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Fri 18 October 2024 | View online Estimated reading time: 4-5 minutes |
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Medicines for Europe raises the alarm over Urban Waste Water Treatment Directive |
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Medicines for Europe, which represents the generic and biosimilar pharmaceutical sector, is raising the alarm ahead of next week's Coreper I discussions on the Urban Waste Water Treatment Directive (UWWTD).
“The European Union is working hard to improve patient access to affordable medicines and reduce shortages with a strengthened supply of generic medicines. However, by endorsing the proposed UWWTD Extended Producer Responsibility (EPR) system, the EU risks undoing these efforts,” says Adrian van den Hoven, Medicines for Europe Director General.
The Commission claims that 92% of micro pollutants found in urban waste come from pharmaceuticals and cosmetics. The needed quaternary water treatment to eliminate these pollutants is costly and the EPR is seen as a way to cover the expense.
However, the generics business has very tight margins according to Medicines for Europe and additional costs present an existential threat to their production in Europe. For some basic medicines, such as paracetamol and meformin for type 2 diabetes this could amount to up to 45% and 48% increase in cost.
The association is not alone. Similar concerns have been raised by member states, including Bulgaria, Czechia, Estonia, Germany, Hungary, Lithuania, Malta, the Netherlands, Poland and Portugal.
While supporting the objective of removing these pollutants, Germany has said that all producer groups should be included, “The isolated consideration of only two sectors, in particular with regard to the production of patent-free medicinal products, which are already under severe cost pressure, is not acceptable and will further exacerbate the critical supply of medicinal products in the EU and the vulnerability of supply chains.”
Germany has said that it will accelerate the production of patent-free products to countries outside the EU.
Estonia, has criticised the Commission’s feasibility study, saying that the clear added value of EPR in case of pharmaceuticals has not been confirmed. While Malta calls for the Directive to be aligned with the aims of the proposed revision of the Pharmaceutical Legislation, which tries to address the issue of accessibility and affordability of medicines.
The incoming Commission is committed to addressing Europe’s access to medicines through the Critical Medicines Act, which might mean that states may want to reassess how they address the problem. Back to the top |
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🟡 Resilient healthcare systems |
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MEPs will start looking into the sustainability of health systems within the EU by the end of the year |
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MEPs will begin work by December on a report proposed by Lithuanian MEP Vytenis Andriukaitis (S&D) on the sustainability and resilience of healthcare systems within the EU.
According to our information, the initiative report will specifically address the issue of access to healthcare in the EU, with a focus on medical deserts and the most vulnerable populations.
The text will also raise questions about the capacity of healthcare systems to meet citizens' needs, the challenge of an ageing, and chronic diseases. A section of the report will be dedicated to crises and the responses the EU can provide in a “post-pandemic context”.
While the EU's competences in health matters are limited, and a comprehensive overhaul is nearly impossible due to the significant disparities among the 27 member states, the report is expected to advocate for common indicators and the implementation of stress tests across the EU to assess the resilience of healthcare systems. Back to the top |
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Brain health intergroup needed, says European Brain Council |
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On Thursday (17 October), Professor Claudio Bassetti, Vice-President of the European Brain Council (EBC) proposed an EP intergroup dedicated to brain health to members of the Parliaments public health (SANT) committee, highlighting the need for an overarching EU strategy to tackle the burden of brain conditions and neurological diseases.
“Up to 43% of the entire population suffers today from a brain disorder. Not all of them are deadly diseases, such as dementia and stroke, but also headaches and anxiety. It is the number one cause of disability in the European population,” said Bassetti. Professor Bassetti sees mental health as one of the issues to address along with other risk factors for neurological diseases with a need for early detection and prevention. The call for an intergroup is supported by over 100 organisations. Former Commissioner for Health and Food Safety Vytenis Andriukaitis (S&D) said that the lack of specialists, including those for brain health, was a ‘ticking bomb’ in the EU. Other topics covered were the discrepancies between member states in detecting rare neurological diseases (Stine Bosse, Renew Europe), heavy metals and impacts on brain health (Tilly Metz, Greens) and the link between post-COVID syndrome and neurological inflammation. Back to the top |
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EU4Health and the health component of the Horizon Europe program merged into the EU Competitiveness Fund in the next MFF? |
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The draft of the next Multiannual Financial Framework (MFF) for the EU, covering the 2028-2034 period and still in its very preliminary stages, could see the EU4Health programme and the health component of the Horizon Europe program merged into the single global Competitiveness Fund for the EU.
According to our sources, this idea is supported by part of the EPP group, while the idea of a competitiveness fund itself was promised in July by European Commission President Ursula von der Leyen.
