PSCI News Update - December 2019
Message from the Chair

Dear All,

What a year! Growth and innovation would sum up 2019 for PSCI.

Our recent Annual General Meeting at the Biogen site in Boston was a perfect opportunity to reflect on our key achievements, and we did this in the spirit of innovation. For the first time we live-streamed our event to give more members the chance to participate. The meeting was interactive, using feedback tools and a ‘World Café’ format to foster an agile exchange of views.

PSCI now has 40 members and we continue growing. We have established a new Working Committee on Partnerships in India and China, to further drive sustainable growth in our key markets. We demonstrated our reach and pace by informing and upskilling roughly 400 suppliers during our consecutive events in India and China, all in one month, and by broadcasting six webinars over the year. And, our new blockchain project has the potential to develop into the first of its kind in the entire industry; an inspiring new development.
Underpinning all these achievements, we have lightly refreshed the PSCI Principles to reflect the changing environment and to zoom in on challenges and opportunities; for example, strengthening our focus on Human Rights. And, we have released our new platform, ‘The Link’, to improve collaboration amongst members and with our suppliers.
Finally, we were successful in engaging new participants to our Advisory Panel. Acting as sounding boards and provocateurs, and introducing disruptive and innovative ideas, our Advisory Board is holding us accountable to our true North, the PSCI vision and mission. 
Moving ahead, priorities include revisiting our strategy and roadmap to ensure PSCI’s sustainable growth and leadership for the industry.
In 2020 I will hand over the Chair role to Caroline O’Brien, AstraZeneca and I will take up the Past Chair role. My tenure as Chair was a very rewarding experience, full of learnings and inspirations; I recommend all members consider applying for it! I welcome again our two new Board Members – Manjit Singh, Centrient and Bridget Ferrari, Takeda and thanks again to Clare Lumkong, Bristol-Myers Squibb and Birg it Skuballa, Bayer, who will both leave the Board at year-end.
By looking at all of this, I feel proud to be part of PSCI and I am looking forward to continue working with all of you. Wishing you all a nice and relaxing end of the year and a fully energized start into a great 2020!
Take care and best wishes,

Gabriele Harttung
PSCI Chair and Global Head Human Rights & Third Party Risk Management at Novartis
PSCI Annual General Meeting in November 2019, hosted by Biogen in Cambridge, MA
PSCI Spring Meeting 2020
11th - 14th May, likely Amsterdam

Supplier conferences in India and China  
Dates to be confirmed, likely September
5th December

11th - 13th November, Biogen, USA 

24th October
17th September, India 

17th - 19th September, India  

24th - 25th September, China

26th -27th September, China

10th September

13th August

18th July

27th June

PiE / AMR update
At the AGM we enjoyed a presentation from Steve Brooks, AMR Industry Alliance , updating us on their work towards collaboration for anti-microbial resistance (AMR). We also rearticulated PSCI’s strategy on pharmaceuticals into the environment (PiE) and AMR. In summary, we will continue using our network and experience to train suppliers on best practices, aligned to the most highly regarded standard setting organizations on this topic.

PSCI does not define standards or discharge targets, or work towards influencing policy; however we work closely with organizations that carry out such activities – including the AMR Industry Alliance Manufacturing Group and International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) – to help promote best practice into the supply chain.

In 2020, we will build on the success of the 2019 PiE / AMR “Deep Dive” supplier training day in Hyderabad, India, and our series of webinars on managing the release of PiE through wastewater, to deliver more focused training sessions on PiE / AMR.
Steve Brooks from the AMR Industry Alliance and PSCI members at the PSCI AGM, 2019 in Boston
Environmental improvements in China and the impacts on the pharma-chemical industry
The Chinese government continues its work to improve air quality (its 'Blue-sky' initiative) and this impacts active pharmaceutical ingredient (API) and chemical production in several ways:

