Compare organizations

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”.

EUCOPE is the voice of small to midsize innovative companies active in the field of pharmaceuticals and medical technologies at the European level. The COVID-19 pandemic has again made the vital importance of the European pharmaceutical sector apparent, and while regulatory simplification is welcomed, broader business incentives should also be considered to address the EU’s competitiveness.

EUCOPE acknowledges the objectives of the review. While numerous regulatory provisions will streamline the functioning of the market, changes to the incentive framework outweigh these, weakening EU global competitiveness.

EUCOPE acknowledges the objectives of the Pharmaceutical Package, and welcomes maintaining a separate Directive and Regulation for decentralized and central approval processes. While we appreciate streamlining and digitisation of regulatory procedures, we are concerned that other proposed provisions will undermine R&D, innovation, EU competitiveness, and be particularly detrimental for patients and small 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…

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) is the European trade association for small to mid-sized innovative companies active in the field of pharmaceuticals and medical technologies at the European level.

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) is the European trade association for small to mid-sized innovative companies active in the field of pharmaceuticals and medical technologies at the European level.

EUCOPE, the European association with a strong focus on small to medium-sized companies active in pharmaceuticals and biotechnologies, welcomes the proposal for a regulation 2020/0320 that aims at enforcing the mandate of the European Centre for Disease Prevention and Control (ECDC).

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.

EUCOPE, the European association with a strong focus on small to medium-sized companies active in pharmaceuticals and biotechnologies, welcomes the Commission’s proposal for a regulation 2020/0321 to reinforce the role of the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices.

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.

EUCOPE, the European association with a strong focus on small to medium-sized companies active in pharmaceuticals and biotechnologies, welcomes the proposal for a regulation 2020/0322 within the framework of better cross-border crisis preparedness and management.

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.