1 - Medicine shortages 

There is an issue globally with over-concentration of medicine supply chains in very few countries, mainly in the Far East. That over-concentration is largely driven by the demand side measures that drive prices down in a race to the bottom, creating unsustainable levels. This forces manufacturers to reduce costs, and generally that's done by consolidating both the active pharmaceutical ingredients and the finished goods to fewer and fewer countries. 

Two other things then happen. First, generic manufacturers in Europe or in the US start to discontinue products because they're economically unviable if they haven't had consolidation. And/or once consolidated, if there's any point of failure in that consolidated supply chain, there's limited options to pick up the slack. 

So, segmentation, looking at supply chain diversity, is one of the criteria needed when putting procurement policies in place.

2 - Over-regulation 

There is a need to simplify regulation for companies to be able to operate in Europe. One of the things we’ve questioned is the need to have paper leaflets in every medicine box. They are complex to put in and it’s not a sustainable solution to produce so much paper to fulfil this requirement.

Instead, delivering real-time information in the form of electronic Patient Information Leaflet (ePIL) would be of great benefit to the patient. It is crucial to have greater focus on patient engagement by providing real-time/up to date/regulatory approved patient information, which is user friendly and understandable, to improve patient adherence.

3 – Anomalies in global approvals for biosimilars 

The EU has led the way in biosimilars that need descriptor approvals since 2006. But while the uptake of biosimilars in Europe is generally good, there's a real issue with uptake in the US. Several factors are contributing to this situation, including fundamental differences in regulatory processes and market dynamics.

The main differences include:

• Some EU patents end earlier so blockbuster biologics reach the market sooner and are subject to competition from multiple biosimilars, which results in improved affordability and higher biosimilar uptake in the market.
• The US Food & Drug Administration (FDA) requires that biosimilars prove “interchangeability” with the originator, while the European Medicines Agency (EMA) does not have a specific “interchangeable” designation for biosimilars.
• The EU has more experience in using biosimilars than the US and therefore healthcare professionals and patients are more used to these high-quality affordable medicines.

NPS-ALL-NP-01350-AUGUST-2024

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