Is Pharma doing enough on sustainability?
pharmafile | July 20, 2020 | Feature | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | antimicrobial resistance, manufacturing, pharma, sustainability
Adoption of sustainable practices in pharmaceutical operations is ticking along, but given the environmental and health risks if this is not implemented as a matter of urgency, is progress coming fast enough? Matt Fellows investigates what measures pharma firms are taking in line with current guidance.
Sustainability has become an expectation of manufacturing operations as their effects on the environment become ever and disconcertingly clearer, but less is usually said of environmental pollution caused by pharmaceuticals. The truth is that it’s possible for pharmaceutical products to leak into the environment at any stage of their life, from production to consumption to disposal. As the 2019 UN Environment Global Environment Outlook puts it, “pharmaceuticals are commonly mishandled from cradle to grave.”
A 2013 report, ‘Study on the environmental risks of pharmaceutical products’, published on behalf of the Executive Agency for Health and Consumers, found that between 30% and 90% of an oral dose of a medication can ultimately be excreted in urine. This is a key consideration when it is taken into account that, in the design phase of a drug’s lifespan, active pharmaceutical ingredients are designed to avoid metabolic degradation, meaning they do not expire once they reach the environment, carried by wastewater or other means. Even in the event that wastewater is processed at a sewage treatment plant, it is not uncommon for these facilities to be unequipped to remove pharmaceutical pollution – the small size of many drug molecules means they evade the filtration systems present in many existing treatment plants.
While leaked pharmaceutical waste can eventually pollute aquatic wildlife or seep into agricultural produce and drinking water, which in turn has undue negative impacts including behavioural changes, reproductive failure and growth inhibition, perhaps the most concerning threat comes from the way in which it facilitates antimicrobial resistance (AMR).
AMR is attributable for 700,000 deaths worldwide due to drug-resistant diseases. In the European Union, there are more than 25,000 deaths per year due to AMR, costing the European economy over €1.5 billion in healthcare and lost productivity, and the true figures are thought to be higher still.
In 2019, the UN Ad hoc Interagency Coordinating Group on Antimicrobial Resistance warned in its report ‘No time to wait: Securing the future from drug-resistant infections’ that, if left unchecked, AMR could lead to 10 million additional deaths each year worldwide by 2050. In terms of economic impact, the report predicts it would be of similar magnitude to the 2007-2008 financial crisis and could push as many as 24 million into “extreme poverty”.
Given the gravity of these forecasts, decisive action to change course would seem imperative. But regulations to prevent pharmaceutical pollution vary widely worldwide. [Pharmafocus] reached out to Safer Pharma, a campaign led by the international nongovernmental organisation (NGO) Healthcare Without Harm and focused on protecting the environment from pharmaceutical pollution, to learn more about how this problem evolves on the global stage.
“A large part of the medicine consumed in Europe is being produced abroad for economic reasons. This is particularly true for antibiotics and generic medicines,” Jean-Yves Stenuick, Pharmaceuticals Policy and Projects Officer at Health Care Without Harm Europe, explained: “In the case of antibiotics, for instance, China produces 80-90% of their APIs, the biologically active substances, and Indian companies lead the production of ‘finished dose’ products.
“Pharmaceutical companies and their suppliers do not meet high manufacturing standards in these countries where there is often weak oversight and regulation. APIs are discharged into the wastewater during the manufacturing process and end up in the environment where they can have adverse effects on wildlife and ecosystems.
Touching on the threat of AMR as a result of these practices, Stenuick argued it plays “a crucial threat to human health, as antibiotics underpin modern medicine and play a key role in medical procedures such as chemotherapy, diabetes management, major surgery and organ transplantation.
“Worrying degrees of concentration have been observed. Near Hyderabad, India, the concentration of ciprofloxacin, a common broad-spectrum antibiotic used to treat a number of bacterial infections, in discharged water coming from manufacturing plants into a stream was so high it could treat 44,000 people – every day.”
While guidance has been given by leading authorities, Stenuick argues that it does not go far enough: “The WHO’s Good Manufacturing Practices (GMP), a set of minimum standards for pharmaceutical manufacturers, do not include environmental criteria. Environmental regulation encouraging companies to pursue more sustainable practices in their manufacturing processes is currently left up to national regulators.
