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Stichting Health Action International

HAI

Health Action International is a non-profit, independent global network of consumer groups, public interest NGOs, healthcare professionals, academics, and individuals working and interested on pharmaceutical policy issues.

Lobbying Activity

Response to Digital package – digital omnibus

14 Oct 2025

Health Action International is concerned that the EUs simplification agenda will lead the potential loss of rights and protections, within a broader (and concerning) trend of deregulation. The present call for evidence appears to suggest cutting essential safeguards from a range of digital regulations. We are particularly concerned that the first part of the proposed Omnibus may undermine the GDPR. As to the AI Act, we ask that the agreed upon timelines be respected. The AI Act is still in its early phase of implementation and entry into force. The delays in Member States agreeing to harmonised standards should not be used to postpone the core obligations contained in the Act. Further, delaying or cutting the protections within the AI Act would create legal uncertainty and punish providers that want to protect fundamental rights. We ask that the European Commission does its upmost to protect and safeguard fundamental rights.
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Response to EU Civil Society Strategy

5 Sept 2025

Health Action International (HAI), as an independent, public interest non-governmental civil society organisation (CSO), with over 40 year experience in pharmaceutical and public health issues at national, EU and global levels, welcomes the opportunity to share our insights on the upcoming EU Civil Society Strategy. A timely initiative in the current economic and political climate, in which civil society organisation are struggling to operate under financial constraints and political pressures. Regarding the political context, we believe it is important to highlight the role of independent CSOs in providing expertise and raising awareness on matters of public policy and discussion. We agree that an active and vibrant civil society is critical for a fully functioning democracy, as they are instrumental in holding officials and institutions accountable for the actions and decisions they make. The promotion of EU values is the mission and mandate of EU institutions and Member States, while CSOs that support, embody and abide by such values, must remain independent and aligned only with the public interest. We note positively the multiple ways, including this call for evidence, in which EU institutions engage with civil society. We ask, however, that this engagement be meaningful and consequential, beyond a pro-forma exercise. As such, it is reassuring that this strategy aims to strengthen meaningful engagement and address barriers to CSO activity. Coordinated action between EU institutions and national governments seems the best approach to a multilayered matter with a diverse range of stakeholders and a plurality of agendas. Regarding barriers to continuing CSO activities, we would like to add growing partisan attacks to the legitimacy of CSOs as providers of technical assistance and expertise. are witnessing a sharp increase of public statements by elected officials and office holders casting doubt, often with no evidence, on CSO work on environment, health, migration and development. Such public campaigns have succeeded in changing policies and practices which are critical for CSO to fulfil their mission: from engaging in dialogue with members of the European Parliament to receive funds from European Union programs or participate in meetings with EC representatives. Like many other civic actors we applaud the decisive action taken against the practice of strategic lawsuits against public participation (SLAPPs) with the adoption of Directive 2024/1069; a clear example of the possibility of adopting legal and administrative measures that enhance, not harm, public debate and discussion. The issue of funding is particularly troublesome. At a time in which global and national funding opportunities for health, human rights and development are waning (as noted by the UN Special Rapporteur freedom of peaceful assembly and of association ), the European Commission Directorate for Health has taken the unilateral decision to withhold funds already granted to organisations that had successfully submitted proposals. There has been no plausible explanation for this decision and while it is the right of the EC to take such step, it does send an ominous message to affected CSOs and wider civil society about the value attached to our work. We strongly reject this unilateral decision and we hope for a reconsideration. We expect this Civil Society strategy to provide a clear framework for action and collaboration for all involved stakeholders, guided by transparency, accountability and public interest. On the creation of a Civil Society Platform, we advise to first consider the experience and practices of the Civil Society Facility (CSF) in relation to enlargement and the EU trade civil society dialogue regarding trade negotiations. Any platform or body should be guided by strict Conflict of Interest safeguards and ensure that only genuinely independent civil society organisations are considered for membership.
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Meeting with Tilly Metz (Member of the European Parliament, Shadow rapporteur) and Bureau Européen des Unions de Consommateurs and

