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Medicines for Europe welcomes the opportunity to comment on the targeted revision of the EU rules for medical devices and in vitro diagnostics. We support a revision that makes the system clearer, more efficient and proportionate, as the current Medical Device Regulation (MDR) has created many challenges for products that combine a medicine and a device leading to delays, uncertainty and additional administrative…

Medicines for Europe welcomes the European Commissions proposal regarding the adoption of the MDR. We support the overall aim of making the regulatory framework simpler, more efficient and more proportionate, while continuing to ensure a high level of patient safety.

AbbVie welcomes the Commissions targeted revision of the MDR/IVDR and appreciates the intent to update Regulation (EU) 2017/745 based on practical experience and broadly supports many of the Commissions proposals. These proposals introduce important measures to support innovation and improve regulatory efficiency, however, there is room for further improvement on several aspects.

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.

As a research-driven biopharmaceutical company, AbbVie supports the Commission objectives to create a patient-centered and globally competitive European pharmaceutical policy environment that enhances the availability of medicines across the EU and incentivizes development of treatments for unmet health needs in both diseases where no treatments exist as well as those where the existing treatments do not…

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…

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…

As an innovative biopharmaceutical company with over 11.000 employees in the EU, AbbVie supports the Commission’s aims to develop more medicines for unmet needs, speed access to new therapies for all EU citizens, and ensure the maximum benefits from scientific and technological advances.