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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”.

EFPIA supports an agile regulatory framework and a strong incentives’ system that embrace and encourage advances in science, technology & medicines. This evaluation is an opportunity to implement learnings from COVID-19 and ensure a competitive, world-class regulatory system in Europe supporting a globally competitive research-based industry at a critical time.

EFPIA supports the objectives of enhancing the availability and accessibility of medicines, while fostering a competitive innovation environment in Europe. We welcome the proposal to future-proof the EU regulatory framework, maximising the use of expedited pathways, optimising regulatory decision-making processes, and reducing unnecessary administrative burdens.

EFPIA supports the objectives of enhancing the availability and accessibility of medicines, while fostering a competitive innovation environment in Europe. We welcome the proposal to future-proof the EU regulatory framework, maximising the use of expedited pathways, optimising regulatory decision-making processes, and reducing unnecessary administrative burdens.

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…

Bringing new therapies to patients is a long, complex and risky process that requires long-term and continuous investments. Patents are critical to that purpose and to the EU’s innovation and industrial ambitions.

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…

EFPIA supports the stated aims for the SPC revisions. Central SPC issuance for classical European patents and Unitary Patents will improve IP framework efficiency, bringing innovative medicines to patients in a timely manner via reliable protection.

EFPIA supports the stated aims for the SPC revisions. Central SPC issuance for classical European patents and Unitary Patents will improve IP framework efficiency, bringing innovative medicines to patients in a timely manner via reliable protection.

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.

EFPIA fully supports the EU’s goal to enhance its health emergency preparedness and response capacity by, among others, reinforcing the mandate of the ECDC. It is critically important that as part of its extended missions and tasks (art. 3), the ECDC can get full and immediate access to all epidemiological data from Member States.

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.

EFPIA fully supports the EU’s goal to enhance its health emergency preparedness and response capacity by, among others, extending the mandate of the EMA. The current crisis has shown the importance of close dialogue between EU authorities and the industry, to address medicines’ shortages.

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.

EFPIA fully supports the EU’s goal to enhance its health emergency preparedness and response capacity. We welcome the proposed Regulation strengthening Europe’s preparedness against serious cross-border health threats, and believe that it can be improved further to ensure it delivers on its objectives.