agricultural movement with member organizations in more than 80 countries.23 The movement defines food sovereignty as “the right of peoples to healthy and culturally appropriate food produced through ecologically sound and sustainable methods, and their right to define their own food and agriculture systems”.17 Thus, agroecology is a science, a farming system, and a social movement.

First, agroecology applies the science of ecology to agriculture.2 Ecology is a study of the relationships of living organisms, including humans, with the other elements of their natural and social environment. There is a common phrase in ecology that relates directly to agroecology: “You can’t do just one thing.” The relationships in agroecosystems, such as those among living soils, plants, animals, and the people who farm, live in rural communities, and eat food are incredibly complex. Everything is related, somehow and in some way, to everything else. Any individual action a farmer may take affects everything else on the farm – some in small ways and others in important ways. When farmers do one thing, they need to be aware of all of the other things that may be affected on their farms as wholes. They also need to be aware of the impacts of their actions on their neighbours, communities, and larger societies. Unintended consequences of their actions may appear either quickly or at some time in the distant future. The science of ecology addresses temporal as well as functional and spatial relationships.

Second, as a farming system, agroecology respects the fact that the natural ecosystems and societies which sustain individual farming systems are inherently diverse and unique. Sometimes the differences are insignificant and sometimes they are critical to the performance of the farming system as a whole. A set of specific farming methods and practices that are successful for one farmer on one farm may or may not work for another farmer or another farm – even though nature functions by the same ecological principles on every farm. Sustainable farming methods and practices must respect the “natural ecology of place.” Agroecology also respects the “social ecology of place.” Agroecology views humans as members of the earth’s integrally connected ecosystem. The farmer is treated as a member of a farm’s agroecosystem and the relationship between a specific farm and specific farmer

is critical to the farm’s success or failure. This makes it difficult, if not impossible, to conduct traditional agricultural research that is relevant to agroecological farming systems. What works for one farmer might not work for another, even on the same farm. Authentic organic farming also is rooted in the philosophy that a farm is a living organism of which the farmer is a vital organ or integral part. This casts serious doubts on the ability to standardise organic farming. Farming systems that treat farmers as members and caretakers of the earth’s integral community are consistent with the principles of agroecology, regardless of whether they are certified as organic.

Equally important, agroecology recognises that farms are inherently interconnected with the specific communities and societies within which they function. The economic sustainability of a farm obviously is interdependent with the willingness and ability of people in its local community, or the larger society, to buy its agricultural products. Less appreciated, the quality of life of farmers and farm families is critically affected by their personal relationships with others in their communities – their customers, their neighbours, and people they meet in town through churches, schools, or participation in public service. These relationships may affect the farmer’s sense of acceptance, belonging, and self-esteem. The quality of personal relationships affect the quality of farm life and also may affect the economic success or failure of the farm.

Third, as a social movement, agroecology is a natural complement to the global Food Sovereignty movement. Agroecology is a science-based approach to “ecologically sound and sustainable farming methods” that can be used to produce “healthy and culturally appropriate foods” and to retain the rights of people “to define their own food and farming systems” that respect the natural and social ecology of place.

These are key concepts of food sovereignty that are supported by agroecology. The FAO of the UN, in its statement of support for agroecology as a global movement includes the following points:1

1. The global food system is at a crossroads. The industrialisation of agriculture has created a situation where we are faced with a growing global population, persistent hunger and increasing malnutrition, soil degradation, water pollution and depletion, and loss of biodiversity during a time of climate uncertainty. (In other words, the current industrial system of agricultural production is simply not sustainable.) 2. The challenge is to transition to an agricultural system that is capable of meeting the food needs of future society, not only by increasing productivity but also by distributing food more equitably – while not only protecting the natural environment, but also renewing and regenerating the resource essential for agricultural productivity, and increasing agricultural employment opportunities. (The social and economic impacts of agroecosystems are inseparable from the ecological impacts.)

3. Agroecology focuses on optimising the interrelationships among microorganisms in the soil, plants, animals, people, society and the geophysical elements of the earth. Agroecology-based farming systems are capable of increasing food production and nutrition, alleviating hunger through more equitable food distribution, increasing biodiversity, restoring soil health, replenishing available water, and increasing agricultural employment and livelihoods, while sequestering soil carbon and mitigating the effects of climate change. (Agroecological farming systems are multifunctional and thus have the capacity to be sustainable.)

4. Agroecology is adaptable to the ecological, social, economic, and cultural diversity of the many different places on earth where agriculture is carried out to meet the nutritional needs of people. Agroecology works toward farming solutions that conserve and protect ecological integrity above and below ground biodiversity, and respects diverse cultures, aptitudes, and knowledge bases by honouring the contributions of women and youth to family farming, rural communities, and agricultural productivity. (Agroecology respects the ecology of “place.”)

5. Fundamentally different public policies, priorities for public investments, and research and educational agendas for public institutions are needed to meet the agri-food challenges of the future. Agroecology is the logical basis for evolving food systems because it is equally strong in environmental, economic, social and agronomic dimensions. Agroecology is capable of evolving as new challenges emerge and its multiple ecological, social, and economic benefits evolve. (Agroecology supports fundamental change in farm and food policies.)

The FAO’s position is supported by decades of agroecological research, particularly in the so-called developing nations of the world that are in greatest need of food security. A 2016 independent study by an International Panel of Experts in Sustainability (IPES) cited more than 350 scientific sources and described the evidence supporting the indictment of industrial agriculture as “overwhelming”.10 The IPES members represent highly respected academic institutions and international organisations around the world. They concluded: “Today's food and farming systems have succeeded in supplying large volumes of foods to global markets, but are generating negative outcomes on multiple fronts: widespread degradation of land, water and ecosystems; high GHG emissions; biodiversity losses; persistent hunger and micro-nutrient deficiencies alongside the rapid rise of obesity and diet-related diseases; and livelihood stresses for farmers around the world”.13 The report concludes: “What is required is a fundamentally different model of

agriculture based on diversifying farms and farming landscapes, replacing chemical inputs, optimising biodiversity and stimulating interactions between different species, as part of holistic strategies to build long-term fertility, healthy agro-ecosystems and secure livelihoods. Data shows that these systems can compete with industrial agriculture in terms of total outputs, performing particularly strongly under environmental stress, and delivering production increases in the places where additional food is desperately needed. Diversified agroecological systems can also pave the way for diverse diets and improved health.” Olivier De Schutter, leader of the independent panel observed, “It is not a lack of evidence holding back the agroecological alternative. The way food systems are currently structured allows value to accrue to a limited number of actors, reinforcing their economic and political power, and thus their ability to influence the governance of food systems. We must change the way we set political priorities”.11 If the future of farming and food production is to be ensured, the political priorities must be reset and farm policies must be fundamentally reformed – in industrial agricultural nations as well as the rest of the world

Agroecology requires ways of thinking that are fundamentally different from the specialisation, standardisation/mechanisation, and consolidation mindset of industrial agriculture. The “integral ecological” perspective of agroecology also differs from the mindset of many ecologists, in that humans are considered to be integrally connected with all of the other living species and non-living elements of the earth. Pope Francis recently brought integral ecology to widespread public attention when he used it as a central theme in his 2015 landmark Encyclical on Climate Change, Laudato Si. He focused on the failure of the environmental movement to address the social and economic roots of growing threats to “our common home” – the earth. He wrote, “We are faced not with two separate crises, one environmental and the other social, but rather with one complex crisis which is both social and environmental. Strategies for a solution demand an integrated approach to combating poverty, restoring dignity to the excluded, and at the same time protecting nature”.5

Contrary to what many people have been led to believe, the ecological threats posed by the economic exploitation of nature are real, and are certainly not limited to agriculture. Continued denial will not shield humanity from the consequences of inaction. Gustave Speth, founder of the World Resources Institute, co-founder of the Natural Resource Defense Council, advisor to US Presidents Carter and Clinton, wrote in his book, Bridge at the Edge of the Earth, “For all of the material blessings economic progress has provided, for all of the disease and destitution avoided, for all the glories that shine in the best of our civilisation, the costs to the natural world, the costs to the glories of nature, have been huge and must be counted in the balance as tragic loss”.18

Speth proceeds to reference the loss of half of the world’s tropical and temperate forests, half of the world’s wetlands and a third of the mangroves, 90% percent of large predator fish, 75% of healthy fisheries, and 20% of coral reefs, species disappearing a thousand times faster than normal, over half of agricultural lands in states of deterioration to desertification, and persistent agricultural chemicals now in the bodies of nearly every human on earth. Global climate change is but the latest in a long string of environmental crises to gain widespread public attention.

An early benchmark in the modern environmental movement was Rachel Carson’s 1962 classic book, Silent Spring,3 which foretold the consequences of agricultural industrialisation. She warned: “For the first time in the history of the world, every human being is now subjected to contact with dangerous chemicals, from the moment of conception until death”.4 A more recent benchmark is the global Agreement on Climate Change reached at a Convention of the United Nations (UN) in Paris in 2015.20 The environmental movement has been an ongoing battle to convince humanity to avoid self-annihilation through a responsible relationship with nature. The UN call for adoption of the Paris agreement states: “Recognising that climate change represents an urgent and potentially irreversible threat to human societies and the planet and thus requires the widest possible cooperation by all countries, and their participation in an effective and appropriate international response, with a view to accelerating the reduction of global greenhouse gas emissions; also recognising that deep reductions in global emissions will be required… and emphasising the need for urgency in addressing climate change…” (21). Of the 197 nations attending the Paris Convention, only the United States and Syria have refused to sign the agreement. Nicaragua refused to attend the Convention because they did not believe the goals were sufficiently ambitious to address the problem.

Joseph Stiglitz, winner of the “Nobel Prize in Economics”, views the economic, social, and ecological challenges as integrally connected. In his book, The Price of Inequity, he links climate change and ecological degradation in general with economic inequity and blames government policies that have prioritised economic growth over ecological sustainability and social equity. Governments have allowed the resources of nature and society to be exploited to provide “unearned rents” or excess profits for corporations rather than to benefit the rightful owners of the resources – the people in common. Stiglitz documents that recent growth in the US economy has been captured almost entirely by the wealthiest Americans. “For the past 30 years, we’ve become increasingly a nation divided; not only has the top been growing fastest, but the bottom has actually been declining”.19 The richest 20 per cent of Americans earn more, after taxes, than the bottom 80 per cent combined. He makes the case for a Green GDP, which includes social and ecological indicators of progress as well as the usual economic indicators.

Pope Francis also points to the negative ecological and social consequences of economic growth. “The economy accepts every advance in technology with a view to profit, without

concern for its potentially negative impact on human beings. Some critics maintain that current economics and technology will solve all environmental problems, and argue, in popular and non-technical terms, that the problems of global hunger and poverty will be resolved simply by market growth. They may not affirm such theories with words, but… show no interest in more balanced levels of production, a better distribution of wealth, concern for the environment and the rights of future generations. Their behaviour shows that for them maximising profits is enough”.6 Pope Francis challenges global society “to move forward in a bold cultural revolution”.7 Naomi Klein’s book, This Changes Everything, also focuses on the challenges of global climate change and joins Pope Francis in calling for a cultural revolution. She emphasises that climate change is but a symptom of major ecological, social, and economic problems that threaten the future of human life on earth. She points out the futility of relying on technological fixes – which often create more and bigger problems than they solve. She makes the case that addressing the root causes of climate change ultimately must “change everything.” She writes: “So this book proposes a different strategy: think big, go deep, and move the ideological pole far away from the stifling market fundamentalism that has become the greatest enemy of planetary health”.14

Agroecology is a response to the need to abandon the “market fundamentalism” that supports and drives industrial agriculture. The economic industrialisation of agriculture was a noble experiment and well-intended, but it failed. In addition to the host of ecological and economic problems it has created, it hasn’t even fulfilled its most fundamental purpose – it failed to provide food security. Even in the US, one in eight people are classified as “food insecure,” and more than one in six children live in food-insecure households – meaning they risk not getting enough food to support healthy, active lives.22 In addition, the US and other industrial societies are plagued with an epidemic of diet-related illnesses, including obesity, diabetes, hypertension, heart disease, and a variety of cancers. The industrial food system has failed to reduce either hunger or malnutrition. Diet-related health problems threaten the future of humanity, both physically and economically. Sustainability is the ability to meet the needs of the present without diminishing opportunities for the future. Industrial agriculture obviously has failed to meet even the basic food needs of the present – let alone preserve opportunities for the future. Industrial food systems are not sustainable.

Unlike industrial agriculture, which gives priority to economic efficiency, agroecology gives equal consideration to the multiple ecological, social, and economic dimensions of sustainability. Agroecology is consistent with some of the more popular approaches to sustainable farming but differs from others. Perhaps the most important distinction is that agroecology is “context-specific”, meaning it recognises that farming methods and practices that are sustainable for a given farmer, on a given farm, in a particular farming community may not be sustainable for another farmer, farm, or community. Sustainability requires harmony among the farmer, farm, community, and society. Thus, any specific approach to farming that is based on specific farming practices – such as no-till farming, precision farming, or “certified organic” – may or may not be agroecologically sound for any particular farm or farmer. Integral agroecology views the farm as a living organism. As suggested previously, this is consistent with the philosophy of organic farming. However, the holism or integrality of agroecology conflicts with organic

standards for certification which rely primarily on lists of allowable and non-allowable inputs to define “organic.” Current US organic standards allow hydroponic organic production, meaning production without soil, which can hardly be reconciled with the farm as a biological, living organism. Current US organic standards also allow organic animal products to be produced in large confinement animal feeding operations, or CAFOs, which are far more like factories than farms.