  • Challenges in securing approval for constructing new chemical plants or increasing production capacity in many provinces
  • In heavily polluted weather, the authorities may limit or even halt production. Notably, these interruptions can be lessened if the site has achieved a Class A environmental rating
  • The issuance of a new volatile organic chemicals (VOC) standard in 2019, for Pharmaceutical Industry Emission of Air Pollutants (GB 37823-2019). This is a specific legal requirement for API and most intermediates sites. It could result in the need for further upgrades and/or investments. 
In addition, the relocation and upgrade of hazardous chemical manufacturing enterprises and/or industrial zones, which began several years ago, is still in progress. Hubei, Jiangsu, and Shandong have accelerated this process in 2019, especially in areas close to the Yangzi River. 
Project in Hyderabad to revitalize the water in their rivers and lakes
Hyderabad, India has an important position for the pharmaceutical sector, with much of the country’s bulk drug manufacturing and formulations taking place there. The Urban Development Authority of Hyderabad has begun an ambitious project to clean the Musi river, which has become heavily polluted, with high detected levels of active pharmaceutical ingredients (API) including antibiotics.

Pharmaceutical companies are moving their operations into a cluster location with state-of-the-art wastewater treatment facilities. And, a partnership between local government and industry known as RATSAM (Reducing AMR through Sustainable Antibiotic Manufacturing) is working to reduce antibiotics contamination in the water supply by supporting the manufacturers to improve their manufacturing capabilities by adopting AMR Industry Alliance’s Common Manufacturing Framework and Discharge Limits.

These projects aim to reduce pollution affecting two vital water streams from Hyderabad: the Musi River and the Hussain Sagar Lake.

PSCI Partnerships in Asia
PSCI has set up a dedicated new Committee to deliver our Partnerships Strategy. Its focus, initially, is on building partnerships in two important sourcing regions for many of our members – India and China – so that we can better influence and raise standards in the domestic pharmaceutical markets. The Partnerships Committee has already agreed to partner with R&D-based Pharmaceutical Association Committee ( RDPAC ) and China Pharmaceutical Enterprises Association ( CPEMA ) in China, and is exploring opportunities in India.
Webinar program highlights
We continue with our popular program of webinars for members and suppliers, developed and shared with the aim of improving practices across the industry. These webinars are available publicly and for free. Members are invited to share past and upcoming webinar details with their colleagues, partners and suppliers.

Recent and archived webinars:

Planned future webinars will cover topics including the PSCI Management Systems Maturity Model.
Supplier Conferences
PSCI keeps working to raise standards and engagement in key supplier locations. This year, in September, we hosted multi-day conferences in India and China, and specialist training for auditors in China, reaching approximately 400 suppliers, member companies and auditors.

Highlights from the India conference include:
  • Launch of PSCI management systems maturity ladder, to assess and drive progress
  • Presentations on safety in active pharmaceutical ingredients
  • Insights and updates on Pharmaceuticals in the Environment/Antimicrobial Resistance

Highlights from the China conference and training include:
  • Insights and updates on ‘China REACH’
  • Presentations on human rights, high-risk work and red flags to spot at sites
  • Emergency preparedness and responses

Slides and photos from both conferences are accessible here for members only.

The conferences were led by PSCI and its members, with invaluable support from our partners International Safety Systems Inc (ISS) in India and Carnstone Asia Ltd.
We are currently planning supplier events to take place in 2020. We intend to host conferences in both India and China again in 2020, likely to take place in September, and will also develop our strategic long-term model of how best to build capability beyond conferences and webinars. Be sure to check The Link , our social media channels and future newsletters for the latest information.
Dinesh Subhedar presenting on Third Party Labor Rights in the Supplier Conference in Hyderabad in September 2019

Launch of ‘The Link’
This fall, we’re delighted to launch our new online platform for members and suppliers. ‘The Link’ is a place for members to communicate with each other and better access information. It will make it easier to understand what’s going on across PSCI and to actively participate. Key features for members include:

  • A central newsfeed that pulls together key news and announcements
  • Enhanced personal profiles and the ability to join or leave committees via the platform
  • Dedicated areas for each committee and sub-team, with its own newsfeed to share updates, key documents and quick polls. Any member can ‘dip in’ and view all committee and sub-group pages, supporting cross-committee visibility and engagement.