13 Jun 2025 · Critical Medicines Act

Meeting with Tilly Metz (Member of the European Parliament) and European Patients' Forum (EPF) and

10 Oct 2023 · Pharma Package

Meeting with Helmut Scholz (Member of the European Parliament, Rapporteur) and Médecins Sans Frontières International

5 Oct 2023 · Compulsory licenses

Meeting with Helmut Scholz (Member of the European Parliament, Rapporteur) and Médecins Sans Frontières International and Drugs for Neglected Diseases initiative

4 Oct 2023 · Compulsory licenses

Response to Compulsory licensing of patents

29 Jul 2023

The European Commission proposal COM(2023)224 and accompanying documents is an overdue step forward towards a more nuanced balanced between innovation and access as it aims to streamline and facilitate the use of Compulsory Licenses. It has been a longstanding position of Health Action International (HAI) that Compulsory Licenses are not only a legitimate legal instrument to manage Intellectual Property (IP) rights but also a critical component of public interventions to achieve health policy objectives regarding access to health technologies and economic sustainability of public health systems. The covid-19 pandemic and the difficulties associated with access to health goods have highlighted the trouble faced by EU governments to expedite access to life-saving health technologies. At the same time, we welcome that the new regulation will address some of the obstacles and hurdles currently hindering the use of Compulsory Licenses such as national disparities and the lack of an effective Single Market for licensed products. We must voice our concern that the measure would only be invokable as a last resource in an emergency context. As we have repeatedly stated we believe the reasons to make use of a Compulsory Licence are to be determined by national authorities and can include excessive high pricing, anti-competitive practice, or failure to exploit a patent among other instances. Such an approach has been endorsed by the Doha Declaration (2001) and has not been challenged at the World Trade Organisation dispute settlement mechanisms. This proposal, framed within an IP package that also addresses essential patents and Supplementary Protection Certificates (SPC) is being considered at the same time as other initiatives like the update of the European Pharmaceutical Strategy or interventions by The European Health Emergency Preparedness and Response Authority (HERA). It is critical that the legislative coherence is upheld and that the removal of obstacles for CL (like Data Exclusivity) is not impeded by new incentives for specific products such as antibiotics or drugs for rare diseases. Beyond the scope of this proposal, but of interest for EU lawmakers, is whether products manufactured under an EU-wide CL could be exported to fulfil eventual demand in Low and Middle-Income Countries (LMIC) with no or insufficient pharmaceutical manufacturing capabilities as stated in Regulation (EC) No. 816/2016; currently this would not be possible as Article 11 prohibits exports of licensed products, we ask the European Commission and EU lawmakers to reconsider. Dissemination and knowledge transfer of good practices and uses are critical for mainstreaming the use of CLs. To this end HAI created the TRIPS Flexibilities Navigator a tool , to provide policymakers, academics, advocates, and other relevant stakeholders with the necessary legal and administrative information in each EU jurisdiction to make use of CLs for medicines. This mechanism is going to be scaled up to widen its scope to cater to the needs of generic medicines manufacturers and include other official EU languages, the community being built by access and use of the platform will be guiding the next steps. We remain at the disposal of EU institutions and concerned parties to engage in this and other important discussions regarding equitable and fair access to innovation and a balanced and sustainable approach to IP and health.
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Meeting with Tilly Metz (Member of the European Parliament)

29 Nov 2022 · Health

Meeting with Rob Rooken (Member of the European Parliament, Shadow rapporteur)

27 Sept 2022 · Health oriented AI

Meeting with Marc Botenga (Member of the European Parliament)

