In principle, a distinction must be made between the active substance manufacturer and the marketing authorisation holder. In many cases, the marketing authorisation holder (i.e. the company that actually markets or sells the medicinal product in Austria and is also legally responsible for the product) buys the active substance/raw material required for the manufacture of tablets, for example, from another manufacturer.

Due to globalisation and the trend towards mass production, such active ingredient manufacturers have mostly relocated to low-wage countries and cover large parts of the world market or sometimes even the entire world market with their mass production at a very favourable price.

This trend has put manufacturing and active ingredient manufacturin in Europe under severe cost pressure for years, which is why production has increasingly been and will continue to be relocated to the Far East.

Europe is thus dependent on these manufacturers, who in many cases manufacture just as good quality, but due to monopolisation and in the event that isolated problems arise with production or quality in the plants in the Far East, the influence and control possibilities for Europe are less than if production were located in Europe.

Moreover, Europe is "only" one of many markets on the world market and therefore has to compete with other markets for quotas when problems arise in Asia. A negative dependence on events in Asia, some of which can no longer be influenced by Europe itself, is thus given.

The distribution chain usually follows the "classic" route: the marketing authorisation holder supplies the wholesaler that distributes the medicinal products to public pharmacies/hospital pharmacies.

In rare, but increasing cases, and especially in cases where high-priced medicinal products are distributed, a delivery model called "direct to pharmacy" (DTP) is also used, where the medicines are delivered directly from the marketing authorisation holder to public pharmacies/hospital pharmacies.

In some cases, medicines are traded between several countries via (sometimes several) parallel traders, exploiting price differentials in the free European movement of goods, until they end up in the pharmacy in the respective target country.

This route is legal and compatible with EU law, but only if sufficient goods are available for the domestic market.

The problem of supply restrictions must be described as a global problem. Due to the increasing and decades-long globalization of the production of pharmaceuticals, but also due to the merger of small and medium-sized pharmaceutical companies and manufacturers into large companies and further from large to "super"-large global corporations, there is (as a result of the formation of oligopolies, in extreme cases also monopolization) an increasing reduction of the worldwide manufacturers and suppliers. A large number of active ingredients are already being manufactured in Asia (the Far East, especially China and India).

Should problems arise in these companies (technical problems, quality problems, natural disasters, strikes, etc.), the market demand can usually no longer be covered for at least several months. As a result, insufficient quotas are now available to supply the world market and thus the individual national countries, including the EU. The replacement of other (smaller) manufacturers, if they still exist, is then not possible or only possible to an insufficient extent.

Another growing problem is the increasing cost pressure on older, but nevertheless essential drugs.

Over the years, many national and international manufacturers have discontinued the production of their expired pharmaceuticals or have postponed marketing authorisation due to falling prices and thus alleged or actual inefficiency. Globally, this trend can be observed by way of example, particularly in the area of complex sterile production of old, so-called "off-patent" i.v. (injection) preparations. This has further accelerated market concentration to only a few players.

The supply of older, but no less important and ultimately essential active substances in particular is therefore increasingly in the hands of a decreasing number of global manufacturers. The danger of shortages caused by this advancing global development has therefore increased in recent years not only in theory but also in practice.

The solutions to these questions and challenges cannot be found only nationally. Solutions must be developed jointly in the EU and ultimately coordinated globally by the EU with its global trading partners and economic areas.

The promotion of European manufacturing with incentive measures should be considered within the framework of a broad-based, overarching master plan.

For the time being, however, we in Austria urgently need a mandatory reporting system in order to be able to make any shortages that arise transparent at an earlier stage and thus initiate countermeasures on a case-by-case basis and at an even earlier stage.

A case-by-case ban on exports in the event of particularly critical shortages should also be considered or its legal provisions tightened in order to prevent quotas for unwanted exports destined for Austria and still stored in Austria from being quickly shifted to other countries in the event of impending shortages and thus effectively withdrawn from the Austrian health system.

FAQs to notifying a medicine shortage are discussed at  "Guidance Notes".

According to the latest information, the supply of medicines is currently largely secured. However, the situation is being closely monitored on an ongoing basis. From today's perspective, there is no need for private overstocking.

The population is therefore advised: There is no need to stock up on medicines as part of much-cited so-called "hoarding purchases". Purchases and dispensing in pharmacies should only take place within a regulated framework and in the quantities necessary for the purpose and requirements. There is no reason for private overstocking.

To better manage and avoid shortages of medicinal products, the EMA and the Heads of Medicines Agency (HMA) have jointly set up the HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use (TFAAM). It provides strategic and structural solutions, with the focus on medicinal products for human and veterinary use authorised in the EU. The Task Force acts as a “supply and availability hub” relating to the supply capability and availability of medicinal products. It monitors the progress made in the framework of various EU projects and aims to streamline processes, ensure synergies, and avoid duplication of work within the network. The task force is composed of a steering committee and two thematic working groups. The BASG participates in the thematic working group "Medicine availability and supply disruptions" and is involved in the implementation of the work programme.

The EMA provides guidance for industry to help ensure the continuity of supply of human medicines, prevent shortages and reduce the impact of any shortages that occur. The EMA/HMA also provides recommendations for patient organisations and healthcare professionals on the measures they can take to help prevent and manage shortages of human medicines in the EU. For information, see the EMA website "Availability of medicines".

