June 2017

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Safer Chemicals

BPA a substance of very high concern – Implications for the Medical Devices Regulation


HCWH Europe welcomes the European Chemicals Agency (ECHA)’s decision (16th June), to classify Bisphenol A (BPA) as a substance of very high concern (SVHC) as part of the REACH process. Including BPA on the SVHC list means that its use may be limited and subject to temporary, renewable authorisation. Additionally the European Commission Regulation (EU) 2016/1179) – 19th July 2016, will take effect on 1st of March 2018, which classifies BPA as a category 1B substance. This classification states it is toxic to reproduction i.e. impacts on human fertility. Both of these decisions will have implications for applying the recently adopted Medical Devices Regulation.

The primary concern with BPA is that it has been shown to play a role in the pathogenesis of several endocrine disorders including female and male infertility, precocious puberty, hormone dependent tumours (such as breast and prostate cancer and several metabolic disorders).

Yet this synthetic chemical has been used for over 50 years, mainly in the plastics industry. As a result, BPA use is widespread - it is contained in plastics that come into direct contact with food, including plastic packaging and kitchenware, and is present in the inner coatings of canned foods and jar lids. But more importantly to HCWH Europe, BPA is also contained in several medical devices.

Annex I of the 2015 report by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) – The safety of the use of bisphenol A in medical devices (18 February 2015) identified examples of device with materials derived from BPA, which includes - but is not limited to: catheters for minimally invasive surgery, catheters for cardiac ablation, surgical and cardiovascular instruments, endoscopes, pacemakers, pacemaker catheter systems, and catheter delivery systems.

HCWH Europe’s specific concern is the risk of exposure to BPA via such medical devices that can potentially leach BPA via various routes of exposure: oral (via dental material), subcutaneous, or intravenous (e.g. during heamodialysis).

This is probably why SCENIHR concluded in 2015 that whilst: “…the benefit of medical devices has also to be considered, the SCENIHR recommends that, where practicable, medical devices that do not leach BPA should be used. The possibility of replacing BPA in these products should be considered against their efficiency in the treatment, as well as the toxicological profile of the alternative materials”.

This was in itself an implicit acknowledgment of the potential hazards of BPA in medical devices...

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Climate & Energy

Building the environmental sustainability of health systems in Europe

Between the 14th-15th of June, ministerial representatives from the 53 countries of the WHO European Region and NGOs participated in the 6th Ministerial Conference on Environment and Health. As part of the European Environment and Health Process, now running for 27 years, the ministerial conferences bring together inter-sectorial players to discuss key policy strategies, to shape and support the implementation key policies, and to forge actions on environment, health, and well-being across the WHO European Region. (WHO Europe)

Almost 1.5 million (16%) of all deaths across the WHO Euro region are due to environmental risk factors such as air pollution, poor water and sanitation services, exposure to harmful chemicals or waste, and climate change. Participants of the sixth ministerial conference gathered to discuss strategies for responding to these environmental challenges.

At the conference, Member States adopted the Ostrava Declaration that has undergone a long process of negotiations between Member States and relevant stakeholders. The declaration includes an action plan for its implementation after 2017.

HCWH Europe is pleased to see numerous references in the declaration affirming the need to strengthen health systems as a strategy of climate change resilience. In addition to strengthen “the public health functions of the health systems” the Declaration addresses the need to build “the environmental sustainability of health systems and reducing their environmental impact.” Furthermore, in its key action points, the Declaration states its commitment to:

“Building the environmental sustainability of health systems, and reducing their environmental impacts through such means as efficiency in the use of energy and resources, sound management of medical products and chemicals throughout their life-cycle and reduced pollution through safely managed waste and wastewater, without prejudice to the sanitary mission of health services."

The European Environment and Health Process is non-binding - it is therefore crucial for organisations and countries to turn words into action. The environment and health outcomes achieved by the 28 European Union Member States would not have been achieved only on a voluntary agreement - it would be worthwhile reflecting on what can be achieved within the WHO Euro region to reduce differences across the region and enable collaboration among countries. By understanding health creation with a “triple win approach” i.e. economic, social, and environmental benefits - countries can achieve measurable savings on health cost, whilst improving citizens’ health and creating healthier environments. It is important to note that efforts also still need to be made for the outstanding deliverables of the previous conference declaration Parma 2010 as well as implementing actions from the Ostrava declaration. 

HCWH Europe in Ostrava

This “greening the health sector” approach has long been advocated by Health Care Without Harm (HCWH) Europe - it is an important step in recognising the contributions the health sector can bring in the fight against climate change.

As well as applauding the inclusion of this vital action, representatives of HCWH Europe attended the conference to observe and participate in the plenary panel sessions and side events, bringing the voice of health professionals to the debate. HCWH Europe team members were also present in the exhibition space, on hand to provide information about the organisation, members, and projects. 

