| Ahead of a high-level ministerial conference on organ donation in Budapest, the Hungarian presidency of the Council of the EU presents its view on the need for a new action plan on organ donation. “The 2009-2015 EU Action Plan on Organ Donation and Transplantation led to significant impacts, such as a 21% increase in the number of donations,” says Dr Péter Takás, Hungarian Minister for Health in the foreword to the presidency’s ‘concept paper‘. “After the expiry of the plan (in 2015), the imperative for a renewed and vigorous approach to organ donation and transplantation has never been clearer.” The concept paper outlines a comprehensive strategy that includes enhanced efficiency and accessibility of transplant systems and improving quality and safety standards. There is also a call to embrace innovative practices. Takás says, “The paper is not merely a policy document; it is a manifesto for hope, solidarity, and life.” There are twenty suggestions for what could be included in a future plan. In particular, the Hungarian presidency will look at how to support the sharing of expertise and financial support for national programmes to be strengthened. The paper suggests that the EU Structural Reform Support Service could provide expert advice on the reorganisation, and the correct form of investment. The European Semester, the InvestEU programme, and the European Structural Investment Funds (ESIF) could all be mobilised to support improving services. “Cross-border collaboration and EU guidance remain essential. Only prolonged and coordinated action will result in sustained efforts to improve conditions for patients and society.” The Hungarian Presidency of the EU says it stands ready to support the preparation and implementation of any future EU and national initiatives in the field of organ donation and transplantation. Other news Thirty-two organisations say Health Technology Assessment rules risk blocking access to new medicines Thirty-two not-for-profit organisations including the Alliance for Regenerative Medicine and Cancer Patients Europe have expressed concern that the new EU Joint Clinical Assessment (JCA), which will come into force in January 2025, will become a barrier to patient access to transformative advanced therapies. The Health Technology Assessment (HTA) Coordination Group’s guidelines developed for the JCA may pose a barrier to adoption of new medicines by insisting on randomised controlled trials (RCTs). The JCA has the objective of accelerating access to medicines, including access to Advanced Therapy Medicinal Products (ATMPs), which include cell and gene therapies. However, by excluding certain types of clinical evidence, including single-arm trials and real-world evidence, it might actually become a barrier to new treatments. Stefano Benvenuti of Fondazione Telethon (an Italian NGO) said: “The HTA Coordination Group has to appreciate the ethical dilemma associated with adopting a randomised controlled trial over a single-arm trial when developing an ATMP for ultra-rare diseases, when a patient with no therapeutic alternative could be given a placebo. If EMA can grant marketing authorisation for some ATMPs on the basis of clinical efficacy based on single-arm trials data, surely the JCA can accept single-arm trials with indirect comparisons, based on very robust observational studies or registries.” “Failing to recognize the value of single-arm trials and of real-world evidence when randomised controlled trials are not feasible introduces a new barrier for ATMPs and risks dramatically delaying patient access to transformative therapies,” said Paolo Morgese, Europe Alliance for Regenerative Medicine (ARM). Parliament’s ENVI Committee remains intact Despite speculation that the Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) could split into two separate committees, members of the European Parliament (MEP) have decided to keep the committee as it is. One of the advocates for the change was Peter Liese MEP (German, EPP), who said that he was happy with the decision, “because I like to work on environment and health”. In the last mandate, the committee was particularly weighed down by a heavy legislative agenda. Liese has called for fewer proposals from the Commission and taking a swipe at the previous Chair of ENVI Pascal Canfin MEP (France, Renew), called for a chair, “who puts enough priority on health and does not only look at environmental issues.” We don’t yet know who will chair the committee, but they will be from the centre-left Social & Democrats (S&D) group. The subcommittee on health is likely to continue. Socialists & Democrats propose a Health First Act In their key demands for the 2024-2029 term, the S&D group calls for the EU to strive for health and wellbeing through their detailed Health First Act. The Act “should provide a clear legal framework for an operational health programme,” the framework should cover everything from a European mental health strategy to a revision of the REACH regulation with regards to endocrine disruptors. The group also wants the systemic underfunding of health to be addressed and to “re-increase funding for the EU4Health and Horizon EU budgets”. It is hard to identify what are the S&D red lines, as the key demands seem to touch on everything from medicine shortages to the European Health Data Space. Renew Europe wants treaty revision on health Renew wants health to become a shared competency in the next – as yet un-tabled – revision of the treaties, arguing that the EU’s response to COVID-19 demonstrated the need for an EU approach. The group wants a ‘Marie Curie’ plan for vaccines, cancer research, Alzheimer’s