Agroecological farming – unlike no-till farming, precision farming, or other systems that focus exclusively on farming methods or practices – also requires economic equity and social justice for farm workers and consideration for the social and economic well-being of people in rural communities. Today’s corporately dominated agricultural operations simply lack the capacity to express the social and ethical values that are essential for agroecological integrity. Agroecology has much in common with Holistic Management, in that both recognise the multiple ecological, social, and economic dimensions essential for sustainable farming. Both are also based on principles and processes of nature rather than specific methods or practices. However, Holistic Management is based on a specific step-bystep decision-making process, which may need to at least be modified to accommodate specific farmers or farming cultures. Regenerative Agriculture is an attempt to emphasise the need to move beyond simply sustaining the current situation to restoring and enhancing the productivity of soils and restoring the integrity of the overall agroecosystem. Sustainability recognises the need for regeneration because it recognises the necessity of meeting the needs of the future. However, sustainability also requires resilience and resource efficiency – as well as the need for social and ecological integrity. If regenerative agriculture is to be consistent with agroecology, it cannot be narrowly focused on ecological sustainability at the expense of social and economic integrity. Several other farming systems – such as ecological

farming, biological farming, biodynamics, and nature farming – have elements in common with agroecology and also have some minor or significant differences. In fact, agroecology can provide a conceptual framework and set of guiding principles by which other approaches to sustainable farming can be evaluated and modified, as necessary, to ensure their consistency with agricultural sustainability. Individual sustainable farmers should use the farming system that seems to fit their individual preferences, their farm, and their community – but should continually reevaluate its ecological, social, and economic integrity. This is the essence of agroecology as a farming system.

Finally, agroecology provides the scientific foundation for a social movement that emphasises “the social ecology of place.” In the US, the principles of agroecology are most prominent in the local food movement. The popularity of local foods – farmers markets, CSAs, and other means of direct sales – grew along with the rapid growth in organic food sales during the 1990s. The organic and local food movements have common roots. They were both a rejection of the industrial agro-food system, were characterised by management-intensive small farms, and emerged and grew in popularity together. However, as organic foods moved into mainstream markets, and organic food production became controlled by large food corporations, organic consumers increasingly turned to local farmers to ensure the ecological and social integrity of their food. While “integrity” may not be the word commonly used, the actions of those who seek out local foods indicate their concerns are deeper than a quest for higher quality or lower price.

The most frequently mentioned motivations of consumers for buying local foods include freshness, flavour or taste, and nutrition. People have learned that shipped-in foods generally are not as fresh and flavourful, and are probably not as nutritious, as fresh-picked, locally-grown foods at farmers markets, CSAs,

MITIGATION

and other local markets.15 Many people consider local foods to be safer because they are more likely to be produced organically, or at least without pesticides or GMOs. In the case of meat, milk, or eggs, hormones or antibiotics are more common concerns. Most farmers who sell locally understand the concerns of people who buy local foods and attempt to address concerns that are not being addressed by the industrial food system. In return, people who buy local foods often mention their desire to support local farmers economically and to help build stronger local economies and communities. Estimates based on comparison of local and industrial food production in general indicate that foods grown for local markets contribute about four times as many dollars to local economies as commodities grown for industrial food production. That said, the popularity of local foods and the incentives to produce local foods cannot be reduced to economics. “Several studies have found that the social desirability of buying local food plays a central role in influencing consumers to participate in the local food economy”.16 Many local food advocates care about community.

People tend to trust “their local farmers” to not only produce “good food” but also to be good neighbours, good community members, and good stewards of the land. In other words, the local food movement in driven by the desire of a growing number of people to restore ecological, social, and economic integrity to their food system – by supporting local sustainable farmers. Some experts may question the importance of social, ecological, and unselfish economic motives for buying local. However, the fact that local foods emerged as a separate movement in response to the perceived industrialisation of organics suggests otherwise. People are trying to restore trust and confidence in “their food system” by “buying local.” For these reasons and others, farmers motivated primarily by profits or economic efficiency are unlikely to be successful in local markets. Eventually, their customers will see their foods as little different from industrial foods and will value them accordingly.

The best current hope for restoring and sustaining the ecological, social, and economic integrity to the global food systems is the Food Sovereignty Movement. Americans thus far have been reluctant to embrace the idea of “food sovereignty” – whether because of corporate propaganda marginalising it as a “poor people or peasant” movement or a “not invented here” mentality. However, the principles of food sovereignty can be embraced and used to reshape farm and food policy in the US as well as globally, regardless of what it is called. The Food Sovereignty Movement emerged as a clear and firm rejection of the industrialisation of the global food system. Food sovereignty claims the right of local control of decisions regarding land use, crop and livestock genetics, and natural resource protection. It seeks to ensure local control of food systems by supporting and rewarding local farmers who contribute to local food security. It is inclusive of all people in local communities and it respects and values diversity of gender, race, income, ethnicity, and other cultural differences. Food sovereignty is firmly rooted in the principles of agroecology.

The success of food sovereignty initiatives obviously depend on effective local governance. Markets have proven fundamentally incapable of providing food security. Hunger is a “market failure.” Markets provide food for those who have enough money to buy enough food. Thus, hunger is inevitable in market economies because there always have been and always will be people

who lack the physical or intellectual capacities or opportunities to contribute enough economic value to society to allow them to buy enough food. Economic value is determined by scarcity, not necessity. Effective governance will always be needed to ensure basic food security and other necessities of life. Past government food assistance programmes have failed because they have been impersonal and thus inherently bureaucratic – rather than local. The taxpayers who have paid for food assistance have had no personal sense of connectedness or responsibility for the recipients. Those receiving food assistance have had no personal sense of appreciation or gratitude for those who have paid for the food. This has left state and federal government food assistance programmes vulnerable to gross inadequacy, economic inefficiency, fraud, and abuse. With community-based programmes based on the principles of food sovereignty, there would be strong personal motives to avoid, detect, and correct any inadequacies, misuse, or abuse of the programmes.

Thus, food sovereignty will require an approach to governance fundamentally different from food assistance programmes of the past. One promising potential model might be that of locally governed, cooperatively managed, “community food utilities”.12 In the US, public utilities are most commonly used in cases of “natural monopolies”, including public utilities for electricity, water, and sewers. In fact, public utilities are appropriate in any case of “market failure” – where markets cannot provide an essential public service for everyone in a community. Public utilities remove provision of such services from the economy to ensure that the needs of all are met. Food security is a market failure, which justifies the establishment of community food

utilities. One important difference between community food utilities and other public utilities in the US is that local farmers, processors, distributors, and food recipients would all be members and included on boards of directors. The utilities would be managed as “vertical cooperatives” to ensure sustainability of the entire local food system. The nutritional needs of food recipients would be met by means that give priority to local food producers and would ensure that their economic return are sufficient to support sustainable production practices. Current government food assistance funds would be integrated into the food utility. Educational programmes would help recipients learn to select and prepare raw and minimally processed nutritious food. Maximum nutrition at minimum costs – without compromising integrity. A community food utility also would provide a stable economic foundation for a sustainable local agri-food system that eventually could be available to all in the community, regardless of income, and could expand beyond the local community. If local food systems of the future are built upon a solid foundation of agroecology, every community could have its own local, community-based food system. Communities would not be “self-sufficient” in food production, but would give priority to buying local foods from local farmers who give priority to local markets. Food sovereign communities would connect through relationships of integrity and trust to create regional, national, and even global networks. The corporate-controlled industrial/global food system of today would be largely replaced by a community-controlled sustainable, local food network.

If changing the global system is viewed as an individual task, it may seem insurmountable. However, even national and global changes always happen locally – one person, one community, one state, one nation at a time. What’s most important is that each person can do his or her part in bringing about the changes that help make the world a better place to live and can create a better future for themselves and for humanity. No one needs to change the world by themselves; each person simply needs to do his or her part. As Pope Francis stated, “If we reflect on the proper relationship between human beings and the world around us, we see the need for a correct understanding of work; if we talk about the relationship between human beings and things, the question arises as to the meaning and purpose of all human activity”.8 “What is the purpose of our life in this world? Why are we here? What is the goal of our work and all our efforts? What need does the earth have of us? It is no longer enough, then, simply to state that we should be concerned for future generations. We need to see that what is at stake is our own dignity. Leaving an inhabitable planet to future generations is, first and foremost, up to us”.9 Agroecology is a science, a farming system, and a social movement. Perhaps most important it is a means of gaining a better understanding how the world works and our place within it, so we can find our purpose and fulfill our uniquely human responsibilities as members and caretakers of the earth’s integral community. What is at stake is not only the wellbeing of others of present and future generations but our own dignity and sense of self-worth.

REFERENCE

1. Agroecology Knowledge Hub. Overview. FAO of UN. http://www.fao. org/agroecology/overview/en/ , visited 27 Jan 2019.

2. Altieri, Miguel. Agroecology: principles and strategies for designing sustainable farming systems. University of California. http://www. agroeco.org/doc/new_docs/Agroeco_principles.pdf , visited 27 Jan 2019.

3. Carson, Rachel, Silent Spring, Boston: Houghton Mifflin Company (1962).

4. Carson, Silent Spring. p 15.

5. Francis. Encyclical Letter Laudato Si’ Of The Holy Father Francis On Care For Our Common Home. (May 24, 2015) para 139. http:// w2.vatican.va/content/francesco/en/encyclicals/documents/ papa-francesco_20150524_enciclica-laudato-si.html , visited 27 Jan 2017.

6. Francis, “Encyclical Letter Laudato Si, para 109.

7. Francis, para 114.

8. Francis, para 125.

9. Francis, para 160.

10. Germanos, Andrea. 'Overwhelming' Evidence Shows Path is Clear: It's Time to Ditch Industrial Agriculture for Good. Common Dreams, (June 02, 2016). http://www.commondreams.org/news/2016/06/02/ overwhelming-evidence-shows-path-clear-its-time-ditchindustrial-agriculture-good?utm_campaign=shareaholic&utm_ medium=facebook&utm_source=socialnetwork , Visited 27 Jan 2019.

11. Germanos, Common Dreams.

12. Ikerd, John. “Enough good food for all: A proposal. Journal of Agriculture, Food Systems, and Community Development. 7(1), p 3–6 (2016). http://dx.doi.org/10.5304/jafscd.2016.071.001 , Visited 27 Jan 2019.

13. IPES – Food, International Panel of Experts on Sustainability. From Uniformity to Diversity: A paradigm shift from industrial agriculture to diversified agroecological systems, (June 2016). http://www. ipes-food.org/_img/upload/files/UniformityToDiversity_FULL.pdf Visited 27 Jan 2019.

14. Klein, Naomi. This Changes Everything; Capitalism vs. The Climate. New York: Simon and Schuster, (2014) p 266.

15. Low, Sara et al. Trends in U.S. Local and Regional Food Systems: A Report to Congress. Economic Research Service, USDA (January 2015). https://www.ers.usda.gov/webdocs/publications/42805/51173_ ap068.pdf?v=42083

16. Low, Sara et al. Trends in U.S. Local and Regional Food Systems. p 30.

17. Nyéléni Forum on Food Sovereignty. Declaration of Nyéléni. (February 27, 2007). http://nyeleni.org/spip.php?article290 . Visited 27 Jan 2019.

18. Speth, James Gustave. The Bridge at the Edge of the World. New Haven CT: Yale University Press (2008). p 1.

19. Stiglitz, Joseph. The Price of Inequity – How Today’s Divided Society Endangers our Future. New York: W. W. Norton & Company. (2013). p 5.

20. United Nations, Framework Convention on Climate Change, The Paris Agreement. https://unfccc.int/sites/default/files/english_paris_ agreement.pdf . Visited 27 Jan 2019.

21. United Nations, Framework Convention on Climate Change, “Adoption of Paris Agreement,” Nov-Dec 2015, https://unfccc.int/ resource/docs/2015/cop21/eng/l09.pdf . Visited 27 Jan 2019.

22. USDA, ERS. Food Security in the U.S., Key Statistics. (September 5, 2018). https://www.ers.usda.gov/topics/food-nutrition-assistance/ food-security-in-the-us/key-statistics-graphics.aspx#foodsecure . Visited 27 Jan 2019.

23. Wikipedia. Food Sovereignty. https://en.wikipedia.org/wiki/Food_ sovereignty . Visited 27 Jan 2019.

Dr. John Ikerd

Dr. John Ikerd is Professor Emeritus of Agricultural Economics, University of Missouri-Columbia, USA. He received his BS, MS, and PhD degrees from the University of Missouri and spent 30 years at four major US universities. He has authored six books and dozens of journal articles. In 2014, Ikerd was commissioned by the Food and Agricultural Organization of the UN to write the report, “Family Farms of North America.”

