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Shortages and lists of critical medicines – AFI and EIGP conference

Medicinali Critici

The scope of the event “Conference on shortages and lists of critical medicines”, sponsored by the pharmaceutical trade associations AFI and AEIPG and held in Rome on 19 April 2024, was to discuss the impact of the shortage of medicines on the European health systems, as well as the practical implications and criticalities of the creation of a shared list of substances considered as potentially “critical”.

The conference was attended by representatives of the Regulatory Agencies of some European countries such as Finland, Spain, and Portugal, as well as AIFA represented by Domenico Di Giorgio, Director of the AIFA Unit for Product Quality and Contrast to Pharmaceutical Crimes. Participants also included representatives of the trade associations such as Giorgio Bruno, chairman of  AFIPiero Iamartino, chairman of  EIPGLuca Paoles for Farmindustria, Adriano Pietrosanto  for Egualia.

In the first part of the conference the concepts of “shortage” and “unavailability” were introduced, with a presentation of the activities implemented nationally and in the European community to prevent and mitigate these phenomena.

Difference between Shortage and Unavailability

If shortage is defined as the difficulty for a patient to find a medicine due to issues ascribable to the MA holder such as, for instance, regulatory measures or manufacturing problems, unavailability is intended as the impossibility to find a drug because of distortions in the distribution chain that can occur in a ununiform way on the national territory.  

As of 2010, AIFA periodically publish and update a list of medicines lacking in Italy. Such list is fed by the reports transmitted by MA holders via the FEC (the section dedicated to Shortages in the FrontEnd system), according to the provisions of Leg.Dec. no. 219/2006 and Law no. 35 of 30 April 2019 (s.c. “Calabria Decree”).

On the other hand, the Technical Table dedicated to Unavailable Products, operating since 2015, was instituted by AIFA, with the involvement of the Ministry of Health, the ISS and Carabinieri, with the goal of preventing and limiting any distortion in the market of medicines enhancing the dedicated vigilance activities.

Market distortion

As the issues related to the distortion of the distribution market are not limited to the Italian territory, but are also linked to the market of  parallel importations, the Chessmen (Coordination and Harmonization of the Existing Systems against Shortages of Medicines) project was started in Europe in the beginning of 2023. This is a Joint Action co-funded by the European Commission and characterized by the participation of 22 EU countries, with the aim of sharing models and initiatives to monitor the state of shortage of medicines  and avoid any waste of resources.

In the same year, the European Commission has published a Communication, adopted on 24 October 2023, containing short-, medium- and long-term actions, to prevent and mitigate the phenomenon of the shortages more effectively.

Measures worth to be mentioned include the publication by EMA of an EU list of drugs considered as “critical”, as well as the definition of the so-called prevention and mitigation plans (SPP – Shortage prevention plan and SMP – Shortage mitigation plan).

The first version of the list includes more than 200 active substances , selected from already existing national lists. These are not medicines that are lacking; they are rather essential drugs whose continuous supply is fundamental.

The second part of the event has allowed the collection of experiences and tools implemented by the individual EU countries for the prevention and management of shortages, thanks to the information provided by the attending members of the various Regulatory Agencies. The share of information has allowed to highlight significant differences among the countries presenting specific criticalities and needs.

The definition itself for “critical” medicine is subject to different interpretations, influenced by parameters and criteria identified at national level.

Therefore, harmonization represents a goal that is necessary as well as brave and complex.

It should be stressed that shortages not only affect patients’ quality of life, but also represent a significant burden for the national health systems.

For instance, parallel importations cause shortage phenomena  and may represent a relevant issue in countries characterized by less solid economies with lower average prices.

Structural solutions and a revision of the European pharmaceutical legislation are required, aiming at allowing the share of effective models and initiatives to avoid resource dispersion, and at harmonizing the processes, not forgetting the peculiarities of each individual country.

Written on 08/05/2024 by Chiara Antonucci e Valeria Cardinale