EC report details EU medicine shortages, offers potential solutions

Regulatory NewsRegulatory News | 10 December 2021 |  By 

A commission ordered by the EC Directorate-General for Health and Food Safety (DG SANTE) to conduct a study on medicine shortages in the EU and European Economic Area (EEA) has released a final report outlining the problem and its recommendations for stakeholders.
Documenting the scope of human medicine shortages in EU/EEA countries between 2004 and 2020, the study conducted by Technopolis Group, Milieu Law & Policy Consulting and Ecorys analyzed data from 22 different countries, which included registries of national shortages (from 2007 to 2020), commercial datasets of pharmaceutical sales, and interviews with stakeholders.
The report notes that there has been a significant increase in the number of notified shortages within the last 5-10 years, which “can be partially explained by more widespread and better notification” but is also “a real increase in the number of times a pharmacist is not able to offer a patient their preferred medicine.”
All 26 member organizations surveyed by the Pharmaceutical Group of the European Union in 2020 said they had experienced an increase in medicine shortages within the last year; of these member organizations, 17 of 26 (65.3%) reported the shortages were worse than the previous year, and 8 of 26 (30.7%) said over 400 medicines were in short supply. According to the report, a 2019 survey from the European Association of Hospital Pharmacists showed 95% of 39 European countries reported medicine shortages were a problem.
One finding of the report: the problem of medicine shortages tends to be localized, the authors said.
“This study has confirmed that shortages are often not so much a problem of whether a medicine is available but one of where it is available,” they wrote. “Even in the context of the European Union, founded on principles of solidarity, some countries face challenges of medicines shortages daily whereas others rarely experience them. 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.”
The most common shortages occur for off patent and generic medicines. In about one-fourth of situations, “the product in shortage may represent the only available version,” the authors explained. The types of medicines most often affected include pain relief medication, antihypertensives, anti-infectives and oncology medicines. When present, national registries documenting shortages “offer very limited insight into the criticality of product shortages and their impact on the quality and continuity of treatment to patients.”

The authors described attempts at discerning the root causes of shortages to be “generally reductionist” and focused on acute causes rather than the systemic issues and market-related factors that led to a shortage. Issues with quality and manufacturing are cited as reasons in approximately half of shortages in reports analyzing root causes, with increased demand and market withdrawals—factors associated with the COVID-19 pandemic—having posed “a major challenge to the continued availability of critical medicines used in the treatment of COVID-19 patients due to surge demand.”
There was not enough information gathered on the impact of outsourcing of pharmaceutical production and parallel production to determine whether they were risk factors of medicine shortages, the authors said. “More generally, austere pricing policies and industry consolidation are viewed by stakeholders as systematic factors that contribute to or aggravate shortages. Market factors play an especially important role in product withdrawals for commercial reasons, which have been happening with increasing frequency in recent years,” they wrote.
While the EU has begun developing guidance and infrastructure to address medicine shortages, “there remains considerable scope for improvement through greater adoption of harmonised definitions and criteria and uniform implementation of guidelines,” the authors wrote. Adding to the problem is that not all EU countries define medicine shortages in the same way. “The lack of standardisation and harmonisation is hampering information sharing and comparative analysis between countries,” they said.
Sixteen recommendations for EMA and EU Member States
Technopolis Group, Milieu Law & Policy Consulting, and Ecorys offered the following recommendations to the European Medicines Agency (EMA) and EU Member States:
  • A single EU-wide definition of medicine shortages should be established and followed
  • Harmonize reporting requirements and criteria of medicine shortages across the EU
  • Create a list of critical medicines in the EU susceptible to shortages and build an action plan around making them more widely available
  • Develop platforms where supply chain stakeholders, patients, and healthcare providers can communicate within each Member State
  • Enact EU-wide legislation to financially sanction stakeholders that don’t meet notification requirements and/or supply responsibilities
  • Require more transparency of industry supply quotas, parallel trader transactions, and parallel wholesaler transactions
  • Mandate shortage prevention and mitigation plans for suppliers operating in the EU
  • Legally require wholesalers and Marketing Authorisation Holders (MAHs) to have a “safety stock of (unfinished) products for medicines of major therapeutic interest at EU-level”
  • Develop and implement common principles for national intra-EU trade restrictions
  • Encourage emergency import of certain products if shortages or market withdrawals occur
  • List information for alternative medicine options in shortage databases
  • Require “more diversified, multiple tenderers,” which would also increase the number of diverse supply sources
  • Reduce the administrative and cost requirements for post-approval changes in the EU
  • Standardize an EU-wide packaging and labeling scheme with “flexibilities for digital leaflets and multi-country/multi-language packaging and labelling”
  • Create an EU-wide accelerated mutual recognition procedure (MRP)
  • Develop a Repeat Use Procedure for MRPs that is more efficient
“There is no reason to believe this problem is temporary or that it will go away on its own. It is thus safe to say that action is needed: action by those working in the different parts of the pharmaceutical value chain but also action by policymakers, at both the national and European levels,” the authors of the report wrote. “Crucially, any policy actions should aim to maximise the potential for achievement of its objectives while minimising the risk of unwanted consequences.”
Future-proofing pharmaceutical legislation — study on medicine shortages



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