Email: jeikerd@gmail.com

The Consumer Driven Path to Circularity through Future Pharmaceutical Packaging

In an age where sustainability has taken centre stage on the global agenda, industries are reimagining the way they operate in order to align with sustainability principles and the application of increased circularity practices. Across all industries, the call for environmentally sustainable products and responsible practices has initiated a transformation that touches every aspect of consumer behaviour and the companies that serve them. Drug delivery technology and pharmaceutical device manufacturers face a more challenging task. Their task is to find a way to achieve the intricate balancing act to be found between manufacturing capabilities, the consumer drive for enhanced sustainability, and meeting the stringent regulatory requirements that govern the pharmaceutical industry.

Demands for Circularity in the Pharma Space

Sustainability has become a major focus for companies across many industries around the world. In part, this is due to increasing consumer demand for more sustainability, including circularity and recyclability, in the products they select. Consumers interact directly with packaging systems from every industry, in their day to day lives. For most, a plastic drug dispensing device is not thought of much differently with respect to recycling and circularity than many common plastic consumer or cosmetic products. Both are predominantly made of plastic, both protect the product stored inside, and when the consumer finishes with them, both need to be disposed of in a responsible way. One major difference, however, is that the pharmaceutical product is subject to different regulations and performance requirements because of the criticality of its role in patient health. At the end of the day, consumers are increasingly expecting enhanced sustainability through circular and recyclable products. A recent Innova Market Insights survey found that consumer behaviour was the biggest contributor to plastic pollution.1 Therefore, one of the goals of the pharmaceutical packaging industry must be to find practical but safe solutions that allow the consumer to easily recycle product packaging. This would directly contribute to circularity and help reduce plastic pollution. One of the most pressing questions for the pharmaceutical packaging industry has become, how can it design products that deliver more circularity while also maintaining product performance and compliance with applicable regulatory requirements.

Current Gaps in Circular Plastic Usage

The vast majority of packaging systems are plastic based. This is largely because they represent some of the most lightweight, robust, versatile, and hygienic packaging materials available. As a result, plastics will continue to be consumed at increasing levels, which in turn will lead to increases in the amount of plastic waste generated. This is unless steps are taken to increase their ability to

be reused or recycled. For example, 40% of the conventional plastic consumed in the EU is destined for packaging applications, and without any intervention, the EU is expected to see a 46% increase in plastic packaging waste by 2030.2 A survey of global consumers also indicated that 61% of respondents believed the increased use of plastic packaging seen since the COVID-19 pandemic was necessary for safety reasons,1 even if the increased use was viewed as undesirable. 72% of the same consumers surveyed also believed that plastics currently offer average or above average recyclability, despite much poorer real-life recycling rates and the notable global explosion of plastic pollutants. In reality, singleuse plastic consumption is at an all-time high, with the ratio of new conventional plastic to recycled plastic feedstock is still at 15:1.3 This represents a huge opportunity to expand plastics circularity through increased plastics recycling. Achieving much higher plastic recycling rates across all industries, helps reduce overall plastic waste. Optimising all steps of the recycling process, qualitatively and quantitatively, will contribute to generating higher quality recyclates, potentially leading to circular feedstock that is suitable for use in pharmaceutical packaging applications. We know that the principle of circularity is supported by consumers with respect to their packaging choices. Encouragingly, over half of consumer survey respondents (52%)1 indicated they are willing to pay more for products that come in recyclable packaging systems, clearly demonstrating their willingness to participate in initiatives that bring about more circularity. Aptar Pharma conducted its own international consumer insights survey that found waste recycling was “important”, if not “very important” to the vast majority of respondents4 (Figure 1A). The majority of the consumers surveyed affirmed that they at least sometimes considered the recyclability of a product when they buy it (Figure 1B). Over 80% of respondents confirmed that they would even prefer to buy a product that could be reused (Figure 1C). Consumer demand for products with enhanced recyclability and circularity is clearly growing.

A: Surveyed consumers consider it important or very important that their waste can be recycled. Almost 70% of respondents in the U.S. and in the Netherlands consider waste recyclability to be important, whereas an average of nearly 80% of respondents from European countries including Italy, Germany, Poland, and France think it is important to very important.

types, but an extension until 2035 has been granted for packaging that meets the definition of primary pharmaceutical packaging under Directive 2001/83/EC or medical devices under the Medical Device Regulation (MDR) 2017/745. Qualifying Medical or Primary Pharmaceutical packaging/devices will be exempt from composting or recycled content requirements and will not be required to be refillable or reusable. These exemptions are largely due to the critical nature of drug delivery devices intended for medical purposes. It is expected that under the new EU directives, any packaging placed on the EU market after January 1, 2035, will need to demonstrate a minimum recyclability performance of 70%, although these recyclability performance measurements have not yet been clearly defined. Many pharmaceutical packaging companies have already started the potentially lengthy and complex product optimisation process so they will be in a position to offer packaging solutions that can meet these strict regulations when they become effective.

Recycling Plastic Packaging Today

B: Recyclability influences the consumer buying decision, as seen in the European countries (Italy, German, Poland, and France) where 66–75% consider product recyclability in their buying decisions, whereas 55–58% consider recyclability in purchase decisions in the U.S. and the Netherlands.

C: Surveys show that products that feature “reusable” or “refillable” packaging have the strongest impact on the consumer’s buying decision. More than 80% and up to 94% of surveyed consumers responded that they prefer to buy a product that can be reused, demonstrating their demand for more circular packaging solutions.

Figure 1: Aptar Pharma conducted a 2023 global consumer insight survey in 8 countries, investigating consumer attitudes towards recycling, recyclability of products, and reusable or refillable packaging solutions.

Minimising conventional plastic consumption can only be achieved through implementing enhanced recycling strategies. The global packaging industry can contribute to circularity through reduced plastics use and improving the recyclability of their packaging. Pharmaceutical and consumer goods companies who apply robust action plans with achievable targets, must also apply innovative approaches that consider medical performance and strict regulatory requirements.

Pharmaceutical Packaging Macro Boundaries in the European Union (EU)

Pharmaceutical packaging companies are subject to considerable and increasingly strict regulations when it comes to their packaging systems. Along with shifting consumer sentiment towards demanding enhanced sustainability of packaging systems, the regulatory environment is changing as well. The EU published its draft regulations on packaging and waste on November 30, 2022, with a final version expected in 2024. This will become binding law for EU member states covering all packaging

Even when the latest plastic packaging systems can meet the new regulatory requirements, how will they actually be recycled? There are many differences to be found in current recycling streams around the world. Some streams are more advanced and can efficiently separate and recycle a range of plastics, while other jurisdictions offer very limited recycling capabilities. The countries that are the most advanced in recycling, are typically developed economies with strong regulatory environments, like Western Europe and Japan. According to the OECD global plastics outlook 2022, only 9% of global plastic waste is being recycled per year (evaluation based on 2019),5 which points to a huge opportunity to increase the amount of successfully recycled plastics. Despite the large quantity of plastic items being put into many recycling streams, a large proportion of them are either unrecyclable plastics or unsortable items that end up incinerated or in landfills. It is the duty of the packaging industry to design product packaging systems that consider, not only the product’s recycling requirements at the end of their life, but also how they will be handled within existing recycling streams. This consideration has the potential to increase the proportion of plastics that are successfully recycled, which in turn can contribute to the availability of higher quality recycled plastic feedstocks. If the plastic packaging industry took a more harmonized approach to packaging design that considered these important parameters, the result could be a more consistent recycling process that produces less plastic waste and more high-quality recyclate.

Certified for Recyclability

As regulations are still pending on packaging design for recyclability, it is important for packaging producers to rely on independent organisations and laboratories who are experts in packaging collection, sorting, and recycling to determine their relative success. Each organisation applies their own consistent and standardised methodologies to provide an objective evaluation of the recyclability of individual packaging systems. Otherwise, how could customers and end users be able to determine which packaging systems are the most recyclable? In Europe, two of the most recognized organizations with this role include cyclos-HTP and RecyClass. They can evaluate semi-finished packaging systems, as they do for Aptar Pharma, or they can assess complete finished products submitted by the product owners. These organisations can incorporate the compatibility of a material with a specific recycling stream into

their score, and also reflect the ability of recycling facilities to sort and recycle individual packaging systems which can vary greatly from country to country. Both cyclos-HTP and RecyClass have built their own methodologies, each considering a variety of different factors and perspectives which can contribute to each arriving at somewhat different results for the same product.

The two organisations also use different terminology in their rating systems. Cyclos-HTP provides a class rating of AAA+ to C including a corresponding percentage of recyclability, while RecyClass uses a simple alphabetical rating scale that ranges from A to F.

Until there are harmonised recyclability standards around the globe, these large independent organisations provide the best opportunity for primary packaging manufacturers to determine the relative recyclability of their packaging systems using standardised criteria. With continued uncertainty around pending applicable regulations, packaging manufacturers will need to remain flexible and adapt to changing regulations and continued variations in local recycling streams to achieve their sustainability objectives as measured by recycling classification organisations.

Strengthening your Circular Approach

The challenges facing the packaging industry have been closely studied by Aptar over many years. The result has been, the implementation of a number of cross company initiatives and the setting of ambitious sustainability goals captured in the company’s 2022 Corporate Sustainability Report. Aptar recognizes circularity as having the greatest potential to improve packaging sustainability and is a core focus for the organisation. Greater circularity helps to address climate change while delivering measurable benefits to both customers and consumers. In order to achieve its objectives, Aptar doesn’t just develop sustainable solutions in isolation. It also leverages cooperative partnerships with industry leaders and organisations who have aligned goals, and can help achieve system level change, overcoming collective barriers that Aptar could not on its own.

Futurity™ - Aptar Pharma’s Sustainable Solutions Platform

Futurity™ represents all of the initiatives that live at the core of Aptar’s strategic solutions to achieving enhanced environmental sustainability. Some of Aptar’s key sustainability initiatives include:

• Designed for Recycling – Enhanced recyclability of packaging systems is the foundation of a functioning circular economy. Aptar Pharma designs its new dispensing systems to be easily and reliably recycled. We consider the recyclability of our new systems from the earliest design stage, including each and every individual component.

• Reducing the CO2 Footprint – Reducing or eliminating the use of technical plastic materials or energy intensive metal components help us to reduce the CO2 footprint of our products.

• Use of Alternative Materials – Aptar Pharma offers the use of bio-based alternative materials like renewable feedstocks as a bio-based alternative to conventional fossil-based resins, reducing the CO2 footprint of their packaging systems. However, these resins are not currently accepted by the Science Based Targets initiative (SBTi) which helps to define

best practices in emissions reduction and reaching net-zero targets.

Another option is the use of chemically recycled resins. This alternative material consists of used plastic that has been broken down to its molecular level through a chemical process. Feedstock generated from this innovative approach can potentially be used in pharma or medical applications as these materials meet the same quality requirements as conventional fossil-based resins. Some countries have suggested users of chemically recycled resins should be eligible for exemption from future plastic use taxes to encourage their adoption.

• Refill-, Reload- and Reusable Solutions – Aptar continues to invest in the development of refill, reload and reusable solutions, primarily in the Beauty space. Based on this experience Aptar Pharma investigates packaging solutions that can meet product safety and handling requirements for pharmaceutical applications.

Aptar Pharma assesses potential Futurity™ products against a number of key criteria such as recyclability, emission reduction, weight reduction, reusable/refillable capabilities, and recycled content, as well as any recyclability classifications provided by external organisations. Using its proprietary EcoDesign tool, Aptar Pharma designs new product solutions for optimal recyclability. Our developers attempt to eliminate recycling disruptors such as metals or aim to create mono-material solutions that can conveniently be fed into existing recycling streams. Aptar Pharma’s Futurity™ solutions are aimed at improved circularity in the drug-delivery market and the Futurity™ mark helps pharmaceutical manufacturers to make the more sustainable choice when it comes to selecting dispensing systems for their medical products. In an evolving regulatory landscape, where recycling streams and manufacturing processes are continually upgraded to allow for a more circular flow of resources, Aptar Pharma will simultaneously adapt its Futurity™ criteria and solutions to reflect the current environment. For example, even though a device may be too small to be reliably sorted by currently available recycling stream technology, products are being developed with the expectation that recycling technologies will continue to improve and deploy more efficient sorting and recycling processes going forward. Futurity™ represents the drive to always look ahead to future regulations, future technologies, and future realities.

Futurity™ – A Growing Family

Futurity™ is in its inception. Aptar Pharma has launched a number of projects and products that were designed to provide more circularity and sustainability, meeting the requirements of the Futurity™ brand (Figure 2). Some examples of Futurity™ solutions include:

Aptar Pharma’s Proventu mono-material polypropylene (PP) closure for dermal drug delivery earned the Futurity mark for its enhanced recyclability, when combined with matching material tubes.

Our multidose Ophthalmic Squeeze Dispenser (OSD) saves a significant amount of plastic waste and reduces the CO2 footprint when compared to single dose blow-fill-seal eye dropper formats.6

Figure 2: Futurity™ is Aptar Pharma’s platform of sustainable solutions, that has a focus on enhancing circularity in drug delivery, and reducing the CO2 footprint of pharmaceutical packaging solutions through a variety of means. Solutions range from recyclable packaging and drug delivery solutions, to the significant reduction of packaging material through multidose solutions. Aptar Pharma’s Futurity™ solutions also include the use of renewable feedstock and supporting the use of low-global warming potential (GWP) propellants in next generation pMDI solutions.