“At the EU level, the European Commission published last year a strategy to address pharmaceuticals in the environment [2019’s ‘Strategic Approach to Pharmaceuticals in the Environment by the European Commission’]. It commits to encourage, through dialogue and cooperation, action in third countries where pharmaceutical emissions from manufacturing and other sources are suspected of contributing to the development of antimicrobial resistance.”
But in a letter signed by six NGOs, including Healthcare Without Harm, the signatories asserted that the European Commission’s strategy “fails to include key measures to mitigate the devastating impact of pharmaceutical pollution on human, animal, and environmental health.
“[The strategy] needs to become a stepping stone to a more comprehensive legislative framework with ambitious and binding measures to mitigate the increasingly serious impact of pharmaceuticals in the environment throughout their life cycle,” the letter argued.
Following commitments from global leaders on tackling AMR in 2017, over 100 pharmaceutical firms and industry organisations which hold responsibility for around a third of the world’s global antibiotic sales came together to form the AMR Industry Alliance. The alliance has worked to confront the issue, with its members committing to voluntary targets in order to reduce the industry’s environmental footprint.
In its 2020 progress report, the alliance revealed that 15 of its 18 antibiotic-producing members had conducted assessments of their manufacturing sites, with 82% meeting the standards put forward by the alliance. It also projected that, within three years, more than half of all products produced at sites owned by these 18 members would meet proposed targets for predicted no-effect concentrations of antibiotics in the environment; this extends to an estimated 88% of products within seven years.
While this paints a promising picture, the report also pointed to flagging levels of funding in late-stage research and development into developing new measures to fight AMR, arguing that it is currently not enough to meet global health needs. This is despite 56 of the Alliance’s members pooling $1.6 billion in 2018 for this purpose; the report argues that the onus here is on the government to invest, estimating the financial support from governmental sources over the same period was just $500 million.
“The overall investment figure is likely insufficient to deliver the tools needed to address AMR,” the report said. “Levels may further decrease in the coming years if governments do not take urgent action to improve antibiotic reimbursement systems and implement new incentives for development.”
The report raised the alarm on these investment issues in January on its release, and the world has changed very much since then. With the COVID-19 pandemic having erupted at such a rapid pace in the months that followed, completely rewriting economic projections as it went, it is surely a near-certainty that these problematic levels of investment will be exacerbated in the years to come.
With great power…
In lieu of legally binding regulation, what is the value of voluntary targets set by the industry itself? The 2020 progress report from the AMR Industry Alliance suggests that progress is being made, but Stenuick asserts that this is not enough: “Industry initiatives such as the AMR Industry Alliance and the Pharmaceutical Supply Chain Initiative (PSCI) exist, and while these initiatives are welcomed, there is much more to be done in terms of binding commitments regarding targets and transparency. We cannot expect the industry to self-regulate – an ambitious regulatory framework is needed.”
A key component to the success of any self-imposed commitments on pharmaceutical pollution is the understanding from pharmaceutical firms of their responsibility in confronting the issue. On this note, Pharmafocus reached out to AstraZeneca, which has recently been making headlines for its prolific commitment to scaling up manufacture of a COVID-19 vaccine jointly developed with the University of Oxford. With such a huge project accounting for just a fragment of its overall global manufacturing operations in the coming months and years, the company cannot afford to underestimate its environmental footprint.
Speaking to Professor Jason Snape, Head of Environmental Protection, and Juliette White, Vice President, Global External Sourcing, they explained that this responsibility at the pharma firm is a key concern for the company, making the interesting point that, “Currently, pharmaceuticals are the only class of compounds that are approved irrespective of environmental hazard and risk where the societal benefit is assumed to always outweigh any environmental impact.
“As pharmaceutical companies, it is essential that we take responsibility for identifying any environmental concerns as early as possible, so we can mitigate these risks and ensure patient access to medicines does not compromise environmental protection,” Snape and White continued. “Patients and society deserve products that have the smallest possible environmental impact, while not sacrificing medical efficacy or safety. As technologies and healthcare systems evolve, so too should solutions to reduce energy and material use, and waste generated from delivering life-changing medicines to patients. The pharmaceutical industry as a whole is making great progress, but still has some way to go in addressing environmental sustainability. Leading companies are setting ambitious targets that go beyond the aim set by governments around the world to be at zero carbon by 2050.
