Medicine shortages should be an industry priority, EFPIA says

Medicine shortages may negatively impact care and patient experience, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has said.

It said that 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. It also states that it welcomes initiatives to address genuine shortages of medicinal products.

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, the EFPIA said. “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.”

EFPIA has said it calls for:

1. A 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 (FMD) could readily be used for this purpose).
2. Better reporting of shortages through enhanced co-operation between supply chain stakeholders and the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) Task Force and that standardised reporting requirements for information on clearly defined shortages should be agreed, giving priority to critical products with high potential impact and 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 a national level, coupled with measures to enhance transparency and support further dialogue across key stakeholders facilitating the 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 incentivising imports from lower-income to higher-income member states or imposing significant national stockpiling obligations limiting supply for other EU markets
5. Where needed, appropriate and proportionate temporary emergency measures enacted at a national level to prevent shortages due to exports.

“Measures considered to address this issue should be proportionate and provide efficient, workable solutions that serve public health needs,” the EFPIA continued. “It is 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.”