How Do You Choose Partners to Develop the Product?
Integrity of the supply chain (20 min)
Talleen was very fortunate that he did not have supply issues during the clinical trials and early manufacturing of his drug. A common supply chain problem is buying intermediates (not the main ingredient but other parts of drug). If one of intermediates is not available your factory production stops. It’s possible another company will have the intermediates but this needs to be planned as part of the risk assessment.
Always have backups, if supplier becomes a problem find a second one. Labelling can also hold up supply due to requirements of different country regulations on size, type, content on them.
As you succesfully develop your idea through phases then you may encounter supply chain issues which affect the production and research testing that you need to complete. There are several initiatives to improve access to medicines and investigating supply chains:
- Medicines Transparency Alliance from Health Action International & WHO have an international network investigating access to medicines
- Universities Allied for Essential Medicines chapters
A study of supply chain challenges in Jordan in 20071 showed poor availability but good prices for public health drugs and the private sector had higher availability but higher prices. They had 16 internal manufacturing companies but no capacity for oncology or vaccines. Products are imported by a single manufacturer or importer before flowing into wholesaler / distributer channels. Drugs are received in batches via several central warehouses. Issues include
- drugs can be short in supply due to high demand. Additional analysis on historical demand, disease and prescription patterns would help with better forecasting.
- inadequate storage in warehousing
- visibility to track and trace shipments in transport chain
This put pressure on patients to pay out of pocket for medicines for treatment that is affected by specific timescales so your idea may result in poorer health outcomes due to availability of treatment.
A study in Ghana, Malawi and Mali in 20092 showed active ingredients mostly being sourced from India, China and some US, EU countries which are affected by fluctuating prices including taxes and tariffs at import and access to foreign exchanges. Importers are often wholesalers, brokers, manufacturers or pharmacists. In some cases manufacturing had to be stopped or paused because of local corruption issues, the costs of utilities, access to raw materials and poor transport or transportation links causing delays.
See also in Eastern Europe, Central Asia & Caucasus
References
1. Conesa S, Yadav P (2009) Analysis of the Pharmaceutical Supply Chain in Jordan, Medicines Transparency Initiative
2. McCabe et al (2009), Private Sector Pharmaceutical Supply and Distribution Chains, WHO