Our team in Brussels provides expert insights in legal, public policy and government affairs. In close collaboration with our members, we analyse, monitor and engage several topics and themes in our Working Groups, Steering Groups, Task Forces and Partner Networks.
The European pharmaceutical regulatory system sets the scientific standards and framework for getting high quality, safe and effective medicines to patients. It is an essential component of the process that develops research and development into a licensed therapeutic that can transform the lives of patients across Europe.
Our functioning system is also a key factor in Europe’s competitiveness in the global race to attract life-science investment to the region, particularly in the context of intense competition from other global economies, notably the US and China.
EUCOPE and its members provide their practical experience and improvement suggestions on all phases of the medicines lifecycle, manufacturing and regulatory aspects.
Pricing & Reimbursement / Market Access Policies
A stable and balanced framework for pricing and market access policies ensures patients get timely access to the right medicinal product, whilst safeguarding the sustainability of our healthcare systems. Through our Pricing & Reimbursement / Market Access Working Group, EUCOPE helps our members navigate this constantly evolving environment, with advice and insights on the latest developments regarding national pricing decisions, HTA analysis, international reference pricing, etc.
For more information on EUCOPE’s Pricing & Reimbursement / Market Access efforts or how your organisation can contribute to it, please contact Matias Olsen email@example.com
Visit our Resources page for all of EUCOPE’s current and past work on Pricing & Reimbursement / Market Access.
The European regulatory framework provides the clear periods when regulators, patients and industry come together to address different issues, with clear roles and responsibilities of each stakeholder. Working according to the rules set by the regulatory framework means working on a wide range of subjects such as having a scientific dialogue and getting advice in different phases of medicine’s development, until their marketing authorisation.
The Regulatory Working Group provides information and a platform for discussion on regulatory issues. In particular, the Working Group prepares EUCOPE’s participation in various European Medicines Agency (EMA) and European Commission expert groups.
For more information on EUCOPE’s Regulatory efforts or how your organisation can contribute to it, please contact Maren von Fritschen firstname.lastname@example.org
Visit our Resources page for all of EUCOPE’s current and past work on Regulatory work.
EU Pharmaceutical Strategy
In 2020, the European Commission, the European Commission outlined a new vision for the pharmaceutical sector with the new Pharmaceutical Strategy for Europe. As a key means to effect change, the EU will reopen the General Pharmaceutical Legislation, the foundations on which the European Pharmaceutical industry is built.
The EU Pharmaceutical Task Force drives EUCOPE’s response the Pharmaceutical Strategy, including the review of the General Pharmaceutical Legislation. The Task Force is a mechanism to develop and deliver a shared industry position to the most fundamental review to EU pharmaceutical legislation in 20 years, and engage on broad policy developments that will inform the EU pharmaceutical landscape in the coming decades.
For more information on EUCOPE’s EU Pharmaceutical Task Force or how your organisation can contribute to it, please contact Victor Maertens email@example.com
Visit our Resources page for all of EUCOPE’s current and past work on the EU General Pharmaceutical Legislation.
Health Technology Assessment (HTA)
Health Technology Assessment (HTA) is a multi-disciplinary process to evaluate the social, economic, organizational and ethical issues of a health intervention or health technology.
The EU HTA Regulation has entered into force and starting from 12 January 2025, cancer medicines, ATMPs and certain medical devices and IVDs will be subject to joint clinical assessments at the EU level. From 13 January 2028, the scope will be extended to OMPs and from January 2030 all centrally authorised medicinal products will be subject to obligatory joint clinical assessments at EU level.
In the period leading up to the date of application, the European Commission is responsible for developing detailed procedural rules by way of implementing acts. It has further commissioned EUnetHTA 21 to develop advanced HTA methodology that will lay the foundation for the methodology used in EU HTA. The EU HTA Regulation Task Force has been set up to more closely coordinate with members on the engagement with the European Commission and EUnetHTA 12 for the development of the procedural rules and methodology respectively.
For more information on EUCOPE’s EU HTA Regulation Task Force or how your organisation can contribute to it, please contact Matias Olsen firstname.lastname@example.org
Visit our Resources page for all of EUCOPE’s current and past work on HTA.
EUCOPE works to strengthen the whole EU environment for the development of rare diseases treatments. With almost half of our members involved in the research and development of therapies for rare diseases, the OMP Working Group offers an opportunity to members to discuss the latest rare disease and orphan medicinal products‘ national and European legislative and policy developments without neglecting relevant global or international developments (North America & Asia). The OMP Working Group offers the opportunity of the wider membership to provide feedback and contribute to EUCOPE’s engagement on the OMP Regulation and validate the Incentives Steering Group’s approach.
