Five minutes at CPhI worldwide with …
Chemistry Today /Pharma Horizon: You offer a lot of antibiotics. Do you work also on antibiotic resistance (AMR)?
Alice Beijersbergen: Antibiotic resistance is one of the major health threats humanity is facing today – we are rapidly moving towards a post-antibiotic era where this class of medicines will not be useful anymore. It is estimated that if we do not do act now, 10 million people will die annually from multi-resistant bacteria by 2050, with a cost to the world economy of 100 trillion US$. Overconsumption in humans and misuse in agriculture are key causes of antimicrobial resistance. Another important, but formerly largely neglected key cause of AMR, is environmental pollution linked to antibiotics production.
With AMR and superbugs rising to dangerously high levels in all parts of the world, tackling the key causes has become paramount. The overconsumption and misuse of antibiotics among humans and in agriculture and aquaculture, are major drivers of resistance. The problems worsen with the environmental angle of AMR, including the relentless discharge of antibiotic waste by hospitals and pharmaceutical industries.
The significance of the problem was first published in the final report of the AMR Review, an independent global authority on AMR, which estimated that the pharmaceutical supply chain possibly releases around 30,000 to 70,000 tonnes of antimicrobial activity waste annually. An increasing number of scientific studies on industrial antibiotics pollution, report high concentrations of antibiotics in close proximity of some pharmaceutical plants in India and China. Some report concentrations higher than found in patients undergoing treatment, whereas others report levels that are hundreds, thousands, and even 10,000 times higher than clean water, and extensive presence of drug resistant bacteria and genes. Our Sustainable Antibiotics Program, which we started in 2014, calls on the industry to stop buying, using and selling irresponsibly made antibiotics, and thereby reducing further rise of AMR. We take responsibility ourselves through responsible production and waste management measures, which are implemented at all our sites around the world, and call on and work with industry partners to do the same. Next to this, we actively engage with a wide range of stakeholders to create awareness on AMR, address access issues and irresponsible use, and the environmental angle of AMR. This includes the need to work towards sustainable models for antibiotics manufacturing, effluent management and treatment of antibiotic residues in waste.
CT/PH: How do you face such a crucial challenge?
AB: DSP’s activities focus on the responsible production of antibiotics, a topic in our generics antibiotics producer’s direct sphere of influence. Our approach is multifaceted and involves improvement of our own manufacturing through using the best technology available with the lowest environmental impact throughout the supply chain, operating dedicated wastewater treatment plants 24/7 all year around at all our antibiotic manufacturing sites, and applying antimicrobial activity testing (using our in-house developed antimicrobial activity (AMA) test) to ensure disposed water is clean. Beyond improvement of our own production, we are also assessing our full supply chain, for example by the introduction of our own AMR Supplier Survey. We are actively engaging with a wide variety of external stakeholder authorities to support measures reducing the environmental impact from production of antibiotics and cater public-private engagement and collaboration on AMR. Last, but not least, we have taken on a high-profile campaigning role in the fight against AMR by calling on both the industry and the entire value chain to act responsibly and stop buying, using or selling irresponsibly made antibiotics.
CT/PH: Can you tell us more about this high-profile campaigning role?
AB: We work closely with public agencies (UN, WHO), local governments including ministries of health and environment, national Centers of Disease Control, national environmental bureaus, NGOs, think tanks, scientists, the AMR Industry Alliance, Pharmaceutical Supply Chain Initiative (PSCI), and business relationships. We also supported some governments in drafting their National Action Plans (NAPs) on AMR. We are spearheading an awareness campaign for public, customers, employees, suppliers and authorities. In this campaign we proactively approach media, and organize seminars, workshops and multi-stakeholder events. With these initiatives we aim to increase awareness on environmental pollution as important cause of AMR, and call on all players in the industry – from ingredient, API and drug product manufacturers, to pharma companies, distributors, wholesalers, insurers and retailers – to buy, use and sell antibiotics responsibly.