Aptar Pharma is working closely with customers to update their pressurised metered dose inhaler (pMDI) valves and devices to accommodate new lower Global Warming Potential (GWP) propellants for an improved environmental impact. This involves partnering with customers through a complex and multifaceted process that includes activities from valve optimisation to providing in-depth regulatory support.

We’ve also achieved high recyclability ratings from cyclosHTP for our Airless+ and BOV technologies, both designed with recyclability in mind.

Aptar Pharma supports the use of circular or alternative materials. Relevant Aptar Pharma sites have achieved ISCC PLUS certification in preparation for the implementation of a mass balance approach with alternative materials.

The First metal-free and Highly Recyclable Nasal Spray Pump Aptar Pharma recently launched its first metal-free, highly recyclable Advanced Preservative Free (APF) nasal spray pump system that met the sustainability requirements of the Futurity™ brand. The APF Futurity™ was specifically designed to enable the recycling of nasal spray packaging systems used to administer nasal saline or comparable OTC formulations. Removing metals and replacing specific parts of the pump produced a nasal spray solution made of only polyolefin materials, simplifying the recycling of the pump in existing recycling streams. According to Aptar internal Life Cycle Assessment (LCA) calculations, this reduces the CO2 footprint of the product by approximately 45%. The innovative polyolefin tip-seal and actuator bellows spring maintains spray performance as well as its preservative-free multi-dosing capabilities, all the while enhancing its recyclability. Consequently, the APF Futurity™ achieved a rating of highly recyclable (AA) from cyclos-HTP rating organisation.

Aptar found that nasal sprays with round bottles were not being efficiently recycled as they could roll from some automated sorting systems. To avoid this, Aptar Pharma designed a new oval shaped finger flange for the APF Futurity™. Its preservative free multi-dose capabilities reduces the amount of plastic waste and

provides an added benefit as it avoids the use of formulation preservatives, minimising the risk of preservative related side effect risks in patients. The whole polyolefin APF Futurity™ pump allows consumers to simply put the empty product into existing plastics recycling streams with no manual separation of components or disassembly required. The APF Futurity™ demonstrates that taking a holistic approach is crucial when designing products for more circularity and one should always consider material selection, current recycling processes and human behaviours in the design process.

Why a Highly Recyclable Nasal Spray Matters

The broader benefits of developing this highly recyclable nasal spray pump for administering nasal saline or comparable OTC formulations are measurable. Looking at the nasal saline market only, over 150 million such nasal spray devices are used annually and end up in landfill or the incinerator. Using a recyclable pump solution like APF Futurity™ could make these 150 million nasal spray pumps immediately suitable for recycling streams, which represents a major change in the circularity of such delivery devices.7 This new recyclable alternative could make a significant contribution to reducing plastic waste and contribute to the availability of more recycled plastic feedstock that can be used for other applications, avoiding plastic landfill and waste incineration.

Micro+ Futurity™ – Circularity in Dermal Drug Delivery

Aptar Pharma’s latest member of the Futurity™ family is the Micro+ Futurity™ semi-solid drug dispensing system. Based on Aptar’s long proven Airless+ technology platform, the Micro+ Futurity™ advances dermal dispensing systems with enhanced recyclability. Designed to protect and precisely dispense pharmaceutical formulations, such as lotions and gels, Micro+ Futurity™ is constructed entirely of medical grade polyethylene (PE) resins that meet today’s raw material requirements for the primary packaging of medicines. Our original Airless Micro+ systems were differentiated from many competitors by their all-plastic construction of both polypropylene (PP) and Polyethylene (PE) components. The new Micro+ Futurity™ system was constructed of only PE, resulting a truly mono-material drug dispensing system (Figure 3). These changes contributed to the Micro+ Futurity™ system receiving a “Completely Recyclable” or “AAA+” rating with 100% recyclable content from cyclos-HTP, which is their highest rating for recyclability. Aptar Pharma also considered how the product is used in the real world and how it will be recycled by

Figure 3: Micro+ Futurity™ is the mono-material evolution of Micro+ dispensing systems, a member of Aptar Pharma’s Airless+ range. To achieve a mono-material Micro+ solution, several functional parts of the actuator were replaced with alternative components made from polyethylene (PE), but still maintained the functional performance of the Airless+ system. The container and cap of the Airless+ Micro+ Futurity™ product were also replaced by polyethylene parts resulting in a truly mono-material dispensing system that achieved the highest cyclos-HTP rating of “complete recyclability” (certified for Germany and Netherlands).

and that does not require any

the consumer or patient when it is empty. The effortless emptying of Airless Micro+ dispensers starkly contrasts, how patients must struggle to squeeze the last drops of their valuable product from conventional foil tubes. With Micro+ Futurity™ systems, this also means the consumer easily gains access to almost the entire quantity of lotion or gel formulation, especially important for high value drug products, and because of its mono-material construction, it can be placed directly into existing recycling streams with no requirement for the consumer to disassemble and separate any of the materials (Figure 4).

Aptar Pharma fulfilled their mandate of designing new products that are worthy of the Futurity™ name. The Micro+ Futurity™ design process considered the technical requirements of product performance as well as compliance with regulations and built in circularity features that address patient demand for enhanced recyclability. Ultimately, Aptar Pharma made the Micro+ Futurity™ Airless drug delivery system so that it is easy for the end-user to place into existing recycling streams and feed it back into the circular supply of plastic resins.

Conclusion

The pharmaceutical packaging industry has a number of difficult challenges ahead of it with respect to circularity. Improving the recyclability of their primary packaging systems will take a multi-faceted approach that considers materials science, engineering, and regulatory requirements, as well as the real-world impacts of variability in recycling systems and consumer behaviours. Independent certification bodies like cyclos-HTP or RecyClass also play a positive role in defining the recyclability of the industry’s products through standardised assessments. Aptar Pharma has demonstrated its leadership position in the primary packaging industry by taking a holistic approach to device design that considers not only the properties of the device itself, but also the recycling streams they will be placed into and the behaviours of

the end-users that will recycle them. Futurity™ represents realised progress towards this goal, with APF Futurity™ and Micro+ Futurity™ being prime examples of this achievement. Although the industry is facing many evolving challenges to growing the circular economy, Aptar Pharma is ready to take the lead.

REFERENCES

1. Top Packaging Trends 2023: “Plastics circularization” leads sustainability charge amid greenwashing backlash, Packaging Insights, February 22, 2023. https://www.packaginginsights.com/ news/top-packaging-trends-2023-plastics-circularizationleads-sustainability-charge-amid-greenwashing-backlash. html#:~:text=22%20Feb%202023%20%2D%2D%2D%20Innova, increasingly%20stringent%20waste%20management%20regulations

2. European Green Deal: Putting an end to wasteful packaging, boosting reuse and recycling, European Commission, Press Release, November 30, 2022. https://ec.europa.eu/commission/presscorner/ detail/en/ip_22_7155

3. Minderoo Foundation’s 2023 Plastic Waste Makers Index - https:// www.nespsustainable.edu.au/minderoo-foundations-2023-plasticwaste-makers-index

4. Aptar Pharma Internal Market Intelligence, International survey responses reference 2023

5. https://www.dw.com/en/why-most-plastic-cant-be-recycled/a64978847#:~:text=With%20only%209%25%20of%20annual,crisis%20 doesn%27t%20add%20up.&text=Around%2085%25%20of%20plastic%20packaging%20worldwide%20ends%20up%20in%20 landfills%20.

6. All calculations have been made with Aptar’s Eco-design LCA tool. No third-party review was conducted. Secondary packaging / cartonnage has not been considered in this approach.

7. Aptar Pharma Internal Market Intelligence.

Dr. Stefan Hellbardt

Dr. Stefan Hellbardt is Vice-President Business Development and Scientific Affairs within Aptar Pharma's Consumer Health Care (CHC) division. As a trained biologist, he has held various positions in the pharmaceutical industry with established experience in clinical development. At Aptar Pharma, he leads the global business development for dermal drug delivery. In this role, he has been instrumental in delivering Aptar Pharma's expertise and services to customers developing pharmaceutical products for topical dermal application. As Head of Scientific Affairs CHC, Dr. Hellbardt leads a team of scientists supporting customers regarding Aptar Pharma's preservative-free products and material characterisation.

Julien Storz

Julien Storz is Director of Business Development within Aptar Pharma's Consumer Health Care (CHC) division. He holds a bachelor’s degree in business administration and has over 19 years of medical industry experience. Julien has held various positions in marketing, sales, and business development. Julien joined Aptar Pharma and the CHC Global Market Development team in 2019, where he is responsible for supporting business development efforts across numerous application fields in addition to driving CHC sustainability efforts.

Figure 4: Micro+ Futurity™ meets consumer demands for circular solutions: a completely recyclable drug delivery system, that can be put into plastic recycling streams

complicated disassembly or separation steps from the user.

Step-by-step Sustainability: How Nanoform is Shaping a Greener Future for Pharma

Pharmaceutical companies are working to drive more positive outcomes for patients, but to truly benefit patients and the world, it is critical for the industry to examine and improve the environmental impact of their medicine’s value chain. A 2019 study1 estimates that the pharmaceutical industry emits 48.6 CO2e (carbon dioxide equivalent) per million dollars. The impacts of climate change will pose a significant threat to global health,2 bringing about additional deaths from malnutrition, malaria, and heat stress; as such, it is the industry’s responsibility to safeguard human health and well-being by adopting a planet-centric approach to drug development and manufacturing. Many businesses within the sector have already begun working to increase the sustainability of their operations, with major pharmaceutical companies such as Merck3 and AstraZeneca4 adopting ambitious carbon neutrality targets for 2025 and 2030, respectively. When accelerating sustainability efforts across the pharmaceutical value chain, innovative technologies may hold the key to unlocking a greener future for the industry.

Sustainability in Pharmaceuticals

As with nearly every sector, the pharmaceutical industry is under significant pressure to manage sustainability risks.5 A range of issues face the sector including global greenhouse gas emissions and proper disposal of drugs and pharmaceutical waste. Therefore, the solutions must target every step of the product lifecycle.6 These include:

• Research and development methods

• Manufacturing processes

• Logistical operations

• End-use patient administration and disposal

Compared to other, more “industrial” sectors (such as mining or energy), the environmental impact of the pharmaceutical and healthcare sectors has received relatively little attention. Studies1 have specifically pointed out the “dearth of peer-reviewed literature on pharma emissions”. This has often led to the incorrect assumption that the sector is a green one. In actuality, the data that exist show that the pharmaceutical industry has a 55% higher emission intensity than the automotive industry.1 Altogether, the healthcare sector accounts for nearly 5% of global greenhouse gas emissions – the equivalent of a small country.7

Business leaders have recognised the need to build a more sustainable pharmaceutical industry as well. According to Global Data, 43% of respondents to a poll of stakeholders within pharma cited the environment as the segment of ESG (environmental, social, and governance) that needs addressing the most.8

Furthermore, government bodies have also begun implementing legislation designed to push the industry towards more sustainable practices. The European Commission’s proposal for a new Urban Wastewater Treatment Directive is emblematic of this, as government bodies move to tackle the environmental impact of businesses alongside leaders.9

In addition to this, businesses are also facing a changing competitive landscape, as sustainability becomes a more important differentiator within the pharmaceutical sector.10

The signs are clear – sustainability will only grow in importance for pharmaceutical business leaders in the years to come. If the industry is to meet this challenge and help transform every step of the value chain to be greener, it must adopt the latest, cutting-edge technologies.

Improved Bioavailability for Greener Outcomes

Bioavailability is a cornerstone of a drug’s therapeutic efficacy.11 However, it also has a significant impact on the manufacturing and environmental footprint of any given drug. By enhancing the bioavailability of a drug, businesses can potentially reduce the dosage of an active pharmaceutical ingredient (API) required to achieve a therapeutic effect – and, by extension, the quantities involved in manufacturing each unit of drug product. This can have a cascading effect along the value chain, not only reducing the environmental impact of the transport and shipping of materials, but also the cost. Low bioavailability is also a major reason that drug candidates fail to reach the market,12 with an estimated 70% of novel medications13 suffering from poor

solubility, leading to poor bioavailability. This contributes to wasted time and resources.

A variety of methods to improve the bioavailability of APIs exist within the pharmaceutical development sector. Spray-drying of amorphous solid dispersions (ASDs) is one of the most common, however it can be environmentally harmful as it uses large quantities of environmentally damaging organic hydrocarbon solvents.14 Research suggests that organic solvents make up 60% of mass consumption in the pharmaceutical industry,15 highlighting the need to find alternative, less environmentally damaging methods.

Nanoform’s proprietary Controlled Expansion of Supercritical Solutions (CESS®) is a cutting-edge nanoparticle engineering technology, which can increase the bioavailability of drug particles. It works by increasing the specific surface area of API particles, leading to significantly enhanced water solubility – and, by extension, increased bioavailability (see Figure 1). The technique uses GMP-grade CO2 recycled from local industrial side streams instead of harmful organic solvents.

• The CESS® process begins in a pharma grade 40 m3 CO2 tank that sits outside of Nanoform’s facility and feeds CO2 into pressure vessels.

• Bulk API powder is dissolved in CO2 in the pressure vessel at elevated pressure and temperature.

• This is then transferred through a pressure line where pressure is reduced slightly, by just enough to initiate

nucleation and control the particle formation.

