Brussels (Brussels Morning) The European Medicines Agency (EMA) is to establish specialised units dedicated to addressing the shortage of medicines and to anticipate potential events that could disrupt public health.
In a bid to enhance crisis preparedness and ensure timely access to medicines, the Parliament and the Council sealed an agreement yesterday to strengthen EMA, as part of the European Health Union that was proposed by the Commission last November.
“EU-level preparation and coordination are two essential ingredients to fight future health crises. Thanks to this deal we are adding an essential new building block to upgrade the EU’s health architecture”, Janez Poklukar, Slovenia’s Minister for Health, said, speaking on behalf of the Council.
The COVID-19 pandemic exacerbated the growing problem of medical equipment and medicine shortages. During the peak of the pandemic, many national health systems were left struggling to cope with the sudden influx of patients.
In March 2020, the European University Hospital Alliance warned that rising demand in intensive care units for certain anaesthetics, antibiotics, muscle relaxants and medicines that were utilised in the all-out effort to treat COVID-19 meant that inventory stocks were liable to run out.
Decreased production, logistical problems, export bans and stockpiling because of COVID-19 further complicated the risk of bottlenecks.
According to the Parliament, more than 50% of medicines to treat cancer, infections and disorders of the nervous system — epilepsy, Parkinson’s e.g.— accounted for more than half of those in short supply.
“[The new agreement] will allow the EU’s medicines agency to make sure we have the medicines needed to deal with public health emergencies”, Poklukar declared.
“The COVID-19 pandemic has made the general public aware of the vulnerability of supply chains for medicines and medical equipment, a structural issue pharmacies have been faced with for over a decade already”, noted the President of the Pharmaceutical Group of the European Union (PGEU), Alain Delgutte.
EMA’s new role
With the new deal, the EU medicines watchdog’s capacity to manage the regular availability of medicinal products and medical devices will be strengthened. In particular, EMA will set up two “shortages steering groups”, one for medicines, the other for medical devices.
These steering groups will meet regularly and more frequently whenever the situation requires, in order to prepare appropriately for or during a public health emergency, the Parliament stated. The EMA’s new clusters will also welcome relevant expert advice.
The Parliament insisted that, in order to safeguard transparency, summaries of their proceedings and recommendations must be made publicly available.
“With this agreement, Parliament makes both the Agency and all actors in the supply chain more transparent, involving them more in the process and fostering synergies between EU agencies”, MEP Nicolas Gonzalez Casares (S&D), observed.
“EMA will now have a big role to play in keeping medicines flowing and making sure they reach the people who need them”, the Director General of the European Consumer Organisation (BEUC), Monique Goyens, added.
MEPs have also proposed setting up the European Shortages Monitoring Platform to collect and assess information on shortages, supply and demand of drugs. The Platform will act as a starting point for “an early warning system” for drug shortages.
The agency will maintain a public webpage displaying the level of shortages of critical medicines and medical devices.
The digitalisation of the sector has been described as key to an efficient regulation of EU pharmaceuticals and specifically to address the issue of medicines shortages in the EU.
The head of the European association representing generics and biosimilars has complained that current EU regulatory systems are “too overwhelmed” simply by paper and packaging.
“Sometimes we have a lot of barriers within the EU itself. This could be different packaging and leaflet requirements or languages,” Adrian van den Hoven, Director General of Medicines for Europe, noted.
“When you have a shortage situation, you want to move excess stock from Country A to Country B in Europe, it’s actually quite difficult to do”, he added.
On the production side, the EU is highly dependent on third countries. For example, 40% of finished medicines on the European market come from China or India.
The two countries also produce 80% of APIs, the active pharmaceutical ingredients used to manufacture medicines.
Van den Hoven cited the “big discussion” ongoing in Europe on how to reduce the risk of supply disruptions and shortages in welcoming the new arrangement. “Consumers and patients will be better off after today’s agreement which should lead to faster and better coordination in the EU to solve medicine shortages”.