20 Jul 2022 · Access to Health Technologies

Response to Compulsory licensing of patents

29 Apr 2022

Health Action International (HAI) welcomes the step taken by the European Commission towards an enhanced use of Compulsory Licenses (CL) in EU territory; such measure will have a positive impact on access to medicines and health technologies, strengthening the ability of governments to fulfill the human right to health beyond crisis or exceptional circumstances. The policy objectives seem to be well identified even though they may have been too narrowly framed. Regarding Art. 31 bis of the Trade Related Aspects of Intellectual Property (TRIPS) agreement, the discussions around a proposal for a waiver for Covid-19 related health technologies have shown the dissatisfaction of a number of parties to the World Trade Organisation (WTO) with the current legal framework and how countries with no pharmaceutical manufacturing capabilities may make use of TRIPS flexibilities. During deliberations, the EU expressed repeatedly that enhanced CL was the answer to limited production capabilities. It would be important to see, as part of this consultation, some sort of proposal of reform or amendment of the TRIPS agreement is considered. National disparities on regulation of CLs pose a challenge to any EU-wide policy, hence we would support a combination of legislative and non-legislative changes aimed at achieving a greater legal and administrative coherence among member-States. Any kind of proposed “EU-level compulsory license” should not negatively affect the possibility by a Member State of enacting more health-oriented measures stating for instance more legal grounds to issue a CL. Such harmonization should be extended to EU regulation on data and market exclusivity which go beyond what the TRIPS agreement warrants, and seriously hinder the exercise of flexibilities like CLs. In this sense, we call on the European Commission to ensure that there is no contradiction between several discussions currently under way, notably the revision of the pharmaceutical legislation within the European Pharmaceutical Strategy and some components of the Intellectual Property Action Plan as well as the EU Covid-19 vaccine strategy. CLs should not be perceived nor labelled as last-resort measures but as part of a wider frame public interventions. Mainstreaming the use of CLs as part of the legitimate policy options the disposal of governments facing excessively high prices of medicines or/and other anti-competitive practices can contribute to fairer, more efficient markets and ensure the economic sustainability of public health systems. Clarification and consolidation of CL as a public policy instrument should also be brought into negotiations with EU trade partners, to avoid previously reported cases TRIPS+ clauses being inserted international agreements with Low- and Middle-Income Countries (LMIC). At the WTO, the EU should resist efforts by other parties to weaken TRIPS flexibilities and cast doubt about the relevance of the Doha Declaration by publicly stressing the legitimacy of CL as policy instrument. As part of the consultation to carry out the impact assessment of this measure, the European Commission should support initiatives from civil society and academia aiming at a wider dissemination and knowledge of TRIPS flexibilities among EU stakeholders including lawmakers, academics, advocates, policy makers and researcher.
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Meeting with Kim Van Sparrentak (Member of the European Parliament)

9 Mar 2022 · AI Act health sector

Meeting with Caroline Boeshertz (Cabinet of Executive Vice-President Valdis Dombrovskis) and Human Rights Watch and Médecins Sans Frontières International

7 Oct 2021 · COVID Vaccines

Meeting with Caroline Boeshertz (Cabinet of Executive Vice-President Valdis Dombrovskis), Cristina Rueda Catry (Cabinet of Executive Vice-President Valdis Dombrovskis) and

