The geopolitical upheavals of recent years, combined with the pandemic effects, have led to a shortage of drugs, especially antibiotics and pediatric analgesics but also of medical equipment. This is a growing concern in European countries and this deficit is spilling over into national health systems, putting patients’ health at great risk.
As mentioned, there are several responsible factors, including Covid 19, which is increasingly managed at home and is experiencing a new and sudden wave of expansion in countries such as China, the main producer of paracetamol and now also a consumer; then, obviously, the ongoing war between Ukraine and Russia, which in turn has generated numerous production problems linked to scarcity and difficulties in finding raw materials and energy sources; Finally, it is not to be underestimated that we are going through the peak of seasonal flu and there has been a significant increase in demand linked to the increase in respiratory infections.
As early as 2020, the European University Hospital Alliance had identified an increase in the demand for drugs from intensive care units; In particular, anesthetics, antibiotics, muscle relaxants off-label drugs, ie those used for indications other than those for which they are authorized. Subsequently, with the evolution of the war in Ukraine, other obstacles followed, such as the sharp slowdown in the supply of many active ingredients and raw materials used in the production of drugs, among others ammonia and palladium, typically found in these countries in large quantities and at reduced prices.
The European Union, following the pandemic upheaval, in 2020 had adopted a pharmaceutical strategy for Europe and, in 2021, launched the fourth program dedicated to health, the EU4Health, in force for the period 2021-2027, welcomed by MEPs, with the priority aim of making up for further and possible future health crises. Not surprisingly, the main guidelines of this program are: the protection of people from serious cross-border health threats, the increase in the availability of drugs and medical devices, and the strengthening of health systems in the countries of the European Union.
All this as part of a well-known broader program called “Next generation EU”, that is a recovery plan where 750 billion euros have been allocated, and has set itself the general objective of mitigating the effects of the pandemic as much as possible, on all fronts, not only on the health one, investing in the European Union to make it increasingly sustainable, digitized, socially fair and resilient.
Other solutions that were proposed by MEPs included: the introduction of financial incentives to encourage manufacturers of active pharmaceutical ingredients to focus their production in Europe, in order to make the EU increasingly less dependent on third countries (especially India and China, which are the world’s main producers); create a ‘European emergency pharmacy’ to act as an EU reservoir to reduce the risk of shortages; exchange good practices on stock management, increase the joint purchase of medicines and simplify the exchange of medicines between Member States.
During the debate on the increase in respiratory infections and the shortage of medicines in Europe, which took place on 17 January 2023 in the Strasbourg Chamber, the EU Commissioner for Health Stella Kyriakides, announced to Parliament a proposal to revise pharmaceutical legislation, introduced in 2021, the new version is scheduled for March and will include stricter obligations for supplies, advance notification of shortages and withdrawals and greater transparency of stocks.
“We are seeing shortages of some medicines in some Member States, in particular antibiotics and paediatric analgesics. As this is a global issue, we are in close contact with our international counterparts, also supporting Member States and industry. The robust systems and processes put in place during the pandemic and thanks to the extended mandate of the European Medicines Agency, supported by Parliament, are helping to better manage the situation.”
Kyriakides also emphasized the fact that all existing regulatory flexibilities are being implemented and trying to identify procedures with industrial partners to rapidly increase production in order to prevent and mitigate shortages.
In this scenario, at the same time, it has envisaged an intervention and coordination of HERA on behalf of Member States on joint procurement, already done during the Covid pandemic, which consists in connecting through matchmaking events multiple players in the sector, in order to increase and optimize production.
“I have often said that patients across the EU must always have access to the medicines they need, at affordable prices. This is what we have the ambition to secure with the pharmaceutical strategy for Europe. We will propose non-legislative and legislative measures for better access and availability and greater security of supply of medicines in the EU.”
Finally, in this last paragraph, it reiterates that the objective remains to guarantee access to medicines for all patients who need them and to cushion any disruption to the market for medicines in the EU. The limited information revealed reveals some key principles: that the review should aim to ensure access to affordable medicines; promoting innovation, including, if not especially, in areas where unmet medical needs exist; improving security of supply; adapt to new scientific and technological developments and reduce bureaucracy.
Certainly, the unpredictable and sensational adverse conditions that have added up since the beginning of 2020, are causing an extremely complex and challenging context in Europe. Having to face it is part of the duties of politics but also organizing in a far-sighted way to improve in every respect and ensure that in the face of any new future eventuality, the old continent is stronger, better equipped and ready to respond to it.