HAI Europe contributes to European Union (EU) policy that promotes universal and equitable access to affordable needed medicines of assured quality and policy and practice that ensures those medicines are used rationally. HAI Europe’s work plan 2015-2017 is dedicated to identify, monitor and support EU policies that provide a response to persistent shortfalls in access to medicines and that are aligned with HAI’s overarching goals on Access to Needed Medicines, Rational Use of Medicines and Democratisation of Medicines Policy in Europe. HAI will work towards these goals through research, evidence-based policy analysis and intervention, training and information sharing. As a result, HAI will advocate for citizen-centred public health policies that address health challenges in the EU and health inequity both within and between EU member states. HAI Europe’s multi-annual programme addresses the objectives of the Third Health Programme and contributes to EU added-value by supporting medicines policies that have the potential to maximise the impact of policy intervention at a regional level, and thereby contributes to better and safer healthcare for EU citizens. HAI Europe is a non-profit, independent NGO and maintains a membership network of consumers, healthcare providers, academics and public interest groups working on pharmaceutical policy issues in Europe. The growing European regional network is represented in over half of EU Member States. The HAI Europe office coordinates actions with the HAI Europe Members Association, and integrates its work in collaboration with other European civil society organisations.

Health Action International (HAI) is a non-profit, independent, global network with the over-arching aim to achieve equitable health for all. In Europe, HAI has grown to become a pre-eminent voice in medicines policy intervention, driven by a strong regional network comprising of consumers, healthcare professionals, academia and other public health groups.

HAI’s work in Europe focuses on the achievement of three overarching goals: 1) Increased Access to Needed Medicines; 2) Rational Use of Medicines and 3) Democratisation of EU Medicines policy. HAI’s 2015-2017 workplan is dedicated to identify, monitor and support EU policies that provide a response to persistent shortfalls in access to medicines and that are aligned with HAI’s overarching goals. HAI works towards these goals through research, evidence-based policy analysis and intervention, training and information sharing.

Throughout 2015, HAI contributed in particular to improve access to essential medicines, their rational use and good governance by 1) supporting EU policies that contribute to affordable access to medicines through evidence-based advocacy; 2) exploring and promoting innovative models of biomedical research and development (R&D) that meet real health needs; 3) promoting the rational use of medicines by capacitating health professionals to better understand the consequences of pharmaceutical promotion; 4) supporting marketing authorisation procedures that result in the approval of safe and effective medicines; 5) contributing to informed decisions on treatment by supporting public access to medicines safety & efficacy data; 6) advocating for the independence and transparency of EU policy-making; 7) contributing to the sustainability of the HAI Europe Association and bringing independent civil society voice in EU medicines policy.

The 2015 Operating Grant from CHAFEA enabled HAI to develop and strengthen both the scope and the reach of its activities, which reflect the goals of the Third Health Programme. In particular, HAI contributed to the following objectives: 2) Protect Union citizens from serious cross-border health threats – for example by promoting EU policy frameworks that enable the exploration of alternative R&D models such as for a better response to antimicrobial resistance; 3) Contribute to innovative, efficient and sustainable health systems – for example, by encouraging the uptake of policy mechanisms that lead to greater affordability of medicines and sustainability of healthcare systems; 4) Facilitate access to better and safer healthcare for Union citizens – e.g. by supporting marketing authorisation procedures that uphold patient safety and therapeutic advance.

Research and policy papers; press releases and statements; public consultation responses; use of listserves; social media tools; internal newsletters to communicate with members; meetings with stakeholders (EU decision makers, civil society organisations); active participation at workshops and conferences; organisation of workshops and roundtables on HAI areas of work; active engagement in civil society coalitions and strategic partnerships.

The following main activities were implemented in the context of the 2015 workplan:

Activity 1: Strengthen the capacity of civil society groups in Central and Eastern Europe to better engage in EU medicines policy and equitable access to medicines.

Activity 2: Research the economic burden on public finances of highly priced on-patent medicines for chronic diseases.

Activity 3: Provide technical expertise on EU policies that support equitable access to medicines and sustainable health systems.

Activity 4: Contribute independent civil society voice to TTIP negotiations in the field of IP and pharmaceutical regulation for better access to medicines in EU.

Activity. 5: Publish policy paper to raise awareness on the extent to which H2020 funded biomedical R&D (e.g. Innovative Medicines Initiative) project(s) maximise societal value.

Activity 6: Provide technical expertise on the societal benefit of needs-driven and open models of biomedical innovation.

Activity 7: Organise trainings for (future) healthcare professionals on EU regulation of medicines information and how to respond to pharmaceutical promotion for appropriate prescribing.

Activity 8: Assess the impact of EMA’s conditional marketing authorisation processes on access to and safety of medicines.

Activity 9: Provide technical expertise on public disclosure of medicines safety & efficacy data.

Activity 10: Provide independent voice to advance EU policies that are responsive and accountable to public health needs.

Activity 11: Maintain and expand high networks engagement in medicines policy debates.

Activity 12: Develop further the profile of high as a recognized public health advocate.

Activity 13: Ensure the sustainability of HAI.

Main outputs achieved in 2015:

- In the context of an increasing unaffordability of medicines in Europe, HAI organised workshops to discuss policy solutions with civil society representatives in Latvia (July 2015) and Romania (September 2015). The workshop in Riga was co-organised with HAI’s member, Health Projects for Latvia (HP4L). Both workshops included also a session on civil society coalition building (act. 1).

