|
| Thu 24 October 2024 | View online Estimated reading time: 4-5 minutes |
| | | 🟡 Commissioners-designate reply to parliament |
| | Várhelyi puts forward his credentials - and they aren’t bad |
| Olivér Várhelyi puts forward a solid case for his ability to do the job of Health Commissioner. His most relevant experience comes from his time as a senior civil servant, including as Deputy Permanent Representative at the Permanent Representation of Hungary to the EU.
There aren’t many sitting around the Council table who can say they were there for the review of the general pharmaceutical legislation in 2003, or when the medical devices regulation was being adopted, or for the review of the Tobacco Products Directive; three dossiers that will be revisited in the coming years.
On the Pharma Package he sees his role more as shepherding it through the process now that it has undergone its first reading in parliament and is in detailed discussion in the Council.
In his answers he says that he is acutely aware of the need to boost EU competitiveness, highlighting biotechnology “and work on a new European Biotech Act” as well as “health data, including by implementing the European Health Data Space” as areas that are particularly important to promoting innovation.
He touches on many other issues, such as a Critical Medicines Act, medical devices and mental health echoing the political guidelines without adding much by way of substance.
On prevention Várhelyi is more ambiguous; on food labelling he says there should be “particular attention” to finding “pragmatic solutions”. On the revision of the Tobacco Product Directive,” he anticipates the inclusion of cigarette alternatives, “The use of emerging tobacco products should be a key focus of the revision of the directive.”
MEPs may want to nail him down on specifics and his record as Commissioner for enlargement, but it is questionable that MEPs would want to disrupt the process to wait for another Orban choice and possibly cause significant delays. Back to the top |
| | | | Belgian Commissioner ready to step up work on medical countermeasures |
| In response to questions on health security from the Environment, Public Health and Food Safety Committee (ENVI), Belgian Commissioner-designate for Preparedness and Crisis Management and Equality, Hadja Lahbib said she would work on a new strategy to support the availability of medical countermeasures against health threats, as well as a broader EU stockpiling strategy.
“The new strategy on medical countermeasures, which the President has tasked me with developing, should cover treatments, vaccines, diagnostics, medical devices, and protective equipment,” writes Lahbib.
This strategy would be based on an “end-to-end” approach, ranging from “threat assessment to supporting the research and development of new prototypes and products, including the ability to scale up production during crises and the creation of stockpiling mechanisms for these critical products.” Read more here. Back to the top |
| | | | Commissioners will reform chemical rules without compromising on health protection |
| In her political guidelines for her second mandate presented to EU lawmakers following the European elections, von der Leyen said she would simplify the REACH regulation on the use of chemical substances and provide clarity on "forever chemicals" by creating a Chemicals Industry Package.
Séjourné, the French nominee for the Commission's vice-presidency for the Prosperity and Industrial Strategy file, outlined his priorities for implementing the chemicals package, along with Sweden's Jessika Roswell - von der Leyen's choice for Environment, Water Resilience and Competitive Circular Economy. Séjourné wrote, “The REACH revision should aim to modernise the regulatory framework to increase sustainable competitiveness and security in the EU without compromising on the protection of human health and the environment.” Read more here. Back to the top |
| | | | Research Commissioner-designate answers short on detail but promises Strategy on European Life Sciences |
| Research Commissioner designate Ekaterina Zaharieva, of the Bulgarian centre-right GERB party, fell short on detail about health-related research and innovation in her written answers to MEP’s yesterday (22 October).
She said the Commission is committed to developing a Strategy for European Life Sciences, with a Biotech Act to come under its umbrella. Additionally, she plans to expand the European Innovation Council to further boost support for start-ups, as well as the Framework Programme.
Biotech Act: French nominee for Vice President for Prosperity and Industrial Strategy, Stéphane Séjourné said that the Biotech Directive which is over two-decades old needs to be brought up to date, “to ensure that intellectual property protection optimally contributes to fostering the EU biotech sector and is considered one of the elements when preparing the future EU Biotech Act.”
Life Sciences Strategy: The European Federation of Pharmaceutical Industries (Efpia) have been campaigning for a new life sciences strategy for the EU since earlier this year, including creating a dedicated Life Sciences office within the European Commission, investing in health innovation, ensuring agile clinical trials, and addressing EU skill gaps by improving STEM education. Back to the top |
| | | | Ribera determined that ‘killer acquisitions’ do not escape scrutiny |
| MEPs asked Spanish Commissioner-designate Teresa Ribera who would have responsibility for competition as Executive Vice President what she would do to protect EU innovators from so-called ‘killer acquisitions’.
The European Court’s decision to overrule the European Commission on the blocking of the merger between Illumina and Grail genetic sequencing companies, put these mergers in the spotlight.
There is growing concern that the current competition rules are unable to hinder large companies buying much smaller companies with low turnover and “killing” an emerging source of competition. This is proving to be a particular problem in the highly innovative tech and pharma sectors.
Ribera says she is, “determined to swiftly find the best way to ensure that ‘killer acquisitions’ of target companies with low or no turnover, but with high competitive and innovative potential do not escape scrutiny under EU merger rules, just because they do not meet the turnover-based notification thresholds.” Back to the top |
| | | | European Parliament backs Peter Liese's resolution on medical devices |
| On Wednesday, 23 October, MEPs adopted the joint resolution of the EPP, S&D, ECR, Renew Europe, and Greens/EFA groups regarding the revision of the regulation on medical devices and the regulation on in vitro diagnostic medical devices.