• Once the nano-nuclei suspension is produced, it is then atomised into a collection vessel. In this step, the droplets rapidly expand and instantly freeze around the API nanoparticle, preventing the particles from aggregating.

• The result is nanoparticles in dry ice in the collection chamber, which resembles snow. The process is then stopped, and the pressure is reduced, allowing the CO2 to sublimate and leaving behind a dry nanoparticle powder. These particles can be utilised in dry formulations or wet formulations.

The process produces uniform nanoparticles that are tunable in size, shape, and morphology. This enables manufacturers to produce excipient-free, dry API nanoparticles directly from solution. Ultimately, the particles can achieve sizes as small as 10 nm, significantly increasing dissolution and therefore bioavailability.

How AI Can Enable More Sustainable R&D

By using technologies such as AI and digital twinning, manufacturers can drive more efficient R&D timelines as well as reduce waste and streamline drug discovery. Typically, companies test a number of drug design pathways to identify potential candidates in what is often a time-consuming, labourintensive and wasteful process. But by informing decision-making processes with AI, pharmaceutical companies can carry out in silico experiments to rule out drug design pathways that would have proved unviable.

Nanoform leverages this concept in its STARMAP® online platform – the digital twin of its CESS® process – which can characterise a molecule based on its physicochemical properties and its chemical structure. STARMAP® utilises these to predict its solubility in CO2, its propensity to crystallise, and whether it will produce an amorphous or crystalline end result. This information is then used to predict an API molecule’s success with the CESS® process. The technology augments experimental results with detailed expert knowledge and the power of sparse-data AI to allow reliable predictions of nanoformability. STARMAP® is used alongside CESS® to identify the candidate molecules compatible with the process, thereby ensuring labs invest resources in the

Nanoform’s CESS® is the only ‘solution-to-particle’ technology that can manufacture nanoparticles without organic hydrocarbon solvents, excipients and complex production processes.

Figure 1 – Nanoform data illustrating the link between particle size and surface area

The Controlled Expansion of Supercritical Solution – CESS®

Measured surface area (BET) and SEM particle size of nanoformed APIs

Figure 2 – The CESS® process stepwise

Nanoform uses captured CO2

Supercritical CO2 is guided into a pressure vessel loaded with API

The CO2 and the API are released from the pressure vessel and the flow, pressure and temperature profiles are actually controlled

In a collection vessel the CO2 is submitted resulting in final nanoparticles ready for collection and formulation

CESS® increases the specific surface area more thank 100x compared to bulk API

ADAPTATION

drug candidates with the greatest chance of success – and minimise waste from an environmental perspective.

Targeting Waste Downstream

Unused and expired medicines can pose a significant public health risk. The US produces over 3.5 million tons of medical waste annually.16 It has even been found that 11% of surveyed households possess residual medicines and 8% of medicine packs are partially or completely unused.17

Waste is often generated downstream when formulation and presentation routes do not align with patient preferences. Therefore, by aligning manufacturing processes with patient needs, pharma companies can create drugs that are both patient- and planet-centric. For example, one in six US adults report dysphagia,18 or difficulty swallowing. CESS® can potentially facilitate smaller pill sizes by decreasing the amount of API needed to achieve a therapeutic effect, leading to improved compliance for the many patients suffering from dysphagia. This empowers more patients to finish their drug courses, resulting in fewer discarded medicines and less overall waste.

Another way that CESS® can help to improve patients’ quality of life and adherence to treatment regimens is by facilitating alternative delivery routes. CESS® achieves this by producing API nanoparticles that are small enough to cross previously impassable biological barriers,19 such as nasal membranes, the corneal layers in the eye, or even potentially the blood-brain barrier. Traversing these barriers enables access to local delivery routes that bypass systemic circulation, leading to reduced adverse side effects and further strengthening compliance for patients. CESS® may also be able to reduce the initial burst release for long-acting injectables in combination with other approaches, leading to enhanced sustained-release

nanoparticle formulations. Opting for oral delivery and long-acting injectables instead of parenteral routes can also mean fewer hospital trips for patients, easing the process and resulting in better health outcomes for patients.

Alongside the enabling power of CESS®, the expertise of Nanoform’s pharmaceutical development team in a wide range of delivery routes – including oral, inhaled, injectable and ophthalmic – is key to unlocking the full potential of nanoparticle formulations and enabling more patient-friendly therapeutics. By doing so, improved outcomes are possible from an environmental and global health standpoint.

Forging the Pharmaceutical Industry of the Future

The facts are unequivocal – the pharmaceutical industry requires a rapid shift towards a more sustainable value chain. A crucial component of the future of pharma, the call for more sustainable drug development will only get louder. It is the responsibility of the sector to answer this call and respond appropriately.

Nanoform’s suite of proprietary offerings can help businesses with this transition, making every step of the value chain more sustainable. With Nanoform’s game-changing technologies, pharma companies can find solutions to their complex drug development challenges, enabling a better future for both patients and the planet.

REFERENCES

1. Belkhir, L. and Elmeligi, A. Carbon footprint of the global pharmaceutical industry and relative impact of its major players. Journal of Cleaner Production, 214, 185-194 (2019).

2. https://www.who.int/news-room/fact-sheets/detail/climatechange-and-health, visited on 6 October 2023.

3. https://www.merck.com/news/merck-accelerates-climate-goals-

announces-carbon-neutrality-in-operations-by-2025/, visited on 6 October 2023

4. https://www.astrazeneca.com/media-centre/press-releases/ 2020/astrazenecas-ambition-zero-carbon-strategy-toeliminate-emissions-by-2025-and-be-carbon-negative-acrossthe-entire-value-chain-by-2030-22012020.html#, visited on 6 October 2023

5. https://ecovadis.com/initiatives/pharma/, visited on 6 October 2023

6. Deloitte Centre for Health Solutions. Embedding environmental sustainability into pharma’s DNA. Overview report October 2022: Available at: https://www2.deloitte.com/content/dam/Deloitte/ uk/Documents/life-sciences-health-care[…]k-embeddingenvironmental-sustainability-into-pharma-dna.pdf

7. Watts, N. et al. The 2020 report of The Lancet Countdown on health and climate change: responding to converging crises. The Lancet, 397, 129-170 (2021).

8. https://www.globaldata.com/media/pharma/addressing-esgissues-may-help-pharma-repair-reputation/, visited on 6 October 2023

9. European Environment Agency. Waterbase - UWWTD: Urban Waste Water Treatment Directive – reported data. Published 24 September 2023. Available at: https://www.eea.europa.eu/en/ datahub/datahubitem-view/6244937d-1c2c-47f5-bdf1-33ca01ff1715

10. https://www.vetter-pharma.com/en/cdmo-insights/in-pursuit-ofsustainability-how-the-biopharma-industry-can-contribute/, visited on 6 October 2023

11. Price, G. and Patel, D.A. Drug Bioavailability. Updated 2023. Available at: https://www.ncbi.nlm.nih.gov/books/NBK557852/

12. Ahmed, S. S. J. and Ramakrishnan, V. Systems Biological Approach of Molecular Descriptors Connectivity: Optimal Descriptors for Oral Bioavailability Prediction. PLOS ONE, 7, (2012).

13. Bhalani, D. V. et al. Bioavailability Enhancement Techniques for Poorly Aqueous Soluble Drugs and Therapeutics. Biomedicines, 10, 2055 (2022).

14. Bhujbal, S. V. et al. Pharmaceutical amorphous solid dispersion: A review of manufacturing strategies. Acta Pharma Sin B, 11, 2505-2546 (2021).

15. Gallou, G. et al. Surfactant technology applied toward an active pharmaceutical ingredient: more than a simple green chemistry

advance. Green Chem. 18, 14-19 (2016).

16. Makki, M. et al. The Prevalence of Unused Medications in Homes. Pharmacy (Basel), 13, 7 (2019).

17. York Health Economics Consortium; School of Pharmacy, University of London. Evaluation of the Scale, Causes and Costs of Waste Medicines. Final Report. November 2010. Available at: https:// discovery.ucl.ac.uk/id/eprint/1350234/1/Evaluation_of_NHS_ Medicines_Waste__web_publication_version.pdf

18. Adkins, C. et al. Prevalence and Characteristics of Dysphagia Based on a Population-Based Survey. Clin Gastroenterol Hepatol., 18, 1970-1979 (2020).

19. https://nanoform.com/en/nanoform-and-celanese-demonstrateenhanced-drug-delivery-through-the-power-of-smaller-implants/, visited on 6 October 2023

Dr. Jamie Unwin

Dr. Jamie Unwin is the VP Strategic Insights at Nanoform, an innovative nanoparticle medicine-enabling company. Jamie's role is to help clients understand the value Nanoform's services and solutions can bring to their individual drug candidates, and portfolios as a whole. A twenty-year pharma industry veteran, Jamie and his teams have provided Insights to maximise patient, physician, and payer access to twenty three new drug launches. Jamie is a recognised opinion leader in the Business Insight world, and has held senior roles at GlaxoSmithKline, GE Healthcare, Janssen (Pharmaceutical Companies of Johnson and Johnson) and most recently was VP Enterprise Insights for Biocon Biologics. In addition to his role at Nanoform, Jamie is also a visiting lecturer at Imperial College Business School (London, UK) where he teaches classes on advanced analytics in healthcare.

Owen Mumford: Supporting Pharma Partners to Reduce Scope 3 Emissions

Analyses of the pharmaceutical industry’s carbon footprint often cite the same study, which found that the sector’s emissions are 55 percent greater than the automotive sector.1 Later studies point out that scope 3 emissions of the two industries – i.e., indirect emissions occurring in the supply chain – were not included in the comparison,2 most likely due to the additional complexity this would add. Yet this category often accounts for more than 70% of a business’ carbon footprint.3 Indeed, among the top twenty pharmaceutical companies, it is estimated that scope 3 emissions are the largest share of emissions, though reporting is varied and sometimes incomplete.4

Scope 3: The Next Challenge

Pharmaceutical companies are making good progress with scope 1 (direct, in-house emissions) and scope 2 (emissions from purchased energy) emissions. The above review of the twenty largest pharmaceutical companies concludes that nineteen companies have committed to reducing greenhouse gas (GHG) emissions, ten to carbon neutrality and eight to net zero emissions between 2025 and 2050.5 The study notes that, “Strategies to reduce emissions included optimising manufacturing and distribution, and responsible sourcing of energy, water, and raw materials.” This correlates with Owen Mumford’s own analysis of leading pharmaceutical companies; we found that the most mature areas where hard targets have been publicly set are energy, water, waste and air emissions.6

However, as in other industries, scope 3 is proving more difficult to address.7 Future targets are likely to have a greater focus on this area, and this is essential to meet ambitious targets set by healthcare providers. For instance, the UK’s National Health Service (NHS), which contributes around 4–5% of total UK carbon emissions,8 is aiming for net zero by 2040 for emissions controlled directly by the service, and net zero by 2045 for emissions it can influence.9 In the US, where the healthcare sector accounts for 8.5% of emissions, the Health Sector Climate Pledge commits to reducing greenhouse gas emissions by 50% by 2030.10

Owen Mumford’s Sustainability Initiatives

As a business with its own scope 1, 2 and 3 emissions, and as a supplier (and source of scope 3 emissions) to pharmaceutical companies through the Pharmaceutical Services division, we at Owen Mumford have been well aware of our responsibilities for some time. We were quick to recognise that we needed to dedicate time and effort to reducing our footprint as a matter of urgency, and that it should not be done by halves. There is both a social and commercial imperative – as outlined above – which made this investment a necessity.

B Corp Certification

It is difficult to begin this journey alone, without any third-party expertise or support, though many organisations (including Owen Mumford) now have sustainability experts in-house. Specialist organisations speed up progress by providing a framework for transition and keeping organisations accountable. This is why one of our first steps was to achieve B Corp certification,11 becoming one of the first medical device companies in the world to become a B Corp. The rigorous assessment covers company practices and outputs across five categories: governance, workers, community, the environment, and customers. We highly recommend going through this process to holistically strengthen Environment, Social and Governance (ESG) standards. There are currently over 7,000 Certified B Corporations,12 contributing to the development of sustainable best practice among businesses globally, and raising standards across participating organisations.

Science-based Target Setting

Similarly, we liked the premise of the Science Based Targets initiative (SBTi). Setting targets to align with the NHS or other organisations may be arbitrary and unrealistic. Using science-based targets, companies can determine how much and how quickly they need to reduce their GHG emissions to prevent the worst effects of climate change. The initiative provides target-setting resources and guidance, and then independently assesses and approves companies’ targets in line with strict criteria. We expect Owen Mumford’s carbon emissions to decrease by 42% over the next seven years, and to achieve net zero by 2045.13 This aligns with NHS objectives, reassuring any partners who work with us.

SDG selection

Owen Mumford has also selected five Sustainable Development Goals (SDGs) to focus on: Good health and well-being, 3 gender equality, 5 industry, innovation and infrastructure,9 responsible consumption and production,12

and of course, climate action.13 The latter three goals in particular complement our sustainability initiatives.

SDG13 FOR CLIMATE ACTION Efficiency Gains

Reducing the overall impact of drug delivery products comes with many challenges, given that these products are often single use only, to protect users from infection. However, it is possible to make initial easy gains by improving the efficiency of manufacturing premises and processes, i.e., scope 1 and 2 emissions.

