Health Action International Overtoom 60 (2) 1054 HK Amsterdam The Netherlands Changing Markets 40 Bermondsey Street London SE1 3UD Shona Robison MSP Cabinet Secretary for Health and Sport St Andrew’s House Regent Road Edinburgh EH1 3DG Tuesday 22 November 2016 Dear Ms. Robison, In light of the recent discovery of drug-resistant bacteria as a result of pharmaceutical pollution at several Indian manufacturing sites directly or indirectly supplying antibiotics to NHS Trusts, we are calling on you to urgently launch a review of pharmaceutical procurement policy in Scotland. As you are aware, antimicrobial resistance (AMR) poses one of the gravest threats to global public health this century. Unless drastic measures are taken to contain the proliferation of drug-resistant microbes, the resulting annual death toll is expected to rise from today’s level of 700,000 to 10 million people worldwide by 2050, significantly more than the number of deaths currently caused by cancer. AMR is a matter of particular concern in the case of antibiotics. While much emphasis is rightly placed on reducing the volume of antibiotics prescribed to people and animals, most governments and public health bodies have, until now, neglected to address a third key cause of antibiotic resistance, namely environmental discharges from the pharmaceutical manufacturing process right at the beginning of the drug supply chain. Indeed, there is a large and growing body of evidence that global pharmaceutical companies—whose role should be to cure sick people and channel resources into the development of new medicines—are actually contributing to the spread of drug-resistant infections through pollution at their own production sites or those of their suppliers. A series of recent reports1 have shone a light on this by revealing how dirty production processes and the dumping of inadequately treated antibiotic manufacturing waste in China                                                                                                             1 See, for example, SumOfUs, June 2015, Bad Medicine: How the pharmaceutical industry is contributing to the global rise of antibiotic-resistant superbugs, https://s3.amazonaws.com/s3.sumofus.org/images/BAD_MEDICINE_final_report.pdf and Nordea Asset Management, March 2016, Impacts of Pharmaceutical Pollution on Communities and Environment in India (report researched and prepared by Changing Markets and Ecostorm) http://www.nordea.com/en/responsibility/responsible-investments/responsible-investmentsnews/2016/New%20report%20on%20pharma%20industry%20in%20India.html. and India, where the majority of our medicines are made, is fuelling the worldwide spread of superbugs, amplifying the already considerable impact of the excessive consumption of antibiotics in human medicine and their profligate use in livestock rearing. Research published in October 2016 by Changing Markets2 showed high levels of drugresistant bacteria at pharmaceutical manufacturing sites in three Indian cities: Hyderabad, New Delhi and Chennai. In total, out of 34 sites tested, 16 were found to be harbouring bacteria resistant to antibiotics. Detailed examination of publicly available supply chain data, and evidence obtained through freedom of information requests, revealed how some of the companies operating these sites, including the Hyderabad-based company, Aurobindo, are supplying antibiotics to NHS Trusts in the United Kingdom, sparking public concern about the provenance of our medicines. With the NHS spending millions of pounds a year to contain the devastating and very costly damage that AMR is already wreaking in the United Kingdom (UK), urgent action must be taken to address every single cause of resistance, whether of human, animal, or industrial origin. If any one of these sources is left unaddressed, we will lose the fight against AMR. There is increasing official recognition of the fact that manufacturing discharges must be brought under control as a matter of urgency. The UK Government’s recent Response to the Review on Antimicrobial Resistance3 contains a clear acknowledgement of this in its recommendations for enforceable targets for maximum levels of antimicrobial active pharmaceutical ingredient (API) discharge associated with the manufacture of pharmaceutical products, and improved monitoring of API emissions from directly-operated manufacturing facilities and those of third-party suppliers. In addition to this, it also recommends the installation of proper waste processing facilities to reduce or eliminate API discharge. We view this as a positive development which should be implemented as soon as possible and in a transparent manner. However, in light of the gravity of the AMR threat, it is crucial that major purchasers of antibiotics, such as NHS Trusts, show leadership and act by cleaning up their own supply chains. The clinical procurement framework does not currently contain criteria on pharmaceutical pollution caused by irresponsible manufacturing practices. This is a major oversight which must be corrected. We are therefore calling on all NHS trusts to: •   Review their pharmaceutical suppliers, and identify those that are contributing to the spread of AMR through irresponsible manufacturing practices; •   Demand that the pharmaceutical industry clean up its supply chain and introduce greater transparency on the origin of antibiotic drugs;                                                                                                             2 Changing Markets, October 2016, Superbugs in the Supply Chain: How pollution from antibiotics factories in India and China is fuelling the global rise of drug-resistant infections, http://epha.org/wpcontent/uploads/2016/10/Superbugsinthesupplychain_CMreport.pdf 3 United Kingdom Government’s Response to the Review on Antimicrobial Resistance https://www.gov.uk/government/publications/government-response-the-review-on-antimicrobialresistance •   Review ethical procurement policies with a view to embedding environmental/AMR criteria in contractual requirements; •   Review all related procurement levers, including supplier codes of conduct with a view to mainstreaming environmental/AMR criteria across all relevant policies; •   Promote legislation to incorporate environmental criteria into Good Manufacturing Practices (GMP). We enclose a hard copy of the report Superbugs in the Supply Chain: How pollution from antibiotics factories in India and China is fuelling the global rise of drug-resistant infections for your information. We look forward to hearing back from you on how you intend to tackle this important issue and are at your disposal should you have any questions or comments. Kind regards, Gemma Buckland-Merrett Senior Research Manager Health Action International gemma@haiweb.org Natasha Hurley Campaign Manager Changing Markets natasha.hurley@changingmarkets.org