Glossary of pharmaceutical and GMP terms with explanations

In this section of GMP-inspection.com, our translators provide definitions and explanations of various specialized terms from the pharmaceutical industry and GMP (Good Manufacturing Practice).

Compulsory licenses

Compulsory licenses strike a balance between the rights of rights holders and the public interest by making important products and technologies available when they are of critical importance to society.

Compulsory licenses are a mechanism provided for in international and national legal systems that allows a state or another rights holder to grant a third party (usually another company) the right to manufacture, use or sell a product or technology for which this third party does not have exclusive rights (patents, copyrights, etc.) without the consent of the rights holder and under certain conditions.

Compulsory licenses (German translation: Zwangslizenzen) can be applied in the following cases:

  • Emergencies: In crisis situations such as epidemics (German: Epidemien), national disasters or diseases that pose a threat to public health, states can issue compulsory licenses for the manufacture or import of the necessary drugs or vaccines.
  • High drug prices: If the prices of certain drugs or medical technologies are too high and make access difficult for the general public, states can issue compulsory licenses to reduce prices and make the necessary drugs (British English: medicinal products; German translation: Arzneimittel) available.
  • Inaccessible technologies: If technologies or knowledge needed to solve certain problems (e.g. climate change) remain inaccessible due to intellectual property restrictions, the granting of compulsory licenses can help to disseminate these technologies or knowledge in order to achieve common goals.

Compulsory licenses strike a balance between the rights of rights holders and the public interest, as they can serve to ensure that important products and technologies are available and accessible at times when they are critical to society. However, the compulsory licensing procedure is generally subject to strict legal and procedural conditions in order to ensure the fair and balanced use of this mechanism.

You can book experts to interpret during your GMP inspection at GMP-inspection.com. Our experienced pharmaceutical interpreters and GMP translators are happy to assist you on site and help you achieve a successful inspection result. We also offer additional services such as consultancy in the run-up to a GMP inspection, representation of international pharmaceutical companies and distribution of their products in Germany.

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