At Owen Mumford, our UK and German sites use 100 percent renewable sources for energy. Solar panels installed at our UK sites have generated over 134,000kWh of clean energy in 2023 (to date), while solar panels at our Malaysian site are expected to generate approximately 420,000kWh this year, saving 288 tonnes of CO2. Adaptions such as LED lighting and movement sensors have been rolled out across all sites to reduce energy use. Thanks to these continued energy saving initiatives, our global energy usage for business processes is down by 8.4 percent in 2023, compared with the previous year. We are also supporting employees in reducing their own emissions, with electric car charging points available across our UK and German sites; the former will have points expanded in 2023 to facilitate our growing electric vehicle usage.

SDG9 FOR INDUSTRY, INNOVATION AND INFRASTRUCTURE

Owen Mumford’s New Centre of Excellence

Figure 1 highlights changes we have made at existing sites, but we have also been fortunate enough to create a brand-new site designed with sustainability principles high on the agenda. We are delighted that construction at the Centre of Excellence in Witney is now complete.

During design, we worked with conservation specialists to protect local flora and fauna, incorporating features such as bat and bird boxes, as well as hedgehog gates, to ensure

the local wildlife thrives. During construction, 97 percent of waste was diverted away from landfill – a real achievement. Once running, the centre will be powered by 100% renewable energy and its solar panels will generate over 11,000kWh of clean energy a year. Associates working at the site will benefit from its ergonomic interior, designed to support their well-being. To keep us on track and ensure each decision we make is anchored in sustainability, we partnered with the Trust for Oxfordshire’s Environment (TOE), an organisation that funds immediate and long-term investment in projects which enrich nature.

Thanks to these efforts, the building will be included in the top 25 percent of buildings assessed through the Building Research Establishment Environmental Assessment Method (BREEAM). The certification recognises top environmental, social and economic performance for buildings that protect natural resources during construction and enhance the well-being of those who use them.

SDG12 FOR RESPONSIBLE CONSUMPTION AND PRODUCTION Life Cycle Assessment

When examining the medical devices themselves, a holistic methodology is required to fully understand environmental impact at every stage of design and development, from raw material extraction and manufacturing to distribution and end of life. This methodology should allow immediate changes to products already on the market, as well as support the creation of entirely new – more environmentallyfriendly – products. The existing ISO Standards 14040 (14) and 14044 (15) provide a framework and guidelines for life cycle assessment (LCA) but they do not specify the methodologies or impact measures to be used, contributing to fragmentation and differences in reporting across the industry. As a result, it is hard to accurately compare the environmental impact of products from different manufacturers.

Figure 1: 2023 highlights in numbers

COLLABORATION

In this area too, we sought an expert partner, collaborating with a specialist sustainability consultancy to build our own lifecycle assessment tool. The tool measures the impact of new and existing product ranges and identifies opportunities for improvements across the entire product lifecycle. The tool uses Owen Mumford’s selected LCA methodology to score products in impact categories such as water and land use. Users can enter product specifications into the software to generate scores, instead of carrying out time-consuming research and calculations manually. Using the resulting data insights, we then refine product development in the early stages, until we reach satisfactory parameters for environmental impact in each category. This helps to avoid unintended consequences from the product’s manufacture and use.

The upcoming reusable auto-injector 16 that Owen Mumford Pharmaceutical Services has developed is an excellent example of why the LCA tool is a necessity. The auto-injector comes with the option of inbuilt connectivity via automatic Bluetooth® connection. Though the device is reusable, adding connectivity may impact the overall footprint of the product. Using the LCA tool, we can directly compare overall impact with previous auto-injectors, giving us full confidence in the final product. Moreover, as new materials and technologies are developed, we can continually improve the auto-injector’s sustainability credentials using this methodology.

Knowledge Pooling for Sustainability

High stakes in the drug development and delivery industry have understandably created a secretive and competitive

mindset among manufacturers. However, this mindset may be damaging for environmental objectives; businesses in the sector have been taking diverse approaches and measures, rather than working together to efficiently develop standardised methods and create more far-reaching change.

There is so much to consider when discussing sustainability in the pharmaceutical and medical device sectors that, without a collective effort and pooling of knowledge, achieving net zero goals will be much harder and slower. However, this is starting to evolve, with a clear focus on sustainability issues in pharmaceutical conferences, and the creation of dedicated associations and roundtables bringing organisations together to evaluate progress and share successful routes forward.

REFERENCES

1. The Conversation (2019). Big Pharma emits more greenhouse gases than the automotive industry. https://theconversation. com/big-pharma-emits-more-greenhouse-gases-than-theautomotive-industry-115285; cpi (2022). The future of the pharma industry can be sustainable. https://www.uk-cpi.com/blog/ the-future-of-the-pharma-industry-can-be-sustainable

2. Booth A, Jager A, Faulkner SD, Winchester CC, Shaw SE. Pharmaceutical Company Targets and Strategies to Address Climate Change: Content Analysis of Public Reports from 20 Pharmaceutical Companies. International Journal of Environmental Research and Public Health. 2023; 20(4):3206. https://doi.org/10.3390/ijerph20043206

3. World Economic Forum (2022). What is the difference between Scope 1, 2 and 3 emissions, and what are companies doing to cut all three? https://www.weforum.org/agenda/2022/09/

Figure 2: Owen Mumford's new Centre of Excellence in Witney, Oxfordshire

scope-emissions-climate-greenhouse-business/

4. Booth A, Jager A, Faulkner SD, Winchester CC, Shaw SE. Pharmaceutical Company Targets and Strategies to Address Climate Change: Content Analysis of Public Reports from 20 Pharmaceutical Companies. International Journal of Environmental Research and Public Health. 2023; 20(4):3206. https://doi.org/10.3390/ijerph20043206

5. ibid

6. Owen Mumford Pharmaceutical Services (2022). So Far so Good: Maintaining the Momentum of Progress for Sustainable Policies. https://www.ompharmaservices.com/wp-content/ uploads/2022/02/129_2022_Feb_PFS_Owen_Mumford.pdf

7. Booth A, Jager A, Faulkner SD, Winchester CC, Shaw SE. Pharmaceutical Company Targets and Strategies to Address Climate Change: Content Analysis of Public Reports from 20 Pharmaceutical Companies. International Journal of Environmental Research and Public Health. 2023; 20(4):3206. https://doi.org/10.3390/ijerph20043206

8. BMA (2023). More support needed to help the NHS reach net zero. https://www.bma.org.uk/what-we-do/population-health/ protecting-people-from-threats-to-health/more-supportneeded-to-help-the-nhs-reach-net-zero#:~:text=The%20 health%20service%20contributes%20around,of%20the%20 public%20sector's%20emissions.

9. NHS Supply Chain (2023). Collaboration With Suppliers is Key to Achieving Net Zero. https://www.supplychain.nhs. uk/news-article/collaboration-with-suppliers-is-key-toachieving-net-zero/#:~:text=Now%20onto%20the%20NHS%20 ambition,reduction%20by%202028%20to%202032.

10. The White House (2022). FACT SHEET: Health Sector Leaders Join Biden Administration’s Pledge to Reduce Greenhouse Gas Emissions 50% by 2030. https://www.whitehouse. gov/briefing-room/statements-releases/2022/06/30/ fact-sheet-health-sector-leaders-join-biden-administrationspledge-to-reduce-greenhouse-gas-emissions-50-by-2030/

11. Owen

Owen Mumford Joins the B Corp Movement!

https://www.owenmumford.com/en/responsibility/b-corp

12. B Lab Global Site. https://www.bcorporation.net/en-us/

13. Owen Mumford (2023). Carbon Reduction Plan. https://www. owenmumford.com/sites/owen-mumford/files/owen-mumford/ responsibility/carbon-reduction-plan.pdf

14. International Organization for Standardization. (2006) Environmental management – Life cycle assessment – Principles and framework (ISO Standard No. 14040:2006) https://www.iso. org/standard/37456.html

15. International Organization for Standardization. (2006) Environmental management – Life cycle assessment –Requirements and guidelines (ISO Standard No. 14044:2006) https://www.iso.org/standard/38498.html

16. Owen Mumford Pharmaceutical Services. UniSafe® 1mL Auto-injector. https://www.ompharmaservices.com/products/ unisafe-platform/unisafe-auto-injector/

Michael Earl

Michael Earl joined Owen Mumford as Director of Pharmaceutical Services in November 2020. He was previously the Commercial VP at Bespak, leading the commercial team there to drive growth in their substantial medical devices business. Prior to that, he worked for a number of pharma, biotech and device companies. In a career spanning more than 35 years, he has been responsible for all aspects and stages of drug and device development and commercialisation. Michael has also completed a substantial number of commercial, licensing and M&A transactions.

Figure 3: Installing solar panels at Owen Mumford's Witney site

Mumford.

Driving Sustainability in Drug Discovery: A Community Approach

The pharma and biotech industry is growing. While this brings the promise of new therapeutics for currently untreatable diseases, the increasing environmental impact of the industry cannot be ignored. As a significant contributor to the global climate change crisis, biotech and pharma must also be part of the solution, if the net zero by 2050 Paris Agreement is to be realised. But sustainability can only be achieved if the drug discovery community works together.

To support the sustainability efforts of the industry, ELRIG, Europe’s largest community of life science professionals, launched a new event, Sustainability Practices in Drug Discovery Research in April 2023 at St Hilda’s College, Oxford. At this forum, ELRIG brought together leaders who are driving sustainable practices in biotech and pharma with colleagues from across the industry to share ideas and learning. From the problematic accumulation of plastic waste to the vast volumes of water used, all aspects of sustainability were discussed. By coming together, and learning from each other, the pharma and biotech industry can unlock the sustainability opportunity, and benefit the wider, global community.

Ahead of the event, we spoke to three leading organisations as they explore why improving sustainability in drug discovery is critical to the health of the planet, the core areas they see as being important, and what the future of sustainable practices looks like. Each interviewee brings a unique perspective to the challenges that need to be overcome and demonstrate how a multi-angled approach to sustainability is required.

In this article, we hear directly from James Connelly, CEO, My Green Lab, a non-profit formed to unify scientists, vendors, designers and energy providers in a mission to build a global culture of sustainability in science. Joining James is Annie Lu, Co-Founder and CEO of H20k Innovations, an IoT-enabled analytics platform that provides data driven optimisation of industrial liquid systems for pharmaceutical development and manufacturing. And Carey Ann Comeau, Senior Director of Wet Lab Operations, Greentown Labs, a climatetch incubator that provides community, resources and laboratory space for startups and unites them with corporates, investors, politicians and many others to shape a sustainable future.

Why is Driving Sustainability in the Drug Discovery Industry So Important?

The total carbon impact of the pharma and biotech industry is significant. My Green Lab was one of the first organisations to quantity this, and we found that public companies in the biotech and pharma industry produce nearly 230 million metric tonnes

of carbon equivalent annually, which is equivalent to 578 natural gas power plants. When you realise that biotech and pharma produce more carbon emissions than forestry and paper, it really puts the scale of the challenge into perspective. And the industry is growing, so, if we’re going to solve the global climate change crisis, this is one of the industries we need to address. Ultimately, we have to be part of the solution.

The impact of pharma and biotech on planet health can’t really be argued. Data shows the industry is a significant contributor of carbon and waste and uses incredible amounts of energy and water. To me, sustainability in drug discovery in its purest form is the intersection between both environmental and social governance. By protecting the environment, we’re helping to protect public health. For this to become a reality, we need to think about sustainability right across the entire drug life cycle; from early discovery, to manufacture and getting it to the end user. CC: There are sustainable actions you can take no matter what industry you work in, no matter what kind of life you live. Often, when assessing areas to improve, we think about the largest greenhouse-gas-emitting sectors including transportation, electricity, manufacturing, buildings and agriculture. Frankly, drug discovery can fit into any of these categories. For example, new facilities can be built more sustainably, the transportation methods used to ship therapies can be greener, let alone improvements that can be made to reduce the waste caused by consumables. I was at the bench for over 11 years, I know how much I threw out, and I’m only one person. To me, it’s clear that driving sustainability in drug discovery can have a significant and positive impact on tackling climate change.

What are the Core Areas to Improving Sustainability in Drug Discovery, and How Can they Make a Difference?

I think sustainability can be improved in so many ways, and the difference they make will vary for each organisation. In fact, I’d encourage any organisation starting their own sustainability journey to recognise and embrace the freedom you have –choose where you start. It has to make business sense too, so it could be that you focus on reducing your water usage first, and then explore how you can best implement green chemistry

principles second. For other companies, they might best be served by assessing their cold storage capabilities to see if they can save energy. There really is no one size fits all solution.

There are a few core areas that jump out: consumables usage, the use of toxic chemicals, energy and water. Biopharma in particular is a very heavy user of water, and you see this in R&D labs in particular. And it’s not just the use of water and resulting wastewater. The treatment of wastewater itself uses a lot of energy and chemicals. Yet, without access to real-time data that shows how water is used, you’re essentially operating part-blind and can’t begin to identify ways you can reduce your water usage. With this in mind, I think enabling the collection of real-time data to measure and assess all aspects of waste production is crucial, which is what we focus on at H2Ok Innovations.

