EUCOPE’s Activities

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.

Please see below some of the priorities guiding our policy and legal activities.

Pricing & Market Access Policies

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

Position Papers

Unlicensed Medicines

Off-label use refers to any intentional use of an authorised product not covered by the terms of its marketing authorisation.

A medicine is ‘unlicensed’ when it does not have a marketing authorisation. An unlicensed medicine is not available on the market and it can only be used in clinical studies or in a compassionate use/expanded access setting.

EUCOPE 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.

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[1].

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.

[1] https://ec.europa.eu/health/human-use/orphan-medicines_en

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

Gene & Cell Therapies

Gene & Cell therapies bring with them the promise not simply of treatment 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 drugs so that they actually reach the patients.

Position Papers

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[1].

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[2].

Recent developments

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[3].

Our work at EUCOPE is to keep our members abreast of the many developments and changes that influence the medical devices sector.

[1] http://ec.europa.eu/growth/sectors/medical-devices_en

[2] https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en

[3] Ibidem

Position Papers

Brexit

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

Regulatory Developments

EUCOPE provides periodic updates via emails or physical meetings on the developments impacting the pharmaceutical regulatory environment both at the European and National levels.