February 12, 2025
By Marios Georgiou, Manager, Lead for Communications and Advocacy
Plasma Protein Therapeutics Association (PPTA) has recently published a position paper expressing concern about the unilateral decisions made by some European Union (EU) Member States to implement mandatory stockpiling requirements for certain medications. The EU is working to establish a common strategic approach for stockpiling the most critical medicines to support national efforts in tackling ongoing medicine shortages.
In this new publication, PPTA notes that such a policy still may lead to counterproductive outcomes for European patients relying on plasma-derived medicinal products (PDMPs), such as:
- Diversion of critical medicines away from patients
- Higher costs and potential wastage of unused stock
- Complication of existing supply challenges
- Interfere with free movement of goods within the EU
- Introduction of unnecessary barriers to equitable patient access
PPTA position paper emphasises that while stockpiling medicines at national and EU level can be a practical short-term solution to a sudden increase in demand for medicines, e.g. for the seasonal increase in demand for Antimicrobials, it is not a sustainable long-term strategy to address shortages of medicines for which clinical need is constantly increasing. The effectiveness of stockpiling can vary depending on the type of medicine. For plasma-derived medicines in particular, stockpiling does not address the root causes of shortages, such as inadequate plasma collections and different regulatory requirements in different countries.
Therefore, when selecting medicinal products for stockpiling, EU policymakers should consider plasma-derived medicines' unique supply chain challenges. Decision-makers are encouraged to adopt a more tailored approach rather than applying one-size-fits-all strategies to regulate PDMPs. Instead, the emphasis should be on strengthening the entire supply chain for plasma-derived medicines. This focused approach will enhance the availability of PDMPs and improve responses to potential shortages.
Why doesn’t stocking work for plasma-derived medicines?
Plasma-derived medicines are a unique category of treatments within the broader pharmaceutical sector. It encompasses various biological therapies, such as clotting factors, immunoglobulins, alpha-1 proteinase inhibitors, C1-esterase inhibitors, and albumin. These treatments are vital for patients facing life-threatening conditions, including bleeding disorders, autoimmune diseases, neurological conditions, and inflammatory disorders. Furthermore, plasma-derived medicines are crucial in everyday medical practice, emergency care, and preventive medicine. Almost all plasma-derived medicines are listed on the European Union’s List of Critical Medicines.
Plasma-derived medicines have unique properties that require more flexible and adaptable strategies to avoid medicine shortages than depending solely on stockpiling. Firstly, they are derived from human biological material (plasma) and require millions of plasma litres per year to manufacture. Plasma collection depends entirely on the generosity of voluntary human donors, which means that the availability of this limited resource can fluctuate at times. Secondly, the manufacturing process of PDMPs is lengthy, complex, and highly regulated. The production of these medicines may take up to 12 months, from plasma collection to final product.
- Plasma is limited: PDMPs rely on human plasma donations. Plasma is scarce and a finite resource. Unlike synthetic medicines, which can be produced quickly, the plasma collection and manufacturing of plasma-derived medicines are lengthy and cannot be sped up. This exceeds typical timelines for stockpiling strategies. The supply chain—from donor to patient—must be meticulously planned months ahead of time to ensure medicine availability.
- Short shelf life: PDMPs have a limited shelf life, usually ranging from 24 to 36 months. If large quantities are stockpiled, there is a risk that some doses may expire before they can be used. Once expired, these medicines cannot be distributed or administered, wasting lifesaving medicines.
- Increased cost: Producing plasma-derived medicines is much more expensive than traditional medicines. If marketing authorisation holders are required to stockpile large amounts, production costs will rise even more, especially since these medicines often need cold storage and careful distribution. Moving stock between countries is also difficult because packaging and labelling are market specific.
- Inequities across borders: When a country accumulates an excessive stockpile of medications, it can decrease the availability of those medications for neighboring countries. This is especially concerning because it creates inequities and can exacerbate existing shortages of PDMPs elsewhere.
The importance of focusing on the entire PDMP supply chain
Stockpiling of plasma-derived medicines can worsen supply challenges and create disparities in access among EU Member States. It could undermine the goal of ensuring uninterrupted access to critical medicines. While an EU-level approach to stockpiling may offer temporary relief for certain medicinal products during emergencies, it is not a viable solution to the increasing demand for plasma-derived medicines.
Instead, EU policymakers should concentrate on strengthening the supply chain, increasing plasma collection, and streamlining regulatory processes that impact the availability of plasma-derived medicines. The clinical need for plasma-derived medicines is constantly increasing, and stockpiling does not address the root causes of shortages over the long term. In other words, relying solely on stockpiling will not be enough to ensure a reliable and continuous supply of medicines. The EU can ensure more equitable and reliable patient access to these lifesaving medicines by tackling the root causes of shortages in plasma-derived medicines. Policymakers are welcome to engage in ongoing dialogue and close collaboration with the industry to address the underlying issues affecting the supply of critical medicines.
Why This Matters
Public health preparedness has become increasingly important in the aftermath of the COVID-19 pandemic. This crisis highlighted significant vulnerabilities within health care systems worldwide. For instance, many health care facilities were caught off guard by an unprecedented surge in demand for medicines and supplies. As a result, the European Union has begun re-evaluating its health readiness strategies and exploring lessons learned from the pandemic to prevent similar incidents from repeating.
Over the years, several policy initiatives have been developed to address and strengthen the fragility of medicinal supply chains. Recently, in 2024, the European Commission established the Critical Medicines Alliance (CMA), a consultative group focused on enhancing the supply chain of critical medicines. One of the strategies discussed is stockpiling, which is viewed as a proactive solution to medicine shortages. Additionally, the recently appointed EU Commissioner for Preparedness and Crisis Management Hadja Lahbib, has been tasked with developing an EU stockpiling strategy.
Read Now
This position paper reflects the collective expertise of our members and outlines the industry's perspective on national and EU stockpiling requirements.