TAG overview

Pharmaceutical supply chain

In many parts of the world, medicines are not always available where and when they are urgently needed. We want patients in low- and middle-income countries to have fast, safe and affordable access to our products. We believe that this can be accomplished through efficient supply chain management and by utilizing local manufacturing. Our actions in this area reflect our high standards for improving access to healthcare for underserved populations.

Our approach to local supply chain solutions

During product development and manufacturing we favor approaches that enable us to control the cost of goods and allow for local supply chains that strengthen the local economy. This is the model applied in the context of the Pediatric Praziquantel Consortium, for instance, in which the manufacturing and supply are planned to be undertaken locally.

We partner with pharmaceutical companies and other supply chain stakeholders to improve supply chains in developing countries and to guarantee the targeted supply of medicines. We manufacture some of our products directly in the regions where they are needed in order to build local capacity, reduce travel time and distance, and achieve cost savings that can be passed on to the consumer.

Our pharmaceutical supply chains are organized efficiently to ensure that our products reach the right place in the right condition and quantity, at an affordable price and on time. Modern supply chain solutions allow us to monitor our inventory and current deliveries, as well as to predict expected demand for medicines, partly in real time.

How we organize our supply chains

The Global Planning unit is responsible for our efficient medicine supply chains and is part of Biopharma Supply Network Operations within our Healthcare business sector. Global Planning collaborates with our Global Health unit and consults experts from other business sectors as needed.

Our commitment: High quality standards for pharmaceutical production

All our pharmaceutical production plants operate to the same high standard of quality worldwide. This ensures full for us and our contract manufacturers with the internationally harmonized guidelines and .

In 2018, we refined our “Right First Time” (RFT) concept, which aims to reduce the number of temperature excursions that happen during transportation worldwide. At the same time, we encourage shipping sites and receiving units worldwide to improve their processes together with freight forwarders and carriers.

Our uniform quality assurance system ensures that our quality standards are universally adhered to. It comprises training courses, quality control monitoring and technologies that are tailored to each site. The results of all audits conducted by health authorities are published Group-wide, allowing the respective units to share lessons learned and benefit from the improvements of others.

Through our Virtual Plant Teams, we support our contract manufacturers in complying with quality standards. Our external partners in Africa, Asia and Latin America are each assigned a production expert from our company to act as a virtual site leader who is able to provide guidance. This approach was again recognized as a best practice in the 2018 Access to Medicine Index.

Leveraging technological possibilities for efficient market access

Accurate business forecasts are the foundation of efficient supply chain management. We use harmonized Biopharmaceutical business planning processes across our Group, including a special software platform that enables us to plan centrally for specific demand for medicines. The data generated by the software platform is used to manufacture and deliver medicines according to demand, which allows us to prevent local inventories from running out or expiring.

We employ a software-based solution for our customers in northwestern Africa, which gives them continuous access to our e-shop so that they can quickly and easily order medicines approved by the respective regulatory authorities. The system makes demand more transparent whilst reducing lead times and miscommunications. Combined, both systems enable us to react more quickly to local demands, including in developing markets, than ever before.

Working with partners to achieve more

Our collaborations and partnerships are founded on the Group-wide exchange of centrally stored information, which allows us to organize shared supply chains in a more efficient manner.

Shared data platform for medicine donations

NTDeliver is our digital information tool, which facilitates transparency in supply chains for medicine donations that are created through . Deliveries from companies running donation programs are clearly displayed – from purchase orders made by the World Health Organization (WHO) through to delivery to the first warehouse in the destination country. This improves the coordination of our efforts and provides WHO, the local experts and us with a more transparent overview of the in-country inventory. Following a pilot in 2017, where we tracked deliveries all the way to the treatment point in the destination country, we fully implemented the system in 2018. We started using NTDeliver last mile tracking as a standard reporting tool in the school-based deworming program for schistosomiasis in Kenya. This system is now fully functional in collecting and consolidating field information and has helped us reach out to more than 12,000 teachers throughout Kenya. In addition to supply chain data, we have started to integrate the first level of impact data requests from the teachers, such as the number of children treated.

Further partnerships

We are a founding member of the Accessibility Platform, which meets to discuss local supply chains during our Access Dialogues. This is an informal effort spearheaded by the private sector to raise awareness of supply chain issues as part of the access to health challenge. It seeks to increase knowledge-sharing and information exchange through open, multi-stakeholder dialogue, and to identify opportunities for collective action. We also share best practices with other companies and partners on efficient, end-to-end, secure supply chains. The Accessibility Platform was recognized by the Access to Medicine Foundation’s white paper on “Shortages, stockouts and scarcity: the issues facing the security of antibiotic supply and the role for pharmaceutical companies.” In the paper, the Foundation acknowledges that companies have a strong role to play in helping to address supply chain complexities and recognizes the Accessibility Platform as a best practice in information sharing through partnerships.

