Health Action International (HAI) Europe is a non-profit, independent, European network of consumer groups, public interest NGOs, healthcare providers, academics and individuals. HAI`s mission and goals follow an overarching global work programme set every five years. HAI Europe devises plans and strategies to inform medicines` policy in Europe and acts as a regional coordinating centre.

HAI`s mission is:

- To increase access to essential medicines: Ensuring that medicines meeting priority healthcare needs are available, accessible and affordable to all;

- To improve the rational use of medicines: Ensuring that all licensed medicines meet real medical needs, have therapeutic advantages, are acceptably safe, offer value for money and are appropriately prescribed, in tailored doses, for an adequate time at the lowest cost to citizens and their community;

- To promote the participation of citizens in medicines policy: Encouraging and supporting the participation of patients and consumers in decisions that will affect their health and well-being, whilst advocating for the highest levels of transparency, independence and accountability in all aspects of medicines policy.

HAI Europe monitors and encourages EU policy-making around these three thematic priorities. HAI Europe works by implementing innovative methodologies that generate key data, develop and publish key publications and commentary as well as promote knowledge exchange on the impact of medicines policy on public health. The paucity of coherent medicines policies in Europe has driven HAI`s unique focus over the last 30 years and continues to be at the centre of HAI`s research, advocacy, capacity building and expertise, and as a result, has established HAI`s reputation as an authority on pharmaceutical policy issues.

HAI`s vision is:

Poverty and social injustice represent the greatest barriers to sustainable health and development and HAI works for a just and equitable society where people can participate in decisions affecting their health and well being, including the allocation of resources.

HAI`s goal is to increase access to essential medicines and improve their rational use through research excellence and evidence-based advocacy.

To promote essential innovation, research and development (R&D) and access to medicines, HAI contributes to the advancement of innovation models that dissociate the cost of R&D from medicines prices. Specifically, by:
- Following up on EU commitments to explore these alternative models through pilots or feasibility studies;
- Seeking partnerships with other health stakeholders to promote equitable licensing principles in publicly funded R&D to ensure that public funds derive a public good.
In order to encourage equitable access to medicines in Europe, HAI advocates for changes to the EU internal market laws that diminish accessibility and affordability of medicines to citizens, by:
- Monitoring and commenting on developments in anti-competitive practice in the pharmaceutical sector;
- Presenting the citizens` perspective to the policy process, policy makers and other relevant stakeholders;
- Formulating evidence-based policy materials to inform policy on EU`s IP enforcement laws; and
- Sharing expertise to build the capacity of civil society organizations on IP and access to medicines issues.

To encourage the rational use of medicines, HAI promotes the use of medicines that have tangible and proven therapeutic advantage, are acceptably safe and cost-effective. HAI seeks to increase health security by:
- Educating civil society about the link between promotional messages, over consumption of medicines and medicine induced harm;
- Advocating for treatment decisions based on objective information;
- Encouragement of health literacy through access to independent medicines information;
- Increasing awareness about appropriate prescribing and rational antibiotic use by future healthcare professionals (students).

HAI upholds consumer rights and improves European patient safety by:
- Supporting effective and robust medicines regulation; and
- Fostering greater patient involvement in monitoring medicines safety to reduce threats to public health.
In order to advance accountability in medicines decision-making, HAI encourages and supports the participation of patients and consumers in decisions that affect their health and well-being.

HAI supports initiatives for greater public funding of independent health advocates by forging partnerships with health NGOs in European Member States to ensure that their voice is amplified at the EU level.

HAI promotes EU policy coherence with the EU`s commitments to health and development, by presenting key messages from the patient and consumer perspectives to policymakers in EU institutions.

HAI advocates for the highest levels of transparency and independence in the EU`s medicines policy process by:
- Promoting disclosure of information on which regulatory decisions are based, including data concerning medicines safety;
- Highlighting the link between conflicts of interest surrounding medicines and their impact on public health;
- Encouraging balanced stakeholder involvement and transparent in interest representation in EU policy making about medicines.

