The Members of the European Alliance for Responsible R&D and Affordable Medicines have published a note today outlining key recommendations to prevent and mitigate shortages of medicines in the upcoming revision of the pharmaceutical legislation 

The note highlights that the EU needs a bold patient-centred policy on the prevention and management of medicine shortages based on public health considerations and enhancing the accountability of the pharmaceutical industry. Transparency of the supply chains should be at the core of this revision process. To ensure equitable access to medicines across the Union, public production strategies and stock supply are also discussed.  

The Alliance Members developed recommendations around 3 pillars that should guide the new EU pharmaceutical legislation: 

  1. Information on medicine shortages
  • Strengthening the obligation for pharmaceutical companies to notify unexpected shortages and shortages risks as soon as they are identified 
  • Require a well in advance notification period for withdrawals due to commercial reasons 
  • Establish harmonized and detailed reporting criteria for shortages and shortage risks 
  • Allow patients to report shortages of medicines
  • Ensure effective and transparent communication on medicine shortages through a comprehensive EU database accessible to the public 

2. Prevention measures

  • Establish an independent and proactive monitoring system of stocks of medicines in the EU to anticipate shortages risks upstream
  • Create a legal obligation for pharmaceutical companies to prepare and submit transparent shortage prevention and management plans
  • Introduce a legal obligation for pharmaceutical companies to maintain relevant safety stocks of medicines of major therapeutic interest at the EU-level
  • Adapt the model of joint procurement used for COVID-19 vaccines to buy medicines in limited supply and distribute them fairly among Member States 
  • Promote public production strategies whenever needed to ensure the availability of essential medicines and therapies

3. Mitigation measures and sanctions 

  • Adapt the regulatory framework to allow hospital pharmacists to prepare and distribute medicines of major therapeutic interests in case of shortage
  • Ensure that pharmaceutical companies comply with their legal obligations and set dissuasive sanctions in case of non-compliance 

Read the full note here. 

Endorsing organizations

  1. European Public Health Alliance (EPHA)
  2. Asociación por un Acceso Justo al Medicamento (Spain)
  3. Consumer Association the Quality of Life-EKPIZO (Greece)
  4. Médecins du Monde (Spain)
  5. Prescrire
  6. AIDS Action Europe (AAE)
  7. Organización de Consumidores y Usuarios (Spain)
  8. La Ligue contre le cancer (France)
  9. TRT-5 CHV (France)
  10. AIDES (France)
  11. France Assos Santé
  12. Salud por Derecho (Spain)
  13. Pharmaceutical Accountability Foundation (Netherlands)