EFPIA: Medicines Shortages – from Assumptions to Evidence to Action

| By | Drug Exports, Drug Supply, EFPIA
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Medicine shortages may negatively impact patient care and the patient experience. Shortages should be a priority of industry, supply chain stakeholders and national competent authorities, and deserve more than empathy or ‘lip-service’ but serious engagement and action, EFPIA report says.

EFPIA welcomes initiatives to address genuine shortages of medicinal products. The industry shares a common goal with all partners in healthcare – that is to ensure that all patients around the world have timely access to high quality medicines and vaccines. In Europe, the industry is committed to working closely with competent authorities to help ensure that medicines are accessible to all people, wherever they live, and to make healthcare more sustainable whilst securing future medical innovation.

Pharmaceutical companies should address issues relating to the manufacturing and supply of medicines and vaccines within their control to ensure the continuity of supply to people who need them. This is however a complex issue involving multiple stakeholders, and we need the active engagement and support of all of them to address this and minimise any negative impact on patient access.

Measures considered to address this issue should be proportionate and provide efficient, workable solutions that serve public health needs. It is also key to provide the right conditions and business environment to support the long-term sustainability of supply. This includes predictable and fair pricing and market access systems that reflect the various economic and healthcare needs across Europe.

EFPIA calls for:

  1. Better understanding of the root causes and drivers of shortages. This should include identification of bottlenecks in the supply chain (the European Medicines Verification System set up in the context of Falsified Medicines Directive could readily be used for this purpose);
  2. Better reporting of shortages through enhanced cooperation between supply chain stakeholders and the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) Task Force. Standardised reporting requirements for information on clearly defined shortages should be agreed, giving priority to critical products with high potential impact. The information should be uploaded onto a common portal to ensure a streamlined and effective alert system;
  3. Effective enforcement of existing regulatory requirements on all actors in the supply chain at national level, coupled by measures to enhance transparency within the supply chain and support further dialogue across key stakeholders facilitating sharing of best practices;
  4. Emergency intervention as the last resort, with greater solidarity among Member States to reduce disruptions in the supply chain by abolishing the distortive effects of national schemes incentivizing imports from lower income to higher income Member States (e.g. dispensing quotas for parallel imported products in Germany) or imposing significant national stockpiling obligations limiting supply for other EU markets;
  5. Where needed, appropriate and proportionate temporary emergency measures enacted at national level to prevent shortages due to exports, to follow the good practice guidelines set
    out in this paper.
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