3 Jun 2021 · Trade in relation to COVID-related technologies

Response to Evaluation and revision of the general pharmaceutical legislation

26 Apr 2021

HAI welcomes the opportunity to provide feedback to the evaluation and revision of the general pharmaceutical legislation and appreciates the importance of the initiative taken by the European commission to update and adapt a keystone of the European Health Union. While the European Pharmaceutical strategy is of substantive significance, other initiatives are also valuable for comprehending and responding to ongoing and upcoming health problems such as Anti-microbial Resistance, medicine shortages or lack of accountability in public funding of Research and Development. While we commend the efforts in place to ensure policy coherence, we encourage decision makers to clearly distinguish pharmaceutical policy goals from industrial policy objectives. Boosting private for-profit pharmaceutical manufacturing must not be a priority for health authorities. It is our understanding that listing topics of a very different nature together - such as unmet medical needs or unequal access to affordable medicines alongside legislative and regulatory reforms in fields like artificial intelligence and market authorisations - may be misleading. HAI believes that guaranteeing equitable access to health technologies in a sustainable way should be an overarching priority. We positively note connection to the European Green deal and the pledge to reduce the environmental footprint already part of the Strategic Approach to Pharmaceuticals in the Environment (PiE). We differ on the diagnosis regarding the best response for unmet medical needs: as a public interest civil society organizations with more than 4 decades of evidence-based advocacy and expertise on access to medicines, we believe that actionable innovation to meet health needs shall not be harnessed only by legal reforms or regulatory amendments, but that it is necessary to address the core issue at the heart of the current Research and Development model (R&D) and the incentives system upon which it is built. IP-based monopolies and other forms of market exclusivity have shown their limited capacity to reward true innovation with no apparent commercial return, and their potential for abuse and market tampering. We seek a thorough revision of all pharmaceutical incentives, including orphan designation, pediatric formulations and supplementary protection certificates. It is not acceptable that some of these mechanisms are, by instilling data exclusivity notions, de facto nullifying EU Member States’ ability to make use of such TRIPS flexibilities like compulsory licenses in a moment when these mechanisms are needed the most. Finally, we are heartened to read for the first time European Health authorities acknowledge that affordability of medicines is an obstacle that must be overcome to guarantee access and fulfill the right to health of all citizens. We also note positively that transparency safeguards, march-in rights and pooling of IP rights will be part of the new Health Emergency Preparedness and Response Authority. As we have shown in the past, we remain willing to collaborate with the European Commission and engage will all stakeholders to implement a public health agenda guided by general interest and common good.
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Response to European Health Emergency Response Authority

24 Feb 2021

Health Action International (HAI) appreciates the opportunity to offer our reaction to the proposed European Health Emergency Preparedness and Response Authority. We welcome the political support for public-funded R&D and we fundamentally we agree there is a need to move away from overuse of emergency instruments. The ad hoc actions the EU institutions have had to take to respond COVID-19 pandemic thus far have undermined transparency and shaken the balance of competencies between within the EU institutions and Member States, so it is evident that an alternative route needs to be sought. However, we have concerns about whether developing a so called European BARDA is the best way to achieve these aims. We query whether the creation of a new body is required when the European Centre for Disease Control and European Medicines Agency have clear, and in the case of EMA recently extended, mandates. A new body with such an ambitious mission risks hindering the development of previous, similar initiatives like Horizon Europe. We note positively mention of anti-microbial resistance (AMR) and supply chain disruptions as cross-border health threats and we expect decisive action on both counts. Regarding the proposed horizon scanning activities we would like to see coordination with horizon scanning and mapping processes already in existence, be that via the EMA or through existing voluntary inter-country cooperation schemes. The whole edifice seems to be based on public-private partnerships. It is concerning that there are no explicit safeguards for public interest nor mechanisms to ensure public return on public investments via accessibility clauses of end products. Of particular concern is the discussion regarding incentives for private industry to invest in unmet public health needs without the necessary transparency and accountability mechanisms. Finally, we are surprised about the fact that key preliminary components of HERA seem to be already designed as part of the HERA Incubator without consultation nor involvement of civil society. While it is encouraging to see the European Commission supporting intellectual property pooling mechanisms, we must caution about the wisdom of suggesting a geographically limited version of an initiative that is already being tried at the global level with the WHO’s Covid 19 Technologies Access Pool (C-TAP) , in lieu of the Commission throwing its support behind the C-TAP. In connection with the announced Clinical Trials network, we will seek more information on the kind of cooperation there might be with the soon-operational Eudamed and CTIS databases. We remain open and willing to collaborate with HERA and other EU institutions to protect and promote public health and improve access to medicines and vaccines for all European citizens.
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Response to Revision of the EU legislation on medicines for children and rare diseases

