Safety / Projects

3rd Health Programme (2014-2020)
Health Action International proposal for a Specific Grant Agreement on operating costs for 2020 [SGA 2020 HAI]
Objectives: 1.Access to Affordable Medicines 2. Medicines Safety, Added Therapeutic Value and Responsible Use 3. Democratisation of Medicines Policy
Activities:
1: Seek policy support from the Govern...
Objectives: 1.Access to Affordable Medicines 2. Medicines Safety, Added Therapeutic Value and Responsible Use 3. Democratisation of Medicines Policy
Activities:
1: Seek policy support from the Governments of Member States for alternative models of biomedical innovation—delinking R&D costs from the final price of a given medicine—as one component of improving access to currently unaffordable medicines
2: Promote the use of public-health sensitive IP management tools and TRIPS flexibilities in the EU to secure affordable access to medicines and ensure the sustainability of health systems
3: Seek public and high-level government support for initiatives that improve public access to clinical trial data and data on risk biases, and that enhance medicines’ pricing and reimbursement policies that contribute to sustainable health systems
4: Advocate for improved marketing authorisation procedures
5: Continue to engage new cohorts of medical students on the need to respond critically to pharmaceutical promotion, expanding our influence to research facilities and teaching staff
6: Monitor, contribute and react to emerging and ongoing EU policy developments and issue communication and policy materials related to HAI’s areas of expertise
7: Facilitate knowledge exchange on HAI’s areas of expertise to civil society and to new MEPs through the dissemination of recommendations related to EU medicines policy, engagement in meetings and events
8: Strengthen the HAI Europe Association of members to ensure that civil society’s voice is well represented in medicines policy discussions
9: Ensure continuation and transparency of HAI’s work and expand donor relations
We expect to reach over 1000 policy-makers, civil society representatives and members of the research community in the EU through our online and in-person advocacy efforts in 2020. We will produce over 60 outputs in line with the 16 deliverables outlined in our proposal.
Start date: 01/01/2020 - End date: 31/12/2020

Call: Financial Contribution to the Functioning of Non-Governmental Bodies - Invitation to submit proposals for Specific Operating Grant Agreements (SGA)
Topic: Safety
3rd Health Programme (2014-2020)
A Plan for Action: Ensuring Equitable, Affordable and Responsibly Used Medicines in the European Union [HAI SGA 2021]
Health Action International’s work in Europe focuses on improving access to medicines through evidence-based advocacy, sharing expertise and engaging for change. To do this we campaign for greater t...
Health Action International’s work in Europe focuses on improving access to medicines through evidence-based advocacy, sharing expertise and engaging for change. To do this we campaign for greater transparency, and rationally used, affordable, safe and effective medicines.

PRIORITIES FOR 2021
European Parliament Working Group on Innovation, Access to Medicines and Poverty-related Diseases: HAI and MSF provide the secretariat for a group of European Parliamentarians interested in access to medicines issues. Over 2021 we will mobile this group to advocate on numerous issues.

Furthermore, we aim to change the narrative around TRIPS flexibilities to encourage more regular use of these legitimate tools. In 2021, we will implement the conclusions of the Great Health Hack, including producing the beta version of the technical solution suggested by participants. We hope to broaden understanding of the evidence base behind IP flexibilities and facilitate more policymakers to support implementation of a sustainable pricing system.

We will continue to share our recommendations how Member States can achieve greater transparency in medicines prices, research and development (R&D) costs and reimbursement decisions.

We will facilitate medical students and healthcare professionals to detect, counter and avoid exposure to pharmaceutical promotion.

As always, there will be many other upcoming issues and opportunities in access to medicines this year, both regionally and globally. We will be watching how other dossiers and events unfold in the fight against medicine shortages, also in light of COVID-19.

We pride ourselves on being active members of European civil society and part of the global access to medicines movement, via groups like the European Alliance for Responsible R&D and Affordable Medicines, Medicijnen Netwerk Nederland, HTA Network Stakeholder Pool and the EMA PCWP.