For suppliers, The Link makes it easier to see what PSCI is doing and access the support we provide. Enhancements allow us to better promote events and resources aimed at suppliers, and build a broad and diverse community of suppliers to share news, progress and best practice. The Link is available to all suppliers, not only those who have already been involved in a PSCI audit.
To access The Link, navigate to and log into the site as either a member or supplier. To get started on The Link, click here to watch our demo video . If you require support using The Link, please do not hesitate to contact the Secretariat .
Promoting the work of PSCI
Over recent months, PSCI has been well represented by our members at key industry events, including but not limited to:
  • The CPHI Worldwide conference in Frankfurt, at which Birgit Skuballa, Bayer, fronted a table discussion on board roles, during the Women in Leadership session
  • The Salon Internacional Logistica (SIL) conference in Barcelona, at which Enric Bosch, Boehringer-Ingelheim, presented PSCI
  • The International Bar Association (IBA) Annual Conference, at which Caroline O’Brien, AstraZeneca presented PSCI’s approach to responsible supply chain practices in relation to contracts and legal frameworks
  • The Association of Innovative Medicines Netherlands, at which Frank Buijs, Takeda presented PSCI
  • The Industrial Green Chemistry Workshop (IGCW), at which Manjit Singh, Centrient presented PSCI.
Frank Buijs presents an introduction to PSCI, to members of the Association of Innovative Medicines in the Netherlands, in November 2019
In addition, PSCI was featured in several publications, including:
  • The Pharmaceutical Manufacturing and Packing Sourcer magazine (PMPS), which showcased PSCI as an example initiative to manage responsibility in the Pharma packaging supply chain
  • Risk & Compliance Magazine, with an article by Gabriele Harttung, Novartis, which featured PSCI as a tool for ensuring good third-party risk management.
Thanks to members and suppliers for sharing the word, and a reminder to use our suite of communications materials, made available to support such opportunities. These include:
Please contact the Secretariat for advice and support related to sharing information on PSCI.
Welcoming new members
Recently approved new members include Abbott, Zoetis, Vertex, Sobi and Sai Life Sciences. We anticipate a healthy rate of growth continuing into 2020.
“We at Zoetis are proud to participate in the Pharmaceutical Supply Chain Initiative. The PSCI Principles for Responsible Supply Chain Management are very well aligned with our own programs as we actively strive to improve the sustainability of our supply chain.”

Mark Bauman n , i nterim leader Global Environment, Health and Safety , Zo etis
Principles Update
At the recent AGM, the membership approved the light refresh of the PSCI Principles – the cornerstone of our initiative. The changes were previously circulated to members, who were invited to comment.

The changes include:
  • Specific reference to human rights and PSCI’s support of the United Nations Guiding Principles on Business and Human Rights (UNGPs)
  • A revised ethics sections including patient safety
  • Inclusion of resource efficiency and sustainable sourcing.

The updated Principles are already published, and will formally apply from 1 st January 2020.
Annual General Meeting
This year’s AGM reached a record number of members, for the first time using a livestream feature that enabled a further 60 attendees on each day of the two-day event. This brought the total attendees to at least 130 individuals. Thank you for joining!

The AGM format featured several new ways of working in response to your feedback:
  • Pulse ‘polling’ during the presentations, giving us an informal sense of member views
  • World café sessions enabling discussion and detailed focus on specific workstream
  • A greater focus on interactivity and discussion, with less time spent watching formal presentations, and more of the materials shared in advance as pre-read
  • Strong focus on Human Rights and AMR topics within several agenda topics
  • Actively engaging key markets and local collaborators, such as Arvind Kumar’s presentation on the Musi River remediation project.

Members can access the full event recorded and also view photos taken at the event. These resources are available to members only.

The Spring member meeting will take place on 11th - 14th May, likely in Amsterdam, a hub location which offers convenience of travel and the opportunity to reduce our carbon footprint.
Member Accountability
Thanks to members for providing responses to our annual Member Accountability Survey. One-to-one calls will now take place with every member company to follow up on any gaps and answer any questions you have. These will take place in January and February 2020.
Maturity models
Recently, several groups within PSCI have been working to build maturity models related to their specific area of activity. Whilst each will have different technical details related to the specific topic area, we see a need to set a common framework to ensure alignment and consistency. Members can access this framework here .
Peer-to-Peer Mentoring Program for members  
A multitude of members expressed interest in the Peer-to-Peer Mentoring Program following the pilot version. Volunteers for the full-scale rollout will be matched during the coming weeks so that mentoring relationships can begin in early 2020.