Next to this, we are a signatory of important industry-wide initiatives, like the Davos Declaration and the UNGA Industry Roadmap, as well as member of the AMR Industry Alliance. The UNGA Industry Roadmap for Progress on Combating AMR is a series of commitments made in September 2016 by 13 leading global pharma companies, such as Pfizer, Merck, Sanofi, and others including DSP. Together they agreed to commit to four improvement areas: reduction of environmental impact, appropriate use of antibiotics, improved access to antibiotics and more focus on R&D. Research is crucial, since the pipeline of new classes of antibiotics is now practically empty as emphasized by a recent report of the WHO. The AMR Industry Alliance drives and measures the progress to ensure that signatories collectively deliver on the commitments made in both the Declaration and the Roadmap.
CT/PH: Do you employ any special green chemistry technology?
AB: We use a proprietary enzymatic technology that we developed 20 years ago. This technology has the lowest environmental impact throughout the supply chain. We also built our own waste water treatment plants, that we operate at all our manufacturing sites 24/ 7 and 365 days a year. This way we make sure no antimicrobial activity enters the environment. To ensure that our waste water is clean, we test before releasing it, using our own in-house developed AMA-test.
CT/PH: You also work seriously on serialization.
AB: This is a different topic, since it concerns drug products rather than APIs. According to the WHO, up to 15% of all medicines circulating in the developed countries and 30 – 40% in developing countries, are falsified. The effects of these counterfeit drugs cause major threats to both human health as well as the reputation of pharmaceutical brands. Product serialization – the global answer to counterfeit drugs – is the tracking and tracing of a drug product, by means of a unique serial number that identifies its origin, shelf life and batch number, shows the product lifecycle from production, distribution to the end-user. The European legislation on this, coming up in 2019, requires all partners in the supply chain to implement a multitude of comprehensive systems and processes. At DSP we are one of the first generics companies to be fully prepared to help customers and partners to implement serialization, and connect their systems to ours for optimal communication and seamless collaboration. In addition, we offer extra services in the serialization process, such as generating serial numbers on behalf of our marketing authorization holders. Our main goal is to fully unburden our clients in both the preparation and actual execution of serialization.
What serialization and the fight against AMR have in common, is the need for increased transparency. In the case of AMR, we believe that pharma companies should push for mechanisms to improve transparency, like via the PSCI or a ‘Quality mark’, so that environmental and sustainability criteria can be included in sourcing mechanisms.
CT/PH: Is the industry finally becoming aware of the resistance problem?
AB: Between 30.000 and 70.000 tons of antimicrobial waste enter into the ecosystem every year and irresponsible producers still get away without any repercussion. But the industry is increasingly taking the threat seriously and has started to unite itself against AMR. The AMR Industry Alliance, launched in May 2017, has brought together over 100 research-based pharmaceutical, generics, biotech and diagnostic companies and associations, to drive and measure the life-sciences’ industry progress to curb antimicrobial resistance. It ensures that signatories collectively deliver on the specific commitments made in the Industry Declaration (in January 2016) and the Roadmap (in September 2016). We see the momentum on AMR growing, not only in the industry but also among regulators. There are National Action Plans (NAPs) in many countries, but regulation is still lacking. We believe that improved transparency and introduction of targets for discharge concentrations for antibiotics as well as introduction of good practice methods to reduce environmental impact from production discharges, should become part of regulatory frameworks. The right mechanisms for these need to be defined. We believe that there should be strict regulatory frameworks that determine not only the quality, and safety of antibiotics, but also takes into consideration whether they have been produced responsibly. Through improved transparency, science-driven, risk-based limits on concentrations of discharges of antibiotics waste, and clear incentives for responsible manufacturers (or punishment of irresponsible producers) the industry can play its role in reducing further rise of AMR.
CT/PH: How is the market going in antibiotics and what trends do you see in the future?
AB: The generic antibiotics industry faces a number of challenges, like substandard and falsified products, issues on access to antibiotics and increasing shortages. Developments that all need to be addressed. These unwanted and unsustainable developments are worsened by the enormous price pressure, making some antibiotics as cheap as chewing gum, or simply, too cheap to bottle. As long as antibiotic manufacturers will be allowed to keep on taking short-cuts in waste management, harmful discharges of antibiotics into the environment will continue and contribute to further rise of AMR.
Antibiotics have save billions of lives. But, with a nearly empty pipeline of new antibiotics, we must act now to save them!