Approval & Market Surveillance
We have competencies in the handling of medicinal products in various business areas. The main tasks are performed by the AGES Medical Market Authority (MEA). This is where the efficacy, safety and quality of medicinal products are examined. For this purpose, the Medical Market Authority evaluates all data required by the Federal Office for Safety in Health Care (BASG) for the approval of medicinal products as well as for updating or amending existing approvals.
As soon as a drug is approved and available on the market, it is automatically recorded by the pharmacovigilance system (system for recording side effects) of the Medical Market Surveillance. This system includes, among other things, the legally anchored reporting obligation(Medicines Act, Pharmacovigilance Ordinance 2013), which serves to minimize risks such as side effects or interactions. In the course of so-called "lifecycle management", medicinal products continue to be reviewed at regular intervals for their existing efficacy, safety and quality, even after they have been approved. In addition, marketing authorizations must be reassessed at least once every five years.
Another pillar of drug safety is drug analysis. In the Official Medicines Control Laboratory (OMCL) of AGES, all medicinal products, such as oral or injectable medicines, vaccines and also blood, plasma and tissue products are tested for quality in accordance with the specification. Any quality deficiencies detected are immediately reported to BASG, which in relevant cases informs healthcare professionals and, if necessary, the public, and recalls the affected products from the market if necessary. Medicines delivered via dubious Internet orders as well as medicines of unknown origin (e.g. customs seizures) are also examined for their composition and authenticity. Data obtained in the laboratories are shared in national and international networks to protect consumers from low-quality medicines and illegally produced or traded products.
Drug supply shortages
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.
Reasons for supply bottlenecks
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.
Measures against supply bottlenecks
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.
Sales restrictions in Austria
The Federal Office for Safety in Health Care (BASG) provides information on its website in connection with distribution restrictions (supply shortages) for medicinal products in Austria. The notifications are published in the Distribution Restrictions Register after a thorough review.
Last updated: 12.01.2024