Guidance / Projects

3rd Health Programme (2014-2020)
Statistical data and Guidance Document for medicinal product pricing and for the use of ERP [EURIPID]
The proposal is an answer of the Executive Committee of the EURIPID Collaboration to the call “Statistical data for medicinal product pricing” of the EC, DG Sanco, operated by the CHAFEA. EURIPID ...
The proposal is an answer of the Executive Committee of the EURIPID Collaboration to the call “Statistical data for medicinal product pricing” of the EC, DG Sanco, operated by the CHAFEA. EURIPID is a joint undertaking of currently 24 EU Member States, EEA and candidate countries to operate an online database for medicinal products prices and related information. The proposal’s main objective is to achieve a better coordination at the EU level in order to facilitate the control by the Member States of public budgets for medicinal products (e.g. external reference pricing, ERP) and to avoid/mitigate possible negative impacts on patient access to medicines.

To attain this objective the proposal identifies the following specific objectives: 1) optimisation of the dataset and layout of the existing EURIPID database and website, 2) providing the necessary information related to medicinal product pricing in a standardised web-based format and 3) developing a Guidance Document (an operational policy paper) on a coordinated approach of national competent authorities regarding the use of ERP to avoid/mitigate negative impact for patient access to medicines.

The expected outcomes of the proposed activity are: 1) an optimised dataset and lay-out in EURIPID database, 2) continuous information provision for the national authorities in a sustainable way to improve their understanding and use of ERP and 3) a Guidance Document that could serve as a technical reference document for countries using ERP.
The national competent authorities in Europe and stakeholders as e.g. represented in the Platform on Access to Medicines in Europe will be invited to jointly reach the objectives.
The proposal was approved by the Board of Participants of EURIPID Collaboration. The broad support of the national authorities, the experienced project team and the proven technical platform of EURIPID which is operational since 2010 is a solid and reliable basis to successfully achieve these objectives.
Start date: 01/08/2015 - End date: 31/07/2018

Call: Call for Proposals for Projects 2014
Topic: Guidance
3rd Health Programme (2014-2020)
Joint Action on HIV and Co-infection Prevention and Harm Reduction [HA-REACT]
The Joint Action proposal on “HIV and Co-infection Prevention and Harm Reduction” (HA-REACT) addresses existing gaps in the prevention of HIV and other co-infections (especially tuberculosis and h...
The Joint Action proposal on “HIV and Co-infection Prevention and Harm Reduction” (HA-REACT) addresses existing gaps in the prevention of HIV and other co-infections (especially tuberculosis and hepatitis) in priority areas of the EU. Despite huge advances in treatment and care and successful implementation of evidence-based preventive interventions in many EU member states, these infections are still not controlled among certain population groups and regions. The HA-REACT Joint action (JA) directly addresses the Communication from the Commission [COM(2009)569] on “Combating HIV/AIDS in the European Union and neighbouring countries, 2009 -2013” and relevant actions laid out in the associated [SWD(2014)106] action plan extension 2014-2016. The project takes a practical rather than a theoretical or purely guiding approach. It will implement concerted, multi-country, and multi-actor actions, strengthening evidence-based practices in the focus countries, where the situation and needs are particularly challenging. Focused action for greater impact is the leading principle of this proposal. The HA-REACT will focus on pragmatic actions targeting the most vulnerable populations, i.e. people who inject drugs (PWID). The focus countries for the JA were selected according to an objective and transparent selection criteria, developed by the ECDC and the EMCDDA in which the countries were ranked according to their epidemic situation and coverage of preventive measures. In addition to work packages of Coordination, Dissemination and Evaluation, HA-REACT actions are organized into five core work packages: Testing and linkage to care, Scaling up harm reduction, Harm reduction and continuity of care in prisons, Integrated care, Sustainability and long-term funding.
Start date: 01/10/2015 - End date: 31/01/2019

Call: Grants for actions co-financed with Member State authorities 2014 (Joint Actions)
Topic: Guidance
3rd Health Programme (2014-2020)
Market surveillance of medical devices [JAMS]
This Joint Action aims to reinforce market surveillance between Member States. Best practice, training, knowledge and resource will be shared to increase public health protection in the medical device...
This Joint Action aims to reinforce market surveillance between Member States. Best practice, training, knowledge and resource will be shared to increase public health protection in the medical devices sector. A key aim is to improve coordination and help lower-resourced Member States develop skills and capacity in the market surveillance network. It will help to ensure consistent and proportionate approach across all Member States in manufacturer inspections and clinical process and resource development.

Methods will be developed as follows:
1. Manufacturer inspections:
• Develop methods, agreed tools and guidance’s for a joint, consistent and proactive approach
• Establish specific inspection scopes and objectives to complement those conducted by conformity assessment bodies
• Develop different approaches and focus to manufacturer inspections
• Develop and deliver collaborating mechanisms designed to maximize the efficiency and effectiveness of resource deployment
• Develop an inspector training course to provide inspectors with basic skills and establish an inspectors expert group for ongoing collaborative approaches
2. Clinical process and resource development:
• Establish communication platforms and protocols
• Establish current practices and identify development and/or training needs and evaluation of clinical data by authorities
• Identify and prioritise medical devices which require development of common specifications to define clinical criteria for safety and performance.

In harmonising the European market surveillance system detection and reduction in the occurrence of safety issues will lead to increased public health protection by ensuring that medical devices conform especially to the requirements relating to safety and performance.


Start date: 17/10/2016 - End date: 16/01/2020

Call: Health Programme Adhoc Call for invited (named) beneficiaries
Topic: Guidance