Supply shortages are a global problem. In Austria, 323 medicines were affected in 2019. With the entry into force of the obligation to report distribution restrictions, the total number of reports increased to 1,096 in 2020. In 2021, there were a total of 788 reports, in 2022 1,257 an in 2023 1,515 reports of medicinal products that were not available or not sufficiently available. To date, no cases have been reported to the Federal Office for Safety in Health Care (BASG) in which a patient was harmed due to drug supply shortages. In almost all cases, drugs with the same active ingredient or therapeutically equivalent substitutes with the same effect are available. As a general rule, the primary responsibility for maintaining the ability to supply medicines lies with the marketing authorization holder or the wholesaler.

The reasons for supply shortages are complex and multifactorial; some reasons may include:

• Outsourced production: active pharmaceutical ingredients are increasingly being manufactured in low-wage countries such as China and India for cost reasons. There, they sometimes have to contend with quality deficiencies. This can lead to delivery delays and, in some cases, to production stoppages. In addition, the long transport route from Asia to Europe increases the risk of delivery complications. Both of these factors lead to increased downtime.
• Mergers between pharmaceutical companies: As a result, certain active ingredients are increasingly manufactured by only one company, and often at only one location. If production fails there, the corresponding drug is missing on the entire global market. In this case, as far as possible, a substitute drug with an alternative active ingredient must be found.
• Different drug prices/parallel trade: If products from countries with low drug prices are exported in large quantities to countries with higher prices, supply bottlenecks may occur in some cases in countries with lower prices. The trade in pharmaceuticals by parallel traders taking advantage of price differentials in the free European movement of goods is in principle legal and compatible with EU law, but only if sufficient goods are available for the domestic market. The Federal Office for Safety in Health Care can issue a parallel export ban for reasons of public health protection. This is published in the "List pursuant to the Ordinance on Securing the Supply of Medicinal Products in accordance with Section 57a(2) of the German Medicines Act"(https://medicineshortage.basg.gv.at/parallelexportverbot) and is available for public inspection at any time.

Note: Coronavirus outbreak

China is a major player in the market for active pharmaceutical ingredients. Due to the current coronavirus pandemic, there is a risk that the embargoes and travel restrictions imposed will have an impact on the production and supply of APIs, and thus on the availability of drugs for the global market. At present, no bottlenecks have been reported by the pharmaceutical industry in this regard.

The Federal Ministry of Social Affairs, Health, Care and Consumer Protection has published an ordinance that is intended to help prevent supply shortages for medicines. The Ordinance on Securing the Supply of Medicines, effective April 1, 2020, requires the marketing authorization holder to report an anticipated inability to supply a prescription drug for more than two weeks or an anticipated limited ability to supply for more than four weeks to the Federal Office for Safety in Health Care (BASG) reporting register, which is open to public inspection. After a thorough review by the BASG, a temporary export ban may be imposed for certain products.