What steps are pharma companies taking to ensure continuous supply?
Antibacterial medicine and vaccine supplies are hampered by a fragmented supply chain and vulnerable to delays and shortages.
- Supply chains are key to fighting AMR but are complex to maintain
- To ensure an uninterrupted supply, companies should prepare for stockouts and monitor supply and demand
To reduce the threat of AMR, the right treatment must be used to treat the right
type of infection. Yet antibacterial supply chains are complex and highly fragmented. Batches of medicines and vaccines pass through multiple distributors with little alignment to ensure continuous supply.
These inefficiencies can lead to stockouts, while the fragmentation of the supply chain is a driving factor for shortages. The Benchmark evaluates the steps companies are taking to deliver an uninterrupted supply of quality products.
Supply chain challenges
Global antibiotic supply chains are highly fragmented, consisting of many players at some stages of the chain, and very few at other vital stages. Supply inefficiencies can be caused by failures in manufacturing processes, scarcity of active pharmaceutical ingredients (APIs), the concentration of API manufacturing in only a few countries (mainly India and China), pressure on margins, and heavy dependence on only one or a few producers of some antibiotics.
What are companies doing to ensure a continuous supply of antibiotics, antifungals and vaccines?
Here are some of the priority activities for companies to ensure the uninterrupted supply of their products, along with examples of company activity in each area.
How: To maintain a continuous supply of products, companies make use of short- and longterm forecasting mechanisms to ensure there are sufficient APIs and finished products to meet future demand for those products.
Example: Aurobindo makes a monthly rolling forecast and monitors supply in some countries on a weekly basis. Aurobindo also uses long range planning to provide medium- to longerterm forecasts.
How: Companies exchange information with external stakeholders (such as government ministries of health) to align supply with demand.
Example: Novartis ensures that forecasts for all countries are carried out according to a standardised - at least monthly rolling - process, 1-36 months in advance. The company ensures weekly data exchange with its anti-infective stakeholders.
How: To mitigate against shortages, companies can maintain a buffer stock of extra inventory in case of manufacturing delays or an unexpected increase in demand.
Example: Abbott maintains a buffer stock of critical APIs and finished goods that is reviewed quarterly and adjusted as needed.
How: To mitigate against shortages, companies can work with several API suppliers.
Example: The APIs in Viatris’ products are sourced from third parties or manufactured internally. Viatris has a global supply network consisting of more than 40 locations worldwide, including for the antibacterial and antifungal agents in scope. The company registers several of its products in multiple locations to mitigate the risk of shortages, and to allow flexibility to meet demand.
How: To support the development of local manufacturing in low- and middle-income countries (LMICs), pharma companies can invest in capacity building and technology transfers – whereby skills, knowledge, technologies, and manufacturing methods are shared with local manufacturing partners.
Example: Otsuka is ensuring a technology transfer to Viatris (previously Mylan) for delamanid (Deltyba®). The first phase of the technology transfer was completed in 2020, allowing Viatris to manufacture, package, and distribute delamanid in its own access countries. The second phase of the technology transfer for full API manufacturing is on-going and expected to be completed in 2021. Following this technology transfer, Viatris’ manufactured delamanid has been made available in a number of LMICs, including South Africa and India, and will be available for procurement through the GDF following WHO prequalification.
How: Companies prevent or mitigate the production or supply of medicines that appear to be authentic, but are of low quality or contain replacement and/or non-working ingredients.
Example: Sanofi has several structures, governance and policies dedicated to fighting substandard and falsified products. These include a pharmaceutical crime investigation department, an anti-counterfeiting coordination network, a security department that helps detect illegal sales on the Internet, and a dedicated central laboratory in France for analysis of falsification. If a substandard and falsified product is identified, it will be reported to the relevant local authorities within seven days and a market withdrawal may be decided. If necessary, doctors, pharmacists and patients may also be informed. Investigations and legal action may be taken to identify the origin of the substandard and falsified product.
How are companies ensuring a continuous supply of their products in LMICs?
Accessibility relies on companies having strategies to ensure a continuous supply of antibacterial and antifungal medicines and vaccines, both on- and off -patent. To ensure an uninterrupted supply of high-quality products, companies need to prepare for stockouts by ensuring the supply of active pharmaceutical ingredients (APIs), keeping sufficient buffer stock, and aligning with external stakeholders on supply and demand. When people are assured of a continuous supply, this decreases the chance they will resort to obtaining substandard or falsified medicines and thereby increasing the risk of AMR.
A stockout occurs when a doctor or pharmacist cannot dispense an antibiotic because there is no stock available in that location, at that time.
A shortage occurs when supply does not meet demand. Shortages can occur on a national level (i.e., when specific regions or countries cannot bring in supplies for any reason), or at a global level (i.e., when all countries struggle to access the medicine).