There’s another aspect that I also want to highlight, and that’s staff turnover. We see high staff turnover in many industries, including pharma and biotech. The challenge here is that knowledge gets lost. This can negatively affect sustainability, as if researchers who are experts in sustainable practices leave, their replacements may come in and start using less optimal ways of working, which can result in organisations taking a step backward on their journey to greater sustainability.

The importance of green chemistry shouldn’t be underestimated. If, at the outset, researchers can incorporate green chemistry principles to minimise the use of toxic chemicals and select more energy-efficient routes of synthesis, the benefits of doing so will be scaled drastically downstream when it comes to production and manufacturing. Having said that, sustainability does go beyond green chemistry. Even simple things like closing fume hoods or changing the set points of freezers can significantly reduce energy consumption. When it comes down to it, a single person can make a big difference.

What is your Organisation Doing to Aid Sustainability Efforts and What Do You See as Being Important to the Future?

H2Ok Innovations is a flexible, AI-powered operating system for any facility that uses water and other mediums of liquid on scale. The suite is modular, so the entire platform can be configured to meet the individual needs of each organisation. By using optical sensing and machine learning, we can measure various parameters to elucidate insights into industrial liquid and liquid-adjacent systems like never before. But why are we so passionate about this? In short, by analysing data and making recommendations, we actually cut the water usage of one of our customers by 10%. Now, imagine if we could help every organisation do that. Not only does it result in cost savings for them, but the environmental impact is also huge. To date, we’ve seen a lot of great work when it comes to identifying and setting goals that, when met, will help achieve sustainability in drug discovery. But now, we need to see organisations and individuals take steps to actually meet those goals. To do so, we need to think creatively and tap into non-traditional partners. Ultimately, what got us here today, might not get us to where we need to be tomorrow, so we need to continue to evolve our thinking and approaches.

We engage with researchers, organisations, and laboratory suppliers to unify and lead the whole life science community, including drug discovery, to a greener, more sustainable future. Dedicated to building a global culture of sustainability in science, we work with partners and supporters from small laboratories,

through to some of the scientific community’s largest corporations and institutions. The My Green Lab Certification programme provides scientists and the teams that support labs with actionable ways to make meaningful change. Labs that acquire the My Green Lab certificate often save money and preserve resources.

But we quickly realised that labs adopting change is only part of the puzzle. That’s why we introduced ACT certification for suppliers. This makes it easier for labs and procurement to choose more sustainable consumables, equipment, and chemicals. It’s this joined up thinking and combined efforts that we see as being critical to achieving sustainability in drug discovery and helping meet the UN’s net zero target.

At Greentown Labs, our members, partners and staff are united to solve the climate crisis through entrepreneurship and collaboration. To support our members, we provide thriving environments with access to the wet and dry lab space they need to develop prototypes and optimise their products, but that’s not all. By fostering innovation from various industries in one space, our members have a unique opportunity to learn from each other and make connections that could help them get their business to the next level. And establishing these relationships is something we passionately help with. We know who would benefit from collaborating across startups, investors and corporate companies, and frequently make those initial introductions happen.

Going forward, we really do believe that it will take a village to drive sustainability and combat climate change. By taking steps to reduce emissions and be less wasteful, the planet benefits, and organisations can save money – so why wouldn’t you join the sustainability movement?!

What Are You Waiting For?

It’s globally acknowledged that real changes have to be made now to prevent global warming from going above 1.5 ºC. As a large waste contributor and energy user, the pharma and biotech industry has to be part of the solution. To be successful, the whole community must come together to enact change and share learnings, which can then be transferred to other industries.

ELRIG

At ELRIG, we bring together all aspects of the drug discovery community, from large pharma to small biotechs, investors and academics. Our mission is to provide an open communication forum within which members can learn through sharing information and experiences, and network with other members. We run a series of open-access, free-of-charge conferences, webinars, and networking events to equip life scientists with knowledge of cuttingedge research areas with the potential to revolutionize drug discovery. Our flagship event, Drug Discovery, returns to Liverpool in October 2023.

Web: www.elrig.org

Animal Feed and Pet Food

The Cost of Safety, Innovation and Sustainability

In the mature market of animal feed and pet food manufacturing, safety and quality of products is viewed by consumers as an absolute and fundamental expectation. Going beyond that, claims of innovation and sustainability are key to differentiate products, to provide better positioning for meeting consumer demands and to generate product sales and market leadership.

Retailers are increasingly feeling the effect of sustainabilitydriven industry disruptions. Already feeling their margins pinched, retailers are among the first to gain or lose a competitive advantage from changing consumer demands for sustainable products, and retailers are aligning with these changing consumer demands.

Eighty-two per cent of grocery retail CEOs now cite sustainability as a key priority, 90 per cent of the top 50 global grocery retailers market their own private-label organic products and 68 per cent publish a sustainability report.1

Retailers are deploying multiple approaches simultaneously and requesting additional data, time commitments and other resources from suppliers in pursuit of sustainability goals.1

Organisations looking to validate their sustainability claims often turn to an independent third-party organisation. For example, NSF International evaluates three main pillars to determine if a supply chain is sustainable: the environment, the economy and animal/social welfare. Certain third-party organisations may look into the environment, the economy and the animal/social welfare to determine if a supply change is sustainable. Consumers will look for and select products and brands that stand for the “right” things as they see them. This can include (or exclude) social ethics, animal welfare and environment claims.

Understanding the direct and collateral impacts that accompany these perspectives and trends is where the real challenge lies.

General Supply Chain and Risk Management

The entire food supply chain must not just be aware of, but also accept, the appropriate responsibility for risk management and control at all points along the supply chain in order to ensure that the supply of animal feed, pet food and human food is fundamentally safe and meets sustainability pillars.

The industry of feed ingredient and feed and food manufacturing continues to have an ever-increasing degree of complexity. There are contributing factors including increased global trade in feed ingredients, feed novel ingredients, natural evolution of biological hazards, new technologies,

etc. Around the globe, there are differences in the priority of and/or emphasis on some or all pillars of sustainability. Every business is unique and global challenges impact supply chains in different ways.

Amplified attention to sustainable supply chains in retail has been driven by factors including brand reputation, risk mitigation, compliance and cost savings.1

All entities along the supply chain need to be able to demonstrate awareness about:

• What their supply chain is and where they are sourcing ingredients from

• The risks to food safety and sustainability in their supply chain

• What the targets and expectations within the supply chain are

• The process to measure and report on achievement of food safety and sustainability

Clearly mapping out a company’s supply chain is essential to any approach to responsible sourcing. This includes knowing the raw material sources and the complexity of supply chains. What are some challenges that accompany this trend? Understanding and evaluating a company’s supply chain is truly a difficult task, particularly when sources are global. Some companies have virtually integrated their supply chains to truly understand and manage them. The ability for companies to utilise software applications for clients results in

full transparency into their supply chains. Effectively managing supply can be achieved by:

• Establishing goals and policies to build a framework for the organisation

• Identifying key suppliers and commodities and working to uncover supplier best practices

• Engaging with suppliers to generate buy-in to goals and policies

• Leveraging technology to integrate data, allowing for easy data gathering, reporting and decision-making

Establishing and maintaining key stakeholder relationships and partnerships with entities within a supply chain must include strong communication. Communication based on and supported by good documentation and data is essential for the health, integrity and continual improvement of any supply chain. To ensure success of their sustainability programmes, retailers are engaging directly with suppliers to generate buy-in to retailer sustainability goals. Successful programmes make this a practice early, and it often can facilitate suppliers exchanging best practices.

Agriculture, livestock and poultry production, feed and pet food manufacturing face multiple risks that are dynamic, complex and interconnected; potentially threatening the security or supply of raw materials and the reputation of brands. Managing these risks requires the right strategies and policies, a clear understanding of supply chains and the ability to positively influence them – to ensure the long-term demands of the business are met.

Risk management should first be based on preparedness, prevention and reducing the hazard; then on eliminating any problem detected from the food supply chain. Risk management includes identification of the points of control to prevent, reduce or eliminate the hazard and the tools to detect and confirm effectiveness of those controls. Risk assessment is a critical factor that enables companies to truly understand their supply chains. These interventions can not only reduce risk to the business but may also create significant opportunities to differentiate the brand and sustain competitive advantages.

Companies must develop a strategic approach to responsible sourcing that is communicated within the organisation itself and throughout the supply chain; its effectiveness will be

impacted by how well the feed/food safety and sustainability commitments are understood.

Ultimately, quantifying sustainability impacts, setting and meeting scientific goals and targets is a difficult but crucial task. The framework outlined can be a useful guide for companies as they begin or expand upon their sustainability journey.

Regardless of where companies are in this journey, it is important to remember the broader purpose of measuring and setting sustainability goals. Customers, investors and regulating bodies are demanding data-driven metrics for a reason, and it is the company’s responsibility to respond to those demands with aggressive and scientific time-bound goals.

What is the best method for quantifying and reporting sustainability impacts?

Utilising corporate audit strategies in combination with third-party audits and certification programmes is key to verifying supply chain practices, policies and data. However, business sustainability requires having a reliable supply. It’s essential to minimise the operating overhead of suppliers and to provide clarity in responsible sourcing targets and immediate, mid-term and long-term expectations to achieve continual improvement.

Enhancing business intelligence involves analysis of large data sets and making use of the conclusions from that analysis to optimise opportunities for competitive advantage. When measurement begins, data is available. The cost and technology to collect, organise, analyse and interpret the data has to be addressed. With results in hand, the process of opportunity prioritisation can determine the relative cost, potential impact and importance of options to achieve ongoing programme success.

Drivers for Innovation and Sustainability

Consumers are becoming increasingly aware that their purchasing decisions can and do have impacts on the environment – from the choice and disposal or recycling of packaging to seeking more local goods and considering the impacts of manufacturing and agricultural operations. So, consumers demand and are willing to make their choices based on the evidence that a product has met higher standards of sustainability; they further demand greater transparency about the products and how they are manufactured.

Figure 1: Framework for Developing and Reporting Sustainability Metrics

This demand has a domino effect. It forces retailers and manufacturers to really examine how to achieve and then demonstrate that they are meeting consumer perceptions of sustainability. A broad spectrum of mechanisms can be implemented to achieve improved sustainability, ranging from minimal changes to thinking-outside-the-box innovations. In every case, though, this will ultimately impact a company’s ability to source sustainable ingredients.

Ingredient Sources

A current trend is integrating human-grade food products into pet food; for example, pet products made with ingredients such as blueberries, carrots and sweet potatoes are quite popular. A higher demand for human-grade ingredients increases the strain on the food supply system and there is current debate as to whether this is a sustainable process.

Using by-products from other industries where the primary product is for human consumption is viewed as having an important role in sustainability. Many companies have been focused on finding alternative markets for their “by-products” from the production of human food products.

Spent grains are a major waste product of the distillery and brewery industries. With the multitude of smaller craft breweries, the generation of spent grains is a growing source. If not used as a by-product, there is usually an associated cost for disposal. Local livestock producers have benefitted in some cases from the opportunity to obtain locally available, free ingredients, but with limited control of product safety, consistency and nutrient value. The companies providing the by-products are, in some jurisdictions, subject only to minimal requirements of feed safety, such as documenting and providing adequate storage for the by-product that keeps it free of harmful contamination.

Distillers grains are not new as an ingredient in animal feed. The fuel ethanol production industry is a continually growing source of distillers grains that are also used in animal feeds. This sparks ongoing interest and research into feeding and optimising the use of distillers grains in livestock feed. When corn is the fermented grain, there remains the challenge of monitoring of mycotoxins. The parameters of product quality are aligned with the primary product, which is not for edible use, thus there are potential gaps in measures of quality of a by-product.

Bakery, confectionery, fruit and vegetable processing all generate currently utilised by-products that can be found in livestock feed and pet food. Instead of letting fruits and veggies go to waste because they don't meet the cosmetic quality standards, “ugly” products are being used more sustainably by incorporation into livestock rations and pet food and treats.

The use of rendered animal protein continues to be a sustainably viable ingredient source in pet food. However, cases where there is recall of pet food containing pentobarbital has created a shock to the system and triggered extreme precaution. Some companies choose to narrow their pool of suppliers, refuse to accept ingredients from certain sources such as rendering operations or limit ingredients sourced from imports in order to remain viable in the market. Calls have been made to prohibit the use of deadstock in animal food and to take pentobarbital off the market. There have been

times when drug availability was severely limited, impacting the veterinary care of livestock. This has resulted in solutions such as research into improved detection methods, alternative methods of euthanasia, requiring euthanised animals to be permanently marked and pressure on the rendering industry to address the risk in its supply of incoming material.

Innovation for Types and Sources of Ingredients

Meeting global needs for human consumption impacts demand for products that are also traditionally found in animal feed and pet food, and pushes the thinking, thereby opening the door to innovative options.

Animal feed and pet food manufacturers are now being innovative and looking at alternative products – such as insects – as another form of protein. Insect-based agriculture has a much smaller environmental footprint (less resources are needed to cultivate this protein). In the EU, legislation defines insects reared for protein in the category of “farmed animals” and the International Platform of Insects for Food and Feed (IPIFF) published the 2019 Guide on Good Hygiene Practices for EU Producers of Insects as Food and Feed.2 The guidelines include recommendations on safety, biosecurity and prevention of adverse effects on environments. However, in order to generate insect protein in sufficient quantities as feed for livestock sectors, this requires large-scale production facilities. There is also the question of feed source for the insects. A sustainable insect chain may best rely on sources of animal protein as feed source for the insects, but prohibitions to use of this protein in feed for pigs and poultry force producers to seek sources from a specific list of approved materials of vegetal origin and/or animal origin.

