The ongoing COVID-19 pandemic has highlighted the fragility of our healthcare systems and the imperative need of ensuring that all patients have access to the medicines they need. The European Parliament has recently been looking into issue of accessibility to key medicines, which resulted in a Resolution on ‘Shortages of medicines - How to address an emerging problem’, in late 2020.
However, having the appropriate access to medicines is not new for patients with plasma-related, rare, chronic and often genetic diseases. Among them are patients affected by primary immune deficiencies diseases and bleeding disorders such as haemophilia and Alpha-1 antitrypsin deficiencies.
“The COVID-19 pandemic introduced additional pressure on the fragile PDMP ecosystem and has shed light on certain plasma collection barriers… which led to a significant decline in plasma collections due to social distancing and other mobility restrictions”
Plasma-derived Medicinal Products (PMDPs) replace their missing or deficient proteins. Without these treatments, many patients would either not be able to survive or would have a substantially reduced quality of life.
Today, around 300,000 European patients rely on PDMPs - obtained from human plasma from healthy donors - to treat a variety of rare, chronic, and potentially life-threatening conditions. More patients in the EU are diagnosed each year with life-threatening plasma protein-related disorders.
In many cases, PDMPs are the only treatment option for these rare diseases. New indications, improved diagnostic techniques, the greater use in emerging markets and an increased use in cancer treatment-induced secondary immunodeficiency are further contributing to the growing clinical need for PDMPs.
The COVID-19 pandemic introduced additional pressure on the fragile PDMP ecosystem and has shed a light on certain plasma collection barriers that existed prior to the pandemic, which led to a significant decline in plasma collections due to social distancing and other mobility restrictions caused by the Coronavirus crisis.
Given that the complex manufacturing cycle of PDMPs, from the collection of plasma up to the administration of the final PDMP to the patient, can take between seven and twelve months, any decline in plasma donations could affect patients’ ability to access their life-saving therapies later on.
Aside from plasma collection practices, reimbursement and procurement policies at national level also have a direct impact on access to plasma treatments and products.
In October last year, I had the pleasure of hosting an online round table on the topic of access to Plasma-derived Medicinal Products. All the stakeholders, patients, healthcare professionals, industry, regulators and policymakers that took part confirmed that there are inequalities in access to PDMPs across Europe.
In some EU Member States, patients still face difficulties in getting their treatments reimbursed. In addition, certain procurement practices, such as single-winner tenders, force patients to switch therapies. And, unlike generic or biosimilar medicines, PDMPs are not interchangeable.
“Given that the complex manufacturing cycle of PDMPs can take between seven and twelve months, any decline in plasma donations could affect patients’ ability to access their life-saving therapies”
As policymakers, we have the responsibility of building adequate policies and legislative frameworks to address these issues in order to collect more plasma across Europe and to respond to patients’ growing need for Plasma-derived Medicinal Products.
The EU Pharmaceutical Strategy has identified the need to tackle national pricing and reimbursement policies which impact patient access, and to look at sustainable public procurement practices.
Additionally, the EU Pharmaceutical Strategy also addresses the need to reduce Europe’s dependency on raw materials from third countries, which is clearly the case for PDMPs, as European patients are reliant on 38 percent of plasma being imported from the United States.
The roundtable highlighted a number of steps and actions that can, and should, be undertaken to ensure appropriate patient access to Plasma-derived Medicinal Products. European and national policies must recognise the unique nature of PDMPs and their ecosystem and ensure greater access and availability to them by putting in place the most appropriate policy frameworks.
Against this background, Europe needs to collect more plasma to decrease its reliance on third countries to meet its growing clinical need for Plasma-derived Medicinal Products. In order to do so, plasma collection programmes via plasmapheresis and coordinated awareness campaigns towards plasma donors should be established in all EU Member States.
It is also crucial that we work on education and raising awareness on what plasma is, on the importance of plasma donations and how simple it is to become a donor.
Therefore, all stakeholders have a major role to play in raising awareness on the need to collect more plasma across Europe, and policymakers can play their part by establishing more appropriate frameworks to significantly increase collection in Europe.
It’s in us all to save a life: join the call to support more plasma collections in Europe. This is the European Union for Health that most Europeans desire.