Why the COVID-19 crisis might be a catalyst for tackling drug shortages in Europe?

The discussion around drug shortages is anything but new. Healthcare stakeholders have been trying to address stockouts for several decades. But when the European Medicines Agency reported in early April 2020 that several EU member states were close to running out of medicines to treat COVID-19 infections, the discussion on drug shortages gained additional momentum. In this article, Alcimed explores the root causes of drug shortages in Europe and how they could be addressed.

Beyond their impact on patients, drug shortages also negatively affect other stakeholders

When discussing drug shortages, it is important to differentiate between product shortages and actual molecule shortages. A product shortage occurs when a specific product is not available while other products with the same active product ingredient (API) can still be used. This might lead to additional costs for patients or public health systems. A genuine molecule shortage, by contrast, can be a truly problematic situation. Such a stockout can imply that a patient cannot be provided with the needed medication, with potentially life-changing consequences.

These bottlenecks are more common than we think. In a report by the European Association of Hospital Pharmacists in 2014, 86% of roughly 600 European hospital pharmacists reported an existing molecule shortage with a negative impact on patient care. Examples included amoxicillin, an antibiotic, and levothyroxine, a thyroid hormone. But the impact is not limited to patients: pharmacists and clinicians lose time searching for alternatives, hospitals’ expenditure on drugs increases and manufacturers see their revenues shrinking.

Difficulties in manufacturing, regulatory requirements and economics as the root causes of drug shortages

Drug shortages can occur due to a variety of reasons. Very often, they are caused by poor manufacturing practices, a lack of production capacity or quality issues leading to a suspension of work. Another reason for stockouts is the constantly evolving regulatory framework in which pharma companies must navigate. The European Falsified Medicines Directive, for example, introduced new obligations for packaging serialisation with barcodes. This initiative, although well-conceived, had a negative impact on manufacturing capacity and speed in numerous production sites due to a high need for coordination across different supply chain actors, according to industry experts. Hospital’s budget restrictions for generic drugs also had an impact on drug availability. Several producers of mature, complex generics, such as injectable antibiotics, oncology products and anaesthetics had to withdraw from the market as they could no longer sell their products at a profit, leading to a less robust supply.

Finally, recent changes in China’s industrial policies have also contributed to medicine stockouts, according to Medicines for Europe, the association of providers of generic pharmaceuticals. The Chinese government is aiming at consolidating the local chemical industry and imposing stricter environmental and tax policies on manufacturers. This has led to a lower level of exports of APIs and key intermediates from China, which could not yet be compensated by competitors in India and Europe.

An update of the European Union’s medicine procurement rules and improved shortage management as the two first steps forward

Industry experts argue that reducing the probability of shortages will be the first critical step to ensure an optimal supply of medicines in the European Union. To do so, one possibility would be to modify the European Commission’s directive on the procurement of medicines. This guidance, which is currently strongly focused on price as a criterion for provider selection, could be extended to include additional criteria on supply chain security. Pharmaceutical manufacturers could thereby be encouraged to increase security of supply, for example by working with several manufacturers of APIs, according to Medicines for Europe.

As the risk of drug shortages cannot be reduced to zero, an improved shortage management is the second major building block for a more stable supply of medicines. The European Public Health Association (EPHA) is calling for the European Union to play a more important role in this area and to strengthen the European legal framework on the notification of medicine shortages. Currently, shortages are primarily handled on the national level. Secondly, EPHA proposes to oblige market authorization holders and wholesalers to supply the market, by requesting them to draft European shortage prevention and management plans.

Drug stockouts are a highly complex, systemic challenge. Now that several European countries have been close to significant medicine stockouts due to the COVID-19 pandemic, all involved stakeholders should use the momentum in the debate to build a more robust system of medicine supply in Europe. They will have to collaborate to tackle the underlying causes in manufacturing, regulatory affairs, and economics. Some stakeholders, like Dr Matti Aapro, President of the European Cancer Organisation, are optimistic that this is about to happen. “Let 2020 be the year when COVID-19 broke down engrained reluctance for more systematic health cooperation between countries, and a year of real progress in tackling medicine shortages,” he stated recently.

About the authors :

Dorothée, Project Manager in Alcimed’s Healthcare team in Belgium
Martin, Senior Consultant in Alcimed’s Healthcare team in Belgium