Import drugs

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Imported drugs are drugs that are imported from other EU or EEA countries. The purpose of importing drugs is to lower drug costs.

A special form to be distinguished is the individual import (in Germany according to Section 73 (3 ) AMG ), according to which a medicinal product that is not available in Germany but which is required in terms of active ingredient and strength can be imported from EU or EEA countries or from third countries.

Classification

In contrast to generics, imported pharmaceuticals are usually identical preparations from the production of the original manufacturer.

A distinction is made between re-import and parallel import. Via re-importers and parallel importers, it is possible for wholesalers to procure medicines cheaper than they would be in their own market.

Reimport

A reimport occurs when pharmaceutical companies produce drugs in Germany for the export market and sell them there cheaper. The drugs offered there are bought up by reimport companies at a favorable price, repackaged and sold back to Germany.

Parallel import

A parallel import is when a drug that has already been approved in another EU country is bought there (cheaper) and imported into Germany. This medicinal product must be "essentially" the same as a reference medicinal product authorized in Germany, i. H. The type and amount of the medicinal substance, as well as the dosage form and method of application, must be identical. Deviations in the auxiliary materials may be permissible. In many cases, the importer imports pharmaceuticals in parallel with the original manufacturer's imports, so that the preparations are completely identical.

The market share of pharmaceuticals imported in parallel in Germany in 2010 was 11.8%. In 2009, importers in Germany achieved sales of 3 billion euros. Parallel imports make up the vast majority of import trade.

background

For reasons of market policy and health policy, drug manufacturers charge different prices in different countries. The prices for pharmaceuticals in many EU member states are subject to direct or indirect state price regulation. In Germany z. B. The price is regulated indirectly via the fixed amount introduced in 1989 .

In Germany, public pharmacies are obliged, within the framework of statutory health insurance, to cover at least five percent of their turnover with finished medicinal products for which there is no discount agreement via imports. The price of the imported drug must either be at least 15 euros or at least 15% below the price of the original drug.

The legislature originally introduced the import quota, which is anchored in Section 129 (1) No. 2 SGB ​​V , in order to save costs through cheaper imported preparations. In practice, it is becoming more and more common that the cheapest supply alternative is not the import drug, but a corresponding generic from the domestic market. Even if the imported drug is cheaper than the original product, the required price gap of 15 euros or 15% is often no longer achieved.

Legal basis

Within the European Union (EU), the free movement of goods is regulated in the Treaty on the Functioning of the European Union (TFEU). It also forms the legal basis for parallel imports. In addition, special regulations apply to the placing on the market of medicinal products. The parallel importer must prove to the competent drug authority of the member state (in Germany the Federal Institute for Drugs and Medical Devices or the Paul Ehrlich Institute ) that the imported drug is identical to the original and then receives approval via a simplified approval procedure.

The situation is different if the imported medicinal product has an authorization from the European Commission that is valid for the entire EU ( central authorization ). The importer does not need his own authorization for these medicinal products, but only reports the import to the EMA and the country into which he is importing the medicinal product. This special form of parallel trade is also called parallel sales and now makes up the majority of parallel trade.

Due to the current drug price situation in Germany (as of 2012), Germany is a high-priced country for many drugs and therefore a recipient country of imported drugs .

For over 30 years, parallel imports have been fiercely contested between manufacturers and importers and have repeatedly been the cause of legal disputes before the ECJ . These disputes mainly take place in the area of trademark law and / or patent law .

Market structure

The market for imported pharmaceuticals in Germany is dominated by several companies (market shares as of 2009):

Associations

The German drug importers are organized in the Association of German Pharmaceutical Importers (VAD) , the Federal Association of Pharmaceutical Importers (BAI) and the Association of Individual Importers of International Drugs VEIA eV .

The associations BAI and VAD founded the joint umbrella initiative Die Arzneimittel- Importeure in 2019 in order to join forces and take a joint position on important issues in the healthcare market.

Web links

Individual evidence

  1. Import drugs . PTAheute , Deutscher Apotheker Verlag. Retrieved June 21, 2018.
  2. Import / Reimport / Parallel Import… , DAZ 40/2011.
  3. a b Statistics 2011 - The drug industry in Germany , Association of research-based drug manufacturers , 2011.
  4. Framework agreement on the supply of pharmaceuticals ( Memento of the original dated August 19, 2016 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. according to § 129 Abs. 2 SGB V @1@ 2Template: Webachiv / IABot / www.abda.de
  5. AKNR
  6. Jochheim: The parallel distribution of pharmaceuticals - synonym or real difference to parallel import ?, dissertation 2012.
  7. Douglas: The exhaustion of trademarks under the parallel import of pharmaceuticals, dissertation 2005.
  8. Lieck: The parallel trade in pharmaceuticals within the European Union, dissertation 2008.
  9. Hanna Grabbe: Medicines import: No pills from abroad . impulse.de. May 17, 2010. Retrieved May 17, 2011.
  10. Die Arzneimittel-Importer , Retrieved March 24, 2020.