The "Medicine Shortages Single Point of Contact (SPOC) Working Party" is responsible for monitoring and reporting events that could affect the supply of medicines in the European Union (EU). This group meets regularly and the BASG represents Austria.

For crisis preparedness and management, Regulation 2022/123 foresees a reinforced role for EMA, which is performed by the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), and which also provides for the development of the European Shortages Monitoring Platform (ESMP) by February 2025. The ESMP roadmap as of June 2023 is publicly available on the EMA website. The BASG is also working in this area to be able to provide the necessary information to the EMA or MSSG via the ESMP for future public health emergencies or major events.

According to EU Regulation 2022/123, marketing authorisation holders must register an Industry Single Point of Contact (i-SPOC)" for medicine shortages for all human medicinal products authorised in the European Union (centrally or nationally authorised medicinal products). The i-SPOC will facilitate rapid communication between the EMA and marketing authorisation holders to detect, report and prevent or manage supply and availability issues of medicines included in the list of critical medicines for a "public health emergency" or a "major event".

The generation of an i-SPOC contact is a 2-step-process. For more information see: Industry contact points for supply and availability of critical medicines and the BASG registration page for distribution restrictions at the EMA

In accordance with its role in crisis preparedness as defined in EU Regulation 2022/123, the EMA published on 8^th July 2022 the list of the main therapeutics groups (MTGs) in crisis preparedness that are used for emergency care, surgeries and intensive care. This list was established by the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG). It will be used to help setting up the major event and public health emergencies critical medicines list, respectively.

The list of the main therapeutic groups which is based on the WHO ATC classification, consisting of five levels, indicates the therapeutic subgroups (level 2) and the relevant pharmacological subgroups (level 2).

Further Information: List of the "main therapeutic groups" (MTGs) in crisis Preparedness

The Solidarity Mechanism Working Group was established by the MSSG in July 2023. The BASG joined this working group by then and worked on the development of a voluntary solidarity forum for the EU/EEA member states. At the end of October, the EU Solidarity Mechanism was presented. This voluntary mechanism allows Member States to support each other in the face of a critical medicine shortage. This voluntary mechanism can only be used under very limited conditions and was developed as a last resort for Member States after they have exhausted all other possibilities.

The solidarity mechanism complements a number of actions that the MSSG can carry out to address critical shortages in the EU. These were also published in 24^th October 2023 as part of the MSSG Toolkit. The toolkit includes recommendations for monitoring supply and demand, guidance on interactions with marketing authorisation holders and manufacturers to increase and redistribute existing stocks and the implementation of regulatory flexibilities, such as the exceptional supply of certain medicines that may not be authorised in a particular EU Member State, or full or partial exemptions to certain labelling and packaging requirements for medicines.

References

MSSG solidarity mechanism (at the bottom of the website)

EMA takes further steps to address critical shortages of medicines in the EU (EMA-News 24/10/23)

Commission steps up actions to address critical shortages of medicines and strengthen security of supply in the EU (EC-News 24/10/23)

A surge in respiratory infections across the EU in winter 2022-23 led to an increased demand for antibiotics such as amoxicillin (alone and in combination with clavulanic acid), especially for use in children. Since then, EMA, the European Commission's Health Emergency Preparedness and Response Authority (HERA) and the Heads of Medicines Agencies (HMA) are taking important steps to avoid shortages of antibiotic medicines for European patients, via the Executive Steering Group on Shortages and Safety of Medicinal Products. For this purpose data were collected at national level to estimate supply and demand in the EU of the these antibiotics: amoxicillin, amoxicillin/clavulanic acid, penicillin V, azithromycin, clarithromycin, ceftriaxone, cefotaxime, piperacillin-tazobactam.

The data (as of July 2023) suggest that the supply of oral formulations of key first and second-line antibiotics for respiratory infections will match demand, assuming demand does not exceed the average over the past few years.
EMA and HERA continue to monitor supply and demand closely and interact with marketing authorisation holders to step up the production. To better assess the situation in the individual Member States across the EU the "Medicine Shortages SPOC Working Party" has been monitoring availability and reported shortages since last winter.

For information, see the EMA website "Preventing shortages of antibiotics during winter"

European Health Union: EU steps up action to prevent shortages of antibiotics for next winter (EMA-News 17/07/23)

The Austrian Medicines and Medical Devices Agency takes part in the project "CHESSMEN". The aim is a harmonised network of authorities responding to the monitoring of medicine shortages.

CHESSMEN is a Joint Action of 27 organisations from a total of 22 EU/EEA countries and means "Coordination and Harmonisation of the Existing Systems against Shortages of Medicines – European Network". The existing systems in the EU/EEA member states for monitoring medicine shortages are to be coordinated and harmonised more effectively over the next three years.

For information see

BASG

AGES

Project Website

The Health Emergency Preparedness and Response Authority (HERA), created by the European commission, will anticipate threats and potential health crises for EU citizens to detect, prevent, and rapidly respond to health emergencies if necessary.

Essentially, HERA operates in two phases: In the preparatory phase, it works with the individual member states to identify, analyse, and prioritise potentially threatening scenarios. This work forms the basis for coordinating the implementation of medical countermeasures, including the necessary industrial capacities.

In the crisis phase, HERA will rely on its forward-looking overall management system and activate an emergency framework, which will be deployed by the European Council on a proposal from the Commission, depending on the economic situation and the need to protect public health.