“Environmental sustainability is becoming an increasing factor in a pharmaceutical company’s commercial success. Shifting market demands are seeing healthcare systems take a holistic view of the complete care pathway; the environmental impact of the medicine itself, use of power and resources by the organisation and its supply chain, and the impacts of patients with poorly managed chronic disease.”
In striving to make good on these responsibilities, self-imposed targets – particularly those made in mutual collaboration with a wider group of key industry players – can have a number of benefits, Snape and White continued to explain. “Setting ambitious and long-term environmental goals means you are forced to innovate. And, in a world that’s changing fast, this matters more than ever if you are to be successful in the future. For pharmaceutical companies like AstraZeneca, driving innovation to protect natural resources is perhaps even more important, given that it takes many years to bring a medicine from early discovery to patients.”
Like others in the industry, the company has committed to zero carbon emissions from operations across the world by 2025 and to ensure its entire value chain is carbon negative by 2030 as part of its Ambition Zero Carbon programme. But this is just one part of its plan on pharmaceutical pollution.
“We have initiatives in place to identify and address the environmental impact of products from discovery in early R&D through to launch of a new product and during its commercial lifetime to end-of-use. We evaluate all materials and all processes used to make our products. By emphasising the environmental stewardship of our products, we address other critical material focus areas including responsible R&D, responsible supply chain, greenhouse gases, pharmaceuticals in the environment, water and waste. So, we strive to design out negative environmental impacts, including natural resource depletion, waste, and emissions to air, water and land.
“Engaging supply chains and employees is equally critical. A large supply chain amplifies impacts on society and the planet, both the positives and negatives. In our industry, success depends on a resilient, transparent and inclusive supply chain that supports responsible development and manufacturing. We interact with an extensive network of suppliers globally, and this reach gives us the opportunity – and responsibility – to promote practices with our suppliers that are socially and environmentally sustainable.
“And environmental impacts do not end with the packaged product. To address the polluting effects from the distribution of our medicines, we have implemented improved transportation solutions – switching from air to sea, which is less carbon intensive and pollutes less. In 2019, 62% of freight of our transportation was converted from air to sea.”
Hope for the future
While it is great to see industry giants like AstraZeneca lead the way in shouldering the responsibility that drug developers and manufacturers bear, is this enough in the absence of legally enforceable regulation? As Stenuick notes, the Safer Pharma campaign continues to call for the industry to “develop clear processes to control the release of pharmaceutical effluents into the environment throughout the supply chain,” arguing, “The pharmaceutical industry cannot turn a blind eye to this problem anymore. It cannot be accepted of an industry, even less so of one that aims to improve the lives of patients, that it pollutes the environment and threatens human lives, nor that it outsources its pollution abroad. It needs to address the environmental implications of production to fully meet the objectives of a green economy.”
The campaign may get its wish later this year when the European Commission is due to release a new pharmaceutical strategy, hopefully addressing the concerns raised by NGOs over gaps in its guidance released last year. Stenuick mused: “It is expected that it will seek to improve the assessment of environmental risks and strengthen the regulatory framework to address the environmental implications of production, use and disposal of medicines to meet the objectives of the European Green Deal.”
Efforts to push forward a more sustainable agenda for pharmaceutical design and production continue despite a global pandemic diverting resources and attention. Progress rolls on with or without more stringent regulation, but the one certainty is that there is more work to be done, and Snape and White believe that collaboration is the key to making that happen: “It’s clear that we collectively need to do more to mitigate the environmental impacts of our industry, and there are no easy solutions to these challenges. They require sustained, long-term action from governments, corporations and NGOs, all playing their part. Smart, forward-looking policy helps companies to prioritise, innovate and align to solutions that will be good for society and good for business to help individuals and economies prosper.
“Collectively, we must collaborate – not only within but beyond the healthcare industry – to put societal and environmental health at the forefront of economic prosperity and co-invest rather than compete for natural resources to meet business demand.”
Astellas Pharma has announced that it is preparing to submit a planning application to build …
The technological pharmaceutical company IMIDEX has been granted clearance from the US Food and Drug …