Clinical trials are at the core of the pharmaceutical research and development (R&D) process. The results of these studies inform decision-making on market approval, medicines pricing and reimbursement, and clinical practice. Clinical trial transparency is therefore extremely important for a wide range of stakeholders, including policymakers, public health bodies, the research community, healthcare professionals and patients. Since 2013, the European Parliament and other European Union (EU) institutions have endorsed reforms of clinical trial regulations that would ensure greater transparency and accountability. However, implementation of these essential amendments is being hindered due to a lack of commitment from a number of key actors. A public discussion around the EU Clinical trials regulation (including the EU clinical trials portal) and how it contributes (or not) to greater transparency. This includes implementation challenges and opportunities for coordination with other national and supranational databases. • Clinical trials and transparency in R&D: what role for the European Parliament? • Cooperation between EU institutions and national authorities: which way forward? • EU Member States and transparency resolution. Till Bruckner #transparency
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Glad to have contributed, together with my colleague Alice Beck, with this guest essay in Geneva Health Files on the discussions around European Commission proposal of a EU-wide compulsory license, with special attention to deliberations in the European Parliament. With the file now in the hands of the Council of the European Union the debate is far from over and it may overlap with the ongoing negotiations at World Health Organization (INB 10 Scheduled for late April) on a pandemic treaty or other international instrument, with the European Commission purportedly refusing to explicitly acknowledge or endorse the role of TRIPS flexibilities (like Compulsory licenses) in achieving an equitable response to pandemics and other health emergencies. https://lnkd.in/dmv6HtUb
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An opinion piece we published at Nonprofit.xarxanet.org on the role of civil society in Global Health Civil society and Global Health after the storm Since Health Action International (HAI) was founded over 40 years ago, the role of civil society in Global Health has dramatically evolved. From ad-hoc interventions mostly linked to charity and goodwill, non-governmental organisations have become singular actors with specific goals and the ability to mobilise resources, and exert influence to bring about change. HAI is a good example of this transformation. Despite necessary changes it remains a research-based organisation that engages in outreach, advocacy and lobby through high-quality evidence-based materials and resources. Covid-19 pushed the work of organisations like HAI to the forefront of public health policy as never before, yet the results were not reassuring. Campaigns around topics such as a waiver on the Trade Related Aspects of Intellectual Property (TRIPS) for Covid-19 related health goods or the need for greater transparency on vaccine procurement contracts were not successful in substantially changing the stance of governments or international organisations. At the same time, public interest civil society was not meaningfully involved in the inception of a number of international ventures created to harness the global response to the pandemic. A handful of Global North-based organisations and individuals were nominally consulted, falling short of comprehensive public discussions and exchanges. Read in full https://lnkd.in/etzRCJGU
Civil society and Global Health after the storm
nonprofit.xarxanet.org
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Health Action International statement at the at the 8th session of the Intergovernmental Negotiating Body (INB) https://inb.who.int/ "Health Action International (HAI) is pleased to be able to share our reaction to the texts relating to pandemic agreement having been made available just recently. We commend the efforts of the INB Bureau as well as the co-facilitators of the different drafting sub-groups. We will focus our comments on Article 9 and 10. Affordable and sustainable R&D is critical for an effective and equitable response to the next pandemic. We welcome the acknowledgement of the need for enhancing access to innovative health technologies and ensuring that data from clinical trials is properly reported and compiled. We believe however that stronger, meaningful wording is still missing regarding the management of intellectual property rights in times of pandemic and health emergencies: patents cannot and should not be absolute nor limit the ability of governments to protect and promote public health. Reaching a consensus on a number of issues that have proven to be contentious in the past was always going to be challenge and the efforts made to date by most parties to reach workable document are laudable. However, we feel obliged to express our concern that we are heading towards an outcome that would not meet the expectations, needs and hopes entrusted in this process. Finally, we must insist once again on the need for greater transparency and accountability of this negotiating process, particularly regarding undue influence of private actors." Web https://lnkd.in/d8id9BX5 Pdf https://lnkd.in/dGRmssWZ Social https://lnkd.in/dNFjYunf om/HAImedicines/status/1759540413226971545 #pandemicpreparedness #Accesstomedicines #Transparency
INB 8 - HAI Statement - Health Action International
https://haiweb.org
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A timely event and good opportunity to address and discuss some of the most salient topics in Global Health and EU policy discussions (FP10, EU pharma legislation, fate of HERA...) : public production of medicines, technology transfer and the need for an access-based industrial policy among others. Make sure you register before March 1st!