Other innovative ingredient sources include oil from natural marine algae and protein derived from methane-eating bacteria.

Safe and Sustainable Pet Food Packaging

The push for innovation, particularly in the pet food market, goes beyond just the ingredients and products. Aside from the shelf appeal, there is also the consideration of quality. High barrier resistance capabilities in pet food packaging are important considerations in the protection against spoilage.

However, another key driver for consumers shopping for pet foods still relies on “look and feel”. Visual cues are essential to the buyer about all the things that matter – food safety, animal welfare, and ethical and environmental commitments. The packaging must also contain the label information consumers desire; labels such as “natural”, “organic” and “clean” are motivating sales as they often do in human food selections. 3 “Clean” can extend to both the food within the packaging through reduced ranges of ingredients, as well as to the packaging itself.

Packaging that is clearly linked to environmental sustainability promotes the overall “clean” platform. The target for design of packaging focuses on the use of biodegradable and recyclable bags. Packaging is being manufactured using recycled content or content from certified sources like Sustainable Forestry Initiative (SFI) or Forest Stewardship Council (FSC). Keeping in line with consumer desire for confidence in safety and freshness, resealable packaging and recyclable individual portion packaging are providing a solution.

However, the contradiction comes in the fact that a “cleaner” label pet food product, with fewer preservatives and other chemicals that have in the past contributed to quality over a longer shelf life, now have to have reengineered packaging that can keep microorganisms at bay. These reengineered packaging solutions often are not as amenable to recycling, so packaging manufacturers are looking to the other Rs (reducing and reusing) as potential options to promote.

Beyond Just Feeding Animals

Key recommendations for feed ingredient suppliers and feed and pet food manufacturers who want to source their ingredients more responsibly and sustainably are to:

• Understand and really know your supply chain and its associated risks

• Think outside the box when considering sources

• Set goals and communicate clear expectations for both food safety and sustainability

• Obtain third-party audits and certification to help verify supply chain practices, policies and data

• Capture and analyse the data gathered to provide insight into progress, roadblocks and areas to focus on

REFERENCES

1. Increasing Emphasis on Sustainable Supply Chains: Implications for Retailers and Manufacturers, NSF International, 2017, http://www.nsf.org/newsroom/white-papersupply-chain-sustainability-implications-retailersmanufacturer

2. International Platform of Insects for Food and Feed (IPIFF), Guide on Good Hygiene Practices for European Union (EU) producers of insects as food and feed, 2019

3. McMurter S., Pet Food Packaging Report–Key Trends and consumer insights on pet food brands (white paper), 2013

Elaine Vanier

Elaine Vanier is Technical Manager, Animal Wellness Programs at NSF International. She is responsible for leading standards development and audit delivery for NSF programs for animal health and welfare, animal feed and pet food. Elaine had a 26-year career with the Canadian Food Inspection Agency, where she held positions related to food safety, animal and plant health. She earned her BSc. Agriculture with animal science major at the University of Alberta and Doctor of Veterinary Medicine from the Western College of Veterinary Medicine. She is a member of the Canadian Veterinary Medical Association.

Nicole C.K. James

Nicole C.K. James is the Technical Scheme Manager at NSF International. She has over 25 years of experience in quality assurance, operations, product development and audit services within the food industry. She is currently involved in technical management as part of the NSF International Supplier Assurance team, and is affiliated with the NSF International in Guelph, ON, Canada.

Ryan Daly

Ryan Daly is the Senior Marketing Manager for Sustainability Services at NSF International, where he has held numerous roles in the sustainability and quality/ environmental management systems sectors. Ryan attended the University of Michigan and has worked at NSF International since 2014.

Net Zero Healthcare –Priorities for Decarbonising the Pharma Supply Chain

The climate and our health are inextricably linked. The effects of climate change on global health systems and outcomes are already clear, with WHO proclaiming it to be the biggest health threat facing humanity today.

And it’s projected to get worse over time. Every year between 2030 and 2050, climate change is expected to cause an additional 250,000 deaths.

Pharma, as one of the largest global industries, is both part of the problem and the solution for minimising the adverse effects.

A first-of-its-kind study by environmental engineers found the pharmaceutical industry is significantly more emission-intensive (13 percent more) than the automotive industry despite the sector being 28 percent smaller. Over half of these emissions are produced by supply chains.

Given this link and the seriousness of the situation we find ourselves faced with in the near future, the pharmaceutical industry has a unique responsibility to act. And act fast.

So, what progress is being made to decarbonise the pharma supply chain and help combat the negative health impacts of the climate emergency?

Latest Progress and the Health Systems Taskforce

As part of the Sustainable Markets Initiative, the Health Systems Taskforce (HST) was formed in 2021 at the 26th United Nations Climate Change Conference (COP26) in Glasgow, UK.

The HST is a public-private partnership set up with the collective and ambitious goal of decarbonising supply chains to help pharma organisations reach net zero. Taskforce members include senior pharma leaders and experts from NHS England, GSK, Roche, AstraZeneca, WHO and Unicef.

Actions focus on three priority areas: Supply Chain and Patient Care Pathways, Decarbonisation, and the use of Digital Innovation in Clinical Research.

Within these areas, the HST recommends eight levers to create low-carbon, climate-resilient health systems. These include product and packaging redesign to reduce material and energy use, increasing process efficiency to cut emissions and save costs with smarter data use, and cleaner transport, shifting to sea, road and rail freight instead of air and transitioning to electric or bio-based fuels within the fleet.

In November 2022, at COP27 in Sharm El Sheikh there was a call for greater cross-sector partnership to accelerate

action on climate as the world faces a critical juncture. Active Pharmaceutical Ingredient (API) supply chains were a key focus, addressing this shared challenge through the newly launched Activate programme.

COP27 also marked a major milestone for the Energize programme and the first buyers’ cohort for renewable electricity was announced. By enabling suppliers to reduce their Scope 2 emissions, the programme assists pharma manufacturers to reduce their Scope 3 emissions too. These are indirect emissions that occur in the upstream and downstream activities of an organisation.

It was also an opportunity for Big Pharma to engage with key stakeholders about their personal flagship decarbonisation programmes, and present how they are delivering this in key countries and through partnership.

Towards a whole Lifecycle View

All products and services have lifecycles. The lifecycle refers to the period from the product’s first launch into the market until its final withdrawal.

Traditionally, Product Lifecycle Management (PLM) has first and foremost been used to help companies understand and realise its position in the market compared to competitors and a product’s success or failure.

But having a unified view of the entire product development lifecycle with the ability to view and trace every detail throughout the entire process can be hugely valuable from a sustainability standpoint.

It’s important to consider the whole lifecycle of a medicine, from design and development and production to sale, consumption and disposal, to reduce pharma’s negative impact on the environment.

Different stages of the lifecycle produce different levels of carbon and other waste.

Product Development and Manufacturing

Pharmaceutical development and manufacturing require huge amounts of energy to output a comparatively small amount of Active Pharmaceutical Ingredient (API). Like any industrial process, where there is significant energy, there also tends to be significant waste.

Solutions to reduce energy-related emissions in the manufacturing process include on-site anaerobic digestion plants to treat hybrid waste, energy-efficient lighting and solar panels to power facilities using renewable energy.

Firms can also choose to install rainwater harvesting systems, solar panels, inverter driven machinery and reactive lighting designed to maintain a consistent lux output whenever an area is occupied, to robotics which increase production yields and accuracy with reduced input.

Packaging Design

Prioritising waste prevention from the outset of packaging design can also improve pharma’s environmental footprint.

3D visualisation and printing technologies are helping manufacturers meet their sustainability goals by being more mindful of waste prevention strategies and improving the quality of design. From the outset, manufacturers can plan and test their products’ efficiency to the highest standard, reducing the volume of substandard defunct packaging.

At this stage, packaging designers can also integrate key safety features into the core of their designs to limit the use of

multiple packaging materials. In doing so, packaging is both more efficient and easier to recycle. For example, printing product information directly onto the secondary packaging can reduce labelling materials while QR codes can allow patients to access their private information and specific dosage requirements without the need for excessive labelling.

Manufacturers are also experimenting with more sustainable materials for their packaging, with plant-based plastics becoming more readily adopted by pharmaceutical companies.

Astellas Pharma, for example, made waves switching to sugarcane-derived blister packaging in 2021 – a world first for biomass-based plastic for blister packages. Plant-based materials made up 50 percent of the raw materials used in its development while still providing the same protection function and usability.

The move to biomass-based materials could prove more common in the coming years as technologies evolve and consumer demand for sustainable alternatives grows.

Distribution

While manufacturing carries a large carbon footprint, the distribution of medicines from the factory and into patients’ hands also has a significant impact on the environment.

One of the most energy-intensive processes is delivering temperature-sensitive products, like insulin and some vaccines, from the point of manufacture to the patient within

LOGSTICS & SUPPLY CHAIN

the cold chain. Refrigerated vehicles require additional energy to power the cooling systems, known as transport refrigeration units.

The simplest way to reduce the carbon footprint of shipping is to use cleaner fuels and transport types, such as rail, road and sea freight instead of air.

Hydrotreated vegetable oil, a renewable, bio-based fuel that can be used in diesel engines, can reduce greenhouse gas emissions by up to 90 percent compared with diesel. Other alternative fuels include: compressed natural gas, liquefied natural gas, liquefied petroleum gas (LPG), and their renewable counterparts – biomethane and bio-LPG.

Localised manufacturing, or re-shoring, can also reduce the carbon footprint by reducing the miles the final product has to travel to reach the consumer. This approach optimises the amount of time a product needs to be maintained within a storage environment or shipped amongst the different transportation solutions.

Use and Disposal

Once waste and carbon emissions have been minimised in the product’s production and distribution, attention should focus on to how it will be used and ultimately discarded by the end consumer.

Currently, most medicine packaging – particularly primary – ends up in a landfill or is incinerated, losing its value as a material resource. So, brands must continue to think about not only innovative recycling methods but upcycling and repurposing materials too.

End users play a key role in the lifecycle of these products and must be committed to act alongside manufacturers. But this requires education initiatives, clear instructions and simple steps to follow to maximise compliance.

If materials cannot be recycled and re-introduced in the lifecycle, manufacturers must invent innovative ways to repurpose the discarded materials.

For example, Novo Nordisk has innovated a way to repurpose its insulin pens. Despite being mostly made of plastic, they cannot be put in plastic recycling bins. In response, Novo created a system that sorts the pens into many component parts and partnered with a Danish design company to make office chairs using the waste plastic and lamps using the discarded glass.

Data-driven Digital Transformation to Unlock Further Gains

Pharma is one of many industries trying to become smarter in collecting, analysing and leveraging the power of data to make decision-making faster, solving inefficiencies and meeting sustainability targets.

Historically, the transition from industrial-age to digital-era operating models has been slow.

Inflexible IT infrastructure is a barrier to digitisation, particularly making old and new systems interoperable. Pharma 4.0 demands the gap between the digital and physical is closed, allowing for a 365-degree view of business

operations. In a global supply chain, this can be difficult to achieve.

Supply chains are healthcare’s climate Achilles heel –technology that connects the lab to the marketplace is lagging. But recent advancements in big data technologies, machine learning and artificial intelligence are propelling digital strategies forward, unlocking sustainability gains.

Big data and AI have a synergistic relationship. AI requires large volumes of high-quality data to learn and improve decision-making processes. Over time, the more data the algorithm receives, the more accurate and efficient it can become – and so can pharma.

With greater automation and real-time data accessibility, combined with AI, pharma firms can collect, analyse and act on data insights before an issue occurs. It can also minimise human error, provide end-to-end visibility, and protect the integrity of supply chains.

Over time, AI will transform the industry’s operating models and help it achieve its sustainability targets. However, full digitalisation takes time and strategic thinking, and involves a fundamental shift from linear supply chains to dynamic, interconnected and open AI-enabled digital supply networks (DSNs).

The workforce will also need further diversification to ensure the industry has the skillsets and knowledge that matches its ambitious digital-driven aims.

Today, manufacturers that want to move into an end-to-end digital supply chain are increasingly leaning on external experts given the lack of dedicated teams with established knowledge on AI design thinking.

Tomorrow, the talent pipeline needs to be agile, digitally literate and open to continuous learning to maximise the opportunities these new technologies present pharma.

Steve Brownett-Gale

Steve Brownett-Gale is a marketing professional with a career spanning both communications and products in B2B and B2C markets across Manufacturing and Services sectors. At Origin, in his role as Marketing Lead, Steve is responsible for positioning the company as a world-leading supplier of innovative and ground-breaking pharmaceutical packaging devices, as well as offering a unique and disruptive supply chain model. Established 60 years ago, Origin offers customers a remarkable range of versatile packaging solutions that respond to the unique needs of the global pharmaceutical marketplace. Origin engages in the design, manufacture, and consolidated supply of pharmaceutical packaging, partnering with licence holders and CMOs.

Web: www.originltd.com

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