In contrast to the EPP, the S&D group is currently more sceptical. “We must not, under any circumstances, accept a dismantling of research policy! It is absolutely crucial that member states and the European Commission ensure the continuity of public health funding in the EU budget,” said French Socialist MEP Christophe Clergeau, who is also the group’s vice-president in charge of health. Back to the top |
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G7 and EU members sign on new charter for disability rights |
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G7 members and the EU agreed to make disability rights "a priority on the political agenda" in a joint declaration on Wednesday (16 October).
“The realisation of human rights of persons with disabilities is our top priority,” said G7 members in the document, dubbed the Solfagnano Charter.
The full list of priorities includes universal accessibility, prevention of emergencies (including humanitarian and climate emergencies), independent living and work inclusion, full participation in civil, social, and political life, developing artificial intelligence for disabled people and sport and services for all.
Ambitious words must be followed up with political will, according to The European Disability Forum, who helped consult the G7 on the document.
“The Solfagnano Charter is a promising declaration, but its true impact will depend on it being followed by real improvements. We call on G7 leaders to back their words with actions and funding, both within their borders and on the international stage,” said Yannis Vardakastanis, president of The European Disability Forum. Read more here. Back to the top |
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European Medicines Agency hosts Clinical Trials Information System clinic |
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The European Medicines Agency (EMA) held an information day for Clinical Trials Information System (CTIS) on 17 October. The event was to aid sponsors in submitting their clinical trials applications via the new CTIS before the 31 January 2025 deadline. A revised transparency rule was added in June 2024 when the new public portal was launched. The updated rule removed the deferral mechanism, preventing sponsors from delaying the publication of specific data for up to seven years after the trail. Read more about the revised rule here. Back to the top |
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EFPIA wants to push the EU to accelerate its work on precision oncology |
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The European Federation of Pharmaceutical Industries and Associations (EFPIA) will host a roundtable discussion on 13 November to explore ways to advance and enhance the adoption of precision oncology at the local level.
Precision oncology takes a personalised approach to treating cancer that is targeted at molecular or genomic alterations in tumours, regardless of their location. Its potential was recognised in the Draghi report as a field where Europe should be taking a leading role.
“We aim to provide equal access to diagnostics and treatments for cancer patients today while laying the foundation for a resilient healthcare system that prevents, diagnoses, and treats cancer earlier, more effectively, and sustainably,” EFPIA stated in a press release. Back to the top |
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Mpox still sees a very low incidence rate in Europe |
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Updated mpox data from the European Surveillance System (TESSy) compiled by the World Health Organization (WHO) and the European Center for Disease Prevention and Control (ECDC) have released their updated mpox data report.
The report included the total number of mpox cases reported up to 10 October 2024, with 221 new reported cases spread out among 15 countries in the past four weeks. Since the single reported case of Clade 1b in Sweden back in August, all other reported cases were linked to the Clade II variant. Read more here. Back to the top |
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Spanish minister of health presents strategy against healthcare fraud and corruption in Luxembourg |
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Spain - The Spanish Minister of Health, Mónica García, presented Spain's National Strategy against Fraud and Corruption in the Healthcare Sector in Luxembourg (17 October) during her speech at the meeting of the European Network on Fraud and Corruption in the Healthcare Sector (EHFCN).
"Corruption in healthcare not only erodes trust, but also affects lives and compromises the health and well-being of entire populations," she said.
García highlighted the importance of international collaboration, emphasising that the European legislative framework and cooperation with national and international organisations are essential for an effective strategy.
“This is the way in which we can lead a health service with a renewed mission of integrity, which improves the health of citizens and their trust in our institutions,” she said. Read more here. Back to the top |
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Bundestag approves hospital reform |
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Germany - The Bundestag has passed the Hospital Care Improvement Act (KHVVG). The reform aims to improve the quality of treatment in hospitals and strengthen comprehensive medical care for patients, including in rural areas.
“With this structural reform, we are improving health care for a rapidly ageing society and are also enabling the federal states to plan their hospitals more accurately,” said Federal Health Minister Prof. Karl Lauterbach.
The reform is scheduled to come into force on 1 January 2025. The government aims to complete the reforms in full by 2029. Read more here. Back to the top |
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| Heads of government meet in Brussels |
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| EMA's human medicines committee outcome published |
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| Strasbourg plenary week, agenda to be finalised |
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| Working Party on Pharmaceuticals and Medical Devices Hungary compromise proposal on incentives |
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| Strasbourg plenary week: Vote on budget for 2025 |
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| Urban wastewater treatment (recast) on the agenda |
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Today’s brief was brought to you by Euractiv’s Health team |
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Today’s briefing was prepared by the Health team: Catherine Feore, Clara Bauer-Babef, Emma Pirnay, Thomas Mangin, and Lydia Williams. Share your feedback or information with us at [email protected]. |
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