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Pharmaceuticals and priority chemicals in the Highlands and Islands environment

On Wednesday 21st June 2017 HCWH Europe and Highlands and Islands Enterprise (HIE) held a joint workshop in Inverness, Scotland, on ‘Pharmaceuticals and priority chemicals in the Highlands and Islands Environment’. The workshop brought together experts from Scotland and around Europe in order to discuss, debate, strategise, and work together to come up with innovative potential solutions to protect the Highlands and Islands environment and people from pharmaceutical pollution.

The workshop was opened by Diane Duncan, Head of Low Carbon & Clean Technologies for HIE, who welcomed participants and set the scene in Scotland, presenting the work of HIE in bringing together stakeholders to work towards a ‘Green and Healthy Highlands and Islands’. This vision is based on the four pillars of inclusive growth, international collaboration, innovation, and investment, and ten low carbon and circular economy priorities: Leadership, Water, Pharmaceuticals, Chemicals, Waste, Procurement, Food, Construction, Transport, and Energy. In her address, Ms. Duncan also spoke about how a circular, low carbon economy presents a great opportunity for economic development for the region and about how each of the ten priorities in the strategy are interlinked and will require collaboration from a number of stakeholders.

Next, HCWH Europe Executive Director, Anja Leetz gave an overview of HCWH Europe and the organisation’s work throughout Europe in bringing the voice of health professionals to the European policy debate and educating the health sector to understand the importance of the environment, encouraging public health and healthcare leaders and professionals to advocate for broader social policies and changes.

In the first session of the day, Elaine Mead, Chief Executive of NHS Highland introduced the organisation and their work in delivering high quality healthcare for a fairer, healthier Scotland. In her presentation, Ms. Mead spoke about how NHS Highland felt a very strong “social, economic, and environmental responsibility” to the communities they serve, reiterating their commitment to delivering low carbon, environmentally responsible healthcare...

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G20 Health Ministers' declaration on AMR

The crisis of antimicrobial resistance (AMR) is an ever-emerging global concern: increased number of deaths and escalating medical costs for health systems caused by AMR. For these pressing reasons, AMR was at the top of the agenda for the G20 Health Ministers’ meeting in Berlin 19th – 20th May 2017.

The ministers published a declaration entitled “Together Today for a Healthy Tomorrow, in this declaration the G20 Health Ministers recognised “the leading role of the World Health Organization (WHO) […] in global health cooperation”.

With the common goal of “shaping an interconnected world” in mind, the G20 declaration acknowledged the major negative impact that AMR could have on public health, hampering both growth and global economic stability. Within the declaration the G20 also made several commitments with the aim of combatting AMR.

International collaboration

Only one third of the 194 WHO Member States currently have national action plans on AMR in place; the G20 declaration aims to build upon the Hangzhou G20 Leaders’ Communiqué, recognising the need for international collaboration to avoid a post-antibiotic era.

The G20 welcomed the United Nations High Level Meeting on AMR in New York September 2016, which urged UN Agencies to take the lead in combating AMR. The G20 Health Ministers made a commitment to support and cooperate with the Inter-agency Coordination Group.

Based on the ‘One Health’ approach (the collaborative effort of multiple disciplines: working locally, nationally, and globally to attain optimal health for people, animals, and the environment), the G20 leaders committed to produce multi-sectoral AMR national action plans (in line with the WHO Global Action Plan on AMR) that will be implemented by the end of 2018. G20 leaders also committed to support one other, and the WHO, FAO, and OIE in implementation and sharing of best practices.

Strengthen surveillance

Articles 26 and 27 of the declaration emphasise the need to strengthen surveillance for both antimicrobial resistance and antibiotic consumption. G20 leaders will combine efforts to improve international data collection to be reported in the WHO Global Antimicrobial Surveillance System (GLASS).  Simultaneously, prevention and stewardship campaigns will be set in place to raise awareness on AMR amongst relevant stakeholders to address the five objectives of the WHO Global Action Plan on AMR. In article 27, G20 leaders committed to take immediate action to strengthen infection prevention and control and to promote immunisation and strengthen water quality, sanitation, and hygiene at the international level and they support the involvement of the healthcare facilities in WHO awareness campaign at global level "Save Lives: Clean Your Hands".

Prudent use of antimicrobials

G20 Health Ministers recognised that prudent use of antimicrobials - in both human and animal health, is crucial in preserving the effectiveness of both existing and new antibiotics. They have committed to develop the WHO Global Framework for Development and Stewardship to combat Antimicrobial Resistance. In order to reduce the inappropriate antibiotic consumption, G20 leaders will work to promote the development and support the implementation of antimicrobial stewardship programmes, to improve prescription practices, and to promote appropriate access to antimicrobials when needed. The education and training of health professionals will be further employed to achieve this...

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European Commission lacks substance on antimicrobial resistance action plan

On the 29th of June, the European Commission adopted a new action plan to tackle antimicrobial resistance (AMR), described as "the greatest single challenge in infectious diseases today." - Dr Keiji Fukuda, WHO’s Assistant Director-General for Health Security.

Adela Maghear, Pharmaceuticals Policy Officer at Health Care Without Harm Europe writes:

"The European Commission's goal to make the EU a best practice region in tackling AMR is admirable yet lacking substance. The quoted figure of 25,000 AMR deaths annually in Europe is out of date (ECDC, 2009); to achieve the Commission’s goal, up to date and accurate data for AMR-related deaths is required."

