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Mon 21 October 2024 | View online Estimated reading time: 4-5 minutes |
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Hello , It’s October, so MEPs will enjoy a second week in Strasbourg! We will be keeping an eye on votes for the resolution on medical devices and the parliament’s position on the EU’s budget for 2025. We’ll also be wondering if the Council’s Working Party on Pharmaceuticals and Medical Devices can overcome the impasse on incentives in the Pharma Package? And will be looking out to see if Coreper I, meeting on Wednesday, merely rubber stamps the urban waste water directive or takes on the concerns of industry. Today’s news
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EPP resolution piles pressure on the European Commission for the revision of the regulation on medical devices |
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The EPP wants to push the European Commission to immediately review the regulation on medical devices (MDR). A resolution led by German MEP Peter Liese (EPP), will be put to a vote in the European Parliament on Wednesday, 23 October.
“The Commission is not acting fast enough,” Liese said, expressing his desire to see the European executive address the issue “within the first 100 days” of the new term of the College of Commissioners.
"We want to adapt the rules according to the levels of risk, without obviously compromising on patient safety. On the contrary, we want medical devices that are fully compliant with the regulations to be brought to market as quickly as possible," Tomislav Sokol MEP, the EPP Group's spokesperson on health issues.
Predictable timelines, limiting the need for recertification and removing what they consider to be unnecessary bureaucratic barriers are among the measures proposed by the EPP.
Liese says there is support from Renew and the ECR groups. He believes that some members of the S&D group will also join them, as well as certain members of the Greens/EFA. Read more here. Back to the top |
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🟡 Urban wastewater treatment |
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EFPIA shares concern over urban wastewater directive |
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As reported in Friday’s Pro Brief, Medicines for Europe, which represents the generic and biosimilar sectors is sounding the alarm over the Urban Wastewater Treatment Directive.
On Friday, EFPIA (European Federation of Pharmaceutical Industries) added its voice to a call for a review of the directive.
“The industry is 100% behind the ambition to tackle water pollution,” said Nathalie Moll, Director General, EFPIA. “However, putting the entire responsibility of European water pollution on the shoulders of two sectors [pharmaceutical and cosmetics] is neither logical nor fair.”
EFPIA says that the selection of the pharma and cosmetics sectors is arbitrary and ignores the impact of other sectors. There is concern that the Commission has miscalculated the cost of treatment, which could be several times higher according to the German Environment Agency and EurEau (European Federation of National Associations of Water Services). The Commission has not shared its methodology.
Additional costs, especially for off-patent medicines could disrupt supply, they warn. Back to the top |
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🟡 Health technology assessment |
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Rules on cooperation with EMA on health technology assessments adopted |
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On Friday (18 October), the European Commission adopted an implementing regulation that sets out the rules for cooperation with the European Medicines Agency (EMA) under the Health Technology Assessment Regulation (HTAR) .
The regulation concerns the sharing of information for planning and forecasting of joint clinical assessments and scientific consultations; the identification of patient and experts for joint procedures; and, general scientific and technical matters relating to HTA.
The rules also concern the sharing and protection of confidential information between EMA, the HTA secretariat within the Commission and with the Member State Coordination Group on HTA and its subgroups.
This is the second of six implementing acts foreseen in the HTAR which must be adopted before it comes into force on 12 January 2025. Back to the top |
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🟡New medicines approved by EMA |
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Ten new medicines receive market authorisation |
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The European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP) has granted market authorisation to ten new medicines, extended the therapeutic indications for six others and agreed to withdraw two already on the market.
Positive decisions were granted to: Alhemo (concizumab): A treatment for haemophilia for those who have developed inhibitors immune response to the clotting factors normally used as a treatment.
“The positive opinion from the CHMP is a major milestone for patients,” said Stephanie Seremetis, chief medical officer for haemophilia at Novo Nordisk (Denmark). “It is delivered in a pre-filled, multi-use, portable pen that can be stored at room temperature for up to four weeks. This could enable patients to have greater confidence in the pursuit of daily activities.”
Two flu vaccines, Fluad and Flucelvax, developed by Sequirus (Netherlands) were approved. Korjuny (catumaxomab), developed by Lindis Biotech, received a positive opinion from the CHMP for the treatment of malignant ascites, which cause a build-up of fluid containing cancer cells in the abdomen of cancer patients. Siiltibcy developed by Serum Life Science Europe GmbH for the diagnosis of infection with Mycobacterium tuberculosis, which is easier to use than one of its alternatives. To read about others, read more here. The Commission gives final approval within two months. Back to the top |
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EMA’s human medicines committee elects new vice-chair |
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EMA’s Committee for Human Medicinal Products (CHMP) has elected Outi Mäki-Ikola as its new vice-chair for a three-year mandate, starting on 15 October 2024.
