European Commission publishes study report on medicines shortages in the EU

The European Commission has published a comprehensive study report on medicines shortages in the EU.

A very brief overview of the study is available here.

About medicines shortages in the EU

Medicine shortages present a growing problem for many EU/EEA countries. Consequences of shortages include a decreased quality of treatment received by patients and an increased burden on healthcare professionals, who need to identify and provide alternative treatments, and on health systems.

Who requested the study?

The study was requested by stakeholders, the European Parliament and the Council.

In recognition of the problem of shortages and of the need for concerted action at the European level, in March 2020, the European Commission issued a request for services for a study on medicine shortages. The study was to provide:

  • an overview of medicines in shortage in the EU, including their specific characteristics, aswell as an analysis of the root causes of the shortages
  • an evidence-based assessment of whether the current framework (at EU and national levelto address the issue of shortages is fit for purpose, in line with the Better Regulation guidelines
  • an overview of potential solutions to address shortages, taking into account their root causes and the shortcomings of the current system, as identified by this study

The study and its findings are reported in the 283 page final study report. The scope of the study was limited to medicines for human use, thus excluding veterinary medicines.

About the study
  • The study involved analysis of data from sources including:
    • national shortage registers,
    • extensive consultations with key stakeholders and
    • published literature.
  • It highlights that comprehensive comparative analysis is severely hampered by a lack of high-quality, standardised information about shortage monitoring at national level.
  • In spite of data limitations, the study confirms that medicine shortages occur frequently across the region, most often involving older, off-patent and generic medicines.

Shortages can arise for any type of medicine, but those at highest risk include pain relief medication, antihypertensives, anti-infectives and oncology medicines.

The study posed 23 questions and the first 5 are listed below:

  • What are the positions of the main stakeholders regarding medicines shortages?
  • According to stakeholders, what are the main reasons for shortages?
  • According to stakeholders, what are the (potential) solutions to address shortages?
  • How do stakeholders define a shortage (essential elements of the definition)?
  • How do stakeholders feel shortages should be measured?
What are the causes identified in the study, for medicines shortages in the EU?

The causes of medicines shortages are multifactorial, with bottlenecks identified along the entire pharmaceutical value chain, from manufacturing of raw materials to national pricing and procurement practices.

Shortages are classified under the following headings:

  • Quality issues
  • Manufacturing issues
  • Regulatory issues
  • Safety and efficacy issues
  • Unpredicted major events or natural disasters
  • Unexpected increased demand
  • Distribution issues
  • Commercial reasons

To further illustrate the causes of shortages and their impacts on patients, health providers and health systems, a series of product case studies are presented in the study report. The case studies concern the products epinephrine auto-injectors used as an emergency tratment for severe, allergic reactions , 5-Fluorouracil, DTP vaccines, midazolam and amoxycillin (with or without clavulanic acid). Lessons learnt from these case studies are also included in the report.

According to the report, proper understanding of the root causes of shortages remains substantially challenged by inconsistent and limited reporting. Moreover, reporting of root causes is generally reductionist, singling out the most acute cause (e.g. a problem at the production site) but without considering the underlying more systemic issues (e.g. consolidation of manufacturing, resulting in a very limited number of production sites) and market-related factors (e.g. single-winner procurement practices).

Provisions of the current EU legal framework that may help prevent and mitigate shortages

The current EU legal framework, through the Community Code relating to medicinal products for human use (Directive 2001/83/EC), contains two provisions that may help prevent and mitigate shortages.

  • Article 23a requires MAHs to notify the NCA at least two months in advance of their intent to suspend the marketing of a product it has placed on that market, whilst
  • Article 81 mandates MAHs and wholesalers to ensure, within the limits of their responsibility, the continued and appropriate supply of medicines placed on the market.

This study shows that all Member States have transposed these provisions into national legislation but have operationalised them in different ways.

What actions does the study propose, to deal with medicies shortages?

A series of 16 policy measures are presented in the report, (for action at EU and national level) which could address different aspects of the issue of shortages. They include the following:

  • Establish and follow a centralised and harmonised EU-wide definition of medicine shortages
  • Establish and mainstream harmonised reporting criteria for shortages, collecting sufficiently detailed information on key parameters (e.g. product details, MAH, details on the shortage and impact)
  • Develop an EU-wide list of medicines for which shortages are the most critical and develop policies and/or regulations to improve their availability
  • Set up stakeholder dialogue platforms for/between supply chain stakeholders, patients, and healthcare providers, respectively at Member States level
  • Develop EU-wide and uniform legislation allowing for imposing financial sanctions if notification requirements and/or supply responsibilities are not met.
  • For EU authorities to reduce the administrative and cost burden submission of postapproval changes
  • Enable an accelerated mutual recognition procedure (MRP) within the EU
  • Enable a (more) efficient Repeat Use Procedure
  • Develop an EU-wide medicines packaging and labelling regulation that included flexibilities for digital leaflets and multi-country/multi-language packaging and labelling
Final reflections

The report has a section entitled ‘Final reflections’ which includes the following information:

  • This study has confirmed that shortages often are not so much a problem of whether a medicine is available but one of where it is available.
  • Even in the context of the European Union, founded on principles of solidarity, some countries are fighting shortages daily whereas others hardly experience them at all. This points towards some fundamental issues that have little to do with sourcing and manufacturing and much more with commercial decisions by suppliers on the one hand and national policies on the other. Here, many parties share responsibility. Suppliers take decisions based on considerations of profitability, selecting markets to supply based on willingness and ability to pay and ignoring others.
  • Governments have also put pressure on prices that has led to supply chains that are lean to the point of vulnerability. This requires critical reflection on the part of all stakeholders not only of the roles of others but also of their own responsibilities.

Source: Europa website