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Medicines for Europe represents manufacturers of off-patent medicines supplying close to 70% of dispensed prescription medicines in Europe. The pharmaceutical legislation should foster access to follow-on off-patent medicines on day-1 after IP expiry by extending the scope and harmonising the Bolar exemption to cover API supply and all administrative steps needed to effectively launch generic/biosimilar medicines.

HAI welcomes the opportunity to provide feedback to the evaluation and revision of the general pharmaceutical legislation and appreciates the importance of the initiative taken by the European commission to update and adapt a keystone of the European Health Union.

Medicines for Europe, representing manufacturers of generic, biosimilar and value added medicines across Europe, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe covering 80% of therapeutic areas, we fully share the goals of ensuring that all patients across the EU have timely and equitable access to safe…

Medicines for Europe, representing manufacturers of generic, biosimilar and value added medicines across Europe, welcomes the proposals to review the EU general pharmaceutical legislation. As the off-patent sector accounting for 70% of medicines dispensed in Europe across 80% of therapeutic areas, we fully share the goals of ensuring that all patients in the EU have timely and equitable access to safe, effective and…

Health Action International (HAI) welcomes the opportunity to contribute to the ‘Revision of the EU legislation on medicines for children and rare diseases’ and commends the European Commission for the thorough and comprehensive consultation process that is shaping the reform of legislation on this topic.

Medicines for Europe recognises the importance of incentives for orphan & paediatric medicines and appreciates the opportunity to submit a feedback on the Inception Impact Assessment (IIA). As highlighted in the IIA, while overall existing incentives have generated some success, there is a need to fine-tune elements to ensure incentives achieve the objectives intended by the Regulation whilst avoiding abuses/misuses…

Medicines for Europe welcomes the chance to provide feedback on the proposal to review the compulsory licensing system in Europe. Medicines for Europe is strongly convinced that voluntary licensing agreements are the right way forward to tackle health crises.

Health Action International (HAI) welcomes the step taken by the European Commission towards an enhanced use of Compulsory Licenses (CL) in EU territory; such measure will have a positive impact on access to medicines and health technologies, strengthening the ability of governments to fulfill the human right to health beyond crisis or exceptional circumstances.

Medicines for Europe welcomes the opportunity to provide valuable feedback on the EC proposal to review the compulsory licensing system in Europe. At Medicines for Europe, we firmly maintain that voluntary licensing agreements present the most effective approach to tackle health crises.

The European Commission proposal COM(2023)224 and accompanying documents is an overdue step forward towards a more nuanced balanced between innovation and access as it aims to streamline and facilitate the use of Compulsory Licenses.