Promoting local production

Having started to supply pharmaceutical products in 2017, our production facility in Nantong (China) increased its production volume to full capacity in 2018, in order to serve local markets. In addition, we manufacture drugs for diabetes, cardiovascular conditions and diseases of the lower respiratory tract in India and Indonesia. This local capacity building supports local economies and allows us to supply medicines faster and more affordably here and in neighboring countries such as Sri Lanka and Myanmar. In 2018, we further expanded the scope of local production with a contract manufacturing organization (CMO) in Russia.

CURAFA

In 2017, we started the project CURAFATM. The name is derived from the Latin word ‘curare’, which means care, and the Swahili word ‘afya’, which means health. CURAFATM facilities serve as points of care for integrated primary healthcare services and are run by local pharmacists and nurses, who provide pharmaceutical and clinical services, medicine, digital health solutions, insurance and financing schemes. The staff is supported by a modern facility with WiFi access and charging stations, tablet PCs and TVs, refrigerators for cold chain medicines, and solar power.

We created the project as part of our vision to achieve primary healthcare for everyone everywhere. Our mission is to address inequalities in primary healthcare access in emerging economies and to enable accessibility, availability and affordability of primary healthcare. We also aim to leverage on-the-ground learning to build a sustainable business model for primary healthcare and provide a space for co-creation with fellow innovators. The project was implemented in collaboration with the non-governmental organization Amref Health Africa and benefits patients as well as communities. In 2018, five primary healthcare points were opened in the Kenyan counties Kajiado, Kiambu and Machakos.

Fight against falsified medicines

According to a WHO report published in 2017, more than 10% of all medicines in developing and emerging countries are counterfeit or substandard, creating a major health risk. The Global Pharma Health Fund (GPHF) is a non-profit initiative funded by our company that is fighting counterfeit medicines with its GPHF MinilabTM.

The GPHF MinilabTM is a portable, compact laboratory that fits into a tropics-resistant suitcase and can detect fake medicines quickly, easily and cheaply. Around 90 chemical substances can be tested for their authenticity. The GPHF develops these Minilabs, supplies them at cost and provides training on how to use them. The WHO report cites the Minilab as one of the most important tools for detecting poor quality and falsified medicines. As part of a study published in this report, over 20,000 pharmaceutical samples were tested using the MinilabTM, with more than 1,000 of them identified as falsified. An international study conducted by the Difäm-EPN Minilab Survey Group in 2017 also highlighted how the GPHF MinilabTM has helped ensure access to safe medicines in developing countries. The Minilab is currently the only product of its kind.

The majority of Minilabs are deployed in countries in Africa and Asia. These test kits are primarily utilized by national health agencies, often in partnership with the labs of governmental drug inspection centers or within multilateral health interventions led by various UN bodies, aid organizations in the United States and Germany, faith-based networks or the incoming goods inspection unit in the medicines supply chain in all kinds of healthcare facilities, for example medical stores and major hospitals.

Through our Global Health Institute, we are also co-developing a new user-friendly technology that will enable users to detect falsified medicines at the qualitative and quantitative level. Initial models will focus on measuring the presence and quantity of the active pharmaceutical ingredient for malaria and other bacterial infections.

Expanding Minilab use

In 2018, the GPHF developed testing methods for five additional active ingredients, effectively covering a total of 90 active agents from the  list. Test protocols for ten more active pharmaceutical ingredients were developed and 30 existing protocols reviewed. All test protocols will be put together into a single volume in 2019, and made available in three languages in 2020. By 2020, the Minilab will then cover 100 active ingredients, ranging from antipyretic, antimalarial and antiviral, to antibacterial and antimycobacterial medicines.

Since 1998, the GPHF has supplied a total of 843 Minilabs to nearly 100 countries, with seven new Minilab shipments made in 2018. The GPHF and its partners held three official seminars for Minilab users in 2018 with 60 participants.

Compliance
Adherence to laws and regulations as well as to voluntary codices that are internal to a company. Compliance is a component of diligent corporate governance.
Good manufacturing practice (GMP)
Good manufacturing practice (GMP) is a system for ensuring that products are consistently manufactured and controlled according to quality standards. These guidelines are used in the production of medicines, pharmaceutical active ingredients and cosmetics, as well as foodstuffs and feed.
Good distribution practice (GDP)
An EU guideline that regulates the proper distribution of medicinal products for human use.
Public-private partnership (PPP)
A collaboration between public sector (government) organizations, private companies and/or not-for-profit organizations.
Essential medicines
Defined by the World Health Organization as “those drugs that satisfy the health care needs of the majority of the population”.

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