Get the free Compulsory licensing for crisis management and amending Regulation (EC)

European Parliament 20192024Committee on International Trade2023/0129(COD) 30.10.2023AMENDMENT 22 109 Draft opinion Helmut Scholz (PE 753.730v0100) Compulsory licensing for crisis management and amending Regulation (EC) 816/2006ubject Proposal for a Regulation (COM(2023)0224 C90151/2023 2023/0129(COD))AM1289106EN.docxENPE754.992v0100 United in diversityENAM_Com_LegOpinionPE754.992v0100EN2/52AM1289106EN.docxAmendment 22 Samira Rafaela Proposal for a Regulation Recital

How to fill out compulsory licensing for crisis

How to fill out compulsory licensing for crisis

1. Identify the specific drug or treatment that requires compulsory licensing.
2. Check the national regulations regarding compulsory licensing in your country.
3. Gather evidence to demonstrate the need for the licensed product during a crisis, such as public health emergencies.
4. Prepare the required documentation, including a request letter for compulsory licensing and supporting data.
5. Submit the application to the appropriate governmental authority overseeing intellectual property or pharmaceutical regulation.
6. Follow up on the application status and provide any additional information requested by the authority.
7. Once approved, ensure compliance with any terms and conditions set forth in the license.

Who needs compulsory licensing for crisis?

1. Governments in countries facing public health crises.
2. Pharmaceutical companies needing to produce generic versions of patented drugs.
3. Healthcare providers seeking access to essential medicines for treatment.
4. Non-governmental organizations (NGOs) advocating for affordable medication access.

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What is compulsory licensing for crisis?

Compulsory licensing for crisis allows governments to authorize the use of a patented invention without the consent of the patent holder, typically during a national emergency or significant public health crisis.

Who is required to file compulsory licensing for crisis?

Governments or relevant authorities are required to file for compulsory licensing in order to ensure access to essential medicines or technologies during a crisis.

How to fill out compulsory licensing for crisis?

To fill out compulsory licensing for crisis, the government must submit a formal request detailing the reasons for the licensing, the terms of use, and assurances that the patent holder will be compensated.

What is the purpose of compulsory licensing for crisis?

The purpose of compulsory licensing for crisis is to ensure that necessary medical or technological interventions are accessible and affordable during emergencies where public health is at stake.

What information must be reported on compulsory licensing for crisis?

The information that must be reported includes the details of the patent, the nature of the crisis, the scope of the license, the proposed compensation for the patent holder, and any relevant public health data.