Action point 20 - Strategy to strengthen the capacity of SEARN Members to monitor and address shortages

Last update: 16/07/2025

Background

The vision of SEARN is to ‘support timely access to affordable medical products of assured quality, safety and efficacy in all countries of the South-East Asia region and beyond’.

In 2016, the World Health Assembly adopted the resolution WHA 69.25 on addressing the global shortage of medicines and vaccines. This resolution urged Member States to take various actions, including to develop strategies that may be used to forecast, avert or reduce shortages/stockouts, in accordance with national priorities and contexts, including: (a) to implement effective notification systems that allow remedial measures to avoid medicines and vaccines shortages; (b) to ensure that best practices for medicines and vaccines procurement, distribution and contract management processes are in place to mitigate the risk of shortages; (c) to develop and/or strengthen systems that are capable of monitoring medicine and vaccine supply, demand, availability and of alerting procurement departments to possible medicine and vaccine availability problems; (…) (f) to advance, gradually, regional and international cooperation in support of national notification systems including, but not limited to, sharing of best practices, training for human capacity building through regional and subregional structures where necessary. It also called upon manufacturers, wholesalers, global, and regional procurement agencies and other relevant stakeholders to contribute to global efforts to address the challenges of medicines and vaccines shortages, including through participation in notification systems.

Since, shortages of medical products have continued to be a growing source of concern at the global level. This situation hampers timely access from patients to the most effective treatments. National Regulatory Authorities (NRAs), including in the region, have more and more been tasked with some missions related to addressing these situations. This has been even more the case after the COVID-19 pandemic. However, few guidance is available to support these new missions. In addition, considering that the causes of these shortages are systemic and global, there would be benefits in addressing shortages beyond the national level.

Considering these challenges, the Assembly of SEARN adopted in its Work Plan the action point 20, led by Working Group 4 (WG4) Information Sharing: ‘Strengthen the capacity of SEARN Members to monitor and address shortages’.

Main objective

To develop a strategy to strengthen the capacity of SEARN Members to monitor and address shortages.

Scope and definitions

It was agreed that the strategy should include medicines, vaccines, medical devices, including in vitro diagnostics.

Challenges in defining shortages

In 2016, WHO conducted a meeting focused on technical Definitions of Shortages and Stockouts of Medicines and Vaccines. URL: https://www.who.int/publications/m/item/WHO-EMP-IAU-2017.03. The literature review revealed fifty-six definitions. The meeting report highlighted that technical definitions would need to be accompanied by guidance on their use and applicability in different contexts to avoid unintended consequences.

Definitions were drafted as follows:

  • On the supply side: a “shortage” occurs when the supply of medicines, health products and vaccines identified as essential by the health system is considered to be insufficient to meet public health and patient needs. This definition refers only to products that have already been approved and marketed, in order to avoid conflicts with research and development agendas.
  • On the demand side: a “shortage” will occur when demand exceeds supply at any point in the supply chain and may ultimately create a “stock out” at the point of appropriate service delivery to the patient if the cause of the shortage cannot be resolved in a timely manner relative to the clinical needs of the patient.

Further, a definition framework was developed:

2 VEN is a reference to Vital Essential and Necessary medicines which is an expression used by some countries to distinguish a subset of their national list of essential medicines.

Several criteria were further identified as relevant in the refinement of the definitions during this meeting:

  • Patient centered definitions, including time bound criteria for how long treatment is delayed;
  • Public health impact;
  • Ability to use in measurement / monitoring and evaluation;
  • Responsible reporting, including avoidance of conflation or other forms of over-reporting
  • Focus on reporting that facilitates a response or other diagnostic is important noting that facility stock out reporting can be useful in multiple types of assessments but alone does not take the place of other forms of reporting;
  • Harmonization on units of measure will be needed to make data sharing practical and useful;
  • Situational definitions, including durations ranging from temporary, long term, permanent will be needed;
  • API or final product recalls and shortages caused by problems with quality;
  • Markets are regional and global, implying that reporting of shortages and stock outs needs to involve sharing of information and harmonization of reporting;
  • Quality of information will also require guidance on what, when and who should report on shortages and stock outs of medicines and vaccines, and to whom it should be reported.

Survey

A survey was conducted to identify the situation in the different SEARN members, the role and practices of NRAs in the region with respect to shortages, the connection with other organisations, and their challenges.

