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Thu 17 October 2024 | View online Estimated reading time: 4-5 minutes |
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Pharma Package: Czechia proposal could incentivise EU research and production |
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Czechia has put forward a proposal that could provide valuable incentives to pharma companies while promoting research and production in Europe.
EU member state representatives will meet on Monday (21 October) in the Working Group on Pharmaceutical Products and Medical Devices to discuss how they can overcome the impasse on incentives in the pharma package.
Hungary will put forward a proposal, but part of a potential solution has been presented by the Czech government.
"Our proposal was sent to our colleagues in the Hungarian Presidency of the EU Council in September. The section on production may be the most controversial, but no one has rejected it," said Deputy Minister of Health Jakub Dvořáček in response to a question from Euractiv.
Supporting EU R&D: Prague aims to modify the proposed system of additional regulatory data protection periods to incentivise research and production in the EU. The requirement would be for “a substantial part of research”, say 30% of patients involved in phase II and phase III clinical trials to be from the EU. This would be rewarded with an additional six months of data protection.
Production in the EU: The second part of the Czech proposal is to reward manufacturing within the EU intended for the benefit of European patients with an additional year of regulatory data protection. They attach two conditions to this proposal. Eligible manufacturing capacities should have the capacity to cover the needs of the entire EU market and should be able to start production no later than three years after the market authorisation.
Dvořáček argues that linking incentives for manufacturing products within the EU would be a way to recuperate costs. In the Czech Republic alone, which has a population of around ten million, each additional year of protection for a medicine is estimated to cost almost €126 million from the public health insurance budget. Read more here. Back to the top |
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Parliament’s budget committee backs call to boost 2025 health funding |
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MEPs from the European Parliament's Budget Committee (BUDG) voted on Monday (14 October) in favour of a resolution that included strengthening multiple EU health funding programmes for 2025.
The resolution, which outlines the Parliament's view on how the EU budget should be spent next year, proposed to increase the budget of the EU4Health programme by €50 million above the Commission's initial proposal, in order to "strengthen resilience and preparedness for future health crises and support investments in the prevention of cardiovascular diseases (CVD), cancer, rare diseases, and diseases affecting children." The initial proposal allocated just over €580 million for 2025.
In the section of the document dedicated to the Health Union, MEPs specify that they would support "actions aimed at achieving universal health coverage in the Union, including access to quality sexual and reproductive health services, particularly given the rollback of women’s rights in several Member States." The vote takes place next week. Read more here.
The issue of the 2025 budget has been a concern for MEPs responsible for health issues for some time. In early September, the new chairman of the Environment Committee, Italy's Antonio Decaro (S&D), sent a letter to his counterpart in the Budget Committee, in which he lamented the cuts made by the European Council to health and environmental programmes. Read more here. Back to index |
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MEP Stine Bosse held discussions with DG SANTE on action plan on rare diseases |
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Last February, 48 MEPs sent a letter to Ursula von der Leyen, calling on her to propose an EU strategy on rare diseases, but since the EU elections nothing has happened according to Danish MEP Stine Bosse (Renew).
The Vice Chair of the SANT Subcommittee decided to meet with Director for Public Health, Cancer, and Health Security, DG SANTE Antonio Parenti on Wednesday. “We had a very good talk,” Bosse told Euractiv.
“We agreed that building up expertise across member states is extremely important,” Bosse insisted on the importance of European Reference Networks (ERN), cross-border networks that bring together data on low-prevalence diseases from hospitals across Europe. “Patients can be treated with the same drugs but have a 20% difference in survivability outcomes across member countries, which is why it’s important to enable experts to work closer together and apply best practices,” she said.
Bosse and Parenti also discussed how to solve the ‘volume problem’ with rare diseases could be addressed by enabling larger and more multi-country trials. There is “still a lot of work to be done, but we believe this can form the basis for a good collaboration over the next five years.” Back to the top |
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EU urges member states to deliver emergency medical aid to Lebanon |
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Outgoing Health Commissioner Stella Kyriakides and Commissioner for Crisis Management Janez Lenarčič have urged member states to participate in distributing vital medical equipment and medications in Lebanon following the Israeli Defense Forces (IDF) attacks on their healthcare systems.
Since the 17 of September 2024, the World Health Organisation has verified 23 attacks on healthcare in Lebanon, leading to 72 deaths and 43 injuries among health workers and patients. Fifteen health facilities were affected, while 13 impacted medical vehicles.