21 Dec 2020

Health Action International (HAI) welcomes the opportunity to contribute to the ‘Revision of the EU legislation on medicines for children and rare diseases’ and commends the European Commission for the thorough and comprehensive consultation process that is shaping the reform of legislation on this topic. The inception impact assessment acknowledges the 2016 Council conclusions and the European Parliament resolution on pediatric medicines. However, it fails to mention the 2017 resolution on EU options for improving access to medicines which explicitly calls for the European Commission to, among other tasks, revise the concept of unmet medical need and “to evaluate existing incentive schemes to facilitate the development of effective, safe and affordable medicines for rare diseases compared to the best available alternative”. While we remain convinced of the role to be played by the European Pharmaceutical Strategy, we understand there will not be an operational version of the document until Parliament examines and amends it.The globalised nature of medicine development calls for an harmonisation in the spirit of certain norms and regulations, however, we would discourage embracing regulatory without thorough analysis and assessment. Finally, we are concerned about the choice of Supplementary Protection Certificate (SPC) as a possible incentive to counter market failure when the instrument is under evaluation precisely because its misuse and abuse is hindering affordable and sustainable access to medicines. Unmet medical needs constitute a challenge for medicine and society. It is an indictment of the shortcomings of our current research and development (R&D) model, for which the size of the market constitutes the litmus test for what disease to tackle or which ailment to forget. Pharmaceutical companies deserve to be rewarded for their contributions to society, but they should also be held accountable when the failure to deliver cannot be justified on scientific grounds.This regulation must go beyond improving the competitiveness of EU industry and address (even within the current institutional imitations) the imperative of affordable and sustainable access to medicines for all EU inhabitants,particularly children. Regarding the various options presented for medicines for children, we support Option 4, which offers the best combination of novel incentives, limited number of possible beneficiary medicines and enhancements to earlier generic medicines entry into the market. In relation to medicines for rare diseases common elements, we believe that the EU Court’s jurisprudence regarding designation criteria for orphan medicinal products should be taken into account, but with some nuance for the case-by-case, and welcome acknowledgement of the need for faster generic/biosimilar competition; we believe that an incentive other than market exclusivity could be a possible way forward, as embodied by Option 4. Regarding the economic impacts we note positively that funding will be made available to academia for research on medicines for rare diseases and children; we expect that public return will be guaranteed and access to the results of such research will be made widely available following the recommendations of the Manifesto for EU COVID-19 Research, put forward by the European Commission. Finally, there are two issues which we believe are of special importance on this topic and where this document should be more forceful. Firstly, the fight against the misuse and abuse of incentives which is allowing some pharmaceutical companies exact exorbitant prices while benefitting from the market and other exclusivities. Secondly, the availability of all EMA-authorized medicines, including for rare disease, in all EU Member States, with no exceptions. While there is an overlap in competencies in both counts, it is important that the European Commission shows the political will to counter excesses and ensure responsible market behavior.
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Response to Intellectual Property Action Plan