- HAI contributed to share evidence-based information by publishing a research report on Access to High-priced Medicines in Hospital Settings in Europe. The study assessed the official published price of five high-priced, patented medicines in the hospital sector in four Member States (actv. 2).

- HAI participated from its beginning in the setup of the EU Alliance for Responsible R&D and Affordable Medicines. The Alliance constitutes a pan-European movement of NGOs and individuals compromised with public health rights, who have joined forces to lead the change in the medicines policy debate at national and EU level. (Act 3, 6).

- To prevent EU free trade agreements from damaging access to medicines, HAI provided input on the potential impacts of TTIP (Trans-Atlantic Trade and Investment Partnership) by issuing communication materials, meeting with decision-makers and contributing to build up an informal civil society coalition to work on the topic. (Act. 4)

- Together with several partner organisations (the so-called ‘EACH coalition’: Aeras, DNDi, DSW, Global Health Advocates France, Medicines for Malaria Venture, PATH, RESULTS UK and TB Alliance), HAI published a report entitled “Investing for Impact in R&D for Poverty-Related and Neglected Diseases: Assessing the European Union’s funding schemes”. (Act. 5).

- In view of the Dutch EU Presidency, HAI and its partners (MSF, DNDI, Aidsfonds, KNCV Tuberculosis Foundation and UAEM), organised a joint expert meeting with the Dutch Ministry of Health, Economics and Foreign Affairs in November 2015 in The Hague. This meeting was an opportunity to convey key concerns about the current innovation model and discuss solutions (Act 6).

- To capacitate medical students to better understand the implications of promotions to clinical practice and enable critical thinking, HAI organised two workshops in the Netherlands (17 November) and the UK (25 November). The workshops were organised in collaboration with the Universities Allied for Essential Medicines (UAEM). Each workshop consisted of a lecture based on HAI’s guide on pharmaceutical promotion and interactive work group sessions (Act. 7).

- HAI commented on the use of expedited approval schemes for marketing authorisations and issued policy recommendations. Together with partner organisations (MiEF and ISDB) HAI evaluated the safety implications of such procedures and their contribution to therapeutic innovation. The paper informed a public consultation by the European Medicines Agency (EMA) (Act. 8).

- In the context of the discussions on a Trade Secrets directive, HAI contributed to consolidate a civil society coalition that warned against the perils of trade secrets protection to public access to regulatory data and consumer protection (Act 9).

- HAI contributed to the EMA’s Patients and Consumers Working Party (PCWP) by attending its meetings and commenting on several EMA policy initiatives (Act. 10).

HAI’s evaluation shows that the expected outcomes for 2015 were successfully attained. CHAFEA’s Operating Grant enabled HAI to develop and strengthen both the scope and the reach of its actions, contributing to its long-term overarching goals of 1) Increased Access to Needed Medicines; 2) Rational Use of Medicines and 3) Democratisation of Medicines Policy.


Key achievements include:

-Strengthened the capacity of workshop participants to better engage in EU medicines policy and advocate for policy mechanisms that contribute to affordable access to medicines;

-Contributed relevant data on the economic burden of the cost to public finances of highly priced hospital medicines through a research paper;

-Contributed knowledge and raised awareness about the need to ensure a social return of investments of EU biomedical R&D funding streams through a joint research paper and an expert meeting with the upcoming Dutch EU Presidency.

-Capacitated medical students to better understand the implications of pharmaceutical promotion to clinical practice and enabled critical thinking through the organisation of workshop sessions and distribution of an educational guide;

-HAI’s policy papers and communication materials were utilised by partner organisations as tools for evidence-based information and helped to inform the EU policy debate.

Dissemination:
To ensure maximum impact and transparency, HAI has in place protocols to tailor its dissemination strategy to a given output. The interventions are targeted at European citizens, European and national patient and consumer organisations, healthcare professionals, EU institutions and national-decision making bodies. Distributed materials included research and policy papers, responses to public consultations, press releases and statements. Tailored materials were also distributed to workshop attendees (e.g. a guide on pharmaceutical promotion).

Communication materials were successfully distributed to the media and frequently reported by some of the most influential medicines policy outlets. HAI was quoted in more than 20 media outlets that publish on nationally and/or broader EU level. In addition to influencing policy, HAI’s communication materials helped to increase the visibility of the organization. The launch of a new, more dynamic website in July 2015 has contributed to strengthening HAI’s online presence, which is complemented by our social media presence, including Twitter and Facebook. Specific tools were used to inform members about HAI’s activities, for example bio-monthly newsletters and a listserve. The Annual General Meeting provided an additional opportunity to discuss European-based work with the members. It was also an opportunity for members to provide presentations about their work.

Evaluation:
HAI maintains a monitoring and evaluation plan which undergoes continuous improvement. Progress on campaigns and projects was reported quarterly by the staff to the Executive Director, presented to the HAI Europe Association Board and to the membership of the organisation at the Annual General Meeting organised in 18-19th September in Amsterdam. Based on our evaluation, the link between the tasks, outputs and outcomes related to an improved a) Access to Needed Medicines, 2) Rational Use of Medicines, 3) Democratisation of Medicines Policy is direct and reasonable.