Responding to the growing, and European-wide, problem of medicines shortages, the European Medicines Agency has published a plan to help the European medicines regulatory network cooperate in resolving some of the causal factors involved.
The paper, published by the Agency on 26th November,:
- summarises the lessons the Agency has learned from previous crises where it played a supporting or coordinating role;
- provides a short and medium-term plan to help the European medicines regulatory network prevent, mitigate and manage shortages of important medicines; and,
- identifies the globalisation of manufacturing and supply chains as a major contributing factor to the occurrence of supply shortages.
The paper acknowledges that, whilst control and supervision of the national pharmaceutical markets remain a national responsibility, Member States may experience difficulties in acting in a purely national way when faced with a pan-European crisis. Therefore, EMA considers it has a role in co-ordinating the development and communication of appropriate risk management measures arising from unexpected shortages in supply.
Some of the public safety concerns identified by EMA in relation to medicines shortages include:
- defective medicines being left on the market to prevent shortages of life saving medicines; and,
- the restricted ability of regulators to ensure GMP compliance at a production site due to the impact such measures could have in exacerbating shortage problems.
Amongst the causal factors identified by EMA in the paper include:
- globalization of manufacture extending supply chains which increases the risk of supply disruption;
- the location of manufacturing centres in areas “that have uncertain political and regulatory systems and which may be prone to natural disaster”.
The paper criticizes industry risk management in relation to shortages as being too reactive rather than proactive, and also considers that more discussion is required about the risks involved when monopolies in supply of medicines exist.
Accompanying the EMA paper is a list of short and medium term actions EMA intend to take forward through its own secretariat, and its national regulatory partners. These include:
- establishing an internal catalogue of Centrally Authorised Products (CAPs) and non-CAPs requiring coordination at EU level (e.g. referrals) that have experienced product shortages to facilitate future analysis of trends and communication on shortages;
- maintaining a public catalogue of current shortages of CAPs and medicinal products where an EU co-ordination of assessment has been undertaken;
- developing a common understanding of the concept of “essential” medicine, and develop a decision tree to assist decision-making on what shortages should be addressed at EU level;
- establishing and publishing an SOP for handling reports of shortages in supply of medicinal products due to quality defects and manufacturing problems; and
- exploring if “crisis” situations arising from product supply shortages can in the future also be addressed in the context of the EU Regulatory Network Incident Management Plan.
The EMA reflection and action papers on medicines shortages is available here
EAHP passed policy on medicines shortages at its General Assembly in June 2012. More information here
PGEU, the organization representing community pharmacy in Europe, has recently also passed policy in this area.