A medical doctor by training, with a PhD in immunology, Dr Mäki-Ikola has worked in medicine development for Orion and Amgen pharma companies. She has also worked at EMA as a Scientific Administrator from 2004 to 2009. Since 2012, she has been a Senior Medical Officer at the Finnish Medicines Agency (Fimea) and the Finnish representative on the committee. Back to the top |
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Ozempic and other weight-loss treatments could target drug and alcohol addiction, new study says |
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A new large-scale study published in the scientific journal Addiction on Thursday (17 October), has found that that the weight loss treatments could also help tackle addiction.
An examination of 1.3 million medical records of people with opioid and alcohol use disorders who were taking GLP-1 agonist drugs had a 40% lowered risk of overdose and 50% lower rate of alcohol intoxication.
Some of the GIP/GLP-1 drugs included in the study were Novo Nordisk's Ozempic and Wegovy and Eli Lilly's Mounjaro.
While opioid use in the EU is lower than in the US, more than 1 in every 11 adults experiences alcohol use disorders in Europe, according to the World Health Organisation (WHO). These are promising initial findings, but will require more clinical trials and research.
The European Medicines Agency (EMA) has previously asked licence holders of GLP-1 receptor agonists for evidence into associations with suicidal ideation. Danish Novo Nordisk said in May that it would be looking into the link between semaglutide — the active ingredient in Wegovy — and alcohol use, but without a specific focus on addiction. Back to the top |
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Sanofi saga continues with France taking a stake in its healthcare offshoot Opella |
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France - In a tweet sent yesterday evening, French Minister of Economy and Finance, Antoine Armand wrote, “We have obtained guarantees for the maintenance and development of Opella in France.
“Our requirements on employment, production and investment will be respected. For Doliprane and other essential medicines in the country.”
Armand wrote that the state would ensure this by becoming a stakeholder via the national investment bank (BPI - Banque Publique d’Investissement).
As reported last Monday, the sale of 50% of Sanofi’s consumer healthcare business Opella to a US-based private equity firm CD&R had caused alarm among French politicians.
In an interview with La Tribune the CEO of the BPI, Nicolas Dufourq said, “We have been examining the file since July. We agree to go with the winner of the auction, with - as in all our investments - a presence on the board.”
BPI are already shareholders of Seqens, which manufactures the active ingredient in Doliprane.
Dufourq says that the BPI is already very active in the areas of biotechnology and medicines, saying that in the coming years it plans to allocate more than €10 billion euros to health.
French MEPs react: French MEP Laurent Castillo believes that the laboratory has a responsibility in terms of production, sovereignty and jobs. "It's a case of give and take," Castillo pointed out.
For his part, Christophe Grudler, a Renaissance MEP (Renew), who sits on the Industry, Research and Energy Committee (ITRE), prefers to put things into perspective, "I understand the concerns, but if Sanofi needs money to invest in research, they are doing the right thing by making this sale," he told Euractiv.
"Paracetamol is an ageing drug. This sale could be a blessing in disguise. If we reinvest in new production, to stay one step ahead of global competition, it's worth it," said Grudler. Back to the top |
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Czechia includes pharma sector in ambitious new economic strategy |
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Czechia - The Czech government has designated the pharmaceutical sector as a strategic industry, aiming to reduce dependence on non-EU imports and to avoid medicine shortages.
“Supporting the production of critically important medicines is a key agenda not just for Czechia but for the entire EU,” said Czech Deputy Health Minister and co-chair of the EU’s Critical Medicines Alliance, Jakub Dvořáček. “We have a unique opportunity to influence the EU’s approach to industry and to ensure that medicine supplies for patients are secure.”
“After years of effort and significant support from the health ministry, important tools could now be created to support the development of the pharmaceutical industry. This, in turn, will strengthen the national health system and the Czech economy,” said Filip Vrubel, executive director of the Czech Association of Pharmaceutical Companies (ČAFF).
The inclusion of pharmaceuticals as a strategic sector reflects its growing economic importance. While Czechia's pharmaceutical sector may be smaller in size compared to its automotive industry, its value is disproportionately higher, generating twice the added value per employee compared to other manufacturing industries, according to ČAFF. Read more here. Back to the top |
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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, Resolution on MDR |
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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. Additional reporting from Aneta Zachová. Share your feedback or information with us at digital@euractiv.com. |
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