Our team in Brussels provides expertise in legal, public policy and government affairs. In close collaboration with our members, we analyse, monitor and engage when necessary on multiple topics.
Pricing & 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. EUCOPE is helping its members in navigating this constantly evolving environment.
- Health Technology Assessment
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.
HTA at the EU level:
On 31 January 2018, the European Commission put forward a legislative proposal for a new HTA Regulation, calling for a more collaborative framework in the EU, to improve business predictability and avoid duplication of work and discrepancies between HTA mechanisms.
EUCOPE welcomes the proposal as it contributes to more transparency in value assessment, can reduce burden and compliance costs and proposes a mandatory uptake of joint clinical assessment by Member States. However, EUCOPE would consider some adjustments to provide for a sufficient level of flexibility in specific cases, e.g. for Orphan Medicinal Products (OMPs).
- Cross-Country Collaboration
Cross-country collaborations are voluntary-based initiatives from different countries to work together on different areas pertaining to the pricing and reimbursement of medicines, including horizon scanning, information sharing, HTA process and pricing and reimbursement decisions.
- International Reference Pricing
International reference pricing (IRP) is a method used by most EU Member States to set drug prices based on the prices of medicines in other countries.
- National Developments
EUCOPE provides its members with regular updates on market, regulatory and legal developments in Member States via internal mailings or EUCOPE’s Working Group.
- Position Papers
Intellectual Property Rights & Incentives
Intellectual property (IP) protection allows for an idea to be first protected and then transformed into a pharmaceutical discovery. That part plays a central role in the whole life cycle of medical research. Without proper IP protection and incentives, less research will be done and fewer medicines will be discovered.
- Position Papers
- Off-Label Use
Off-label use refers to any intentional use of an authorised product not covered by the terms of its marketing authorisation.
EUCOPE has long supported the development of the Good Off-Label Use Practices (GOLUP) declaration and held various European and national roundtables to raise awareness notably on our members’ concerns vis-à-vis the off-label use for economic reasons.
The GOLUP Declaration does not seek to prevent off-label use, rather to ensure that patient safety remains a priority and that it is not undermined by economic interests. To ensure this EUCOPE is echoing the principles that have proved to be essential in keeping patients safe:
Off-label use is the practice of prescribing a medicine outside its approved indication. It can benefit patients when no other treatment option is available and it is based on the therapeutic needs of the patient. However, some EU Member States are imposing prescribing guidelines to promote off-label use solely for reducing healthcare spending. This creates unnecessary and avoidable risks to patient’s safety.
If a patient is prescribed a medicine off-label, it is essential that they are aware of the benefits and risks. It is also crucial to put in place mechanisms for patients to easily report adverse events from off-label use.
Orphan Medicinal Products
- Orphan Medicinal Products
Orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect no more than 5 in 10,000 people in the European Union.
The Orphan Regulation 141/2000 has fostered the advancement of research and development (R&D) in the area of complex diseases, for which knowledge remains confined and patient numbers limited, encouraging the development of orphan medicinal products.
You can find more detailed information on our work on OMP and related news on our Rare Diseases Hub.
- Multi-Stakeholder Initiatives
The Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA) is an initiative bringing together stakeholders from European countries to collaborate on coordinated access to orphan medicines in a voluntary, dialogue-based approach, intended to create a fluid set of interactions between key stakeholders, across all aspects of a product.
Participation in MoCA is open to several stakeholder groups, including:
- National competent authorities for pricing and reimbursement;
- Rare disease patients;
- Candidate marketing authorisation applicant/holders willing to be involved in a pilot focused on a particular product of theirs.
For further information, please visit the MoCA website
Advanced Therapy Medicinal Products (ATMPs)
- Gene & Cell Therapies
Gene & Cell 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.
Our work at EUCOPE is to collectively find solutions for funding, pricing and reimbursement of advanced therapies medicinal products so that they actually reach the patients.
- Position Papers
Medical Devices and IVDs
- Medical Devices and IVDs
Medical devices cover a wide range of products, from simple bandages or sticking plasters to the most sophisticated X-ray equipment. They play a crucial role in the diagnosis, prevention, monitoring and treatment of diseases and help improve the quality of life of those with disabilities.
In Vitro diagnostic medical devices mean any medical device intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body.
- Recent Developments - New Regulations
Two new Regulations were adopted in 2017, which will apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (May 2020) and 5 years after entry into force (May 2022) for the Regulation on in vitro diagnostic medical devices.
Our work at EUCOPE is to keep our members abreast of the many developments and changes that influence the medical devices sector.
- Advanced Diagnostics
Advanced diagnostics exploit 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.
Advanced diagnostics are evolving with new cutting-edge techniques rapidly being developed such as gene expression profiling, immune sequencing and liquid biopsy methods from blood plasma, and the EUCOPE 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.
- EUCOPE Position Paper on In Vitro Diagnostics Devices
- EUCOPE Position Paper on Medical Devices
- EUCOPE White Paper on Advanced Diagnostics
- The UK Leaving the EU
The decision of the United Kingdom (UK) to leave the European Union has triggered difficult and complex negotiations between the two parties. This had led to many uncertainties for many of EUCOPE’s member companies. Our work is to support in preparing for a smooth transitional period, with as few regulatory hurdles as possible, in ensuring there is minimal disruption to patients receiving medicines after the UK leaves the EU.
- Position Papers
- EU and National Monitoring
EUCOPE provides periodic updates via emails or physical meetings on the developments impacting the pharmaceutical regulatory environment both at the European and National levels.