Enhancing the strategic framework of pharmaceutical industries to bolster European autonomy
The legislative term is now coming to an end. Five years that were deeply impacted by an unprecedented health crisis. Little did we know that just a few months after we arrived in the Parliament we were going to be forced to focus all our efforts in the urgent management of a pandemic. However, we decided that this situation should make us learn some valuable lessons, not only to prevent future emergencies, but also to unwrap all the capacity of European health policies to coordinate all Member States in protecting the health of all Europeans.
In the last years, we have strengthened the existing legislation and adopted new texts to prevent diseases, facilitate the authorization of safe and effective treatments and improve the access to medicines for all patients.
However, we still have many pending issues for the coming years and one of the most urgent ones is to manage the shortage of medicines that year after year threaten patients’ wellbeing. Shortage of supply of essential medicines and pharmaceutical active ingredients in the EU has been increasing in recent years, with a 60% increase in shortage notifications between 2017 and 2019 and a worsening of the situation in 2022. As stressed in European Commission official studies and Parliamentary reports, the causes of this problem are multiple and complex, including both internal factors of the pharmaceutical industry and external factors, and cause serious supply disruptions that negatively affect patients.
The EU faces a growing dependence on a small group of manufacturers and regions, especially China and India, for the supply of medicines and pharmaceutical active ingredients, evidencing a critical concentration of production at a global level.
The COVID-19 pandemic and the Russian military aggression against Ukraine exposed Europe’s supply chains dependencies and the risk that economic dependency could be weaponised.
As the High Representative Josep Borrell pointed out during those months in which securing essential medicines and medical equipment was the most urgent priority, “not a single gram of paracetamol was produced in Europe” when the pandemic started.
This strong dependency is especially notable for generic medicines, which are the 70% of medicines dispensed in Europe. The EU has focused its pharmaceutical production on more complex products, which require high-tech infrastructure, a skilled workforce and sophisticated processes, becoming a global leader in research and development of innovative medicines. However, regrettably, the EU is also facing a continuous loss of competitiveness and innovation capacity towards other countries, such as US and China.
During this term, we reinforced the mandate of the European Medicines Agency (EMA) in order to strengthen and coordinate the management of critical shortages at EU level; the Commission’s Health Emergency Preparedness and Response Authority (HERA) is supporting with foresight and emergency preparedness to ensure the availability of medical countermeasures; and the recently voted position of the Parliament for the revision of the general pharmaceutical legislation of the EU welcomes and reinforces the measures described in the Commission proposal regarding the monitoring of shortages.
Thus, we are taking the right steps towards ensuring the availability of essential medicines in the EU, but now is time to address the root causes of the shortages and our strong dependence.
In the 2021-updated industrial strategy, the Commission had already identified six key areas of dependency: raw materials, batteries, active pharmaceutical ingredients, clean hydrogen, semiconductors, and cloud and edge technologies. Over the past two years, the EU has proposed a support policy for each of these sectors, with the exception of drug production.
Just a few months ago, I initiated an oral question to the Commission, together with other two Spanish MEPs, that in the end was presented with more than 80 co-signatures from different political groups, requesting to explore the implementation of initiatives and tools that, similarly to the Critical Raw Materials Act and the Chips Act, and with appropriate financing mechanisms, aim to increase the European market share in the production of essential medicines, APIs, intermediate ingredients, and innovative medicines, such as new antimicrobials or advanced therapy medicinal products (ATMPs), for which the EU is either completely dependent or lagging behind third countries.
In October last year, the Commission adopted its Communication on addressing medicine shortages in the EU, in which they propose the creation of a new Critical Medicines Alliance that would help exploring how to diversify global supply chains for critical medicines, enhance security of supply through public procurement and boost Europe’s capacity to produce and innovate in the manufacturing of critical medicines and ingredients in coordinated and competitive way.
This is, of course, a first step in the right direction towards a future Medicines Act and we will work together in the coming years to define a strategy that works for the EU. Maintaining and increasing both innovation and the internal production capacity will not only strengthen our resilience in the face of possible health crises but will also accelerate access to treatments for patients, make healthcare systems sustainable and provide significant economic benefits, boosting the European pharmaceutical industrial ecosystem and fostering employment.