"it is unimaginable that this action plan does not address pharmaceutical discharges in the environment"

"Unlike the previous action plan (2011-2016), this new plan opens the discussion about AMR in the environment, however the only action proposed on this issue is to close knowledge gaps (i.e. the link between the release of antimicrobials in the environment and the threats and risks this poses to human and animal health)."

"This alone will not be enough to tackle the problem of pharmaceuticals in the environment – an overlooked factor in the rise of AMR." - Adela Maghear, Pharmaceuticals Policy Officer - HCWH Europe

"AMR is a global crisis, projected to cause 10 million deaths by 2050 (The Review on Antimicrobial Resistance, 2016) it is therefore unimaginable that a “One Health” action plan from the EC does not address placing limits on pharmaceutical discharges in the environment or include environmental criteria for Good Manufacturing Practice (GMP). Omitting these points undermines the EC’s plan, rendering it ineffectual."

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Webinar recording | Pharmaceutical pollution - the need for sustainable procurement

According to a recent German Environment Agency report, approximately 4,000 active pharmaceutical ingredients (APIs) are being used in pharmaceuticals (i.e. medicinal drugs), be they prescription, over the counter, or for veterinary use.

Residues of these APIs can enter the environment during the production, consumption, and disposal of pharmaceuticals. Scientists say that the APIs of everyday medicines are entering waterways and reaching our drinking water supplies. The main pathways to our drinking water are pharmaceutical manufacturing waste, animal excretion, the runoff from animal feeding procedures, and leaching from municipal landfills. 

The healthcare sector can contribute to pharmaceutical pollution through poor waste management practices. Wastewater treatment plants are unable to completely destroy or remove pharmaceuticals, therefore sustainable procurement is an important factor in tackling pharmaceutical pollution. 

The joint UN Procurement project is an example of procurers working with supply companies to shift towards procuring more sustainable products. Public procurers have an important role in setting environmental criteria for tendering, thus driving a change in markets through purchasing socially responsible and environmentally sound pharmaceuticals. In this webinar, you will learn from recent research on the presence of pharmaceuticals in water and will be presented with the key issues of integrating sustainable procurement into the health sector.

A recording of the session and featured presentations are now available on the HCWH Europe website.

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Member Update

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Other News

EPP eHealth Joint Statement of Unmet Needs

The main aim of the EPP-eHealth project is to mobilise the procurement power of healthcare institutions and major companies to help accelerate progress towards deployment and market uptake of eHealth solutions. One approach to mobilise such procurement power is to develop Joint Statements of Unmet Needs that demonstrate a common need for new solutions. These can then be communicated to potential solution providers (through a process known as ‘market sounding’) with the aim of creating a dialogue that will result in new solutions becoming available to city authorities and their suppliers - known as innovation procurement.

The EPP-eHealth project consisted of four healthcare institutions whom have identified several specific unmet needs related to eHealth unmet challenges. The Joint Statement of Unmet Needs (JSUN) document is aimed at encouraging other healthcare institutions that are interested in the same eHealth unmet needs to lend their support to the broad communication of JSUN.

JSUN offer an aggregated means of communicating common unmet needs to the market in a way that demonstrates scale and replicability. They are not about joint procurement but are aimed at convincing innovative businesses that there is substantial customer demand for new solutions to address these unmet needs.

With this in mind, we invite your organisation to express interest in the unmet needs identified during the EPP-eHealth project. Contact: Laura Sanchez (BRAVO Solution)

- EPP-eHealth project team

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Sustainable health symposium

25th July 2017, Cambridge, UK

This one day symposium will harness learning across the globe to consider the transformations required for a healthy sustainable world, and brings the best minds together with the expertise of key individuals to help solve these conundrums in practical, sustainable, and hopeful ways and highlight recommendations for the next five to ten years. 

Across the globe the health of individuals, their communities and the planet is in crisis as key drivers including rising inequity, food insecurity, the burden of chronic diseases and climate change continue unabated. Access to healthcare is subjected to increasing stresses from global economics because of the rising cost of healthcare and ever increasing differences between communities. These interconnected issues are threatening the health and well being of people and communities globally: yet this crisis offers us the opportunity to rethink our understanding of health and healthcare delivery.

As the healthcare sector shifts its emphasis from sickness to health creation, it has an important role in the transformative shift from sickness to wellness, from products to services, towards innovative and frugal technological solutions that support people and communities, and a new health operating system.  It can demonstrate the principles and develop practices to address the profound challenges and multiple opportunities in shaping a fair, healthy and resilient world. Such transformation must be grounded in both science and the lived experience whilst sufficiently compelling to be implementable in a world driven by other motivations such as the health of economies.

The Sustainable Health Symposium has a real opportunity to influence, by bringing together researchers, policy makers, and practitioners from disciplines encompassing health, sustainability and global issues who posses the passion, knowledge and interest in the co-development of these transformations.

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