“The healthcare system [in Lebanon] is unable to cope with the growing number of casualties," the commissioners said in their letter.
“It is crucial that we act swiftly and in a coordinated manner. We extend our sincere gratitude to those member states that have already generously offered assistance to Lebanon in this very difficult moment.” Read more here. Back to the top |
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WHO says majority of humanitarian missions in northern Gaza blocked by Israel |
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Only one in 54 UN missions providing medical aid to northern Gaza was successfully facilitated in October, said the World Health Organisation (WHO) on Wednesday (16 October).
According to WHO Director-General Tedros Adhanom Ghebreyesus, Israel blocked emergency medical supplies from reaching Palestinians in northern Gaza, amid its continuous attacks on healthcare such as the bombing of Médecins sans Frontières (MSF) supported al-Aqsa al-Aqsa hospital on Monday (14 October).
All but one of the missions "were denied, cancelled or impeded. We ask Israel to give WHO and our partners access to the north so we can reach those who desperately need aid,” he said.
The UN released a report last Thursday (10 October), which accused Israel of seeking to destroy Gaza’s healthcare system.
The report found that the Israeli Defence Forces (IDF) were deliberately targeting medical workers, ambulances and restricting medical vehicle permits to leave the territory. Between 7 October 2023 and 30 July 2024, Israel carried out 498 attacks on healthcare facilities in Gaza, according to the inquiry. Read more here. Back to the top |
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First clinical trial for Marburg virus treatment started in Rwanda |
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Rwanda started the world's first clinical trial for Marburg virus disease treatments, in partnership with the World Health Organisation yesterday (16 October).
The trial will test the safety and efficiency of remdesivir, a broad-spectrum antiviral drug developed by the biopharmaceutical company Gilead Sciences already used to treat COVID-19, and MBP091, an antibody designed to fight Marburg virus.
This trial is the result of two years’ work by nearly 200 researchers, developers, ministry of health officials and partners globally and from 17 African countries at risk of outbreaks of filoviruses such as Ebola and Marburg. Back to the top |
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Belgian university hospitals invest €14 million in new cell and gene therapy facility |
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Belgium - Belgian university hospitals UZ Leuven and KU Leuven are investing €14 million in a new facility for the production of Advanced Therapy Medicinal Products (ATMPs). It's expected to be operational by the end of 2025.
The new centre will place the Belgian institutions at the forefront of cell and gene therapy development, offering personalised treatments for complex conditions.
The ATMP facility will focus on conditions where standard treatments often fall short, such as haematological malignancies, brain cancers, and rare genetic diseases.
“These are logical targets for cell and gene therapy development. We will also be looking at technologies with future potential, such as treatments for dermatological malignancies and neurological disorders,” said Bart Geers, investment manager at KU Leuven Research & Development. Read more here. Back to the top |
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Slovak backlash against Kotlár pandemic investigation riddled with disinformation |
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Slovakia - Slovak MP Peter Kotlár (SNS) has submitted a pandemic review report, which is riddled with controversial claims which have sparked a backlash from doctors, scientists, the opposition, and some government members.
Kotlár has underplayed the role of COVID-19 testing and mask mandates, he has recommended that the government reject the WHO's pandemic treaty and distance itself from the new International Health Regulations amendments, he believes the virus is a lab-made bioweapon. At the time of writing, MP Kotlár did not respond to Euractiv's questions.
The medical and scientific community have rejected his view, among others, by the Society of General Practitioners, Association of Outpatient Providers, Slovak Medical Association, Faculties of Medicine and Pharmacy of Comenius University in Bratislava, Slovak Medical Chamber, Institute of Virology of the Biomedical Centre of the Slovak Academy of Sciences, and University Hospital Bratislava. However, he enjoys Prime Minister Fico’s support. Read more here. Back to the top |
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| Heads of government meet in Brussels |
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| Subcommittee on Public Health (SANT), European Parliament, Brussels Presentation of the Commission proposal for a Council Recommendation on smoke and aerosol-free environments by Antonio Parenti, Director for Public health, Cancer and Health security, DG SANTE; Exchange of views with Professor Claudio Bassetti from the European Brain Council on neurological health; Presentation of the study of the Policy Department for Economic, Scientific and Quality of Life Policies' on ‘Current challenges and opportunities for addressing obesity’ |
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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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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. Additional reporting from Filip Áč and Nicole Verbeeck. Share your feedback or information with us at [email protected]. |
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