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.
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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.

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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.
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