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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.

The pharmaceutical legislation should foster access to follow-on off-patent medicines on day-1 after IP expiry. The legislation should ban patent linkage – a major cause of generic/biosimilar entry delays, which the EC considers anti-competitive and “unlawful”.

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 Poland, representing manufacturers of generic, biosimilar and value added medicines across Poland, 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 Poland, representing manufacturers of generic, biosimilar and value added medicines across Poland, 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 Poland has a negative opinion on the plans to implement the Unitary Supplementary Protection Certificate (SPC) system. The same view is also shared by Medicines for Europe. In the discussion on the possible introduction of a single SPC, the following issues should not be overlooked: • A unitary SPC system would actually increase the geographic scope of protection: Currently, SPCs are not registered in…

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 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 Poland 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 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 Poland, 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.

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 Poland 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.

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.