31 Jul 2020

Health Action International and Wemos welcome the opportunity to contribute to the Intellectual Property (IP) action plan put forward by the European Commission through DG Grow. This consultation should not be considered in isolation from other ongoing important initiatives, such as the EU Pharmaceutical Strategy Review and the Pharmaceutical Incentives Review. We consider it important to pay attention to how these ongoing initiatives influence each other and that policy coherence between them is assured. In relation to the document under examination, we do not share the assumptions concerning the overall importance given to IP rights. Moreover, we consider that the full extent of its impact on society in general, and access to medicines in particular, should have been mentioned and suggest that novel IP management initiatives, in response to COVID-19, should be stressed. Regarding the use of Supplementary Protection Certificates (SPC) on pharmaceuticals, we recall the intense discussions held on the manufacturing waiver clause, which involved a wide range of stakeholders, including the European Parliament. The finally approved text called on the Commission to undertake an impact evaluation of SPC on access and innovation of medicines. The possibility of granting an SPC should be contingent on a number of factors. Namely, the ability of the requesting party to demonstrate, not only prejudices due to administrative or bureaucratic delays in the approval of the original patent, but evidence that costs of R&D incurred are higher than the profit during the regular patent protection period. Critically, instruments such as SPCs and Data Exclusivity (DE) provisions, can dissuade EU Member States from using TRIPS flexibilities, including compulsory licenses or the Bolar exemption, and thereby hinders access to medicines. This negative impact must be addressed in an eventual adjustment process, including the possibility of setting up a system of waivers and exceptions for Member States. We agree that tools to share out IP are insufficiently explored by governments and EU institutions. We also believe that any successful response to COVID-19 must be collaborative and global; the EC should endorse and proactively support the World Health Organization (WHO) COVID-19 Technology Access Pool (C-TAP), a mechanism that will hasten the development and improve universal access to an effective vaccine as, well as other elements of a therapeutic response such as diagnostics. The EU invests a substantial amount of public funding into development COVID-19 health technologies. As such, conditions must be attached to that funding, by among other things, sharing of knowledge, data and IP with C-TAP. We concur with the commission on the need to improve the quality and consistency of the IP protection framework, and believe that a stringent innovation threshold and examination guidelines, that acknowledge genuine innovation, are critical steps in such a direction. Exploring IP protection and innovation stimulus beyond patents should be a priority of this strategy; particularly in relation to the results of public-funded research and in exceptional circumstances, such as pandemics, medicines shortages or other emergencies. Patents and other IP protection arrangements on innovations that have resulted from public investments made by the EC should be made conditional, to safeguard public interests and ensure a return on investment. Trade conditionality and IP rules in particular can have an enormous impact on access to medicines. It is therefore encouraging that the EC is seeking to promote global fair play regarding IP observance. However, we do not believe that unilaterally pressing trade partners to prevent the use of IP management tools, specifically the use of TRIPS flexibilities, is the best strategy to achieve this goal. We would also encourage further clarification of the EC position regarding Art. 31 bis of the TRIPS agreement.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

7 Jul 2020

We welcome the European Commission (EC)’s initiative in launching a new Pharmaceutical Strategy that puts the need for equal access to safe, effective and affordable medicines by all patients at the centre of the European Union (EU) actions on the matter, including the response to the COVID-19 pandemic. While we commend the identification of problems to be tackled—and the comprehensive enumeration of factors and circumstances leading to such problems—we believe that Section A fails to highlight the role of pharmaceutical companies in causing excessively high prices, a lack of transparency of research and development (R&D) costs and, on some occasions, shortages of medicines. Governments must do more to probe and eradicate anticompetitive practices in pharmaceutical markets that hinder access to medicines. We agree that there are challenges to the EU pharmaceuticals innovation ecosystem, but they go beyond the non-commercial exploitation of biomedical research and include the lack of public return on public investment—of public support, resources and other types of investment—in R&D. We believe there is a need to update the regulatory framework on medical technologies in a way that enhances access while guaranteeing safety and ensuring efficacy. This update should include a thorough and public assessment of the impact of measures, such as data exclusivity and instruments like Supplementary Protection Certificates (SPC), on access to and innovation of medicines. The COVID-19 pandemic has contributed to a reassessment of Intellectual Property protections afforded to the pharmaceuticals framework by several Member States; The Commission should acknowledge the shift in thinking of Member States in light of COVID-19 and work to complement this progress and other nationally based processes. We agree with the importance that the strategy grants to added therapeutic value, however the consideration of the pharmaceutical sector as a major contributor to the EU economy should be qualified. The sector must be valued based on the health outcomes of its products first, rather than benefits to the economy and shareholders. Innovation is meaningless unless it leads to improved therapeutic value and health outcomes for EU citizens – as the roadmap itself makes clear in reference to innovation and the paucity of research into areas of unmet need. Public health needs must be at the forefront of R&D planning decisions. We understand the EC is treaty-bound to seek the coherence of its different strategies and initiatives. However, we are concerned about the stated links between the Pharmaceutical Strategy and the steps taken as part of an industrial promotion scheme to boost the global competitiveness of EU-based pharmaceutical companies. These private, profit-seeking entities are often part of transnational holdings, which have been found on occasion to use financial mechanisms to avoid their fiscal responsibilities. We are encouraged to see the Commission prominently addressing cross-border health threats like anti-microbial resistance (AMR) and medicine shortages; both cases exemplify the need for governments and public authorities to step up to protect the wellbeing of citizens. We do not believe, however, that new incentives are the answer to the shortcomings of the current R&D model and disruptions in supply and stock, which we consider attributable to pharmaceutical companies. We support the goal of promoting public pharmaceutical manufacturing capabilities and improving supply chains within the EU, but demand that such plans be guided by a public health agenda, not eventual market returns. We acknowledge the need for health systems to be better equipped in order to efficiently deploy and absorb innovation, and for the European Medicines Agency (EMA) to play an effective role in these endeavours. To do this, a revision of marketing authorisations processes may be necessary.
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Response to Europe’s Beating Cancer Plan

