Shortages of medicinal products are an increasing problem in the EU, therefore, one of the objectives of the new proposed European pharma REFORM is to enhance the security of supply and ensure medicines are available to patients in the EU. The new proposed pharma regulation sets out the specific rules on the security of supply of critical medicines.
But while awaiting the new regulation to become effective, several European actions have are already been set up to prevent shortages in EU on the short-term. Today, the compilation of the Union list of critical medicines has been established, see link to EMA website: https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-and-availability-issues/availability-critical-medicines
Next, the vulnerabilities in the supply chain of these critical medicines will be analysed and measures may be recommended to prevent shortages for these medicines, as its unavailability could cause significant harm to patients and pose substantial challenges to health systems.
The proposed measures, including recommendations for companies to diversify suppliers or increase production within the EU, investment incentives and additional regulatory obligations for companies, will apply to those companies, who market one of the medicines belonging to this Union list of critical medicines.
Hence, it is recommended that each company reviews this list and that priority is given to those critical medicines in the prevention against shortages. In addition, it is important to continuously monitor the ongoing proposed measures and position your company accordingly, to remain compliant with the current legislation and avoid critical setbacks in the future.