For more information on EUCOPE’s OMP efforts or how your organisation can contribute to it, please contact Vittoria Carraro email@example.com
Visit our Rare Disease Hub to see all current and past work on Rare Diseases and Orphan Medicinal Products.
Advanced Therapy Medicinal Products (ATMPs)
Cell and Gene therapies bring with them the promise not simply to manage the symptoms of a diverse group of severe, disabling or life-limiting conditions but the promise of one-time disease-modifying treatments that can transform and save lives. As these technologies are paradigm changing, they still face regulatory and market access challenges. EUCOPE aims to find solutions to build a path and policy framework appropriate for these technologies, contributing to a healthcare system that works for industry, patients, payers, and the healthcare community at large.
The Cell and Gene Therapies Working Group is a forum to discuss developments and collectively find solutions for funding, pricing and reimbursement of advanced therapies medicinal products so that they actually reach the patients.
For more information on EUCOPE’s Cell and Gene Therapies Working Group or how your organisation can contribute to it, please contact Victor Maertens firstname.lastname@example.org
Visit our Resources page for all of EUCOPE’s current and past work on ATMPs.
Advanced diagnostics leverage the improved understanding of genomics, or the study of genes and their functions, and related techniques. Used for a variety of clinical purposes that span both research and clinical decision-making including: screening for disease, diagnosis, prognosis, therapy selection and prediction of treatment benefits, monitoring and risk of recurrence and support in clinical trial designs, advanced diagnostics are disrupting existing paradigms around value, utility and adoption of genomic testing.
The Genomics Working Group is working to ensure these technologies can be made more widely available to patients through fit-for-purpose assessment procedures and viable pathways towards reimbursement.
For more information on EUCOPE’s Genomics Working Group or how your organisation can contribute to it, please contact Matias Olsen email@example.com
Visit our Resources page for all of EUCOPE’s current and past work on Advanced Diagnostics.
The European Health landscape is undergoing a real-time transition as the EU develops the European Health Data Space, which will lay the foundations for the interplay between data and healthcare. The Digital Health Working Group was created to respond to members’ needs and current political impetus on artificial intelligence (AI) and digital health. EUCOPE is also part of the eHealth Stakeholder Group, an expert group that provides advice and expertise to the European Commission on topics related to the digital transformation of health and care, such as health data, digital health services or the use of artificial intelligence.
For more information on EUCOPE’s Digital Health Working Group or how your organisation can contribute to it, please contact Leander Vranken firstname.lastname@example.org
Visit our Resources page for all of EUCOPE’s current and past work on Digital Health.
We believe that in order to improve the entire health innovation environment in Europe, policy solutions need to be devised all along the lifecycle of medicines, from very early research to patient access.
Our Commitment is to lead and engage in partnerships spanning the entire medicine lifecycle to find actionable solutions that benefit our members, the patients they serve and healthcare systems overall.
The following are some of our current partners:
The European Expert Group on Orphan Drug Incentives is multi-stakeholder initiative producing proposals to strengthen the incentives environment for orphan drugs
The European Alliance for Transformative Therapies (TRANSFORM) is a multi-stakeholder Alliance that connects Members of the European Parliament (MEPs) and policy-makers with patient groups, medical experts and associations, scientists, researchers, industry actors, networks and other relevant stakeholders. TRANSFORM aims to foster effective dialogue and provide evidence-based policy recommendations to enable safe and timely patient access to cell and gene therapies, whilst ensuring the sustainability of healthcare systems.
Together4RD aims to identify and launch areas to pilot cooperation between ERNs and industry in registries and clinical trials (leveraging EUCOPE advisory roles in ERICA and EJPRD)
RWE4Decisions is a payer-led multi-stakeholder initiative aimed at developing models to include RWE in HTA assessment. The group developed rrecommendations on adopting standards and legal basis for use of Real-World Evidence
Rare Impact is a Patient-focused collaboration that seeks to improve patients’ access to Gene and cell therapies. The initiative aims to identify and validate the challenges to patients’ access across countries
ORPH-VAL, the group of experts developed a set of principles to be applied across European markets to assess feasibility of enacting greater consistency in P&R systems assessment of OMPs at national level. Building on existing cooperation mechanisms ( e.g. MoCA-OMP)