I am honored to be a part of the organizing committee for the conference "Public Pharma for Europe: Strengthening Public Health and Advancing Equity," a collaborative effort led by a diverse group of European civil society organizations, networks, activists, and experts. 📅 Dates: Friday, March 15th - Saturday, March 16th, 2024 📍 Location: Mundo Madou, Brussels 🌐 Format: Hybrid (online and in-person) 🎉 How to Get Involved: 📝 Register to attend: https://lnkd.in/e-mM_QXT 🌐 Learn more on the website: https://lnkd.in/e5SywjiR Let's make this event a resounding success together! I encourage you to register and spread the word. The more diverse voices we have, the richer the conversation will be.
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Statements by Health Action International at the World Health Organization 154 Executive Board (22-27.1). https://lnkd.in/drE7W_3N Agenda Item 6 Universal Health Coveragehttps://lnkd.in/dsPfEZJN Agenda Item 13 Antimicrobial resistance: accelerating national and global responses https://lnkd.in/dRTmPcga Agenda Item 23 Economics and Health for All https://lnkd.in/dDJk-Vud All statements delivered by Public Eye's Patrick Durisch
Statement to EB154 - Universal Health Coverage - Health Action International
https://haiweb.org
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Round table: Licensing and access to public-funded/developed medicines and vaccines .Wednesday 22 November 15 -16 CET Public support, through funding and other form of assistance, is critical for biomedical research & development (R&D) and instrumental in allowing innovative health technologies to reach markets and patients. On many occasions such support, economic or in-kind, is decisive in the early stages of R&D which are then marketed by companies for extortionate prices, generating huge profits. However, it is difficult to ensure a minimum of public return on that investment. Non-exclusive licensing of publicly generated knowledge is not the prime option favoured by technology transfer officials at universities and research institutions. Extensive research has established that patenting or setting up an independent entity are more appealing choices to develop, upscale or explore further promising results. Health Action International and Salud por Derecho - Right to Health Foundation invite you to round-table titled “Licensing and access to publicly-funded medicines and vaccines: obstacles and proposals for improving access” discussion to address: - Ongoing discussions at EU (pharma strategy) and Global (INB) levels regarding access to results from publicly supported R&D - Trends in dissemination of publicly generated knowledge: licensing strategies, access clauses and societal impact. Identify opportunities and obstacles for effective tech transfer from public research institutions Gather the inputs of advocates, practitioners and experts on technology transfer, public return and benefit sharing. Moderator Elena Villanueva Public Health Consultant Speakers: Jaume Vidal Health Action International (HAI) Irene Bernal Salud x Derecho Rachel Cohen Drugs for Neglected Diseases initiative - DNDi Gaspar Morgado University of Chile Registration https://lnkd.in/euyAZM_M Habrá traducción al español disponible
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A good opportunity to join again Health Action International friends at Transparimed and Consilium Scientific discuss what is working (and what is not) in achieving greater availability of clinical trials results in Nordic countries. What could be done? and by whom?. With the backdrop of discussions at EU level on pharma legislation (and European Medicines Agency extended mandate) and global negotiations at Pandemic Prevention Preparedness and Response (INB and revision of IHR at World Health Organization ) these are interesting times for transparency, accountability and full-disclosure of CT results, protocols and costs.
On November 30th! The results of hundreds of clinical trials involving patients in Denmark, Sweden, Norway, Finland and Iceland have not been made public. Gustav Nilsonne will present his research into the problem, followed by a discussion with experienced transparency advocates on how to use these data to campaign for positive change. ❓Reporting of Nordic registered clinical trials 📅November 30th, 5pm GMT 🎟️Signup: https://lnkd.in/euiEzTET Results from clinical trials are an important basis for decision making in clinical medicine. However, trials may be reported late or not at all, which may lead to ineffective or harmful clinical decisions. In this talk, I will present results from a follow-up of clinical trials reporting in the Nordic countries. We included 2113 registered trials completed 2016-2019. Overall, about one quarter were reported within a year, half by two years, and just over three quarters were reported at end of follow-up. This project will enable further meta-research on characteristics, quality, and usefulness of Nordic clinical trials. We are seeking to collaborate with stakeholders to improve the reporting of clinical trials in the Nordic countries. Discussants: Gustav Nilsonne Sarai Keestra Bettina Ryll Jaume Vidal #cancer #cancerprevention #cancerpolicy #healthpolicy #cancerdiscussion John Hickman, Francois MAIGNEN, Till Bruckner, Sarai Keestra, Bettina Ryll, Jaume Vidal, Eric Low
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