Availability of medicines
Table of contents
- Impact of COVID-19 pandemic
- Medicine shortages
- Public information on shortages from EMA
- EU-level coordination on medicines availability
- Guidance for marketing authorisation holders
- Voluntary sharing of market launch intentions: pilot project (new)
- Guidance for regulators on public communication
- Guidance for regulators on shortages due to manufacturing or quality issues
- Preventing Brexit-related shortages
This content applies to human and veterinary medicines.
Improving the availability of medicines authorised in the European Union (EU) is a key priority for the European medicines regulatory network. Shortages or other problems with the availability of medicines create challenges for the medicine supply chain, with a potentially serious impact on human and animal health.
Since 2016, a task force set up by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) looks at availability issues, including medicines that are authorised but not marketed and supply chain disruptions, to improve continuity of supply of human and veterinary medicines across Europe. This builds on the network’s efforts since 2012 to improve processes for handling shortages caused by good manufacturing practice (GMP) non-compliance.
The?European medicines regulatory network?is closely monitoring the?impact of the COVID-19 pandemic on the human and veterinary medicine supply chains in the EU. For more information, see?Availability of medicines during COVID-19 pandemic.
Medicine shortages can occur for many reasons, such as manufacturing difficulties or problems affecting the quality of medicines that can impact on patient care.
In the EU, most medicine shortages are dealt with at national level by national competent authorities.?However, EMA can be involved in certain situations, for example when a medicine shortage is linked to a safety concern or affects several Member States.
Regulatory authorities within and outside Europe are increasingly working together to prevent shortages and to limit their impact whenever they occur. The European medicines regulatory network aims to minimise the impact of medicine shortages on patients by:
- working with pharmaceutical companies to resolve manufacturing and distribution issues;
- sharing information with international partners about alternative sources of supply;
- seeking input from patients and healthcare professionals on the impact of medicine shortages, to support decision-making;
- taking measures to allow alternative medicines or suppliers to be used.
Since 2016, EMA publishes a public catalogue for shortages?assessed by its Committee for Medicinal Products for Human Use (CHMP) and/or the Pharmacovigilance Risk Assessment Committee (PRAC),?providing?clear?information and recommendations, if relevant, to?patients, healthcare professionals and other stakeholders.?For more information, see:
For a?list of national medicine registers in the Member States of the EU?and the EEA, seeNational registers of authorised medicines.
EMA's communications on shortages are in line with the HMA/EMA good practice guidance on communicating shortages to the public and EMA's discussion paper on Communication by EMA on supply shortages of medicinal products
EMA and the Heads of Medicines Agencies (HMA) created an HMA/EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use in December 2016 to provide strategic support and advice to tackle disruptions in supply of human and veterinary medicines and ensure their continued availability.
Its key priorities include:
- looking at ways to minimise supply disruptions and avoid shortages by facilitating approval and marketing of medicines using the existing regulatory framework (for example by work sharing and reduced timetables when possible);
- developing strategies to improve prevention and management of shortages caused by disruptions in the supply chain (for example developing guidance for companies on reporting of shortages);
- encouraging best practices within the pharmaceutical industry to prevent shortages;
- improving sharing of information and best practices among EU regulatory authorities to better coordinate actions across the EU;
- fostering collaboration with stakeholders and enhancing communication of supply problems to EU citizens.
For more information on the task force's work and composition, see:
- Heads of Medicines Agencies
- HMA/EMA Task Force on Availability of Authorised Medicines for Human and Veterinary Use
- Work programme of the HMA/EMA Task Force on Availability of Authorised Medicines for Human and Veterinary Use
- Multi-stakeholder workshop with the HMA/EMA task force on availability of authorised medicines?(09/11/2018)
Since April 2019, the task force has been?running a pilot?programme on establishing a single point?of contact?(SPOC) network?to improve information sharing between Member States, EMA and the European Commission?on important medicine shortages of human and veterinary medicines and to coordinate?actions to help prevent and manage shortages. This includes information sharing on alternative medicines that are available in other Member States.
The first phase of the pilot ran from April to August 2019 to?test the functioning and usefulness of the information exchange via the SPOCs. During this phase,?24 Member States used the SPOC system?and circulated 52 notifications?of shortages.?
