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October 2013

Common Position adopted for preventing, managing and solving medicine shortages


Medicine package with only one tablet leftThe shortage of medicines is a growing problem, one which is potentially dangerous for all patients. Currently, there exist a number of medicine shortages across Europe affecting different conditions – including rare diseases, which frequently have no alternative treatment available. In response, EURORDIS initiated a process to develop a Common Position for preventing, managing and solving medicine shortages.

Medicine shortages can cause a patient’s condition to deteriorate, leading to serious harm that is avoidable. The shortages of treatments for Fabry disease and for Gaucher disease, which began in 2009, are two examples of rare disease therapy shortages that posed serious problems to patients, including worsening of the conditions, recurrence of the disease manifestations, increased pain, and other adverse effects. Currently European Union Member States report shortages for between 30-60 different medicines.

In response to this ongoing problem, EURORDIS proposed that patient, consumer and healthcare professional organisations involved with the European Medicines Agency (EMA) adopt a common position responding to the supply shortages of medicines. Since February 2013, a drafting group of patient and healthcare professional organisations, spearheaded by EURORDIS Treatment Information and Access Director François Houÿez and including EURORDIS volunteers in the Drug Information Transparency and Access (DITA) task force, has been analysing the various causes and consequences of shortages and has developed a comprehensive list of proposals. This work has resulted in a Common Position between patient, consumer, and healthcare professional organisations on the supply shortages of medicines. To date, over a dozen of these organisations have adopted the Common Position, including EURORDIS. At a workshop devoted to medicine shortages held at the EMA on 14 October 2013, the propositions elaborated in the Common Position were welcomed and utilised to generate discussion.

 

The causes for medicine shortages vary, resulting from manufacturing problems (as was the case for the Fabry and Gaucher disease therapies) or stemming from different medical, regulatory, economic or marketplace issues. Besides patients, healthcare professionals are also impacted by medicine shortages, reporting an increased, often unmanageable workload as they strive to find ways to compensate for the absence of adequate treatment. A lack of transparency over the extent and duration of shortages compounds the situation for health professionals and patients. At the national level, a growing number of EU Member States have begun monitoring the problem and establishing websites to keep the public informed of shortages. Despite these efforts, information on shortage occurrences and duration remains hard to find.

The Common Position on supply shortages of medicines adopted by EURORDIS and other organisations petitions for a more efficient regulation of shortages. Patient and healthcare professional organisations are urged to add their signatures in support of the proposed actions to prevent, manage and resolve medicine shortages. To add the signature of your group to the Common Position, please contact François Houÿez


Louise Taylor, Communications and Development Writer, EURORDIS