Start date: 01/01/2021 - End date: 31/12/2021

Call: Invitation to submit proposals for Specific Operating Grants (SGA) for the year 2021 under the Annual Work Programme 2020 of 3HP
Topic: Safety
3rd Health Programme (2014-2020)
Good Practices for demonstrating safety and quality through recipient follow-up [Euro-GTP II]
The main objective of this project is to set up the good practices applied to tissues and cells (T&C) preparation processes and patient follow-up procedures, to ensure their safe and effective impleme...
The main objective of this project is to set up the good practices applied to tissues and cells (T&C) preparation processes and patient follow-up procedures, to ensure their safe and effective implementation.
The outputs of this project will provide tools for assessing and verifying the quality, promote safety and assure efficacy of therapies with human tissues, Hematopoietic Stem Cells (HSC) and Assisted Reproductive Technologies (ART), addressing mainly to the implementation of novel T&C preparation processes and clinical indications, but also to the need of retrospective studies where weaknesses or insufficient safety data currently exist.
Recommendations will be forwarded to Tissue Establishments (TE) and Organizations Responsible for Human Application (ORHA), as the main actors in the process of validation and designing T&C preparation processes and patient follow-up according to a clinical indication.
This project aim to define the threshold of novelty, including definition of the factors that should be considered to determine the scope and depth of the clinical follow-up studies needed. The scope and extent of the recommended studies will be determined on the basis of a risk based approach performed taking into account factors such as the novelty of the product/preparation process/clinical indication, and its technical complexity.
A T&C Database of products, preparation procedures, clinical applications and their current status of authorisation and implementation will be established, working as a starting point for determining the ‘novelty’ of processes/therapies by TEs and ORHAs, and allowing the use of established processes/therapies by any centre that strictly follows the same procedure/clinical procedure/indication.
This project also aims to define a “GTP’s management model” that could provide impetus for future standards harmonisation and promotion, and allow the establishment of European accreditation and training programs for TE.
Start date: 01/04/2016 - End date: 31/03/2019

Call: Call for Proposals for Projects 2015
Topic: Safety
3rd Health Programme (2014-2020)
European Cornea and Cell Transplantation Registry [ECCTR]
Disease of the cornea (the transparent layer covering the front of the eye) is the second cause of blindness worldwide. The cornea is the most transplanted tissue with over 100,000 corneas transplan...
Disease of the cornea (the transparent layer covering the front of the eye) is the second cause of blindness worldwide. The cornea is the most transplanted tissue with over 100,000 corneas transplanted annually. In Europe an estimated 30,000 corneal transplants are performed each year.
Currently there is no harmonisation of information across the European Union on the numbers or origins of the scarce corneas tissue available for transplant, the optimum procedure for transplant and the visual outcome and quality of life of corneal transplant patients.
The ESCRS in 2006 with the support of the Executive Agency for Health and Consumers pioneered an online Quality Registry of the outcomes of cataract and refractive surgeries (EUREQUO). ESCRS continues to support this Registry and has currently a database of over 2,000,000 surgeries.
ESCRS proposes to extend this platform to create a registry of corneal transplantation surgeries in Europe. The European Cornea and Cell Transplantation Network (ECCTR) will link three existing registries and recruit additional centres of excellence and eye banks to contribute data on availability of corneal tissue, methods of transplantation, and visual outcomes of surgery.
The focus of our consortium is on bringing added value and making a positive impact on one of the priority actions set out in the annual Work Programme for 2015; contributing to the fourth overall objective:” To build a common assessment methodology to allow academics, health professionals and authorities to assess and verify safety, quality and efficacy of (new) transplantation therapies and/or other types of clinical applications of human tissues and cells (e.g. assisted reproductive technologies).”
After the completion of this action the ECCTR will have all the data necessary to develop European Guidelines for Corneal Transplant Surgery to better utilise scarce cornea tissue ensure European self-sufficiency and reduce patient waiting lists.
Start date: 01/05/2016 - End date: 31/10/2019

Call: Call for Proposals for Projects 2015
Topic: Safety