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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”.

Health systems in the EU face the challenge of ensuring a high quality of affordable supply of medicines in the face of high prices. The German Social Insurance Agency therefore welcomes the EU’s intention to revise European pharmaceutical legislation.

Filed in German · English published by the European Commission

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…

The German Social Insurance Board (DSV) welcomes the Commission’s objectives of the reform proposals. They provide an opportunity to ensure equal access to medicines for patients in all Member States and to strengthen the security of supply of medicines as well as the adequacy of existing incentive schemes for drug development.

Filed in German · English published by the European Commission

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 Commission is examining measures to optimise the existing system of Supplementary Protection Certificates (SPCs) in order to make it more transparent and efficient. SPCs are an intellectual property protection instrument that has the effect of extending the term of protection of a pharmaceutical patent by up to five years.

Filed in German · English published by the European Commission

On April 27, 2023, the European Commission submitted proposals for the reform of intellectual property rights for medicinal products. Among other things, a unitary European supplementary protection certificate is to be established to complement the unitary European patent already introduced by Regulations (EU) No. 1257/2012 and (EU) No. 1260/2012 and due to start in 2023.

On April 27, 2023, the European Commission submitted proposals for the reform of intellectual property rights for medicinal products. Among other things, a unitary European supplementary protection certificate is to be established to complement the unitary European patent already introduced by Regulations (EU) No. 1257/2012 and (EU) No. 1260/2012 and due to start in 2023.

On 11 November 2020, the European Commission presented ist outline for a European Health Union. The current pandemic has particularly highlighted defitis in pan-EU crisis management. The communication is accompanied by three draft regulations with which the European commission is focusing on the legislative strengthening of the EU framework for serious cross-border health threats on the one hand and the capacity…

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.

Member States’ cooperation during the coronavirus pandemic has revealed weaknesses in the area of public health. The German Social Security Committee welcomes the Commission’s intention, within the framework of the current Treaties, to develop constructively the structures of cooperation between the Member States and European and national institutions.

Filed in German · English published by the European Commission

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.