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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”.

As the association representing the medical technology sector, MedTech Europe welcomes the recognition in the inception impact assessment that pharma health solutions bring about technological advances, and the inclusion of the potential of the digital transformation of health and care.

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 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.

MedTech Europe welcomes the objective and the proposed text on the extended role of the ECDC, as part of the European Health Union and suggestes to take the following considerations into account: 1. Involvement of Civil Society (Articles 5a and 5b): a.COVID-19 has demonstrated the need to involve the civil society in order to combat public health threats – in particular prevention, preparedness and response planning…

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.

Regaring the proposed Regulation on the reinforced role of EMA, MedTech Europe suggests to take the following considerations into account (full position attached): 1. Involvement of Civil Society in the Executive Steering Committee on Medical Devices (Art19): a.COVID-19 has demonstrated the need to involve the medical technology industry and other partners of civil society in an ongoing dialogue throughout the full…

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.

MedTech Europe welcomes the objective of the European Commission’s proposed ‘Health Union’ package of 11 November 2020. Better coordination and pooling of efforts are needed across the Union to strengthen Europe’s preparedness to tackle future public health emergencies, and the proposed Regulation on serious cross-border threats to health constitutes an important step in this direction.