The task force plans to run a second phase of the pilot in 2020, to?test the criteria for identifying cases deserving EU-wide coordinated action and for network alerts of upcoming public communications that could have a high impact on patients.
The task force will publish more information after?completion of the second phase of the pilot.
In July?2019, EMA and HMA published guidance for marketing authorisation holders on detecting and reporting medicine shortages:
- Guidance on detection and notification of shortages of medicinal products for Marketing Authorisation Holders (MAHs) in the Union (EEA)
The guidance is based on a harmonised definition of a shortage, as agreed by all national competent authorities and EMA.?
When a shortage occurs, or is expected to occur, in one or more EU Member State, the marketing authorisation holder?should report it?to the national competent authorities concerned.?If the shortage concerns a centrally authorised product, the marketing authorisation holder should also notify?EMA.?
The guidance contains a reporting?template for use if none is provided by?the?country in question.
EMA and HMA intend to launch a pilot project on implementing the guidance, which is delayed to the first quarter of 2021 due to the COVID-19 pandemic. EMA and HMA will provide further information for marketing authorisation holders before starting the pilot.
The guidance aims to facilitate the early notification of shortages to national competent authorities, allowing them sufficient time to make contingency arrangements where necessary. It covers:
- what constitutes a shortage;
- what issues marketing authorisation holders should report;
- who is responsible for monitoring supply and reporting shortages;
- when and whom to notify;
- what information to?include?in notifications
It does not cover issues such as withdrawals of marketing authorisations, which can also affect a medicine's availability.?
New: From?25?March 2021,?marketing authorisation?applicants for?orphan medicines?and medicines to treat?cancer?will be invited to take part in a?pilot project by declaring their?market launch intentions?on a voluntary and confidential basis.
The pilot aims?to help regulators understand why delays may occur in the marketing of certain medicines in EU Member States after they receive a marketing authorisation.
They will be also asked to provide feedback on challenges and limiting factors they face in ensuring the availability of their medicines in the EU.
The pilot project will run for 18 months,?until August 2022.
More information and guidance for applicants is available on the European Commission's website?and in the question-and-answer (Q&A) document below.?
In July?2019, EMA and HMA published?guidance for national competent authorities and EMA?on good practices in communicating to the public on medicines' availability issues:
- who should communicate on a medicines shortage;
- who?the target audience is;
- which format and communication tools to use;
- what information and when to publish;
- how to involve stakeholders in the preparation and dissemination of information;
- internal collaboration within the European medicines regulatory network;
- existing examples and initatives that could be implemented in other Member?States.
The guidance is based on a survey?on how issues related to shortages and availability of medicines are measured and communicated to the public?in EU Member States, which was carried out by the HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use.
EMA has published a set of documents to support regulators involved in coordinating shortage situations due to good manufacturing practice (GMP) non-compliance:
- Criteria for classification of critical medicinal products
- Decision tree on escalation from national to European level
- Points to consider for the overall assessment of a supply shortage of a medicinal product due to GMP Non-compliance /quality defects
- Closing report on assessment of a supply shortage of a medicinal product due to manufacturing and quality problems
- Resources for issuing treatment recommendation during shortages of medicinal products
- Risk indicators for Shortages (Manufacturing and Quality)
The documents for regulators build on an EMA reflection paper on public health incidents that can arise due to manufacturing disruptions and an implementation plan to coordinate the assessment of shortages, develop risk-minimisation measures, alleviate the impact on patients and communicate within the European medicines regulatory network:
- Reflection paper on medicinal-product supply shortages caused by manufacturing / good-manufacturing-practice compliance problems
- Implementation plan 2012-2015
They also draw on input from an EMA workshop on product shortages due to manufacturing and quality problems in 2013 and a stakeholder meeting to review progress in 2015:
- Developing a proactive approach to the prevention of medicines shortages due to manufacturing and quality problems: Report from stakeholder meeting
For more information, see:
In the context of the?Brexit: the United Kingdom's withdrawal from the European Union , EMA has published a questions-and-answers document to address potential questions from stakeholders on the supply of medicines in the EU after Brexit and what the Agency, the European Commission and national competent authorities in the Member States are doing to prevent potential medicine supply shortages due to Brexit: