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The Vereniging Innovatieve Geneesmiddelen (VIG) considers the evaluation of the pharmaceutical legislation an opportunity to draw lessons from the COVID-19 pandemic and prepare for the future. To remain attractive for innovation and R&D while effectively responding to future challenges and threats.

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…

On behalf of the Association Innovative Medicines (VIG), the Dutch industry association of 44 innovative medicines manufacturers, our response to the proposed revision of the EU pharmaceutical legislation. The members of the VIG are active in the biopharmaceutical ecosystem of the Netherlands, which extends from academic institutions and hospitals to medicine developers and service companies.

Filed in Dutch · English published by the European Commission

On behalf of the Association Innovative Medicines (VIG), the Dutch industry association of 44 innovative medicines manufacturers, our response to the proposed revision of the EU pharmaceutical legislation. The members of the VIG are active in the biopharmaceutical ecosystem of the Netherlands, which extends from academic institutions and hospitals to medicine developers and service companies.

Filed in Dutch · English published by the European Commission

EUCOPE welcomes the opportunity to participate in the evaluation process of the European Commission proposal for a European Health Data Space (EHDS). Representing small and medium-sized companies active in pharmaceuticals, biotechnologies and medical technologies, EUCOPE shares the Commission’s ambition to see the EU becoming a leader in digital innovation.

The Vereniging Innovatieve Geneesmiddelen (VIG) is positive towards the proposal of the European Commission to establish a European Health Data Space (EHDS). This proposal enables the EU to better grasp the potential of health data for research and innovation on new preventive strategies, as well as on diagnosis and treatment of diseases to improve health outcomes.

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) welcomes the proposal on the European Health Data Space (EHDS). It recognises the importance of EU-level data collection standards and the promotion of data interoperability and exchange protocols. However, such a domain-specific common data space is expected to face challenges. Therefore, we submit the following recommendations.

Pharmaceutical companies are committed to develop solutions for unmet needs and to ensure available treatments reach all patients in Europe. Patients with rare diseases and children have benefited greatly from the progress which has been realised with the OMP Regulations.

EUCOPE’s represents 130 small to medium-sized companies playing a key role in the European pharmaceutical environment, many focused on rare diseases. Some of them have unique profiles due to their highly specialised product portfolio, no or limited revenues to date and/or significant risky R&D investments.

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.

Without the continuous and substantial investments in R &D, new technologies would not be developed. The (mRNA) vaccines and medicines used in the COVID pandemic would not have been there without the robust EU Intellectual Property (IE) system. IE, more specifically patents provide incentives for innovation through knowledge-sharing and in return temporary market protection to recoup (financial) investments.

Filed in Dutch · English published by the European Commission

The development of new medicines requires extensive research and considerable time and resources, the path from basic research to a new authorised medicine is long and involves many uncertainties. To deal with uncertainties, and the long timelines for development and marketing authorisation, IP rights are fundamental.

The development and marketing of new medicines requires time and investment in research, the outcome of which is uncertain: many developments do not lead to a useful medicine. There is no doubt that a well-functioning IP system is indispensable for a good innovation and investment environment.

Filed in Dutch · English published by the European Commission

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.