Europe Sees Surge in Generic Medicines Withdrawals; UK Faces Doubling of Drug Shortages

Generic medicines for cancer and mental health on the Union List of Critical Medicines are disappearing, study reveals

Adding to the growing evidence of global medicine shortages, a new study has revealed that the European generic medicines market is “not in shape” to help Europe meet its public health priorities.

In the past decade, the rate of generic medicines withdrawals has risen by 12 per cent, while there has been a three per cent decrease in the launch of generic products, as per Teva Pharmaceuticals’ recent analysis of IQVIA data.

Within the mental therapeutic area, seven per cent of generic products disappeared between 2013 and 2023, while there was a seven per cent decrease in the availability of generic cancer medicines in just six years (2017-2022).

These medicines were listed on the Union List of Critical Medicines to help avoid potential shortages, as the European Commission (EC) said this could cause “significant harm to patients and pose important challenges to health systems.”

While mature generic products constitute the majority of the List, they remain susceptible to withdrawals, despite containing products crucial for safeguarding Europe's public health, the Teva analysis report noted.

Since 2013, the number of generic products for the treatment of schizophrenia and bipolar disorder has declined by 25 per cent, with Hungary and Bulgaria experiencing the biggest loss at 83 per cent and 58 per cent respectively.

However, low-volume products, such as generic oral liquid antibiotic products like pediatric syrups, are also experiencing a decline. The Teva Europe 2024 data analysis found that 21 per cent of products from this segment disappeared between 2013 and 2023.

As per the report, the number of generics starts to decline just 3-4 years after the launch for several reasons, such as the race to the bottom on pricing.

Generic long-acting injectables seeing rapid growth  

Nevertheless, there has been an 86 per cent increase in the number of generic long-acting injectables (LAI), with the biggest growth observed in cytostatic hormones, hormones of pituitary gland and hypothalamus, and antipsychotics.

LAI belongs to a group of generic medicines called “complex generics” that are hard to develop, produce and get approved by the authorities.  While this group is experiencing rapid growth, it comprises only 1 per cent of all medicines.

This is not the first time that the Israeli multinational pharmaceutical company has sounded an alarm bell regarding the increasing risk of generic drug shortages. Its 2023 analysis titled "The case of Europe's disappearing medicine cabinet” revealed that:

• 69 per cent of generics introduced to the market in 2022 have less than two suppliers each.
• 26 per cent of generics that were available in 2012 are no longer present in the European market.

Its previous study also demonstrated a 46 per cent reduction in the number of suppliers of one generic oncology medicine.

In the latest study, the same trend was observed in the availability of generic products, showing a 49 per cent decrease since 2015.

In its report, the company highlighted that this worrying trend in the European generic medicines market has “the potential to jeopardize Europe’s ambition of supporting its citizens in accessing critical medicines” in areas defined as health priorities, such as mental health, cancer and even antibiotics.

Need policies to safeguard citizens’ health

To address this issue, the Teva study recommended developing policies that support patients’ access to medicines, including:

• Establishing a rewarding and ambitious incentive framework to support innovations.
• Ensuring clear and predictable legal conditions for developers of generic medicines to facilitate a day-1 launch after the expiry of exclusivity.
• Introducing multi-criteria, multi-winner tenders and novel pricing practices, while optimizing, simplifying and digitalizing the regulatory framework.

“We need policies in support of a vibrant pharmaceutical industry that will help safeguard European citizens’ health,” the study report added.

UK at risk of losing the global medicines competition

The British Generic Manufacturers Association (BGMA) recently warned that the UK could become a “backwater” supply market for medicines with a supportive policy environment.

In its new manifesto, the BGMA has outlined the policy areas where generics and biosimilars, which represent four out of five NHS prescriptions, can be optimised.

Mark Samuels, chief executive of the BGMA, said: “Despite being intrinsic to the health and well-being of our nation, the generic and biosimilar medicine sector has been largely ignored from a policy perspective.

“The EU-UK Trade and Cooperation Agreement has hurt the UK’s medicines supply resilience, adding regulatory and logistical complexity to an industry that relies on simplicity to survive.”

Furthermore, a volatile government pricing system and significant domestic regulatory delays have contributed to the UK “becoming an increasingly unattractive market for international companies.”

“The culmination of these issues has seen a doubling in the number of shortages, as manufacturers are finding the UK a commercially unsustainable market to supply,” the BGMA said in its manifesto, urging the next government “to create a dedicated and targeted set of policies to support this critical sector's survival and economic growth.”

In an article published in the Financial Times, Samuels expressed concern that patients are experiencing a lack of critical medicines, while the NHS is facing the risk of losing billions of pounds of vital savings.

He highlighted the prolonged record-high shortages of medications used to treat conditions such as diabetes, Parkinson’s, ADHD, asthma, multiple sclerosis, HRT and tuberculosis, as well as antibiotics.

“Politicians must commit to an industrial strategy that encourages manufacturing, solves regulatory delays and gives manufacturers the certainty they need to return the UK to a priority supply market,” he said.

According to the British Generic Manufacturers Association, medicine shortages in the UK have doubled over the past two years, with 101 reported drug supply issues in February 2024 compared to 52 in February 2022.