Issue: March / April 2022

Drug shortage and inaccessibility, stemming from exorbitant pharmaceutical drug prices, is only but a fraction of the many factors affecting global health. Most recently, the world was reminded of the role of pandemics in fast tracking the above-mentioned problem. A potentially sustainable solution would entail establishing cost effective and efficient local drug manufacture capacity in different regions. Using the HIV/AIDS epidemic as a case example, efforts by various research groups towards this goal are presented herein.

The pharmaceutical supply chain has been ripe for innovation for quite some time, and the pandemic has further highlighted the need to look at ways to make processes more efficient while increasing transparency and increasing data security. Blockchain is an open, distributed ledger that can efficiently record transactions between two parties in a verifiable and permanent way. Since blockchains are decentralized, distributed, transparent, and immutable, they not only easily solve the issue of counterfeit medicines but can address issues around advanced therapeutic medicinal products (ATMP) tracking.

Specific immunotherapy (SIT) is the first-choice treatment for allergic respiratory diseases. Over the years, the literature has demonstrated that the focus of specific allergen immunotherapy has always been on the search for a safe, easy to use treatment to ensure good patient compliance. The COVID-19 pandemic has severely put many treatment plans to the test but, in the immunotherapy sector, it has been and is still possible to adopt safe treatments that allow them to be continued even during the course of emergency vaccinations, like that of COVID-19.

COVID-19 has shown that coordinated action at EU level is necessary to effectively respond to health emergencies. While during the pandemic the EU reacted to issues as they arose, the creation of HERA is a first step to putting Europe on the front foot in addressing global health threats.
This paper outlines EFPIA and VE’s views and recommendations on a number of elements included in the Commission’s Decision establishing the Health Emergency Preparedness and Response Authority (HERA)] and in the Proposal for a Council Regulation on a framework of measures for ensuring the supply of crisis relevant medical countermeasures in the event of a public health emergency at Union leveP. EFPIA and VE, their national associations and member companies, look forward to working with HERA and all stakeholders towards the shared goal of a safer, healthier and more resilient Europe.

Various digital technologies are currently available to help biopharmaceutical and pharmaceutical manufacturers drive significant process improvements. There are numerous areas where process automation and simplification can be enabled using electronic data (eData) from key raw material suppliers. This article describes some current use cases in which the manufacturer’s analytical capabilities are enhanced using a standard eData platform, and also explores future opportunities to optimize other critical parts of the production process including logistics-related applications.