Highlights:

  • A mapping exercise was conducted to identify key responsibilities of different organizations. NRAs were frequently responsible for identification of shortages, alternatives, publication and sharing of information.
  • Identification of shortages was identified as particularly challenging, followed by monitoring of shortages, assessment of impact and identification of alternatives
  • The main challenges faced by NRAs to address shortages were at organizational level: lack of legal provisions/clear responsibility and tools, and insufficient number of staff or access to experts
  • Paediatric medicines have been frequently reported by NRAs during recent shortages, followed by chemotherapy and antibiotics. Medical devices, in vitro diagnostics and vaccines were also impacted.
  • The main causes of shortages highlighted by NRAs were related to low price/low quantities, lack of application from MAH/absence of MA, and monopoly situations.

Scoping review

European Union

The EU has developed a strategy to address medicines shortages which is build around several pillars. This strategy was supported by an extended legal mandate laid out in Regulation (EU) 2022/123, which includes a definition of shortages as ‘a situation in which the supply of a medicinal product that is authorised and placed on the market in a Member State or of a CE-marked medical device does not meet demand for that medicinal product or medical device at a national level, whatever the cause’.

Transparency & information sharing

EMA maintains a public Shortages Catalogue for ongoing and resolved supply disruptions affecting multiple EU countries. This complement national shortage registers.

EMA also issues alerts through Medicine Shortage Communications (MSCs) and Direct Healthcare Professional Communications (DHCPs).

The European Shortages Monitoring Platform (ESMP)

EMA has launched a European Shortages Monitoring Platform (ESMP) to collect real-time data on medicine availability, supply and demand in order to prevent, detect, and manage human medicine shortages. The platform is open to marketing authorization holders and National Authorities. Reporting is mandatory for MAHs, and in certain situations for NRAs.

SPOC and MSSG

The Medicine Shortages Single Point of Contact (SPOC) Working Party is responsible for monitoring and reporting events that could affect the supply of medicines in the European Union (EU). The SPOC WP may escalate shortages and availability issues to the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG).

The MSSG

  • List key medicines used in emergency care and during crises and critical medicines.
  • Monitor supply and demand of critical medicines to detect shortages.
  • Coordinate EU response and recommend actions to prevent or reduce shortages.
  • Advise the EU Commission on declaring major events.
  • Assess medicines’ safety and quality during emergencies.
  • Oversee solidarity mechanism for cross-country support during shortages.
  • Address supply chain risks and collaborate on long-term solutions through
    • the Critical Medicines Alliance whichis a consultive mechanism with EU Member States, key industries, the civil society, and the scientific community.
    • Recommendations targeting supply chain resilience

USP

The United States Pharmacopoeia published a report on Economic factors underpinning shortages which highlights the following causes of shortages in the US:

  • Low prices: Drugs with low prices paid to manufacturers face a higher risk of shortage. In 2023, product discontinuation rose by 40%, from 100 in 2022 to 140 in 2023, as tight margins drove manufacturers out of the market.
  • Manufacturing complexity: Drugs with higher manufacturing complexity are more vulnerable to shortage. Complexity can include therapeutic classes that need dedicated facilities, or active ingredients that require complex chemical synthesis.
  • Geographic concentration: Drugs in which the active pharmaceutical ingredient (API) and/or finished dose are made in a single or few locations are more at risk of shortage. Among drugs newly in shortage, the U.S. produces nearly half of total volume for solid orals (43%) and sterile injectables (49%).
  • Quality concerns: Facilities where drugs in shortage are made are more likely to have had inspection issues. Poor inspection results can provide a warning signal about the potential location of future problems.

It also developed the USP Medicine Supply Map intended to simplify and optimize supply chain management for manufacturers and buyers.

Next steps

  1. To conduct a survey to collect current definitions related to shortages and existing mechanisms to address these in SEARN members
  2. To develop a system to compile, analyse and share information related to shortages at SEARN level to support Members in forecasting, reducing and averting shortages/stockouts
  3. To learn from the experience and best practices of SEARN members and other regions / organizations in addressing shortages, including public procurement agencies (e.g. iCAPS)
  4. To develop collaboration with public procurement agencies to support the development and implementation of the SEARN strategy
  5. To support SEARN Members in addressing shortages through capacity building, including at the organizational level (e.g. legal provisions, clear responsibilities, tools)