The ACF for decision-makers
The ACF is proud to work with key policymakers in the areas of cancer care, research and pharmaceuticals. We contribute to the development of policy frameworks and regulations that promote drug repurposing, improve public health, facilitate access to treatments and increase benefits to patients and society as a whole.
European Commission: Directorate-General for Health & Food Safety
A key advisory group to the EC’s Directorate-General for Health & Food Safety is the Expert Group on Safe and Timely Access to Medicines for Patients (STAMP). The group provides advice and expertise to the Commission in relation to the implementation of EU pharmaceutical legislation, as well as on EU programmes and policies in this field. The ACF has the privilege to participate in STAMP meetings as an expert cancer treatment representative from a non-profit organisation. We see contribution to this group’s work as a major opportunity to provide expertise on drug repurposing and influence the direction of cancer treatment in the EU.
Bringing off-label on-label
In terms of regulatory pathways, there are still many hurdles to making repurposed drugs accessible to patients. Off-label use is not sustainable due to liability issues for prescribing physicians, reimbursement and supply chain guarantees. Transferring treatments from off- to on-label is prevented by the intellectual property rights of the producer and its lack of commercial incentive to do so.
Approval of new indications by the European Medicines Agency evaluation system could keep approval costs independent from the pharma industry, removing the financial obstacles to market production. But to do so, the regulatory framework must be adjusted.
European Commission: Directorate General for Research and Innovation
The EC’s Directorate-General for Research and Innovation defines and implements European Research and Innovation (R&I) policy with a view to the Europe 2020 strategy to boost jobs and growth, and to tackle the main current and future societal challenges – of which cancer ranks in the top. DG RESEARCH launches calls for project proposals for EU grant support on the basis of multi-annual work programmes, the current one being Horizon 2020, running from 2014-2020.
Today, EU research money is mainly oriented towards economic value and driven by the goal of bolstering European economies. According to our mission and vision, the ACF advocates for the enforcement of public health improvement, focus on patient needs and other non-commercial objectives to the selection criteria of EU research funding.
Beyond Horizon 2020, preparations are already underway for its successor, Framework Programme 9 (FP9), due to kick off in 2021. The ACF will continue to call for a strong focus on innovation towards patient-centric, needs-driven and sustainable cancer treatment in the next research framework programme.
Adoption and implementation of EU policy, particularly in the field of health, is considered a national competence, meaning that member states’ relevant authorities are responsible for putting a policy into practice at the national level. We keep an eye on all activities at the member state level and aim to inform partner organisations where needed.
Brussels-based, the ACF is EU-oriented
The ACF’s advocacy contacts are mainly focussed on Europe. Being confronted by common challenges, we closely follow regulatory developments in other regions, particularly the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK and the Food and Drug Administration (FDA) of the USA, as doing so presents interesting options and inspiration for Europe.
The European Parliament is directly elected by citizens of all EU member states. Members of the European Parliament (MEPs) have the power to draft European policy in nearly all areas of EU activity, together with the Council of the EU, including medicines regulation. In the coming years, the ACF will interact with the European Parliament through roundtables, open meetings and more. Our goal is to generate awareness of the potential of repurposed medicines in improving health systems, and of how regulatory authorities can stimulate progress in cancer research and treatment. The ACF maintains its political independence throughout its engagement.