and autism. It is also calling on the next mandate to strengthen the European cancer strategy and cardiovascular prevention programmes. On medicines they want the EU to promote generic drug production, coordinate price negotiations and invest in research to develop new treatment methods. They also see a stronger role for the European Medicines Agency (EMA) for joint procurement programmes and support a Critical Medicine Act, “to make Europe’s pharmaceutical industries competitive and make sure that essential medicines are developed and available in Europe at affordable prices.” WHO presents assessment for effective therapies for quitting tobacco WHO assessment finds that combining pharmacotherapy with behavioural interventions significantly increases quitting success rates. Countries are encouraged to provide these treatments at no or reduced cost to improve accessibility, particularly in low- and middle-income countries. WHO recommends varenicline, Nicotine Replacement Therapy (NRT), bupropion, and cytisine as effective treatments for tobacco cessation. ECDC recommends increased vigilance over avian flu While the EU is experiencing relatively low levels of avian flu virus in the wild bird population, the new ECDC (European Centre for Disease and Control) Director, Pamela Rendi-Wagner, says, “there is reason for increased awareness but not for increased concern”. The transmission of highly pathogenic avian influenza HPAI A(H5N1) viruses has recently been observed in dairy cattle in the US and four cases of human avian influenza have been reported among farm workers exposed to cattle since April 2024. WHO updates laboratory biosecurity guidance The World Health Organisation has updated guidance for national authorities and biomedical laboratories. The guidance includes strengthened cybersecurity for patient records, risk mitigation for genetic modification and AI technologies, and safety protocols during emergencies. It aims to help states establish frameworks for managing high-consequence pathogens and reducing the release of biological materials. WHO platform aims to simplify medical devise naming systems The World Health Organization has introduced an online global platform called MeDevIS (Medical Devices Information System) to consolidate international naming systems – principally the EU’s EMDN system and the GMDN system adopted by the US, UK, New Zealand, Canada and Australia. The aim it to make it easier for national policymakers and health agencies to improve procurement and track pricing. “The number of medical technologies used in health care is growing, as is their complexity, which can make it challenging for health care practitioners and patients to navigate,” said WHO Assistant Director-General for Access to Medicines and Health Products Dr Yukiko Nakatani. “We aim to provide a one-stop shop of international information.” Our World in Data to expand work on global health with support from Wellcome The Wellcome Charitable Foundation has agreed on a seven-year investment in Our World in Data. The funding will support an expansion in global health data, focusing on infectious diseases, climate and health, mental health, and genomics. This project will leverage cross-disciplinary analysis and provide freely accessible results under a Creative Commons license. Tariq Khokhar, Wellcome’s Head of Data for Science and Health wants to make expertise and data more accessible to a wider audience, from decision-makers to journalists and campaigners: “It’s critical that those in a position to act on urgent global health issues can access digestible and accurate information to make informed decisions.” Facilitating cross-border clinical trials The pan-European public-private EU-X-CT initiative which aims to facilitate cross-border access to clinical trials has published a report from its public stakeholders’ forum, held in April of this year. The report looks at the barriers that prevent access to trials and what can be done to overcome these. The report touches on the need for minimum requirements for ethics committees, the need for recommendation for hosting patients from another country, working with insurers to cover costs and raising awareness that a trial may be available. Novartis, Pfizer, Otsuka and Novo Nordisk fined in UK for breaching code of practice Novartis, Pfizer, Otsuka and Novo Nordisk have breached an Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry. Novo Nordisk was publicly reprimanded by the Code of Practice Appeal Board, for its involvement in a free weight management course which featured Saxenda. Pfizer promoted an unlicensed vaccine and made a misleading claim that did not reflect evidence, all organisations were criticised for not maintaining high standards. Workers with disabilities facing inaccessibility and lack of support in workplaces The European Disability Forum’s report on employment of persons with disabilities shows that employers are falling very short of ensuring equal access to work, only 51% of persons with disabilities are employed compared to 75% of persons without disabilities. Only one in four employers have developed accessible recruitment processes, 81% of employers have no policy in place for the acquisition of assistive technology and only 25% are aware of public support to provide reasonable accommodation to workers with disabilities. Flame retardant listed as toxic Bis (α,α-dimethylbenzyl) peroxide has been labelled as toxic for reproduction by the European Chemicals Agency (ECHA). If a substance is on this list, companies cannot use it unless they apply for authorisation and the European Commission authorises its continued use. | 