HAI Europe`s advantage and credibility stem from its widely recognised expertise, and its ability to draw on expertise from staff, members and partners throughout Europe and beyond.

HAI Europe performs an advocacy and monitoring role by actively promoting the involvement and inclusion of CSOs in EU policy analysis, implementation and evaluation.

HAI Europe`s role is to identify potentially problematic policy and initiate action. On one hand, HAI Europe serves as a multiplier and mobilises and coordinates initiatives, through research, policy analysis, and information sharing and capacity-building of civil society. On the other hand HAI Europe acts as a watchdog, monitoring governments, the European Commission, European agencies and intergovernmental organisations involved in medicines policy.

HAI`s work programme is drafted in consultation with the HAI network, advisory board and staff.

OBJECTIVES

1. To increase ACCESS TO ESSENTIAL MEDICINES (A2M)

1.1 Equitable access: Promote policies to support equitable A2M & sustainable health systems

Activities: Conduct a feasibility study on A2M in new MS; Monitor EU`s IP enforcement policies and other practices that can hamper medicines competition; Exchange expertise with policymakers on strategies to promote the sustainability of public finances, access and health equity in the EU.

Methods & means: Implement feasibility study; develop report on A2M context and policy options; host event; meet relevant stakeholders; generate media coverage.

1.2 Essential innovation & access: Advance EU actions to explore new models of medical innovation

Activities: Provide technical advice to EU stakeholders and policymakers to promote new innovation models that maximise the benefit from EU investments in health research; Capacity build patients/consumers to advocate for innovation models that meet the challenges of health and demographic changes; Monitor implementation of biomedical R&D in Horizon 2020.

Methods & means: Develop publication & outreach materials; Meet with policymakers and stakeholders; Generate media coverage to support public awareness.

2. To encourage RATIONAL USE OF MEDICINES

2.1 Reduce health threats: Promote health security by highlighting links between access to safety data, objective information & safe medicines use

Activities: Monitor EU policies on medicines information and safety; Advocate for public access to medicines safety data to reduce health threats, enhance the European competitiveness and the cost-effectiveness of MS investments in medicines; Promote the reporting and collection of safety issues suspected to relate to medicinal products(i.e. ADRs); Disseminate the HAI/WHO student guide to promotion.

Methods & means: Publish report on ethical, social and economic need for open access to data and related EU policy options; Liaise with members to promote and/or assess safety data collection tool; Generate media coverage; Appraise EMA documents.

3. To support the DEMOCRATISATION OF MEDICINES POLICY

3.1 Good governance for medicines: Ensure that EU policies are transparent, responsive & accountable to public health needs

Activities: Monitor the impact of HAI E campaigns for independence and transparency in EU medicines policy; Advise and contribute to EU dialogues on health & development.

Methods & means: Participate in health and transparency coalitions; Meet with relevant stakeholders; Generate media coverage; Participate in EU consultations.

3.2 Network building: Support the next generation of health advocates to align EU policies and decision-making with wider public health and societal interests

Activities: Encourage network outreach & increased member participation in HAI E activities; Host student workshops to transfer skills to future healthcare workers and promote professional development.

Methods & means: Publish workplan brochure & monthly newsletter; Update website, Facebook and Twitter; Organise meetings with HAI members; Host student workshops; Maintain Student Associates programme; Submit funding applications.

TARGET GROUPS: European public via media coverage; Consumers, patients, healthcare professionals, students, social partners, and transparency CSOs via HAI membership and outreach; national & local policy makers; EU institutions & agencies.

EXPECTED OUTCOMES: enhanced health outcomes through improved treatment outcomes, reduced morbidity and mortality, and (cost-)effective health services through CS engagement in medicines policy and the re-alignment of public resources to achieve citizen-centred health policies.

ETHICAL ASPECTS: HAI applies and promotes ethical principles, human rights, dignity and fundamental rights. HAI sources data from the public domain and seeks informed consent from potential study participants.

See HAI WP2013 sections 3, 4 & 5.