"We have witnessed numerous scandals, for example with breast implants, and it is crucial that there be unannounced inspections and better oversight of notified bodies. However, EU institutions have largely overstepped their bounds, which is why I am very pleased that the Parliament has taken a clear stance," commented Peter Liese.
While the resolution was broadly supported, political groups in the European Parliament showed divisions regarding the timeline.
An amendment by Peter Liese calling for the European Commission to conduct a systematic review of all relevant articles, accompanied by an impact assessment "as quickly as possible, by the end of the third quarter of 2025," was rejected by Social Democrats, Liberals, and Greens.
Few other modifications have been made to the proposed resolution. However, an amendment submitted by Ruggero Razza (ECR, Italy) was adopted to emphasise "the need to protect health data collected by online health applications, by explicitly incorporating these into the scope of the medical devices regulation during its revision." Read more on the proposal here. Back to the top |
| | | | 2025 Budget: MEPs confirm their commitment to defend the EU4Health programme |
| MEPs approved the Parliament’s position on the 2025 budget, affirming their commitment to defending health funding in the upcoming mandate. “The vote today is a strong signal of support for an EU budget focused on citizens and aimed at investments in economic development and improving citizens' lives. That’s why we are calling for an increase of €110 million for health-related actions,” commented one of the two co-rapporteurs on the matter, Victor Negrescu (S&D, Romania).
Negotiations with the EU Council are expected to be tense. The Parliament will enter negotiations having increased the overall proposal from the Commission by €1.24 billion. Read more here. Back to the top |
| | | | WHO postpones polio vaccination campaign in sharply deteriorating humanitarian situation |
| Since September, WHO has led two partnered vaccine campaigns in Gaza. The final campaign, which aimed to vaccinate 119,279 children throughout Northern Gaza, has officially been postponed due to the escalating violence and lack of humanitarian pauses in the area.
Intense bombardments, mass forced displacements and lack of a definite humanitarian pause has postponed the second-dose polio vaccination campaign in northern Gaza, which aimed to reach over 119,000 children under ten years old, according to the WHO and UNICEF.
“The current conditions, including ongoing attacks on civilian infrastructure, continue to jeopardize people’s safety and movement in northern Gaza, making it impossible for families to safely bring their children for vaccination, and for health workers to operate,” said the WHO and UNICEF in their joint press release.
WHO has once again called for more protection of healthcare workers, uninterrupted missions and access to supplies and a ceasefire.
Patient transfers: On 22 October, 14 patients and caregivers were transferred in a WHO-led mission to Al-Shifa Hospital in Gaza City. This transfer was due to a lack of essential resources in Kamal Adwan in Northern Gaza, in contradiction to the agreement for a humanitarian pause. The transfer took two days and faced many delays because of intense security screenings. “Some patients on stretchers were left lying on the ground for some time during the screening was conducted, while some partner staff were subjected to humiliating treatment,” WHO wrote in their news release. Back to the top |
| | | | | Pharma calls for urgent revision of Greek public hospital medicines budget |
| Greece - The pharmaceutical industry has highlighted the need for an urgent revision of Greek public hospitals' pharmaceutical budgets.
Clawbacks reached an all-time high for the first half of 2023, raising concerns about ongoing patients’ access. At first, it involved only the public pharmaceutical outpatient expenditure, but since 2016 it was extended to the state’s pharmaceutical spending in public hospitals.
The state's pharmaceutical budget has remained more or less stagnant, while expenditures have increased following the growing needs of an ageing population and advances in medicines.
“The major problem remains the underfunding of pharmaceutical expenditure, a consequence of the Memorandums of Understanding imposed during the crisis (2010-2018),” Mihalis Himonas, General Manager of SFEE, the Hellenic Association of Pharmaceutical Companies, told Euractiv.
“Even though we have exited this era, the gap in pharmaceutical funding continues to widen. Currently, we have observed that only one in five new medicines are available in Greece (IQVIA study 2024 covering the four-year period 2020 – 2023), with our country maintaining the highest pharmaceutical industry returns in the EU,” he added. Read the article in full here. Back to the top |
| | | | | | | | | | | | Working Party on Public Health Negotiation with EEA on medical countermeasures |
|
|
|
|
|
|
|
|
|
|
|
| | | | MEPs have an external week, no committee or group meetings |
|
|
|
|
|
|
|
|
|
|
|
| | Working Party on Pharmaceuticals and Medical Devices |
|
|
|
|
|
|
|
|
|
|
|
| | | | Working Party on Pharmaceuticals and Medical Devices |
|
|
|
|
|
|
|
|
|
|
|
| | Launch of OnHomeAlliance , Online Order and Home Delivery of Medicines Alliance
|
|
|
|
|
|
|
|
|
|
|
|
| | | | | | | | Today’s brief was brought to you by Euractiv’s Health team |
| | | | | Today’s briefing was prepared by the Health team: Catherine Feore, Clara Bauer-Babef, Emma Pirnay, Thomas Mangin, and Lydia Williams. With additional reporting from Vasiliki Angouridi. Share your feedback or information with us at digital@euractiv.com. |
| | | | Transfer to third parties is not authorised. If you found this newsletter valuable, please recommend a free trial. |
| | | | | | | | |
|
|
|
| |
|