2 Mar 2020

Health Action International (HAI) welcomes the attention brought by the European Commission to Cancer, a disease exacting a heavy burden on patients and heavy price on societies across Europe and beyond. We appreciate this initiative’s holistic approach that focuses on prevention and treatment, with patients and caregivers at its centre, while acknowledging the grave challenges in front of us that range from inequality to shortages, both of which have an impact on access to medicines for patients'. We note positively how this initiative will draw from previous efforts such as Europe Against Cancer and the European Guide on Comprehensive Cancer Control, while at the same time considering and benefitting from other EU endeavours like Horizon Europe’s Mission on Cancer. The quest for cancer treatment is a case study of the obstacles that hinder access to medicines. Most notably these include: the need to make innovation accessible to those in need, regardless of their income or residence; the imperative to ensure that only true, genuine and effective innovation is rewarded; and above all, that there must be a public return on public investment in biomedical research, especially when it results in medicines marketed at high prices. These are the core principles that should guide the development, implementation and evaluation of this plan. Special attention should be paid to clinical trials involving cancer drugs. HAI has supported extensive research on the risk of bias in clinical trials, be it in their design, conduct or analysis. Findings concluded that 50% of the cancer drugs (16 of 32) approved by the European Medicines Agency between 2014 and 2016 had clinical trials that were at risk of bias. EMA’s Committee for Medicinal Products for Human Use (CHMP) identified other concerns for seven of the 16 cancer drugs that had at least one Randomised Controlled Trials (RCT) at low risk of bias. As we have stated on many occasions, we believe that determining a medicines prices based on investments which cannot be independently verified is not the most efficient patient-centred care. Excessively high prices for oncological medicines provides an example of this pattern. Delinking the cost of production from final price is a strategy endorsed by a growing number of academics, advocates and patient representatives. A feasibility study of delinkage on the development and delivery of cancer medicines could be a major contribution to improving access. We are concerned about the ‘ad hoc’ nature of important components of this initiative, as well as the institutional contradictions that may arise in its implementation which would hinder accomplishing the stated goals. While many institutions, both at the EU and member-state level, have a responsibility to undertake the plan, we highly recommend that DG Health take an effective and decisive lead in this effort, with the relevant committees of the European Parliament following closely and the European Council being informed periodically. HAI would recommend that the plan incorporate findings and recommendations from additional sources such as technical documents issued by the World Health Organisation (WHO). For example, ‘Pricing of Cancer Medicines and its Impacts’ or the conclusions of the ‘Report of the United Nations Secretary General High Level Panel (HLP) on Access to Medicines’. These and other sources highlight the need for greater transparency in Research and Development (R&D) and the effectiveness of such measures such as more stringent patentability guidelines that reward true innovation or issuing compulsory licenses to spur competition and lower prices. We remain committed, as part of civil society, to continue to, and engage in fruitful conversations with other stakeholders in order to make sure that public interest and common good prevail as we work together against cancer.
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Meeting with Maria Asenius (Cabinet of Vice-President Cecilia Malmström), Pedro Velasco Martins (Cabinet of Vice-President Cecilia Malmström) and

15 May 2018 · Access to medicines in poor countries

Meeting with Vytenis Andriukaitis (Commissioner) and

15 May 2018 · HTA

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

18 Oct 2016 · Access to medicines