Europe’s generic medicines are disappearing – according to new research – drastic action required to prevent crisis

Amsterdam, 3 April 2024 – Research from Teva Pharmaceuticals shows that Europe’s critical medicine cabinets – in hospitals, pharmacies, and homes – are home to fewer generic medicines. These are the often-cheaper alternatives to brand name medicines, that make up 67%[1] of all medicines.

Over the last ten years, the number of generic medicines withdrawn from the market increased by 12%, while on average 3% fewer generics products were launched. In other words, on 31 December 2012, there were 40 280 separate generic products and 10 years later, only 29 836 generics were left – a 26% decline.

Generic medicines are part of the critical list of medicines adopted by the EU in December 2023 and designed to treat critical illnesses in adults and children such as infectious diseases, cancer and mental health. However, during the past 10 years, the research from Teva Pharmaceuticals shows a drastic decline in the number of critical generics available in these therapeutic areas. 

This alarming fall in the number of medicines comes at a time when many health issues are worsening across Europe.

At the same time, OECD nations spend less on public healthcare (9.7% of GDP in 2021 versus 9.2% in 2022) [7]. Moreover, the EU itself recently warned that, “EU countries must continue to prepare to face the “epidemic” of chronic diseases[8]”.

How generic medicines are disappearing – and why

Teva’s timely research – “The Critical Medicines Health Check”, published on 27 March 2024 – found that, in the decade to 31 December 2023:

• There’s been an increasing rate of generic product withdrawals (+12%) while generic product launches are decreasing (-3%) 
• Although the new launches are driven by hard-to-make generics, generics of the EU critical medicines list are dramatically disappearing from the market
• Generic medicines on the Union List of Critical Medicines need to be safeguarded as we see them disappearing from the market

o   In just 6 molecules in the mental health therapeutic area, 7% of generics from the Critical Union list of medicines disappeared over the last ten years (2013-2023). This number falls to  –25% in the case of a treatment to manage schizophrenia or bipolar disorder.

o   Among the 31 molecules identified in the Union List to treat cancer, 7% of products disappeared in just three years (2020-2022). A number which falls to –43% in case of specific generic medicines to treat breast cancer.

• Additionally, 21% of generic oral liquid antibiotic products (e.g. pediatric syrups) disappeared from the market, increasing supply vulnerability
• The market is starting to consolidate 3-4 years after the introduction of generic competition

The disappearance of generic medicines is caused by an onerous regulatory environment and excessive race to the bottom on price. For example, an ovarian and small-cell lung cancer medicine saw a 49% decline in the number of available products between 2015 and 2023, as inflation and production costs increased and prices collapsed, forcing 46 % of its providers out of the market.

Moreover, of all generics marketed in 2022, 69% are supplied by just one or two firms – representing bottlenecks in supply.

With a drastic decline in the diversity of essential generics Teva calls for three essential actions by legislators and regulators to ensure the whole life cycle of medicines is functioning properly from innovative medicines which are delivering new hope for patients, to the efficient launch of new generic medicines which are increasing access and finally to more mature medicines which are still critical for the healthcare system:

1. A better incentive framework for innovation. This will bolster the rise in more complex and innovative treatments to address unmet medical needs. 
2. More legal clarity for generic “day 1” launches. This could boost access – and generic medicine variety – from the moment exclusive innovative medicine protections expire.
3. Safeguard mature essential medicines. Instead of letting generics wither and disappear – thereby reducing patient choice – work towards a more sustainable market, with better procurement and an optimized cost-effective regulatory framework.

Philippe Drechsle, VP EU Portfolio Management at Teva Europe, says: “We’ve taken the temperature of the generics market – and our diagnosis is that critical medicine cabinets are under pressure. There are fewer generic medicines, less choice and future potential shortages.

“At a time when state budgets are under pressure, and public health systems face greater demand, critical generic medicines should be available and not removed from the Europe’s medicines cabinet. The pharmaceutical industry, healthcare professionals and patients need more support from central authorities before we can issue a healthier prognosis for the generics market.”