Decisive Action Called For On EU Drug Shortages

A public health advocacy group in the EU has issued tangible recommendations to address the perennial problem of drug shortages in the region.

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Drug Shortages Is An Ongoing Concern In The EU

The exponential rise in drug shortages across the EU, exacerbated by the COVID-19 pandemic, has prompted calls for clear definitive actions to remedy this pressing cross-border health threat.

While addressing drug shortages has always been a major concern for EU regulators, recent developments, such as Brexit and now the COVID-19 pandemic, has brought the issue to the fore. (Also see "‘Impossible' To Prepare UK Supply Chain For October No-Deal Brexit" - Pink Sheet, 19 Jun, 2019.) (Also see "Stark COVID-19 Drug Shortages Warning From Senior EU Regulator" - Pink Sheet, 6 Mar, 2020.)

Public health advocacy group, the European Public Health Alliance, has now called for decisive action on the matter, supported by legislative changes where needed.

The EPHA notes that the current approach to handling drug shortages in the EU has largely involved a patchwork of initiatives in member states, such as the adoption of national regulations and the introduction of temporary restrictions on parallel trade. (Also see " Pharmacists To Get New Substitution Powers To Tackle Brexit Shortage Risk " - Pink Sheet, 21 Jan, 2019.) (Also see "Belgium Imposes Selective Export Ban As COVID-19 Threatens Stocks" - Pink Sheet, 6 Apr, 2020.)

The alliance says that although some “praiseworthy” EU-wide initiatives have been launched since 2019, such as a pan-EU guidance on the detection and notification of shortages by marketing authorization holders (MAHs), and a new system (i-SPOC) to improve information sharing between member states, “their impact may be limited.” (Also see "Defining & Reporting Drug Shortages in the EU - New Guidance " - Pink Sheet, 4 Jul, 2019.) (Also see "EU Launches Fast-Track Monitoring Of Crucial COVID-19 Drug Shortages" - Pink Sheet, 21 Apr, 2020.)

While the guideline’s effectiveness “will depend on the goodwill of MAHs, who have already requested to delay its implementation,” the i-SPOC system “mainly focuses on crisis management and will not help prevent shortages,” the EPHA states in a new position paper in which it makes nine principal recommendations to address the issue.

The alliance believes that national efforts on tackling drug shortages can have a greater impact if these are coordinated, complemented and supported by EU initiatives. The EPHA recommends measures relating to:

• MAH/wholesaler obligations – The alliance says that although EU regulations include general obligations for MAHs and wholesalers to supply medicines and for MAHs to notify about temporary or permanent supply interruptions, their implementation has been uneven in member states. It says it supports legislative changes to improve the notification system, reinforce obligations of MAHs and wholesalers relating to medicines supply and to make all obligations on medicine supply chain actors enforceable.

• Shortage management and prevention – The EPHA has recommended introducing a legal requirement for all medicines marketed in more than one member state to have an EU shortage management and prevention plan based on an analysis of the manufacturing and distribution risks.

• Early warning systems – The adoption of early warning systems, already in place in some members states, at the EU level and by other member states can help ensure that preventive/mitigation measures are initiated as early as possible, the alliance says.

• EU guidance on parallel trade restrictions – Guidance on the scenarios in which parallel trade restrictions can be imposed without the threat of proceedings for breach of EU free movement rules would give countries more certainty and greater ability to respond quickly to emerging threats of medicine shortages, according to the alliance.  (Also see "Belgian Court Overturns Parallel Export Ban" - Pink Sheet, 25 Oct, 2019.)

• EU guidance on procurement – Focusing solely on price can result in suppliers pulling out of national markets, contributing to market consolidation and increasing the risk of medicine shortages. The EPHA recommends developing EU guidance to help member states adopt prudent procurement practices and help prevent the occurrence of shortages in generic medicines.

• Monitoring – At present, there is no common EU platform to publicly share information on drug shortages, the alliance says. The EPHA recommends creating a permanent EU monitoring system that gathers and publishes all data reported at the national level to improve transparency on the scale of shortages and their causes.

• Impact on patients – While the European Commission is planning a study on the root causes of shortages in the EU, the EPHA says investigations into the impact of shortages on patient care should also receive equal attention.

• EU strategy – The EPHA wants the commission to develop a comprehensive EU strategy on medicine shortages with the active contribution of the European Parliament.

• EU joint action – Although a joint task force of the European Medicines Agency and Europe’s Heads of Medicines Agencies on the availability of authorized medicines is already in place, its main focus is on improving the management of shortages, the alliance notes. The EPHA supports another collaboration between member states to develop and share tools, and methods to prevent medicine shortages.