The results of a pilot research that sought to comprehend the challenges associated with maintaining safe medication supply chains have been made public by the European Commission. The panel identified information gathering for essential medicinal items as a significant obstacle. Nonetheless, notable limitations in the research were identified, which impede the interpretation of the results.
Numerous cases of crucial medication shortages occurred in EU member states during the COVID-19 pandemic, which prompted inquiries into the root causes and possible remedies by the Commission and other relevant parties. A list of 200 necessary medications at risk of shortage was released in December by the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA), and the Commission.
To determine what could be causing a possible shortage of 11 medications, the Commission launched a pilot study. It published a preliminary technical study outlining the difficulties that may cause these shortages on July 10. The Commission anticipates that this information will contribute to conversations in places like the Critical Medicine’s Alliance (CMA), the Joint Industrial Cooperation Forum of Health Emergency Preparedness and Response Authority (HERA), and the Medicine Shortages Steering Group (MSSG).
The European Health Union must make sure that medications are always available, according to the Commission. It emphasized the need of bolstering supply chains’ resilience by guaranteeing access to critical competencies at several stages, from locating raw materials and active pharmaceutical ingredients (APIs) to producing final products.
In addition, the Commission recommended that domestic manufacturing capacity inside the EU be increased, as well as strategic alliances with like-minded nations throughout the world, in order to improve strategic autonomy and reevaluate manufacturing dependence in the healthcare sector.
The research found that Marketing Authorization Holders (MAHs) often depend on a small number of suppliers throughout their supply chains, despite limitations in the data obtained. It brought attention to a number of economic difficulties, such as rising prices, fierce competition, and unstable markets. The study also said that businesses usually plan their production capacity across three time periods: short-term (three to six months), mid-term (two to three years), and long-term (five to ten years).
According to the research, MAHs often base their projections for short-term production planning of generic medications on current sales rates. It was discovered, however, that this strategy was severely constrained in situations when there were notable variations in demand, such those that occurred during and after the epidemic.
Regulatory concerns were mentioned less often in the research, which listed manufacturing and logistical issues as the main reasons for supply chain interruptions. It said that in addition to the time needed for regulatory clearances, these difficulties are exacerbated by the complexity of manufacturing and the financial risk involved in investing in new or modified production lines.
Similarly, statistics from member states revealed a significant dependence on active pharmaceutical ingredients (APIs) produced outside of the European Union. The main problems mentioned by the member nations were unanticipated spikes in demand, production problems, and quality difficulties.
Notwithstanding these difficulties, the report outlined the several approaches used by member nations to deal with supply chain problems, including export limitations, regulated distribution, alternative protocols, regulatory flexibility, and stakeholder communication.
According to a research by the European Commission, among the most often used measures were those pertaining to regulated distribution and regulatory flexibility. It was said that almost half of the member nations said they gave exemptions, such as for using unlicensed medications and packaging in foreign languages.
