Medicines for Europe

Medicines for Europe, representing generic, biosimilar and value added medicines manufacturers across Europe, welcomes the opportunity to contribute to the call for feedback on the rules on national register of producers (PPWR). Please find our submission attached.

Call for evidence – Circular Economy Act Medicines for Europe response Medicines for Europe, representing generic, biosimilar, and value-added medicines, supports the objectives of the Circular Economy Act to enhance circularity across the single market, while underlining the importance of duly considering the specificities of the strictly regulated pharmaceutical sector and the need to ensure consistency with…

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

Medicines for Europe welcomes the opportunity to contribute to this call for evidence, as the revision of the Public Procurement Directive 2014/24/EU (PPD) provides a framework for the public procurement of medicines (PPM). The off-patent pharmaceutical sector is operating in a highly regulated pricing framework, which does not allow for the adjustment of prices to increasing costs (e.g.

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.

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 the European Association representing generic, biosimilar and value added medicines across the EU and supplying 70% of dispensed medicines in Europe, supports the European Green Deal and the new EU circular economy and the introduction of rules which will reduce packaging waste and harmonise the requirements across the single market to address environmental concerns.

Medicines for Europe, representing generic, biosimilar, and value-added medicines in Europe, welcomes the opportunity to contribute to the call for feedback on the review of the EU Taxonomy Environmental Delegated Act. Please find our submission attached.

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 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.

Dear Sir/Madam, Enclosed you will find the contribution of the Biosimilar medicines group, a Medicines for Europe sector group to the European Commissions call for feedback on the proposed European Biotech Act I (Health). We remain at disposal should you need any clarification. Kind regards

On behalf of the Biosimilar medicines group, a Medicines for Europe sector group, please find attached our contribution on the future Biotech Act. The Biosimilar Medicines Group represents the leading companies developing, manufacturing and/or marketing biosimilar medicines across Europe. Our members contribute actively to the European biotech ecosystem, including through innovation on processes.

Dear Sir/Madam, Enclosed you will find the contribution of the Biosimilar medicines group, a Medicines for Europe sector group on the EC Call for Evidence for the Biotech Act II (industrial biotech). We remain at disposal should you need any clarification. Kind regards,

Medicines for Europe represents the generic, biosimilar and value-added medicines manufacturers in Europe. We welcome the opportunity to contribute to the call for evidence on the future reform of the Union customs legislation. Generic, biosimilar and value-added medicines play a crucial role for patient access to equitable treatments and healthcare sustainability in Europe and globally.

Medicines for Europe, representing generic, biosimilar, and value-added medicines manufacturers across Europe, welcomes the opportunity to contribute to the call for evidence on the Packaging and packaging waste - sustainability criteria for plastic recycling technologies. Please find our submission attached.

Medicines for Europe, representing the generic, biosimilar, and value-added medicines manufacturers across Europe welcomes the opportunity to contribute to the call for evidence on Plastic packaging harmonisation of rules for calculating and verifying recycled content in plastic packaging. Please find our submission attached.

Medicines for Europe, representing generic, biosimilar and value-added medicines industries across Europe, which supply 70% of dispensed medicines in Europe and cover 80% of the therapeutic areas, welcomes the opportunity to provide feedback on the proposal to revise the Urban Wastewater Treatment Directive (UWWTD).

Medicines for Europe, representing generic, biosimilar, and value-added medicines manufacturers across Europe, welcomes the opportunity to contribute to the call for evidence on the Packaging and packaging waste conditions for importing recycled materials into the EU for use in packaging. Please find our submission attached.

Medicines for Europe, the European voice for the off-patent medicines, welcomes the possibility to give its views on the proposal for a regulation establishing a common data platform on chemicals. We believe in fostering a collaborative environment that ensures the safety of chemicals while facilitating access to essential products, particularly to generic, biosimilar and value-added medicines.

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 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.

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.

Medicines for Europe is glad to be able to provide its feedback and emphasizes the need for safeguards to ensure high quality SPCs, prevent litigation strategies and ensure access to affordable medicines. First, SPC holders should be able to obtain a SPC protection so to enjoy an overall maximum of 14 years of exclusivity from the marketing authorisation.

Medicines for Europe welcomes the chance to provide feedback on the proposal to reduce fragmentation in the SPC system. The Call for Evidence (CfE) makes almost no reference to a need to tackle fragmentation in enforcement/litigation phase of SPC lifecycles, arguably the highest priority for ensuring timely patient access to generic/biosimilar medicines, legal certainty & address national budget issues, ignoring the…

Medicines for Europe, representing generic, biosimilar and value-added medicines industries across Europe, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Association of the European Self-Care Industry (AESGP) welcome the opportunity to submit feedback to the Commission Proposal on the Integrated water management i.e.

Medicines for Europe welcomes the reform of the mandate of the European Centre for Disease Control (ECDC) especially in light of its response to the first wave of the COVID-19 pandemic in Europe when it struggled to collect data from member states and to provide forecasts of the progression of the virus.

Medicines for Europe, taking into account to the lessons learned from COVID-19 crisis, believes that the proposal on management and mitigation of medicines shortages should be improved for better outcomes of the collaboration between the manufacturers and National and European medicines agencies to improve the supply of medicines to patients and to ensure EU solidarity.

Taking the lessons learned from COVID-19, Medicines for Europe has two main reflection points on the proposal. 1.We highlight the important challenges of using joint procurement (JP) for generic multisource medicines. The joint procurement of ICU medicines during the pandemic was not an efficient way to secure medicines supply.

Medicines for Europes comments of the EMA fees regulation. Medicines for Europe supports a cost-based EMA fee system with a simpler fee structure. For generic medicines with very low margins, regulatory costs can be critical to maintain older products (with low to zero profitability) or supply products to small markets.

Medicines for Europe welcomes an opportunity to comment on the concept of the EMA fees revision. Despite the fact that the current EMA fee system is complex due to many different categories and types of fees, the feedback from the Medicines for Europe’s membership is that EMA fees system is not that difficult to apply it and it is quite predictable.